The Food and Drug Administration (FDA) is accepting comments about current practices with opened but unused single-use medical devices. The FDA is interested in comments related to:
- whether hospitals have a written policy or procedure for handling sterile, single-use medical devices that are opened, for whatever reason, but are unused;
- how hospitals determine if a single-use medical device that has been opened but unused is contaminated;
- what types of single-use medical devices are resterilized because they are opened but unused.
Submit written comments by Nov. 26, 2002. Individuals may submit one copy; all others should submit two copies. Identify comments with the docket number fr28au02-118. E-mail comments to www.fda.gov/dockets/ecomments. Scroll down to "00D-0053 — Determining Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices." Send written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.