By Gay Gordon-Byrne
Ventilator repair is in the news. It seems that everyone wants to make sure that hospitals can fix the ventilators they have. Consequently, the pandemic has created demands from state governments that OEMs make service materials available. Ventilator OEMs have commendably responded with more open access to service materials, which appears to be a moment of corporate benevolence.
But they had to. As BMETs have known for a long time, various federal regulations referencing NFPA 99 require OEMs to provide everything needed for hospital-directed repair. A single media voice could make the requirements public, and the PR firestorm would be lit. We thought our petitions and advocacy had stimulated availability of manuals but, looking back, I think the OEMs were already worried. In any case, in the short term, it’s easier to repair ventilators than in the past.
The same cooperation does not extend to other products in the ICU or elsewhere. It seems reasonable to assume that once the door is kicked open for ventilator repair, the logic can be easily applied to anything else used for pandemic purposes. Even with a period of forced cooperation during the pandemic, no one can trust that the door will not shut as soon as it can. Legislation is the only way to keep the door open for the future. Regulators might help, but their history of enforcement is not encouraging.
Medical equipment repair is being thwarted not just by blocked access to repair documentation, but through service access passwords, pairing software, and monopolized training.
A digital key commonly controls the service access mode. Some of the keys are physical and carried by the repair tech, or increasingly provided by a secure linkup to the OEM website for authentication. Without the ability of the BMET to access the OEM website to reset parts to operate, repairs are impossible. And without service keys, used equipment cannot be bought and sold freely on the international market.
Newer forms of repair limitation are now common in the form of parts pairing. Components are serialized and factory-paired to the motherboard. If parts are swapped, even from other owned equipment, the motherboard does not recognize the part. BMETs cannot pair the parts without active help from the OEM—who also control the prices and timeframes.
OEMs have weaponized training in their zeal to control repair. Many won’t provide access to their service materials unless each technician that might work on “their” equipment has attended specific product trainings and mandatory refresher courses. Unfortunately, the training courses are not free or frequent. The profit motive behind having only a few officially qualified technicians supports high pricing for services that only the OEM can provide.
Lobbyists for OEMs talking with legislators claim that without their unique training, BMETs will be unable to safely repair “their” equipment, which will then lead to a barrage of wrongful death lawsuits. (More on liability below.) Yet the FDA did a year-long study about patient harm as the result of botched repair and concluded that many third-party entities [along with OEMs] “provide high-quality, safe, and effective servicing of medical devices.”
That same argument cuts both ways. BMETs are on staff 24×7 and have to fix whatever breaks, even if they do not have official permission. Lack of OEM official repair materials only makes for a higher likelihood of mistakes and potentially deadly delays while BMETs search for the materials they should already have on hand.
Moreover, the requirement to buy training is an illegal tying agreement under anti-trust laws; and worse, when training is not available to independents, it violates an anti-trust law governing abuse of market position. Moreover, ISO standard 60601 affirms the requirements of NFPA 99 and then creates a loophole for training: “The manufacturer may designate the minimum qualifications for service personnel. If present, these requirements shall be documented in the technical description.”
We don’t know how well these requirements are being communicated or if buyers have any opportunity to negotiate such terms. As with “end user license agreements,” it is common for ugly terms and conditions to be hidden until after the purchase is made. These types of contracts fall under general business law as “Unfair and Deceptive” and are amended to prevent such sneaky terms in our template Right to Repair legislation.
Back to liability for a moment. In our system of laws, owners are responsible for safe operation or use of their purchases. Medical equipment is owned in the same way as tractors, cars, or any other potentially dangerous device. Every contract of sale, including those for medical equipment, always disclaims responsibility to the limits set by state law. OEMs do not want responsibility of ownership and have carefully tried to control access to repair for their benefit while absolving themselves of responsibility in contracts.
If OEMs were following requirements, or if regulators were enforcing the rules, medical equipment wouldn’t need to be included in Right to Repair legislation at all. Perhaps the improper limitations on repair have simply gone on for so long that hospitals simply assume OEMs are within their rights to withhold information. To prevent future monopolization, it’s time to speak out for enforcement of existing regulations and new laws.
Gay Gordon-Byrne is executive director of The Repair Association. Questions and comments can be directed to 24×7 Magazine chief editor Keri Forsythe-Stephens at firstname.lastname@example.org.