From: CARMEL GULLEY [carmelgu@msn.com]
Sent: Saturday, September 07, 2002 2:37 AM
To: fdadockets@oc.fda.gov
Subject: reuse of single use items (reprocessing of) for surgical procedures

I work for  Sentara located in the state of Virginia.  The hospital is telling us to place used items, such as drill bits, external fixation device parts, shaver blades for arthroscopy procedures, as well as many other items, into the "reprocessing bin".  Frankly, I am VERY concerned about this.  Most of our patients are extremely sick with AIDS, MERSA, HEP C, and I don't think that laproscopic single use trocars, among the other things, are acceptable items to be resterilized.  What are the guidelines?  Who is going to regulate this behavior of trying to save a penny, at the cost of a possible infection to a patient?  Who is at fault if the patient gets an infection, certainly not the original manufacturer, who clearly states that it was a single use item, used, then reprocessed.  I understand the guidelines on reprocessing UNUSED items, but don't feel ethically comfortable with the thought of used single use items being reprocessed..  PLEASE HELP!!!  Would like some guidelines, or some kind of regulation, PLEASE!!!!