Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello, 

Has anyone had experience with the FDA requiring 50-150 cycles of repeat testing for reuse life?  We have not received this requirement on any of our prior reusable device submissions. For reference, this device is not an endoscope and does not have direct patient contact..

The reusable device IFU contains inspection and maintenance directions for the continued use of the device and if the device does not pass inspection, to immediately stop using and return the device.  

We based the reuse life on the FDA guidance document:  https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/reprocessing-reusable-medical-devices-information-manufacturers, Section L: Reuse Life.  Reviewing this  guidance and the FDA Reprocessing of Reusable Medical Devices web pages, we  have not found a requirement that indicates a number of repeat cycles to demonstrate reuse life.  A review of other guidance documents, such as AAMI TIR:12, ISO 17664-1, etc. also do not state an approach of a specified number of cycles to demonstrate reuse life

Any idea's on where this requirement would be stated? Thanks in advance. 

From my knowledge, there is a not a specific requirement for this stated anywhere in a regulation, i.e. stating number of reuse cycles.  However, this is one of those "GMP requirements" where current state of the art and knowledge of regulatory activities raises the bar.  In my personal experience, with other devices (non-endoscope also) we were asked this question and needed to provided evidence during a FDA premarket notification (510(k) submission).  We had to show how many times the devices could be reprocessed without affecting the safety or efficacy of the device.  One device went through a cold sterilant process the other device was cleaned and autoclaved.  In fact, one of the device 510(k) response we had to update the IFU with specific wording about general number of uses and specific criteria the user needs to examine the device in order to self determine whether the device could continue being used.  Generally, I think this is FDA's regulatory knowledge being increased where device lifecycle management needs to be considered by the medical device manufacturer including any reprocessing.  It is just not a matter like it was a few years ago where a medical device manufacturer could say: yep our device can be reprocessed.  There are many regulatory questions being asked about reprocessing now.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 20-Jan-2020 13:20
From: Anonymous Member
Subject: Device Reuse

This message was posted by a user wishing to remain anonymous

Hello,

Has anyone had experience with the FDA requiring 50-150 cycles of repeat testing for reuse life?  We have not received this requirement on any of our prior reusable device submissions. For reference, this device is not an endoscope and does not have direct patient contact..

The reusable device IFU contains inspection and maintenance directions for the continued use of the device and if the device does not pass inspection, to immediately stop using and return the device.

We based the reuse life on the FDA guidance document:  https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/reprocessing-reusable-medical-devices-information-manufacturers, Section L: Reuse Life.  Reviewing this  guidance and the FDA Reprocessing of Reusable Medical Devices web pages, we  have not found a requirement that indicates a number of repeat cycles to demonstrate reuse life.  A review of other guidance documents, such as AAMI TIR:12, ISO 17664-1, etc. also do not state an approach of a specified number of cycles to demonstrate reuse life

Any idea's on where this requirement would be stated? Thanks in advance.