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  Vol. 283 No. 1, January 5, 2000 TABLE OF CONTENTS
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FDA's Proposed Strategy on Reuse of Single-Use Devices

JAMA. 2000;283:46.

Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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 . . . [Full Text of this Article]



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