I work for a medical device company that sends product out in consignment sets. The company wants to retro grade the materials for use in workshops and training upon return instead of scrapping this product. Is this allowable under 13485 and 12 cfr 820 requirments?
I work for a medical device company that sends product out in consignment sets. The company wants to retro grade the materials for use in workshops and training upon return instead of scrapping this product. Is this allowable under 13485 and 12 cfr 820 requirments?
The main concern is compliance with the requirements for control of returned product, specifically contaminated product. The requiremetns are outlined in clauses 6.4 & 8.3, if I recall correctly. If the organization decides that the product is 'scrap' and there are no subsequent requirements for contamination control or disposal (i.e. it's ok to throw it in the dumpster) then it makes no difference what the organization does with the product. The only consideration is the identification of such product (training materials) to prevent unintended use.
Someone else please confirm or correct my statement.
If the product was exposed to a hospital or patient environment you should be very careful because of the potential of bio-hazard contaminants like body fluids, blood, etc (won't say more because it is lunch time) In this case I would rather not use those. If you scrap the product and it was never used, then have very clear labels on it that the device is not for human use. I don't see any restriction from the ISO 13485 req's., but be careful with the identification of the samples.
I work for a medical device company that sends product out in consignment sets. The company wants to retro grade the materials for use in workshops and training upon return instead of scrapping this product. Is this allowable under 13485 and 12 cfr 820 requirments?
In reference to the above good information, please clarify the tyoe of product (disposible devices or equipment?)
If this is equipment, than "contaminated" product is a possibility that you need to address. If however, this is a single use product - you want to make sure that product is still usable and identified properly for Demo Use only (not for clinical use!)
One more precaution: if the device is intended to be sold sterile, you may want to mark the sample as non-sterile as well. This because often times the packaging integrity in samples can get compromised with handling
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