The U.S. Food and Drug Administration (FDA) announced new recommendations to help device manufacturers develop safer reusable medical devices.
The goal of the agency's actions is to help abate the spread of infectious agents between uses, especially with complex devices that are harder to sterilize.
The FDA's new guidance document outlines six criteria that should be addressed in the instructions for use with every reusable device. It also includes recommendations device manufacturers should follow pre- and postmarket.
"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," William Maisel, MD, MPH, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, said in a press release. "Doing so should provide greater assurance to patients that the devices used on them are safe and effective."
The FDA first issued a draft of the guidance in 2011 and considered almost 500 comments before issuing the final guidance. The new document provides more clarity about testing protocols and what data should be submitted to the agency for a premarket submission.
