The U.S. FDA has recognized four AAMI standards and one technical information report?TIR69, which helps provide a reliable method to assess how well wireless medical device systems are able to operate in an increasingly congested wireless environment.

TIR69, Risk management of radiofrequency wireless coexistence for medical devices and systems, was released in April and applies to medical devices and systems that incorporate radio frequency wireless technology to perform or control a medical function or to communicate medical data. The report provides manufacturers and users with a consensus process to help determine and manage the risks associated with the coexistence of wireless medical devices and systems with other wireless products that can operate in the same location or vicinity.

“More and more untethered devices are coming online every day, needing more and more bandwidth,” says Wil Vargas, director of standards at AAMI.

“Healthcare facilities needed a way to test their devices and manage the associated risks in a way that helps ensure these devices are able to connect to the wireless network and deliver the expected care,” he adds. “Once the risks and test results are understood, the facilities can actively take steps to improve device connection reliability and availability.”

Most medical device manufacturers rely on consensus standards while developing and testing their products, and the FDA allows manufacturers to submit a “declaration of conformity” to those standards to help facilitate the review process.

The other AAMI standards recognized in the August 21 Federal Register notice include:

  • ANSI/AAMI/ISO 15223-1:2016, Medical devices—Symbols to be used with medical device labels, labelling, and information to be supplied—Part 1: General requirements
  • ANSI/AAMI/ISO 14160:2011/(R)2016, Sterilization of health care products—Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives—Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
  • ANSI/AAMI CI86:2017, Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
  • ANSI/AAMI/ISO 80369-5:2016, Small-bore connectors for liquids and gases in healthcare applications—Part 5: Connectors for limb cuff inflation applications