Usually there are local requirements. As an example, in the United States, specifically Utah, Massachusetts, Oregon, New York where I was doing some work we needed to have returned medical devices disposed of by incineration. While we still cleaned and sterilised them, they were still considered used and potentially biohazardous. We kept track of all this information, records of disposal, and record of incineration by the third party. For unused medical devices, we just had to make sure they were unusable, such as cutting the catheters up into small pieces, destroying the drapes, recycling circuit boards, crushing treatment devices, etc. Then we just put those in the regular bin in a sealed box, just as an extra precaution. Any sharps that were used either with the device or in production were disposed of in a sharps container and incinerated with the other biohazard materials. And of course we had procedures and records that described how we did all this.
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Richard Vincins RAC
Vice President Regulatory Affairs
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Original Message:
Sent: 24-Apr-2018 11:25
From: Subha Alladi
Subject: Disposal of unused expired medical device inventory
Hi,
Could I please get some suggestions on FDA guidance documents, EPA guidelines or QMS requirements for disposal of unused expired medical devices like masks? Is there a regulatory requirement on how to dispose expired medical devices? My question is more from an inventory management perspective.
Thanks in advance,
SA
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SA
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