Systems for reprocessing medical devices

Abstract

The present invention relates to the health sector and to the reprocessing of medical devices. In particular, the present invention relates to a system and a method for reprocessing medical devices. A system 1 for reprocessing medical devices 2 according to the present invention comprises: - a housing 3 suitable for the processing of medical devices 2, each of the medical devices 2 having at least one RFID tag 4; - at least one support 5, by means of which at least one medical device 2 to be reprocessed is intended to be suspended within the housing 3; - at least one RFID tag reader6; at least one reprocessing ejector 7 arranged in the housing 3; - electronic control system 8; - a data management system 9 comprising processing software and a database relating to said medical devices and reprocessing cycles; Equipped with The at least one RFID tag reader 6 is at least partially positioned in a wall of the housing 3 so as to transmit signals and / or receive return signals emitted from at least one RFID tag 4 of at least one medical device 2 suspended within the housing 3.

Description

[Technical Field]

[0001] The present invention relates to the health sector and to the reprocessing of medical devices. More particularly, the present invention relates to a system and method for reprocessing medical devices. [Background technology]

[0002] In the health sector, medical devices undergo reprocessing cycles such as sterilization, cleaning and / or disinfection.

[0003] These cycles can be tracked using tags, such as RFID tags or barcode tags, that are affixed to or engraved into these devices, where the unique identifier for each medical device can be detected by reading these tags, enabling the reprocessing process for each tracked medical device.

[0004] However, the reliability of reprocessing cycle traceability is not optimal because tag detection is typically performed before the reprocessing cycle by a tag reader located outside the reprocessing enclosure. Therefore, multiple tag reading steps outside the reprocessing enclosure and multiple device positioning within the enclosure increase the risk of error and make it impossible to guarantee the correct execution of the reprocessing cycle for each device.

[0005] Furthermore, when a reprocessing tool malfunctions, information regarding the validation of the reprocessing cycle is not immediately generated and requires manual entry of error codes issued by the reprocessing tool into a database.

[0006] Therefore, there is a real need for a method of reprocessing medical devices that increases reliability by minimizing the number of manual steps using a system that allows traceability and verification of the reprocessing cycle to be managed efficiently and quickly. U.S. Patent Application Publication No. 2022 / 0047745 describes a system for reprocessing medical devices, including a tag reader external to the housing and a support. The tag can be affixed to a portion of the device located outside or inside the housing. International Publication No. 2008 / 142300 by the same applicant discloses a system for reprocessing probes, including an active part and a cable for connection to an imaging device. The active part is placed within a housing volume for disinfection, and a hanging part carries an RFID tag outside the housing, allowing the cable to be hung. None of these solutions address optimizing the transmission quality between the tag and reader of medical devices located within the housing, especially when multiple medical devices are being processed simultaneously.

[0007] U.S. Patent Application Publication No. 2022 / 0211891 describes a system for reprocessing catheters, each of which can be mounted on a tray, but the tray handling remains manual and does not allow for optimization of the position or orientation of the medical device according to its type or size in order to improve the reliability of the transmission of traceability information in real time for each medical device processed.

[0008] US 2005 / 0148819 A1 describes an endoscope cleaning system equipped with an RFID tag, which is placed in a cleaning tank and has an RFID unit arranged in one part of it. Again, no attempt is made to optimize the transmission for such individual processing of medical instruments. The same logic applies to the solution disclosed in the document US 2009 / 0220377 A1, which relates to an apparatus for cleaning and disinfecting endoscopes.

[0009] U.S. Patent Application Publication No. 2002 / 0161460 discloses yet another endoscope disinfection system that includes an RFID box located behind one of the walls of the washing chamber. The wall is made of a non-metallic sheet (plastic or rubber) and allows for electromagnetic transmission of identification data. The RFID tag can be attached directly to the endoscope placed in the washing chamber, or the endoscope can be attached to a support fixed within the washing chamber. However, again, it is not possible to improve the reliability of transmission between the tag and the reader, each linked to multiple medical devices as part of a batch process. [Prior art documents] [Patent documents]

[0010] [Patent Document 1] US Patent Application Publication No. 2022 / 0047745 [Patent Document 2] International Publication No. 2008 / 142300 [Patent Document 3] US Patent Application Publication No. 2022 / 0211891 [Patent Document 4] US Patent Application Publication No. 2005 / 0148819 [Patent Document 5] US Patent Application Publication No. 2009 / 0220377 [Patent Document 6] US Patent Application Publication No. 2002 / 0161460 Summary of the Invention [Problem to be solved by the invention]

[0011] It is an object of the present invention to provide a system that allows for improved reliability in the reprocessing of medical devices.

[0012] Another object of the present invention is to provide a system that makes it possible to ensure traceability of reprocessing cycles and fast, more reliable and more efficient verification. [Means for solving the problem]

[0013] Therefore, the present invention provides - a housing suitable for processing medical devices, each of the medical devices having at least one RFID tag; - at least one support, by means of which at least one medical device to be reprocessed is intended to be suspended in the housing; - at least one RFID tag reader; at least one reprocessing ejector disposed within the housing; - an electronic control system; - a data management system comprising processing software and a database relating to said medical devices and reprocessing cycles; 1. A system for reprocessing medical devices, comprising: the at least one RFID tag reader is disposed at least partially on a wall of the housing to transmit signals and / or receive return signals emitted from at least one RFID tag of at least one medical device suspended within the housing; at least one support includes at least one movable part that allows both adjustment of the orientation of each medical device to be reprocessed relative to the RFID tag reader and adjustment of the position of the support within the housing; The system for reprocessing medical instruments is characterized in that the support, the at least one reader, and the at least one ejector are connected to the electronic control system.

[0014] Medical devices within the scope of the present invention are instruments and articles used in the medical, dental, surgical, pharmaceutical, and / or veterinary fields. According to their design, medical devices within the meaning of the present invention have surfaces, fronts, backs, slots, grooves, joints, and / or openings. They are made from materials such as steel, copper-nickel alloys, and / or polymers that are resistant to reprocessing cycles, such as polyetheretherketone (PEEK) or polyamide-imide (PAI).

[0015] Preferably, the medical instruments are dental and / or surgical instruments. These instruments may have a side part, a rear part, and a front part, which is the active part of the instrument. Preferably, the medical instruments are selected from among turbines, contra-angles, and / or straight handpieces. Therefore, within the framework of the present invention, the position and orientation of the support can be individually adjusted for each medical instrument to be processed, in particular depending on its type (which determines its size within the housing, which is not the same for, for example, straight handpieces and contra-angles) and the positioning of the tag.

[0016] Within the scope of the present invention, each medical device includes at least one tag. The tag associates a unique identifier with each medical device. Advantageously, the unique identifier is a unique numeric or alphanumeric code linked to the medical device, allowing unambiguous and formal identification of the device and facilitating its traceability. This identifier can be detected when the tag is read by a suitable tag reader.

[0017] Preferably, each medical device is equipped with two tags to optimize detection reliability, for example by ensuring that at least one of the two tags remains readable when one is damaged, the tags typically being RFID and / or barcode tags.

[0018] In the context of the present invention, the tags are RFID tags. Thus, according to the present invention, the identification information comprises a unique identifier linked to each of the RFID tags of the medical device. The RFID tags are selected from passive and / or active RFID tags.

[0019] Passive RFID tags do not have a built-in power source. The electromagnetic signal emitted by this type of RFID tag is generated by a signal emitted by an RFID reader. Advantageously, passive RFID tags are resistant to the very high temperatures, irradiation, and / or chemicals used during reprocessing cycles.

[0020] Active RFID tags have an internal power source, such as a battery. This type of tag can transmit an electromagnetic signal to a tag reader using radio technology and does not require an interrogation signal from the tag reader. Advantageously, the electromagnetic signal of an active RFID tag is stronger than that of a passive RFID tag.

[0021] Preferably, the tags are passive RFID tags that can withstand the very high temperatures, irradiation and / or chemicals used during the reprocessing cycle.

[0022] Additionally, the tag may be attached to and / or integrated into the side of the medical device by gluing, pressing, or screwing to increase the reliability of tag detection and reading.

[0023] In the context of the present invention, the system comprises an enclosure suitable for reprocessing medical devices, regardless of the complexity or variety of the medical devices.

[0024] The housing comprises a top wall, a bottom wall, side walls, and at least one door providing access to the interior of the housing designed to receive the medical device. Preferably, the housing includes at least one removable door that facilitates access to the interior of the housing. The closed housing is also airtight or watertight to ensure proper execution of the reprocessing cycle, ensure sterility of the device, and prevent the entry of bacterially contaminated fluids or gases outside the housing.

[0025] Various methods for cleaning and sterilizing medical instruments use heat, water, chemicals, various gases, and / or ionizing radiation that are released into the housing during various reprocessing cycles. Accordingly, within the scope of the present invention, a system includes at least one reprocessing ejector disposed within the housing.

[0026] The reprocessing ejector is configured to eject steam, chemicals, water, gas, ionizing radiation, and / or compressed air to clean and / or sterilize medical devices.

[0027] Within the housing, at least one support is designed to suspend at least one medical device to be reprocessed. Preferably, each support is designed to suspend only one medical device to be reprocessed. Advantageously, suspending the medical device allows for effective reprocessing of a greater proportion of the device's surface, cavities, and / or channels compared to devices arranged in cassettes or on trays.

[0028] According to the invention, the support comprises fastening means adapted to hold at least one medical instrument in a suspended state, preferably selected from among clamps, screws, clips or magnetic adhesives, adapted to hold the instrument to be reprocessed in a suspended state at the height of a specific part of the instrument to ensure complete reprocessing of the part intended to treat the patient.

[0029] In the context of the present invention, it is envisaged that the at least one ejector may be arranged within the support body. Preferably, the support body has a tubular shape and the at least one ejector may be arranged within the tubular shape of the support body. Advantageously, therefore, the material produced in the reprocessing cycle is ejected into the interior of the medical device at openings such as cavities or internal channels, rather than onto the exterior surface of the medical device.

[0030] In the particular case of dental and / or surgical instruments, the fastening means are adapted to suspend the instrument to be reprocessed at the rear part and ensure complete reprocessing of the front part, which is the active part intended to treat the patient.

[0031] The fastening means may also comprise an envelope designed to receive the suspended medical device. Advantageously, the envelope suspended by the fastening means allows for full reprocessing of the medical device. Preferably, the envelope is a sterilization pouch.

[0032] Each envelope can also include an RFID tag. Thus, by combining the device identifier with the envelope identifier, traceability of the envelope containing the device is ensured all the way to its use. Specifically, this system makes it possible to track the sterility period of the device within that envelope. This is particularly advantageous since sterility is often limited to a few days. If such a period is exceeded, additional sterilization / decontamination is recommended.

[0033] In the context of the present invention, the support is attached to a wall of the housing, preferably to the top wall of the housing, and the position of the support within the housing is adjustable to adjust the distance between the medical devices according to their size, to avoid contact between the devices, and to optimize the orientation of the RFID tags of each of the medical devices.

[0034] Advantageously, each medical device remains suspended within the housing without direct contact with other devices or elements within the housing, such as walls or metal surfaces, thereby limiting damage to tags affixed to and / or integrated into the sides of the medical device.

[0035] According to the invention, the support comprises at least one movable part that allows adjustment of the orientation of the medical devices in order to optimize the orientation of the RFID tag for each of the medical devices.

[0036] In the context of the present invention, RFID tags attached to and / or embedded in the medical devices are read by an RFID tag reader, and therefore the system comprises at least one RFID tag reader arranged at least partially in a wall of the housing to emit signals and / or receive return signals coming from the RFID tags of the medical devices suspended within the housing.

[0037] Advantageously, locating the RFID tag reader at least partially within a wall of the housing means that signals from the RFID tags of the medical devices can only be received reflected back within the housing, and this location protects the RFID tag reader from materials projected during reprocessing cycles, while minimizing the footprint of the reader within the housing.

[0038] It is conceivable that one portion of the RFID tag reader, e.g., the portion containing the electrical / electronic circuitry, is positioned so as to be fully integrated into the wall, and another portion is positioned so as to extend into the interior of the housing volume.

[0039] In a particular embodiment, the present invention relates to a system in which the at least one RFID tag reader comprises a guide means arranged to guide a portion of the RFID tag reader within the housing to obtain the identification information of each medical device. The guide means is, for example, an articulated arm adapted to orient the read head of the RFID tag reader near the RFID tag of the medical device. The ability to adjust the position of the portion of the RFID tag reader within the housing depending on the type and size of the medical device being reprocessed is advantageous. This ensures optimal radio transmission quality between the RFID tag and the RFID reader. This minimizes the risk of errors during the reprocessing procedure and the transmission of identification information, thus maximizing tracking reliability. Furthermore, the articulated arm is designed to fold during the reprocessing cycle to protect the read head of the RFID tag reader from substances released during the reprocessing cycle.

[0040] According to another particular aspect, the present invention relates to a system for reprocessing medical devices, wherein the at least one RFID tag reader is positioned entirely within a wall of the housing so as to emit signals and / or receive return signals from RFID tags on medical devices suspended within the housing. Advantageously, this positioning protects all parts of the RFID tag reader from substances released during the reprocessing cycle, while minimizing the footprint of the reader within the housing. In particular, the parts including the electrical / electronic circuitry and the read head are protected while still functioning.

[0041] Advantageously, partial or complete placement of the tag reader on the wall maximizes the angle or area of ​​detection of RFID tags positioned on the equipment being reprocessed to cover most or all of the volume of the enclosure.

[0042] In the context of the present invention, it is conceivable that the RFID tag reader is formed in at least one wall of the housing by extrusion or overmolding, so that the tag reader is integral with the wall and the system can be easily implemented without any assembly steps during use.

[0043] The RFID tag reader is also configured to acquire the identification information of each medical device suspended within the housing before, during, and after a reprocessing cycle of the medical device. In this way, the system can know the status of the medical device just before the start of a reprocessing cycle, during the reprocessing cycle, and just after its completion. In this way, the system ensures that the status of the medical devices can be monitored and makes it possible to verify the processing status of the medical devices after each reprocessing cycle, i.e., whether they need to be reprocessed or have actually been reprocessed.

[0044] The system according to the present invention also includes at least one metal plate arranged so that it can be movably positioned outside the housing to prevent the RFID tag from being read from outside the housing. The arrangement of the at least one metal plate on one or more sides of the housing can be adapted to the installation location of the system. Preferably, the system includes at least two, three, four, five, or six metal plates. The metal of the plates is selected from conductors such as aluminum and stainless steel, and / or plastic materials (PET) metallized with electric or magnetic dopants (aluminum, fluorine, tin, etc.) to prevent the RFID tag from being read from outside the housing.

[0045] Advantageously, traceability and verification of reprocessing cycles are immediately ensured in the most reliable and efficient manner by an electronic control system linked to a management system, preferably comprising processing software and a database that manages identifiers individually associated with the equipment, for example via RFID tags. In this way, the processing status can be updated in real time for each equipment individually as different reprocessing cycles are performed. Thus, rapid information transmission optimizes the reliability of the reprocessing system and the methods implemented by this system.

[0046] The electronic control system - controlling one or more RFID tag readers and one or more reprocessing ejectors; - controlling one or more supports; - collecting identification data obtained by one or more RFID tag readers; - transferring the identification data acquired by the one or more RFID tag readers to a data management system; - Transferring data on reprocessing cycles to a data management system; The device is provided with a control unit capable of performing the following:

[0047] According to the present invention, the identification data obtained by the RFID tag reader is a unique identifier of the medical device and / or the envelope.

[0048] During a reprocessing cycle, an error code may be issued by the electronic control system if, for example, the enclosure seal fails or is lost and a full reprocessing cycle is not completed. Thus, the reprocessing cycle information includes the cycle number, the type of reprocessing cycle performed, and any error codes generated during the reprocessing cycle.

[0049] Within the scope of the present invention, the electronic control system comprises a control unit capable of transferring the identification information and reprocessing cycle information to a data management system, which is responsible, in particular through processing software interacting with a database, for ensuring and monitoring the smooth execution of each reprocessing cycle and simultaneously updating the processing status of the medical devices, for which data from the data management system comprises the medical device identifier, the envelope identifier, the medical device reference, the number and type of reprocessing cycles performed for each medical device, as well as any error codes generated during the reprocessing cycles.

[0050] The invention also relates to a method for reprocessing medical devices carried out using a system such as defined above.

[0051] One object of the present invention is to provide a method for reprocessing medical devices, which makes it possible to improve the reliability of reprocessing of medical devices.

[0052] Another object of the present invention is to provide a method for reprocessing medical devices that makes it possible to ensure traceability and verification of the reprocessing cycle in a more reliable and efficient manner.

[0053] Accordingly, the present invention provides a method for reprocessing a medical device using a system for reprocessing, comprising: i. equipping at least one medical device to be reprocessed with at least one RFID tag; ii. positioning the at least one medical device comprising at least one RFID tag in a reprocessing enclosure and using a support to suspend and hold each of the at least one medical device; iii. closing the housing; iv. adjusting the position of at least one support within the housing and the orientation of said support relative to at least one RFID tag reader for each medical device to be reprocessed; v. activating said at least one RFID tag reader to collect identification data from each of the medical devices prior to performing a reprocessing cycle; vi. actuating said at least one reprocessing ejector to perform at least one reprocessing cycle; vii. collecting reprocessing cycle data; viii. activating said at least one RFID tag reader to collect identification data from at least one medical device after completion of a reprocessing cycle; ix. transferring the identification data and data relating to the reprocessing cycle acquired by said at least one RFID tag reader to a data management system; x. updating the data for each medical device in the database of said data management system after each reprocessing cycle; The present invention relates to a method for reprocessing a medical device, comprising:

[0054] In the method of reprocessing a medical device of the present invention, activation of one or more reprocessing ejectors allows for the execution of one or more reprocessing cycles selected from cleaning, disinfecting, lubricating, and / or sterilizing.

[0055] It is envisaged that at least one of the medical devices to be reprocessed is placed in an envelope that is held suspended within the housing by a support. Advantageously, the envelope suspended by a support allows complete reprocessing of the medical device. Preferably, the envelope is a sterilization pouch.

[0056] Each envelope may also include an RFID tag. Thus, by combining the device identifier with the envelope identifier, traceability of the envelope containing the device is ensured right up to its use. In particular, this method makes it possible to track the period of time the device remains sterile within the envelope. This is particularly advantageous if sterility is limited to a few days.

[0057] According to one embodiment of the method, the RFID tag reader is operated continuously throughout the entire reprocessing cycle.

[0058] Therefore, the identification information and reprocessing cycle information of each medical device are transmitted by the electronic control system to the data management system to obtain traceability information for each medical device. This traceability information consists, for example, of the number of reprocessing cycles each device has already undergone and their timing, thereby determining an instantaneous status for each medical device indicating, among other things, whether reprocessing is scheduled but not yet performed, whether reprocessing is in progress (in which case both the RFID reader and the RFID identifier remain activated throughout the entire reprocessing cycle), or whether reprocessing has just been successfully performed. Advantageously, this traceability information is immediately obtained by the data management system.

[0059] A further validation step of the reprocessing method may also be envisaged, in which case the data management system is configured to validate the reprocessing of each medical device based on the traceability information.

[0060] The specific features and advantages of the present invention will become more apparent in connection with the following description of an example of an embodiment given by way of illustration and not of limitation, with reference to the accompanying drawings in which: [Brief explanation of the drawings]

[0061] [Figure 1]1 is a schematic diagram of a system for reprocessing medical devices according to one embodiment of the present invention. [Figure 2] FIG. 1 is a schematic diagram of a system for reprocessing medical devices according to another embodiment of the present invention. [Figure 3] FIG. 1 is a schematic diagram of the interior of the housing of a system for reprocessing medical devices, where the support has a movable part and allows adjustment of the orientation of the medical device relative to the position of the RFID tag reader. DETAILED DESCRIPTION OF THE INVENTION

[0062] 1 shows a schematic and functional diagram of a system 1 for reprocessing medical devices 2 according to a preferred embodiment of the present invention. The medical devices 2 each have an RFID tag 4, and the system comprises a housing 3, a metal plate 10, a plurality of supports 5 (only one of which is shown), an RFID tag reader 6, a plurality of reprocessing ejectors 7, an electronic control system 8, and a data management system 9 including processing software, i.e., computer software with programs for carrying out various reprocessing cycles. The processing software interacts with a regularly updated database to show the instantaneous reprocessing status of each medical device 2 before, during, and after each reprocessing cycle.

[0063] The housing 3 includes right and left side walls, a rear wall (not shown), a top wall, a bottom wall, and a door (not shown) that allows access to the interior of the housing 3.

[0064] In certain embodiments, the housing 3 includes at least one removable door that facilitates access to the interior of the housing 3 .

[0065] The housing 3 defines a volume within the housing 3 in which the reprocessing cycle of the medical device 2 is carried out. When the door is closed, the housing 3 defines a sealed volume in a manner that ensures the correct performance of the reprocessing cycle and the sterility of the medical device 2.

[0066] In the embodiment shown in FIG. 1, the system 1 for reprocessing comprises a support 5 fixed to the upper wall of the housing 3 .

[0067] In other embodiments, multiple supports can be provided and attached to the top wall of the housing 3. The fastening of the supports 5 to the top wall of the housing 3 can be adjusted depending on the overall dimensions of the medical devices 2 relative to each other.

[0068] According to another embodiment, the support 5 can be provided with a movable part that allows the orientation of the medical device 2 to be adjusted.

[0069] The support 5 is adapted to suspend and hold preferably one medical device 2 during reprocessing within the housing 3 by fastening means not shown in Figure 1, such as clamps, screws, clips or magnetic adhesives. In other alternative embodiments, the support 5 can suspend and hold multiple medical devices (2) simultaneously.

[0070] Holding the medical device in a suspended manner as shown in FIG. 1 allows for efficient reprocessing of a larger portion of the surface and / or cavity of the medical device 2.

[0071] 1, the reprocessing system 1 includes multiple reprocessing ejectors 7 disposed within the housing 3 for performing reprocessing cycles on the medical devices 2 within the volume defined by the housing 3. In other embodiments, a single ejector may be provided within the housing 3. The ejectors 7 may be configured to perform various reprocessing cycles, such as ejecting steam, chemicals, water, gases, ionizing radiation, or compressed air to clean and / or sterilize the medical devices 2.

[0072] 1, the support 5 has a tubular shape, although this is not limiting. It is conceivable that at least one ejector 7 is arranged within the tubular shape of the support 5. Advantageously, the reprocessing material is ejected into the interior of the medical device 2 at the level of an opening in the medical device 2, such as a cavity or internal channel.

[0073] In the embodiment shown in FIG. 1 , the reprocessing system 1 comprises an RFID tag reader 6 partially positioned in a wall of the housing 3 to emit signals and / or receive return signals from RFID tags 4 of medical devices 2 suspended within the housing 3.

[0074] According to this embodiment, the RFID tag reader 6 is partially arranged in one of the lateral walls of the housing 3 .

[0075] According to another embodiment, the system may comprise a plurality of RFID tag readers 6 partially positioned in one or more walls of the housing 3 to emit signals and / or receive return signals from RFID tags 4 of medical devices 2 suspended within the housing 3.

[0076] In this way, RFID tag reader 6 can receive return signals from RFID tags 4 on medical devices 2 located only within the housing 3 and not outside the housing 3. This arrangement also protects RFID tag reader 6 from materials projected during the reprocessing cycle and minimizes the space required by reader 6 within the housing 3.

[0077] In the embodiment shown in FIG. 1 , a portion of the RFID tag reader 6 including the electrical / electronic circuitry is located outside the housing 3, and a portion of the RFID tag reader 6 including the read head extends through one of the side walls of the housing 3 towards the interior of the volume of the housing 3, so as to emit signals and / or receive return signals coming from the RFID tags 4 of the medical devices 2 suspended within the housing 3.

[0078] In another embodiment, the portion of the RFID tag reader 6 containing the electrical / electronic circuitry is fully integrated into one of the side walls of the housing 3, and the portion of the RFID tag reader 6 containing the read head extends through this wall into the volume of the housing 3.

[0079] In another embodiment, the RFID tag reader 6 further comprises guiding means arranged on one of the side walls of the housing 3 and adapted to direct a part of the RFID tag reader 6 or a read head of the RFID tag reader 6 in the vicinity of the RFID tag 4 of the medical device 2. These guiding means are, for example, an articulated arm. Advantageously, the articulated arm is adapted to be folded during the reprocessing cycle so as to protect the read head of the RFID tag reader 6 from materials projected during the reprocessing cycle.

[0080] In another embodiment, the reprocessing system 1 comprises an RFID tag reader 6 located entirely in one wall of the housing 3 to emit signals and / or receive return signals from RFID tags 4 of medical devices 2 suspended within the housing 3.

[0081] In the embodiment shown in FIG. 1, the system 1 for reprocessing comprises an electronic control system 8, which: - controlling the RFID tag reader 6 and the reprocessing ejector 7; - controlling the support 5; - collecting identification data acquired by the RFID tag reader 6; - transferring the identification data acquired by the RFID tag reader 6 to a data management system 9; - Transferring reprocessing cycle information to the data management system9 The control unit includes a control unit capable of performing the following:

[0082] The support 5, the RFID tag reader 6, and the reprocessing ejector 7 are connected to the electronic control system 8 by wired connections. In another embodiment, the support 5, the RFID tag reader 6, and the reprocessing ejector 7 are connected to the electronic control system 8 by wireless connections.

[0083] The electronic control system 8 is connected to the data management system 9 by a wired connection. According to another embodiment, the electronic control system 8 is connected to the data management system 9 by a wireless connection.

[0084] In the embodiment shown in FIG. 1, the system 1 for reprocessing comprises a metal plate 10 placed outside the housing to prevent the RFID tag from being read from outside the housing.

[0085] According to another embodiment, the system 1 for reprocessing can comprise a plurality of metal plates 10 .

[0086] FIG. 2 shows a schematic diagram of a system (1) for reprocessing a medical device 2, comprising a housing 3, two metal plates 10, a plurality of supports 5, an RFID tag reader 6, a plurality of reprocessing ejectors 7, an electronic control system 8, and a data management system 9.

[0087] In the embodiment shown in FIG. 2, the medical devices 2 each equipped with an RFID tag 4 are each placed in an envelope 11 suspended within the housing 3 using supporting fastening means 5 .

[0088] Advantageously, the envelope 11 suspended by means of the supporting fastening means 5 allows complete reprocessing of the medical device 2 .

[0089] According to another embodiment, the medical devices 2 may each be equipped with two RFID tags 4 .

[0090] According to another embodiment, the envelopes 11 may each be equipped with an RFID tag.

[0091] FIG. 3 is a schematic diagram of the interior of a housing 3 of a system 1 for reprocessing medical devices 2 equipped with RFID tags 4 .

[0092] The support body 5 is fixed to the upper wall of the housing 3 and comprises a first mounting part 5A attached to the wall part corresponding to the top of the housing, i.e. the ceiling part, and a second movable part 5B having fixing means adapted to maintain the medical device 2 suspended within the housing 3.

[0093] The position of the support 5 within the housing 3 can be adjusted by the first mounting portion 5A to adjust the distance between the medical devices 2 according to their size, avoid contact between the devices, and optimize the orientation of the RFID tag 4 of each of the medical devices 2.

[0094] In a specific, non-limiting example, the instrument can be held in a first vertical position P1 or moved to a second, inclined position P2 as needed. Arrows indicate the transition from the first position P1 to the second position P2, which can be at an angle to the vertical along two orthogonal axes (FIG. 3).

[0095] According to the variant shown in Figure 3, the first mounting part 5A is in the form of a spherical ball-joint which, thanks to two rotational degrees of freedom θ, φ in a spherical coordinate system, allows any positioning of the second mobile part 5B, to which the medical device 2 is fixed within the housing.

[0096] The positioning of the medical device 2 about the longitudinal axis along which the second movable part 5B extends varies between a first position P1 and a second position P2, corresponding to a third rotational degree of freedom about this longitudinal axis. This latter adjustment can be achieved by freely positioning the medical device 2 relative to the second movable part 5B of the support 5 when the medical device 2 is attached, or by providing a third rotational degree of freedom to the ball-and-socket joint that allows this adjustment to be made.

[0097] Whichever variant is chosen, the purpose of adjusting the third rotational degree of freedom is not only to bring the RFID tag 4 as close as possible to the reader 6, but also to adjust the orientation of the RFID tag 4 relative to the reader 6 in order to ensure efficient transmission over the air interface.

[0098] The methods described in Figures 1-3 are equally suitable for use with passive and / or active RFID tags.

[0099] The method of reprocessing medical devices 2 according to the present invention may be achieved using a system 1 for reprocessing such as those described or exemplified above.

[0100] The first step involves equipping each medical device 2 with at least one RFID tag 4. The RFID tag 4 may be affixed to and / or integrated into the side of the medical device 2 by methods such as gluing, pressing or screwing.

[0101] The medical devices 2 equipped with at least one RFID tag 4 are then positioned in a reprocessing enclosure 3 and held in a suspended state using a support 5 with fastening means such as clamps, screws, clips or magnetic adhesive. In a particular embodiment of the method, each medical device 2 to be reprocessed is placed in an envelope 11 that is held in a suspended state within the enclosure 3 using the fastening means of the support 5.

[0102] The door of the housing 3 is closed to ensure the airtightness required for the proper execution of the reprocessing cycle and to ensure the sterility of the medical device 2 .

[0103] Prior to performing a reprocessing cycle, an RFID tag reader 6 is activated by an electronic control system 8 to collect identification data from each of the medical devices 2 held suspended within the housing 3. The identification data, including a unique identifier linked to each of the medical devices 2, is then detected by reading an RFID tag 4 affixed / integrated to the surface of the medical device 2.

[0104] The reprocessing ejector 7 is then activated by the electronic control system 8 to perform a reprocessing cycle, such as ejecting steam, chemicals, water, gas, ionizing radiation, or compressed air, to clean and / or sterilize the medical device 2.

[0105] All data related to the reprocessing cycles, such as the number, type, and error codes of the reprocessing cycles, are collected by the electronic control system 8.

[0106] A subsequent step involves activating the RFID tag reader 6 by the electronic control system 8 to collect identification data from each of the medical devices 2 after the reprocessing cycle is complete.

[0107] During the method, all identification data and reprocessing cycle data acquired by the RFID tag reader 6 are immediately transferred by the electronic control system 8 to a data management system 9. This information makes it possible to optimally ensure the traceability of the reprocessing of each individual medical device.

[0108] The method also includes a step in which the data management system 9 can be configured to validate or not validate the reprocessing of each medical device 2 based on the traceability information. If any error code is issued during the reprocessing cycle, the data management system will not immediately validate the reprocessing of the medical device.

Claims

1. a housing (3) suitable for the processing of medical devices (2), each of said medical devices (2) having at least one RFID tag (4); - at least one support (5) by means of which at least one medical device (2) to be reprocessed is intended to be suspended within said housing (3); at least one RFID tag reader (6), at least one reprocessing ejector (7) arranged inside said housing (3); an electronic control system (8), a data management system (9) comprising processing software and a database relating to said medical devices and reprocessing cycles; A system (1) for reprocessing a medical device (2), comprising: the at least one RFID tag reader (6) is at least partially disposed on a wall of the housing (3) to transmit signals and / or receive return signals emitted from the at least one RFID tag (4) of the at least one medical device (2) suspended within the housing (3); the at least one support (5) comprises at least one movable part that allows both adjustment of the orientation of each medical device (2) to be reprocessed relative to the RFID tag reader (6) and adjustment of the position of the support (5) within the housing; 1. A system (1) for reprocessing medical devices (2), characterized in that the support (5), the at least one reader (6), and the at least one ejector (7) are connected to the electronic control system (8).

2. The electronic control system (8) - controlling a number of RFID tag readers (6) and a number of reprocessing ejectors (7); - individually controlling the position of each of the supports (5) in the housing (3) and the orientation of the movable part of each of the supports (5); - collecting the identification data obtained by said RFID tag reader (6); - transferring said identification data acquired by said RFID tag reader (6) to said data management system (9); - transferring data relating to the reprocessing cycle to said data management system (9); The system of claim 1 , comprising a control unit capable of:

3. 3. The system of claim 1, wherein the at least one RFID tag reader (6) comprises an adjustable guiding means consisting of an articulated arm adapted to direct the read head of the RFID tag reader (6) near the RFID tag (4) of the medical device (2).

4. 4. The system of claim 1, further comprising at least one metal plate (10) arranged so that it can be movably positioned outside the housing (3) to prevent the RFID tag from being read from outside the housing (3).

5. 5. The system of claim 1, wherein the RFID tag reader is configured to obtain identification information from each of the medical devices before, during, and after the reprocessing cycle of the medical devices held suspended within the housing.

6. The system according to any one of claims 2 to 5, wherein the identification data comprises a unique identifier linked to each of the RFID tags (4) of the medical devices (2).

7. 7. The system of claim 2, wherein the reprocessing cycle data includes the number and type of reprocessing cycles performed and any error codes generated during the execution of the reprocessing cycles.

8. 8. The system according to claim 1, wherein the at least one RFID tag reader (6) comprises guiding means arranged to guide a portion of the RFID tag reader (6) within the housing (3) in order to obtain the identification data of each of the medical devices (2).

9. 9. The system (1) for reprocessing medical devices (2) according to any one of claims 1 to 8, wherein the at least one RFID tag reader (6) is positioned entirely in a wall of the housing (3) so as to emit signals and / or receive return signals coming from the RFID tags (4) of the medical devices (2) suspended within the housing (3).

10. The system according to any one of claims 1 to 9, wherein the RFID tag reader (6) is formed in at least one wall of the housing (3) by extrusion or overmolding.

11. 11. The system according to any one of claims 1 to 10, wherein the at least one support (5) has a tubular shape and the at least one ejector (7) is arranged within the tubular shape of the support (5).

12. A method for reprocessing a medical device (2) using a system according to any one of claims 1 to 11, comprising: i. Equipping at least one medical device (2) to be reprocessed with at least one RFID tag (4); ii. Positioning the at least one medical device (2) equipped with the at least one RFID tag (4) in a reprocessing enclosure (3) and using a support (5) to suspend and hold each of the at least one medical device (2); iii. Closing the housing (3); iv. adjusting the position of at least one support (5) within the housing (3) and the orientation of the support (5) relative to at least one RFID tag reader (6) for each of the medical devices (2) to be reprocessed; v. activating said at least one RFID tag reader (6) to collect identification data from each of said medical devices (2) prior to performing a reprocessing cycle; vi) activating said at least one reprocessing ejector (7) to perform at least one reprocessing cycle; vii. Collecting data regarding the reprocessing cycle; viii. activating said at least one RFID tag reader (6) to collect identification data from each of said medical devices (2) after completion of said reprocessing cycle; ix. transferring the identification data and reprocessing cycle data acquired by said at least one RFID tag reader (6) to a data management system (9); x. updating the data relating to each medical device (2) in the database of said data management system (9) after each reprocessing cycle; A method for reprocessing a medical device (2), comprising:

13. 13. The method for reprocessing medical devices (2) according to claim 12, wherein at least one of the medical devices (2) to be reprocessed is placed in an envelope (11) held in a suspended state by means of a support (5) within the housing (3).

14. 14. The method of reprocessing medical devices (2) according to claim 12 or 13, wherein the at least one RFID tag reader (6) is continuously activated throughout the reprocessing cycle.

15. 15. The method for reprocessing medical devices (2) according to any one of claims 12 to 14, wherein identification data and reprocessing cycle data of each medical device (2) are transmitted by the electronic control system (8) to the data management system (9) in order to obtain traceability data of each medical device (2) in real time.

16. 16. The method for reprocessing medical devices (2) according to claim 15, further comprising a supplementary verification step of the reprocessing method, wherein the data management system (9) is configured to verify the reprocessing of each medical device (2) based on traceability data when no error code is generated by the data management system (9).

17. 17. The method for reprocessing medical devices (2) according to any one of claims 12 to 16, wherein when the system for reprocessing (1) is a system according to claim 3, the at least one RFID tag reader (6) comprises adjustable guiding means consisting of an articulated arm adapted to direct the read head of the RFID tag reader (6) near the RFID tag (4) of the medical device (2), and the method comprises the step of adjusting the position of a part of the RFID tag reader (6) within the housing depending on the type and size of the medical device (2) to be processed.

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