FDA seeks comment on open, unused SUDs

Should they be reprocessed or thrown out?

Open but unused single-use devices — are they safe? The Food and Drug Administration (FDA) wants your opinion, asking for interested people to submit comments about current practices with respect to opened but unused, single-use medical devices. "The FDA is publishing this notice in order to gather informed comment from individuals, professional organizations, original equipment manufacturers, reprocessors, and hospitals as it examines its policy with respect to opened but unused, single-use medical devices," the FDA stated in requesting the information.1

The agency has made sweeping restrictions on the reprocessing of single-use devices in recent years, but has largely left the open/unused issue unresolved. The FDA defines opened but unused devices as: "single-use, disposable devices whose sterility has been breached or compromised, or whose sterile package was opened but was not been used on a patient, that is, they have not been in contact with blood or bodily fluids." Thus, when some single-use device like an aneurysm clip is opened during surgery, but not subsequently used, do you reprocess it or throw it out?

"As the FDA final guidance did not address the issue of opened/unused single-use medical devices in its final guidelines, we do not allow the practice," says Patti Grant, RN, BSN, MS, CIC, director of infection control at RHD Memorial Medical Center in Dallas. "The community gold standard is silent on this very critical issue. When the FDA includes a final guidance on the issue, we will add it to our policy. I feel the science of reprocessing opened unused SUDs is appropriate if the proper checks and balances are in place," she says.

The FDA is interested in comments related to:

1. Whether or not hospitals have a written policy or procedure for handling sterile, single-use medical devices that are opened, for whatever reason, but are unused.

2. How hospitals determine if a single-use medical device that has been opened but unused is contaminated.

3. What types of single-use medical devices are resterilized because they are opened but unused.

Submit written comments by Nov. 26, 2002 to the Dockets Management Branch (HFA-305), (Docket No. 00D-0053) Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.


1. 67 Fed Reg 55,269 (Aug. 28, 2002).