Originally Published PMPN October 2002
NEWS
FDA Seeks Input on Opened but Unused DevicesFDA's guidance for reprocessing single-use medical devices has not applied to opened but unused single-use devices, but that may change.
The agency is now soliciting input from hospitals as to what their current practices are on reprocessing such opened but unused devices. These practices may prompt FDA to reexamine its policy.
Specifically, the agency wants to know whether hospitals have a written policy or procedure for single-use sterilized medical devices that are opened but not used, how they determine whether such devices are contaminated, and what kinds of devices are resterilized after being opened but not used.
"Opened but unused" is defined as devices whose sterility has been breached or compromised or whose sterile package was opened, but the devices have not come in contact with blood or bodily fluids.
The agency is soliciting comments until November 26, 2002. Submit written comments and information to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. The current guidance can be viewed at http://www.fda.gov/cdrh/reuse/1168.html.
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