On September 11, 2015, the United States Center for Disease Control (CDC) and Food and Drug Administration (FDA) issued Health Alert Network Update 382 on “Procedures for Cleaning, Disinfecting and Sterilizing Reusable Medical Devices” (HAN382)(updated by HAN383 (Oct. 2, 2015)). HAN382 is a response to infection control lapses, e.g. duodenoscopes, that alerts hospitals and healthcare providers about the need to properly maintain, clean, and disinfect or sterilize reusable medical devices.

AMDR member companies in the U.S. are commercial third-party “reprocessors” of single-use devices and do not reprocess the reusable medical devices that are the subject of this notice. The notice urges hospitals and healthcare facilities to ensure policies and procedures are in place to obviate failures to follow “manufacturers’ reprocessing instructions.” Original manufacturers of single-use devices do not include reprocessing instructions. Rather, AMDR’s U.S. members are treated as manufacturers by the FDA and are held to the same standards, e.g. premarket clearance and quality system requirements, including sterilization validation. Accordingly, the reprocessing of single-use devices in the U.S. is akin to re-manufacturing as opposed to the disinfection and sterilization contemplated by HAN382. All of AMDR’s U.S. members are subject to FDA inspection and are in substantial compliance with FDA’s requirements.