Unplugged

The Federal Communications Commission is on the cusp of unleashing technology that could release patients from the constellations of machines that monitor them in the hospital and revolutionize the level of monitoring possible at home.

The FCC said it is likely to approve a proposal that will allocate spectrum for wireless patient monitoring technology, potentially creating a lucrative new market for companies developing the technology and lowering healthcare costs by reducing hospital-acquired infections, preventing unplanned emergency transfers and keeping elderly and chronically ill patients out of the hospital.

The FCC chairman and commissioners are scheduled to vote this week on the proposed rules, which would increase spectrum capacity and reliability for medical body area networks, or MBANs, in hospitals, clinics and physicians' offices.

The proposed rule also recommends setting aside a portion of the spectrum for patient use outside of a hospital.

MBAN devices collect physiological data, such as a patient's temperature or blood pressure, using a small wireless sensor on a patient's body. The sensor would automatically transmit the data to a nearby “hub” device and then on to a monitoring system.

The MBAN technology, some of which may be disposable, will eliminate the need for most wires that connect a patient to monitoring equipment. An example of MBAN technology is fetal telemetry, which continuously monitors a baby's health but does not limit a mother's movement.

FCC Chairman Julius Genachowski said during a May 17 news conference at George Washington University Hospital that the “real game-changer for MBAN technology” will be health-monitoring devices that patients can wear at home.

“This creative use of spectrum also provides wireless health manufacturers with the certainty they need to streamline their product development, which for many years operated on a variety of frequencies,” Genachowski said in prepared remarks. “I expect it will eventually lead to technologies not just for healthcare facilities, but also for in-home use.”

GE Healthcare, which manufactures patient monitoring systems, identified the need for spectrum to be set aside for this type of technology in 2007. That year, the Waukesha, Wis.-based company filed a petition with the FCC to request the commission allocate spectrum and establish service and technical rules for MBAN technology.

Matt Grubis, chief engineer for GE Healthcare's monitoring solutions business, said what the FCC is proposing is similar to what GE requested almost five years ago.

Philips Healthcare, Texas Instruments and the American Society for Healthcare Engineering, whose membership includes hospital facility managers and clinical and biomedical engineers, later joined GE Healthcare in its push for the FCC to allocate MBAN spectrum.

“GE Healthcare is incredibly pleased to see a ruling on medical body area networks,” Michael Harsh, GE Healthcare's vice president and chief technology officer, said during the FCC news conference. “By opening this new wireless spectrum for communicating healthcare information through this promising technology of MBANs, patient care and disease monitoring will be revolutionized in the not-too-distant future.”

It's not the first time the FCC has set aside spectrum for wireless medical devices used in hospital settings. In 2000, the agency allocated spectrum for wireless telemetry devices, such as heart monitors, to protect the devices against the possibility of interference from radio and TV broadcasts.

The ASHE, a personal membership group of the American Hospital Association, was appointed as the frequency coordinator for the wireless medical telemetry service spectrum in 2001 and said in a May 17 statement that it would accept the role of frequency coordinator for MBANs.

The organization said both associations believe that MBANs will provide numerous clinical benefits for patients.

“Traditional wireless telemetry systems are often restricted to certain areas or floors of a hospital because the signals are limited,” the ASHE said. “MBANs would not have that issue, so patients could be placed in the hospital unit based on their specific medical condition, rather than based on a unit's wireless monitoring capability.”

Still, one concern is that the spectrum that the FCC has proposed for use by MBAN technology is also used by aeronautical telemetry. It has been used almost exclusively by commercial test pilots, according to the FCC.

The appointed MBAN frequency coordinator would need to “work with hospitals and MBANs manufacturers to ensure that medical telemetry does not interfere with aeronautical telemetry, such as data collected from test flights,” the ASHE said.

For device manufacturers, the proposed rule, which won't publicly be available until May 24, provides clarity about the regulations behind the development of these kinds of devices.

It also presents market opportunities for the manufacturers that would develop MBAN technology.

“MBANs provide a cost-effective way to monitor every patient in a healthcare institution, so they can provide real-time and accurate data, allowing doctors and nurses to identify life-threatening problems or events before they occur,” Genachowski said in his remarks.

He also said the FCC is considering the adoption of new rules that would permit more intensive use of spectrum for wireless medical devices

Genachowski cited studies finding that half of hospital patients are not monitored and that a monitored hospital patient has a 48% chance of surviving cardiac arrest, while unmonitored patients have only a 6% chance of survival.

The devices can “provide the best quality monitoring at the lowest possible cost,” GE Healthcare's Grubis said. “It brings our customers a new level of being able to care for their patients.”

GE Healthcare and Philips Healthcare said they have technology in development that would use the newly allocated MBAN spectrum if the proposal is approved by the FCC.

A spokesman for Philips Healthcare's patient care and clinical informatics business unit said the company is developing a respiratory monitoring sensor and plans to submit the device to the Food and Drug Administration for clearance this year.

The market for MBAN technology could be in the hundreds of millions of dollars, said Anthony Jones, chief marketing officer for Philips Healthcare's patient care and clinical informatics unit.

Grubis confirmed that GE Healthcare is also developing MBAN technology, but declined to provide additional information. He said the company's available wireless patient monitoring products use the wireless medical telemetry service spectrum, as well as a Wi-Fi network.

Wireless medical devices used on the WMTS and MBAN spectrums must be approved by the FDA and licensed by the FCC. Two years ago, the FCC and the FDA announced an initiative to work together to support the development for wireless medical devices.

However, the FCC's announcement last week that it is proposing the allocation of spectrum specifically for MBAN technology ensures a pathway for devicemakers to develop this type of technology.

“It's a fantastic idea,” said Dr. James Killeen, director of information technology services for the emergency department at UC San Diego Health System. “It opens up private industry to certainly contribute more to medical devices.”

Concern about bandwidth also is of concern for hospitals. When the 531-bed San Diego hospital added new buildings to its campus a year ago, it also built separate bandwidth for medical devices. Killeen said it's not common for hospitals to do this, but UCSD's proximity to the local health IT industry in the San Diego region was one factor in the decision.

Killeen also said he agreed with the FCC's proposal that MBAN devices would lead to lower costs, noting how care models are changing.

Dr. Joseph Smith, chief medical officer and chief science officer for the West Wireless Health Institute, a medical research group that focuses on lowering healthcare costs through technology and innovation, said the proposed rule clarifies concerns and questions for a number of stakeholders involved with wireless medical devices.

Smith said manufacturers will have a defined regulatory pathway to follow when developing technology, the FDA will have additional clarity about the spectrum requirements when reviewing MBAN devices, and hospitals will have more information to consider when building wireless networks.

It also sends a signal to the venture capital community that there is an established pathway for manufacturers that develop MBAN technology, Smith said. “It provides clarity about the kinds of solutions that will work.”

TAKEAWAY: A slice of wireless spectrum for medical body area networks could transform the way providers monitor patients in hospitals and at home.