Docket Management
Docket: 02N-0456 - Determining Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices
Comment Number: EC -25

Accepted - Volume 1

Comment Record
Commentor Mr. Bobby Osburn Date/Time 2002-11-07 10:43:56
Organization Departement of Veterans Affairs
Category Health Professional

Comments for FDA General
Questions
1. General Comments FDA must take a stand on products that are used in patient care. It is our (Department of Veterans Affairs) policy that medical devices that are labeled as single use will not be reprocessed or reused in the VA. When it comes to the opened but un-used single-use medical devices, they should only be reprocessed by the OEM or the OEM be required to give written instructions on how they may be reprocessed. The real problem with the issue of open-but un-used single used medical devices is that does not mean that they were not contaminated. They have been handled by a gloved hand when placed on a field and/or removed from the sterile package or field. They then are handled and transported from the point of being opened. Many times expensive items fall on the floor or touch an unsterile item and that is the reason they were not-used. It does not mean that they were not contaminated. In many cases the OEM uses gamma for sterilization and when item are reprocessed the method is usually EtO, this combination may cause adverse chemical recation on the items as well as a build up of EtO. Also, there are concerns relative to toxins that remain behind.




EC -25