FDA and ECRI Partner on Materials Safety in Medical Devices


PLYMOUTH MEETING, PA — ECRI announced a new partnership with the U.S. Food and Drug Administration (FDA) to improve the safety of medical devices through the use of safer materials. Through an ongoing, multi-year endeavor, ECRI, an independent nonprofit health services organization, 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 that may harm them.

In an online statement, Ed Margerrison, Ph.D., Director of the Office of Science and Engineering Laboratories in the FDA’s CDRH, said the FDA believes this information will be a useful tool to guide innovators in selecting materials and components for future medical products, resulting in patients and doctors having better access to more effective and safer medical devices. Additionally, this work will help increase transparency, minimize patient risk, and have a profound impact on patient health.

“ECRI’s groundbreaking work involves systematic evidence review, underpinned by robust methodology, and evaluation of adverse event reports from a wide range of sources,” says ECRI’s Michael Argentieri, vice president of technology and safety. “We applaud the FDA for their commitment to advancing innovation and working to reduce harm from implantable and inserted devices. The scope of this work has never before been undertaken and it should significantly reduce risks to patients.”

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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.

For more information about ECRI’s Medical Device Materials Safety FDA initiative, visit www.ecri.org.

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