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FDA's Proposed Strategy on Reuse of Single-Use Devices
JAMA. 2000;283:46.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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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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