Dear Cove's

have a question.

The manufacturing guys wants to rework the devices returned from the customers on an Return Material Authorization (RMA), Me a quality Guy :mg:. These are Medical Devices and have critical applications.:confused: Can some one suggest me what are the Quality System requirements in a Class 1 medical Device Manufacturing industry.

:rolleyes:
I can on the top of my head can think of the following.
1) validation of each manufacturing station
2) PFMECA for each subprocesses......what else ?

your inputs will be a great help !

- Nirlep

I moved your thread to an appropriate forum for better responses.

If in fact this is positively-known-unused product that's been to a distributor or end-user site and then come back, I'd think one of your regulatory goals would be to avoid having this processing characterized as remanufacturing/refurbishing/rework as those terms are recently used from a regulatory perspective. You don't want anybody mis-understanding that what you're doing is re-processing product that's been used on patients.

Are you subject primarily to FDA regulation, or 13485/MDD?

Is the product sterile and in barrier packaging? Or, non-sterile but in other verifiably-original-and-unopened unit packaging? If so, you can document your inspection of each package as your people open it, as an additional individual-unit verification that the product has not been used.

Is the product batch-date-coded, so that you know its age and how it relates to the product life you claim relative to original manufacturing? You might want to determine how the road trip, field storage time and remanufacturing process will affect what you state as that product life, if at all.

Will the twice-manufactured product meet the same performance specifications that you applied to the originally manufactured product? If it's being sterilized twice, what about residuals, pyrogens, discoloration and plastics degradation? Will it be possible for an end user to tell in any way that it's been manufactured again?

Dear miregmgr, thanks for the reply ! here is the answers to the questions you asked.


Yes we are subjected to FDA Regulation 13485
No the product is not sterile
It is not verifiably-original-and-unopened unit packaging, it is opened product
yes the product is batch-date-coded, however the product life expectancy is unknown
we have no idea on what will be the effects of the road trip, field storage time and remanufacturing process on the product life
we do not know if the twice manufactured product will meet the same performance standards
the end user will know as it will have refurbished label on it


:rolleyes:

Boy, any way you slice it, it sounds like "desperately at least need to turn the raw peanuts on our floor into money" approach to medical devices...

Is the money saved REALLY worth the risk?

yeah sounds crazy idea, but I am the QE not SR. management, who decided this !

Maybe the next thing they should practice is:

"Mr. Chairman and members of the committee, on advice of my counsel, I respectively decline to answer your questions based on the protections afforded me under the U.S. Constitution"

They will hold some personal liability in the risk, I hope they know. That is how the FDA rolls. I hope their personal umbrella liability insurance is paid up. :rolleyes:

Were these devices originally marketed as single-use?

If so, have you been here (http://www.fda.gov/cdrh/reprocessing/)?

Not having data-based answers on product life and specification compliance isn't going to fly, I don't think. Certainly not with your ISO auditor, and I assume equally not with the FDA.

If the implication is that there may be an unknown additional level of user and patient risk that is communicated to the purchaser by means of the "refurbished" label, that's not going to make your regulators very happy either. It might even be illegal in some jurisdictions.

Certainly device refurbishing can be an entirely acceptable activity and can make good economic sense in some cases. I'd think that knowing the quality and compliance of the output product would be sort of a minimum expectation, though.

Dear miregmgr, thanks for the reply ! here is the answers to the questions you asked.


Yes we are subjected to FDA Regulation 13485
No the product is not sterile
It is not verifiably-original-and-unopened unit packaging, it is opened product
yes the product is batch-date-coded, however the product life expectancy is unknown
we have no idea on what will be the effects of the road trip, field storage time and remanufacturing process on the product life
we do not know if the twice manufactured product will meet the same performance standards
the end user will know as it will have refurbished label on it



At a minimum it appears that the remanufacturing or refurbishing of class 1 medical devices would require full process validation for the reprocessing flow. There was some more cool information at
Reprocessing of Single-Use Devices FAQ (http://www.fda.gov/cdrh/reprocessing/faq.html#6)