METHOD FOR OPERATING A CLEANING AND DISINFECTION DEVICE

Description

[0001] The invention relates to a method for operating a cleaning and disinfection device which is configured to process a surgical instrument belonging to a predetermined group of validated surgical instruments in a validated cleaning and disinfection process using at least one cleaning agent belonging to a predetermined group of validated cleaning agents.

[0002] Cleaning and disinfection systems for surgical instruments serve to clean and disinfect both the outer surface of the surgical instruments and their channels or channel system. These systems are also frequently referred to as reprocessing units. For example, a cleaning and disinfection system for endoscopes is known as the ETD (Endo-ThermoDisinfector) from the manufacturer Olympus Winter & Ibe GmbH, Hamburg.

[0003] From WO 2014 / 205366 A1, a device for disinfecting and / or sterilizing medical or laboratory clothing is known. A disinfection cabinet includes an RFID reader for tracking the clothing. The garments are equipped with RFID tags so that they can be identified and tracked during the reprocessing process. Alternatively, instead of identification via RFID tags, a barcode on the clothing and a corresponding barcode reader on the disinfection device are provided.

[0004] WO 2015 / 040366 A1 discloses a decontamination system for cleaning and disinfecting a medical instrument, such as an endoscope. The system comprises a variety of pre-cleaning wipes for wiping the instrument to be decontaminated. It is a system in which several different wipes are used sequentially. Each of these wipes is individually wrapped, and each wrapper is marked with a machine-readable code. To ensure efficient cleaning, the system requests the barcodes of each disinfection stage in succession.

[0005] From the subsequently published WO 2016 / 087244 A1, a reprocessing system is known in which a sensor is located in the front panel of the reprocessing unit. This sensor detects a machine-readable identifier, such as an RFID tag, on a cleaning basket or a medical device. If the RFID tag is located directly in front of the door of the reprocessing unit, a door opening signal is automatically generated, thus granting access to the reprocessing chamber by opening the door.

[0006] US 2012 / 0249060 A1 shows an autoclave for sterilizing a battery. It is designed so that during a first operating phase the battery temperature is reduced. The battery temperature then rises to a second temperature during a second operating phase.

[0007] A washing and disinfection device for endoscopes is known from US 2009 / 0220377 A1. This device includes a fluid supply unit that monitors the flow of the rinsing solution through the individual endoscope channels using a flow meter. The endoscope 2 is equipped with an RFID tag, which is read by a corresponding RFID reader in the washing and disinfection device. Specifications for the endoscope type identified in this way are stored, so that the endoscope channels are rinsed at the appropriate flow rate. The flow through the endoscope channels is monitored by a flow meter. If the actual flow is outside the specified target values, a corresponding error message is displayed.

[0008] JP 2010 / 110417 A1 shows a system in which a bottle of disinfectant solution is equipped with an RFID tag that is read by an RFID reader on the machine side. This ensures that the intended disinfectant solution is used as a consumable.

[0009] US 2016 / 0081540 discloses a device for cleaning and disinfecting endoscopes. The endoscopes are equipped with an RFID tag. This tag stores information such as the type or a production number. The device detects whether the endoscope is inserted into or removed from the tank.

[0010] EP 1 600 173 A1 shows a cassette for holding an item to be sterilized. This cassette is designed for a specific number of sterilization cycles. To enable identification of the cassette, it is marked with a barcode, which can also be replaced by an RFID tag.

[0011] WO 2012 / 148868 A2 discloses a method for reducing the consumption of a disinfectant. A disinfectant is introduced, and then the surrounding area is dehumidified, thereby increasing the disinfectant concentration on the surface. The source of the disinfectant, for example a canister, can be equipped with an RFID tag for identification purposes.

[0012] Furthermore, a system is known from EP 1 121 942 A in which a liquid sterilizing agent is evaporated. The system is not functional unless the container holding the sterilizing agent is identified as approved by scanning its barcode.

[0013] DE 10 2010 002 031 A1 discloses a device for disinfecting, sterilizing, and / or maintaining dental instruments. A cleaning and maintenance agent is provided in a reservoir equipped with a corresponding constriction or notch. Only such reservoirs can be accommodated in the device.

[0014] EP 1 550 465 A1 shows another sterilization device for an endoscope. It includes an RFID unit that communicates with an RFID tag on the endoscope. The sterilization process is set according to the information read from the endoscope's RFID tag.

[0015] WO 2016 / 006270 A1 discloses a control unit which prevents an endoscope reprocessing machine from being accidentally opened during the reprocessing process.

[0016] Strict hygiene standards are applied to the reprocessing of surgical instruments, especially endoscopes. To meet these high standards for the quality of cleaning and reprocessing of surgical instruments and to ensure this quality over the long term, both the cleaning and disinfection facilities and the cleaning process itself are validated. Such validation typically takes place annually.

[0017] In Germany, for example, the validation of the reprocessing process is specified in detail in the "Guideline for the validation of machine cleaning and disinfection processes for the reprocessing of thermolabile endoscopes".

[0018] As part of the validation process, the functionality of the cleaning and disinfection equipment, i.e., the functionality of the machine, is determined. Furthermore, the effectiveness of the reprocessing process is checked and validated. This includes, for example, the process flow with regard to rinsing blocks, temperatures, and the concentration of the cleaning chemicals used. The process chemicals themselves are also checked during the validation.

[0019] Finally, validation includes the matching of the reprocessing process to the surgical instrument to be cleaned and disinfected. For this purpose, the surgical instruments to be reprocessed in a specific process, such as endoscopes, are assigned to a particular group. For the instruments in this group, it is then ensured that the cleaning and disinfection of the respective instrument takes place with the required quality in the corresponding reprocessing process.

[0020] Based on this prior art, it is an object of the invention to provide a method for operating a cleaning and disinfection device, a cleaning and disinfection device and a medical system, wherein the cleaning and disinfection process is to become safer.

[0021] The problem is solved by a method for operating a cleaning and disinfection device according to claim 1.

[0022] The method according to aspects of the invention is based on the following considerations: Cleaning and disinfection equipment is equipped with a multitude of monitoring functions that ensure correct machine functionality. However, the cleaning and disinfection process (reprocessing process) is not currently checked with regard to all relevant parameters that are verified within the framework of validation. These are process-relevant parameters that are not influenced by the machine itself. Examples include the cleaning agents or chemicals used, as well as the endoscope to be reprocessed, for example, its type or series.To ensure that the reprocessing programs, cleaning agents, and surgical instruments being reprocessed (e.g., endoscopes) used by the operator of the cleaning and disinfection facility actually comply with a validated process, the classification of the surgical instrument and / or the cleaning agent as belonging to a corresponding group of validated units is verified. This verification determines whether the operator of the cleaning and disinfection facility has defined and implemented all necessary measures to ensure reprocessing within a validated process. In other words, the operator is enabled to determine at any time whether or not reprocessing is taking place within a validated process.

[0023] The method for operating a cleaning and disinfection facility according to aspects of the invention is therefore safer than conventional methods.

[0024] In the context of this description, validation refers specifically to the validation of the reprocessing process, as detailed in Germany according to the "Guideline for the Validation of Automated Cleaning and Disinfection Processes for the Reprocessing of Thermolabile Endoscopes." This guideline is published, for example, in the journal "Zentralsterilisation" in issue 3 / 2011 as Supplement 3.

[0025] The procedure for operating a cleaning and disinfection system has been further developed, in particular, by the fact that if the classification of the surgical instrument to be cleaned as belonging to the validated group of surgical instruments and / or the classification of the cleaning agent to be used as belonging to the group of validated cleaning agents and / or the validation of the cleaning and disinfection process is not positively confirmed, the cleaning and disinfection system generates a warning message. Specifically, it is intended that the system verifies whether the reprocessing procedure for the relevant group of surgical instruments and / or cleaning agents is indeed validated. For example, it is ensured that the validity period of any such validation has not expired.

[0026] Furthermore, it is specifically intended that the warning message be issued as an error message by the cleaning and disinfection facility and / or saved as an error message in an error log maintained by the cleaning and disinfection facility.

[0027] For example, the cleaning and disinfection system displays a corresponding warning or error message on the machine's screen. In this case, the user is informed that reprocessing is taking place in a non-validated process. It is also provided that a warning or error message is communicated to a central computer. Furthermore, the cleaning and disinfection system may, for example, maintain a public (i.e., user-accessible) or non-public error log. Error messages are optionally stored in this log.

[0028] Validation is primarily defined as having a time limit. For example, the reprocessing process might be validated annually and is valid for one year. Afterward, a new validation must be performed. It's also possible that the validity of the validation depends on current regulations. For instance, if the regulations for reprocessing surgical instruments change, some or even all of the reprocessing procedures performed by the cleaning and disinfection facility become invalid. A corresponding revalidation is then necessary.

[0029] According to a further embodiment, the method is further developed in that the belonging of the surgical instrument to be cleaned to the validated group of surgical instruments and / or the belonging of the cleaning agent to be used to the group of validated cleaning agents and / or the validity of the validation of the cleaning and disinfection process is determined by comparison with entries in a database of the cleaning and disinfection facility, wherein entries relating to all surgical instruments belonging to the validated group of surgical instruments and / or entries relating to all cleaning agents belonging to the group of validated cleaning agents and / or entries relating to the validity of the validation of all cleaning and disinfection processes of the cleaning and disinfection facility are stored in this database.

[0030] The database is stored primarily on non-volatile memory within the cleaning and disinfection system. Data synchronization is performed, for example, by a control unit of the cleaning and disinfection system. Specifically, the database is designed to be imported and / or updated remotely.

[0031] A negative confirmation occurs, for example, if a database check reveals that the surgical instrument to be cleaned is not among the validated surgical instruments. Similarly, a negative confirmation occurs if the validation period for this group of instruments has expired, for example, because the last validation was more than a specified time interval, such as one year. The same applies to cleaning agents. Regarding the validity of the cleaning and disinfection process validation, a check is also performed against a date specified in the database, indicating when the process was last validated. A comparison of this date with the date of the reprocessing to be carried out, taking into account the prescribed validity period, yields the corresponding result.

[0032] The method is further developed in particular by the fact that the cleaning and disinfection device reads a machine-readable identification feature present on the surgical instrument and / or on the cleaning agent, wherein the identification feature includes specific information for the surgical instrument and / or for the cleaning agent, which is read or received by the cleaning and disinfection device.

[0033] A machine-readable identification feature, such as a barcode, QR code, or RFID tag, is provided. For example, the surgical instrument includes a corresponding RFID tag. Similarly, such an identification feature, such as an RFID tag or barcode, is provided on the canister containing the cleaning agent.

[0034] The cleaning and disinfection system is equipped with a barcode or QR code reader or an RFID interrogator to read the barcodes or RFID tags on the surgical instrument or cleaning agent. The machine-readable identifier includes information such as the type and / or classification of the surgical instrument and / or cleaning agent. It is also intended that, for example, a serial or batch number is stored as information. The cleaning and disinfection system determines the group affiliation, for example, for surgical instruments, or the validity of a validation, for example, for cleaning agents, based on the batch or production number. This is done, for example, by comparing the batch or serial number with data stored in the database.

[0035] According to a further embodiment, the method is further developed in that the cleaning and disinfection device reads the machine-readable marking feature present on the surgical instrument and / or on the cleaning agent without contact.

[0036] A contactless system simplifies the detection of, for example, a canister of cleaning agent or a surgical instrument placed in the cleaning and disinfection unit. The usual workflow, such as placing surgical instruments in the cleaning and disinfection unit or refilling or replacing consumables / cleaning agents, remains unchanged.

[0037] Further features of the invention will become apparent from the description of embodiments according to the invention, together with the claims and the accompanying drawings. Embodiments according to the invention may fulfill individual features or a combination of several features.

[0038] The invention is described below, without limiting the general concept, with reference to exemplary embodiments and the drawings, whereby for all details of the invention not explained in detail in the text, explicit reference is made to the drawings. The drawings show: Fig. 1 a simplified and schematic flowchart of a method for operating a cleaning and disinfection device and Fig. 2 a cleaning and disinfection device in a medical system in simplified schematic and perspective representation.

[0039] In the drawings, identical or similar elements and / or parts are provided with the same reference numbers, so that a re-presentation is omitted.

[0040] Fig. 1 shows a simplified and schematic flowchart of a procedure for operating a cleaning and disinfection facility 2, as exemplified by Fig. 2 shown in a simplified, schematic and perspective representation.

[0041] The cleaning and disinfection unit 2 is designed to reprocess a surgical instrument 4, in particular an endoscope, in a validated cleaning and disinfection process. To ensure that the surgical instrument 4 is indeed reprocessed in a validated cleaning and disinfection process, the cleaning and disinfection unit 2 checks at the beginning of the cleaning and disinfection process, i.e., before the cleaning and disinfection of the surgical instrument 4 to be cleaned begins, whether the surgical instrument 4 belongs to a validated group of surgical instruments 4 and / or whether the cleaning agent 8 to be used belongs to a group of validated cleaning agents 8 and / or whether a validation of the cleaning and disinfection process is still valid at the time of reprocessing.It is intended that the above-mentioned criteria may be applied individually, in combination or, in particular, cumulatively.

[0042] The procedure for operating the cleaning and disinfection facility 2 will now be illustrated using the following example: Fig. 1As explained, at the beginning of the reprocessing process (step S1), before the actual cleaning and disinfection process starts, the aforementioned check (step S2) is performed. For example, it is checked whether the surgical instrument 4 to be cleaned belongs to a validated group of surgical instruments 4. It is also checked whether the cleaning agent 8 to be used belongs to a group of validated cleaning agents 8. Furthermore, it is checked whether the validation of the cleaning and disinfection process to be carried out is still valid. If all these criteria are confirmed positively, the procedure follows the branch of the flowchart marked with a "+". The cleaning and disinfection program starts in step S3.

[0043] If, however, one of the criteria is not positively confirmed, the procedure follows the branch marked with a "-". A warning message is generated (step S4). This warning message is displayed, for example, on an output unit 6, such as a display, of the cleaning and disinfection system 2. Alternatively or additionally, the warning message is saved as an error message in an error log of the cleaning and disinfection system 2 (step S5). This enables the operator of the cleaning and disinfection system 2 to always determine whether the reprocessing is taking place in a validated process or not.

[0044] Alternatively, the reprocessing process is stopped or does not begin at all (step S6). According to this embodiment, the cleaning and disinfection unit 2 refuses to operate if there is a possibility that the surgical instruments 4 to be reprocessed could be cleaned and disinfected in a non-validated process.

[0045] The functionality described above is provided on the cleaning and disinfection system 2 by a control unit 10. This unit includes, for example, a database 12 stored on a non-volatile storage medium within the control unit 10. Database 12 contains entries relating to all surgical instruments 4 belonging to the validated group of surgical instruments. These are, for example, surgical instruments 4, such as endoscopes, of a specific series or type for which the reprocessing process has been validated. Furthermore, database 12 contains entries relating to all cleaning agents 8 belonging to the group of validated cleaning agents 8. The group of validated cleaning agents 8 includes, for example, cleaning agents from a specific manufacturer for which the reprocessing process has been validated.The database also contains 12 entries indicating the validity of the validation of all cleaning and disinfection processes or programs of the cleaning and disinfection facility 2, particularly with regard to their validity period. By comparing the data of the surgical instrument 4 to be cleaned, the cleaning agent 8 to be used for reprocessing, and the intended cleaning and disinfection program (taking the current date into account) with the corresponding entries in database 12, it is possible to verify the aforementioned criteria. If the validation is valid in each case, the cleaning and disinfection process is confirmed and reprocessing begins.

[0046] According to one embodiment, the surgical instrument 4 and / or the cleaning agent 8 are each provided with a machine-readable identifier 14, 16. The corresponding machine-readable identifier 14, 16 contains information specific to the surgical instrument 4 to be reprocessed or the cleaning agent 8 to be used. For example, the machine-readable identifier 14, 16 contains information relating to a type, a serial number, a manufacturer, or the like.

[0047] The machine-readable identification feature 14, 16 is, for example, a barcode, a QR code, and, in particular, an RFID tag. To read an RFID tag, the cleaning and disinfection unit 2 includes a sensor 18. This advantageously enables contactless identification of the surgical instrument 4 or the cleaning agent 8 to be used. Contactless identification is particularly advantageous because the usual workflow is not interrupted by this step. For example, the surgical instrument 4 to be processed can be placed in a cleaning basket (not shown) as usual, and this cleaning basket can then be inserted into the interior of the cleaning and disinfection unit 2 after the door 20 has been opened.As soon as the intended cleaning and disinfection program is started, the surgical instruments 4 present inside the cleaning and disinfection unit 2 are first detected. The corresponding validation of the intended cleaning process then takes place. Similarly, the changing or refilling of the cleaning and disinfection unit 2 with cleaning agents 8 is practically unchanged compared to the conventional process. For example, if a canister containing new cleaning agent 8 is placed in the cleaning and disinfection unit 2, the RFID tag on the canister containing the cleaning agent 8 is automatically read as a machine-readable identification feature 16 after the new canister is detected.The control unit 10 of the cleaning and disinfection device 2 is thus enabled, for example by comparing it with data records available on the database 12, to determine whether the replaced cleaning agent 8 belongs to a validated reprocessing process or not.

[0048] As a result, in a medical system 22, as simplified and schematically described Fig. 2 shows, and which, in addition to the cleaning and disinfection equipment 2, includes at least one cleaning agent 8 to be used and at least one medical instrument 4 to be cleaned, significantly improves the reprocessing, i.e. the cleaning and disinfection of the surgical instrument 4, with regard to process safety.

[0049] All features mentioned, including those discernible from the drawings alone as well as individual features disclosed in combination with other features, are considered essential to the invention, both individually and in combination. Inventory embodiments may be fulfilled by individual features or a combination of several features. Within the scope of the invention, features marked "in particular" or "preferably" are to be understood as optional features. Reference symbol list

[0050] 2 Cleaning and disinfection unit 4 Surgical instrument 6 Dispensing unit 8 Cleaning agent 10 Control unit 12 Database 14, 16 Machine-readable identifier 18 Sensor 20 Door 22 Medical system

Claims

1. A method for operating a cleaning and disinfecting device (2) which is designed to treat a surgical instrument (4) which belongs to a predetermined group of validated surgical instruments (4), using at least one cleaning agent (8) which belongs to a predetermined group of validated cleaning agents (8), in a validated cleaning and disinfecting process, characterized in that the cleaning and disinfecting device (2) checks, at the start of the cleaning and disinfecting operation, before the treatment of a surgical instrument (4) to be treated begins, whether the surgical instrument (4) to be cleaned belongs to the validated group of surgical instruments (4) and whether a cleaning agent (8) to be used belongs to the group of validated cleaning agents (8) and whether a validation of the cleaning and disinfecting process is valid.

2. The method according to Claim 1, characterized in that in the case in which the question of whether the surgical instrument (4) to be treated belongs to the validated group of surgical instruments (4) and the question of whether the cleaning agent (8) to be used belongs to the group of validated cleaning agents (8), and the validation of the cleaning and disinfecting process for the group of surgical instruments (14) and the group of validated cleaning agents (8), are not positively confirmed, the cleaning and disinfecting device generates a warning message.

3. The method according to Claim 2, characterized in that the warning message is output as an error message by the cleaning and disinfecting device (2) and / or is stored as an error message in an error log kept by the cleaning and disinfecting device (2).

4. The method according to any one of Claims 1 to 3, characterized in that the question of whether the surgical instrument (4) to be cleaned belongs to the validated group of surgical instruments (4) and the question of whether the cleaning agent (8) to be used belongs to the group of validated cleaning agents (8) and the question of whether the validation of the cleaning and disinfecting process is valid are checked by a comparison with entries present in a database (12) of the cleaning and disinfecting device (2), wherein entries regarding all of the surgical instruments (4) which belong to the validated group of surgical instruments (4), and entries regarding all of the cleaning agents (8) which belong to the group of validated cleaning agents (8), and entries regarding a validity of the validation of all of the cleaning and disinfecting processes of the cleaning and disinfecting device (2), are stored in said database (12).

5. The method according to any one of Claims 1 to 4, characterized in that the cleaning and disinfecting device (2) reads out a machine-readable characterizing feature (14, 16) which is present on the surgical instrument (4) and / or on the cleaning agent (8), wherein the characterizing feature (14, 16) for the surgical instrument (4) and / or for the cleaning agent (8) comprises specific information which is read out or, respectively received by the cleaning and disinfecting device (2).

6. The method according to Claim 5, characterized in that the cleaning and disinfecting device (2) reads out the machine-readable characterizing feature (14, 16) which is present on the surgical instrument (4) and / or on the cleaning agent (8) contactlessly.