Rashmi,
That is part of the legal manufacturers responsibility to ensure the reusable medical device can be cleaned, disinfected, and/or sterilised according to established user sterilisation validation. If the facilities do not have access to cleared disinfectant or sterilant, then as the legal manufacturer there needs to be determination from a user perspective how this can be accomplished.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 01-Jul-2019 08:13
From: Rashmi Pillay
Subject: alternative to use of FDA cleared High level disinfectants /sterilants
Hi,
For a Class II reusable medical device (semi-critical), if the user facilities do not have access to FDA cleared disinfectants or sterilants, is there an alternative?
Thanks & Regards,
Rashmi Pillay
Regulatory Affairs Associate
Ellex
3-4 Second Avenue
Mawson Lakes SA, 5095
W ellex.com
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