FDA and ECRI partner on materials safety in medical devices

Oct. 1, 2021

ECRI announced a new partnership with the U.S. Food and Drug Administration (FDA) to improve the safety of medical devices. ECRI is developing safety summaries for materials commonly used in implantable medical devices and assessing the possible effects of those materials on patients over time.

ECRI’s evaluations are part of the FDA Center for Devices and Radiological Health’s (CDRH) broader initiative to improve the safety of medical devices through the use of safer materials and to help prevent at-risk patients from receiving devices that contain materials which may harm them.

For each study, ECRI performs a comprehensive literature search and systematic review to identify the current state of knowledge about medical device material performance after implantation. In addition, ECRI analyzes data derived from its Patient Safety Organization, accident investigations, Problem Reporting Network (PRN) and healthcare technology alerts.

In compiling and analyzing this information, ECRI and FDA team members work collaboratively to answer key questions about local and systemic responses to materials commonly used in medical devices. Specifically, the team has compiled a unique view of the effects that materials may have on a patient’s body over time and the effects of the patient’s body on the materials.

The first four reports are available now on FDA.gov: magnesium, polypropylene (often used in surgical meshes), polyurethanes, and siloxanes (often used in breast implants). The FDA will release new reports as they become available.

ECRI release