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  1. Science and Research | Medical Devices

Medical Device Material Safety Summaries

The U.S. Food and Drug Administration (FDA) 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. 

As part of the FDA’s ongoing commitment to promote the safety of medical devices, the FDA and ECRI are publishing these safety summaries for materials that are commonly used in implantable medical devices and the effects of those materials on patients over time.

UPDATE February 2023: The FDA added 3 new safety summary reports to the list of safety summaries below:

  • Colbalt Chromium (CoCr)
  • Stainless Steel
  • Titanium

The vast majority of patients implanted with medical devices have no adverse reactions. The device works and performs as expected to treat medical conditions or help patients better manage their health. However, a growing body of evidence suggests that a small number of patients may have biological responses to certain types of materials in implantable or insertable devices. For example, they develop inflammatory reactions and tissue changes causing pain and other symptoms that may interfere with their quality of life.

The FDA is also beginning to see manufacturers incorporate new types of materials in devices. CDRH’s Office of Science and Engineering Laboratories (OSEL) has been conducting a wide array of research studies to learn more about the new advances in device materials.

The FDA believes that an increased understanding of the behavior of materials over time will ultimately result in an overall improvement in the safety and effectiveness of medical devices. 

Safety Summaries

The following safety summaries are now available. The FDA will continue to release reports as they become available.

Five Key Questions

In compiling this safety information, the team focused on the following five key questions about local and systemic response to materials commonly used in medical devices.

  1. What is the typical or expected local host response to the material?
  2. Does the material elicit a persistent or exaggerated response that may lead to systemic signs or symptoms – beyond known direct toxicity problems?
  3. Are there any patient-related factors that may predict, increase, or decrease the likelihood and/or severity of an exaggerated, sustained immunological/systemic response?
  4. Are there any material-related factors that may predict, increase, or decrease the likelihood and/or severity of an exaggerated, sustained immunological/systemic response? 
  5. What critical information gaps exist and what research is needed to better understand this issue?

More Information

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