Investigating an Essentially Nickel- and Cobalt-Free Stainless-Steel Alloy for Medical Devices

As patient sensitivities to materials rise and regulatory scrutiny increases, the medical design community is searching for alloy alternatives to common stainless steels or cobalt chrome molybdenum for new medical devices. According to the FDA Center for Devices and Radiological Health, an estimated 12–15 percent of the population in the United States is sensitive to nickel. It is difficult to accurately predict patient susceptibility to metal hypersensitivities, even in those with an established metal-allergy history pre-implant. Additionally, under new EU Medical Devices Regulation (EU MDR, 2017/745), medical devices that contain >0.01 percent cobalt are required to indicate on the device or a warning label to the presence of cobalt as a potential CMR (carcinogenic, mutagenic, reproductive toxin) substance.