FDA and ECRI partner on material safety in medical devices

PLYMOUTH MEETING, PA — ECRI announces a new partnership with the United States Food and Drug Administration (FDA) to improve the safety of medical devices through the use of safer materials. As part of an ongoing, multi-year effort, ECRI, an independent non-profit health services organization, is developing safety summaries for materials commonly used in implantable medical devices and evaluating the possible effects of these materials. on patients over time.

ECRI’s assessments are part of the FDA Center for Devices and Radiological Health’s (CDRH) larger initiative to improve the safety of medical devices through the use of safer materials and to prevent patients at risk from receive devices containing materials that could harm them.

In an online statement, Ed Margerrison, PhD, director of the FDA’s Office of Science and Engineering Laboratories at CDRH, said the FDA believes this information will be a useful tool to guide innovators in the selection of materials and components for future medical products, giving patients and physicians greater access to more effective and safer medical devices. In addition, this work will help increase transparency, minimize risks to patients and have a profound impact on patient health.

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“ECRI’s groundbreaking work involves a systematic review of the evidence, underpinned by a robust methodology, and the assessment of adverse event reports from a wide range of sources,” said Michael Argentieri, Vice-President of ECRI’s technology and security. “We applaud the FDA for its commitment to advancing innovation and working to reduce damage from implantable and inserted devices. The scope of this work has never been undertaken before and it is expected to significantly reduce the risk to patients. ”

For each study, ECRI carries out a complete documentary search and a systematic review in order to identify the current state of knowledge on the performance of medical device materials after implantation. In addition, ECRI analyzes data derived from its organization for patient safety, accident investigations, problem reporting network (PRN) and health technology alerts. By 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 compiled a unique view of the effects materials can have on a patient’s body over time and the effects of the patient’s body on materials.

The first four reports are now available on FDA.gov: magnesium, polypropylene (often used in surgical nets), polyurethanes, and siloxanes (often used in breast implants). The FDA will release new reports as they become available.


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