By Leticia Reynolds and Kevin O’Reilly
With the coronavirus (COVID-19) pandemic pushing ventilators and other essential medical equipment into around-the-clock use, timely maintenance and repair is needed to keep these machines working to save lives. This work falls to biomedical repair technicians, also called “biomeds” or BMETs. Yet despite the urgency of biomeds’ work, many of them are running into repair restrictions that can prevent them from doing their job.
I (Leticia) am one of those biomeds. In addition to being president of the Colorado Association of Biomedical Technicians (CABMET), I am an expert on ventilators. Because it’s time consuming for manufacturers to build new ventilators, my colleagues and I have been doing everything we can to maintain and repair existing machines, while refurbishing older models to use.
Some manufacturers provide service information to BMETs, but many make this difficult to acquire. Medical device companies make it so that only their authorized repair technicians can fix the machines that they make. They refuse to provide hospital technicians with service manuals and often require passwords or service keys to access diagnostic information. Some replacement parts need software authorization before use — software that is not provided to hospitals or independent technicians.
Manufacturers who do provide access to service information often require biomeds to go through costly training to get certified, so hospitals can’t afford to train every technician for every device. This, despite a 2018 FDA report which found that independent biomeds “provide high quality, safe, and effective servicing of medical devices.”
Such tactics allow manufacturers to completely control the repair market.
Such tactics allow manufacturers to completely control the repair market. If a ventilator breaks, hospitals have to wait for an authorized technician with all the required service information, hardware and software, or they have to ship the equipment out, which can take even longer. Meanwhile, hospital biomeds are left sitting on their hands.
In the midst of a global pandemic, this model is untenable, and potentially deadly. It takes too long, costs too much and requires manufacturer technicians to hop from COVID-infected hospital to COVID-infected hospital.
As a result, biomeds face additional pressure to find creative ways to obtain service information. Forums such as MedWrench, DOTmed and iFixit are common places for BMETs to turn when in need of service information or passwords. Despite an active community, sometimes the best that a biomed can find is a manual in Turkish .
The lengths to which biomeds have to go to get repair information have caught the attention of the public. U.S. PIRG, which supports Right to Repair reforms for all electronic devices, delivered more than 43,000 petitions to ventilator manufacturers urging them to provide easy access to repair and maintenance documentation. A group of state treasurers , led by Pennsylvania’s Joe Torsella, has done the same.
Some manufacturers have responded to U.S. PIRG’s request: Medtronic /zigman2/quotes/206816578/composite MDT +0.75% has shared service manuals and provided additional design information for older model ventilators, while Fisher & Paykel /zigman2/quotes/206886323/composite FSPKF -2.78% sent PDFs of requested manuals to U.S. PIRG. GE /zigman2/quotes/208495069/composite GE +1.67% is providing access to the technical reference manuals and PC service applications associated with their Carescape R860 and Engstrom ventilators without forcing biomeds to take the four-day training that the manufacturer typically requires.
Repair advocates continue to target Vyaire and Draeger, which still refuse to provide manuals or service keys. In a statement , Pennsylvania’s Treasurer Torsella called on both companies to “follow the example of their peers and make this information available to hospitals immediately.”
Companies starting to provide biomeds with repair information are taking steps in the right direction. But BMETs and repair technicians across industries should not be forced to rely on the goodwill of device manufacturers, only sparked by an international crisis.
This is the rallying cry of the Right to Repair movement, which calls for open access to the parts, tools and information that people need to fix stuff they technically own, but still rely upon the manufacturer for proprietary help in repair. More than 20 states have considered Right to Repair legislation over the past year.
Having the manuals, test equipment and diagnostic tools to fix stuff is not only important during this crisis. This has value every day, because it ultimately affects patient care.
Others in the healthcare world agree. Patrick Flaherty, vice president of the University of Pittsburgh Medical Center’s (UPMC) supply chain and BioTronics divisions, negotiated with medical device companies to make sure that UPMC’s 180 technicians have what they need to fix some 250,000 pieces of equipment . As a result, he estimates that UPMC saves, “into the high, very high tens of millions per year, and it might actually be more than that.” Flaherty adds that repair independence allows his team to react much faster when machines break down.
Few hospitals have the scale or negotiation leverage that UPMC wields, so most are still subject to the barriers to repair that manufacturers construct. Even with such purchasing power, Flaherty says there’s only so much he can negotiate; the monopolies certain manufacturers hold over technologies such as surgical robotics means they do not need to provide repair information, regardless of the size of the hospital they’re dealing with.
Our healthcare system needs the right to repair its medical equipment — especially as it battles a global pandemic. We need to provide technicians on the front lines with the repair information and service keys that they need. Ventilator manufacturers who have yet to do so should change course immediately. Those who have should follow suit for other important medical devices, from dialysis machines to diagnostic imaging equipment. If they fail to do so, state governors should take executive action to force them. With lives at stake, there’s no time to be proprietary.
Leticia Reynolds is a biomedical repair technician in Colorado and president of the Colorado Association of Biomedical Technicians (CABMET). Kevin O’Reilly is Right to Repair Campaign advocate for U.S. PIRG.