Component Lot Number Traceability - Class I reusable and "resposable" Medical Devices

Ronen E

Problem Solver
Moderator
Re: Component Lot Number Traceability - Class I reusable and "resposable" Medical Dev

I'm not criticizing your device's intended use and post-use handling. I'm sure your distribution and marketing is appropriate for safety and effectiveness. My critique was because the neologism "resposable" can easily be misunderstood to have a meaning other than the one you intend. Every previous use of the word I've seen has had a different meaning than how you use it.

The mere fact of the need for this discussion to clarify what you mean by the word, i.e. a device that may be reprocessed about fifty times and then is to be disposed, seems to me to be indicative that there may be potential for a problem...especially for global labeling.

The term I'd prefer to see for a device of the same intended use as yours is "up to fifty cycle reprocessable". I think everyone in the medical device user community likely would have the same understanding of that term, in English or as translated.

I agree. :agree1:

I don't see why the use pattern described should not be termed "reprocessing". The limitation for 50 cycles is simply the device's (validated?) life span, and all other details regarding how to do the reprocessing are simply part of validating recommended methods and providing adequate instructions for use.

Cheers,
Ronen.
 
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