In a review of adverse event reports on endoscopes filed with the agency from Jan. 1, 2007 to May 11, 2010, the FDA identified 80 reports of inadequate reprocessing and 28 reports of infection that may have occurred from inadequate reprocessing.
The FDA believes that the risk of acquiring an infection from a reprocessed device is relatively low and that the benefits of these important devices outweigh their risks. The agency does not recommend that patients cancel or delay procedures that involve such devices.
To help manufacturers produce safer reusable devices, the FDA is issuing a draft guidance that, when final, will provide greater clarity on how to scientifically validate the reprocessing instructions that are part of the device labeling.
The FDA also is working with standards-setting groups, such as ASTM International and the Association for the Advancement of Medical Instrumentation, in the development of standards and Technical Information Reports that update processes, materials, test methods, design, and acceptance criteria for cleaning reusable medical devices.
In addition, the FDA developed a webpage of useful resources for use by health care facilities seeking to implement their reprocessing quality assurance programs. Included are links to guidelines, self-audit tools, education and training materials, and safety communications from other government agencies and professional organizations.
For more information:
FDA: Medical Devices
FDA: Reprocessing Reusable Devices
|SOURCE U.S. Food and Drug Administration|
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