System for reprocessing medical device

Abstract

The present invention relates to the field of health and reprocessing of medical devices. In particular, the present invention relates to a system and method for reprocessing a medical device. The system (1) for reprocessing medical devices (2) according to the invention comprises:-a housing (3) adapted to reprocess 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 the at least one medical device (2) to be reprocessed is intended to be suspended inside the housing (3); -at least one RFID tag reader (6); -at least one retreatment injector (7) arranged inside the housing (3); an electronic control system (8); and-a data management system (9) comprising processing software and a database associated with the medical device and the reprocessing loop; the device is characterized in that the at least one RFID tag reader (6) is arranged at least partially in a wall of the housing (3) in order to send a signal to the at least one RFID tag (4) of the at least one medical device (2) suspended inside the housing (3) and / or in response to receive a signal from the at least one RFID tag of the at least one medical device suspended inside the housing (3).

Description

Technical Field

[0001] The present invention relates to the field of health and reprocessing of medical devices. More specifically, the present invention relates to a system and method for reprocessing a medical device. Background Art

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

[0003] These cycles can be tracked using tags (such as radio frequency identification (RFID) tags or barcode tags) affixed to or engraved on these devices. These tags can then be read to detect the unique identifier of each medical device, thereby enabling tracking of the reprocessing cycle of each medical device.

[0004] However, the reliability of the traceability of the reprocessing cycle is not optimal, since the tag detection is usually performed before the reprocessing cycle by a tag reader arranged outside the housing for reprocessing. Therefore, the multiplication of the reading steps of the tag for reprocessing located outside the housing and the positioning of the device inside the housing increases the risk of errors, making it impossible to guarantee the correct implementation of the reprocessing cycle for each device.

[0005] Furthermore, in the event of a malfunction of the device for reprocessing, information on the verification of the reprocessing cycle is not immediately generated, and the error code issued by the device for reprocessing needs to be manually entered into the database.

[0006] Therefore, there is a real need for a method for reprocessing a medical device, which improves the reliability of the method by limiting the number of manual steps by means of a system that enables traceability and verification of the reprocessing cycle to be managed efficiently and immediately. Patent document US2022047745 describes a system for reprocessing a medical device, the system comprising a tag reader located on the outside of the housing and a support. The label can be attached to a part of the device located outside or inside the housing. The solution described in the international application WO2008142300 from the same applicant discloses a system for reprocessing a probe, the system comprising an active part and a cable for connecting to an imaging device. The active part is arranged inside the housing volume for disinfection, while the hanging member carries the RFID tag outside the housing and enables the cable to be suspended. None of these solutions involve optimizing the transmission quality between the medical device tag arranged inside the housing and the reader, especially for multiple medical devices to be processed simultaneously.

[0007] Patent document US2022211891 describes a system for reprocessing catheters, each of which can be attached to a tray. However, the handling of the tray is still manual, and the handling of the tray cannot optimize the position or orientation of the medical device to be processed according to the type or size of the medical device to improve the reliability of real-time transmission of traceability information for each of the medical devices.

[0008] US20050148819 describes an endoscope cleaning system comprising an RFID tag arranged in a cleaning tank, the RFID unit being arranged on a portion of the cleaning tank. Again, no attempt is made to optimize the delivery of such a single treatment for a medical device. The same reasoning applies to the solution disclosed in document US20090220377 regarding a device for cleaning and disinfecting an endoscope.

[0009] US20020161460 discloses yet another endoscope disinfection system, which includes an RFID box arranged behind one of the walls of a clean room. The wall is made of a non-metallic (plastic or rubber) plate, so that electromagnetic transmission of identification data can be performed. The RFID tag can be directly attached to an endoscope arranged in the clean room, and the endoscope can be attached to a support fixed in the clean room. However, it is also impossible to improve the reliability of transmission between tags respectively connected to multiple medical devices and readers as part of batch processing. Summary of the invention

[0010] The object of the present invention is to provide a system which makes it possible to improve the reliability of the reprocessing of medical devices.

[0011] Another object of the invention is to provide a system making it possible to ensure traceability and to verify reprocessing cycles immediately, more reliably and more efficiently.

[0012] Therefore, the present invention relates to a system for reprocessing a medical device, the system comprising:

[0013] - a housing suitable for reprocessing medical devices, each of the medical devices having at least one RFID tag;

[0014] - at least one support, by means of which at least one medical device to be reprocessed is intended to be suspended inside the housing;

[0015] - at least one RFID tag reader;

[0016] - at least one aftertreatment injector, at least one aftertreatment injector being arranged inside the housing;

[0017] - electronic control systems; and

[0018] - a data management system comprising processing software and a database related to said medical device and reprocessing cycles;

[0019] characterised in that the at least one RFID tag reader is at least partially arranged in a wall of the housing to send signals to at least one RFID tag of at least one medical device suspended inside the housing and / or to receive signals in response from at least one RFID tag of at least one medical device suspended inside the housing,

[0020] at least one support comprises at least one movable component, the at least one movable component enabling an adjustable orientation of each medical device to be reprocessed relative to the RFID tag reader and enabling adjustment of the position of the support within the housing,

[0021] The support, the at least one reader and the at least one injector are connected to the electronic control system.

[0022] Medical devices within the scope of the present invention are devices and articles used in the medical, dental, surgical, pharmaceutical and / or veterinary fields. Depending on the design of the medical device, a medical device within the meaning of the present invention comprises a surface, a front, a rear, a slot, a groove, a joint and / or an opening. The medical device is made of materials such as steel, copper-nickel alloys and / or polymers that resist reprocessing cycles, such as polyetheretherketone (PEEK) or polyamideimide (PAI).

[0023] Preferably, the medical device is a dental and / or surgical device. These devices may comprise a side surface, a rear part and a front part, the front part being the active part of the device. Preferably, the medical device is selected from a turbine, a contra-angle part and / or a straight handpiece. Therefore, within the framework of the present invention, in particular depending on the type of medical device, the position and orientation of the support, which determines the size of the medical device in the housing and the positioning of the label, can be adjusted individually for each medical device to be reprocessed, the position and orientation of the support being different, for example, between a straight handpiece and a contra-angle part.

[0024] Within the scope of the present invention, each medical device comprises 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, thereby enabling clear and formal identification of the device and facilitating traceability of the device. The identifier can be detected when the tag is read by a suitable tag reader.

[0025] Preferably, each of the medical devices is equipped with two tags to optimize detection reliability by ensuring that at least one of the two tags can be read (eg in case one of the tags is damaged).The tags are typically RFID tags and / or barcode tags.

[0026] In the context of the present invention, the tag is an RFID tag. Thus, according to the present invention, the identification information comprises a unique identifier on each RFID tag linked to the RFID tag of the medical device. The RFID tag is selected from passive and / or active RFID tags.

[0027] Passive RFID tags have no built-in power source. The electromagnetic signal emitted by this type of RFID tag is generated by a signal originating from an RFID reader. Advantageously, passive RFID tags can withstand very high temperatures, radiation, and / or chemical agents used during the reprocessing cycle.

[0028] Active RFID tags have an internal power source (e.g., a battery). This type of tag is able to send an electromagnetic signal to a tag reader using wireless 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.

[0029] Preferably, the tag is a passive RFID tag that is resistant to very high temperatures, radiation and / or chemical agents used during the reprocessing cycle.

[0030] Furthermore, the tag is attached and / or integrated on the side surface of the medical device by gluing, pressing or screwing to increase the reliability of tag detection and reading.

[0031] In the context of the present invention, the system comprises a housing suitable for reprocessing a medical device, regardless of its complexity and diversity.

[0032] The housing is composed of a top wall, a bottom wall, side walls and at least one door, the at least one door providing access to the interior of the housing designed to receive the medical device. Preferably, the housing comprises at least one removable door, the at least one removable door facilitating access to the interior of the housing. Furthermore, the closed housing is airtight or watertight to ensure the correct implementation of the reprocessing cycle, to ensure device sterilization, and to prevent bacterially contaminated fluids or gases from escaping to the exterior of the housing.

[0033] Various methods of cleaning and sterilizing medical devices use heat, water, chemical agents, various gases and / or ionizing radiation emitted into the housing during various reprocessing cycles. Therefore, within the scope of the present invention, the system includes at least one reprocessing injector, the at least one reprocessing injector being arranged inside the housing.

[0034] The reprocessing injector is configured to inject steam, chemicals, water, gas, ionizing radiation, and / or compressed air to clean and / or sterilize the medical device.

[0035] Inside 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 one and only one medical device to be reprocessed. Advantageously, suspending the medical devices enables a greater proportion of the device surface, cavity and / or channel to be effectively reprocessed compared to devices arranged in a box or on a tray.

[0036] According to the invention, the support comprises fastening means adapted to keep at least one medical device suspended. Preferably, the fastening means are selected from clamps, screws, clips or magnetic adhesives. These fastening means are adapted to keep the device to be reprocessed suspended at certain parts of the device to ensure complete reprocessing of the parts for treating the patient.

[0037] In the context of the present invention, it is conceivable that at least one injector may be arranged inside the support. Preferably, when the support has a tubular shape, at least one injector may be arranged inside the tubular shape of the support. Advantageously, therefore, the substances generated by the reprocessing cycle are injected into the interior of the medical device at the opening (e.g., cavity or internal channel) instead of being injected onto the outer surface of the medical device.

[0038] In the particular case of dental and / or surgical devices, the fastening means are suitable for suspending the device to be reprocessed at the rear part, thereby ensuring complete reprocessing of the front part, which is the active part used to treat the patient.

[0039] It is conceivable that the fastening member further comprises an enclosure designed to receive a suspended medical device. Advantageously, the enclosure suspended by means of the fastening member enables complete reprocessing of the medical device. Preferably, the enclosure is a sterilization bag.

[0040] Each enclosure may also comprise an RFID tag. Thus, by combining the identifier of the device with the identifier of the enclosure, the traceability of the enclosure containing the device until the enclosure is used is ensured. In particular, the system enables the tracking of the sterility period of the device in the enclosure of the device. This is particularly advantageous since sterility is usually limited to a few days. If this period is exceeded, additional sterilization / decontamination is recommended.

[0041] In the context of the present invention, the support is attached to the wall of the housing. Preferably, the support is attached to the top wall of the housing. The position of the support inside the housing is adjustable to adjust the distance between the medical devices according to the size of the medical devices, to avoid any contact between the medical devices, and to optimize the orientation of the RFID tag of each of the medical devices.

[0042] Advantageously, each medical device remains suspended inside the housing without direct contact with other devices or elements inside the housing (such as walls or metal surfaces), thereby limiting damage to labels adhered and / or integrated on side surfaces of the medical device.

[0043] According to the invention, the support comprises at least one movable component to enable adjustable orientation of the medical devices, thereby optimizing the orientation of the RFID tag of each of the medical devices.

[0044] In the context of the present invention, an RFID tag attached and / or embedded on the surface of a medical device is read by an RFID tag reader. Thus, the system includes at least one RFID tag reader, at least one RFID tag reader being at least partially arranged in a wall of the housing to transmit signals to and / or receive signals from an RFID tag of a medical device suspended inside the housing in response.

[0045] Advantageously, the RFID tag reader is at least partially disposed within the wall of the housing, meaning that signals from the RFID tag of the medical device can only be received back inside the housing. In addition, this arrangement protects the RFID tag reader from substances that are placed during the reprocessing cycle, while minimizing the footprint of the reader inside the housing.

[0046] It is conceivable that a portion of the RFID tag reader (eg the portion containing the electrical / electronic circuitry) is arranged to be fully integrated into the wall, while another portion is arranged to extend into the interior of the housing volume.

[0047] In a particular aspect of the invention, the present invention relates to a system, wherein the at least one RFID tag reader comprises a guide member, the guide member being arranged to guide a portion of the RFID tag reader inside the housing to obtain identification information of each of the medical devices. The guide device is, for example, an articulated arm, which is suitable for guiding the reading head of the RFID tag reader close to the RFID tag of the medical device. Advantageously, the position of a portion of the RFID tag reader inside the housing can be adjusted according to the type and size of the medical device to be reprocessed. This ensures the best quality of wireless transmission between the RFID tag and the RFID reader. This minimizes the risk of errors in the process for reprocessing and transmitting the identification information. Thus, the reliability of tracking is maximized. In addition, the articulated arm is designed to fold back during the reprocessing cycle to protect the reading head of the RFID tag reader from the effects of substances released during the reprocessing cycle.

[0048] According to another specific aspect, the present invention relates to a system for reprocessing medical devices, wherein the at least one RFID tag reader is arranged entirely in the wall of the housing to transmit signals to and / or in response receive signals from an RFID tag of a medical device suspended inside the housing. Advantageously, this arrangement protects all parts of the RFID tag reader from substances released during the reprocessing cycle while minimizing the footprint of the reader inside the housing. In particular, the electrical / electronic circuitry and the portion comprising the read head are protected while remaining functional.

[0049] Advantageously, partial or full placement of the tag readers in the wall maximizes the detection angle or area of ​​RFID tags positioned on the device to be reprocessed to cover a large volume or even the entire volume of the housing.

[0050] In the context of the present invention, it is conceivable that the RFID tag reader is formed by extrusion or secondary molding in at least one wall of the housing. Therefore, since the tag reader is integral with the wall, the system does not require any assembly steps when in use and can be easily implemented.

[0051] Furthermore, the RFID tag reader is arranged to acquire identification information of each medical device before, during and after a reprocessing cycle of the medical device held suspended inside the housing. In this way, the system enables the status of the medical device to be known immediately before a reprocessing cycle begins, during the end of the reprocessing cycle and just after the end of the reprocessing cycle. In this way, the system ensures that the status of the medical device can be monitored and enables verification of the therapeutic status of the medical device (i.e. whether the medical device requires reprocessing or has actually been reprocessed) after each reprocessing cycle.

[0052] Furthermore, the system according to the invention comprises at least one metal plate, which is arranged to be movably positioned outside the housing to prevent the RFID tag from being read outside the housing. The arrangement of the at least one metal plate on one or more sides of the housing is adapted to the location of the system. Preferably, the system comprises 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 from plastic materials (PET) metallized with electrical or magnetic dopants (such as aluminum, fluorine or tin) to prevent the RFID tag from being read outside the housing.

[0053] Advantageously, the traceability and verification of the reprocessing cycles are immediately ensured in the most reliable and effective way by an electronic control system coupled to a management system, which preferably comprises a processing software and a database that manages identifiers individually associated with the devices, for example via RFID tags. In this way, the processing status can be updated in real time and individually for each device as different reprocessing cycles occur. Thus, the immediate information transmission optimizes the reliability of the system for reprocessing and of the method implemented by the system.

[0054] The electronic control system comprises a control unit capable of:

[0055] - Controlling one or more RFID tag readers and one or more aftertreatment injectors;

[0056] - Control one or more supports;

[0057] - Collect identification data acquired by one or more RFID tag readers;

[0058] - transmitting identification data acquired by one or more RFID tag readers to a data management system; and

[0059] -Transmitting data related to the reprocessing cycle to a data management system.

[0060] According to the present invention, the identification data acquired by the RFID tag reader is a unique identifier of the medical device and / or enclosure.

[0061] During the reprocessing cycle, the electronic control system may issue an error code when a full reprocessing cycle has not been completed (e.g., in the event of a seal failure or loss of the housing). In this manner, the reprocessing cycle information includes the number of cycles, the type of reprocessing cycle performed, and the error code generated during the reprocessing cycle.

[0062] Within the scope of the invention, the electronic control system comprises a control unit capable of transmitting identification information and reprocessing cycle information to a data management system whose function is to ensure and monitor the smooth running of each of the reprocessing cycles, in particular through a processing software interacting with a database, while updating the processing status of the medical device. In this way, the data from the data management system includes the medical device identifier, the enclosure identifier, the medical device reference, the number and type of reprocessing cycles performed for each medical device, and any error codes generated during the reprocessing cycles.

[0063] The invention also relates to a method for reprocessing a medical device, the method being performed with the aid of a system such as defined above.

[0064] An object of the present invention is to provide a method for reprocessing a medical device which makes it possible to increase the reliability of the reprocessing of the medical device.

[0065] Another object of the present invention is to provide a method for reprocessing a medical device which enables the traceability and verification of the reprocessing cycle to be ensured in a more reliable and efficient manner.

[0066] Therefore, the present invention relates to a method for reprocessing a medical device by means of a system for reprocessing, the method comprising the following steps:

[0067] i. Equipped with at least one RFID tag for at least one medical device to be reprocessed;

[0068] ii. positioning the at least one medical device comprising at least one RFID tag inside the housing for reprocessing, and maintaining the at least one medical device suspended by means of a support;

[0069] iii. Close the housing;

[0070] iv. adjusting the position of at least one support member in the housing and the orientation of the support member relative to at least one RFID tag reader for each medical device to be reprocessed;

[0071] v. activating the at least one RFID tag reader to collect identification data from each of the medical devices before performing a reprocessing cycle;

[0072] vi. activating the at least one aftertreatment injector to perform at least one aftertreatment cycle;

[0073] vii. Collect reprocessing cycle data;

[0074] viii. activating the at least one RFID tag reader to collect identification data from at least one medical device after completing the reprocessing cycle;

[0075] ix. transmitting the identification data and reprocessing cycle data acquired by the at least one RFID tag reader to a data management system;

[0076] x. Updating the data associated with each medical device in the database of the data management system after each reprocessing cycle.

[0077] In the method for reprocessing a medical device of the present invention, activation of one or more reprocessing injectors enables execution of one or more reprocessing cycles selected from cleaning, disinfection, lubrication and / or sterilization.

[0078] It is conceivable that at least one of the medical devices to be reprocessed is arranged in an enclosure held suspended by means of a support inside the housing. Advantageously, the enclosure suspended by means of a support enables complete reprocessing of the medical device. Preferably, the enclosure is a sterilization bag.

[0079] It is also conceivable that each enclosure comprises an RFID tag. Thus, by combining the identifier of the device with the identifier of the enclosure, the traceability of the enclosure containing the device until the enclosure is used is ensured. In particular, the method enables tracking of the period during which the device in its enclosure is sterile. This is particularly advantageous in cases where sterility is limited to a few days.

[0080] According to one embodiment of the method, the RFID tag reader is activated continuously throughout the reprocessing cycle.

[0081] Thus, the identification information of each medical device and the reprocessing cycle information are sent by the electronic control system to the data management system to obtain traceability information for each medical device. This traceability information includes, for example, the number and time of reprocessing cycles that each device has undergone to determine the instantaneous state of each medical device, which specifically indicates whether reprocessing is due but not yet performed, whether reprocessing is in progress (in the case where the RFID reader and RFID identifier remain active throughout the reprocessing cycle), or whether reprocessing has just been correctly performed. Advantageously, this traceability information is immediately obtained by the data management system.

[0082] Furthermore, a further validation step of the method for reprocessing may be envisaged, wherein the data management system is configured to validate the reprocessing of each of the medical devices based on the traceability information. BRIEF DESCRIPTION OF THE DRAWINGS

[0083] Particular features and advantages of the invention will emerge in more detail in the context of the following description of examples of embodiments given by way of illustration and in a non-limiting manner and with reference to the accompanying drawings, in which:

[0084] - Figure 1 is a schematic diagram of a system for reprocessing a medical device according to an embodiment of the present invention.

[0085] - Figure 2 is a schematic diagram of a system for reprocessing a medical device according to another embodiment of the present invention.

[0086] - Figure 3is a schematic diagram of the interior of a housing of a system for reprocessing a medical device wherein a support has a movable component and enables an adjustable orientation of the medical device relative to the position of an RFID tag reader. DETAILED DESCRIPTION

[0087] Figure 1 A system (1) for reprocessing a medical device (2) according to a preferred embodiment of the present invention is schematically and functionally shown. The medical devices (2) are each equipped with an RFID tag (4), and the system includes a housing (3), a metal plate (10), a plurality of supports (5) (only one of the plurality of supports (5) is visible), an RFID tag reader (6), a plurality of reprocessing injectors (7), an electronic control system (8) and a data management system (9), the data management system (9) including processing software (i.e., computer software including programs for performing various reprocessing cycles). The computer software interacts with a regularly updated database to indicate the respective instantaneous reprocessing status of the medical device (2) before, during and after each reprocessing cycle.

[0088] The housing ( 3 ) comprises right and left side walls, a rear side wall (not shown), a top wall, a bottom wall and a door (not shown) which enables access to the interior of the housing 3 .

[0089] In certain embodiments, the housing (3) comprises at least one removable door, the at least one removable door facilitating access to the interior of the housing (3).

[0090] The housing (3) defines a volume inside the housing (3) in which the reprocessing cycle of the medical device (2) is performed. When the door is closed, the housing (3) defines a hermetically sealed volume to ensure the correct implementation of the reprocessing cycle and the sterility of the medical device (2).

[0091] exist Figure 1 In the embodiment shown, the system (1) for reprocessing comprises a support (5) which is fixed to the top wall of the housing (3).

[0092] In other embodiments, multiple supports may be provided, which are attached to the top wall of the housing (3). The fixing of the support (5) to the top wall of the housing (3) may be adjusted according to the overall dimensions of the medical devices (2) relative to each other.

[0093] According to other embodiments, the support (5) may include movable parts to allow the medical device (2) to have an adjustable orientation.

[0094] The support member (5) is suitable for Figure 1Fastening means (such as clamps, screws, clips or magnetic adhesives) not shown in the figure preferably keep one medical device (2) to be reprocessed suspended at a time inside the housing (3). In other alternative embodiments, the support (5) can hold multiple suspended medical devices (2) at the same time.

[0095] like Figure 1 The suspended retention of the medical device shown enables a larger portion of the surface and / or cavity of the medical device 2 to be effectively reprocessed.

[0096] exist Figure 1 In the illustrated embodiment, the system (1) for reprocessing includes a plurality of reprocessing ejectors (7) arranged inside the housing (3) to perform a reprocessing cycle of the medical device (2) in a volume defined by the housing (3). In other embodiments, a single ejector may be disposed inside the housing (3). The ejector (7) may be configured to perform different reprocessing cycles (e.g., ejecting steam, chemical reagents, water, gas, ionizing radiation, or compressed air) to clean and / or sterilize the medical device (2).

[0097] exist Figure 1 In the embodiment shown, which is not limiting, the support (5) has a tubular shape. It is conceivable that at least one injector (7) is arranged inside the tubular shape of the support (5). Advantageously, the reprocessing substance is injected into the interior of the medical device at an opening (e.g. a cavity or an internal channel) in the medical device (2).

[0098] exist Figure 1 In the illustrated embodiment, the system (1) for reprocessing includes an RFID tag reader (6) partially arranged in the wall of the housing (3) to transmit signals to the RFID tag (4) of the medical device (2) suspended inside the housing (3) and / or receive signals from the RFID tag of the medical device suspended inside the housing in response.

[0099] According to this embodiment, the RFID tag reader (6) is partially arranged in one of the side walls of the housing (3).

[0100] In another embodiment, the system may include a plurality of RFID tag readers (6) partially arranged in one or more walls of the housing (3) to transmit signals to an RFID tag (4) of a medical device (2) suspended inside the housing (3) and / or receive signals from an RFID tag of a medical device suspended inside the housing in response.

[0101] In this way, the RFID tag reader (6) can receive in response a signal from an RFID tag (4) of a medical device (2) that is only located inside the housing (3) and not outside the housing (3). In addition, this arrangement protects the RFID tag reader (6) from substances that are introduced during the reprocessing cycle while minimizing the space required for the reader (6) inside the housing (3).

[0102] exist Figure 1 In the illustrated embodiment, a portion of the electrical / electronic circuit including the RFID tag reader (6) is arranged outside the housing (3), while a portion including the reading head of the RFID tag reader (6) extends through one of the side walls of the housing (3) toward the interior of the volume of the housing (3) to transmit a signal to an RFID tag (4) of a medical device (2) suspended inside the housing (3) and / or receive a signal from an RFID tag of a medical device suspended inside the housing in response.

[0103] In another embodiment, the portion of the electrical / electronic circuitry comprising the RFID tag reader (6) is fully integrated into one of the side walls of the housing (3), while the portion comprising the reading head of the RFID tag reader (6) extends through the wall into the volume of the housing (3).

[0104] In another embodiment, the RFID tag reader (6) further comprises a guide member arranged in one of the side walls of the housing (3) and adapted to guide a portion of the RFID tag reader (6) or a reading head of the RFID tag reader (6) close to the RFID tag (4) of the medical device (2). These guide members are, for example, articulated arms. Advantageously, the articulated arms are adapted to fold back during a reprocessing cycle to protect the reading head of the RFID tag reader (6) from substances introduced during the reprocessing cycle.

[0105] In another embodiment, the system (1) for reprocessing includes an RFID tag reader (6) arranged entirely in one wall of the housing (3) to transmit signals to an RFID tag (4) of a medical device (2) suspended inside the housing (3) and / or to receive signals from an RFID tag of a medical device suspended inside the housing in response.

[0106] exist Figure 1 In the embodiment shown, the system (1) for reprocessing comprises an electronic control system (8), which comprises a control unit capable of:

[0107] - Controlling the RFID tag reader (6) and the injector (7) for reprocessing;

[0108] - a control support (5);

[0109] - Collecting identification data acquired by the RFID tag reader (6);

[0110] - transmitting the identification data acquired by the RFID tag reader (6) to a data management system (9); and

[0111] - Transmitting reprocessing cycle information to the data management system (9).

[0112] The support (5), RFID tag reader (6) and aftertreatment injector (7) are connected to the electronic control system (8) via a wired connection. In another embodiment, the support (5), RFID tag reader (6) and aftertreatment injector (7) are connected to the electronic control system (8) via a wireless connection.

[0113] The electronic control system (8) is connected to the data management system (9) via a wired connection. According to another embodiment, the electronic control system (8) is connected to the data management system (9) via a wireless connection.

[0114] exist Figure 1 In the illustrated embodiment, the system (1) for reprocessing comprises a metal plate (10) arranged outside the housing to prevent the RFID tag from being read outside the housing.

[0115] According to another embodiment, a system (1) for reprocessing may include a plurality of metal sheets (10).

[0116] Figure 2 A system (1) for reprocessing a medical device (2) is schematically shown, the system comprising a housing (3), two metal plates (10), a plurality of supports (5), an RFID tag reader (6), a plurality of reprocessing injectors (7), an electronic control system (8) and a data management system (9).

[0117] exist Figure 2 In the illustrated embodiment, the medical devices (2), each equipped with an RFID tag (4), are respectively arranged in an enclosure (11) suspended inside the housing (3) by means of a supporting fastening member (5).

[0118] Advantageously, the enclosure (11) suspended by means of the supporting fastening member (5) enables complete reprocessing of the medical device (2).

[0119] According to another embodiment, the medical devices (2) may each be equipped with two RFID tags (4).

[0120] According to another embodiment, the enclosures (11) may each be equipped with an RFID tag.

[0121] Figure 3 Schematic diagram of the interior of a housing (3) of a system (1) for reprocessing a medical device (2) equipped with an RFID tag (4).

[0122] The support member (5) is fixed to the top wall of the housing (3) and includes a first attachment part (5A) and a second movable part (5B), wherein the first attachment part (5A) is mounted on the wall corresponding to the upper part (i.e., the ceiling of the housing), and the second movable part (5B) includes a fixing member suitable for keeping the medical device (2) suspended inside the housing (3).

[0123] The position of the support member (5) inside the housing (3) can be adjusted with the aid of a first attachment member (5A) to adjust the distance between the medical devices (2) according to the size of the medical devices, avoid any contact between the medical devices, and optimize the orientation of the RFID tag (4) of each medical device in the medical devices (2).

[0124] In a specific non-limiting example, the device can remain in a first vertical position (P1) or move to a second inclined position (P2) as desired. The arrows indicate the positions of the devices along two orthogonal axes ( Figure 3 ) transition from a first position (P1) to a second position (P2), the second position (P2) may be at a predetermined angle to the vertical direction.

[0125] according to Figure 3 In the variant shown, the first attachment member (5A) is in the form of a spherical joint, due to the spherical coordinate system The spherical joint enables the second movable part (5B) to which the medical device (2) is fixed to be positioned in any direction inside the housing, with two degrees of rotational freedom.

[0126] The positioning of the medical device (2) around the longitudinal axis along which the second movable part (5B) extends varies precisely around the longitudinal axis between the first position (P1) and the second position (P2) (corresponding to the third rotational degree of freedom). The third rotational degree of freedom adjustment can be made by free positioning of the medical device (2) relative to the second movable part (5B) of the support (5) when attached, or by imparting the third rotational degree of freedom on the ball-and-socket joint, thereby enabling such adjustment.

[0127] Regardless of which variant is chosen, the three rotational degrees of freedom adjustment is intended, on the one hand, to bring the RFID tag (4) as close as possible to the reader (6), and also to adjust the orientation of the RFID tag (4) relative to the reader (6) so as to ensure effective transmission via the air interface in a reliable manner.

[0128] Figures 1 to 3The methods described in are equally applicable to passive and / or active RFID tags.

[0129] The method for reprocessing a medical device (2) according to the invention can be implemented with the aid of a system (1) for reprocessing, such as the system described or shown above.

[0130] In the first step, each of the medical devices (2) to be reprocessed needs to be equipped with at least one RFID tag (4). The RFID tag (4) can be attached and / or integrated on the side surface of the medical device (2) by methods such as gluing, pressing or screwing.

[0131] Then, the medical device (2) equipped with at least one RFID tag (4) is positioned inside the housing (3) for reprocessing and is kept suspended by means of a support (5) comprising fastening means, such as clamps, screws, clips or magnetic adhesive. In a specific embodiment of the method, each of the medical devices (2) to be reprocessed is arranged in an enclosure (11), which is kept suspended by means of fastening means of the support (5) inside the housing (3).

[0132] The door of the housing 3 is closed to ensure the tightness required for the correct implementation of the reprocessing cycle and to ensure the sterility of the medical device (2).

[0133] The RFID tag reader (6) is activated by the electronic control system (8) to collect identification data from each of the medical devices (2) held suspended inside the housing (3) before performing a reprocessing cycle. The identification data is then detected by reading an RFID tag (4) attached / integrated on the surface of the medical device (2), the identification data comprising a unique identifier linked to each of the medical devices (2).

[0134] The reprocessing injector (7) is then activated by the electronic control system (8) to perform a reprocessing cycle (eg, injecting steam, chemicals, water, gas, ionizing radiation or compressed air) to clean and / or sterilize the medical device (2).

[0135] All data related to the reprocessing cycles (eg number, type and error codes of reprocessing cycles) are collected by the electronic control system (8).

[0136] The next steps involve 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 completed.

[0137] During the method, all identification data and reprocessing cycle data acquired by the RFID tag reader (6) are immediately transmitted by the electronic control system (8) to the data management system (9). This information enables the traceability of the reprocessing of each individual medical device to be ensured in an optimal manner.

[0138] Furthermore, the method comprises the following steps: The data management system (9) can be configured to verify or not verify the reprocessing of each medical device (2) based on the traceability information. Any error code issued during the reprocessing cycle will immediately result in the data management system being unable to verify the reprocessing of the medical device.

Claims

1. A system (1) for reprocessing a medical device (2), comprising: - a housing (3) suitable for reprocessing the medical devices (2), each of the medical devices (2) having at least one RFID tag (4); - at least one support (5) by which at least one medical device (2) to be reprocessed is intended to be suspended inside the housing (3); - at least one RFID tag reader (6); - at least one aftertreatment injector (7), said at least one aftertreatment injector being arranged inside said housing (3); - electronic control system (8); and - a data management system (9) comprising processing software and a database related to the medical device and the reprocessing cycle; The invention is characterized in that the at least one RFID tag reader (6) is at least partially arranged in the wall of the housing (3) to send a signal to at least one RFID tag (4) of at least one medical device (2) suspended inside the housing (3) and / or to receive a signal from at least one RFID tag of at least one medical device suspended inside the housing in response, at least one support (5) comprising at least one movable part, said at least one movable part enabling each medical device (2) to be reprocessed to have an adjustable orientation relative to said RFID tag reader (6) and enabling the position of said support (5) within said housing to be adjustable, The support (5), the at least one reader (6) and the at least one injector (7) are connected to the electronic control system (8).

2. The system according to claim 1, wherein: The electronic control system (8) comprises a control unit capable of: - controlling a plurality of RFID tag readers (6) and a plurality of aftertreatment injectors (7); - individually controlling the respective positions of a plurality of said supports (5) inside said housing (3) and the orientation of said movable part of each of said supports (5); - collecting identification data acquired by the RFID tag reader (6); - transmitting the identification data acquired by the RFID tag reader (6) to the data management system (9); and - Transmitting data related to the reprocessing cycle to said data management system (9).

3. A system according to any one of the preceding claims, wherein: The at least one RFID tag reader (6) comprises an adjustable guide member consisting of an articulated arm adapted to guide a reading head of the RFID tag reader (6) close to the RFID tag (4) of the medical device (2).

4. A system according to any one of the preceding claims, wherein: The system comprises at least one metal plate (10) arranged to be movably positioned outside the housing (3) to prevent the RFID tag from being read outside the housing (3).

5. A system according to any one of the preceding claims, wherein: The RFID tag reader (6) is arranged to acquire identification information of each of the medical devices (2) before, during and after a reprocessing cycle of the medical devices (2) held suspended inside the housing (3).

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

7. A system according to any one of claims 2 to 6, wherein: The reprocessing cycle data includes the number and type of reprocessing cycles performed, and error codes generated during the execution of the reprocessing cycles.

8. A system according to any one of the preceding claims, wherein: The at least one RFID tag reader (6) comprises a guide member arranged to guide a portion of the RFID tag reader (6) inside the housing (3) to acquire the identification data of each of the medical devices (2).

9. System (1) for reprocessing a medical device (2) according to any one of the preceding claims, wherein: The at least one RFID tag reader (6) is arranged entirely in the wall of the housing (3) to transmit signals to the RFID tag (4) of the medical device (2) suspended inside the housing (3) and / or to receive signals from the RFID tag of the medical device suspended inside the housing in response.

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

11. A system according to any one of the preceding claims, wherein: At least one support (5) has a tubular shape, at least one injector (7) being arranged inside the tubular shape of the support (5).

12. A method for reprocessing a medical device (2) by means of a system according to any one of claims 1 to 11, comprising the following steps: i. Equipped with at least one RFID tag (4) for at least one medical device (2) to be reprocessed; ii. positioning the at least one medical device (2) comprising at least one RFID tag (4) inside the housing (3) for reprocessing, and keeping the at least one medical device (2) suspended by means of a support (5); iii. closing the housing (3); iv. adjusting the position of at least one support member (5) in the housing (3) and the orientation of the support member (5) relative to at least one RFID tag reader (6) for each medical device (2) to be reprocessed; v. activating the at least one RFID tag reader (6) to collect identification data from each of the medical devices (2) before performing a reprocessing cycle; vi. activating at least one aftertreatment injector (7) to perform at least one aftertreatment cycle; vii. Collect reprocessing cycle data; viii. activating the at least one RFID tag reader (6) to collect identification data from each medical device (2) after completing the reprocessing cycle; as well as ix. transmitting the identification data and reprocessing cycle data acquired by the at least one RFID tag reader (6) to a data management system (9); x. Updating the data associated with each medical device (2) in the database of the data management system (9) after each reprocessing cycle.

13. The method for reprocessing a medical device (2) according to claim 12, wherein: At least one of the medical devices (2) to be reprocessed is arranged in an enclosure (11) which is held suspended by means of a support (5) inside the housing (3).

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

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

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

17. A method for reprocessing a medical device (2) according to any one of claims 12 to 16, when the system (1) for reprocessing is the system according to claim 3, the at least one RFID tag reader (6) includes an adjustable guide member formed by an articulated arm, the articulated arm being suitable for guiding the reading head of the RFID tag reader (6) close to the RFID tag (4) of the medical device (2), the method comprising the step of adjusting the position of a portion of the RFID tag reader (6) inside the housing according to the type and size of the medical device (2) to be reprocessed.

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