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FDA outlines considerations to assess medical devices with nitinol
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In its draft guidance, the FDA recently outlined technical considerations to evaluate medical devices that contain the metal alloy nitinol.
“Nitinol has unique properties that have led to an increase in its use in devices — particularly for orthopedic fracture fixation, cardiovascular stents, guidewires and other devices used in minimally invasive medical procedures,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in an FDA brief. “Devices made with nitinol provide many important benefits to patients, but we need to be able to assess whether, among other things, there are any health risks when the material comes into contact with various parts of the body for extended periods of time.”
Draft guidance by the FDA includes proposed recommendations for manufacturers on what should be included in premarket submission for devices that contain nitinol. The recommendations include tests to assess susceptibility to corrosion, biocompatibility and performance under certain conditions of stress/strain or temperature, labeling that includes information about the risk of potential allergic reactions to nitinol, and information on how the device was manufactured and how other factors may impact how the body breaks down the material.
“To ensure that the benefits patients receive from these devices outweigh any risks resulting from their use, the FDA needs to receive the right information as part of the premarket review process,” Shuren said.
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