CDC, FDA update device reprocessing recommendations for health care facilities

The Centers for Disease Control and Prevention and Food and Drug Administration Friday updated a recent advisory urging health care facilities to review their procedures for cleaning, disinfecting and sterilizing reusable medical devices. The update rescinds one of the earlier recommendations, and clarifies that health care facilities which hire contractors to perform device reprocessing should verify that the contractor has an appropriate training program. In addition, the FDA today ordered three duodenoscope manufacturers to conduct post-market surveillance studies to better understand how the devices are reprocessed in real-world settings. “These studies will provide critical information about the effectiveness of current reprocessing instructions and practices that may provide additional information to inform the FDA’s actions to protect the public health and help reduce the risk of infections,” said William Maisel, M.D., deputy director for science at the FDA’s Center for Devices and Radiological Health. The manufacturers – Olympus America Inc., Fujifilm Medical Systems USA Inc., and Hoya Corp. (Pentax Life Care Division) – will have 30 days to submit post-market surveillance plans to the FDA.