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FDA's Proposed Strategy on Reuse of Single-Use Devices

FDA's Proposed Strategy on Reuse of Single-Use Devices The FDA is inviting comments on its blueprint to protect health care professionals and patients from potential harm caused by the growing practice of reuse of single-use devices (SUDs). The document, FDA's Proposed Strategy on Reuse of Single-Use Devices, includes the following steps that are being considered by the agency: regulate third-party reprocessors and health care facilities that reprocess SUDs in the same manner as the manufacturers of original equipment. The FDA would also consider collaborating with accredited third-party organizations or other federal agencies to inspect these facilities for compliance with its Good Manufacturing Practices. explore the development of a device categorization system and enforcement strategy based on the level of risk presented by reprocessing and reusing SUDs; solicit comments on a draft list of frequently reprocessed SUDs; request the original equipment manufacturers to provide information on their labels about risks associated with reuse of SUDs; examine the need to create working definitions for the terms single-use device, reuse, reprocessing, and resterilization; explore the application of recognized as well as newly developed consensus standards to reprocessing of SUDs; and consider developing a research program on reuse of SUDs. The full text of the proposed strategy and information on where to send comments can be found at http://www.fda.gov/cdrh/reuse/singleuse.html. Written inquiries may be directed to Jane E. Henney, MD, Commissioner of Food and Drugs, HF-1, Room 14-71, 5600 Fishers Ln, Rockville, MD 20857. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

FDA's Proposed Strategy on Reuse of Single-Use Devices

JAMA , Volume 283 (1) – Jan 5, 2000

FDA's Proposed Strategy on Reuse of Single-Use Devices

Abstract

The FDA is inviting comments on its blueprint to protect health care professionals and patients from potential harm caused by the growing practice of reuse of single-use devices (SUDs). The document, FDA's Proposed Strategy on Reuse of Single-Use Devices, includes the following steps that are being considered by the agency: regulate third-party reprocessors and health care facilities that reprocess SUDs in the same manner as the manufacturers of original equipment. The FDA would also...
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Publisher
American Medical Association
Copyright
Copyright © 2000 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.283.1.46-JFD90011-3-1
Publisher site
See Article on Publisher Site

Abstract

The FDA is inviting comments on its blueprint to protect health care professionals and patients from potential harm caused by the growing practice of reuse of single-use devices (SUDs). The document, FDA's Proposed Strategy on Reuse of Single-Use Devices, includes the following steps that are being considered by the agency: regulate third-party reprocessors and health care facilities that reprocess SUDs in the same manner as the manufacturers of original equipment. The FDA would also consider collaborating with accredited third-party organizations or other federal agencies to inspect these facilities for compliance with its Good Manufacturing Practices. explore the development of a device categorization system and enforcement strategy based on the level of risk presented by reprocessing and reusing SUDs; solicit comments on a draft list of frequently reprocessed SUDs; request the original equipment manufacturers to provide information on their labels about risks associated with reuse of SUDs; examine the need to create working definitions for the terms single-use device, reuse, reprocessing, and resterilization; explore the application of recognized as well as newly developed consensus standards to reprocessing of SUDs; and consider developing a research program on reuse of SUDs. The full text of the proposed strategy and information on where to send comments can be found at http://www.fda.gov/cdrh/reuse/singleuse.html. Written inquiries may be directed to Jane E. Henney, MD, Commissioner of Food and Drugs, HF-1, Room 14-71, 5600 Fishers Ln, Rockville, MD 20857.

Journal

JAMAAmerican Medical Association

Published: Jan 5, 2000

Keywords: health care facility,medical devices,health personnel

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