Advancement of Medical Instrumentation (AAMI) Report - Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems.
The U.S. Food and Drug Administration (FDA) join the Association for the Advancement of Medical Instrumentation (AAMI) in announcing a new AAMI Technical Information Report (TIR) 69 on “Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems.”
A technical information report (TIR) is a publication of AAMI Standards Board that addresses a particular aspect of medical technology
This TIR applies to medical devices and systems (also known as medical electrical equipment) that incorporate Radio Frequency (RF) wireless technology used to perform or control a medical function or to communicate medical data. This includes wireless technology whose operation and function directly support the medical device's intended use, as it relates to the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.
The TIR 69 provides manufacturers and users with a consensus process and guide 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. The types of medical devices that incorporate wireless technology continues to grow and now includes implanted cardiac pacemakers and cardioverter defibrillators, numerous physiological monitoring devices, implantable neurostimulators, drug and insulin infusion devices, diagnostic imaging systems, and a wide range of other medical devices.
TIR 69 coordinates closely with the wireless coexistence points in the FDA guidance Radio Frequency Wireless Technology in Medical Devices, and fills a gap to address the hazards associated with loss or disruption of wireless device functions. The TIR 69 document was developed in coordination with the ANSI C63 subcommittee (SC) 7 draft standard ANSI C63.27™/D1.0 Draft Standard for Evaluation of Wireless Coexistence that was approved in January and is expected to be published later this year.’
Included with today’s notice is an example policy addressing the use of wireless technology in medical devices.
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