Class II Medical Device Refurbishment Requirements

D

dwayneq

#1
We have a medical device that is reusable but is limited to the number of total uses by electronic means. We have found out that a third party is "re-programming" our used product as selling it as refurbished. Besides the financial implications there is also a concern that we have verified and validated our device for a reasonable number of uses which support the labeled maximum number of uses. I cannot find anything on the web about any FDA requirements for third party refurbishers which is scary to me not only as a manufacturer but also as a consumer/patient. Is it true that just about anyone today can pick up a used medical device or piece of equipment, clean it up and resell it as refurbished? How can a third party ensure that the device meets the original manufacturer's specifications and test requirements? Scary indeed. Comments?
 
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M

MIREGMGR

#2
Re: Class II Device Refurbishment

Does your 510(k) for the device in question document the number of uses for which you validated the device's safety and effectiveness, and that your electronic counter is intended to limit?

FDA policy is that a refurbisher of a device for use beyond the boundaries (intended use, and number of uses) established in that device's 510(k) becomes responsible for that device and must have their own 510(k) supporting the safety and effectiveness of the additional uses of the device that they offer. For clarification on this, you should start with FDA DSMICA.

If the refurbisher isn't playing by the rules, the FDA might be interested to hear of the situation. The FDA provides several ways for persons to report problems.

I assume that your device has an on-device permanent regulatory label. To make your device harder to refurbish beyond what you think is valid, you could strengthen your X-maximum-number-of-uses statement by adding a statement to the effect that your company as the responsible maker of the device has validated the device for safety and effectiveness for X uses, and any use of the device beyond X uses is not consistent with that safety and effectiveness validation and the device's FDA pre-market approval and is at the sole responsibility of the user.

If the refurbisher is removing your regulatory label from the device, you could re-design that label to integrate it with the device's basic functionality...for instance, have the label diecut to wrap around the controls, and integrate the control legends into the same label.
 

rob73

looking for answers
#3
Dwayne
If they are "re-programming" your device, that implies that they have "hacked" it. Can you stop them from the "unauthorised modification of software" angle or is it a plain infringement of software copyright protection?
Rob
 
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