From: Jerlyons@aol.com
Sent: Thursday, September 05, 2002 7:19 PM
To: fdadockets@oc.fda.gov
Cc: rkreitzer@mhs-nepa.com
Subject: Single Use Devices
Folks:

Seems to me that once an item is categorized for single use (in the best interests of patient care) IT NEEDS TO REMAIN SO.

The only exception that I would recommend is that if the same protocol is used for resterilization that the manufacturer had to comply with for the initial sterilization, reprocessing might be considered - one time - and one time only!!!!!!

Thank you,

Jerry Lyons
Former Certified CS Tech and Manager.