From: Anderson, Sara [SaraA@BaylorHealth.edu]
Sent: Friday, October 04, 2002 12:55 PM
To: fdadockets@oc.fda.gov
Subject: opened-but-unused, single-use medical devices


	I am  against the reuse, resterilization of opened-but-unused, single-use medical devices. I have worked in the OR and CS and you really do not know what conditions the device was exposed to. On the OR side we cant insure how the product was handled. On the Central Processing side, you don't know how the product was manufactured, you could have a breakdown of the product if it was Gamma and then you resterilize using ETO. 
The idea of these reprocessing plants sticking there neck out, by the product going through an inspection system before sterilization process. How do they know if the parts are working? How do they know what has happened to it before it got to them? 
Who takes the risk of harm to a patient? I have always taught my folks  that if an institution resterilizes the product we are liable for anything, so don't resterilize anything that a manufacturer processed. Who knows when a product is used was it resterilized or was it a new product? Answer that one?
Yes I believe we must save money and the way things are going we must look at cost. But lets take a look and investigate before we jump the guns. There may some products that we could resterilize and not cause any harm to a patient. lets look at these items on and individual basis..


Sara Anderson
214-820-2885





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