JP6570150B2 - Device for cleaning, disinfecting, drying and / or sterilizing - Google Patents

Description

  Devices and methods for cleaning, disinfecting and / or sterilizing medical, dental, laboratory and / or pharmaceutical articles. The device is adapted to allow a user to digitally sign a progress record generated by the device and optionally store the signed progress record on the device.

  The pharmaceutical industry, hospitals, care centers, laboratories and similar industries and facilities are constantly struggling with contamination such as bacterial and viral infections. Hygiene issues are constantly on the topic and are continuously evaluated. One hygiene problem of particular nature is the cleaning, disinfection and sterilization of articles, such as sterilizing medical, dental, laboratory and / or pharmaceutical articles. The article may be a reusable article or a disposable article.

  Reusable items used in such facilities include surgical instruments such as scalpels, capture devices, clamps, retractors, dilators, probes, scopes, drills, and saws, bottles, bowls, condensers, and funnels. , Laboratory equipment such as flasks, pipettes and plates, or the like. Any object that is intended to be reused and may be contaminated with harmful or biological substances is the subject of severe hygiene conditions. Whenever a reusable article, such as a reusable medical device, is in use, the reusable article is sent for cleaning, disinfection and / or sterilization.

  The process of cleaning, disinfecting and sterilizing items such as the reusable medical devices described above is a rule and regulation, the facilities used, staff, process parameters, equipment and the surrounding environment surrounding the equipment. It is a very demanding process from the standpoint of even. All constraints and conditions that serve the purpose of reducing or eliminating the risk of contamination make it difficult and expensive to operate the cleaning, disinfection and / or sterilization process.

  For example, a pharmaceutical production site simply needs to clean and sterilize different reusable medical devices, steam generators, water pre-treatment devices, closed treatment systems, discharge systems, component washers, glassware washers, components May be equipped with sterilizer, terminal sterilization system, isolator and sterilization test equipment. Cleaning and sterilization devices are further divided into different environmental zones, each environmental zone having its own environmental conditions imposed on it. Such environmental conditions may be the availability of humidity, temperature, air pressure, ventilation systems, and clean water, or the like.

  Examples of different environmental areas or zones in which environmental conditions may vary are distribution areas, receiving areas, clean areas and sterilization areas. Each area is generally separated by a zone barrier. A zone barrier is a physical wall that maintains a differential air pressure, and is sometimes called a cross-contaminated wall. Cross-contaminated walls may be airtight and may be adapted to physically prevent personnel from moving between environmental areas and air moving between them. Therefore, all precautions are taken to prevent cross contamination between environmental areas.

  Some cleaning devices, such as sterilizers, may be a pass-through model. The pass-through sterilizer extends across the zone barrier and allows personnel to load articles at one end of the sterilizer and to remove sterilized articles at the other end. Thus, the sterilizer extends across at least one zone barrier.

  The stringent hygiene conditions imposed on each environmental area, the zone barrier between environmental areas, and the limited degree of freedom for personnel to move between environmental areas are critical to the equipment and the cleaning, disinfection and sterilization processes used therein. Impose high demands.

  To ensure that items are properly treated, cleaned, disinfected or sterilized, personnel may also be required to check progress records, sometimes referred to as batch or process records. is there. The progress record is recorded by a separate computer or printer and examined using a graph in analog or digital form. Personnel also typically have to visually inspect the article to ensure that the article is in good condition, eg, not wet or damaged. If these tests are successfully performed, the staff will print out the progress log and sign it. The progress record is then placed in a folder and stored. However, nothing prevents staff from releasing sterilized items sooner before these tests are performed.

  Due to human error, the article may be removed from the sterilizer and released without being officially approved. If the sterilized article is not inspected, there is a risk that no errors or obstacles in the sterilization process will be found. Furthermore, if formal approval is lacking, it clearly indicates that the test was not performed successfully or properly. This can have serious consequences that cause unsterile or contaminated medical, dental, laboratory and / or pharmaceutical articles to be released.

  Therefore, there is a need to simplify the formal approval process for batches prior to releasing the batch from the sterilizer. There is also a need for improved sterilizers to prevent accidental or accidental release of unsterilized medical, dental, laboratory and / or pharmaceutical articles.

  It is an object of the present invention to provide devices and methods that eliminate or at least reduce the above-mentioned drawbacks or provide useful alternatives to known prior art.

  The purpose is at least in part by a device for cleaning, disinfecting and / or sterilizing medical, dental, laboratory and / or pharmaceutical articles using a cleaning, disinfecting and / or sterilizing process. It is filled. The device includes a chamber for receiving medical, dental, laboratory, and / or pharmaceutical articles, at least one user interface that allows a user to operate the device, and a door associated with the chamber. Prepare. The device further comprises processing circuitry for generating a progress record of at least one parameter of a cleaning, disinfection and / or sterilization process performed by the device. The user interface is operable by the user to cause the processing circuitry to electronically sign the progress record, the progress record signature being associated with at least one condition on the device.

  Imposing at least one condition on the device enhances batch approval and ordering of imposed conditions, such as physical release of medical, dental, laboratory and / or pharmaceutical articles A procedure is established. It is a very cost effective solution compared to using a separate system. It is a robust system that automatically generates electronic progress records that may be stored by the device itself, such as a washer, disinfector, autoclave, or sterilizer. It can reduce reliance on communication with a separate system for signature and record generation. In addition, it eliminates the need for printout and storage, and a separate tracking system for paper copies.

  The present invention provides a procedure and device for quality assurance that medical, dental, laboratory and / or pharmaceutical articles are properly cleaned, disinfected and / or sterilized. , Based on the belief that, optionally, in combination with an audit trail, the steps of inspecting, approving, releasing and / or generating a digitally signed progress record may be included. Each of the steps may be conditioned. The condition may further be suppressed, activated and / or revealed by an electronic signature of the progress record.

  According to one aspect, the condition is imposed on the device door. This condition relates to the release of medical, dental, laboratory and / or pharmaceutical articles. The condition imposed on the device door may be allowing the device door to open and / or closing. For example, when a user signs a progress record on the user interface, the device unlocks the door, the user opens the door, and the medical, dental, laboratory, and / or pharmaceutical loaded into the device Allows the item to be removed. The condition may additionally or optionally be that the door is opened or closed by the device itself.

  According to one aspect, a checklist may be displayed on the user interface, preferably before or after the cleaning, disinfection and / or sterilization process is initiated or completed. The checklist may be interactive so that the user can “tick” when a point on the checklist is made or checked. Once the checklist is complete, for example, the device door may be opened or allowed to be opened so that items may be loaded or released. The checklist may be a standard checklist or a custom checklist customized for example by the user. The checklist may be displayed before or after the signature is made.

  According to one aspect, the device has two doors, one for loading items from the unsterilized or contaminated side, and one door for cleaning or sterilized items. Used for taking out. The loading door cannot be opened before the removal door is opened and closed to indicate that the processed article has been removed. If a one-door solution is used for both loading and unloading items, it is the user's duty to ensure that the progress record is properly signed.

  According to one aspect, at least one user interface is integrated with the device, and optionally the user interface can comprise a mobile unit such as a touchpad, a mobile smartphone or the like. The at least one user interface may comprise a touch sensitive display for signing a progress record. It is advantageous if the signed progress record is stored locally at least as a backup.

  According to one aspect, the signature of the progress record is irreversible. It is important that once the user signs the progress record, the signed progress record cannot be manipulated or changed thereafter. At least the signer's identity and / or date of approval should not be removed or manipulated from the progress record, so that traceability and auditing of the stored progress record is possible In addition, it may be made without the risk of the signed progress record being manipulated accidentally or deliberately.

  According to one aspect, at least one parameter of the process is: temperature, pressure, time, volume such as wash liquid volume, rinse water volume, concentration, pH, media quality, ions (hardness) in the wash water, detergent, salt, etc. Goods or similar. One or more parameters for generating a progress record may be selected.

  The progress log can of course include the identification of significant events and an audit trail with time and date. Therefore, both the audit trail and other selected one or more parameters are digitally signed.

  According to one aspect, the device is a sterilization device. The process is in this case a sterilization process. The device may also be a high-level disinfection device and the process is critical for reprocessing semi-critical devices, including flexible endoscopes, or not compatible with heat sensitive or traditional sterilization methods. A high level disinfection (HLD) process for sterilization of semi-critical devices. For example, endoscopic reprocessing involves cleaning and disinfecting the endoscope and may include cleaning, rinsing, disinfecting, secondary rinsing, drying and storage steps. For drying, drying cabinets are commonly utilized, which may include doors, cabinets, control circuitry, and loading systems such as one or several shelves or hooks. The use of a drying cabinet allows, for example, immediate reuse of an endoscope even after its extended shelf life. The drying cabinet may comprise the present invention as described herein.

The present invention also relates to a method for electronically signing a progress record of a process for cleaning, disinfecting and / or sterilizing medical, dental, laboratory and / or pharmaceutical articles performed by a device. Related. The device comprises a chamber for receiving medical, dental, laboratory and / or pharmaceutical articles, at least one user interface for operating the device, at least one door associated with the chamber, and the device And a processing circuit for generating a progress record of at least one parameter of the process to be performed. This method
-Registering at least one parameter of the process;
-Forming a progress record based on the registration;
-Digitally signing the progress record via the user interface;
-Imposing conditions on the device based on the electronic signature of the progress record.

  At least one condition is imposed on the device, and the condition is applied so that the medical, dental, laboratory and / or pharmaceutical article is cleaned, disinfected and / or disinfected in an acceptable manner or to an acceptable level of cleanliness. Or batch approval, such as physical release of medical, dental, laboratory, and / or pharmaceutical articles by associating with a signature of a progress record that is equivalent to the user accepting or accepting that it has been sterilized And a procedure is established that enforces that the ordering of imposed conditions is maintained.

  The method may be operated so that an electronic progress record is automatically generated for the user to be signed. The signed progress record may then be stored by the device itself, for example in an autoclave / sterilizer. The method reduces reliance on communication with a separate system for signature and record generation. In addition, it eliminates the need for printing out and storing paper copies.

  According to one aspect, the condition is associated with a device door. Therefore, the method includes the step of opening the device door after digitally signing the progress record via the user interface, or the door after digitally signing the progress record via the user interface. Can be included to allow the to be opened.

  The method may additionally or optionally include electronically signing the progress record via the user interface, or closing the device door after the progress record is digitally signed via the user interface. And allowing the door to be closed after. Since the door to the chamber cannot be closed until the signature is complete, this step will prevent any user from starting the device until the progress record is signed. In one embodiment, a new process cannot be started before the progress record of the previous process is officially approved or disabled by signing the device display. This is particularly beneficial for a one-door system where the means for ensuring that the user signs the progress record and releases the item before proceeding is limited.

  According to one aspect, the method is a disinfection or sterilization process performed by the device. The device may be a dedicated sterilization device.

  According to one aspect, the present invention relates to a computer program product for use in a device for cleaning, disinfecting and / or sterilizing medical, dental, laboratory and / or pharmaceutical articles. The device includes a chamber for receiving medical, dental, laboratory, and / or pharmaceutical articles, at least one user interface that allows a user to operate the device, and at least one associated with the chamber. A door and processing circuitry for generating a progress record of at least one parameter of a cleaning, disinfection and / or sterilization process performed by the device. The computer program product comprises code instructions configured for execution by a processing circuit, which code instructions, when executed on the device, allow the user to electronically sign a progress record via the user interface to the device. And associating the progress record signature with at least one condition for the device.

  When loaded on a device, the computer program product may be in the form of a data carrier that carries computer program code for performing the embodiments herein. One such carrier may be in the form of a CD ROM disk, memory stick, server or other suitable carrier or medium. The computer program code may further be provided as program code on a server, downloaded to the device, and executed on the device. The device may further comprise a memory comprising one or more memory units.

  In general, at least one signature may be required. In one embodiment, more than one signature is required to sign a progress record to impose conditions on the device. The signature may be from the same person or may be required to be signed by two unique people. It is also possible that the condition imposed on the device is that an additional signature is required.

  Non-limiting embodiments of the present invention will be described in more detail with reference to the accompanying figures.

FIG. 2 shows a schematic diagram of a facility for cleaning, disinfecting and / or sterilizing medical, dental, laboratory and / or pharmaceutical articles. It is a figure which shows a sterilization device. FIG. 3 shows a process flow for a sterilization device and a process flow for parameters being tracked. It is a figure which shows the process flow about the electronic signature of a progress record.

  FIG. 1 shows a schematic perspective view of a facility 1 adapted for cleaning, cleaning, disinfecting and / or sterilizing medical equipment, but the present invention is directed to biopharmaceutical production, medical device production, biomedicine. Research, research, hospitals (sterilization departments and wards), outsourced sterilization, clinics and practitioners (ie dentists) and / or medical, dental, laboratory use for or used in elderly care And / or applicable to pharmaceutical articles.

  The facility 1 has, in the illustrated embodiment, different environmental areas, each serving its own specific purpose. The facility 1 comprises a dirty or contaminated area 10, a clean area 20, and a sterilization area 30. Each area is separated by a zone barrier adapted to restrict access between environmental areas.

  The dirty area 10 is adapted to receive used medical devices such as articles that need to be cleaned, washed, disinfected and / or sterilized, in this case scalpels, capture devices, clamps, retractors and the like. The dirty area 10 is also a receiving area for used medical devices, as shown. A first zone barrier 11 in the form of a cross-contaminated wall separates the dirty area 10 from the clean area 20. As can be seen, the first zone barrier 11 restricts all personnel direct access between the dirty area 10 and the clean area 20 to prevent accidental contamination between the areas. .

  A washer 12 for cleaning used medical devices is arranged in the zone barrier 11. The washer 12 is a pass-through model that allows personnel to load on the washer 12 in the dirty area 10 and to be removed from the washer in the clean area 20 after the used medical device has been cleaned. Used medical devices are now considered cleaned and are therefore referred to as clean medical equipment.

  When staff removes cleaned and disinfected equipment in the clean area 20, the staff, referred to hereinafter as the user, may want to manage and document that the cleaning process has been performed correctly. This is done visually by examining a track record of the cleaning process. The progress record can comprise information such as time, temperature curve, water consumption or the like so that the user can confirm that the cleaning process has been performed correctly. When reprocessing medical devices that cannot be sterilized due to material incompatibility, material incompatibility with the sterilization process, or thermal sensitivity, it is advantageous if adherence to the reprocessing method is ensured. The user can electronically sign the progress record directly on the washer 12 so that the medical device may be removed and released to the next station. The electronic signatures, devices and methods used will be described in more detail below.

  In the clean area 20, clean medical devices are placed and prepared for further treatment. The clean medical device may be stored, for example, in an airtight bag and packed. The second zone barrier 21 separates the clean area 20 from the sterilization area 30. An autoclave pass-through model, in this case a steam sterilizer, is arranged to extend across the second zone barrier 21 for further treatment of a clean medical device. Examples of further treatment of clean medical devices include sterilization (discharge) cycle for pathogenic waste decontamination, balance for open liquid to minimize product liquid loss It may be a good process, conforming to the required BSL level, or other specific application. In general, treatment is performed at high temperatures using steam (but not all).

  After a clean medical device is sterilized, it may be referred to as a sterile medical device. The sterile medical device may now be released and is ready to be transported to the facility's storage room and ready to be used again.

  When the staff member removes the sterile medical device in the sterilization area 30, the staff member, referred to as the user from now on, will need to manage and document that the sterilization process has been performed correctly. This is done visually by examining a progress record of the sterilization process. The progress record can comprise information such as time, temperature and pressure curves or the like so that the user can confirm that the sterilization process has been performed correctly.

  FIG. 2 shows the steam sterilizer 40, hereinafter referred to as the sterilizer 40, in more detail. The sterilizer 40 is a one-door type or a pass-through model that has doors on both sides of the sterilizer and allows the sterilizer 40 to bridge across zone barriers such as cross-contaminated walls 11, 21. Also good. The sterilizer comprises a chamber 41 for receiving medical equipment for sterilization. A slidable door 42 is adapted to seal the chamber 41. The tray 43 is configured to receive medical articles inside the chamber. The tray can be removed from the chamber 41. The user interface 44 is adapted to allow a user to operate the sterilizer 40, and in the illustrated embodiment, a touch-sensitive display is used as the user interface.

  Sterilization or sterilization, as used herein, is an infectious agent present on the surface and contained in fluids, drugs, and / or on and / or in a complex such as a biological medium. It relates to the process of eliminating, removing or killing microbial organisms, including substances (such as fungi, bacteria, viruses, spore shapes, etc.). Sterilization may be achieved by applying heat, chemicals, radiation, high pressure, and filtration or combinations thereof.

  Steam sterilization, or autoclaving, involves subjecting an article to high temperature steam. Steam sterilization involves the use of saturated steam under pressure and is a non-toxic method for sterilization. Furthermore, steam sterilizers (autoclaves) are available in different sizes for different purposes.

  Four factors are related to the result of steam sterilization: steam, pressure, temperature and time. Device 40 for cleaning, disinfecting and / or sterilizing medical, dental, laboratory and / or pharmaceutical articles using a cleaning, disinfecting and / or sterilizing process is preferably above 100 ° C Should preferably be adapted to operate at a temperature above 120 ° C., more preferably at a temperature between 120 ° C. and 140 ° C., at a suitable pressure above at least 101.3 kPa, or a pressure corresponding to saturated steam . The sterilizers disclosed herein should preferably meet at least the requirements of the EN285: 2006 and A2: 2009 standards used in the art and known to those skilled in the art.

  The required sterilization time varies depending on the article to be sterilized, and the required sterilization time at a specified temperature will also depend on the article to be sterilized. Chemical and biological indicators can be used to monitor the sterilization process and ensure that sterilization is achieved. Proper steam sterilization will inactivate all fungi, bacteria, viruses and bacterial spores. If all fungi, bacteria, viruses and bacterial spores need not be inactivated, the temperature, time and pressure should be at most 1 / 1,000,000, preferably 1 sterilization devices and methods. Is selected to have a sterility assurance level SAL lower than / 1,000,000. SAL is used to describe the probability of a non-sterile unit exiting a device or method after the sterilization process is complete.

  Sterilizer 40 includes a processing circuit (not shown) for generating a digital progress record of the sterilization process. A progress record is created by registering at least one parameter of the sterilization process, such as temperature, pressure, time, volume of wash solution, volume of rinse water, or the like. Registration may be performed by registering at least one parameter measurement result, which is stored locally or remotely. If stored remotely, the sterilizer 40 comprises a communication unit adapted to transfer a progress record or part thereof to a remote storage device. By local it is meant that the progress record is stored on the sterilization device itself on a storage device such as a hard drive or the like.

  The sterilization process generally involves loading medical, dental, laboratory and / or pharmaceutical articles to be sterilized, selecting a sterilization program, performing a sterilization process, and sterilized medical, dental , Laboratory and / or pharmaceutical article removal steps, but is not limited thereto. At some time after the sterilization process has been completed or partially completed, the user may wish to check that the sterilization process has been performed correctly. The inspection may be done by visually looking at a temperature / time graph that tracks the steam temperature during the sterilization process, or by looking at computer-generated parameters, values, or graphs that are associated with registered progress records. In the case of a graph, the graph may be plotted directly on the user interface, in this case on the touch-sensitive display 44. The user can then confirm that the progress record has been managed and received. The confirmation is performed by digitally signing the progress record, for example, by digitally signing the progress record.

  The electronic signature of the progress record may be made using a personal and / or group identification code. An example of a personal identification code is a unique identification code for an individual, while a group identification code may be used by a limited number of people, for example 2-20 users. In the latter case, the group's people are generally authorized to sign the progress record. Examples of identification codes are personal codes such as identification numbers, names, passwords or the like, fingerprints, voice recognition, eye reticule identification, or the like.

  FIG. 3 shows a schematic diagram of a sterilization process with three distinct states, and FIG. 3 shows a standby state 100, an in-process state 110, and a process completion state 120. It should be noted that the sterilization process can include additional steps other than those described herein.

  With reference to FIGS. 2 and 3, for the standby state 100, the user is free to load medical, dental, laboratory and / or pharmaceutical articles to be sterilized into a batch of sterilization devices 40. The appropriate sterilization program is selected on a program selection menu displayed on the user interface 44, in this case the touch screen 45. Once the appropriate program is selected, an interactive graphical user interface object representing the start button is activated on the touch screen so that the user can start the sterilization program. Thus, an interactive graphical user interface object associated with the current state of the sterilization process is displayed, while at least one interactive graphical user interface object not associated with the current state is not activated. The user is now free to start the sterilization program. As an alternative, the program to be selected and started may be managed by a separate device such as an automatic loading system or the like.

  After the sterilization program is initiated, the sterilization device 40 is in the in-process state 110. In this state, the sterilization device 40 initiates and performs a sterilization program to sterilize medical, dental, laboratory, and / or pharmaceutical articles in the chamber 41. In this state, the user interface displays the remaining time of the sterilization program, and the only interactive graphical user interface object that is activated for use is a cancel function. An exception may be for interactive graphical user interface objects that are not related to the sterilization process, such as general menu buttons.

  When the sterilization device 40 ends the sterilization program, the sterilization device 40 enters the process complete state 120. In the process complete state, the user may open the door 42 to access the chamber 41 of the sterilization device 40.

  The processing circuit is adapted to register different parameters during the sterilization process. For example, during the standby state 100, the processing circuitry may include the weight or location of medical, dental, laboratory and / or pharmaceutical articles loaded in the chamber 41 of the sterilization device 40, the heating element for the steam generator. Standby related parameters 200 such as the current temperature or condition of the device, the time elapsed since the last sterilization program was performed, or the like can be registered.

  During the in-process state 110, the processing circuitry may register sterilization program related parameters 210 such as temperature, pressure, time, incoming media quality, or the like. Registration is performed using at least one sensor. Sensors and methods for registering each parameter are known per se and will not be discussed further herein. Examples of other parameters are volumes such as cleaning solution volume, rinse water volume, consumables such as detergents, pH, salt concentration.

  In the process completion state 120, the processing circuitry is either open or closed doors, medical, dental, laboratory and / or pharmaceutical items are removed, the measurement time from the end of the program, or Relevant parameters after the sterilization program, such as similar ones, can be registered.

  When the progress record is generated or subsequently thereafter, the user is prompted to digitally sign the progress record 300.

  FIG. 4 illustrates a non-limiting embodiment of how the box 300 (FIG. 3) may be configured. As stated, the sterilization device 40 is adapted to allow a user to electronically sign a progress record using the user interface of the sterilization device 40.

  The language conversion circuit 301 converts the registered data into acceptance format data for image conversion. The image generation circuit 302 is used to convert the received format data into an image. The image is displayed on the user interface display unit 303. The user interface display unit 303 is the user interface 44, in this case, the touch screen 45 shown in FIG. The user can sign his or her name directly on the user interface display unit 303. Optionally, the user interface display unit 303 may allow the user to enter authentication information, such as a code and a user ID, to confirm who has approved that the sterilization program has been performed in an acceptable manner. Displays interactive graphical user interface objects such as alphanumeric pads or the like that allow. If an alphanumeric pad is used, the user may enter one or several codes that represent the user's identity and process approval.

  The signature identification circuit 304 identifies the signature and hence the identity of the user who signs the user interface display unit 303. Identification may be done by comparison with locally stored data or data stored remotely.

  The PDF conversion circuit 305 converts the signed acceptance format data into a PDF file or other similar tamper-evident format. A tamper-evident digitally signed file is now formed. The tamper-proof digitally signed file of the progress record may be stored locally on the hard drive or in the cloud or remotely to the server. Tamper-proof electronically signed files of progress records include date and time, sterilized medical, dental, laboratory and / or pharmaceutical article identification information, batch number, and optional sterilization program May be stored along with additional information such as at least one parameter or similar. Optionally, such additional information is included in the progress record and is therefore signed with the progress record.

  Optionally, the user can use speech recognition to sign the progress record, and other methods of electronic signatures are also possible.

  The signature of the progress record causes at least one condition 307. The condition may be triggered when the signature identification circuit 304 identifies the user's identity, when the PDF conversion is complete, or when a signed progress record is achieved, eg, saved.

  Referring to FIG. 2, at least one condition may be that a user may be able to open or close the door 42 to the chamber 41, or it may be that the sterilization device 40 opens the door 42 to the chamber 41. It may be opening or closing. In a preferred embodiment, the conditions are associated with the door 42 of the chamber 41 of the sterilization device to prevent the user from opening or closing the door 42 to the chamber 41. Optionally or additionally, the user interface display unit may be prohibited from entering other input data until the signature is complete.

  The conditions imposed with the signature of the progress record are medical, dental, laboratory and / or pharmaceutical articles without user control that the sterilization program was performed in a prescribed or acceptable manner. Will be prevented from being released. In one embodiment, this is done by preventing the door 42 from being opened before the progress record of the sterilization process is signed by the user. In another embodiment, the sterilization device 40 prevents the door 42 from being closed so that a new medical, dental, laboratory, and / or sterilization process must be sterilized before the progress record of the sterilization process is signed. Or it is prohibited to load pharmaceutical articles. If a two-door system is used, the retrieval door may be prohibited from being closed until the progress record is signed. If the retrieval door is open, the loading door cannot be opened, preventing new items from being loaded into the machine and starting a new process.

  After the signature has been made, the signed document preferably cannot be manipulated in the sense that the signature of the progress record is irreversible, except for at least the user identified through the signature.

  To ensure that a poorly cleaned, disinfected or sterilized article, or contaminated article, accidentally exits the sterilization area 30, the article, in this case the medical device, is removed from the device; Or other conditions to prevent release from a specific area are possible in combination or alone.

  As an option or in addition, the device is tamper proof in that only authorized staff can access the device and be allowed to use the device. As an option or in addition, all adjusted data is maintained, can be reconstructed, and is immediately searchable. Optionally or additionally, the uniqueness of the authentication (eg, user ID and password combination) for using the device and applying the electronic signature may be ensured.

  As an option or in addition, the electronic signature cannot be removed, copied / pasted to other electronic records, or otherwise tampered with.

DESCRIPTION OF SYMBOLS 1 Facility 10 Dirty area 11 1st zone barrier, cross-contamination wall 12 Washing machine 20 Cleaning area 21 2nd zone barrier, autoclave, cross-contamination wall 30 Sterilization area 40 Sterilizer, sterilization device, steam sterilizer 41 Chamber 42 Door 43 Tray 44 User interface, touch-sensitive display 45 Touch screen, user interface 100 Standby state 110 In-process state 120 Process completion state 301 Language conversion circuit 302 Image generation circuit 303 User interface display unit 304 Signature identification circuit 305 PDF Conversion circuit

Claims (20)

A device (40) for cleaning, disinfecting, drying and / or sterilizing medical, dental, laboratory and / or pharmaceutical articles, said device (40) comprising said medical, A chamber (41) for receiving dental, laboratory and / or pharmaceutical articles, at least one user interface (44, 45) allowing a user to operate the device (40), Two doors (42) associated with the chamber (41) and processing circuitry for generating a progress record of at least one parameter of the cleaning, disinfection, drying and / or sterilization process performed by the device (40); In a device (40) comprising:
One of the two doors (42) is a loading door and the other is a take-out door,
The user interface (44, 45) is operable by the user to cause the processing circuit to electronically sign the progress record, the electronic signature of the progress record being at least one condition to the device And the condition includes allowing the removal door to be closed only after an electronic signature on the progress record, the loading door being new until the removal door is closed. Device, characterized in that it cannot be opened for loading medical, dental, laboratory and / or pharmaceutical articles.   The device of claim 1, wherein causing the electronic signature to the progress record comprises providing an individual and / or group identification code.   The device of claim 1 or 2, wherein the loading door cannot be opened until the electronic signature is made on the progress record.   The device according to any one of the preceding claims, wherein the device (40) is a pass-through device extending across a zone barrier, the zone barrier separating a clean area and a contaminated area.   The device according to any one of claims 1 to 4, wherein the device (40) is a washing machine.   The device according to any one of claims 1 to 4, wherein the device (40) is a steam sterilizer or an autoclave.   7. A device according to any one of the preceding claims, wherein the loading door is arranged for receiving contaminated articles and the retrieval door is arranged for taking out clean articles.   The device according to any one of the preceding claims, wherein the user interface (44, 45) is a touch-sensitive display. A device (40) for cleaning, disinfecting, drying and / or sterilizing medical, dental, laboratory and / or pharmaceutical articles, said device (40) comprising said medical, A chamber (41) for receiving dental, laboratory and / or pharmaceutical articles, at least one user interface (44, 45) allowing a user to operate the device (40), At least one door (42) associated with the chamber (41) and processing circuitry for generating a progress record of at least one parameter of the cleaning, disinfection, drying and / or sterilization process performed by the device (40) In a device (40) comprising:
The user interface (44, 45) is operable by the user to cause the processing circuit to electronically sign the progress record, the electronic signature of the progress record being at least one condition to the device And the condition is imposed on the at least one door (42).   The device of claim 9, wherein causing the electronic signature to the progress record includes providing an individual and / or group identification code.   The device according to claim 9 or 10, wherein a new contaminated article cannot be loaded into the device (40) and a new process cannot be started until the electronic signature is made on the progress record.   12. Device according to any one of claims 9 to 11, wherein the at least one door (42) cannot be opened until the electronic signature is made on the progress record.   The device (40) has two doors (42), the two doors (42) being one door for loading contaminated or non-sterile items and the other being cleaned The device according to any one of claims 9 to 12, which is a door for taking out a sterilized article.   14. A device according to any one of claims 9 to 13, wherein the device (40) is a pass-through device extending across a zone barrier, the zone barrier separating a clean area and a contaminated area.   15. A device according to any one of claims 9 to 14, wherein the device (40) is a washer.   15. A device according to any one of claims 9 to 14, wherein the device (40) is a steam sterilizer or an autoclave.   The device according to any one of claims 9 to 16, wherein the user interface (44, 45) is a touch-sensitive display.   18. A device according to any one of claims 9 to 17, wherein the signature of the progress record is irreversible.   19. A device according to any one of claims 9 to 18, wherein the device (40) generates an audit trail comprising event identification, time and date.   20. A device according to any one of claims 9 to 19, wherein the device (40) displays a checklist, a condition associated with at least one condition for the device.

Images