“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.
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. Additionally, this work will help increase transparency, minimize patient risk and have a profound impact on patient health.
A key objective of the FDA is to continually improve the quality of life for U.S. patients. 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. 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.”
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The U.S. Food and Drug Administration partnered with ECRI (originally founded as Emergency Care Research Institute), an independent nonprofit organization, to perform a comprehensive literature search and systematic review to identify the current state of knowledge about medical device material performance after implantation. Additionally, ECRI analyzed data derived from ECRI’s Patient Safety Organization (PSO), accident investigations, Problem Reporting Network (PRN) and healthcare technology alerts.
In compiling this information, the team focused on key questions about local and systemic response 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).
This is an ongoing effort, as highlighted in the May 2021 statement by FDA’s Center for Devices and Radiological Health Director Dr. Jeff Shuren on the safety of materials. The FDA will release new reports as they become available.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.