FDA and ECRI Partner on Medical Device Materials Safety

ECRI has formed 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.
 
The scope of this work has never before been undertaken and it should significantly reduce risks to patients.
 
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.
 
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.”
 
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 the FDA’s website: 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 is an independent, nonprofit organization improving the safety, quality, and cost-effectiveness of care across all healthcare settings. With a focus on patient safety, evidence-based medicine, and health technology decision solutions, ECRI is respected and trusted by healthcare leaders and agencies worldwide. Over the past 50 years, ECRI has built its reputation on integrity and disciplined rigor, with an unwavering commitment to independence and strict conflict-of-interest rules. ECRI is the only organization worldwide to conduct independent medical device evaluations, with labs located in North America and Asia Pacific. ECRI is designated an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality. ECRI and the Institute for Safe Medication Practices PSO is a federally certified Patient Safety Organization as designated by the U.S. Department of Health and Human Services. The Institute for Safe Medication Practices (ISMP) formally became an ECRI Affiliate in 2020.