NEBH: FDA Focuses on Reprocessing Instructions in New Guidance

The U.S. Food and Drug Administration (FDA) has finalized guidance that includes recommendations for writing clear reprocessing instructions for reusable medical devices. The document comes at a time of heightened interest in the sterility of medical devices, especially with the outbreak of a deadly superbug linked to contaminated duodenoscopes. “Despite the recent concerns about multi-drug resistant bacteria infections associated with duodenoscopes, patients and healthcare providers should know that the risk of acquiring an infection from a reprocessed medical device is low,” said William Maisel, MD, deputy director for science and chief scientist at the agency’s Center for Devices and Radiological Health, in a prepared statement. “This guidance is an important step toward further enhancing the safety margin by outlining for manufacturers the steps they should undertake to make their reprocessing instructions effective and clear to the healthcare community that uses them.”

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