Advocates are pursuing a state-by-state approach to reform in hopes of tipping the scale toward national legislation
There appears to be nothing straightforward about getting biomedical equipment technologists the right to repair and service their facilities’ own equipment. In fact, the most promising “right to repair” route seems to be that followed in the automotive industry.
In November 2012, the Massachusetts “Right to Repair” Initiative—then known as Question 1—was put on the state’s general election ballot and passed overwhelmingly by 87.7% of voters. This yes vote allowed vehicle owners and independent repair facilities in Massachusetts to have access to the same vehicle diagnostic and repair information made available to the manufacturers’ in-state dealers and authorized repair facilities.
But, as we’ve seen, the right to repair is an issue that transcends the automobile industry. As outlined in a June 2014 article for 24×7, the issue has roiled the health technology management community for decades. Biomedical equipment technicians have had to deal with apparent efforts on the part of original equipment manufacturers (OEMS) to curtail their ability to service and repair their own equipment.
Which begs the question: What does a right to repair bill affecting the automobile industry in one state have to do with biomeds and the equipment they are charged with servicing and repairing across the country?
A little more history is in order.
The Massachusetts Model
When the Massachusetts law was signed in 2013, the automobile manufacturers (represented by the Alliance of Automobile Manufacturers and the Association of Global Automakers) decided to cut their losses. They soon came to an agreement with independent garages and retailers to make Massachusetts’ law a national standard.
Beginning with the model year 2018, all automakers will make their diagnostic codes and repair data available in a common format, just as the Massachusetts law requires. In addition, lobbying groups for repair shops and parts retailers won’t pursue state-by-state legislation.
“A patchwork of 50 differing state bills, each with its own interpretations and compliance parameters doesn’t make sense,” said Mike Stanton, president of Global Automakers, at the time. “This agreement provides the uniform clarity our industry needs and a nationwide platform to move on.”
This logic is exactly why a group called The Repair Association (formerly known as The Repair Coalition) is pursuing a similar strategy at the state level for its members from other industries, including consumer electronics, agriculture, farming, and medical device repair.
“There is nothing like a good pattern,” says Gay Gordon-Byrne, executive director of The Repair Association. “So we are using the template of the automobile right to repair law that was passed in Massachusetts, which became that national agreement between the manufacturers and the aftermarket.”
Gordon-Byrne also points out that the agreement covering the automotive industry was followed last year by an agreement between truck and engine manufacturers and the aftermarket repair industry on the sharing of heavy-duty vehicle service information. Access to this material gives truck owners and independent repair facilities more options for diagnosing and repairing commercial vehicles.
While that’s a promising development, says Gordon-Byrne, that kind of success will be much more difficult to replicate in areas like the medical device industry. “The problem with medical equipment is that there isn’t an organization that is as well as organized as the auto industry that could negotiate these types of agreements.”
Scot Mackeil, a CBET from Quincy, Mass, who works as a senior biomedical engineer at a major academic medical center in Boston, has long been a vigorous right to repair advocate. He agrees this is a dilemma for members of the healthcare technology management community, who are on the front lines of repairing and maintaining hospital equipment.
“Within our industry, our professional organizations and continuing education leadership have to put their support fully behind right to repair. It is my hope that ACCE [the American College of Clinical Engineering] and AAMI [the Association for the Advancement of Medical Instrumentation], as well as regional biomed associations, will get involved at the grassroots level,” Mackeil says, pointing to repair.org, The Repair Association’s Web site, as a resource. “Not just because the future survival of our profession is tied to right to repair, but because it helps lower the cost of technology ownership for the individual hospital and increase equipment uptime. It also drives down technology costs, leading to lower health insurance costs across the entire healthcare system.”
So, as Gordon-Byrne says, the most promising avenue for right to repair reform seems to be a legislative approach at the state level, with the hope that if one state falls in line, then agreements will be forged nationally. “Otherwise, we’ll continually be in the legislatures banging on the same issues over and over again,” she says.
Right now, according to The Repair Association, efforts are underway in at least four states—Massachusetts, Minnesota, Nebraska, and New York—to pass right to repair legislation.
In Massachusetts, Bill H.3383—“An Act relative to the digital right to repair”—was introduced in the House of Representatives in 2015. If passed, the bill would mean that the manufacturers of digital electronic products sold on or after December 31, 2016, would (among several requirements) have to:
“Make available to independent repair facilities or owners of products manufactured by the manufacturer diagnostic and repair information, including repair technical updates, diagnostic software, service access passwords, updates and corrections to firmware, and related documentation, free of charge and in the same manner the manufacturer makes available to its authorized repair providers.”
“Make available for purchase by the product owner, or the authorized agent of the owner, such service parts, inclusive of any updates to the firmware of the parts, for purchase upon fair and reasonable terms.”
Both Mackeil and Gordon-Byrne testified at a Massachusetts State House hearing on the bill before the Joint Committee on Consumer Protection and Professional Licensure in September. They were two of nine people representing different repair industries who spoke at the hearing.
“We were well received,” Gordon-Byrne says. “My basic argument was that manufactures shouldn’t be able to tell you as the owner of a piece of equipment what to do with it. And that is the kind of principle medical equipment owners should operate under.”
An especially powerful piece of testimony had to do with one specific medical device—a wheelchair. The man in question was “a quadriplegic and tinkers with his own wheelchair to keep it running the way he wants,” says Gordon-Byrne. “One of the things that was clear is that the manufacturers won’t provide him with the necessary parts or diagnostic equipment.”
The problem, she said, is that while OEMs preset wheelchairs to accommodate the most severely disabled individuals, this individual has some hand function and wants to modify his wheelchair to account for that. “But he’s getting no help from the manufacturers,” Gordon-Byrne says.
Mackeil is hopeful the bill will eventually pass, but he expects “it will take a considerable amount of public support and lobbying, and letters and emails to our state reps.”
“But I’ll continue following it and working on it,” he adds.
“We’ll keep going until we get this fixed,” says Gordon-Byrne. “These rights are very basic for the owners of these devices.” She believes that digital right to repair will follow the path of automobile right to repair—one state will pass legislation and a national agreement will follow.
“Can you imaging how hard it would be for a manufacturer like GE to have to deal with an open repair policy in Massachusetts and not in Connecticut?” she asks. “How would they would able to do that? That’s a problem the automakers face, and while it took them a while—about 18 months—they came to an agreement in all 50 states. So I think it will take just one state and then a lot of these [manufacturers’ repair] policies will collapse because of the difficulty of compliance.”
Whatever happens, the status quo is becoming intolerable, says Mackeil. He points out that while bodies such as the Joint Commission and the Centers for Medicare and Medicaid Services expect hospitals to follow OEM procedures when it comes to maintenance and repair of equipment, “if you have manufacturers who aren’t providing the service manuals and access to service documentation and software, you’ve got a stalemate. And this right to repair legislation would go a long way to relieving that.”
In the meantime, Mackeil and Gordon-Byrne both suggest it might be time biomeds took a stand with vendors on this issue.
“This is a problem we have created for ourselves in many respects. Too many biomeds give too many medical equipment salesmen and equipment manufacturers a free pass,” says Mackeil. “Biomeds should stop them at the door and say, ‘You’re not going to bring this piece of equipment into my hospital for a demo unless you cough up a NFPA-99-compliant, PDF copy of the operator’s and factory service manuals, and as part of the purchase contract you agree to sell us parts for the life of this device.’ ”
Hospitals need to learn to assert their rights with manufacturers, says Gordon-Byrne. “But in the end, it may be easier to get legislation through rather than to try and educate the entire procurement community that it needs to get tough.”
As to the question of third-party service providers, there could be some action at the regulatory level that could have an impact on their ability to provide service and repair medical devices.
Wayne Moore is president and CEO of Acertara Acoustic Laboratories in Longmont, Colo. He also serves on various technical and regulatory affairs committees of the Medical Imaging and Technology Alliance (MITA), a division of the National Electrical Manufacturer’s Association (NEMA), and is the 2016 chair of MITA’s Ultrasound Technical Committee.
Accordingly, Moore says he understands why this has become such a contentious issue—OEMs are concerned about protecting service revenue streams, third-party service providers are trying to protect their turf, hospitals are interested in restraining costs associated with service and repairs, and regulatory agencies are tasked with ensuing that medical devices are repaired and serviced properly.
Moore says that MITA’s technical and regulatory affairs committee is currently pushing for a standard that will apply to all service entities, including third-party service providers. “I think the standard will at a minimum say what is required to perform service and define exactly what service means,” he says. “I suspect that one way or another a standard will be developed throughout the course of this year and will ultimately be adopted by the FDA and other servicing stakeholder organizations.”
He also suspects the standard probably won’t please third-party service providers. “The term service may mean significantly less than what some non-OEM service providers are trying to do right now,” Moore says. “And if they try to do more, there may be FDA involvement. The FDA has indicated affirmatively that it does have jurisdiction over third-party service providers. Even though currently most third-party service providers are not required to be registered with the FDA, the FDA has the authority to inspect a facility if it performs repairs beyond what the standards say—especially if there may be a patient safety-related issue.”
Moore points out that while the wrangling over right to repair has been related to a number of issues, he thinks concerns over patient safety will end up driving a resolution.
Take, for example, “patient safety and the efficacy of an imaging study—is the service restoring the imaging device to manufacturer specifications and proving a safe, high-quality diagnostic study?” he asks. “That outcome will trump a lot of the consternation about this issue between the competing interests. And I don’t think the third parties currently have a good answer for the clinical safety and efficacy issue. There’s a lot of shouting on both sides right now, but the preponderance of evidence in favor of creating and adopting a service standard will weigh in on clinical safety.”
Moore also says that some non-OEM service providers might currently be crossing the line between service and actually remanufacturing devices. “Like anything else, a few bad actors cause laws and regulations to be made,” he says. “Some third-party providers cross the line—and I don’t mean just a toe, but both feet—into the realm of remanufacturing. And the FDA does regulate remanufacturers. So ultimately some of these companies will have to decide whether they are going to be service companies or remanufacturers.”
Mike Bassett is a contributing writer for 24×7. For more information, contact chief editor Jenny Lower at firstname.lastname@example.org.
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