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Requirements for Certificate of Destruction for Surgical Instruments

#1
Friends,

My company is transferring stock (FDA Class I and Class 2 medical devices) to a 3PL as part of an outsourcing strategy. We have discovered excess inventory on a number of class 1 reusable surgical instruments. We intend to dispose of these, rather than transfer the inventory. Am I required to obtain a Certificate of Destruction for these instruments, or is is sufficient to demonstrate that I have decommissioned them within my inventory system?
 
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pziemlewicz

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#2
In the Aerospace and Defense world, regulators use the phrase "rendered unusable." Dispositioning a device or component scrap in an inventory system doesn't prevent someone from pulling it out of a dumpster and using it. You may be able to drill a hole in it, bend, break a tip to accomplish the task yourself; if you can't, then work with a company for certificate of destruction.
 

Miner

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#3
There is a major issue right now with counterfeit product in many industries, particularly in electronics, but not limited to that. Groups will dumpster dive for scrapped product and resell it, sometimes claiming it as your product and your warranty. There are companies that will take your scrap, render it unusable and provide objective evidence of that. Then there are others that will take it and resell it, or so poorly controll it that employees or outsiders will take and sell it.
 
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