From: Mcintire, Cathy [CMcin@SEORMC.ORG]
Sent: Wednesday, August 28, 2002 4:07 PM
To: 'fdadockets@oc.fda.gov'
Subject: Comment on Open but Unused single use devices

We do have a policy on handling opened, but unused single use devices.
These are all handled with a third party vendor doing the reprocessing.  
We determine contamination just as we handle it every day in the OR.  The
associates using the items are trained to know what is contaminated and what
isn't.  If in doubt, it is thrown out.
Items we are having re-sterilized that are opened and then not used are
implants, laparoscopic instruments (staplers, trocars, etc.), suction
instruments, drains, skin staplers, electrosurgical instruments, etc.
Cathy McIntire RN CNOR
Director, Surgical Services
Southeastern Ohio Regional Medical Center
Cambridge, Ohio
740-439-8096
Fax# 740-439-8689
cmcin@seormc.org


 




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