Posted in Policy

Medical device makers should focus on interoperability, risk management, FDA recommends

Chris Nerney
Chris Nerney, Contributing Writer |
Medical device makers should focus on interoperability, risk management, FDA recommends

Medical device manufacturers can reduce the risks of interoperability by defining the function and purpose of a product’s electronic interface, identifying the needs of users, and anticipating how things could go awry, the U.S. Food and Drug Administration (FDA) said in a final guidance issued on September 6.

“Manufacturers of interoperable medical devices should perform a risk analysis and conduct appropriate testing that considers the risks associated with interoperability, the anticipated users, reasonably foreseeable misuse, and reasonably foreseeable combinations of events that can result in a hazardous situation,” the FDA said in the guidance, titled “Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices.” The FDA emphasized that medical device manufacturers should be very specific about what their products can do in order to help avert potential problems.

“One action manufacturers can take to reduce risk and facilitate safe and effective interoperability is to clearly set forth in device labeling the functional and performance requirements of their electronic interface,” the guidance said. “Providing these characteristics along with limitations of the interface or use of the device in an interoperable system can minimize the risks associated with failure to exchange and use data as intended.”

In a blog post announcing release of the final guidance, Bakul Patel, associate director for digital health in the FDA’s Center for Devices and Radiological Health, highlighted three specific recommendations for medical device manufacturers:

  • Design devices with interoperability as an objective
  • Conduct appropriate verification, validation and risk management activities
  • Clearly specify relevant functional, performance, and interface information to device users

“Failure to develop and provide this information to the user may lead to an inappropriate use of the device interface in a way that can lead to device malfunction, including the failure to operate, and may lead to patient injury and even death,” Patel wrote.