Tip of the week: Steps to consider during a recall under EC.02.01.01 - www.hospitalsafetycenter.com - a division of HCPro, Inc. - the leader in providing information to the healthcare compliance, regulation, and management industry.


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Tip of the week: Steps to consider during a recall under EC.02.01.01

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January 6, 2010

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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