The U.S. FDA has partnered with nonprofit organization ECRI to study and publish the effects of commonly used materials in medical devices in patients over time. The FDA says its goal is to improve medical device safety by using safer materials that will ultimately help prevent patients from experiencing adverse effects from certain materials used in medical devices.
“The FDA believes this information will be a useful tool for 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,” says Ed Margerrison, PhD, director of the Office of Science and Engineering Laboratories in the FDA’s Center for Devices and Radiological Health. “Additionally, this work will help increase transparency, minimize patient risk, and have a profound impact on patient health,” he says.
The FDA and ECRI comprehensively examined data to learn more about how the medical device material performed after patient implantation. Moreover, ECRI analyzed the data from its Patient Safety Organization, accident investigations, Problem Reporting Network, and healthcare technology alerts.
Margerrison says the FDA’s main objective in the study is to “continually improve” the quality of life of patients in the U.S.
“We are pleased to be at the forefront of supporting this era of medical device innovation while maintaining patient safety. We know that both work in tandem to bring access to safe and effective medical devices,” he adds. “One of the many ways that the FDA can help to stimulate innovation in products is to use its unique position to help innovators make better choices early in product development, which results in improved safety and effectiveness of medical devices.”