Format

Send to

Choose Destination
Gastrointest Endosc Clin N Am. 2000 Apr;10(2):385-92.

Third-party reprocessing of endoscopic accessories.

Author information

1
Association of Medical Device Reprocessors, Washington, DC 20036, USA.

Abstract

Third-party reprocessing of medical devices labeled for single use is a safe, FDA regulated practice that helps hospitals reduce costs without compromising patient care. Simply because a device is labeled as single use does not mean it cannot be safely reprocessed. To the contrary, the single use label is chosen by the manufacturer, sometimes for economic gain, as there are no formal FDA regulations or standards to distinguish between reusable and single use devices. The current FDA regulatory framework for third-party reprocessors, which emphasizes compliance with FDA quality assurance requirements, is presently under review, and the agency is in the process of developing a new regulatory scheme for reprocessing.

PMID:
10683223
[Indexed for MEDLINE]

Supplemental Content

Loading ...
Support Center