[Federal Register Volume 67, Number 167 (Wednesday, August 28, 2002)]
[Pages 55269-55270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-21891]



Food and Drug Administration

[Docket No. 00D-0053]

Determining Hospital Procedures for Opened-But-Unused, Single-Use 
Medical Devices; Request for Comments and Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is providing an 
opportunity for interested persons to submit comments about current 
practices with respect to opened-but-unused, single-use medical 
devices. 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.

DATES: Submit written comments by November 26, 2002.

ADDRESSES: 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 

[[Page 55270]]

FOR FURTHER INFORMATION CONTACT: Larry Spears, Center for Devices and 
Radiological Health (HFZ-300), Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20850, 301-594-4692.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 14, 2000 
(65 FR 49583), FDA published a guidance entitled ``Enforcement 
Priorities for Single-Use Devices Reprocessed by Third Parties and 
Hospitals.'' The guidance defined ``opened-but-unused'' devices as:
    Single-use, disposable devices whose sterility has been breached 
or compromised, or whose sterile package was opened but not been 
used on a patient, that is, they have not been in contact with blood 
or bodily fluids.
    The guidance did not apply the agency's enforcement priorities for 
reprocessed devices to opened-but-unused, single-use medical devices 
reprocessed in hospitals. The guidance did state, however, that the 
agency would examine its policy with respect to opened-but-unused, 
single-use medical devices. In doing so, FDA is soliciting information 
about current practices regarding this issue. A copy of the guidance is 
available on FDA's Web site at http://www.fda.gov/cdrh/reuse/1168.html.
    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; and (3) what types of 
single-use medical devices are resterilized because they are opened but 
    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES), written or electronic comments or information regarding 
this issue by [insert date 90 days after date of publication in the 
Federal Register]. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: August 19, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-21891 Filed 8-27-02; 8:45 am]