Determining the the maximum number of reprocessing cycles of attachments

#1
Hi everyone. This is my very first post on this platform, so excuse me if it's not the right section for my question. I'm currently doing my thesis in a company that produces surgical motor systems (not OEM). My task is to determine the the maximum number of reprocessing cycles of the reusable attachments of this motor system. I'd very much appreciate it if you'd give me some information on how to go about it. I'm not a complete beginner, so feel free to use technical terms.

In the IFU it's mentioned: "Frequent reprocessing has minor effects on the instruments (motor, attachments, accessories). The end of the device’s lifespan is normally determined by wear and tear, and damage resulting from usage."


This is confusing; although the IFU clearly states that frequent reprocessing has minor effects on the instruments, including the attachments, I'm still expected to come up with the maximum number of the reprocessing cycles. I assume the trick lies in the word "minor", i.e., the effects are there and my task is to know at which point these minor effects become significant in determining the the durability of the attachments (maximum reprocessing cycles). Is my understanding right? If so, how do I go about determining it?

Your help would be very much appreciated.
 
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planB

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#2
Assuming that you are talking about a re-usable medical-device accessory, ISO 17664:2017 applies, saying in section 6.3.2
6.3.2 If the service life of the medical device is limited by the number of processing cycles or some other end of life indicator(s) this information shall also be provided.
NOTE For example, this information if applicable, can provide a method to monitor the actual number of processing cycles.
The German ZLG provides more guidance on this topic in RDS007, section 8 (unfortunately, German only)

8 Festlegung des letztmöglichen Verwendungszeitpunktes

8.1 Grundlagen

Entsprechend Nr. 13.6 h) des Anhangs I der Richtlinie 93/42/EWG muss die Gebrauchsanweisung Angaben zu einer „eventuellen zahlenmäßigen Beschränkung der Wiederverwendungen“ enthalten. Grundlage hierfür sind die Anforderungen aus Anhang I Nr. 4 und Nr. 5 der Richtlinie (Erfüllung der Anforderungen bis zum letztmöglichen Verwendungszeitpunkt, dies umfasst auch die Biokompatibilität, wie auch in den Kapiteln 4.7 und 4.8 von ISO 10993-1: 2018 [7] vorgegeben). Bei für die Aufbereitung vorgesehenen Medizinprodukten muss grundsätzlich von Veränderungen ausgegangen werden, die ab einem bestimmten Zeitpunkt die Produktsicherheit beeinträchtigen können, wenn eines der folgenden Kriterien zutrifft; insbesondere wenn
• das Produkt aus mehreren Komponenten zusammengesetzt ist
• das Produkt mit beweglichen Teilen ausgestattet ist
• das Produkt kritische Elemente wie z. B. Kavitäten, Bohrungen, Blindbohrungen, Gelenke, Kugeldruckstücke, Federn enthält
• das Produkt aus Kunststoffen und/oder nicht aus Metallen mit zusammensetzungsbedingt zu erwartender langfristig hoher Korrosionsbeständigkeit besteht
• das Produkt mit poröser Oberflächen ausgestattet ist oder
• stärkere mechanische oder sonstige (z. B. chemische) Beanspruchung bei der Anwendung und ggf. des Aufbereitungsverfahrens auftreten können.

8.2 Nachweiserbringung

Ohne einer dieser Vorgehensweisen den Vorzug zu geben, können die erforderlichen Nachweise erbracht werden, durch z.B.
• Simulation des letztmöglichen Verwendungszeitpunktes und Vergleich mit einem nur einmal aufbereiteten Medizinprodukt
• dokumentierte Anwendungserfahrung (z.B. mit einem Vorgänger- oder ähnlichem Produkt)
• Literaturdaten
• Hierbei sind alle relevanten Aspekte wie Funktion, Aufbereitbarkeit, Anreicherung von Detergentienrückständen (Nichtbeeinträchtigung der Biokompatibilität) mit einzubeziehen und – sofern möglich - „worst case“–Parameter in Bezug auf die Aufbereitungsanweisung zu berücksichtigen. Bei Medizinprodukten mit stärkerer mechanischer oder sonstiger Beanspruchung (z.B. chemisch) bei der Anwendung sollten diese Aspekte zusätzlich berücksichtigt werden.
HTH,
 
#3
Hey, planB. Thank you very much for your quick and helpful reply. I'm doing my project in German, so luckily I don't have trouble with the language.

Yes – the attachments (handpieces), of which the maximum number of reprocessing cycles is to be determined, are reusable. I'm well familiar with the ISO 17664, but as far as I'm concerned, the IFU isn't being clear on this issue; it says (I quote the original, German text for accuracy): "Das Produkt kann 500-mal wiederaufbereitet werden. Dies wird durch Überprüfung aller technischen Akzeptanzkriterien nach 500 Aufbereitungszyklen belegt." the way I understand it is that 500 is not necessarily the limit or the maximum number of the reprocessing cycles, so the reusable attachments could possibly undergo more than 500 cycles and still be safe to use. That's how I personally understand it.

Thanks a lot for the ZLG link! Definitely helpful.
 
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