Stakeholders: FCC Decision Will Have Impact On Patient Monitors

A recent ruling from the Federal Communications Commission could affect the operation of patient monitoring equipment in hospitals.

In early August, the FCC adopted rules that will permit unlicensed television white space devices — including Wi-Fi and Bluetooth technologies — and wireless microphones to operate on Channel 37 in the 600 MHz band, as long as they don’t interfere with licensed wireless medical telemetry systems.

The vote comes as the commission prepares for a scheduled March 29, 2016, incentive auction to make available high-quality, low-band spectrum for mobile broadband.

Through these auctions, television broadcasters will go off the air, and share their spectrum or move channels in exchange for part of the proceeds from wireless providers seeking additional broadband, according to the FCC’s website.

Many healthcare stakeholders have expressed concern that adequate protections would not be put in place. Commissioner Ajit Pai said the FCC assumed that hospitals with WMTS devices are no more than three stories tall. That is not the case with the majority of such facilities.

“The WMTS community is not alone in its worry,” he writes. “A bipartisan group of nearly 20 members of the U.S. Senate and House of Representatives recently weighed in on this issue. They noted that the record includes the results of real-world testing at three different hospitals demonstrating that interference to WMTS systems will be caused by a TVWS [TV white space] device operating at the power levels and distances proposed by the commission.”

To guard against potential interference, Pai has proposed that healthcare facilities be able to file a waiver request to extend WMTS protection zones to up to three times their current size. These zones will remain in effect until the FCC can determine the merits of the requests.

The medical device community also has expresses concerns. In comments submitted in March, GE Healthcare, which manufactures patient monitoring devices, said that the proposed separation distance requirements weren’t sufficient to protect WMTS. The company also urged the FCC to require unlicensed devicemakers to comply with a comprehensive system of quality regulations throughout the product’s lifecycle.

Ahead of the FCC announcement, Sens. Tammy Baldwin (D-Wisc.), Amy Klobuchar (D-Minn.) and Debbie Stabenow (D-Mich.) wrote to FCC Chairman Tom Wheeler urging a three-month delay to consider technical rules for the use of Channel 37 by unlicensed TVWS devices.

“Wireless medical telemetry service systems for cardiac and fetal monitoring in hospitals have long used Channel 37 to operate without interference, which could severely impact patient health and safety,” the lawmakers said. “We strongly urge you to give medical technology stakeholders and the unlicensed community more time to work out a technical sharing agreement that will maintain the safe use of all devices in Channel 37.”

The FCC decided against this request.

The American Hospital Association has come out against the decision, saying that if the rules aren’t changed, patient safety could be compromised. “We will continue to work with Congress, the FCC and device developers to seek a remedy that puts patients first,” AHA Executive Vice President Rick Pollack says.

To see the FCC report and order, visit www.fdanews.com/081715-fcc-WMTS.pdf.
— Elizabeth Hollis