US FDA To Examine Safety Of Materials Used In Medical Devices

Maryland, 3 Oct 2019:

The Food and Drug Administration (FDA) is holding a public advisory committee meeting next month with experts and the public to examine the safety of materials used in medical devices, the agency announced this week.

Materials used in today’s medical devices, such as metal, plastic, silicone, animal-derived products, or some combination of these, reflect technology evolution in the field of healthcare. The FDA said it is working to evaluate these materials to ensure patients have access to safe and effective medical devices.

The agency is currently evaluating evidence that some patients who receive medical device implants are having adverse biological responses to certain types of materials in those devices, such as inflammatory reactions and tissue changes that cause pain and fatigue.

The FDA stressed that most patients using medical devices, including medical device implants, do not have adverse reactions and rely on their devices to help manage their health or treat their symptoms.

The agency wants to determine how to identify patients who might be at increased risk of experiencing a hypersensitivity response before they receive a metal-containing implant, so that they are aware of the risks along with the benefits.

The next public meeting on the safety of metal-containing implants will be an immunology devices panel meeting of the Medical Devices Advisory Committee on Nov. 13-14 in Gaithersburg, MD.

The panel will examine the potential for certain patients who receive medical device implants that contain select metal or metal alloys to develop immune and inflammatory reactions and whether current approaches and standards are adequate.

The panel will also evaluate gaps in current scientific knowledge to help determine what additional studies may further the FDA’s understanding of ways to mitigate risks.

The November public meeting will also examine advances in the scientific community’s understanding of immunology and how emerging and evolving scientific data can help address risks to specific patients.

The FDA noted that this information could be useful in helping identify patients who are part of a small subset at increased risk of experiencing a hypersensitivity response to a device and ways in which this risk could be mitigated, whether by testing patients before they receive an implant, modifying device design, or other mechanisms. HITInfrastructure.com