The U.S. Food and Drug Administration (FDA) announced new actions to enhance safety practices associated with the use of reusable medical devices.
The efforts come in the wake of reports of seven serious infections and two deaths believed to be linked to infections spread through these types of devices used at Ronald Reagan UCLA Medical Center in Los Angeles, WebMD reported. The infections were believed to have originated on duodenoscopes contaminated with a dangerous superbug, and this type of incident has occurred at other healthcare facilities in the past.
"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," William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, said in a 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. Doing so should provide greater assurance to patients that the devices used on them are safe and effective."
Medical devices intended for repeated use are subjected to a multi-step process designed to sterilize the tools and remove contaminants, but the "complex design" of some of these devices make them particularly difficult to clean. The FDA's new recommendations include testing protocols for manufacturers as well as six criteria that should be addressed in the instructions for reprocessing between uses.
"Manufacturers seeking to bring to market certain reusable devices, such as duodenoscopes, bronchoscopes and endoscopes, should submit to the FDA for review their data validating the effectiveness of their reprocessing methods and instructions," the FDA stated.
The updated rules were first proposed in 2011 and considered almost 500 comments before releasing the final guidelines.
