By Kelly Lienhard
Third-party medical device servicers say they support Senate Finance Committee ranking Democrat Ron Wyden’s (OR) bill that would allow independent service organizations to repair medical devices for the duration of the COVID-19 emergency, though they would like to see the language extended beyond COVID-19.
Original equipment manufacturers oppose the bill, which would require device makers share needed information about their devices with third-party servicers. OEMs say the bill would be ineffective and endanger patient safety.
Wyden’s Critical Medical Infrastructure Right-to-Repair Act of 2020 (S. 4473), also introduced in the House (H.R. 7956) by Rep. Yvette Clarke (D-NY), would require OEMs to, during the COVID-19 pandemic, give ISOs access to information and tools used to service medical devices, and would invalidate provisions in equipment contracts that restrict ISOs from performing critical medical device maintenance.
The bill also would protect third-party servicers from liability when they create copies of materials or break digital locks when they repair devices that are needed to help COVID-19 patients.
But Peter Weems, director of policy and strategy at the Medical Imaging and Technology Alliance (MITA), which represents OEMS, told Inside Health Policy that the legislation seems to be a “solution in search of a problem.” It appears to track with ISO business demands, he added, as MITA has not heard any complaints from health care providers that there have been device servicing shortages throughout the pandemic.
“We of course share [the lawmakers’] objectives of ensuring ongoing patient access to medical imaging devices during the pandemic but we actually think that their legislation would be counterproductive to that,” Weems said. “We’re taking this seriously, this presents very serious concerns for patient safety, for devices performance and for cybersecurity.”
MITA is especially concerned about one provision that would waive certain controls on patents and copyrights, allowing third-party servicers to copy manufacturer’s parts without FDA regulation.
According to Weems, the ISOs would essentially be able to copy and distribute anything they wanted from manufacturers as they see fit, even for no cost in some circumstances.
Weems added that OEMs have never said ISOs should not have the right to repair, but manufacturers are concerned over the lack of a quality management system and registration with FDA.
“We’re very disappointed that the third-party servicing businesses have decided to take advantage of this pandemic to pursue their own business objectives,” Weems said. “Why is it that they feel comfortable making extensive and inappropriate demands for their competitor’s proprietary intellectual property while they are continuing to refuse to even make themselves known to the FDA?”
Third-party servicers are throwing their support behind Wyden’s bill.
“We would like to see this [bill] established as law and policy,” Scott Trevino, senior vice president of product management and solutions at TriMedx and member of the Alliance for Quality Medical Devices Servicing, told IHP. “[The need for third-party servicers] is not timebound or limited to a special cause like COVID, but rather it’s really the way the health care industry serves patient safety most effectively.”
ISOs assert their industry is adequately regulated, and their services can help fill in the gaps left by understaffed OEMs.
Trevino pointed to a 2018 FDA report in which the agency stated ISOs provide necessary services and require no additional regulation. According to Trevino, third-party servicers are able to service rural areas that OEMs may not be able to reach because of strained staffing resources brought about during periods of increased demand, such as during the pandemic.
In addition to reaching rural areas, Rick Staab, CEO of InterMed Group, asserted that during the pandemic, some manufacturers have been unable to quickly respond to servicing needs in highly populated areas with increased demand, like New York City.
“We have been called in … to places, in particular from Florida to Georgia to New York City [during the pandemic], where we were asked to come in on behalf of the manufacturers because [the] manufacturer couldn’t get there, and we were given access by to do certain [services] that we as a third party [servicer] usually would not have access to,” Staab told IHP.
Staab would like to see the language in the bill applied beyond the pandemic. However, even if passed as is, Staab says it would be a stepping-stone toward giving ISOs more access to manufacturers’ materials beyond the pandemic.
“Why would it not be for forever, if we know that it’s going to happen again? This is not the way we should be providing the services and the best things for patients and health care is to have access to these things now and in the future,” Staab said. “I don’t know why it would stop at any time.”
While there are several examples of OEMs that have good relationships with ISOs, Trevino said Wyden’s bill would address the other end of the spectrum — dismantling alleged unfair practices and high prices sometimes brought about by certain OEMs’ business decisions.
For instance, some OEMs don’t authorize ISOs to fix certain devices because the manufacturers want to sell the newest device upgrade to health care providers instead of fixing the one that is already in place, Staab said.
Advocates in the rural health care and public interest space also praised the bill in a press release from Wyden’s office, stating that the legislation is “common-sense” and will prioritize patient’s safety over proprietary concerns.
“Since the onset of the COVID-19 pandemic in the United States, Color Of Change has pushed ventilator manufacturers to dial-back their dangerous, counterproductive repair restrictions, which have put an unnecessary strain on our medical providers’ ability to tackle the virus,” Color Of Change Vice President Arisha Michelle Hatch said in the press release.
The bill also has been endorsed U.S. Public Interest Research Group, the National Rural Health Association and the Lincoln Network. — Kelly Lienhard (firstname.lastname@example.org)