FDA publishes first batch of device material safety reports in ECRI partnership
The US Food and Drug Administration (FDA) on Wednesday published the first four reports on the safety and performance of materials commonly used in implantable medical devices.FDA commissioned ECRI, a nonprofit organization initially founded as the Emergency Care Research Institute that focuses on safety, quality and cost-effectiveness in health care settings, to compile the reports. Each report is based on a "comprehensive literature search and systematic review to identify the current state of knowledge about medical device material performance after implantation," FDA said. ECRI also analyzed data from its Patient Safety Organization, Problem Reporting Network and other resources as part of its review of each material.
The first batch of safety summary reports pertain to magnesium, polypropylene, polyurethanes, and siloxanes. FDA notes that polypropylene is often used in surgical mesh and that siloxanes are commonly used in breast implants, two types of devices that have prompted regulatory action by FDA in recent years over safety concerns. (RELATED: FDA halts all US sales of surgical mesh, Regulatory Focus 16 April 2019; FDA affirms increased risk with pelvic mesh products, Regulatory Focus 16 August 2021; FDA calls for new warning on breast implants, Regulatory Focus 23 October 2019; Breast implant label guidance finalized by FDA, Regulatory Focus 28 September 2020)
"As part of the FDA's ongoing commitment to promote the greater safety of medical devices, we have partnered with ECRI to study and publish safety profiles for materials that are commonly used in implantable medical devices and the effects of those materials on patients over time. These evaluations are part of the FDA's broader initiative to improve the safety of medical devices through the use of safer materials and preventing patients at risk for an adverse response to select materials from receiving devices that contain them," said Ed Margerrison, director of the Office of Science and Engineering Laboratories within the Center for Devices and Radiological Health (CDRH).
Margerrison also said that FDA believes the information garnered from these reports "will be a useful tool for innovators in selecting materials and components for future medical products [and] will help increase transparency, minimize patient risk and have a profound impact on patient health."
The reports are aimed to address five key questions, including what the typical or expected local host response to a given material is; whether the material elicits a persistent or exaggerated response that may lead to systemic signs or symptoms; and if there are patient- or material-related factors that could predict or affect the likelihood of an exaggerated or sustained immune or systemic response. The reviews also sought to identify any critical information gaps that exist for the materials and what research could be done to improve scientific understanding of the aforementioned issues.
The reports range from 55 to 114 pages each and were submitted to the agency within the last year. FDA said it will publish similar reports on additional materials as they become available.
FDA
