CN108352190A - System and method for preventing error location from performing the operation - Google Patents

Abstract

The present invention provides a kind of systems and correlation technique preventing error location operation and the blade associated injury of operating room personnel, the system comprises computer software (on the computer or hand-held device in medical environment use), which carries part (such as safety blade distributor or other surgery sharp weapon distributors) combination with surgery supply.It includes at least one component such as label that the surgery supply, which carries part, at least one component prevents or prevents surgeon close to the one or more surgical instruments being stored in it, confirm various details, including but not limited to correct patient, correct regulation, correct equipment etc. until surgeon or after authorizing operating room personnel to execute " time-out " until starting expected surgical protocols.Data can be captured in entire medical environment (from " decision to cutting " and wider) with estimation error position surgical data (including " near miss " data), and can largely be analyzed error location surgical prophylaxis.

Description

System and method for preventing error location from performing the operation

Technical field

Present invention relates generally to operation safeties, and more particularly relate to prevent or make error location operation and hand The system and method that the relevant damage of blade of art room (OR) personnel minimizes.

Background technology

Recently, in the U.S., evitable patient injures or the unacceptable rate of so-called Mala praxis receives greatly Concern.The estimation of the annual Mala praxis quantity in the U.S. be difficult to determine, but delivered recently by Lucian doctors Leape one Publication《Men are not saints, how can they be free from faults》Show that the death rate of evitable Mala praxis is suffered between 48,000 to 96,000 Person/annual.Wherein most evitable Mala praxis is so-called " error location " operation.According to the certification of International Medical health organ The definition of joint committee (JCAHO), error location operation include the body side of mistake or the regulation and mistake at position, mistake Patient with operation.

The prevalence rate of error location operation

From January nineteen ninety-five in March, 2001, JCAHO has examined the voluntary report of 1,152 " sentinel event ".Mistake portion Position operation is 114 (9.9%), covers the operation of neurosurgery, urological department, orthopaedics and vascular surgery.Although the alert news of JCAHO Event policy attracts attention, but the low report behavior of medical institutions may influence these statistical data.In 1,152 event, Only 66% has shutting mechanism " self-report "；Its complementary event then comes from patient's complaint or media report.From April 1 in 1998 Day on March 31st, 2000, New York hygiene department have received 46 parts of error locations operation reports by mandatory reporting system, And JCAHO is in China up to having received 114 parts of reports in 3 times of time.This shows that voluntary event report may incite somebody to action The True incidences of error location operation seriously underestimate 20 times or more.

Doctor insurance association of the U.S. (PIAA) has examined 22 doctors of 110,000 doctor of representative to nineteen ninety-five in 1985 The Claim Data for the treatment of accident carrier.There are 331 error location operations.Nearly 1,000 of complete PIAA data-base recordings relate to And the closed malpractice claim of error location operation.However, this number may also underestimate the Sheng of error location operation Row rate.Since the operation of most of error locations is related to relatively small operation (arthrocsopic surgery, rather than limbs amputation or master The neurosurgery wanted), therefore sequelae is seldom, may not cause to claim damages.Therefore, the mistake obtained from lawsuit data The estimation of position operation incidence may underestimate the true prevalence rate of this problem, estimate as made by being reported according to event Like that.

The factor for causing error location to be performed the operation

The increased several factors of error location operation risk may be led to by having discovered that.These risk factors include：(a) Participate in more than one of the surgeon of operation, it may be possible to since it is contemplated that more operations, or because will be to the treatment of patient Another one surgeon is handed to；(b) Repeated Operation has been carried out to same patient during single goes to operating room, especially When operation is when the not ipsilateral of patient carries out；(c) uncommon time pressure related with the uncommon time started or add Speed completes the pressure of preoperative regulation；And (d) uncommon patient characteristic, it such as physical abnormality or is too obese, these may The conventional process of equipment setting or patient's positioning can be changed.

The basic reason that hospital finds usually with link up, patient's preoperative evaluation and regulation for verifying operative site have It closes.Communication problem is divided into two major classes：(1) during identifying correct operative site or in informed consent process or The physical behavio(u)r of predetermined operative site is marked to fail that patient's (or being family members in due course) is made to participate in the process.And (2) operation Linked up between Team Member it is not perfect or inaccurate, typically at the scene in verification process certain members of team (for example, surgery Technical staff) it has neither part nor lot in, or surgeon is relied solely on to determine correct operative site.

The integrality of patient's preoperative evaluation is a common factor, often because failing to examine case history immediately in the preoperative Or imageological examination.In many cases, the regulation for verifying correct operative site is defective, because：Do not advise formally Journey；Operating room does not carry out final inspection；There is no any world-of-mouth communication in verification regulation；There is no all relevant information in operating room Source；Inventory is not checked to ensure all relevant information sources by checking；Some members of operating team, which are excluded, to be tested Except card process, and think that they are not allowed to point out possible mistake；And it fully relies on surgeon and verifies Surgery Position.

JCAHO reduces the strategy of error location operation

Joint committee provides following possible strategy to reduce the risk of error location operation：Clearly mark Surgery Position simultaneously allows patient to participate in labeling process, to improve the reliability of the process；Every member of operating team needs in operating room The oral correct position of verification；A verification inventory is formulated, including the All Files for being related to expected surgical protocols and position, packet Include the operative site marked with case history, X-ray and other imageological examinations and directly observation patient；Surgeon ginseng With acquisition informed consent；Ensure that high risk operation follows verification regulation by continuous surveillance；And immediately begin to hand after " time-out " Art.(source：Certification joint committee of International Medical health organ, alert instruction event warning, the 6th phase, on August 28th, 1998)

Although implementing the strategy of the operation at the position, mistake side of the patient, mistake that prevent mistake, regrettably, This seems that most preventible complication is still occurring.In order to improve the safety of patient, joint committee was on July 1st, 2004 Enforceable general " time-out " agreement has been formulated in the tissue that all joint committees are approved.One as the puppy parc Point, it needs " to suspend " or " time-out ".This is for finally verifying：(1) correct patient；(2) correct regulation, position and side； And the availability of implantation material or instrument before where applicable, (3) notch.At this moment, all members of surgical team should suspend Get off and check case, and agrees to correctly perform the operation to correct patient, correct position and correct side.It is theoretical On, this may insure to detect any mistake having occurred and that before notch.

In fact, " time-out " seldom occurs；When this happens, it is not in a manner of any unification or rule.If do not united The compliance (doing as a mere formality) of one or rule regulation, ritualization can be related to many mechanisms.Puppy parc can not be enforced Pause does not provide about what agreement occurs in interval yet.Puppy parc does not provide the specific time that pause occurs, What do not provide about the agreement that (that is, whom whom what information should be passed to by) should occur in interval.As this master The evidence for the method that fails, a research (" Introduction of Surgical Safety Checklists in Ontario, Canada ", New England Journal of Medicine 2014,370:It 1029-1038) finds, 100 In all types of surgical procedures more than 200,000 that multiple hospitals carry out, although taking enforceable overtime measure, There is no the incidences for changing or improving error location operation.

The blade associated injury of operating room personnel

It is to the needle thorn of operating room personnel and other damages related with sharp weapon, packet that another, which continues existing safety problem, Include damage related with scalpel or blade.Estimate according to Center for Disease Control, there are about 385,000 needles thorn and other and profits every year The related damage of device (average daily more than 1000), wherein blade associated injury accounts for about 10%.Scalpel blade must be very It is sharp, therefore, it is easier to pierce surgeon or the meat of other operating room personnels than needle stick injuries.Therefore blade associated injury pair May be great for operating room personnel, including infection is derived from the disease of blood-borne pathogens, such as HIV/AIDS, the third type liver Scorching, hepatitis B etc., and restore and rehabilitation during revenue losses and since permanent actual bodily harm is (for example, surgery The hand injury of doctor) career forfeits caused by possibility.

Present invention seek to address that preventing or reducing error location operation and preventing or reducing the blade phase of operating room personnel Close the unmet demand of damage.

Invention content

The present invention by provide for prevent error location perform the operation the system and method including safety blade distributor come Solve above-mentioned unsatisfied demand.The present invention includes preventing the blade associated injury of error location operation and operating room personnel from being System and correlation technique.The system includes computer software, which is configured as that operation correlation is combined to set Standby, preferably surgery supply carries part (for example, safety blade distributor or other surgery sharp weapon distributors), and providing a user prevents The method of error location operation.It includes at least one component that surgery supply, which carries part, and such as label, paper or band, this is at least one Component prevents or prevents surgeon close to the one or more surgical instruments being stored in it, until surgeon or authorizes hand Art room personnel confirm various details after executing " time-out " before starting expected surgical protocols, including but not limited to correctly suffer from Person, correct regulation, correct equipment etc..Computer software can be calculated in any one of various computing devices Run on device, the computer that is such as used in medical environment (for example, fixed desktop computer and/or laptop computer) and/ Or hand-held computing device (for example, smart phone, such as IPHONE and/or board device, such as IPAD or SURFACE PRO). Should " medical environment " include patient and medical team (including doctor, clerk, nurse, medical technician, surgery doctor Raw, administrative staff) from surgeon office (carrying out initially seeking advice from and determining operation) to operating room (place performed the operation) Continuous process in interaction from anywhere in.The term can also include being related to the personnel of data collection and/or analysis after operation, Such as (but not limited to) (a) patient, hospital and/or surgical insurance company (b) repay to hospital and/or surgeon The state of fund and/or federal agency department/plan (for example, medical insurance/Medicaid) (c) are directed to the particular procedure Any other mechanism (private and/or government) that case is paid the bill to patient, hospital and/or surgeon, and/or (d) quality control System and/or hospital management, to determine improvement areas and/or best practices.

Prevent the system and correlation technique of error location operation and blade associated injury from being propped up using computer software Multiple functions are held and provide, including but not limited to：Voice record, record playback, the electronic patient knowledge that can be scanned It is other component (such as patient ID bands), the safety blade distributor that can be scanned, and by using system from " determining to cutting Cut ", i.e., it determines to by (in situations in the surgery room) actual operation to perform the operation from (carrying out in surgical office), obtain Data generate or any one of the various analyses based on the data.Patient ID band and/or safety blade distributor are swept Retouching can be completed by the scanning function of computer, hand-held device and/or the scanning system separated with system, the scanning system With cooperative system and and system communication.The system can use any one of various suitable biological identification technologies (for example, Iris scan, fingerprint, science of heredity etc.), to identify in medical environment patient (and/or patient at any time Guardian, in the case where patient is the patient of minor or incompetence).

Safety blade distributor includes the first notch that various scalpel blades execute operation for surgeon's selection. Safety blade distributor (and/or label described below) is with coloud coding, with the inclined side property of instruction operation (for example, rose Rare color or red instruction " right side " side operation, lavender instruction " left side " side operation and muted color (such as grey) instruction are without side position Operation).Safety blade distributor includes having the label for capableing of scanned QR codes, and via component software and come from patient The patient datas of ID bands links, with after being admitted to hospital on the day of operation during hospital carries out preoperative evaluation, to distribute to the spy of patient The full distributor blade in Dingan County creates unique identifier.The unique identifier ensures that patient receives the distributor blade of right type, This means that the correct inclined side property of pre- stage operation, and can be tracked in the rest part of medical environment, and with whole Any data captured in a medical environment are associated to ensure that it is correct and be used to execute expected operation.Only cured in surgery After raw or mandate operating room personnel's time-out, label could be removed from safety distribution device.Once label is removed, surgeon is just Can approach and only have at this moment could be close to the various scalpel blades in distributor blade, wherein a desired scalpel knife Piece can safely be released distributor to be joined to shank so that cut the first notch and proceeded by operation.

Safety blade distributor, which is initially provided as being sealed in transparent dual aseptic packaging, (to be then placed over saturating In the non-sterile container of bright window).Transparent wrapper/window allows to sweep before the removal of any packaging by safety blade distributor Retouch the identification information (for example, QR codes and/or partially side property indicator) confirmed on label.This way it is possible to avoid in the multiple of packaging Identification information having the same on level.It reduce manufacturing cost and otherwise the multiple package members of matching carried out will be needed To ensure its all complexity with same identification information.

Prevent the system of error location operation and blade associated injury from allowing to track before being hospitalized to practical surgical protocols Various data, software systems can generate any one of various analyses using these data.These analysis can be based on but Be not necessarily limited to so-called " near miss " data (that is, the mistake for finding and avoiding during using system), type of surgery and Inclined side property, surgical outcome, postoperative complication, patient demographic, geography information, and interact or use with each of system Associated date, time, position and personnel are to improve efficiency and accountability.For example, the analysis based on " near miss " data It can be provided to hospital and/or insurance company and/or quality improvement expert about the wrong or possible mistake that may be had occurred and that Worth of data accidentally, to push remedial measure to minimize or avoid such mistake occur in the future.These analyses can be with For (" between system ") is collected based in hospital system (" in system ") and/or in multiple and different hospital systems data come It identifies best practices, and is evaluated to identify best practices to be further reduced error location operation mistake.

Certain operations (including but not limited to spinal operation) can be in the certain organs, structure or region of patient anatomy It is executed at interior more than one segment or position, this may correctly identify surgeon the level of pre- stage operation causes to challenge. According to one aspect of the disclosure, prevent the system of error location operation and blade associated injury from may include extending beyond " time-out Record " step and the correct position verification process that can be executed before or after surgeon carries out time-out.More specifically Ground says, which can merge and compare two images (for example, preoperative diagnosis image in hospital database and performing the operation The radiography image that shoots in the process shines during previous procedure in radiation that is identical or being shot close at surgery location Phase images) it is whether correct with position expected from determination or segment.

The system of the disclosure may include about the additional features being imaged to patient for pre- stage operation.More It says to body, software systems can allow surgeon's given patient to undergo certain preoperative imaging (such as computed tomography (CT), Positron emission computed tomography (PET etc.) is for the inspection or removing in preoperative and surgical procedure.Example Such as, software be configured such that surgeon can select or switch (in " decision " stage) " needing to be imaged " option and The specific imaging that he or she is asking can be specified or describe, this can be stored in the electronic bits of data of patient.If necessary It is imaged, then Surgical Scheduler person's (in scheduling phase) can use the information to help to dispatch requested imaging.The software Can also include the correlation function used as patient continues through medical treatment, such as (but being not necessarily limited to) provides selection or cut " imaging is available " option is changed, wherein medical worker (such as preoperative personnel) can check system 10 to ensure that requested imaging is real It is used in situations in the surgery room for surgeon on border, and provides the surgeon with inspection imaging (if available), and is optional Ground selects or the ability of switching " imaging inspection " option.The ability for asking summation check to be imaged is provided for surgeon to can help to prevent Only by other medical professionals (for example, radiologist) read imaging may have been carried out or misregister can Otherwise energy property may cause the information in patient data inaccurate.In this case, surgeon can be directly in operating room In (or after being admitted to hospital) assessment imaging, and determine whether any such mistake.If not provided, operation can continue.Such as Fruit has, and operation can stop carrying out.

According to one aspect of the disclosure, it describes a kind of for associated with the individual of interaction in medical environment outer It is prevented in section's regulation or the system of trace error position mistake.The system includes computer implemented electronic device, the computer The electronic device of realization has for showing the screen of image, the microphone for creating audio file, for playing record The loud speaker of audio file, the processor for being able to carry out instruction and data storage medium for storing instruction, the instruction exist It preserves the processor when being executed by processor and shows the personal electronic bits of data for the interaction in medical environment, record And play with the relevant audio file of medical protocol, and starting that with before the associated surgical protocols of individual electricity can be carried out The time-out of subrecord.The system further includes that surgery supply carries part, and surgery supply carries part and is included in for personal surgery One or more surgical instruments or component to be used in regulation, it includes storage medium that surgery supply, which carries part, the storage medium The associated electronic bits of data of the identification information of part is carried with surgery supply including personal so that unique surgery carries part and suffers from Person is associated.

Surgery supply, which carries part, can have at least one component, at least one component to prevent or prevent personal close to storage One of which or multiple surgical instruments or component.

It can be the safety blade distributor for including one or more surgical blades that surgery supply, which carries part, and suitable for association It helps and one or more surgical blades is fixed to surgical blade shank, while minimally being contacted with user.

Surgery supply carries part or electronic recognition component may be adapted to be fixed to and be handed in the medical environment including tracking mechanism Mutual individual.

The tracking mechanism can be RFID tag.

Personal electronic bits of data may include the data for the one or more types for identifying this people, arrange to individual's execution The instruction of medical protocol and the inclined side property of regulation.

The instruction of the inclined side property of regulation may include the label based on color.

Audio-frequency information, which may include describing, to be arranged to the personal label for executing what regulation.

It can also make the time of the personal interaction in the medical environment of processor display when instruction is executed by processor The analysis of the affairs carried out in section.

Analysis shows that may include error location operation near miss data, error location operation wrong data or combinations thereof.

Computer implemented electronic device can be configured as include surgical protocols stopped decision input instruction.

Processor can show data associated with the mark of people patient.

Processor can show the information about surgical protocols associated with patient.

Information about surgical protocols associated with patient may include required surgical protocols.

Information about surgical protocols associated with patient may include letter related with the inclined side property of required surgical protocols Breath.

Information related with the inclined side property of required surgical protocols can be specific for left side operation, right side procedures or middle part The color coding of position operation.

Computer implemented electronic device may include camera.

Computer implemented electronic device can be configured as scanning and interpreting optical data.

Surgery supply carries part or electronic recognition component may include optical data.

The optical data can be in the form of bar code or QR codes.

Computer implemented electronic device can be configured as reading biological attribute data.

The biological attribute data may include finger print data, face recognition data, iris recognition data, retina scanning number According to, DNA data or combinations thereof.

Computer implemented electronic device can be configured as tracking and indicating when the individual is in the medical environment expert Into when which medical worker inspection is executed to the individual.

According to another extensive aspect of the disclosure, provide a kind of associated with the individual of interaction in medical environment outer It prevents or the method for trace error position mistake, includes the following steps during section's regulation：(a) it is filled using computer implemented electronics It sets, which has for showing the screen of image, the microphone for recording audio file, being used for Play record audio file loud speaker, be able to carry out instruction processor and for storing instruction data storage be situated between Matter, described instruction make processor execute multiple functions, prevent from or track to interact in medical environment when executed by the processor The associated error location mistake of individual, the electronic device includes electronic patient data, and the electronic patient data includes Audio message containing the related information with the individual, described information include at least patient's name or other identifier information and Description to the surgical protocols；(b) it is supplied to the personal distribution surgery based on the information from the electronic patient data Part is carried, wherein the allocation step includes that the electronic bits of data of the individual and surgery supply are carried to the identification of part Information is linked so that it is associated with the individual that unique surgery carries part；(c) when the individual is in entire medical environment The surgery supply is tracked when advance carries part to obtain and record and the personal intercorrelation in the medical environment Data, include the data about error location surgical errors；And (d) as one in the personal and medical environment Or when multiple personnel transfers, the personnel in medical environment is enable repeatedly to listen to recorded audio message.

It prevents during the associated surgical protocols of individual with interaction in medical environment or trace error position mistake Method can also include the following steps：The surgery supply is obtained at a position before the surgery and carry part, and pass through ratio The related information of part is carried to carry out preoperative evaluation compared with information related with the individual and with surgery supply；And pass through Label is provided to the computer implemented electronic device to record the preoperative evaluation, the label description and the personal phase Associated information and to carry the associated information of part with surgery supply be identical or different.

It prevents during the associated surgical protocols of individual with interaction in medical environment or trace error position mistake Method can also include the following steps：Surgery supply is obtained in surgical site and carries part, and by will be with described It the related information of people and carries the related information of part with surgery supply and is compared to carry out operation assessment；And pass through to The computer implemented electronic device provides label to record the preoperative evaluation, and the label description is related to the individual The information of connection and to carry the associated information of part with surgery supply be identical or different.

It prevents during the associated surgical protocols of individual with interaction in medical environment or trace error position mistake Method can also include the following steps：Execute eventually time-out；And the eventually time-out is stored in described computer implemented In electronic device.

It prevents during the associated surgical protocols of individual with interaction in medical environment or trace error position mistake Method can also include the steps that the analysis provided to affairs, and the analysis is to the personal interaction in the medical environment Occur during period.

Analysis may include error location operation near miss data, error location operation wrong data or combinations thereof.

A kind of surgery sharp weapon distributor for surgical protocols is provided according to another aspect, including is dimensioned so as to And it is configured for being maintained at the outer cover unit of the general rectangular in the hand of single user, which has by opposite The periphery that first face and the second face, opposite first end and the second end, the first opposite side and the second side limit, the shell Unit further includes the internal cavity in periphery, and first end is included therein at least one aperture to be formed and suitable for releasable Ground keeps at least one sharp weapon of a surgery sharp weapon that device assembly, at least one sharp weapon is kept to keep device assembly slideably It is located in the internal cavity, and can move between the first position and the second position, in the first position, protected The surgery sharp weapon held are accommodated fully in the internal cavity, and in the second position, the surgery sharp weapon of the holding A part project through the aperture.

First side and the second side may include fan-shaped edge.

The surgery sharp weapon can be scalpel blade, and the scalpel blade is with the front end for including blade section and including connecting Connect the tail end of device part.

Scalpel blade can be positioned in sharp weapon and keep in device assembly so that when sharp weapon keep device assembly to be in second When setting, tail end is protruded from outer cover unit.

The surgery sharp weapon can be scalpel, and it includes the front end of blade section and the tail including shank that the scalpel, which has, End.

The scalpel can be positioned in the sharp weapon and keep in device assembly so that when the sharp weapon keep device assembly to be in When the second position, a part for the shank is protruded from the outer cover unit.

At least one sharp weapon keep device assembly to may include that four sharp weapon positioned side by side keep device assembly.

Surgery sharp weapon distributor can also include the confirmation label for being removably attached to shell, which is positioned At the movement for prevent at least one sharp weapon from keeping device assembly when confirming that label is attached to shell.

A part of at least part that can cover first panel, a part for second panel for attached confirmation label And the first end of shell.

The confirmation label may include electron scanning code, which includes in patient information and surgical protocols information At least one.

Electron scanning code can be one kind in QR codes and bar code.

Attached confirmation label may include at least one visual indicator that the inclined side property of surgical protocols is conveyed to user.

At least one visual indicator may include at least one of word and color.

Surgery sharp weapon distributor can also include the packages groups for being suitable for receiving surgery sharp weapon distributor before surgical protocols Part.

Package component may include the first transparent aseptic bag, the second transparent aseptic bag and non-sterile external container.

Surgery sharp weapon distributor can be sealed in first transparent aseptic bag, and first transparent aseptic bag is sealed in In second transparent aseptic bag, second transparent aseptic bag is placed in the non-sterile external container.

External container may include transparent window.

Surgery sharp weapon distributor can be placed in the package component so that when the electron scanning code is included in the packet It can be scanned by first transparent aseptic bag, second transparent aseptic bag and the transparent window when in arrangement.

By the described in detail below and drawings and claims of the exemplary implementation scheme of the present invention, the present invention is adopted The shortcomings that improving existing apparatus simultaneously realizes that the particular technique of advantage described herein and structure will become obvious.

Description of the drawings

Fig. 1 is the graphical representation according to the error location surgical prophylaxis system of an embodiment of the disclosure；

Fig. 2 is the block diagram of the illustrative computing device for being used in the error location surgical prophylaxis system of the disclosure；

Fig. 3 be show in entire medical environment each stage using Fig. 1 error location surgical prophylaxis system into The flow chart of exhibition；

Fig. 4 A to Fig. 4 C show the error location hand provided in entire medical environment according to present disclosure using Fig. 1 The flow chart of the further details of the progress of art prevention system；

Fig. 5 to Figure 34 is the representative graphical user interface of the software application of Fig. 1, shows a side according to the disclosure The use of the error location surgical prophylaxis system in face；

Figure 35 is an exemplary perspective view of the safety blade distributor of Fig. 1.

Figure 36 is the plan view from above of the safety blade distributor of Figure 35.

Figure 37 is the face upwarding view of the safety blade distributor of Figure 35.

Figure 38 is the elevational perspective view of the safety blade distributor of Figure 35.

Figure 39 is the plan view from above of the safety blade distributor of Figure 35, and one of blade proceeds to moveable position；

Figure 40 is the side plan view of the safety blade distributor of Figure 39.

Figure 41 is the plan view of the first housing face-plate of a part for the safety blade distributor to form Figure 35.

Figure 42 is the perspective view of the first housing face-plate of Figure 41.

Figure 43 is another plan view of the first housing face-plate of Figure 41.

Figure 44 is another perspective view of the first housing face-plate of Figure 41.

Figure 45 is the perspective view of the second housing panel of a part for the safety blade distributor to form Figure 35.

Figure 46 is the plan view of the second housing panel of Figure 45.

Figure 47 is the perspective view of the tip holder component of a part for the safety blade distributor to form Figure 35；

Figure 48 is another perspective view of the tip holder component of Figure 47.

Figure 49 is the side plan view of the tip holder component of Figure 47.

Figure 50 is configured as the exemplary perspective view for the surgical blade being used together with the safety blade distributor of Figure 35.

Figure 51 and Figure 52 is the plan view with the safety blade distributor for confirming label of Figure 35；

Figure 53 is according to one aspect of the disclosure with dual inner packing (sterile and transparent) and with transparent observing The decomposition perspective view of the safety blade distributor of Fig. 1 of the external container of window.

Figure 54 is the plan view for the safety blade distributor of Figure 53 being sealed in dual sterile transparent inner packing.

Figure 55 is the perspective view of the safety blade distributor of Figure 54, the safety blade distributor be sealed in it is dual sterile and It in transparent inner packing, and is further encapsulated in external container, which has transparent watch window, is used for Its label is observed in the case where safety blade distributor is completely sealed and is packed；

Figure 56 is the plan view of the alternative example of the safety blade distributor of type shown in Fig. 1, the safety blade distributor It is configured as keeping assembling or integrated scalpel (that is, blade and shank).

Figure 57 is the plan view of the safety blade distributor of Figure 56, and one of scalpel shank proceeds to removable position It sets；

Figure 58 is an exemplary plan view of the scalpel for being suitble to be used together with the safety blade distributor of Figure 56.

Figure 59 to Figure 64 is the various exemplary plots for the analysis for showing the error location prevention system using Fig. 1；And

Figure 65 is preventing for the optional part for the error location surgical prophylaxis system and method that description can form the disclosure The flow chart of the exemplary method steps of mistake segment surgery (only by way of example, in spinal operation).

Specific implementation mode

The present invention includes preventing the system and correlation technique of error location operation and the blade associated injury of operating room personnel. As shown in the exemplary embodiment of figure 1, system 10 includes computer software 12, which is configured as In conjunction with surgery related device, preferably surgery supply carries part, is shown as safety blade distributor 14 herein, provides a user The method for preventing error location from performing the operation.It includes at least one component that surgery supply, which carries part, and such as label, paper or band, this is at least One component prevents or prevents surgeon close to the one or more surgical instruments being stored in it, until surgeon or awards Power operating room personnel has executed " time-out " before starting expected surgical protocols.Computer software 12 can be in various calculating Any one of device is upper to be run, and the computer 16 such as used in medical environment is (for example, fixed desktop computer and/or knee Laptop computer) and/or hand-held computing device 18 (for example, smart phone, such as IPHONE and/or board device, such as IPAD Or SURFACE PRO).Should " medical environment " include patient and medical team (including doctor, clerk, nurse, medical skill Art personnel, surgeon, administrative staff) from surgeon office (carry out initially seek advice from and determine operation) to operating room (into Row operation place) continuous process in interaction from anywhere in.The term can also include be related to operation after data collection and/ Or the personnel of analysis, such as (but not limited to) (a) patient, hospital and/or surgical insurance company, (b) to hospital and/or The state of surgeon's amortization cost and/or federal agency department/plan (for example, medical insurance/Medicaid), (c) needle To any other mechanism (private and/or government) that the particular procedure case is paid the bill to patient, hospital and/or surgeon, and/ Or (d) quality control and/or hospital management, to determine improvement areas and/or best practices.

Although computing device is well known in the art, deposited as shown in Fig. 2, such device generally includes to be connected to The central processing unit (CPU) 20 and networking hardware of reservoir 22.Computing device can be operably connected with CPU 20 so that CPU 20 can handle the inbound network flow from internet, and will using for example multi-tier networked agreement (such as TCP/IP) Outbound network traffic is transmitted to internet.CPU 20 is preferably connected to input unit 24 or can have the input unit, all Such as keyboard, the touch-screen display of mouse or display alphanumeric and/or numerical chracter.Display unit 26, such as LCD screen Curtain can be used for showing any data output.Memory 22 may include volatile memory and nonvolatile memory, and store The program code 28 that can be executed by CPU 20.Program code 28 makes CPU 20 execute various steps, these steps guide every meter Calculation machine 16 and/or hand-held device 18 execute one or more method embodiments for preventing error location from performing the operation.Program generation Code 28 can reside in permanent memory, such as reside on hard disk, be then loaded into nonvolatile memory for Execute, or can (for example) be obtained from remote server via networking hardware, be then loaded into nonvolatile memory with For executing.It is also contemplated that (not shown using the Computer Database for storing user's specific data and/or program data base Go out), but those of ordinary skill usually stores the data used for CPU 20 using alternative strategy.Computer 16 and/or hand It holds device 18 and may include one or more speakers 30, microphone 32 or camera 34.In order to help to improve trace ability, dress is held It sets 18 and may include one or more tracer techniques 36, such as GPS (global positioning system) transmitters or receiver, RFID (radio frequencies Identification) transmitter or receiver and/or other wireless tracking technologies.Hand-held device 18 includes power supply 38, which can be each Any one of suitable battery types of kind, including but not limited to lithium rechargeable battery.It can be in computer 16 and/or hand It holds and provides USB port 40 on device 18 to help to device power supply and/or transmission data.

Prevent error location operation and blade associated injury system and correlation technique using computer software 12 come Several functions are supported and provided, this will be described in further detail below.These functions include but is not limited to：Voice record 42, record playback 44, can be scanned electronic patient identification component (such as patient ID bands 46), the peace that can be scanned Full distributor blade 14, and by using system 10 from " determining to cutting ", i.e., from (being carried out in surgical office) It determines to perform the operation by (in situations in the surgery room) actual operation, the data of acquisition generate or the various analyses based on the data Any one of 48.The scanning of patient ID bands 46 and/or safety blade distributor 14 can pass through computer 16, hand-held device 18 and/or the scanning function of the scanning system separated with system 10 complete, which cooperates with system 10 and is with this System communication.System 10 can use any one of various suitable biological identification technologies (for example, iris scan, fingerprint, something lost Pass and learn etc.), to identify that (and/or the guardian of patient is not in patient to patient at any time in medical environment In the case of adult or the patient of incompetence).

As will be described in more detail below in like that (with reference to figure 35 to Figure 55), safety blade distributor 14 includes various Scalpel blade executes the first notch of operation for surgeon's selection.Safety blade distributor 14 (and/or it is described below Label) it is with coloud coding, with the inclined side property of instruction operation (for example, rosiness or the operation of red instruction " right side " side, lavender Indicate that the operation of " left side " side and muted color (such as grey) instruction are performed the operation without side position).Safety blade distributor 14 includes having energy The label of enough scanned QR codes, and linked via component software 12 and the patient data from patient ID bands 46, in hand After being admitted to hospital on the day of art during hospital carries out preoperative evaluation, the particular safety distributor blade 14 to distribute to patient creates uniquely Identifier.The unique identifier ensures that patient receives the distributor blade 14 of right type, it means that pre- stage operation it is correct Inclined side property, and can be tracked in the rest part of medical environment, and it is any with being captured in entire medical environment Data are associated to ensure that it is correct and be used to execute expected operation.Only in surgeon or mandate operating room personnel's time-out Afterwards, label could be removed from safety distribution device 14.Once label is removed, surgeon can approach and only have at this moment It can be close to the various scalpel blades in distributor blade 14, wherein a desired scalpel blade can be released safely Distributor 14 is to be joined to shank so that cuts the first notch and proceeds by operation.

Prevent the system of error location operation and blade associated injury 10 from allowing tracking before being hospitalized to practical surgical protocols Various data, software systems 12 can generate various analyses any one of 48 using these data.These analyses 48 can Be based on but be not necessarily limited to so-called " near miss " data (that is, the mistake for finding and avoiding during using system 10), Type of surgery and inclined side property, surgical outcome, postoperative complication, patient demographic, geography information, and it is every with system 10 Secondary interaction or using associated date, time, position and personnel to improve efficiency and accountability.For example, being based on " close difference It is wrong " analyses 48 of data can provides to hospital and/or insurance company and/or quality improvement expert about may have occurred and that The worth of data of mistake or possible mistake, to push remedial measure to minimize or avoid such mistake occur in the future. These analyses 48 can be also used for based on (" in system ") and/or the (" system in multiple and different hospital systems in hospital system Between ") data collected identify best practices, and are evaluated to identify best practices to be further reduced error location operation Mistake.

The system for preventing error location operation and blade associated injury 10 is designed in medical environment when any It carves tracking patient and surgery supply carries the position of part (for example, safety blade distributor 14).In an illustrative embodiment party In case, RFID tag can be embedded in surgery supply and carry in part.This provides one kind tracking surgery supply in surgical environments and carries The mechanism in the geographical location of part.RFID tag can also label to mobile a people patient by surgical environments.RFID is marked Label are associated with patient to be allowed to make about patient wherein and he/her is in the position and has reached determination how long.Such as Fruit patient and surgery supply, which carry part, all has RFID tag, then can collect data and/or if patient and surgery supply are taken Holder separates in hospital or Surgicenter, then can send notice.As described above, system 10 can also include special based on biology The identification technology of sign, to identify patient (and/or guardian, if patient is not at any time in entire medical environment Adult or incompetence patient).

Fig. 3 shows several exemplary stages that system 10 can use in medical environment, including patient it is each this The various parts for the system 10 being likely encountered during the exemplary stages of sample.Stage 50 be related to determining surgeon and patient it Between perform the operation, and using software systems 12 (for example, via computer 16) and 42 function of voice record.That performs the operation determines It is fixed to be usually happened at surgical office, generally go through one or many consultings and pathology and surgical selection to patient Assessment.System 10 allows surgeon to create patient data in software systems 12 for the particular patient, which can Include any information in the various information about pre- stage operation.The expection operation information may include (but being not necessarily limited to) patient Name, date of birth, type of surgery, surgery location, the inclined side property of operation and surgeon's name.Preferably, standard should be used to compile Code system, CPT (the current regulation term) code books such as write by American Medical Association or other common Medical coding systems (such as ICD10), so as not to obscure expected surgical protocols generation.It is important that patient data further includes by surgeon The voice record 42 that (by using software systems 10) are created when he or she loudly gives an oral account expected operation information.Voice record 42 It can also include agreement of the patient to pre- stage operation.Patient data can via positioned at surgeon office computer 16 and/ Or it is input to via 18 (not shown) of hand-held device that (will be described below) runs software system 12 with application forms soft In part system 12.Software systems 12 also preserve the time and date of patient data's establishment, and are created in surgery doctor's office The individual of the data.System 10 can identify patient and/or guardian in conjunction with the identification technology based on biological characteristic, such as when In the case that patient is minor or incompetence patient.

Stage 52 is related to dispatching surgical operation based on patient data/electronic bits of data, and using software systems 12 (for example, Via computer 16) and 44 function of audio playback.For this purpose, surgical office will contact hospital or surgicenter Surgical scheduler person (such as is accessed outer with being based on OR availabilities and surgeon and the supportive OR personnel of any key or expert Section doctor etc..) search the available dates of pre- stage operation.After having selected open date and time, Surgical Scheduler person makes Patient data is updated with date, time and position including plan surgery with software systems 12 (for example, via computer 16) It sets, then these information can be communicated to surgeon office and patient, it is ensured that it is on their respective calendars.It is important , Surgical Scheduler person can be using the audio playback 44 of system 10 come in surgeon, in the decision stage 50, oral account is expected His or her sound is listened to when surgical information.The record plays back 44 features and provides advantageous intersection inspection to scheduling process It looks into, because record playback allows Surgical Scheduler person to reset original record to ensure：(a) by surgeon office (example Such as pass through phone) convey information matches raw tone record 12；And/or (b) (such as pass through from surgeon office Phone) receive information accurately input into software systems 12 by Surgical Scheduler person.Software systems 12 also preserve patient The time and date of data updating, and update in Surgical Scheduler the individual of the data.Once surgical operation is scheduled, Software systems 12 may be configured to via e-mail, text SMS or other electronically send out link to patient, the link Including with surgical operation details (and the date of surgical operation, the time, position and it is any be admitted to hospital before limitation, such as Fasting, reception time, parking instruction etc.) written notice, or patient is directed to online patient's portal to retrieve these contents Link.System 10 can be also used for tracking any preoperative planning and/or assessment, may such as (but not limited to) need in surgery It was carried out before the operation same day and the heart successfully passed and/or blood test.

Stage 54 is related to connecing in surgical site (such as hospital or surgicenter) on the day of plan surgery Wait for patient.The stage uses 46 scanner of software systems 12 (for example, via computer 16), audio playback 44 and patient ID bands. Mark (such as driving license, passport etc..) appropriate is being shown to reception personnel and/or identifies biological characteristic (such as using patient It is upper described) after, identification equipment is distributed to patient, can such as be attached or coupled to patient's identification of patient in some way (ID) band 46, most commonly around patients wrist.Patient ID bands 46 include the bar code with identification information, identification letter Cease such as patient's name, date of birth and Social Security Number.Reception personnel then can be in more new software system 12 patient Data is to include the patient information from patient ID bands 46, such as by using the scanner with 12 electronic communication of software systems. Reception personnel can also be listened to using software systems 12 (for example, via computer 16) surgical raw tone record 44 with Reaffirm that the expection surgical information in software systems (is such as inputted by surgeon office and by Surgical Scheduler Member's update) it is accurate and consistent with the expection surgical information of voice record 44.This representative is complete to the information in software systems 12 Whole property again cross-check, and ensure plan surgical operation as was expected.Software systems 12 also preserve patient's money Expect newer time and date, and updates the individual of the data in reception.

Stage 56 is related to patient and is registered in preoperative stage or section office's (so-called " art in the position of the surgical operation of plan Before ").The stage is using software systems 12 (for example, via hand-held device 18 of operation application), 44 function of audio playback, patient 46 scanning function of ID bands, 14 tag scan function of safety blade distributor and 42 characteristic of audio recording.When patient's arrival is preoperative When, preoperative personnel will be distributed to patient using software systems 12 (for example, via hand-held device 18) and be specified guarded knife appropriate Piece distributor 14.For this purpose, preoperative personnel will use scanner scanning patient ID bands 46, then this trouble that will propose the particular patient Person's data.In the case where showing patient data, then preoperative personnel can select simultaneously according to the inclined side property of expected surgical operation Distribute safety blade distributor appropriate 14 (for example, rosiness is used for right side surgical operation, purple is used for left side surgical operation, Or muted color (such as grey) is without the operation of inclined side property).Then preoperative personnel will carry out scan setting in guarded knife using scanner The unique identifier on label on piece distributor 14, the unique identifier can be in the data storage features being stored on label The form of unique sequence numbers in structure, such as (but being not necessarily limited to) bar code or QR codes.Then preoperative personnel can use Software systems 12 associate the data on the label of data and safety blade distributor 14 from patient ID bands 46.With this Kind mode, specific safety blade distributor 14 are assigned to specific patient, this is conducive to accurately track safety blade distribution Remaining distance of the device 14 in medical environment.Surgeon can change patient data to include using 42 function of voice record Any Additional surgical for being decided to do during being assessed in the preoperative with him or she is performed the operation associated second voice record.Voice record 42 It can also include the agreement that patient performs the operation to Additional surgical.

Preoperative personnel can also listen to surgical raw tone record 44 to reaffirm software system using system 10 System 12 in preserve or preserved by the software systems expection surgical information (such as inputted by surgeon office and by Surgical Scheduler person, reception personnel are newer, and optionally any preoperative planning assessment/inspection) accurately and with voice remember The expection surgical information of record 42 is consistent.This is represented to information being preserved in software systems 12 or being preserved by the software systems Integrality again cross-check, and ensure plan surgical operation as was expected.It is preoperative if detecting problem Personnel can select " NO GO " function in software systems 12.If surgeon judges that the problem has solved, he or she Can check and cover, or alternatively, if he or she judge the problem not yet solve or surgical operation should not according to plan after It is continuous, then cancel surgical operation.Software systems 12 also preserve the newer time and date of patient data, and update the money in the preoperative The individual of material.

Stage 58 is related to system and method for the anesthesia personnel using error location surgical operation and blade associated injury is prevented 10 confirm that they will impose anesthesia to the patient appropriate of appropriate or pre- stage operation.This is an optional step, and is only illustrated How various hospitals or OR personnel are using preventing error location surgical operation and blade associated injury in entire medical environment System and method 10.The stage is using software systems 12 (for example, via hand-held device 18 of operation application), 44 work(of audio playback Energy, 14 tag scan function of 46 scanning function of patient ID bands and safety blade distributor.Anesthesia personnel can use system 10 Listen to raw tone record 42, scanning patient ID bands 46 and/or scan the label of distributed safety blade distributor 14 with Ensure that patient and expected surgical operation meet surgical raw tone record 44, period determines in the preoperative and that agrees to appoints The voice record 44 of what Additional surgical operation, and/or meet anesthesia scheme.If detecting problem, anesthesia personnel can be " NO GO " function is selected in software systems 12.If surgeon judges that the problem has solved, he or she can check simultaneously Covering, or alternatively, if he or she judges that the problem not yet solves or (original and/or additional) surgical operation should not be based on It draws and continues, then cancel surgical operation.Software systems 12 also preserve the newer time and date of patient data, and more in anesthesia The individual of the new data.

Stage 60 is related to OR and prepares (so-called " OR preparations "), and wherein patient is transferred to OR and is ready to receive hand from preoperative Art.The stage is using software systems 12 (for example, via hand-held device 18 of operation application), 44 function of audio playback, patient ID 14 tag scan function of 46 scanning function of band and safety blade distributor.Patient hands to OR from preoperative, this is by that will suffer from Person is placed in stretcher or rolling bed and coordinates to join to complete between preoperative personnel and OR personnel.It can be by allowing preoperative personnel By patient from preoperative mobile or be moved to OR towards OR, so that OR personnel can undertake the responsibility, or alternatively come OR personnel It is preoperative and meet away patient, to complete to join.In either case, during the handing-over exchanges, OR personnel will use software system System 12 (for example, via hand-held devices 18) scanning patient ID bands 46 and/or the safety blade distributor for distributing to patient in the preoperative 14 label.Then OR personnel will check the data that are generated by the scanning, and by the inclined side of itself and safety blade distributor 14 Property color coding etc. be compared, with ensure patient appropriate have it is appropriate and distribution safety blade distributor 14.

OR personnel can also listen to surgical raw tone record 44 using software systems 12, soft to reaffirm Expection surgical information in part system 12 (is such as inputted by surgeon office and by Surgical Scheduler person, any Optional preoperative planning/cleaning, reception personnel, preoperative personnel and surgeon are newer in the preoperative) it is accurate and meet original The expection surgery hand of voice record 44 (from surgeon office) and any second voice record 44 (from preoperative) Art information.This represents the cross-check again to the information integrity in software systems 12, and ensures the surgical operation of plan As was expected.If detecting problem, OR personnel can select " NO GO " function in software systems 12.If outer Section doctor judges that the problem has solved, then he or she can check and cover, or alternatively, if he or she judges that this is asked Topic not yet solves or (original and/or additional) surgical operation should not continue according to plan, then cancels surgical operation.If operation will be after It is continuous to carry out, then patient will be transferred to OR platforms, prepare to undergo surgery and be covered surgical drape there.Software systems 12 are protected The newer time and date of patient data is deposited, and updates the OR personnel of the data.

Stage 62 is related to the pause that can be had to carry out from safety blade distributor 14 close to before blade in surgeon Program.The stage is using software systems 12 (for example, via hand-held device 18 of operation application), 44 function of audio playback, patient 46 scanning function of ID bands, 14 tag scan function of safety blade distributor and 42 characteristic of audio recording.Surgeon sweeps first The label of safety blade distributor 14 is retouched to recall the patient data of the patient on OR platforms.Surgeon can inspect the data, And the inclined side property color coding and the original language from surgeon office for compareing distributed safety blade distributor 14 Sound records and the audio playback 44 from preoperative any addition record augments or reaffirm the data.

If all correct and surgeons decide to continue with operation, he or she holds followed by following operation Row pause：(a) attention of each of OR is obtained；(b) the pause information needed for statement, such as (but being not necessarily limited to) are suffered from Person's name, date of birth, operation, inclined side property (if any) and surgeon's name.Surgeon is preferably at him or she It is recorded using the audio recording characteristic 42 of software systems 12 while speaking during executing pause, this is provided as patient A part for material.Once (and being optionally recorded) is completed in pause, then surgeon can be indicated using the software Through performing pause (such as by switching the designating frame or related application that switch and/or click in software systems 12).

At this point, surgeon will remove label from safety blade distributor 14, and label is put into Patient charts or It puts together with Patient charts.By removing label, by multiple blades of label covering before being able to access that now.Carry out blade It counts to write down the quantity for the blade being maintained in safety blade distributor 14, which can protect via software systems 12 There are in patient data and/or be stored in Patient charts.As will be described in following Figure 39 to 40, label is being removed In the case of, surgeon will distribute one in multiple blades from the shell of safety blade distributor 14, surgeon The blade can be couple to shank, then manufacture initial notch.Software systems 12 preserve patient data's newer time and Date, and update the OR personnel or surgeon of the data.

Fig. 4 A to 4C are the flow charts for the exemplary method steps of the system that shows 10 used, including patient he/her During interaction in medical environment may experience various steps, and its other than the details in addition to being described above with reference to Fig. 3 His details.When patient moves in medical environment, various types of data can be used and/or obtained.Frame 13 lists example Characteristic number evidence may include (but being not necessarily limited to)：The date that every time uses of the system 10 in medical environment, time, group (DTG) (wherein " group " refers to that system 10 is used for the people of the special-purpose)；Patient's name (PN)；Patient date of birth (DOB)； Pre- stage operation (Proc)；The position (Proc L) of operation, such as particular body portion or organ；The inclined side property of pre- stage operation (Lat)；Surgeon's name (SN)；Voice record (VR)；Audio playback (VP)；The position (Loc S) of surgical operation, it is such as special Determine the specific OR in hospital, surgicenter and/or particular hospital or surgicenter；The date of the surgical operation of plan With time (DTS)；Patient's ID bands (ID bands)；Distribute to the sequence number (SB Ser) of the StartBox of patient；About all information Correctly confirm (GO)；To mistake, latent fault, information is insufficient or the instruction (NOGO) of information inaccuracy；The reason of NOGO, Such as positional fault, inclined side property mistake, operation mistake, patient's mistake, explanation causality or the annotating of influence factor, existing feelings Condition (REASON)；Covering and mandatory annotation (OVER), wherein surgeon can inspect and be covered in appointing in medical environment What puts the NOGO created by any other user, is to advance or cancel with surgical operation expected from decision；Suspend information (Time-Out), such as patient ID (ID Band), the date of birth (DOB), imaging (Y/N) and/or inspected (if necessary), Perform the operation (Proc), inclined side property (Lat) and whether there is implantation material and/or equipment (Y/N)；And surgical operation is delayed or is cancelled (Stop).Any combinations of all these data can be a part for Patients ' Electronic data.

The process is since the first step 15, i.e., patient and doctor codetermine and take surgical operation therapy option.It walks herein The example of the type for the action that may occur during rapid includes：(a) diagnosis, conditions of patients, treatment option and potential recovery are discussed； (b) determine surgical operation if appropriate for patient's diagnosis, the state of an illness, symptom and potential improvement；(c) desired result (i.e. advantage is assessed With disadvantage)；(d) discuss it is possible as a result, recognition result risk and probability；And (e) patient and surgeon make decision. Opinion must be consistent.Once decision undergos surgery, patient will be associated with a electronic bits of data.Surgeon can provide knowledge The audio recording 44 of other patient and agreement/expected surgical operation.Surgeon can further obtain patient to the surgery hand Art indicates the audio recording 44 of informed consent.

17 be Surgical Scheduler process in next step, and the action that may include in the process is：By surgical operation sequence It is transmitted to surgical operation expeditor；Surgical operation expeditor calls insurance institution to be authorized (if necessary)；Coordinate preoperative Laboratory examination is checked UP by doctor when necessary, and coordinates anesthesiology coverage area；The position of specified surgical operation, date And the time.In the position (hospital or surgicenter) that the surgical operation occurs, patient information is confirmed and can be via System 10 indicates Go/NoGo.If it is determined that NoGo, then record reason and corrective action.The covering to NoGo can be executed.If It is not carried out covering in this stage, then can stop moving and noting down towards surgical operation.Alternatively, surgeon can wait for Any NoGo instructions are assessed in the later stage of the process, such as in the preoperative." receiving surgical operation " the step of in (step 19), to Date, time and the position of the operation of surgeon and particular notification's plan.This can be completed by traditional approach (phone), or Person preferably make system 10 generate automatic message (such as Email, text, SMS, etc..) cured to patient and/or surgery It is raw.This may also be related to conveying preoperative guidance (such as fasting in 24 hours, etc.. on an empty stomach before surgical operation).It is related to this step Each side can confirm correct patient and correctly operation using audio playback.

If it is required that patient assesses and/or checks (such as preoperative laboratory examination, such as heart or blood before undergoing surgery Check), then the patient that can also be tracked in such action or medical environment moves (step 21).In checking in the preoperative；It may Various actions can occur, such as：If there is the case where not supporting or not allowing operation in vital sign, laboratory or patient, Surgeon (or physician extenders, PA) can stop the program in step 23.Surgeon (or PA) record surgical operation why by Cancel or postpone, and provides this information to patient (or family members/guardian) and electronic bits of data；Surgical operation stopping-is by surgery Doctor covers (why is reason), referring to step 25, " NO GO " (why is reason)；It is recorded in surgical operation data, case history；Profit The reason of stopping specifically being indicated with drop-down option：" position mistake ", " inclined side mistake ", " program error ", " patient's mistake ", with And " other ", and to assess the necessary comment section why this thing happens.This is near miss data and information； Patient (or family members/guardian) is notified after stopping determining.At this point, in movement of the patient in medical environment, can input The instruction of Go/NOGO is simultaneously associated with the electronic bits of data of patient by it.The covering to NoGo can be executed.If surgeon does not have Covering is executed, then can stop moving and noting down towards surgical operation, step 27.If information related with surgical operation It is ordered into, then patient is allowed to be admitted to hospital and carries part with surgery supply or surgical cassette is associated (electronic bits of data), all Such as safety blade device 14 or any other container with any one of feature as described herein or combinations thereof, referring to Step 29 and 31.During these steps, it may occur that following situations：Patient is admitted to hospital；Distribute surgical cassette and data；It closes In patient：Program of being admitted to hospital includes recording personal information (name, address, DOB, insurance, emergency contact, the allergy information of patient (if there is) etc.).Patient (or family members/guardian) fills in any and all tables about detailed history, any advance instruction The table and letter of consent of (medical treatment determines)；Patient's name, age, date of birth, room number, medical record number and surgery will be carried The plastics wrist strap of surgery information information (name, operation, position, inclined side property, DOB) is placed on patients wrist；If patient has One or more allergy, then second bracelet is placed in the wrist of patient with identify specific one or more allergy or Allergy；It selects correct color and its unique sequence number and is distributed to patient.Box/the data stay in patient at one's side, stay In hospital/clinic, and patient is will be left at one's side, until surgical operation starts.Patient receives when the process of being admitted to hospital closes to an end Surgical cassette；Surgical operation stopping-covering (why is reason) by surgeon, " NO GO " (why is reason)；It is recorded in surgery In surgery information, case history；The reason of stopping specifically being indicated using drop-down option：" position mistake ", " inclined side mistake ", " program Mistake ", " patient's mistake ", and " other ", and to assess the necessary comment section why this thing happens.This is Near miss data and information；Patient (or family members/guardian) is notified after stopping determining.

As patient's movement is by the practical surgery component of medical environment, electronic patient data can update accordingly.Example Such as, patient can be transferred to department of anesthesia, can check there and verify patient data.At any time, patient can be by It is designated as Go/NoGo, referring to step 33,35,37 and 39.Action may include preoperative RN, anesthetist execute inspection, surgery doctor Raw decision in the preoperative；And including act such as patient towards operating room move before patient, operative site, inclined side property, The whole correctly another one-time authentications of program；Surgical operation stops-(reason is why) is covered by surgeon, " NO GO " (reason is What)；It is recorded in surgical operation data, case history.The reason of stopping can specifically be indicated using drop-down option：" position is wrong Accidentally ", " inclined side mistake ", " program error ", " patient's mistake ", and " other ", and this feelings occur why to assess The necessary comment section of condition.This is near miss data and information；Patient (or family members/guardian) is notified after stopping determining. If it is indicated that NoGo, then as record the reason of action.New surgery with new unique identifying number can be carried part Patient is distributed to, and is recorded if necessary.In either case, doctor can cover the action or confirmation It.If surgeon does not cover, stops surgical operation and recorded.If patient is considered as Go instructions, Then patient can be further transferred to the next step of surgical protocols, referring to 41.Step 41 may include following action, Go； Patient is transferred to operating room：Circuit nurse (CN) or OR nurse confirm/verify identity and letter of consent；CN/OR nurse, which confirms, to suffer from Person's information, cutting part, operation and operating room；Patient verifies surgical site, any allergy.The action taken may include NoGo is determined, step 43, is covered by surgeon, step 43, surgical operation stops due to NoGo, referring to step 45 or Go. If it is Go, then the ID bands 46 of patient can be scanned, patient is transferred to OR platforms, is ready and is covered surgical drape, referring to Step 49.Before the generation of practical surgical protocols, surgeon will execute pause to verify correct information, referring to step 51. If having any information incorrect in final interval, sends out NOGo and recorded, referring to step 53.Surgeon can To cover this NoGo, reason is recorded, referring to step 55.If do not covered, stop surgical operation, and record original Cause, referring to step 57.This is near miss data and information；Patient (or family members/guardian) is notified after stopping determining.If Operation is Go, surgeon can by label since surgery carry removed on part and surgical operation.

Fig. 5-34 is the software system in the form of the application program (or " application ") run on the hand-held device 18 in system 10 The exemplary example of system 12.Fig. 5 is user role graphic user interface (GUI) screen 64, the user role graphic user interface (GUI) On-Screen Identification may relate to the potential role in entire medical environment using the system and prevent error location surgery The method 10 (via application) of operation and blade associated injury, such as various tasks and responsibility based on each role.Only with citing Mode, user role graphic user interface (GUI) screen 64 may include home office portion 66, preoperative part 68 and operating room (OR) part 70.Role may include the doctor 72 in (but being not necessarily limited to) home office portion 66, the art in preoperative part 68 Preceding registered nurse (RN) 74 and the touring RN 78 in doctor 76 and the parts OR 70 and doctor 80.As will be seen, it uses Family role's GUI screen 64 provides a kind of simple mode to visualize and track process of the patient in entire medical environment, Specific method is addition label after completing in each stage in this process, such as after each role completes the stage Add below corresponding role or nearby StartBox^TMShield logo 82.

Fig. 6 is the example of the main GUI screen of department of office doctor 84, which is that next figure in application process is used Family interface (GUI) screen.When in the main GUI screen of home office portion doctor 84, surgeon (is in this case, empty " the Kelly doctor " of structure) one kind in several functions can be executed using the application in his office.These functions can To include but not limited to give an oral account 86, scanning 88, alarm 90 and search 92.Giving an oral account 86 functions allows surgeon to record audio, all As the expection surgical operation for the part for forming the patient data created by surgeon and/or his deskman is believed Breath (such as patient's name, date of birth, type of surgery, surgery location, the inclined side property of operation and surgeon's name).In addition to expection Except surgical information, record can also be captured in the agreement provided by patient with surgeon's session.Scan 88 work( Surgeon can be allowed to scan the ID bands 46 of patient to identify patient and its relevant patient information.90 function of alarm allows surgery Doctor accesses any one of various notices or alarm, such as pending prescription approval, by other medical matters people for using system 10 Member's assessment " no-go " selection select to determine whether surgeon wishes to cover these and surgical operation is allowed to continue or cancel spy Determine surgical operation.New projects' indicator 94 can appear near 90 icon of alarm, to notify surgeon since last time surgery Doctor accesses the quantity (if any) for the new alarm having been had occurred and that since 90 function of alarm.Searching for 92 functions allows surgery to cure Any record, such as case history, program code, scheduled events etc. in various records in raw search system 10.

Fig. 7, which is shown, to be occurred when surgeon selects 86 icon of oral account on the main GUI of home office portion doctor 84 Give an oral account GUI screen 96.In exemplary embodiment, application will show by surgeon in particular time range (such as that One day, that week, that moon) be previous patient make preceding audio record 98,100 and 102, in this example, these trouble Person is Rusty Walker (98), Josh Dunlap (100) and Amy Gibbons (102).Each previous audio recording can To include that status indication 104 (such as check mark) is deposited with indicating that the previous audio recording has been saved to desired data Storage space is set (such as permanent secure data center based on cloud)." record " 106 function uses for surgeon (and outer Section doctor is based only upon rule and privilege to use) so that only surgeon could record new oral account.Oral account GUI 96 is also wrapped Include the menu bar 108 positioned at bottom of screen, which includes (including oral account 86, being swept for user to be linked to other functions Retouch several icons of 88, alarm 90 and search 92).

When surgeon touches 106 function of record, logging mode 110 shown in Fig. 8 is presented to outer when recording beginning Section doctor-user.Logging mode 110 includes that instruction oral account continues running timer how long 112 and when depressed stop recording Stopping function 114.Referring to Fig. 9, when surgeon given an oral account expected surgical information and patient (or guardian, depending on Depending on situation) provide verbal agreement after surgeon's stop recording (by the stop button 114 for pressing Fig. 8) when, first pop-up Window 116 is presented to surgeon.First pop-up window 116 includes the broadcasting figure for being recorded to surgeon's audio playback Mark 118, (such as name 120, surname 122, date of birth 124, SSN are most by the patient data for creating or updating particular patient 4 data input units 126) afterwards, the switch button 128 for indicating patient's agreement operation, and be somebody's turn to do for executing to be directed to 132 icons of corresponding deletion 130 and preservation of the deletion and preservation function of patient data or oral account.Information can be automatically from electronics disease It goes through in (EMR) system and extracts or be manually entered into various data input units.

Figure 10 shows the first pop-up window 116 of oral account GUI screen 96, wherein for the void of birth on May 21st, 1977 Structure patient " Tim Dentry " fills in information (Social Security Number is blocked).For the ease of explaining, Kelly doctor and Mr. Dentry agrees to that the surgical operation is right carpal tunnel release art.The oral account record of Kelly doctor (can play figure by pressing Mark 118 accesses) may include with subaudio frequency (by way of example)：" I be Wayne Kelly doctors with I together be Patient Tim Mr.s Dentry, his date of birth are on Mays 21st, 1977.I intends to execute right canalis carpi pine to Mr. Dentry Solving skill." audio can optionally include the corresponding of Mr. Dentry and agree to, such as Dentry replied Mr.s Kelly doctor's Solicit " I agrees to " described when agreement problem or " yes, I is ready ", the problem of Kelly doctor such as " Mr. Dentry, you Agree to that this is performed the operationOnce " filling information and patient has agreed to, surgeon can operation button switch 128 It has been obtained for agreeing to reflect, and clicks name, date of birth and the SSN letters for preserving 132 icons to preserve Mr. Dentry Breath and audio oral account (agreement of surgeon and optionally patient), the part of the patient data as Mr. Dentry. If using pop-up window 134 (referring to Figure 11) is substituted, surgeon can also click on " left side " tabs 136, " right side " Tabs 138 or "None" tabs 140 indicate inclined side property.Indicative color such as lavender can be distributed to left tabs 136 click, and red or rosiness is distributed to right tabs 138 and clicked, grey is distributed to no tabs 140 and is clicked.May be used also To input surgery location 142.According on one side, safe data storage device based on cloud can be stored data into, is made Identification data to remove identification/anonymous data or as being used by hospital system and/or insurance company.It can be in Tim Dentry New entry 146 be provided about " work icon " 144 (referring to Figure 12) to reflect that the data are in the mistake being stored in cloud Cheng Zhong.After the completion, work icon 144 will be replaced with " check box " icon 104 shown near patient previous.

Figure 13 is shown in patient by using the system for preventing error location surgical operation and blade associated injury User role GUI screen 64 after the home office portion 66 for passing through medical environment with method 10.For the ease of understanding and quickly Visualization, StartBox is provided about in 72 role of doctor^TMShield 82 is to indicate that the part has been completed.It is determining to carry out surgery Perform the operation and obtain (patient or guardian, depend on the circumstances) agree to after, it would be desirable to scheduling operation, and on the day of surgical operation in Surgical site (such as hospital or surgicenter) receives patient.This can be completed using software systems 12, as above Face is with reference to described in Fig. 3, especially in 50 to 52 stages.Although being retouched above in association with being used together with stationary computers 16 State, it is to be understood that, surgical scheduler 52 and/or patient be admitted to hospital 54 the step of can be via the application version of runs software system 12 Hand-held device 18 execute.If so, the application version (including user role GUI screen 64) of software systems 12 will need It is updated to reflect that the change for the role interaction and function that completion surgical scheduler and patient are admitted to hospital required.

Figure 14 shows that exemplary variation, the application version of wherein software systems 12 are used subsequently in surgery doctor's office In preoperative part 68 in part 66 after use.When patient proceeds to it is preoperative when, preoperative personnel (such as preoperative RN 74) can lead to The handheld apparatus 18 for crossing the application version of runs software system 12 is performed the operation and blade associated injury using error location is prevented System 10 and method.The handheld apparatus 18 that preoperative RN 74 is used is likely to be different from surgeon 72 in its office The physical unit used.Any mode, RN 74 will be needed using password or other safe identification informations (for example, biology before hand Identify such as retina scanning, iris scan, touch tablet digital finger-print, face recognition), so as to the application of access software system 12 The function of version.Once accessing, predetermined role and permission will determine preoperative RN 74 can execute which function and behaviour Make.

Figure 14 shows the rear exemplary preoperative RN GUI screens presented to preoperative RN 74 in his or she access system 10 148, including 92 options of scanning 88 and search.When selection scans 88 function, the scanning function in hand-held device 18 is activated, and Using advancing to scanning GUI screen 150 shown in figure 15.Hand-held device 18 be positioned adjacent to patient patient ID bands 46 ( In this case, Tim Dentry), and scanning function is activated by (automatically or manually) to capture the letter on patient ID bands 46 Breath.In this embodiment, the scanner of hand-held device 18 can scan the bar code or QR codes 152 of patient ID bands 46.This is used In identifying patient using the information being stored in the bar code 152 of patient ID bands 46.In addition to such identification information it Outside, hand-held device 18 may also include any number of biological identification technology and/or with any number of biological identification technology It interacts, such as, but not limited to iris scan, touch tablet electronic fingerprint, heredity matching.Searching for 92 icons allows preoperative RN 74 To execute a variety of search inquiries with above with reference to same way of the surgeon 72 described in its office, there is no need to herein Place repeats.

Figure 16 shows example patient's recording GUI screen 154, in patient ID bands 46 shown in figure 15 by hand-held dress It sets 18 scannings later to occur, including the static information previously preserved in medical environment by other staff is (for example, surgeon does Public room, Surgical Scheduler person, reception etc.), including demographic information 156 (name and age), surgical protocols 158, inclined side 160 (color and titles) of property and surgeon 162.Inclined side property 160 is visualized by the frame 164 coloured with particular color to refer to Show inclined side property, such as red for the inclined side property in right side, and outside colored border 166 is also with red colored.Icon 118 is played back to permit Perhaps preoperative RN 74 plays the audio recording from surgeon office, the audio recording include given an oral account by surgeon it is pre- Phase surgery information, and optionally patient agreement.Pass through the scanner scanning patient ID bands 46 of hand-held device 18, scan arm band Icon 168 will be lit as green or another color, and data of the instruction from patient ID bands 46, which have been incorporated into, prevents mistake In the system 10 and method of position operation and blade associated injury.At this point, scanning StartBox icons 170 need for red or instruction Scan the color of the label of safety blade distributor 14.Then, user (in this case, preoperative RN 74), which can press, sweeps StartBox icons 170 are retouched, which opens pop-up scanning window 172 as shown in figure 17.

Demographic information of the patient's recording GUI screen 154 shown in Figure 17 including pop-up scanning window 172, patient The inclined side property 160 (color and title) of 156 (name and dates of birth) and regulation.Hand-held device 18 is positioned adjacent to pacify The label 174 of full distributor blade 14, and scanning function is stored with capturing in QR codes 176 by (automatically or manually) activation Information (only by way of example).The data on QR codes 176 on the label 174 of safety blade distributor 14 include unique mark Know symbol or sequence number (SN) 177, the identifier or sequence number include indicating associated with the particular safety distributor blade 14 Inclined side property (and color) data.The scanner of hand-held device 18 will read the data from label 174, and by its with it is previous The patient information of preservation and/or expected surgery information are compared.In this illustration, the inclined side property of the regulation is by office Surgeon is determined as right side, and RIGHT (and using red or rosiness) is correctly shown as at band 164 in fig. 17. However, label 174 is " LEFT " in 176 overlay mark of QR codes.

Figure 18 shows the ratio between the patient data by being previously saved and the scanning label 174 of safety blade distributor 14 Compared with " inclined side property mismatches " application screen 178 of generation comprising " inclined side property mismatches " error notification 180 and " NO GO " window Mouth 182.Inclined side property occurs to mismatch mistake 180 to be because being previously stored in prevents error location operation and blade associated injury Patient data in system 10 and method has right avertence side property, and the new scanning label 174 of safety blade distributor 14 has a left side Inclined side property (title and lavender).NO GO windows 182 include replay button 118, to replay the original sound of surgeon office Frequency records, and whether which provides the ability for directly accessing surgery decision source, occurred in patient data with assisting in Error in data, and (if there is) error in data wherein occurs.NO GO windows 182 further include data capture function, with The reason of recording NO GO decisions, including (only by way of example) mistake StartBox check boxes 184, patient record check box Mistake side property partially in 186, and annotation text box 188.

In this case, preoperative personnel have selected safety blade distributor 14 with wrong side property (left side) partially, therefore as schemed Shown in 19, preoperative RN 74 selects " mistake StartBox " check box 184, and annotation is added in annotating text box 188, with Indicate which measure he or she takes (for example, " listening to audio after the inclined side property of determination mismatches.Demonstrate inclined side property.OR It dispatches incorrect.") due to the mistake, then selection " NO GO " button 190, this operation preserve NO GO decisions to preoperative RN 74 And its basic reason, and to surgeon send " NO GO " alert notice, as Figure 20 it is next as shown on screen.“NO GO” Notice will not stop preoperative process, but surgeon is needed to check NO GO notices, and determining if can be in eventually time-out The notice is removed before.If so, eventually time-out (described below) can continue.If it is not, then eventually time-out, hand cannot be executed Art will be cancelled.

Once preventing the system 10 of error location operation and blade associated injury and method that NO GO notices are sent to surgery Doctor, preoperative RN 74 there will be an opportunity to correct the problem, to allow preoperative process to continue.Each correct will depend on wrong generation Code type, the type of the error code may include (but being not necessarily limited to) partially side property mismatch, mistake regulation, mistake patient, Wrongful Birth date, patient refuse regulation etc..In this case, it corrects and is related to abandoning incorrect safety blade distributor 14 (due to left avertence side property), and it is replaced with the new safety blade distributor 14B with right avertence side property.For other Error code, it may be necessary to different amendment steps, including carry out surgeon at this point and intervene with the problem of correcting or cancellation Operation.

Figure 20 shows after sending NO GO notices and is corrected by (in this case, by preoperative RN 74) in problem Exemplary " NO GO " before corrects GUI screen 192, and identical as patient's recording GUI screen 154 of Figure 16, difference exists Include that " NO GO " counter 194 and " NO GO have been sent " notify title 196 in it.After correcting inclined side property and mismatching, then " scanning StartBox 170 " may be selected in preoperative RN 74, and icon is to activate the scanner 200 of hand-held device 18, as shown in figure 21. Then the QR codes 176 of new safety blade distributor 14B can be scanned, and (it is specified by title (RIGHT) and red or rosiness For right avertence side property), and be compared with the patient data being previously saved and/or expected surgery information.Due to present inclined side Property matching, new safety blade distributor 14B can be associated with patient data, and previously occur on NO GO amendments GUI 192 NO GO notice title 196 replaced by the notice title 202 of " StartBox has been associated with ", as shown in figure 22.Hereafter, preoperative RN 74 can select " to continue " icon 204 to verify patient's record, as " patient's record has obtained verification " notice title 206 indicates (being shown in FIG. 23), after this point, preoperative RN can select " continuation " icon 204 as shown in figure 23, so as to Terminate the stage in the process.

Figure 24 shows the example user individual GUI screen 64 that 68 period of stage is presented Xiang doctor 76 in the preoperative.At this In the case of kind, there are 74 icons of RN in the preoperative in the following, indicating the step related to preoperative RN 74 in StartBox icons 82 It completes.

Figure 25 shows pre-operative patients recording GUI screen 208, in patient ID bands shown in figure 15 46 by hand-held device Occur after 18 scannings, including the static information previously preserved in medical environment by other staff is (for example, surgeon handles official business Room, Surgical Scheduler person, reception etc.), including demographic information 156 (name and age), surgical protocols 158, inclined side property 160 (color and titles) and surgeon 162.Inclined side property is visualized by the frame 164 coloured with particular color to indicate partially Side property, for example, it is red for the inclined side property in right side, and outside colored border 166 is also with red colored.Playback 118 allows preoperative doctor Raw 76 play the audio recording from surgeon office, which includes the expection surgery letter given an oral account by surgeon Breath, and optionally patient agreement.Pass through the scanner scanning patient ID bands 46 of hand-held device 18, scan arm band icon 168 To be lit for green or certain color, instruction the data from patient ID bands 46 be incorporated into prevent error location operation and In the system 10 and method of blade associated injury.At this point, scanning StartBox icons 170 need to scan safety for red or instruction The color of the label of distributor blade 14.Then, doctor 76 can press continuation 204 to advance to next screen shown in Figure 26 Curtain.

Since there are inclined side property mismatch, display " covering NO GO " pop screens 210, while showing related previous " NO GO " selection information, including but not limited to nurse's name 212, NO GO times 214 and NO GO the reason of 216.In comment section 218, annotation instruction nurse or doctor listen to audio and confirmed correctly inclined side property.In order to continue The process, doctor touch covering button 220.

Figure 27 is shown once covering button 220 and doctor 76 is activated to scan the pre-operative patients recording GUI after patient Screen 208.The notice title 222 that display covering confirms, and the static information previously preserved in medical environment is (for example, outer Section's doctor's office, Surgical Scheduler person, optionally any preoperative planning/removing, reception etc.), including demographic information 156 (name and ages), surgical protocols 158, inclined side property 160 (color and title) and surgeon 162.Inclined side property passes through use The frame 164 of particular color coloring is visualized to indicate that inclined side property, such as red are used for the inclined side property in right side, and outside colored border 166 also with red colored.Playback 118 allows doctor 76 to play the audio recording from surgeon office, the audio recording Include the expection surgery information given an oral account by surgeon, and optionally patient agreement.Pass through the scanner of hand-held device 18 Patient ID bands 46 are scanned, scan arm band icon 168 will be lit as green or certain color, number of the instruction from patient ID bands 46 According to be incorporated into prevent error location operation and blade associated injury system 10 and method in.At this point, scanning StartBox Icon 170 is red or instruction needs to scan the color of the label of safety blade distributor 14B.Then, doctor 76 can press after Continuous icon 204 is to advance to next screen shown in Figure 28.

Figure 28 shows the example user individual's GUI screens presented to circuit nurse 78 during operating room (OR) stage 70 Curtain 64.In this case, there is 76 icon of doctor in the preoperative in the following, instruction is related to preoperative doctor 76 in StartBox icons 82 The step of completed.

Figure 29 shows OR Phase patient's recording GUIs screen 224, in patient ID bands 46 shown in figure 15 by hand-held dress It sets 18 scannings later to occur, including the static information previously preserved in medical environment by other staff is (for example, surgeon does Public room, Surgical Scheduler person, reception etc.), including demographic information 156 (name and age), surgical protocols 158, inclined side 160 (color and titles) of property and surgeon 162.Inclined side property is visualized by the frame 164 coloured with particular color to indicate Inclined side property, for example, it is red for the inclined side property in right side, and outside colored border 166 is also with red colored.Playback 118 allows touring RN 78 plays the audio recording from surgeon office, which includes the expection surgery given an oral account by surgeon Information, and optionally patient agreement.Pass through the scanner scanning patient ID bands 46 of hand-held device 18, scan arm band icon 168 will be lit as green or certain color, and data of the instruction from patient ID bands 46 have been incorporated into and prevent error location hand In art and the system of blade associated injury 10 and method.At this point, scanning StartBox icons 170 need to scan for red or instruction The color of the label of safety blade distributor 14B.Then, touring RN 78, which can be pressed, continues icon 204 to advance to shown in Figure 30 Next screen.

When Figure 30 is shown in OR 70, and just the exemplary of OR doctor 80 is presented to before executing eventually time-out Individual subscriber GUI screen 64.In this case, StartBox icons 82 appear in 78 icons of touring RN in the following, indicating and patrolling The related steps of RN 78 are returned to have completed.

Figure 31 shows OR Phase patient's recording GUIs screen 224, and OR Phase patient's recording GUI screens are in patient's ID bands 46 are occurred after the scanning of hand-held device 18, including the static information (example previously preserved in medical environment by other staff Such as, surgeon office, Surgical Scheduler person, reception and other patients-healthcare givers are interactive), including demographics Information 156 (name and age), surgical protocols 158, inclined side property 160 (color and title) and surgeon 162.Inclined side property is logical It crosses the frame 164 coloured with particular color to visualize to indicate inclined side property, such as red for the inclined side property in right side, and outside colours Boundary 166 is also with red colored.Playback 118 allows OR doctor 80 to play the audio recording from surgeon office, the sound Frequency record includes the expection surgery information given an oral account by surgeon, and optionally patient agreement.Pass through hand-held device 18 Scanner scanning patient ID bands 46, scan arm band icon 168 will be lit for green or certain color, instruction come from patient's ID bands 48 data have been incorporated into the system 10 and method for preventing error location operation and blade associated injury.At this point, scanning StartBox icons 170 are red or instruction needs to scan the color of the label of safety blade distributor 14B.Then, OR doctor 80 can press continuation icon 204 to advance to next screen shown in Figure 32.

Once verification, doctor activates eventually time-out slider bar 226 (Figure 32), to indicate OR doctor's 80 executed last time Check to ensure that patient, regulation and inclined side property are correct, and regulation can start.Figure 33 is shown to be activated in OR doctor 80 Continue OR Phase patient's recording GUIs screen 224 after button 204.Such as pass through " patient's record has obtained verification " notice title 228 Indicated, have verified that patient records, and have been pointed out eventually time-out activation.Then, OR doctor 80 swashs before operation starts Final continuation button 204 living.

Figure 34 show all parts in method be completed and surgical operation have begun after individual subscriber GUI Screen 64.In this case, StartBox icons 82 appear in 80 icon of OR doctor in the following, instruction and the relevant step of OR doctor Suddenly (most significantly eventually time-out) has been completed.At this point, the confirmation label 174 on safety blade distributor 14 can be removed simultaneously Patient charts (or other suitable positions) are attached to, to allow surgeon to access the surgical blade needed for agendum.

The system 10 (as described above) of the disclosure may include about the additional spy being imaged to patient for pre- stage operation Sign portion.More specifically, software systems 12 (either being used on computer 16 or hand-held device 18) allow surgeon The certain preoperative imagings (computed tomography (CT), positron emission tomography (PET), etc.) of given patient experience, For preoperative and perioperative inspection or removing.For example, software 12 may be configured such that surgeon (in figure 3 The decision stage 50) may be selected or switching " required imaging " option, and with it is specified or describe he or she it is requested it is specific at The ability of picture, the imaging can be saved in the electronic bits of data of patient.If necessary to be imaged, Surgical Scheduler person can be used This information (at the stage 52 of Fig. 3) is to help to arrange requested imaging.As patient continues to treat, software 12 may be used also To include the correlation function for using, such as (but being not necessarily limited to) provides selection or switching " available imaging " option, Chinese medicine Business personnel (for example, preoperative personnel) can check system 10 to ensure that the imaging of request actually makes for surgeon in OR With.If it is not, they can be switched or indicate no available imaging, and " NO GO " is selected, thus surgeon can check simultaneously Decide whether to carry out surgical operation in the case where being imaged without request.Software 12, which may also include, allows surgeon to check imaging (if available), and would optionally select or switch the function of " imaging inspection " option.It is provided for surgeon and asks summation check The ability of imaging can help to prevent the imaging read by other medical professionals (for example, radiologist) may by Otherwise the possibility of execution or misregister may cause the information in patient data inaccurate.In this case, surgery Doctor can be imaged in (or after being admitted to hospital) assessment directly in situations in the surgery room, and determine whether any such mistake.If not provided, Operation can continue.If so, operation can stop carrying out.

Safety blade distributor

Figure 35 to Figure 55 shows that a specific example of safety blade distributor 14, the safety blade distributor are suitble to It is used together with method in surgical protocols with the system 10 of error location operation and blade associated injury is prevented, although safety blade Distributor 14 is independently of the system 10 for preventing error location operation and blade associated injury and method to use.It is described herein Safety blade distributor 14 provide the compact and convenient container for storing and delivering a variety of surgery sharp weapon, the surgery Sharp weapon include but not limited to surgical blade (being shown by the example of this paper), scalpel, needle, probe, syringe etc..It such as will be under Described in the text, safety blade distributor 14 can have removable confirmation label and/or additional features, to help to reduce mistake The accidentally incidence of position operation.In general, the safety blade distributor 14 described by way of example herein includes having storage part Divide and the substantially rectangular container of handle portions, the storage section include being protected with four blades that 1 × 4 matrix configuration is arranged side by side Holder.Tip holder can slide in same direction so that all four surgical blades are removed on the same side of device.To the greatest extent Pipe shows and describes relative to the exemplary implementation scheme, but without departing from the scope of the disclosure, surgical blade Other box-shapeds and/or configuration be also possible.

With reference to Figure 35 to Figure 40, this exemplary safety blade distributor 14 includes shell 302, which includes the first shell Panel 304 and second housing panel 306, and be configured to releasably hold at least one blade holding of surgical blade 310 Device assembly 308.First housing face-plate 304 and the cooperation of second housing panel 306 are to form complete enclosure 302.Preferably, safety Distributor blade 14 includes multiple tip holder components 308.For example, safety blade distributor 14 as described herein includes Four tip holder components 308, however any amount of tip holder component 308 is all possible.Tip holder group Part 308 can move between first position and final position, and in first position, surgical blade 310 is fully accommodated in shell 302 Interior (such as Figure 35 to Figure 38), in final position, at least part of surgical blade 310 is from 302 protrusion of shell (such as Figure 39 To Figure 40) so as to remove surgical blade 310 from shell 302.For example, which can be unidirectional or two-way.

302 general size of shell is compact, is kept to allow safety blade distributor 14 by the palm of used aloned person And operation, while it is sufficiently large to accommodate and distribute at least one surgical blade 310.Shell 302 is substantially rectangular shape, this is outer Shell has round and/or fan-shaped edge 336 in order to grasp.Shell 302 can be made of plastics or any other suitable material. Referring to Figure 42, shell 302 also has an internal cavity 312, and side is the first housing face-plate and second housing panel 304,306, Middle tip holder component 308 and surgical blade 310 reside therein.Blade 310 is by being formed in the distal end of shell 302 Distal openings 316 in 318 occur from internal cavity 312, the proximal end 314 of wherein blade 310 be provided for properly Receiver (such as scalpel shank) be connected.It, can be from tip holder component 308 once blade 310 is attached to receiver It removes completely and is used for surgical protocols.

Figure 41 to Figure 44 illustrates in greater detail the first housing face-plate 304.First housing face-plate 304 includes substantially in flat Face, substantially rectangular component, the component have first end or distal end 320, the second offside or proximal end 322, interior table Face 324 and outer surface 326.When the first housing face-plate 304 coordinates with second housing panel 306 to form shell 302, inner surface 324 towards internal cavity 312.Inner surface 324 is substantially smooth and generally planar, and side connects to form 302 side wall 330 of shell The perimeter ridge 328 of a part.Perimeter ridge 328 can have several features for meeting ergonomics so that user can relax It fits and gripping with one hand and safe operation distributor blade 14, the features includes but not limited to the proximal being bent securely 332, rounding nearside corner 334 and multiple fan-shaped dents 336.334 use of proximal 332 and rounding nearside corner of bending The hand of person can be experienced and smoothly feel, and fan-shaped dent 336 provides additional grasping for the finger of user.

From distal end 320, proximally end 322 extends longitudinally inward multiple parallel elongated walls 338.Two elongated walls Space between 338 forms channel 340, and being sized and configured to of the channel can slidably receive one wherein Tip holder component 308.Therefore it provides the quantity of elongated wall 338 include depending on particular safety distributor blade 14 The quantity and/or type of surgical blade 310 (or other surgery sharp weapon).In this example, the first housing face-plate 304 includes interval Five elongated walls 338 opened, to form four channels 340 to accommodate four tip holder components 308 wherein.Each channel 340 further include passing through the first housing face-plate 304 to be formed and from distal end 320 between the inner surface and the outer surface 324,326 The elongate slit 342 to extend internally.As will be described in detail further below, elongate slit 342 allows tip holder 308 carry out controlled translation in channel 340.Elongate slit 342 is configured to that the blade passed through is slidably received to protect The column 420 of holder 308.Each elongate slit 342 further includes first or nearside those widened sections 344 and second or distal side those widened sections 346. In period of assembly, nearside those widened sections 344 allow the cross bar 422 of tip holder component 308 to pass through the first housing face-plate 304, and And it is shown approximately as the hole of rectangle by way of example.When pivoting (and leaving medium pore 428) far from surgical blade 310, Distal side those widened sections 346 allow the forming end 418 of tip holder component 308 to pass through the first housing face-plate 304 so that work as blade When device assembly 308 being kept to translate completely, shell blade 310 can be removed.For example, distal side those widened sections 346 are included in nearside There are one the substantially rectangular cutout units at edge for tool at end 320.

First housing face-plate 304 further includes locking plate 348, which is configured to prevent the first housing face-plate 304 from existing Do not have to be detached from from second housing panel 306 in the case of enough target force effects.Locking plate 348 include inwardly biasing (for example, into Enter the internal cavity 312 of shell 302) flange 350.When shell 302 is equipped adequately in, outside the adjoining of locking plate 348 second The locking column 380 (referring to Figure 45) of shell surface plate 306 prevents the first housing face-plate and second housing panel 304,306 to be detached from.In order to Safety blade distributor 14 is unlocked, user is inserted into suitable unlock work by the nearside solution lockhole 378 of second housing panel 306 Tool so that unlocking tool engages locking plate 348.Then, user applies enough power so that locking plate 348 resists inside biasing It is pivoted and promotes locking column 380 so that the first housing face-plate 304,306 can be disengaged from each other.For example, if user thinks 310 external member of different surgical blades is loaded before starting surgical protocols, this may be necessary.

Referring now to Figure 43 to Figure 44, when the first housing face-plate 304 cooperatively forms shell 302 with second housing panel 306 When, outer surface 326 is far from internal cavity 312, and the outer surface is the surface with the palmistry interaction of user.Therefore, outside Surface 326 can have one or more friction elements to improve grasping of the user on device.Outer surface 326 further include with often A pair of angled flange 352 that 342 side of a elongate slit connects.Each inclined flange 352 include the first chamfered portion 354, Approximate horizontal middle section 356 and the second sloping portion 358.First sloping portion, 354 proximally positioned those widened sections 344 are attached Closely, and include inclined flange 352 the thinnest part.Middle section 356 is substantially horizontal (for example, being roughly parallel to outer surface 326).Second sloping portion 358 is centrally positioned near part 356, and includes the thick of inclined flange 352.As incited somebody to action It explains more fully below, inclined flange 352 and tip holder component 308 interact with from keeping device assembly Surgical blade 310 is discharged in 308, to enable blade 310 and receiver appropriate (for example, scalpel shank) phase interaction With.

Figure 45 to Figure 46 illustrates in greater detail second housing panel 306.Second housing panel 306 includes substantially in flat Face, substantially rectangular component, the component have first end or distal end 360, the second offside or proximal end 362, interior table Face 364 and outer surface 366.When second housing panel 306 and the cooperation of the first housing face-plate 304 are to form shell 302, inner surface 364 towards internal cavity 312.Inner surface 364 is substantially smooth and generally planar, and side connects to form 302 side wall 330 of shell The perimeter ridge 368 of a part.Perimeter ridge 368 can have several features for meeting ergonomics so that user can relax Suitable and gripping with one hand and operate surgery sharp weapon distributor 300 securely, the features include but not limited to the proximal edges being bent Edge 370, rounding nearside corner 372 and multiple fan-shaped dents 374.The proximal 370 of bending and rounding nearside corner 372 make The hand of user can be experienced and smoothly feel, and fan-shaped dent 374 provides additional grasping for the finger of user.

Second housing panel 306 further includes the multiple elongated opens 376 being located near distal end 360.Elongated open 376 not only act as the effect for allowing the joint flange 396 of tip holder component 308 to pass through second housing panel 306, but also Visual windows are provided, user can check the surgical blade 310 being included in by the window.Nearside solution lockhole 378 is located in Near proximal end 362, and if desired, user is allowed to unlock safety blade distributor 14.Locking column 380 is located in closely Side end 362 nearby and from inner surface 364 extends.As previously explained, locking column 380 interacts with locking plate 348 To prevent shell 302 from separating, except non-user it is expected that it is separated.Nearside connecting flange 382 and distal side connecting flange 384 respectively by The nearside connection holes 386 on the first housing face-plate 304 of engagement and distal side connection holes 388 are configured to, shell 302 is maintained at one It rises.

Figure 47 to Figure 49 illustrates in greater detail the example that surgical blade keeps device assembly 308.It is as described herein outer Section's tip holder component 308 includes the top panel 390 for being connected to bottom panel 382 so that in top panel and bottom faces Space 384 is formed between plate 390,392.Top panel 390 includes the joint flange for being approximately perpendicular to the extension of top panel 390 396.Joint flange 396 extends through the elongated open 376 of second housing panel 306, and includes angled top surface 398, which may include one or more friction elements 400 (such as ridge), used with improving user Period moving blade keeps the ability of device assembly 308.

For example, bottom panel 392 have substantially rectangular shape, and include first or proximal end 402 and Second or distal end 404.Proximal end 402 includes the attachment column 406 extended from the upper surface of bottom panel 392, top surface Plate 390 is attached the attachment column to form space 394.Bottom panel 392 further includes being formed in wherein and from distal end 404 Extend to the elongate recessed concave portion 408 of the inside of bottom panel 392.With proximal end 412, distal end 414 and middle section 416 elongated flanges 410 are extended proximally to be returned across elongate recessed concave portion 408.The proximal end 412 of elongated flanges 410 is attached To bottom panel 392 (or can be used as its integral extension).The distal end 414 of elongated flanges 410 include size and Construction is configured to be securely engaged the forming end 418 of 310 centre bore 428 of surgical blade.Forming end 418 extends super Cross the distal end 404 of bottom panel 392.Middle section 416 includes the cross bar 422 with the end for being located in column 420 Column 420.The elongate slit 342 for being dimensioned to extend through the first housing face-plate 304 of column 420 simultaneously translates wherein.

When tip holder component 308 translates during use, cross bar 422 connects each elongate slit 342 with side Inclined flange 352 interact.More specifically, when tip holder component 308 is translated to the far side along channel 340, cross bar First sloping portion 354 of 422 engagement angled flanges 352 first.This initial interaction is to tip holder component 308 Translational motion provides certain physical resistance, and helps to prevent surgical blade 310 from surprisingly popping up.That is, in order to gram The physical resistance to translation is taken, user must apply joint flange 396 power of bigger.Once cross bar 422 reaches middle part Divide 356, the proximal end 314 of surgical blade 310 starts to expose from corresponding distal openings 316.At this point, user's observable knife Dimension mark in the proximal end 314 of piece 310, to confirm as expected surgical blade 310.Need additional power to cross Second sloping portion 358, because second sloping portion is with the angle tilt bigger than the first chamfered portion 354.This phase interaction With 410 temporary bend of elongated flanges is forced, this promotes forming end 418 to leave the centre bore 428 of surgical blade 310 (for example, figure 40) it, to allow surgical blade 310 to be engaged with another instrument (for example, scalpel shank), and is moved from safety blade distributor 14 It removes.

Figure 50 shows an example of the surgical blade 310 of the safety blade distributor 14 suitable for the disclosure.Citing For, surgical blade 310 includes bonding part 424 and blade 426.Bonding part 424 includes centre bore 428, centre bore tool There are the size and shape complementary with forming end 418, to accommodate forming end 418 wherein securely.

With reference to Figure 51 to Figure 52, safety blade distributor 14 illustrated and described here, which can have, confirms label 174, with side Helping reduces the incidence of error location operation.Confirm that label 174 is placed such that unless and only user removes label 174, user could be close to surgical blade 310.Confirm adhesive-free on label 174, but attached by the adhesive tape of attachment 432 On safety blade distributor 14, label 174 can tear from the adhesive tape.For example, confirm that label 174 may include printing On label, and/or any suitable trouble that can include in the form of scan code (for example, QR codes 176, bar code etc.) by electronics Person's data so that user must first be scanned before removing confirmation label 174.Confirm label 174 further include pulling-on piece 436 with Easily and effectively remove.Other than patient data, confirm that label 174 may include inclined side property indicator 438, the inclined side indicator The inclined side property (if there is) of the regulation can be conveyed to user in a visual manner immediately.The inclined side property indicator 438 may include word Word and/or be that color encodes.For example, label may include words " LEFT ", and/or it is lavender, to indicate a left side Side surgical operation；It is " RIGHT " and/or red, to indicate right side surgical operation；And " NO LATERALITY " and/or grey, To indicate unbiased side property.Once confirming that label 174 is removed, you can attach it to patient's note by any suitable method Record.

As shown in Figure 53 to Figure 55, the safety blade distributor 14 of the disclosure is preferably provided in dual aseptic packaging 440 Interior, which is arranged in the container 442 with transparent window portion 444.More specifically, safety blade distributor 14 are arranged in the first aseptic packaging 446, and then first aseptic packaging is sealed in the second aseptic packaging 448.First nothing Bacterium bag fill 446 and second aseptic packaging 448 be all transparent and relatively easily open (respectively using being located in each packaging 446, the pulling fin 450,452 on 448 one end is opened).In conjunction with aseptic packaging 446,448 be arranged in container 442, make The transparent window portion 444 of container 442 and the first transparent aseptic packaging and the second aseptic packaging 446,448 scanning can be passed through by obtaining Confirm the identification information (for example, QR codes 176 and/or partially side property indicator 438) on label 174.In this way, can avoid needing in office Identification information having the same in what packaging (i.e. the first aseptic packaging 446, the second aseptic packaging 448 or outer container 442).This drop Low manufacturing cost and multiple package members are matched to ensure its complexity with same identification information, if not with transparent Transparent aseptic packaging 446 in the container 442 of window portion 444 (identification information on label 174 can be scanned by it), 448, then above-mentioned manufacture will be required.

Although safety blade distributor 14 is shown and described as with four tip holder components 308 being arranged side by side (for example, 1 × 4 matrix), but other configurations are also possible.For example, relatively narrow container can be provided, wherein blade 310 is with flat 2 × 2 matrix configurations in face arrange that two of which blade 310 pops up in one direction and another two blade pops up in opposite direction. Planar configuration allows all four peep holes to be located on the same side of device in order to be counted to blade.Alternatively possible configuration 2 × 2 matrix configurations including stacking, wherein all four blades 310 can pop up in same direction, but at any time Only there are two visible.User will have to rotation container to check other two blades.In another alternative exemplary, it is possible to provide Non-rectangle container, wherein blade 310 pop up at a slight angle.Blade configuration in this container can be 1 × 4,2 × 2 or Any other configuration to user security.

The blade 310 provided in safety blade distributor 14 is by carefully selecting before corrective surgery.Therefore, safety The physical proximity that distributor blade 14 is constantly in patient before the surgery is vital.Possibility as a kind of is peace Full distributor blade 14 (as provided in dual aseptic packaging 440 and external container 442 in Figure 54 to Figure 55, has clear Clear visible confirmation label 174) case history of patient is attached in a manner of non-obstruction.The attachment can pass through any suitable side Method realizes, for example, including but not limited to rubber band, adhesive tape, binder (integrated or independent), loop fasteners (for example, Velcro), the hole etc. of sucker, zipper strip, buttonhole loose-leaf binder.Another possibility is directly to be attached safety blade distributor 14 To patient, such as pass through wrist strap or ankle strap.Another possible position can be that safety blade distributor 14 is attached to trouble The infusion support or instillation bag of person.

Safety blade distributor 14 described above includes an example of sharp weapon distributor, and the sharp weapon distributor is special (by way of example) is configured safely to accommodate and pop up the surgery sharp weapon 310 of scalpel blade form, for hand It must be subsequently attached to shank before art.However, in some cases, selection and pop-up have pre-assembly (or integrally formed) Blade and the cutting device of shank can be beneficial.Figure 56 to Figure 57 shows an example of surgery sharp weapon distributor 454, The surgery sharp weapon distributor is configured as safely accommodating and selectively popping up one or more larger surgery sharp weapon, all The complete scalpel 456 for including shank 458 and blade 460 as shown in Figure 58 by way of example.

This exemplary surgery sharp weapon distributor 454 is in form and is functionally similar to above-mentioned safety blade distributor 14, Therefore identical feature will no longer carry out second of description.It will be appreciated, however, that above for described in safety blade distributor 14 Any feature can unconditionally be applied to surgery sharp weapon distributor 454 alone or in combination.In general, sides of this paper to illustrate The surgery sharp weapon distributor 454 of formula description includes the substantially rectangular container for having storage section and handle portions, the storage part Divide includes keeping device assembly with four surgery sharp weapon that 1 × 4 matrix configuration is arranged side by side.Keep device assembly can be in same direction Sliding so that all four surgery sharp weapon are removed on the same side of device.

This exemplary surgery sharp weapon distributor 454 includes shell 462, which includes at least one be configured as releasably Ground keeps the sharp weapon of surgery sharp weapon (for example, scalpel 456) to keep device assembly 464.Preferably, surgery sharp weapon distributor 454 wraps It includes multiple sharp weapon and keeps device assembly 464.Only by way of example, surgery sharp weapon distributor 454 as described herein includes four profits Device fastener component 464, however any amount of sharp weapon fastener component 464 is all possible.Sharp weapon keep device assembly 464 can Moved between first position and final position, in first position, surgery sharp weapon 456 be fully accommodated in shell 462 (such as Figure 56), in final position, at least part of surgery sharp weapon 456 protrudes (such as Figure 57) so as to from outer from shell 462 Shell 462 removes surgery sharp weapon 456.For example, which can be unidirectional or two-way.

462 general size of shell is compact, to allow surgery sharp weapon distributor 454 by the palm of single user keeping and Operation, at the same it is sufficiently large to accommodate and distribute at least one surgery sharp weapon 456.With the shell of above-mentioned surgery sharp weapon distributor 300 As 302, shell 462 it is generally rectangular in shape, there is round and/or fan-shaped edge 466 in order to grasp.Shell 462 Further include the proximal end 468 that extends to accommodate larger surgery sharp weapon, such as this exemplary scalpel 456.Shell 462 also has interior Portion's cavity, sharp weapon keep device assembly 464 and surgery sharp weapon 456 to be located therein.Sharp weapon 456 are passed through the distal end of shell 462 Opening in 470 is exposed from internal cavity, and the proximal end 472 of wherein scalpel 454 is provided for keeping device assembly 464 from sharp weapon It removes to be used subsequently to surgical protocols.

As previously mentioned, preventing the system 10 of error location operation and blade associated injury from allowing tracking before being hospitalized to reality The various data of surgical protocols, software systems 12 can generate any one of various analyses 48 using these data.Analysis The one kind being generally divided into following five class：Descriptive, diagnostic, discovery property, predictability and normalization.For most description Property analysis include may the related initial data of the surgery event of acquisition with system 10.These analyses can be based on but the fixed limit that differs In so-called " near miss " data (that is, the mistake for finding and avoiding during using system 10), type of surgery and inclined side property, Surgical outcome, postoperative complication, patient demographic, geography information, and to each interaction of system 10 or using related Date, time, position and the personnel of connection are to improve efficiency and accountability.

Diagnostic analysis indicates next stage analysis, and is usually directed to the descriptive analysis number that parsing is collected by system 10 According to attempt to determine why that particular event (such as " near miss " event) occurs.It was found that property analysis considers want true why The later problem of the fixed content acquired from the data of acquisition.For example, it was discovered that property analysis can be used for finding and specific surgical procedure Team, hospital, geographic area, medical system and/or the associated data of regulation trend.Predictability analysis is established in discovery property On the basis of analysis, to determine the thing that may occur in the future in view of the thing actually occurred in the past.For example, passing through analysis It is attributed to the past trend and/or event of personal contributor, team, place or geographical space level, it perhaps can be to wrong portion The probability of the contribution event of position operation and/or other medical malpractices proposes actively to alert.

Finally, normative analysis all takes into account all previous analysis information, to assist in specific action side Case, to which error location surgical event and/or other medical malpractices be restricted or prevented.For example, according to before collecting and analyzing Data, it may be determined that the team that can be benefited from specific training module or individual, determination can have to the close difference in particular error side The particular protocol of the instruction of wrong event, the medical system that determination can be improved by additional process or communication steps, and/or to Health insurance company determines the risky client and area that medical-risk consulting may be beneficial.For example, based on " near miss " number According to analysis 48 can be provided to hospital and/or insurance company and/or quality improvement expert about the mistake that may be had occurred and that Or the worth of data of possible mistake, to push remedial measure to minimize or avoid such mistake occur in the future.These Analysis 48 can be also used for based in hospital system (" in system ") and/or in multiple and different hospital systems (" between system ") The data of collection identify best practices, and it is wrong to be further reduced error location operation to be evaluated to identify best practices Accidentally.These best practices (for example, the change in shifts eliminated in medical environment during certain stages reduces near miss) can be with It shares and is carried out with the hospital of participation or surgicenter to further decrease the possibility or machine of error location operation Meeting.

Figure 59 to Figure 64 shows the several examples for the analysis that can be acquired during use by system 10.Figure 59 is description Property analysis an example (for example, body part is damaged), frequency of the display damage data relative to average frequency.Figure 60 Show the map in the U.S. and the geographical space incidence of certain medical events.Figure 61 is to have an X-rayed the another of the U.S. illustrated One width map, for example, giving the more three-dimensional view of certain medical events incidences.This is one of the analysis of discovery property and shows Example, analyst finds the pattern or trend of data by the analysis of discovery property, and can therefrom draw a conclusion.Figure 62 is descriptive analysis Another example, it illustrates in specific one week in other success surgery events near miss data incidence. Figure 63 can be an example of discovery property analysis, wherein recordable safety accident presses tissue grouping, perhaps it is to find number According to trend.Figure 64 is another descriptive analysis, shows the damage number that opsition dependent divides, and related to each event Some costs of connection.

Mistake segment surgery prevents

Certain operations (including but not limited to spinal operation) can be in the certain organs, structure or region of patient anatomy It is executed at interior more than one segment or position, this may correctly identify surgeon the level of pre- stage operation causes to challenge. According to one aspect of the disclosure, it is more than " note to prevent the system 10 of error location operation and blade associated injury from may include extending Record time-out " step (for example, the correct position verification process of the step 62) of Fig. 3, and can be before surgeon executes time-out And/or it carries out later.

For example, in spinal operation, even if after eventually time-out inspection has been completed and is verified, however it remains error location The risk of the especially wrong segment surgery of operation.Partially due to the repeated spinal structure of backbone, surgeon may be not It can always identify whether such as operation window changes level for any reason.Surgeon is in spinal operation using in art The details such as positioning, the operative approach angle that fluoroscopy is imaged to verify spinal implant are much.It is as described herein Prevent the system 10 of error location operation and blade associated injury from enabling surgeons to verify impacted spinal segments in art Position to help to avoid wrong segment event.

Figure 65 shows that error location from performing the operation and blade associated injury is to prevent using preventing during being depicted in spinal operation The flow chart of the step of illustrative methods of the system 10 of mistake segment surgery.In step 600, execution, verification are originally exemplary " time-out " sequence is simultaneously recorded in application.This allows regulation to start and carry out initial cut 602.It is having been established to expected spinal segment After the exposure of section, radiographic label object 604 is placed in expected operative site.In next step 606, such as using Image in the art of the expected operative site of C-arm shooting.The image is usually displayed on the screen in OR.Then, user will use The camera 34 (Fig. 2) of hand-held device 18, the hand-held device prevent error location operation and blade phase by the operation of software application 12 The system 10 for closing damage, to shoot an at least photo for impacted spinal segments and be displayed on the screen (step 608).So Afterwards, software application 12 is via the photo and the art in PACS hospital databases for merging or being overlapped the expection position obtained recently Preceding diagnostic image is compared (step 610).If preventing the instruction of system 10 of error location operation and blade associated injury from depositing (step 612) is matched at position, then user can tap " continuation " button to confirm the verification and it is anticipated that (step of being performed the operation 614).But if preventing the system 10 of error location operation and blade associated injury from determining that photo mismatches (step 616), It then generates NO GO message and surgeon's movement indicia object and reimaging (step 618) can be prompted.In step 612, may be used The sequence is repeated as needed repeatedly to obtain position matching verification.

In some cases, preventing the system 10 of error location operation and blade associated injury from including can be in " record time-out " Step is (for example, the more correct position verification process of image executed before the step 62) of Fig. 3.It is based on coming from for example, can be used Pre-operative image of the existing marker in identical or approximated position in previous surgical protocols determines correct segment.For example, In backbone patient, existing marker may include the hardware of any implantation (for example, screw, bar, implantation material, intervertebral spacer Deng).In prostate patient, radiography pearl that the example of existing marker will be implanted into before for it.Then, software application 12 passes through Image by merging or being overlapped the expection position from previous procedure and the preoperative diagnosis image in PACS hospital databases It is compared.If there is matching, then surgeon can confirm targeted level relative to mark before manufacturing initial notch Remember the position of object.

It should be appreciated that the present invention is not limited to the specific device for being described herein and/or showing, method, condition or parameters, and The term as used herein is only used to describe specific embodiment by way of example.Therefore, term is intended to be widely interpreted, and It is not intended to be limited to by right claimed invention.For example, such as including the used in the description of appended claims, Singulative "one", "an" and "the" include plural form, term "or" means "and/or", and to special value Reference includes at least the particular value, unless the context is clearly stated.In addition, any method as described herein is not intended to limit It in the sequence of the step, but can carry out in other sequences, unless clearly stating otherwise herein.

Although describing the present invention with reference to exemplary implementation scheme, it will be understood by those skilled in the art that Various modifications, addition and deletion are all fallen in the scope of the present invention being determined by the claims that follow.

Claims (47)

1. a kind of for being prevented during the associated surgical protocols of individual with interaction in medical environment or trace error position The system of mistake, including：

Computer implemented electronic device, the computer implemented electronic device have for showing the screen of image, being used for Create audio file microphone, for plays record audio file loud speaker, be able to carry out instruction processor and Data storage medium for storing instruction, described instruction make the processor when executed by the processor：

It preserves and shows the personal electronic bits of data for the interaction in medical environment；

It records and plays and the relevant audio file of the medical protocol；And

The time-out of electronical record can be carried out before starting the surgical protocols associated with the individual；With

Surgery supply carries part, and it includes making during for the surgical protocols of the individual that the surgery supply, which carries part, One or more surgical instruments or component, it includes storage medium that the surgery supply, which carries part, and the storage medium includes It is described personal the associated electronic bits of data of the identification information of part to be carried with surgery supply so that unique surgery is taken Holder is associated with the patient.

2. it is according to claim 2 for being prevented during surgical protocols or the system of trace error position mistake, wherein It includes at least one component that the surgery supply, which carries part, and at least one component prevents or prevent individual is close to be stored in it In one or more of surgical instruments or component.

3. it is according to claim 1 for being prevented during surgical protocols or the system of trace error position mistake, wherein It is safety blade distributor that surgery supply, which carries part, the safety blade distributor include one or more surgical blades simultaneously And suitable for assisting one or more of surgical blades being fixed to surgical blade shank, while minimally being connect with user It touches.

4. it is according to claim 1 for being prevented during surgical protocols or the system of trace error position mistake, wherein The surgery supply for being adapted for secure to the individual of interaction in medical environment carries part or the electronic recognition component packet Include tracking mechanism.

5. it is according to claim 4 for being prevented during surgical protocols or the system of trace error position mistake, wherein The tracking mechanism is RFID tag.

6. it is according to claim 1 for being prevented during surgical protocols or the system of trace error position mistake, wherein The electronic bits of data of the individual includes the data for identifying one or more types of the individual, will arrange to the individual The instruction of the inclined side property of medical protocol and regulation of execution.

7. it is according to claim 6 for being prevented during surgical protocols or the system of trace error position mistake, wherein The instruction of the inclined side property of regulation includes the label based on color.

8. it is according to claim 1 for being prevented during surgical protocols or the system of trace error position mistake, wherein The audio-frequency information includes label, and the label description will arrange that regulation executed to the individual.

9. it is according to claim 1 for being prevented during surgical protocols or the system of trace error position mistake, wherein Described instruction further makes the processor show the analysis to affairs when being executed by the processor, and the analysis is described Individual occurs in the medical environment during the period of interaction.

10. it is according to claim 9 for being prevented during surgical protocols or the system of trace error position mistake, wherein It is described analysis shows that including error location operation near miss data, error location operation wrong data or combinations thereof.

11. it is according to claim 1 for being prevented during surgical protocols or the system of trace error position mistake, wherein The computer implemented electronic device be configured as include the surgical protocols stopped decision input instruction.

12. it is according to claim 1 for being prevented during surgical protocols or the system of trace error position mistake, wherein The processor shows data associated with the mark of a people patient.

13. it is according to claim 1 for being prevented during surgical protocols or the system of trace error position mistake, wherein The processor shows the information about surgical protocols associated with patient.

14. it is according to claim 13 for being prevented during surgical protocols or the system of trace error position mistake, In about the described informations of surgical protocols associated with patient include required surgical protocols.

15. it is according to claim 1 for being prevented during surgical protocols or the system of trace error position mistake, wherein Described information about surgical protocols associated with patient includes letter related with the required inclined side property of the surgical protocols Breath.

16. it is according to claim 15 for being prevented during surgical protocols or the system of trace error position mistake, In described information related with the required inclined side property of the surgical protocols be specific to left side operation, right side procedures or middle part The color coding of position operation.

17. it is according to claim 1 for being prevented during surgical protocols or the system of trace error position mistake, wherein The computer implemented electronic device includes camera.

18. it is according to claim 1 for being prevented during surgical protocols or the system of trace error position mistake, wherein The computer implemented electronic device is configured as scanning and interpreting optical data.

19. it is according to claim 1 for being prevented during surgical protocols or the system of trace error position mistake, wherein It includes optical data that the surgery supply, which carries part or the electronic recognition component,.

20. it is according to claim 19 for being prevented during surgical protocols or the system of trace error position mistake, Described in optical data in the form of bar code or QR codes.

21. it is according to claim 1 for being prevented during surgical protocols or the system of trace error position mistake, wherein The computer implemented electronic device is configured as reading biological attribute data.

22. it is according to claim 21 for being prevented during surgical protocols or the system of trace error position mistake, Described in biological attribute data include finger print data, face recognition data, iris recognition data, retina scan data, DNA numbers According to or combinations thereof.

23. it is according to claim 1 for being prevented during surgical protocols or the system of trace error position mistake, wherein Which the computer implemented electronic device is configured as tracking and indicate when the individual advances in the medical environment A little medical workers execute inspection to the individual.

24. a kind of for being prevented during the associated surgical protocols of individual with interaction in medical environment or trace error position The method of mistake, including：

Using computer implemented electronic device, the computer implemented electronic device have for show image screen, For record audio file microphone, for play record audio file loud speaker, be able to carry out instruction processor, And data storage medium for storing instruction, it is more that described instruction executes the processor when being executed by the processor A function, the multiple function are prevented or are tracked and the personal associated error location mistake of the interaction in medical environment, institute It includes electronic patient data to state electronic device, and the electronic patient data includes the audio containing the related information with the individual Message, described information include at least patient's name or other identifier information and the description to the surgical protocols；

Part is carried to personal distribution surgery supply based on the information from the electronic patient data, wherein the distribution walks Rapid includes supplying the electronic bits of data of individual and the surgery to carry the identification information of part and be linked so that uniquely It is associated with the individual that surgery carries part；

Tracked when the individual advances in entire medical environment surgery supply carry part with obtain and record with it is described The data of intercorrelation of the individual in the medical environment include the data about error location surgical errors；And

It is described it is personal with the medical environment in one or more personnel transfers when, enable the personnel in the medical environment It is more than enough time to listen to recorded audio message.

25. prevented during individual's associated surgical protocols according to claim 24 with interaction in medical environment or The method of trace error position mistake, it is further comprising the steps of：

At position before the surgery, obtain surgery supply and carry part, and by will with the individual related information It is compared to carry out preoperative evaluation with the related described information of part is carried with surgery supply；And

The preoperative evaluation, the label description and institute are recorded by providing label to the computer implemented electronic device It is identical or different to state personal associated described information and carry the associated described information of part with surgery supply.

26. prevented during individual's associated surgical protocols according to claim 25 with interaction in medical environment or The method of trace error position mistake, it is further comprising the steps of：

In surgical site, obtain the surgery supply and carry part, and by will with the individual related information and with institute Surgery supply is stated to carry the related described information of part and be compared to carry out operation assessment；And

The preoperative evaluation, the label description and institute are recorded by providing label to the computer implemented electronic device It is identical or different to state personal associated described information and carry the associated described information of part with surgery supply.

27. prevented during individual's associated surgical protocols according to claim 24 with interaction in medical environment or The method of trace error position mistake, it is further comprising the steps of：Execute eventually time-out；And the eventually time-out is stored in institute It states in computer implemented electronic device.

28. prevented during individual's associated surgical protocols according to claim 24 with interaction in medical environment or The method of trace error position mistake further includes the steps that the analysis provided to affairs, and the analysis is in the individual described Occur during the period of interaction in medical environment.

29. according to claim 27 for preventing during surgical protocols associated with the individual of interaction in medical environment Only or the system of trace error position mistake, wherein the analysis bag includes error location operation near miss data, error location Wrong data of performing the operation or combinations thereof.

30. a kind of surgery sharp weapon distributor for surgical protocols, including：

Substantially rectangular outer cover unit, the substantially rectangular outer cover unit are dimensioned so as to and are configured for keeping In the hand of single user, the outer cover unit has by the first opposite face and the second face, opposite first end and second The periphery that end and the first opposite side and the second side limit, the outer cover unit further includes the inner chamber in the periphery Body, the first end are included therein at least one aperture to be formed；

At least one sharp weapon keep device assembly, at least one sharp weapon that device assembly is kept to be suitable for releasably holding a surgery Sharp weapon, at least one sharp weapon holding device assembly are slidably located in the internal cavity and can be in first positions It is moved between the second position, in the first position, the surgery sharp weapon of holding are fully accommodated in the internal cavity, In the second position, a part for the surgery sharp weapon of the holding is protruded from the aperture.

31. surgery sharp weapon distributor according to claim 30, wherein first side and the second side include sector Edge.

32. surgery sharp weapon distributor according to claim 30, wherein the surgery sharp weapon are scalpel blades, the hand It includes the front end of blade section and the tail end including connector part that art knife blade, which has,.

33. surgery sharp weapon distributor according to claim 32, wherein the scalpel blade is positioned in the sharp weapon It keeps in device assembly so that when the sharp weapon keep device assembly to be in the second position, the tail end is from the shell list First protrusion.

34. surgery sharp weapon distributor according to claim 30, wherein the surgery sharp weapon are scalpels, the scalpel With including blade section front end and including the tail end of shank.

35. surgery sharp weapon distributor according to claim 34 is kept wherein the scalpel is positioned in the sharp weapon In device assembly so that when the sharp weapon keep device assembly be in the second position, the part of the shank from it is described outside Shell unit protrudes.

36. surgery sharp weapon distributor according to claim 30, wherein at least one sharp weapon holding device assembly includes Four sharp weapon positioned side by side keep device assembly.

37. surgery sharp weapon distributor according to claim 30 further includes confirming label, the confirmation label is removedly It is attached to the shell, the confirmation label is positioned such that prevent when the confirmation label is attached to the shell described At least one sharp weapon keep the movement of device assembly.

38. according to the surgery sharp weapon distributor described in claim 37, wherein the part covering of attached confirmation label the The first end of at least part of one panel, a part for second panel and the shell.

39. according to the surgery sharp weapon distributor described in claim 37, wherein the confirmation label includes electron scanning code, it is described Electron scanning code includes at least one of patient information and surgical protocols information.

40. surgery sharp weapon distributor according to claim 39, wherein the electron scanning code is in QR codes and bar code One kind.

41. according to the surgery sharp weapon distributor described in claim 37, wherein attached confirmation label includes being conveyed to user At least one visual indicator of the inclined side property of the surgical protocols.

42. surgery sharp weapon distributor according to claim 41, wherein at least one visual indicator includes word At least one of with color.

Further include package component 43. according to the surgery sharp weapon distributor described in claim 37, the package component is suitable in institute The surgery sharp weapon distributor is received before stating surgical protocols.

44. surgery sharp weapon distributor according to claim 43, wherein the package component include the first transparent aseptic bag, Second transparent aseptic bag and non-sterile external container.

45. surgery sharp weapon distributor according to claim 44, wherein the surgery sharp weapon distributor is sealed in described In one transparent aseptic bag, first transparent aseptic bag is sealed in second transparent aseptic bag, and described second is transparent sterile Bag is placed in the non-sterile external container.

46. surgery sharp weapon distributor according to claim 45, wherein the external container includes transparent window.

47. surgery sharp weapon distributor according to claim 46, wherein the surgery sharp weapon distributor is placed on the packet In arrangement so that can be transparent sterile by described first when the electron scanning code is included in the package component Bag, second transparent aseptic bag and transparent window scanning.