FCC carves out spectrum for wireless body sensors due to gov't, industry collaboration
The May 24 vote followed a document issued a few days prior in which the agency’s chairman, Julius Genachowski, a member of the voting panel, openly enthused over the agency’s chance to clear spectrum for MBANs.
It also came about a month after six House members wrote Genachowski and FDA commissioner Margaret A. Hamburg, MD, to press for quicker regulatory decision-making on wireless medical devices and medical applications for smartphones.
Genachowski pointed out that the allocation makes the U.S. the first country in the world to dedicate wireless spectrum for the use of MBANs in hospitals, clinics and doctors’ offices.
The technology uses Band Aid-like sensors placed on patients’ bodies. These collect vital signs and send the data to hubs placed near bedsides. The hubs transmit information to monitoring systems accessed by nurses and clinicians. The omission of wires from the patient-monitoring process frees up patients to move about or be easily transferred and reduces the risk of disconnections and wire-related infections, the FCC noted, adding that the spectrum will not be susceptible to interference from Wi-Fi or consumer devices using unlicensed spectrum.
The response from industry was swift and enthusiastic. GE Healthcare issued a news release that not only applauded the agency but also quoted the competition.
“With access to special-purpose spectrum, the healthcare industry’s research and development efforts can go into overdrive,” said Anthony Jones, a Philips Healthcare marketing officer, in the GE release.
A prominent provider institution also chimed in. “MBANs represent the next evolution in monitoring a patient’s health status,” said Richard Katz, MD, director of cardiology at George Washington University Hospital in Washington D.C. “These wireless innovations can enhance patient safety by giving caregivers the ability to monitor many clinical measurements, wherever the patient is located.”
The FCC stipulated that use of the band designated for hospitals and other healthcare providers, at 2360 to 2390 MHz, be restricted to indoor settings and will be subject to registration with an MBAN coordinator and “additional coordination if warranted by location.”
The agency said devices operating in the 2390 to 2400 MHz band will not require registration and coordination—and may be used in any location, including in-home residential settings.
The FCC also issued a notice of proposed rulemaking that asks questions about the selection process for identifying and recruiting one or more MBAN coordinators.
Some time will likely pass before the first devices to make use of the spectrum show up in hospitals. All are subject to the increasingly cumbersome FDA review process—and, as yet, there is no guarantee that insurers will be willing to pony up for MBAN monitoring.