CareScape V100, a GE patient monitor.

Despite protestations from the American Hospital Association and a cadre of 16 Republican members of Congress, the FCC decided at its August meeting to allow unlicensed devices to use some of the spectrum previously reserved for medical devices.

The AHA and the Representatives both sent letters to the FCC in the last days of July, urging them to postpone this action for three months so the possible risks to patient safety could be explored, but the FCC voted to adopt the rule last week. It will open up the 600 mHz band, which includes Channel 37, a portion of the radio spectrum designated in 2000 for wireless medical telemetry devices such as heart, blood pressure, respiratory and fetal monitors.

"The Federal Communications Commission adopted a Report and Order that modernizes its Part 15 rules to accommodate growing demand for and encourage innovation in unlicensed use," the FCC said in a statement. "The new rules adopted today will permit unlicensed fixed and personal/portable white space devices and unlicensed wireless microphones to use channels in the 600 MHz and television broadcast bands while continuing to protect television and other licensed services from harmful interference."

According to a thorough report in Modern Healthcare, the FCC ruling does make a provision for protecting patient monitoring devices from interference: it creates protected zones 380 meters around hospitals in which unlicensed devices wouldn't be allowed to operate. But the AHA would like to see the buffer zone be at least 3,000 meters, Erik Rasmussen, vice president for legislative affairs, told Modern Healthcare. More to the point, the buffer zone solution requires hospitals to register their devices with a database, which has never before been necessary, so there's a real possibility that interference could occur, posing a threat to patient safety, before hospitals have a chance to get the paperwork in order.

"The AHA, in addition to many members of Congress, requested a delay in FCC action to allow hospitals more time to work cooperatively with the unlicensed device community to create a compromise that protects patients," the AHA said in a statement issued following the FCC meeting. "The FCC did not grant this delay. The FCC did allow for an increased buffer, as advocated by Commissioner Pai; however, the commission ignored technical considerations in setting the distance and will require each hospital to demonstrate that larger protection zones are necessary. Many hospitals do not have the staff expertise and resources to comply with this technical rule."

In the FCC's press release, they noted that "unlicensed devices have grown from basic garage door openers and cordless phones to Wi-Fi and Bluetooth technologies to the 'Internet of Things'" in discussing the need for more spectrum, but beyond that vague description the commission hasn't been forthcoming about why the urgency is required.

"We remain highly concerned that if the rules adopted today are left unchanged, patient safety could be compromised," the AHA's statement concluded. "We will continue to work with Congress, the FCC and device developers to seek a remedy that puts patients first."