From: Harry King [polsonrns@montana.com] Sent: Friday, September 06, 2002 6:55 PM To: fdadockets@oc.fda.gov Subject: opened-unused single use devices I would like to comment that our facility has a policy stating that opened, unused single use devices may be repackaged and resterilized in our central processing dept. if the item appears that it can withstand steam sterilization. This would apply to metal saw blades and burrs and a few other items. Any item that appears to contain non-metal parts is not considered, as we dont have any other method of sterilization. Items that were placed on the sterile field are also not considered as they may have been inadvertently contaminated with body fluids. We find that mainly we are resterilizing a few items that were dropped or opened by mistake, or the packaging has an expiration date that has lapsed. All other items we send to a third-party reprocessor. Lynn King