EP4586952A1 - System zur wiederaufbereitung von medizinischen geräten - Google Patents
System zur wiederaufbereitung von medizinischen gerätenInfo
- Publication number
- EP4586952A1 EP4586952A1 EP23772208.7A EP23772208A EP4586952A1 EP 4586952 A1 EP4586952 A1 EP 4586952A1 EP 23772208 A EP23772208 A EP 23772208A EP 4586952 A1 EP4586952 A1 EP 4586952A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- reprocessing
- medical devices
- enclosure
- rfid tag
- tag reader
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/70—Cleaning devices specially adapted for surgical instruments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/90—Identification means for patients or instruments, e.g. tags
- A61B90/98—Identification means for patients or instruments, e.g. tags using electromagnetic means, e.g. transponders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
- A61L2/26—Accessories
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
- G16H40/20—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
- G16H40/40—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
- A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
- A61L2/08—Radiation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
- A61L2/16—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using chemical substances
- A61L2/20—Gaseous substances, e.g. vapours
- A61L2/202—Ozone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2103/00—Materials or objects being the target of disinfection or sterilisation
- A61L2103/15—Laboratory, medical or dentistry appliances, e.g. catheters or sharps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/10—Apparatus features
- A61L2202/12—Apparatus for isolating biocidal substances from the environment
- A61L2202/122—Chambers for sterilisation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/10—Apparatus features
- A61L2202/14—Means for controlling sterilisation processes, data processing, presentation and storage means, e.g. sensors, controllers, programs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/10—Apparatus features
- A61L2202/15—Biocide distribution means, e.g. nozzles, pumps, manifolds, fans, baffles, sprayers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/10—Apparatus features
- A61L2202/17—Combination with washing or cleaning means
Definitions
- the traceability of these cycles can be carried out using labels affixed or engraved on these devices, such as an RFID label or a barcode label. A unique identifier for each medical device is then detectable by reading these labels, making it possible to establish the traceability of the reprocessing cycles for each medical device.
- 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 with wireless technology, and does not require an interrogation signal from the tag reader. Of advantageously, the electromagnetic signal of an active RFID tag is more intense than that of a passive RFID tag.
- the system according to the invention comprises at least one metal plate arranged to be positioned in a movable manner outside the enclosure to prevent the reading of RFID tags outside the enclosure.
- the arrangement of at least one metal plate on one or more sides of the enclosure is adaptable depending on the location of the system.
- 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 avoid reading RFID tags outside the enclosure.
- An aim of the present invention is to provide a method for reprocessing medical devices making it possible to improve the reliability of the reprocessing of medical devices.
- 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 said at least one medical device comprising at least one RFID tag inside a reprocessing enclosure and maintaining each said at least one medical device in suspension using a support; iii. close the enclosure; iv.
- 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.
- each of the medical devices to be reprocessed is placed inside an envelope held in suspension using a support inside the enclosure.
- the envelope suspended using a support allows complete reprocessing of the medical device.
- the envelope is a sterilization pouch.
- each of the envelopes includes an RFID tag.
- the traceability of the envelope containing a device is ensured until its use.
- the method makes it possible to trace the period during which the device in its envelope is sterile. This is particularly advantageous in cases where sterility is limited to a few days.
- the RFID tag readers are activated continuously throughout the duration of the reprocessing cycles.
- 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 reprocessing is due, but not yet carried out; if a reprocessing is in progress - in case both the RFID reader and the RFID identifiers remain active throughout a reprocessing cycle - or if a reprocessing has just been correctly carried out.
- this traceability information is acquired immediately by the data management system.
- an additional step of validating 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.
- FIG. 1 is a schematic representation of a medical device reprocessing system according to an exemplary embodiment of the invention.
- FIG. 2 is a schematic representation of a medical device reprocessing system according to another embodiment of the invention.
- FIG. 3 is a schematic representation of the interior of the enclosure of a medical device reprocessing system in which the Supports have a movable part and allow adjustable orientation of the medical device relative to the position of the RFID tag reader.
- the enclosure (3) comprises right and left side walls, a rear side wall not shown, an upper wall, a lower wall and a door not shown allowing access to the interior of the enclosure (3).
- Maintaining medical devices in suspension as illustrated in Figure 1 allows effective reprocessing of a larger portion of the surfaces and/or cavities of medical devices (2).
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Surgery (AREA)
- Business, Economics & Management (AREA)
- General Business, Economics & Management (AREA)
- Medical Informatics (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Pathology (AREA)
- Primary Health Care (AREA)
- Heart & Thoracic Surgery (AREA)
- Molecular Biology (AREA)
- Electromagnetism (AREA)
- Physics & Mathematics (AREA)
- Medical Treatment And Welfare Office Work (AREA)
- Accommodation For Nursing Or Treatment Tables (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP22195689 | 2022-09-14 | ||
| PCT/EP2023/075365 WO2024056834A1 (fr) | 2022-09-14 | 2023-09-14 | Système de retraitement de dispositifs médicaux |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| EP4586952A1 true EP4586952A1 (de) | 2025-07-23 |
Family
ID=83318835
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP23772208.7A Pending EP4586952A1 (de) | 2022-09-14 | 2023-09-14 | System zur wiederaufbereitung von medizinischen geräten |
Country Status (4)
| Country | Link |
|---|---|
| EP (1) | EP4586952A1 (de) |
| JP (1) | JP2025529025A (de) |
| CN (1) | CN119923236A (de) |
| WO (1) | WO2024056834A1 (de) |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU755635B2 (en) * | 1998-10-01 | 2002-12-19 | Minntech Corporation | Endoscope reprocessing and sterilization system |
| WO2002032468A1 (en) | 2000-10-13 | 2002-04-25 | Olympus Optical Co., Ltd. | Automatic cleaning and disinfecting device |
| JP3691764B2 (ja) | 2001-03-07 | 2005-09-07 | オリンパス株式会社 | オートクレーブ装置 |
| US8356745B2 (en) | 2007-04-18 | 2013-01-22 | Germitec | Enclosure for the decontamination and identification of a medical apparatus |
| JP2009226193A (ja) | 2008-02-27 | 2009-10-08 | Olympus Medical Systems Corp | 内視鏡洗浄消毒装置 |
| DE102017131195A1 (de) * | 2017-12-22 | 2019-06-27 | Otto Bock Healthcare Products Gmbh | Versorgungssystem für orthopädietechnische Komponente und Verfahren |
| ES2980616T3 (es) * | 2018-03-23 | 2024-10-02 | Log10 B V | Método y sistema de reprocesamiento de instrumental médico reutilizable |
| US10639389B2 (en) | 2018-04-30 | 2020-05-05 | CathBuddy, Inc | Methods and devices for portable sterilization and containment of medical devices |
| FR3092999B1 (fr) | 2019-02-27 | 2022-08-12 | Germitec | Procédés de détection d’un instrument médical dans un système de désinfection et systèmes de désinfection mettant en œuvre les procédés |
-
2023
- 2023-09-14 WO PCT/EP2023/075365 patent/WO2024056834A1/fr not_active Ceased
- 2023-09-14 JP JP2025505579A patent/JP2025529025A/ja active Pending
- 2023-09-14 CN CN202380061163.8A patent/CN119923236A/zh active Pending
- 2023-09-14 EP EP23772208.7A patent/EP4586952A1/de active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| JP2025529025A (ja) | 2025-09-04 |
| WO2024056834A1 (fr) | 2024-03-21 |
| CN119923236A (zh) | 2025-05-02 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: UNKNOWN |
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| STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE |
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| PUAI | Public reference made under article 153(3) epc to a published international application that has entered the european phase |
Free format text: ORIGINAL CODE: 0009012 |
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| STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE |
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| 17P | Request for examination filed |
Effective date: 20250408 |
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| AK | Designated contracting states |
Kind code of ref document: A1 Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC ME MK MT NL NO PL PT RO RS SE SI SK SM TR |
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| P01 | Opt-out of the competence of the unified patent court (upc) registered |
Free format text: CASE NUMBER: UPC_APP_3280_4586952/2025 Effective date: 20250813 |
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| DAV | Request for validation of the european patent (deleted) | ||
| DAX | Request for extension of the european patent (deleted) |