CN112331323A

CN112331323A - Tracing system and tracing method for realizing full life cycle of medical surgical instrument

Info

Publication number: CN112331323A
Application number: CN202011233198.XA
Authority: CN
Inventors: 陈塞涌; 张青; 刘芳
Original assignee: Beijing Zhongxin Yiyuan Technology Co ltd
Current assignee: Beijing Zhongxin Yiyuan Technology Co ltd
Priority date: 2020-11-06
Filing date: 2020-11-06
Publication date: 2021-02-05

Abstract

The invention provides a tracing system and a tracing method for realizing the full life cycle of medical surgical instruments, wherein the system comprises the following components: the application front end comprises a single surgical instrument provided with a radio frequency tag, a plurality of antennas, management equipment and a counting and inquiring interface, wherein the antennas are connected with a reader, and the counting and inquiring interface comprises a sterilized article management module, an item maintenance module, a positioning management module and a dynamic inventory module; the network transmission platform comprises a plurality of control computers and a wireless local area network, wherein the control computers can read the surgical instruments with the RFID, and the control computers and the wireless local area network are connected with the internal local area network of the hospital; the data exchange interface is connected with the local area network inside the hospital and is connected with a plurality of server groups. The volume of the radio frequency tag is much smaller than that of a common radio frequency tag, and the radio frequency tag is more suitable for the requirement of instrument identification; the tag can be directly embedded into the asset without manual reading; hundreds of tags can be read in a short time.

Description

Tracing system and tracing method for realizing full life cycle of medical surgical instrument

Technical Field

The invention relates to the field of radio frequency identification and medical instruments, in particular to a tracing system and a tracing method for realizing the whole life cycle of a medical surgical instrument.

Background

The hospital infection rate in China is about 3%, millions of hospital infections occur every year, the infection causes the problems of excessive use of antibiotics, prolonged residence time of patients in the hospital and the like, the patients suffer additional pain, and the family and social costs of the patients are increased. Therefore, controlling nosocomial infection and reducing medical accidents caused by infection are important problems faced by the medical industry in China. In each link of controlling nosocomial infection, a disinfection supply Center (CSSD) plays a huge role, the disinfection and sterilization quality of reused medical instruments and auxiliary materials is directly related to the safety of patients, and a sterile article information tracing management system in a department can provide effective control and supervision for the circulation process of sterile articles. By taking image identification modes such as two-dimensional codes and bar codes as carriers and taking sterilization bags and instrument baskets as units, the original tracing system cannot completely realize tracing management under the condition that a single surgical instrument is not unpacked.

Disclosure of Invention

In order to solve the problems in the prior art, the invention provides a tracing system and a tracing method for realizing the whole life cycle of a medical surgical instrument.

In order to achieve the purpose, the invention adopts the following technical scheme:

on one hand, provides a tracing system for realizing the whole life cycle of medical surgical instruments,

the system comprises:

the application front end comprises a single surgical instrument provided with a radio frequency tag, a plurality of antennas, management equipment and a statistics and query interface, wherein the antennas are connected with a reader, the statistics and query interface comprises a disinfection article management module, an item maintenance module, a positioning management module and a dynamic checking module, and the statistics and query interface is used for monitoring and tracking the whole processes of recovery, cleaning, sterilization, check before sending, counting in operation and after operation and recovery of the single surgical instrument, so that each surgical instrument can be monitored in the flow, and can be traced back to a surgical patient and a surgical doctor, so that the inventory condition of the surgical instrument and the use condition of the instrument can be queried at any time;

the network transmission platform comprises a plurality of RFID control computers and a wireless local area network, wherein the RFID control computers and the wireless local area network are connected with the internal local area network of the hospital;

the data exchange interface is connected with the local area network inside the hospital and connected with a plurality of server groups.

Preferably, the electronic tag adopts an RFID chip, and the RFID chip is combined with the single surgical instrument in a welding or bonding or embedding mode.

Preferably, the RFID chip is integrated with a single surgical instrument by embedding.

On the other hand, the tracing method for realizing the full life cycle of the medical surgical instrument comprises the following steps:

step 1, in a close-range contact induction mode, an RFID control computer is connected with a reader, and an antenna of the reader is used for identifying a single surgical instrument provided with an electronic tag in a close range, wherein the identification distance of the mode is within 5 cm;

step 2, in a region induction identification mode, a fixed reader is arranged in a room, relevant information of the electronic tag is read through an antenna of the reader, the state of a single surgical instrument is judged through the information, and the relevant information is continuously stored in a corresponding database; this mode is mainly to perform a regional positioning for the layout of the disinfection supply center and the storage room for various disinfection articles.

And 3, in a multi-reader induction identification mode, a plurality of readers are used for reading the same label information, analysis is carried out to realize the effect of positioning management, the multi-reader induction identification mode is respectively applied to inventory management and statistical analysis management of equipment, fixed readers and antennas are arranged in a storage room of a hospital disinfection supply center, and electronic labels are placed at a plurality of positions to serve as positioning references to realize information acquisition and positioning management.

Preferably, the method also marks the maintenance of the basic data of the single surgical instrument, the management of the sterilized article, the dynamic inventory, the positioning management and the statistical analysis of the sterilized article,

the maintenance of the basic data comprises collecting relevant information such as codes, names, specifications, classifications, manufacturers, prices and the like of instruments, and workers need to register information such as job numbers, names, departments, authorities and the like;

the management of the sterilized articles comprises warehousing of instruments, newly building instrument bags, cleaning, checking and packaging, sterilizing, sending and using, recycling, scrapping and losing;

the positioning management is divided into area positioning and accurate positioning;

verification and updating of relevant information by the dynamic inventory of the sterilized article;

and the statistical query generates a statistical report for the related information.

Compared with the prior art, the invention has the following advantages:

1. the volume of the RFID label is much smaller than that of the bar code, which means that the RFID label is more suitable for the requirement of instrument identification under the condition that the size of the label is very critical, such as surgical instruments;

2. the radio frequency identification technology belongs to an automatic technology, and a tag can be directly embedded into an asset without manual reading;

3. the reading speed can read hundreds of labels in a short time, the working efficiency is improved, and the accuracy of information is ensured.

Drawings

Fig. 1 is a structural diagram of a traceability system for realizing the whole life cycle of a medical surgical instrument according to the present invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments.

The system for tracing back the life cycle of a medical surgical instrument provided by the embodiment, as shown in fig. 1, includes:

the application front end comprises a single surgical instrument provided with an electronic tag, a plurality of antennas, management equipment and a statistics and query interface, wherein the antennas are connected with a reader, the statistics and query interface comprises a disinfection article management module, an item maintenance module, a positioning management module and a dynamic checking module, and the statistics and query interface is used for monitoring and tracking the whole processes of recovery, cleaning, sterilization, check before sending, counting in operation and after operation and recovery of the single surgical instrument, so that each surgical instrument can be monitored in the flow, and can be traced back to a surgical patient and a surgical doctor, and the inventory condition of the surgical instrument and the use condition of the instrument can be queried at any time;

The Radio Frequency Identification (RFID) is applied to a single surgical instrument, the optimal chip, the optimal combination mode of the chip and the instrument are determined, the whole hospital HIS system, the hand anesthesia system and the material management system are butted through a software tracing management system, the informatization, the standardization and the integration of management are realized, the working efficiency is improved, and the management reaches a new level. Meanwhile, doctors and patients are clear of responsibility, and hospital management is developed towards a refinement direction. The radio frequency identification label for the medical disinfection supply center surgical instrument management needs to meet the relevant working requirements of the disinfection supply center: the anti-collision performance is high, reliable identification of more than 10 tags can be guaranteed, high safety is achieved, information data stored in the tags are prevented from being leaked, the tags are provided with an un-rewritable unique serial number (UDI) for identification and encryption, data formats and contents can be customized, good data expansibility is achieved, the tags can be read and written in a non-contact mode, the capacity of a chip is large, the tags can resist 136 ℃ of high temperature and various cleaning enzymes and disinfectants are soaked, the reading range is 0-10 m, the tags can be repeatedly erased and written for more than 10 ten thousand times, the storage temperature is-40-220 ℃, and the working temperature is as follows: -25 to 200 ℃, relative humidity: 40 to 100 percent. The label is small in size and diversified, can realize multi-label identification, and has strong sensitivity and penetrability. Meanwhile, the anti-counterfeiting ink has strong anti-fouling property and durability, high storage performance, capability of repeatedly erasing and writing chip information, anti-counterfeiting, anti-tearing, anti-transfer and application requirements of medical equipment.

The adhesive material is selected mainly to ensure biological safety, the surgical instrument is used for clinical operation, the safety of a patient is directly related, for example, no harm is caused to the human body, the safety includes cytotoxicity, skin sensitivity, skin irritation and the like, relevant experiments are required during selection, and the compatibility of the human body is proved to be qualified, and the two labels listed above can be used for retrospective management of the surgical instrument. The combination of the radio frequency chip and a single surgical instrument in a chip and instrument combination mode is compared with various methods, including various modes such as welding, bonding, embedding and the like, and only when the radio frequency identification chip is implanted into the single surgical instrument, the effect of tracing management can be exerted, and meanwhile, the stability and the safety of the radio frequency identification chip are required to be ensured.

The surgical instrument management system utilizes the radio frequency identification technology to implant radio frequency identification into a single surgical instrument, and establishes a surgical instrument control and traceability system. Monitoring and tracking are carried out in the whole process of recovering, cleaning, sterilizing, checking before sending, counting in the operation and after the operation and recovering of single surgical instruments, each surgical instrument can be monitored in the process, the surgical instruments can be traced back to surgical patients and surgical doctors, the inventory condition of the surgical instruments and the use condition of the instruments can be inquired at any time, problems can be found timely, and the problems are solved.

The tracing system for realizing the full life cycle of the medical surgical instrument provided by the embodiment comprises the following specific working steps:

When the system is applied, basic data maintenance of instruments, management of disinfection articles, dynamic inventory of the disinfection articles, positioning management and statistical analysis are marked. The maintenance of the basic data comprises collecting relevant information such as codes, names, specifications, classifications of instruments, manufacturers and prices, and the like, and the information such as job numbers, names, departments, authorities and the like needs to be registered by workers. The management of the sterilized articles comprises warehousing of instruments, newly building instrument bags, cleaning, checking and packaging, sterilizing, sending and using, recycling, scrapping and losing. Location management can be divided into area location and accurate location, and dynamic inventory is the verification and update of relevant information. And finally, performing statistical query, and generating a statistical report for related information, such as instrument package recycling statistics, workload statistics and the like. The tracing quality of the surgical instrument is improved after the RFID chip is applied; the CSSD integral tracing system efficiency is improved after the RFID chip is applied. Particularly, the safety of a surgical patient is effectively improved, the tracing management of a single surgical instrument is realized by utilizing the RFID technology, the use condition of the surgical instrument is fed back quickly, the link and personnel errors are traced back, and corresponding remedial measures are taken in time. The sterilization of surgical instruments is guaranteed to be qualified, the counting conditions of the surgical instruments, dressings, sewing needles and the like before skin incision and before and after body cavity closing are recorded, and the extreme conditions that the instruments are left in the body cavity and the like are avoided.

By using the tracing system and the tracing method, in the test, a mechanical stability test is performed for one thousand cycles, and an ultrasonic cleaning test is performed: 37-40KHz for 30 minutes; wash drop out test OP procedure, maximum temperature 93 ℃, five minutes. The sterilization experiment was repeated one thousand cycles with a maximum temperature of 134 ℃ for four minutes. The relevant experimental data records of this experiment are as follows:

TABLE 1 test procedure problem cases

TABLE 2 test procedure supplementary instrumentation problem situation

The test can confirm that the RFID chip does not fall off and has stable data after being sterilized by conventional and special repeated tests; the performance of the chip wrappage is good after repeated test sterilization treatment; the database, the RFID and identification system are successfully docked with the existing sterile article management system of the disinfection supply center.

The tracing management system of the embodiment is an instrument tracing management mode based on image recognition modes such as bar codes and two-dimensional codes. In the single surgical instrument tracing management system, the technology of a two-dimensional code identification mode is insufficient, and compared with a two-dimensional bar code, the radio frequency identification technology has obvious advantages. Firstly, the volume of the tag is much smaller than that of the bar code, which means that the RFID tag is more suitable for the requirement of instrument identification under the condition that the size of the tag is very critical, such as surgical instruments. Then the radio frequency identification technology belongs to an automatic technology, does not need to be read manually, and the label can be directly embedded into the asset, however, the two-dimensional bar code needs to be read manually, and simultaneously, the reading environment also needs to be ensured, and through the disinfection work of a disinfection supply center, the label is easy to be polluted, damaged and difficult to identify, the radio frequency identification technology does not have the problems, is less limited by the environment, and any environment can be easily read as long as the label is arranged. The reading speed is high, for the traditional two-dimensional code reading, not only manual reading is needed, but also only one two-dimensional code reading is needed, the consumed time and the workload are huge, but the radio frequency automatic identification technology is adopted, so that the situation can not occur. Hundreds of labels can be read in a short time, the working efficiency is improved, and the accuracy of information is ensured. In addition, an algorithm is installed in the reader-writer of the radio frequency identification technology, so that the tag can be effectively prevented from being repeatedly read. Fourthly, the label volume is very little, installs and can not influence the use of apparatus on single surgical instruments to can also help the hospital to check the apparatus automatically. For tag reading, the system needs to be set up in advance, the movement of the asset is recorded and a warning occurs. Moreover, the durability of the radio frequency identification tag is obviously higher than that of a bar code, particularly, some identification codes attached to the radio frequency identification tag are mostly disposable, and once the radio frequency identification tag is used after being sterilized, the radio frequency identification tag needs to be identified again, so that the cost is increased, and the workload is increased.

The tracing mode with the serial number as a main line is that the surgical instrument sets an independent serial number in factory, the independent serial number is used as an identity representative of the instrument, the surgical instrument is identified by using the serial number, and tracing management of the instrument is realized. Aiming at the management of the disposable instruments, a tracing mode with a batch number as a main line is adopted, and the marking means is suitable for realizing the tracing management of the instruments by a coding or laser marking method. The aim of technical development is to gradually become more refined, and the defects of the traditional tracing mode are gradually reflected aiming at a sterile article tracing management system of a disinfection center, such as the condition that a single instrument is lost frequently and the like, on one hand, the semi-automation of management can increase the workload of workers and reduce the working efficiency, and particularly, the two-dimensional code or bar code mode is used, and the sterilization bags need to be scanned one by one to match the corresponding use times and the disinfection condition. On the other hand, the surgical instruments need to go through a whole sterilization process, wherein some marks are easily damaged by chemical cleaning, high-temperature sterilization and the like, and the durability and the reading performance of the labels are affected.

The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art should be considered to be within the technical scope of the present invention, and the technical solutions and the inventive concepts thereof according to the present invention should be equivalent or changed within the scope of the present invention.

Claims

1. A system for enabling full life-cycle traceability of a medical surgical instrument, the system comprising:

2. The system and method for tracing the whole life cycle of medical surgical instruments according to claim 1, wherein said electronic tag is an RFID chip, and said RFID chip is combined with a single surgical instrument by welding, bonding or embedding.

3. The system and method of claim 2, wherein the RFID chip is embedded in a single surgical instrument.

4. A tracing method for realizing the full life cycle of medical surgical instruments is characterized by comprising the following steps:

step 1, in a close-range contact induction mode, an RFID control computer is connected with a reader, and the antenna of the reader is used for identifying a single surgical instrument provided with an electronic tag in a close range, wherein the identification distance of the mode is 5-15 cm;

5. A tracing method for realizing the whole life cycle of medical surgical instruments according to claim 4, characterized in that said method also marks the maintenance of basic data of single surgical instruments, the management of disinfection articles and sterilization articles, the dynamic checking, positioning management and instrument material management, statistical analysis and work efficiency analysis of disinfection articles and sterilization articles;

the management of the sterilized articles comprises warehousing of instruments, newly building instrument bags, cleaning, checking and packaging, sterilizing, sending and using, butt joint of the instruments to operators or therapists in use, and analysis, recovery, scrapping and loss of the use time in use;