System for reprocessing medical devices

Abstract

The present invention relates to the field of health and to the reprocessing of medical devices. In particular, the invention relates to a system and method for reprocessing medical devices. The system (1) for reprocessing medical devices (2) according to the invention comprises - an enclosure (3) suitable for the reprocessing of 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 enclosure (3); - at least one RFID tag reader (6); - at least one reprocessing ejector (7) arranged inside the enclosure (3); - an electronic control system (8); and - a data management system (9) comprising processing software and a database relating to said medical devices and to reprocessing cycles; characterized in that said at least one RFID tag reader (6) is arranged at least partially in a wall of the enclosure (3) so as to transmit a signal and / or to receive in return the signal originating from at least one RFID tag (4) of at least one medical device (2) suspended inside the enclosure (3).

Description

[0001] MEDICAL DEVICE REPROCESSING SYSTEM

[0002] FIELD OF THE INVENTION

[0003] The present invention relates to the field of health and the reprocessing of medical devices. In particular, the invention relates to a system and method for reprocessing medical devices.

[0004] STATE OF THE ART

[0005] In the healthcare field, medical devices are subject to reprocessing cycles such as sterilization, cleaning and / or disinfection.

[0006] Traceability of these cycles can be achieved using labels affixed or engraved on these devices, such as an RFID tag or a barcode label. A unique identifier for each medical device can then be detected by reading these labels, making it possible to establish the traceability of the reprocessing cycles for each medical device.

[0007] However, the reliability of reprocessing cycle traceability is not optimal since label detection typically takes place before reprocessing cycles using label readers placed outside a reprocessing enclosure. The multiplication of label reading steps outside the reprocessing enclosure and the positioning of devices inside the enclosure thus increases the risk of error, making it impossible to guarantee the correct implementation of reprocessing cycles for each of the devices.

[0008] Furthermore, in the event of a malfunction of the reprocessing device, information concerning the validation of the reprocessing cycles is not generated immediately and requires the manual entry of the error codes emitted by the reprocessing device into a database. Thus, there is a real need for a method for reprocessing medical devices whose reliability is improved by limiting the number of manual steps, using a system for efficiently and immediately managing the traceability and validation of the reprocessing cycles. Patent document US2022047745 also describes a medical device reprocessing system comprising, outside the enclosure, a label reader and a support. The label can be affixed to a part of the instrument located outside or inside the enclosure.The solution described in international application WO2008142300 by the same applicant discloses a probe reprocessing system comprising an active part and a cable for connection to an imaging device. The active part is placed inside the volume of the enclosure to be disinfected, while a suspension part carries an RFID tag outside the enclosure and allows the cable to be suspended. Neither of these two solutions addresses any optimization of the transmission quality between tags of medical devices to be processed placed inside an enclosure with respect to a reader, and even less so for several medical devices to be processed simultaneously.

[0009] Patent document US2022211891 describes a system for reprocessing catheters that can each be fixed on a tray. However, the handling of the trays remains manual and does not allow any optimization of the position or orientation of the medical devices to be treated according to their type or size in order to improve the reliability of the transmission of traceability information in real time for each of them.

[0010] US20050148819 describes a system for cleaning an endoscope comprising an RFID tag, placed in a cleaning tank, on one part of which is arranged an RFID unit. Here again, no research into transmission optimization is addressed for this individual treatment of medical devices. The same reasoning applies to the solution disclosed in document US20090220377 concerning a device for cleaning and disinfecting an endoscope.

[0011] US20020161460 discloses yet another system for disinfecting an endoscope comprising an RFID housing arranged behind one of the walls of a cleaning chamber. The walls are formed of non-metallic sheets (plastic or rubber) so that the electromagnetic transmission of the identification data can take place. The RFID tag can be directly attached to the endoscope placed in the cleaning chamber and it can be hung on a support fixed in the cleaning chamber. However, here again there is no possibility of improving the reliability of the transmission between tags linked respectively to a plurality of medical devices and a reader in the context of batch processing.

[0012] SUMMARY OF THE INVENTION

[0013] An object of the present invention is to provide a system for improving the reliability of reprocessing medical devices.

[0014] Another aim of the present invention is to provide a system for ensuring the traceability and validation of reprocessing cycles in an immediate, more reliable and more efficient manner.

[0015] Thus, the invention relates to a system for reprocessing medical devices comprising

[0016] - an enclosure suitable for the reprocessing of medical devices, each of the medical devices comprising at least one RFID tag;

[0017] - at least one support intended to suspend at least one medical device to be reprocessed inside the enclosure;

[0018] - at least one RFID tag reader;

[0019] - at least one reprocessing ejector arranged inside the enclosure;

[0020] - an electronic control system; and - a data management system comprising processing software and a database relating to the medical devices and to reprocessing cycles; characterized in that said at least one RFID tag reader is arranged at least partially in a wall of the enclosure so as to emit a signal and / or to receive in return the signal coming from at least one RFID tag of at least one medical device suspended inside the enclosure at least one support comprising at least one movable part to allow both an adjustable orientation of each medical device to be reprocessed relative to the RFID tag reader, as well as the adjustment of the position of the support inside the enclosure, said support, said at least one reader and said at least one ejector being connected to said electronic control system.

[0021] The medical devices considered within the scope of the present invention are devices and articles used in the medical, dental, surgical, pharmaceutical and / or veterinary fields. Depending on their design, the medical devices within the meaning of the present invention comprise surfaces, a front part, a back part, slots, grooves, seals and / or lumens. They are made of materials such as steel, a copper nickel alloy, and / or polymers resistant to reprocessing cycles, such as polyetheretherketone (PEEK) or polyamide-imide (PAI).

[0022] Preferably, the medical devices are dental and / or surgical devices. These devices may comprise side surfaces, a rear part, and a front part which is the active part of the device. Preferably, the medical devices are chosen from turbines, contra-angles and / or straight handpieces. Thus, within the framework of the invention, it is possible to adjust the position and orientation of the support individually for each medical device to be treated, and in particular according to its type which conditions their size within the enclosure, which is for example not the same between a straight handpiece and a contra-angle, as well as the positioning of the labels.

[0023] Indeed, in the context of the present invention, each of the medical devices comprises at least one label. A label associates a unique identifier with each medical device. Advantageously, the unique identifier is a unique numeric or alphanumeric code linked to a medical device which allows the clear and formal identification of a device and facilitates its traceability. This identifier is detectable upon reading the label by a suitable label reader.

[0024] Preferably, each of the medical devices comprises two tags so as to optimize detection reliability by ensuring that at least one of the two tags can be read, for example in the event of damage to one of them. The tags are typically RFID tags and / or barcode tags.

[0025] In the context of the present invention, the tags are RFID tags. Thus, according to the invention, the identification information comprises a unique identifier linked to each of the RFID tags of the medical devices. The RFID tags are chosen from passive and / or active RFID tags.

[0026] Passive RFID tags do not have any built-in power supply. The electromagnetic signal emitted by this type of RFID tag is created by a signal originally coming from the RFID reader. Advantageously, passive RFID tags are resistant to very high temperatures, irradiation and / or chemical agents used during reprocessing cycles.

[0027] Active RFID tags have an internal power supply such as a battery. This type of tag is capable of transmitting an electromagnetic signal to the tag reader using wireless technology and does not require an interrogation signal from the tag reader. Advantageously, the electromagnetic signal from an active RFID tag is stronger than that of a passive RFID tag.

[0028] Preferably, the tags are passive RFID tags, resistant to very high temperatures, irradiation and / or chemical agents, used during reprocessing cycles.

[0029] In addition, the labels are affixed and / or integrated onto the side surfaces of medical devices, by gluing, driving or screwing, so as to increase the reliability of detection and reading of the labels.

[0030] Within the scope of the present invention, the system comprises an enclosure suitable for the reprocessing of medical devices regardless of the complexity and diversity of the medical devices.

[0031] The enclosure is formed of an upper wall, a lower wall, side walls and at least one door allowing access to the interior of the enclosure intended to receive the medical devices. Preferably, the enclosure comprises at least one removable door facilitating access to the interior of the enclosure. In addition, the closed enclosure is hermetic or waterproof so as to guarantee the proper implementation of the reprocessing cycles, guarantee the sterilization of the devices and prevent the leakage of bacteriologically contaminated fluids or gases outside the enclosure.

[0032] The various methods for cleaning and sterilizing medical devices use heat, water, chemical agents, various gases, and / or ionizing rays emitted into the enclosure during the various reprocessing cycles. Thus, within the scope of the present invention, the system comprises at least one reprocessing ejector arranged inside the enclosure.

[0033] The reprocessing ejector is configured to eject steam, a chemical agent, water, gases, ionizing rays and / or compressed air, so as to clean and / or sterilize the medical devices. Inside the enclosure, at least one support is intended to suspend at least one medical device to be reprocessed. Preferably, each support is intended to suspend only one and only one medical device to be reprocessed. Advantageously, maintaining the medical devices in suspension allows for efficient reprocessing of a greater portion of the surfaces, cavities, and / or channels of the devices, unlike devices arranged in cassettes or on trays.

[0034] According to the present invention, the supports comprise fixing means adapted to hold at least one medical device in suspension. Preferably, the fixing means are chosen from a clamp, a screw, a clip or a magnetic adhesive. These fixing means are adapted to hold the devices to be reprocessed in suspension at certain parts of the device so as to ensure complete reprocessing of the parts intended to treat patients.

[0035] In the context of the present invention, it is conceivable that at least one ejector is arranged inside a support. Preferably, when the support has a tubular shape, at least one ejector can be arranged inside the tubular shape of the support. Advantageously, the products of the reprocessing cycles are thus ejected inside the medical device, at the lumens such as cavities or internal channels, rather than on the external surfaces of the medical device.

[0036] In the particular case of dental and / or surgical devices, the fixing means are adapted to keep the devices to be reprocessed suspended at the rear part, ensuring complete reprocessing of the front part which is the active part intended to treat patients.

[0037] It is conceivable that the fixing means further comprise an envelope intended to receive a medical device in suspension. Advantageously, the envelope suspended using the fixing means allows complete reprocessing of the medical device. Preferably, the envelope is a sterilization pouch. It is also conceivable that each envelope includes an RFID tag. Thus, by combining the identifier of the device with that of the envelope, the traceability of the envelope comprising a device is ensured until its use. In particular, the system makes it possible to trace the sterility period of the device in its envelope. This is particularly advantageous because sterility is often limited to a few days. Additional sterilization / decontamination is recommended if such a period is exceeded.

[0038] In the context of the present invention, the supports are fixed to a wall of the enclosure. Preferably, the supports are fixed to the upper wall of the enclosure. The position of the supports inside the enclosure is adjustable so as to adjust the distance between the medical devices according to their size, avoid any contact between them and optimize the orientation of the RFID tags of each of the medical devices.

[0039] Advantageously, each medical device is kept suspended inside the enclosure without direct contact with other devices or elements inside the enclosure such as walls or metal surfaces, thus limiting the deterioration of the labels affixed and / or integrated on the side surfaces of the medical devices.

[0040] According to the present invention, the supports comprise at least one movable part to allow adjustable orientation of the medical device, so as to optimize the orientation of the RFID tags for each of the medical devices.

[0041] In the context of the present invention, the RFID tags affixed and / or integrated on the surfaces of the medical devices are read by RFID tag readers. Thus, the system comprises at least one RFID tag reader, arranged at least partially in a wall of the enclosure so as to emit a signal and / or to receive in return the signal coming from the RFID tags of the medical devices suspended inside the enclosure. Advantageously, the arrangement of the RFID tag reader at least partially in a wall of the enclosure makes it possible to receive in return the signal coming from the RFID tags of the medical devices only inside the enclosure. Furthermore, this arrangement makes it possible to protect the RFID tag reader from substances projected during reprocessing cycles while minimizing the size of the reader inside the enclosure.

[0042] It is conceivable that a part of the RFID tag reader, for example that which contains the electrical / electronic circuits, is arranged so as to be completely integrated into the wall while another part is arranged so as to extend towards the interior of the volume of the enclosure.

[0043] In a particular case of the invention, the invention relates to a system in which said at least one RFID tag reader comprises guide means arranged to guide a portion of the RFID tag reader inside the enclosure so as to acquire the identification information of each of the medical devices. The guide means are for example an articulated arm adapted to direct the reading head of the RFID tag reader close to the RFID tags of the medical devices. It is advantageous to be able to adjust the position of a portion of the RFID tag reader inside the enclosure according to the typology and size of the medical device to be reprocessed. Thus, the quality of the wireless transmission between the RFID tag and the RFID reader is optimal. This makes it possible to minimize the risk of error during the reprocessing procedure and the transmission of the identification information.This maximizes tracking reliability. In addition, the articulated arm is designed to be folded during reprocessing cycles to protect the RFID tag reader's reading head from substances projected during reprocessing cycles.

[0044] According to another particular case, the invention relates to a system for reprocessing medical devices in which said at least one RFID tag reader is arranged entirely in a wall of the enclosure so as to emit a signal and / or to receive in return the signal coming from the RFID tags of the medical devices suspended inside the enclosure. Advantageously, this arrangement makes it possible to protect all parts of the RFID tag reader from substances projected during reprocessing cycles while minimizing the size of the reader inside the enclosure. In particular, the electrical / electronic circuits and the part comprising the reading head are protected while remaining functional.

[0045] Advantageously, the partial or total arrangement of the tag reader in a wall makes it possible to maximize the angle or region of detection of the RFID tags positioned on the devices to be reprocessed, so as to cover a large volume or even the entire volume of the enclosure.

[0046] In the context of the present invention, it is conceivable that the RFID tag readers are formed by extrusion or by overmolding in at least one wall of the enclosure. The tag reader being thus integral with the wall, the system does not require any assembly steps at the time of its use, and can be easily implemented.

[0047] In addition, the RFID tag readers are arranged to acquire identification information of each of the medical devices before, during and after the reprocessing cycles of said medical devices kept suspended inside the enclosure. Thus, the system makes it possible to immediately know the state of the medical devices before the start of a reprocessing cycle, during and just after the end of said reprocessing cycle. This system thus guarantees the monitoring of the state of the medical devices and makes it possible to validate or not their processing state, i.e. to be reprocessed or having actually been reprocessed, after each reprocessing cycle.

[0048] Furthermore, the system according to the invention comprises at least one metal plate arranged to be positioned movably outside the enclosure to prevent RFID tags from being read outside the enclosure. The arrangement of at least one metal plate on one or more sides of the enclosure is adaptable according 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 chosen from conductors such as aluminum and stainless steels and / or from plastic materials (PET) metallized with electrical or magnetic dopants (such as aluminum, fluorine, or tin), so as to prevent RFID tags from being read outside the enclosure.

[0049] Advantageously, the traceability and validation of the reprocessing cycles is ensured immediately, in the most reliable and efficient manner by an electronic control system linked to a management system preferably comprising processing software and a database managing identifiers individually associated with devices, for example by means of RFID tags. In this way, processing states can be updated in real time and individually for each device as different reprocessing cycles progress. The immediate transmission of information thus makes it possible to optimize the reliability of the reprocessing system and the process implemented by this system.

[0050] The electronic control system comprises a control unit capable of

[0051] - control the RFID tag reader(s) and the reprocessing ejector(s);

[0052] - check the support(s);

[0053] - collect the identification information acquired by the RFID tag reader(s);

[0054] - transferring the identification information acquired by the RFID tag reader(s) to the data management system; and

[0055] - transfer information relating to reprocessing cycles to the data management system.

[0056] According to the present invention, the identification information acquired by the RFID tag readers are the unique identifiers of the medical devices and / or the envelopes. During a reprocessing cycle, error codes may be issued by the electronic control system when a complete reprocessing cycle has not been carried out, for example in the case of a breakdown or loss of sealing of the enclosure. Thus, the reprocessing cycle information includes the number of cycles, the type of reprocessing cycles carried out, and the error codes caused during the performance of the reprocessing cycles.

[0057] In the context of the present invention, the electronic control system comprises a control unit capable of transferring the identification information and the information of the reprocessing cycles to the data management system, the role of which is to ensure and monitor, in particular via processing software interacting with a database, the proper progress of each of the reprocessing cycles by simultaneously updating the processing status of the medical devices. Thus, the data of the data management system includes the identifiers of the medical devices, the identifiers of the envelopes, the references of the medical devices, the number and type of reprocessing cycles carried out for each of the medical devices, and any error codes caused during the performance of the reprocessing cycles.

[0058] The present invention also relates to a method of reprocessing medical devices carried out using a system as defined above.

[0059] An object of the present invention is to provide a method for reprocessing medical devices making it possible to improve the reliability of reprocessing medical devices.

[0060] Another object of the present invention is to provide a method for reprocessing medical devices making it possible to ensure the traceability and validation of reprocessing cycles in a more reliable and efficient manner. Thus, the invention relates to a method for reprocessing medical devices using a reprocessing system comprising the following steps: i. equipping at least one medical device to be reprocessed with at least one RFID tag; ii. positioning inside a reprocessing enclosure said at least one medical device comprising at least one RFID tag and holding each said at least one medical device in suspension using a support; iii. closing the enclosure; iv. adjusting the position of at least one support in the enclosure 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 so as to collect the identification information of each of the medical devices before performing a reprocessing cycle; vi. activating said at least one reprocessing ejector to perform at least one reprocessing cycle; vii. collecting the information of the reprocessing cycle; viii. activating said at least one RFID tag reader so as to collect the identification information of said at least one medical device after performing the reprocessing cycle; and ix. transferring the identification information acquired by said at least one RFID tag reader and the information of the reprocessing cycles to a data management system and x. updating the data relating to each of the medical devices (2) in a database of said data management system (9) after each reprocessing cycle.

[0061] In the method of reprocessing medical devices of the invention, the activation of one or more reprocessing ejectors makes it possible to carry out one or more reprocessing cycles chosen from cleaning, disinfection, lubrication, and / or sterilization.

[0062] It is conceivable that at least one of each of the medical devices to be reprocessed is placed inside an envelope held in suspension by means of a support inside the enclosure. Advantageously, the envelope suspended by means of a support allows complete reprocessing of the medical device. Preferably, the envelope is a sterilization pouch.

[0063] It is also possible for each of the envelopes to include an RFID tag. Thus, by combining the device identifier with that of the envelope, the traceability of the envelope containing a device is ensured until its use. In particular, the method makes it possible to trace the period during which the device in its envelope is sterile. This is particularly advantageous in the case where sterility is limited to a few days.

[0064] According to one method of implementing the process, the RFID tag readers are activated continuously throughout the duration of the reprocessing cycles.

[0065] Thus, the identification information of each of the medical devices and the information of the reprocessing cycles are transmitted by the electronic control system to the data management system so as to acquire traceability information of each of the medical devices. This traceability information consists for example of the number of reprocessing cycles to which each device has already been subjected, and when, so as to determine an instantaneous status for each medical device indicating in particular whether a reprocessing is due, but not yet carried out; whether a reprocessing is in progress - in the case where both the RFID reader and the RFID identifiers remain active during an entire reprocessing cycle - or whether a reprocessing has just been correctly carried out. Advantageously, this traceability information is acquired immediately by the data management system.

[0066] In addition, an additional step of validation of the reprocessing process can be considered, in which the data management system is configured to validate the reprocessing of each of the medical devices based on the traceability information.

[0067] BRIEF DESCRIPTION OF THE FIGURES

[0068] The features and advantages of the present invention will appear in more detail in the context of the description which follows with an example of embodiment given for illustrative and non-limiting purposes with reference to the attached drawings in which:

[0069] - Figure 1 is a schematic representation of a medical device reprocessing system according to an exemplary embodiment of the invention.

[0070] - Figure 2 is a schematic representation of a medical device reprocessing system according to another exemplary embodiment of the invention.

[0071] - Figure 3 is a schematic representation of the interior of the enclosure of a medical device reprocessing system in which the supports have a movable portion and allow adjustable orientation of the medical device relative to the position of the RFID tag reader.

[0072] DETAILED DESCRIPTION OF THE INVENTION

[0073] Figure 1 schematically and functionally illustrates a reprocessing system (1) for medical devices (2) according to a preferred embodiment for the present invention. The medical devices (2) are each provided with an RFID tag (4), and this system comprises an enclosure (3), a metal plate (10), several supports (5) of which only one is visible, an RFID tag reader (6), several reprocessing ejectors (7), an electronic control system (8) and a data management system (9), which comprises processing software, i.e. computer software comprising a program intended to execute different reprocessing cycles. The latter interacts with a regularly updated database to indicate the respective instantaneous reprocessing state of the medical devices (2), before, during and after each reprocessing cycle.

[0074] The enclosure (3) comprises right and left side walls, a rear side wall not shown, a top wall, a bottom wall and a door not shown allowing access to the interior of the enclosure (3).

[0075] In some embodiments, the enclosure (3) comprises at least one removable door facilitating access to the interior of the enclosure (3).

[0076] The enclosure (3) delimits a volume inside the enclosure (3) in which the reprocessing cycles of the medical devices (2) are carried out. When the door is closed, the enclosure (3) delimits a sealed volume so as to ensure the proper implementation of the reprocessing cycles and the sterility of the medical devices (2). In the embodiment illustrated in Figure 1, the reprocessing system (1) comprises a support (5) fixed to the upper wall of the enclosure (3).

[0077] According to other embodiments, several supports can be provided and fixed to the upper wall of the enclosure (3). The fixing of the supports (5) to the upper wall of the enclosure (3) can be adjustable according to the space requirement of the medical devices (2) between them.

[0078] According to other embodiments, the support (5) may comprise a movable part to allow adjustable orientation of the medical device (2).

[0079] The support (5) is adapted to hold in suspension preferably a single medical device (2) at a time to be reprocessed inside the enclosure (3) by means of fixing means not shown in figure 1 such as a clamp, a screw, a clip or a magnetic adhesive. According to other alternative embodiments, a support (5) can hold in suspension several medical devices (2) at a time.

[0080] Maintaining medical devices in suspension as illustrated in Figure 1 allows for efficient reprocessing of a greater portion of the surfaces, and / or cavities of the medical devices (2).

[0081] In the embodiment illustrated in Figure 1, the reprocessing system (1) comprises several reprocessing ejectors (7) arranged inside the enclosure (3) so as to carry out the reprocessing cycles of the medical devices (2) in the volume delimited by the enclosure (3). According to other embodiments, a single ejector may be provided inside the enclosure (3). An ejector (7) may be configured to carry out different reprocessing cycles such as the ejection of steam, a chemical agent, water, gas, ionizing rays or compressed air, so as to clean and / or sterilize the medical devices (2). In the embodiment illustrated in Figure 1, without being limiting, the support (5) has a tubular shape. It is conceivable that at least one ejector (7) is arranged inside the tubular shape of the support (5).Advantageously, the reprocessing products are ejected inside the medical device (2), at the lumens of the medical device (2), such as internal cavities or channels.

[0082] In the embodiment illustrated in Figure 1, the reprocessing system (1) comprises an RFID tag reader (6) arranged partially in a wall of the enclosure (3) so as to emit a signal and / or to receive in return the signal coming from the RFID tags (4) of the medical devices (2) suspended inside the enclosure (3).

[0083] According to this embodiment, the RFID tag reader (6) is partially arranged in one of the side walls of the enclosure (3).

[0084] According to another embodiment, the system may comprise several RFID tag readers (6) arranged partially in one or more walls of the enclosure (3) so as to emit a signal and / or to receive in return the signal coming from the RFID tags (4) of the medical devices (2) suspended inside the enclosure (3).

[0085] Thus, the RFID tag reader (6) can receive in return the signal coming from the RFID tags (4) of the medical devices (2) arranged only inside the enclosure and not outside the enclosure (3). Furthermore, this arrangement makes it possible to protect the RFID tag reader (6) from substances projected during reprocessing cycles while minimizing the size of the reader (6) inside the enclosure (3).

[0086] In the embodiment illustrated in Figure 1, the part comprising the electrical / electronic circuits of the RFID tag reader (6) is arranged outside the enclosure (3), while the part comprising the reading head of the RFID tag reader (6) extends through one of the side walls of the enclosure (3) towards the interior of the volume of the enclosure (3) so as to emit a signal and / or to receive in return the signal coming from the RFID tags (4) of the medical devices (2) suspended inside the enclosure (3).

[0087] According to another embodiment, the part comprising the electrical / electronic circuits of the RFID tag reader (6) is fully integrated into one of the side walls of the enclosure (3), while the part comprising the reading head of the RFID tag reader (6) extends through this wall towards the interior of the volume of the enclosure (3).

[0088] According to another embodiment, the RFID tag reader (6) further comprises guide means arranged in one of the side walls of the enclosure (3) and adapted to direct a part of the RFID tag reader (6) or the reading head of the RFID tag reader (6) close to the RFID tags (4) of the medical devices (2). These guide means are for example an articulated arm. Advantageously, the articulated arm is adapted to be folded at the time of the reprocessing cycles so as to protect the reading head of the RFID tag reader (6) from the substances projected during the reprocessing cycles.

[0089] According to another embodiment, the reprocessing system (1) comprises an RFID tag reader (6) arranged entirely in a wall of the enclosure (3) so as to emit a signal and / or to receive in return the signal coming from the RFID tags (4) of the medical devices (2) suspended inside the enclosure (3).

[0090] In the embodiment illustrated in Figure 1, the reprocessing system (1) comprises an electronic control system (8) comprising a control unit capable of

[0091] - control the RFID tag reader (6) and the reprocessing ejectors (7);

[0092] - control the support (5); - collect the identification information acquired by the RFID tag reader (6);

[0093] - transferring the identification information acquired by the RFID tag reader (6) to the data management system (9); and

[0094] - transfer information from reprocessing cycles to the data management system (9).

[0095] The holder (5), the RFID tag reader (6), and the reprocessing ejectors (7) are connected to the electronic control system (8) by a wired connection. According to another embodiment, the holder (5), the RFID tag reader (6), and the reprocessing ejectors (7) are connected to the electronic control system (8) by a wireless connection.

[0096] 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.

[0097] In the embodiment illustrated in Figure 1, the reprocessing system (1) comprises a metal plate (10) arranged outside the enclosure to prevent the reading of RFID tags outside the enclosure.

[0098] According to another embodiment, the reprocessing system (1) may comprise several metal plates (10).

[0099] Figure 2 schematically illustrates a reprocessing system (1) for medical devices (2) comprising an enclosure (3), two metal plates (10), several supports (5), an RFID tag reader (6), several reprocessing ejectors (7), an electronic control system (8) and a data management system (9).

[0100] In the embodiment of Figure 2, medical devices

[0101] (2) each provided with an RFID tag (4) are arranged respectively in envelopes (11) suspended inside the enclosure (3) using the means for fixing the supports (5).

[0102] Advantageously, the envelopes (11) suspended using the fixing means of the supports (5) allow complete reprocessing of the medical devices (2).

[0103] According to another embodiment, the medical devices (2) can each be provided with two RFID tags (4).

[0104] According to another embodiment, the envelopes (11) can each be provided with an RFID tag.

[0105] Figure 3 is a schematic representation of the interior of the enclosure (3) of a reprocessing system (1) for medical devices (2) equipped with an RFID tag (4).

[0106] Supports (5) are fixed to the upper wall of the enclosure (3) and comprise a first attachment part (5A), mounted to this wall corresponding to the upper part, i.e. to the ceiling of the enclosure, and a second movable part (5B), comprising fixing means adapted to keep the medical devices (2) suspended inside the enclosure (3).

[0107] The position of the supports (5) inside the enclosure (3) is adjustable using the first attachment part (5A) so as to adjust the distance between the medical devices (2) according to their size, avoid any contact between them and optimize the orientation of the RFID tags (4) of each of the medical devices (2).

[0108] In a particular non-limiting example, the devices can be maintained either in a first position (P1), vertical, or moved to a second position (P2), inclined, as required. The arrow indicates the passage from the first position (P1) to the second position (P2), which can have a predetermined angle relative to the vertical, along two orthogonal axes (figure 3).

[0109] According to the variant illustrated in Figure 3, the first attachment part (5A) is in the form of a spherical ball joint allowing any positioning of the second mobile part (5B) to which the medical device (2) is fixed inside the enclosure thanks to two degrees of freedom in rotation in a spherical coordinate system (0, <p).

[0110] The positioning of the medical device (2) around the longitudinal axis along which the second movable part (5B) extends has changed between the first position (P1) and the second position (P2), which corresponds to a third degree of freedom in rotation, precisely around this longitudinal axis. This latter adjustment can be achieved either via free positioning of the medical device (2) relative to the second movable part (5B) of the support (5) during its attachment, or by conferring a third degree of freedom in rotation to the ball joint allowing this adjustment to be carried out.

[0111] Whatever the variant chosen, the adjustment provided according to three degrees of freedom in rotation will aim on the one hand to bring the RFID tags (4) as close as possible to the reader (6) but also to adjust the orientation of the RFID tags (4) in relation to the reader (6), so as to make the transmission efficiency reliable via the air interface.

[0112] The embodiments described in Figures 1 to 3 are equally suitable for the use of passive and / or active RFID tags.

[0113] The method of reprocessing medical devices (2) according to the present invention can be carried out using a reprocessing system (1) as described or illustrated previously.

[0114] In a first step, it is necessary to equip each of the medical devices (2) to be reprocessed with at least one RFID tag (4). The RFID tags (4) can be affixed and / or integrated onto the side surfaces of the medical devices (2) by methods such as gluing, driving in or screwing.

[0115] The medical devices (2) provided with at least one RFID tag (4) are then positioned inside a reprocessing enclosure (3) and held in suspension using supports (5) comprising fixing means such as a clamp, a screw, a clip or a magnetic adhesive. In a particular embodiment of the method, each of the medical devices (2) to be reprocessed is placed inside an envelope (11) held in suspension using the fixing means of a support (5) inside the enclosure (3).

[0116] The door of the enclosure (3) is closed so as to ensure the seal necessary for the proper implementation of the reprocessing cycles and to ensure the sterility of the medical devices (2).

[0117] The RFID tag reader (6) is activated by the electronic control system (8) so as to collect the identification information of each of the medical devices (2) held in suspension inside the enclosure (3) before carrying out a reprocessing cycle. The identification information comprising a unique identifier linked to each of the medical devices (2) is then detected by reading the RFID tags (4) affixed / integrated on the surfaces of the medical devices (2).

[0118] The reprocessing ejectors (7) are then activated by the electronic control system (8) to perform a reprocessing cycle such as the ejection of steam, a chemical agent, water, gas, ionizing rays or compressed air, so as to clean and / or sterilize the medical devices (2).

[0119] All information related to reprocessing cycles such as number, type of reprocessing cycle and error codes are collected by the electronic control system (8).

[0120] The next step involves activating the RFID tag reader (6) by the electronic control system (8) so as to collect the identification information of each of the medical devices (2) after completion of the reprocessing cycle.

[0121] During this process, all identification information acquired by the RFID tag readers (6) and the information of the reprocessing cycles are immediately transferred by the electronic control system (8) to the data management system (9). This information makes it possible to individually ensure the traceability of the reprocessing of each of the medical devices in an optimal manner.

[0122] Furthermore, the method comprises a step in which the data management system (9) can be configured to validate or not the reprocessing of each of the medical devices (2) from the traceability information. Any error code issued during the reprocessing cycles will immediately result in the non-validation of the reprocessing of the medical devices by the data management system.

Claims

CLAIMS reprocessing system (1) for medical devices (2) comprising - an enclosure (3) suitable for reprocessing medical devices (2), each of the medical devices (2) comprising at least one RFID tag (4); - at least one support (5) intended to suspend at least one medical device (2) to be reprocessed inside the enclosure (3); - at least one RFID tag reader (6); - at least one reprocessing ejector (7) arranged inside the enclosure (3); - an electronic control system (8); and - a data management system (9) comprising processing software and a database relating to said medical devices and to reprocessing cycles; characterized in that said at least one RFID tag reader (6) is arranged at least partially in a wall of the enclosure (3) so as to emit a signal and / or to receive in return the signal coming from at least one RFID tag (4) of at least one medical device (2) suspended inside the enclosure (3), at least one support (5) comprising at least one movable part to allow both an adjustable orientation of each medical device (2) to be reprocessed relative to said RFID tag reader (6), as well as the adjustment of the position of said support (5) inside the enclosure, said support (5), said at least one reader (6) and said at least one ejector (7) being connected to said electronic control system (8). 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 reprocessing ejectors (7); - individually controlling the respective position of a plurality of said supports (5) inside the enclosure (3) and the orientation of the movable part of each of said supports (5); - collecting the identification information acquired by said RFID tag readers (6); - transferring the identification information acquired by said RFID tag readers (6) to the data management system (9); and - transferring information relating to reprocessing cycles to the data management system (9). System according to one of the preceding claims, wherein said at least one RFID tag reader (6) comprises adjustable guide means constituted by an articulated arm adapted to direct the reading head of said RFID tag reader (6) close to the RFID tags (4) of the medical devices (2). System according to one of the preceding claims, wherein the system comprises at least one metal plate (10) arranged to be able to be positioned in a movably manner outside the enclosure (3) to avoid reading RFID tags outside the enclosure (3). System according to one of the preceding claims, wherein the RFID tag readers (6) are arranged to acquire identification information of each of the medical devices (2) before, during and after the reprocessing cycles of said medical devices (2) held in suspension inside the enclosure (3). System according to one of claims 2 to 5, wherein the identification information comprises a unique identifier linked to each of the RFID tags (4) of the medical devices (2). System according to any one of claims 2 to 6, wherein the reprocessing cycle information comprises the number and type of reprocessing cycles carried out, and error codes caused during the carrying out of the reprocessing cycles. System according to one of the preceding claims, wherein said at least one RFID tag reader (6) comprises guide means arranged to guide a part of the RFID tag reader (6) inside the enclosure (3) so as to acquire the identification information of each of the medical devices (2).Reprocessing system (1) for medical devices (2) according to one of the preceding claims, wherein said at least one RFID tag reader (6) is arranged entirely in a wall of the enclosure (3) so as to emit a signal and / or to receive in return the signal coming from the RFID tags (4) of the medical devices (2) suspended inside the enclosure (3). System according to one of the preceding claims, wherein the RFID tag readers (6) are formed by extrusion or by overmolding in at least one wall of the enclosure (3). System according to one of the preceding claims, wherein at least one support (5) has a tubular shape and at least one ejector (7) is arranged inside the tubular shape of said support (5). Method for reprocessing medical devices (2) using a system according to any one of claims 1 to 11 comprising the following steps: i. equipping at least one medical device (2) to be reprocessed with at least one RFID tag (4); ii. positioning inside a reprocessing enclosure (3) said at least one medical device (2) comprising at least one RFID tag (4) and holding each said at least one medical device (2) in suspension using a support (5); iii. closing the enclosure (3); iv. adjusting the position of at least one support (5) in the enclosure (3) and the orientation of said support (5) relative to at least one RFID tag reader (6) for each medical device (2) to be reprocessed; v.activating said at least one RFID tag reader (6) so as to collect the identification information of each of the medical devices (2) before performing a reprocessing cycle; vi. activating said at least one reprocessing ejector (7) to perform at least one reprocessing cycle; vii. collecting the information of the reprocessing cycles; viii. activating said at least one RFID tag reader (6) so as to collect the identification information of each. medical devices (2) after completion of the reprocessing cycles; and ix. transferring the identification information acquired by said at least one RFID tag reader (6) and the information of the reprocessing cycles to a data management system (9) x. updating the data relating to each of the medical devices (2) in a database of said data management system (9) after each reprocessing cycle. A method of reprocessing medical devices (2) according to claim 12, wherein at least one of each of the medical devices (2) to be reprocessed is placed inside an envelope (11) held in suspension using a support (5) inside the enclosure (3). A method of reprocessing medical devices (2) according to one of claims 12 or 13, wherein said at least one RFID tag reader (6) is activated continuously throughout the duration of the reprocessing cycles.Method for reprocessing medical devices (2) according to one of claims 12 to 14, in which the identification information of each of the medical devices (2) and the information of the reprocessing cycles are transmitted by the electronic control system (8) to the data management system (9) so as to acquire traceability information of each of the medical devices (2) in real time. Method for reprocessing medical devices (2) according to claim 15, comprising an additional step of validating the reprocessing method, in which the data management system (9) is configured to validate the reprocessing of each of the medical devices (2) from the traceability information when no error code has been generated by said data management system (9).Method for reprocessing medical devices (2) according to one of claims 12 to 16, when the reprocessing system (1) is the system of claim 3, said at least one RFID tag reader (6) comprising adjustable guide means constituted by an articulated arm adapted to direct the reading head of said RFID tag reader (6) close to the RFID tags (4) of the medical devices (2), the method comprising a step of adjusting the position of a part of said RFID tag reader (6) inside the enclosure according to the typology and size of said medical device (2) to be processed.

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