Safety

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

Hospital Safety Insider, 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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