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The Federal Communications Commission has officially set aside a portion of the nation's wireless spectrum to wearable medical sensors, reportedly becoming the first nation in the world to do so.
In a Sept. 11 announcement, the FCC finalized a vote taken on May 24 to set aside spectrum in the range of 2360-2400 megahertz for medical body-area-networks, or MBANs, with the 2360-2390 MHz range restricted to indoor use. The decision, to take effect on Oct. 11, means wearable sensors will be able to send and receive non-voice data in that range without interference from Wi-Fi or other devices, though they'll still be considered secondary users.
According to the ruling, MBANs will be permitted under the FCC's "license by rule" standards, under which healthcare providers must register their devices and coordinate how and when they're used. The rules won't allow for direct communication between monitors and network hubs, but will allow the monitors to integrate with other platforms inside the hospital.
The FCC and the Food and Drug Administration, which has regulatory control over mobile medical devices, are working together to streamline the approval process for medical devices that use the wireless spectrum. While the FDA is regulating how those devices are used in a medical setting, the FCC is regulating the devices as a means of communication.
According to an FCC statement, this action “represents an improvement over traditional medical monitoring devices,” as it allows for increased patient movability and comfort and could represent annual savings of $1.2 billion in expenses accrued after relocating patients to different clinics and departments.
"The MBAN technology will provide a flexible platform for the wireless networking of multiple body transmitters used for the purpose of measuring and recording physiological parameters and other patient information or for performing diagnostic or therapeutic functions, primarily in healthcare facilities," the FCC ruling stated. "This platform will enhance patient safety, care and comfort by reducing the need to physically connect sensors to essential monitoring equipment by cables and wires."
"This decision is the latest in a series of actions to expand the spectrum available for wireless medical use," the statement continued. "The commission finds that the risk of increased interference is minimal and is greatly outweighed by the benefits of the MBAN rules."
The Aerospace and Flight Test Radio Coordinating Council had originally opposed the FCC proposal, saying it would interfere with flight testing in the 2360-2395 MHz band, and had submitted alternate proposals. The FCC is expected to appoint a coordinator by next June to determine how the two uses can share frequency without interfering with one another.
On Sept. 10, executives at GE Healthcare and Philips Healthcare Systems sent comments to the agency asking that a spectrum coordinator be appointed by the FCC. The two companies were the first to suggest designating a healthcare-specific broadband spectrum, and have been working with George Washington University Hospital in Washington, DC, on a number of MBAN projects.
"While the affected parties repeatedly have expressed agreement on the innovative spectrum sharing arrangement adopted in this proceeding, the multiple regulatory steps to appoint a coordinator could delay roll-out of MBAN networks to improve patient care in a cost-effective manner," The joint letter stated. "Philips and GE accordingly urge the commission to proceed expeditiously to meet its articulated target of concluding this proceeding ... so that an MBAN coordinator(s) will be in place by no later than June, 2013."
During testimony before the FCC last May, Barry Wolfman, CEO and managing director of GWU Hospital, and Richard J. Katz, MD, director of the hospital’s cardiology division, said GWU has been working with wireless mobile technology for several years, using it to monitor everything from diabetic patients and those with heart problems to the progress of wound care. The hospital has received a grant from the CTIA, Katz said, to use wireless technology to transmit ECG readings from ambulances to the hospital.
“MBANs represent the future of wireless technology in healthcare,” Wolfman said.
Michael Harsh, vice president and chief technology officer for GE Healthcare, said patients now coming into a hospital’s intensive care unit are attached to a dozen cables or more, thus restricting their mobility and comfort level and making it difficult for clinicians to treat them or move them to another department. In addition, he said the monitoring of vital signs only occurs when the cables are attached to the patient.
With MBANs, he said, “patients stay connected to their clinicians” at all times, allowing for the continuous monitoring of vital signs even while the patient is being moved from unit to unit. In addition, he said, patients can be monitored before they reach a hospital and after they’re sent home.
Anthony Jones, chief marketing officer for patient care and clinical informatics at Philips Healthcare, said the current form of monitoring patient vital signs is expensive, inefficient and open to the risk of hospital-acquired infections and other adverse events. With studies indicating at least half of all hospital patients in the United States aren’t having their vital signs monitored, he pointed out, “minor issues could become major events” and lead to more extensive medical care and even death.
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