Tip of the week: Steps to consider during a recall under EC.02.01.01
Hospital Safety Connection, January 6, 2010
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The Food and Drug Administration’s recent alert about Steris System 1 reprocessors offers a good reminder about a Joint Commission requirement under environment of care standard EC.02.01.01.
Element of performance 11 of EC.02.01.01 requires that hospitals have a way to respond to product recalls and notices.
You may need to show surveyors proof that designees within the hospital took the following steps upon learning of a recall or notice:
- Actually received the notice
- Distributed the information to all potentially affected departments
- Received feedback from those departments
- Returned any recalled products according to manufacturer instructions
- Provided feedback to the manufacturer or sender of the notice
Editor’s: This tip is based on material from HCPro’s Environment of Care Compliance Manual, Fourth Edition.
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