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Practical aspects of wireless medical device coexistence testing
Mohamad Omar Al Kalaa1, Seth J Seidman1, Donald Witters1
1Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993.
Abstract:
Integrating wireless technology in medical devices has proved beneficial for both patients and caregivers. However, the use of shared, unlicensed spectrum bands by both medical and non-medical wireless devices has raised concerns about wireless coexistence. The challenge of incorporating wireless communication into a medical device is to ensure reasonable medical device effectiveness and patient safety. Consequently, work to develop a standardized process to assess wireless coexistence, primarily for wireless medical devices, was carried by Subcommittee 7 of American National Standards Institute (ANSI)-accredited standards committee (ASC) C63 and the Wireless Working Group (SM-WG06) of the Association for the Advancement of Medical Instrumentation (AAMI). Both groups have recently released their respective documents. In this article, we discuss practical aspects of wireless coexistence testing-in the realm of ANSI C63.27 and AAMI TIR69-to help answer basic, yet important, questions such as what to test, how to test, and how to present results.
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