FDA publishes first batch of device material safety reports in partnership with ECRI

Posted on September 22, 2021 | Through Michel mezher

The United States Food and Drug Administration (FDA) released the first four reports on the safety and performance of materials commonly used in implantable medical devices on Wednesday.

The FDA tasked ECRI, a nonprofit organization originally founded as the Emergency Care Research Institute that focuses on safety, quality and cost-effectiveness in healthcare settings, compile reports. Each report is based on a “comprehensive literature search and systematic review to identify the current state of knowledge on the performance of medical device materials after implantation,” the FDA said. ECRI also analyzed data from its patient safety organization, its problem reporting network and other resources as part of its review of each material.

The first batch of safety summary reports are for magnesium, polypropylene, polyurethanes and siloxanes. The FDA notes that polypropylene is often used in surgical nets and that siloxanes are commonly used in breast implants, two types of devices that have prompted the FDA to take regulatory action in recent years due to safety concerns. (RELATED: FDA suspends all sales of surgical nets in the United States, Regulatory guidance April 16, 2019; FDA Says Increased Risk With Pelvic Mesh Products, Regulatory guidance August 16, 2021; FDA calls for new warning on breast implants, Regulatory guidance October 23, 2019; FDA Finalized Breast Implant Labeling Guide, Regulatory guidance September 28, 2020)

“As part of the FDA’s continued commitment to promote greater safety of medical devices, we have partnered with ECRI to study and publish safety profiles for materials commonly used in implantable medical devices and implants. effects of these materials on patients over time. The evaluations are part of the FDA’s broader initiative to improve medical device safety through the use of safer materials and to prevent patients at risk of adverse reactions to certain materials from receiving devices that contain them. Said Ed Margerrison, director of the Office of Science and Engineering Laboratories at the Center for Devices and Radiological Health (CDRH).

Margerrison also said that the FDA believes the information gathered from these reports “will be a useful tool for innovators in the selection of materials and components for future medical products. [and] will help increase transparency, minimize risks to patients and have a profound impact on patient health. “

The reports aim to answer five key questions, including what is the typical or expected local response of a host to a given piece of hardware; whether the material elicits a persistent or exaggerated response that may result in systemic signs or symptoms; and whether there are any patient or material factors that could predict or affect the likelihood of an exaggerated or sustained immune or systemic response. The reviews also sought to identify critical information gaps that exist for materials and research that could be done to improve scientific understanding of the aforementioned issues.

The reports range from 55 to 114 pages each and have been submitted to the agency over the past year. The FDA said it will issue similar reports on additional documents as they become available.


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