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Public Health
FDA Issues Final Guidance on Reuse of Single-Use Medical Devices
September 3rd, 2000
On August 2, 2000, the U.S. Food and Drug Administration issued final guidance on the practice of reusing medical devices intended to be used only once. The guidance is designed to protect the public health by assuring that the practice of reprocessing and reusing "single-use" medical devices is based on good science, while ensuring that the regulatory requirements are equitable to all parties. The reprocessing of medical devices labeled, or intended, for only one use has grown steadily in recent years, as has the complexity of the devices being reprocessed. This trend has intensified concern about patient safety, informed consent, the ethics of...
Source: Medical Letter on the CDC & FDA (2000-09-03)
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