The Federal Communications Commission today granted GE Healthcare’s request for a waiver to allow the importation, marketing and operation of certain GE medical devices from new suppliers for use in healthcare facilities.
The order, which was issued by the Wireless Telecommunications Bureau and Office of Engineering and Technology, waives certain rules in Parts 2, 15, 18 and 95 of the agency’s rules.
It also requires GE Healthcare to test the devices prior to deployment, and imposes a condition that GE must obtain the required equipment certifications for all devices within 18 months or it will have to collect any unauthorized devices at the end of the waiver period.
WHY IT MATTERS
The COVID-19 pandemic continues to cause significant strain on the nation’s healthcare system. The action taken by the FCC is meant to enable GE Healthcare to overcome disruptions in the medical device supply chain as it addresses the surge in demand for critical medical equipment.
Without the waiver, many of GE’s devices that are sourced from new suppliers, or that contain new components, would have required prior FCC equipment certification, which would delay GE’s ability to provide medical facilities with the equipment needed to treat patients.
THE LARGER TREND
Supply chain challenges have become common during the coronavirus pandemic as hospitals deal with shortages of everything from ventilators to the N95 masks that help shield healthcare workers from potential infection by confirmed positive patients. Three out of four hospitals that responded to an April survey from the Office of the Inspector General said they are already treating people with suspected or confirmed COVID-19.
Different approaches have emerged to tackle various issues related to equipment shortages. Just last week, for example, IBM launched Rappid Supplier Connect, a blockchain-based network it said can help healthcare organizations address pandemic-related equipment shortages by helping them find alternative suppliers.
The Worldwide Supply Chain Federation and New York-based Northwell Health, which has been hit particularly hard by the coronavirus, have both joined the network so far, IBM said.
In mid-April, GE Healthcare was among five organizations that entered into ventilator production contracts with the U.S. Department of Health and Human Services. The contracts also outline an agreement on development of immunotherapy treatments for COVID-19 patients.
Hill-Rom, Medtronic, ResMed and Vyaire also entered into ventilator production contracts with HHS.
Meanwhile, according to a Premier survey from March, the vast majority of U.S. hospitals and health systems – 86%, all told – are concerned about their supply of face masks and other personal protective equipment as the global spread of the COVID-19 coronavirus strains the supply chain.
Purchasing data showed that hospitals and health systems across the country typically buy 22 million N95 face masks a year. But during the months of January and February, demand for N95s surged, up 400% and 585%, respectively, largely fueled by a heavy flu season and forward buying in anticipation of a coronavirus outbreak in the U.S. The levels of demand suggest a minimum consumption rate of 56 million masks in 2020, nearly a threefold increase in demand when compared to a typical year.
ON THE RECORD
“The FCC is committed to doing everything in its power to help healthcare facilities treat patients during the coronavirus pandemic,” said FCC Chairman Ajit Pai. “This waiver will enable GE Healthcare to get new medical equipment into the field that will benefit healthcare professionals during this difficult time.”