The Food and Drug Administration (FDA) is flagging a new technical information report (TIR) from AAMI that provides crucial guidance for “wireless coexistence” for a wide array of medical devices and systems.
According to AAMI, an announcement from FDA underscores the growing regulatory interest in the increasing use of radio-frequency (RF) wireless technology in healthcare, as the heavy traffic that results raises the potential for interference and other problems that could threaten patient safety and effective healthcare delivery.
The formal title of the document is TIR69, Risk management of radio-frequency wireless coexistence for medical devices and systems. On Tuesday, FDA sent out an email bulletin that described the TIR and emphasized its relevance to previous agency guidance.
“TIR69 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 FDA said in its announcement.
FDA said that TIR69 applies to medical devices and systems that incorporate RF wireless technology “used to perform or control a medical function or to communicate medical data.” The TIR, added the agency, provides manufacturers and users with a process to “help determine and manage the risks” when wireless medical devices and systems are operating in the same areas as other wireless products.
Wireless medical devices include implanted cardiac pacemakers and cardioverter defibrillators, numerous physiological monitoring devices, implantable neurostimulators, drug and insulin infusion devices, and diagnostic imaging systems.
The TIR itself provides context for the wireless challenge facing healthcare.
Noting the increasingly crowded spectrum, the document states: “The potential for RF wireless devices to affect and potentially interfere with other transmissions is growing and is a regular occurrence in some frequency bands. … RF wireless technology is being put to use in an ever-expanding variety of applications. Healthcare delivery is a full participant in this trend, making it increasingly important that the hazards and associated risks related to the ability of wireless medical devices and systems to coexist are effectively and efficiently managed.”
AAMI has produced a number of other resources intended to help manufactures and healthcare delivery organizations effectively manage wireless technology. For example, the spring 2016 issue of Horizons, AAMI’s peer-reviewed journal supplement, focused exclusively on the coexistence of healthcare and wireless technology.
TIR69 is available for sale in the AAMI Store, www.aami.org/store. The product code is TIR69-PDF.