FDA issues final guidance on reusable medical device reprocessing
March 13, 2015
by Thomas Dworetzky
, Contributing Reporter
The U.S. Food and Drug Administration has issued new guidance about the reprocessing of reusable medical devices and to address the recently headline-grabbing problems of the possible spread of infectious agents.
“Despite the recent concerns about multi-drug resistant bacteria infections associated with duodenoscopes, patients and health care providers should know that the risk of acquiring an infection from a reprocessed medical device is low” said Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health.
“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 health care community that uses them. Doing so should provide greater assurance to patients that the devices used on them are safe and effective,” he added.
The FDA also announced that the agency’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee will hold a public meeting on May 14 and 15, 2015, to discuss recent reports of transmission of infections associated with the use of duodenoscopes at U.S. hospitals.
The final industry guidance, released Thursday, is intended to help device makers in the creation of safer reusable devices and is entitled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.” The document contains recommendations medical device manufacturers should follow during both pre-market and post-market time frames.
The guidance lists six criteria that need to be addressed in the instructions for use with every reusable device, and also also advises manufacturers to think about reprocessing issues during the initial design phase of devices.
Makers of devices are "expected" to do validation testing that shows cleaning, disinfection or sterilization processes will in fact "consistently reduce microbial contamination."
Manufacturers seeking to bring to market certain reusable devices, such as duodenoscopes, bronchoscopes and endoscopes, are expected to submit to the FDA for review validation data about reprocessing.