Ventilators are key to fighting the coronavirus, but members of the “right-to-repair” movement say that if the devices break, manufacturers won't let anyone else fix them. In some cases, such restrictions have forced hospitals to wait days for device makers to send their own repair people.
That kind of delay could cost patients their lives, said Emma Horst-Martz, campaign associate for the Pennsylvania Public Interest Research Group.
“A hospital can’t afford to sit and wait for somebody to come out from the company to make that repair for them,” said Horst-Martz, whose organization has lobbied in Harrisburg to make it easier for third parties to perform repairs.
While Pennsylvania hospitals have thousands of extra ventilators today, right-to-repair advocates like Horst-Martz warn that a surge in COVID-19 could strain the supply.
Pennsylvania Treasurer Joe Torsella shares these concerns, and last week he joined several other state treasurers in urging ventilator makers to disclose service manuals, software login codes, and other repair-related resources. In a letter to two dozen companies that produce the breathing devices, the officials said the information would enable hospitals’ biomedical technicians to fix the equipment, too.
“This is a clear and kind of a no-brainer, commonsense issue that I’ve come across in my three years and three months as treasurer,” Torsella said.
“Most people are doing their part to help us get through this [pandemic],” he continued, “One of the things that [treasurers] can do is to use our voice assertively in this case, and to ask these companies to join that shared sacrifice.”
Torsella hopes state treasuries can use their influence, as investors in medical equipment companies, to push ventilator producers to release repair-related information. He said one company, Medtronic, has begun to share its service manuals, and that a handful of other firms had reached out to discuss the officials’ concerns.
A main opponent of the right-to-repair movement, the Advanced Medical Technology Association, says it’s “working closely with the White House and various government agencies to ensure critical medical devices, such as ventilators and other complex technologies, are available.”
The trade group argues, moveover, that there is no shortage of approved repair people and that, with delicate medical equipment, it’s dangerous to have anyone else do the work.
“The bottom line is that medical technology companies, or their designated representatives, are best equipped to service their products and keep patients who use them safe, and they are effectively serving the needs of patients and health care providers to respond both to the COVID-19 pandemic and other, ongoing health care needs,” the trade group’s head of public affairs, Jim Jeffries, said in a statement.
Horst-Martz, of the right-to-repair campaign, notes that the debate over repairing equipment long predates the pandemic.
“Companies across industries … including the health tech companies, spend millions of dollars lobbying against … the sort of change that we’re asking for,” she said. “They’ve spent years pushing back against the right to repair in general.”
UPMC, for one, has obtained the right to make its own repairs through contract negotiations with manufacturers. The region’s other major health care provider, Allegheny Health Network, did not respond to a request for comment Friday.
Patrick Flaherty, who serves as a vice president for UPMC’s supply chain and BioTronics divisions, said his company maintains a staff of about 180 professionals to service more than 250,000 pieces of medical equipment. He estimates that having an in-house corps of biomedical engineers and technicians saves the company “into the high, very high tens of millions per year, and it might actually be more than that.”
More importantly, Flaherty said, UPMC’s internal capacity can allow quicker response times when a machine malfunctions.
“The ability to efficiently and quickly respond to critical clinical medical equipment where the practitioners and the patients are depending on it in a way that is measured in minutes – not measured in hours – it’s self-evident why you would want to have as much of your own ability to provide the solution as you could,” the executive said.
Flaherty said UPMC has managed to obtain repair rights thanks in part to its buying power. The medical giant also can afford the training that allows its employees to gain necessary repair certifications.
“That does not mean that [the practice of restricting repairs is] not a problem broadly across the United States and areas other than ventilators – it is,” he said. “And that does not mean that it is not completely a problem for suppliers who have a stranglehold on a particular kind of technology. Those suppliers are particularly hard to work with.”
Flaherty said even UPMC cannot negotiate for the training or tools needed to service products on which a manufacturer has a monopoly. He said surgical robotics is one area where this roadblock exists.
University of Pittsburgh law professor Mike Madison said such obstacles are largely a function of device producers’ business models. Profit margins on the machines themselves are relatively low, according to Madison.
“The profit is in servicing the machines: the follow-up, the person who comes around and cleans and updates, and makes sure that everything is working smoothly," Madison said. "So oftentimes, the company that sells you the machine also wants to sell you a service contract.”
Manufacturers argue that those contracts allow them to recoup the investments they make to develop complex medical technologies, and thus incentivize them to continue making such investments, Madison noted.
But he added that producers commonly cite safety concerns as the reason for those limits.
“Companies will often say that this is not just a business imperative that they control the service and the software,” Madison said. “It’s also sort of a health and safety, functionality consumer protection: ‘We want to make sure that the machine is working properly because it has specialized applications, and only the experts who made it and control the software should be able to tinker with it.’”
Madison said the argument dates back to photocopiers in the 1970s and '80s and today also involves cars, tractors, and cell phones. But the U.S. Food and Drug Administration concluded in 2018 that independent repairs to medical devices are no more dangerous than those completed by original equipment manufacturers, OEMs.
“Rather,” the FDA said, “the objective evidence indicates that many OEMs and third party entities provide high quality, safe, and effective servicing of medical devices.”
If manufacturers were to lift barriers to repair information in response to coronavirus, Madison said the result might provide further proof that no disparity exists.
“This whole right-to-repair debate has been conducted for a long time both at the level of ideology and rhetoric and somewhat at the level of experience and data,” Madison said. “So the long-term implication is, what do we learn if we have a short-term experiment?”
WESA receives funding from Allegheny Health Network and UPMC.