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Intentional reprocessing of a single use device

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by dr1vn, Mar 18, 2016.

  1. dr1vn

    dr1vn New Member

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    We've had reports of users reprocessing our devices that are labeled as single-use. Any attempts to autoclave our device renders it useless, so most people (we think) are just cleaning it in some solution and reusing it. Since we have not validated any cleaning process, there is no effective way to clean our device so I imagine that any failures in the field may be attributed to a bad cleaning job.

    Is there anything else we can do to stop this?
    Should we be doing anything else to stop this?
     
  2. Ronen E

    Ronen E Well-Known Member

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    At least add very prominent warnings against it in the labeling. If training is relevant, add it there too.
    FDA's approach is that a use which the manufacturer is aware of and doesn't exclude becomes a part of the intended use, so you will be held responsible for associated failures.
     
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  3. Marcelo Antunes

    Marcelo Antunes Active Member

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    You should probably warn the FDA on this too, and maybe send a warning letter to customers.
     
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  4. yodon

    yodon Well-Known Member

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    Agree with Ronen and Marcelo, of course.

    In addition, you probably want to address it in your risk management (let that drive subsequent actions). Obviously, if you can redesign it to make it un-usable after a single use, that would be best. If that's not possible, you probably are only left with labeling and copious warnings to customers.

    At some point, it has to become intentional misuse but as everyone has pointed out, you do need to take actions.
     
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  5. dr1vn

    dr1vn New Member

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    Thanks for the help. A re-design would help render the device unusable but would mean a new 510k though, so it's not an ideal option. We've since sent additional warnings to our customers about this. It's only a select few who are doing this we think.

    Is it okay to refuse to sell a device to a customer knowing that they will be intentionally misusing the device?
     
  6. Ronen E

    Ronen E Well-Known Member

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    Few or many doesn't matter from a regulatory compliance perspective. If you decide to manage the risk rather than be compliant than perhaps the number of abnormal users matters.

    Sending additional warnings is good but you have to have a method in place to ensure that every user will get them.

    Yes it is OK to refuse to sell your device but you have to consider the marketing impact. I am assuming that your device is not a life saving / life sustaining one and/or has some substitutes on the market.
     

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