By K. Richard Douglas
More than seven decades ago, the right to repair movement was born out of the frustration that manufacturers put certain controls, impediments and barriers to repairs and maintenance by anyone other than their technicians.
These restrictions have hampered the efforts of professionals and home DIY’ers from doing self-repair or maintenance; allowing for quicker repairs, emergency repairs or saving money.
The question in the right-to-repair issue has always been: Why can’t the owner/purchaser have the right to repair/modify or upgrade an item they have purchased instead of relying on the manufacturer? Why does a consumer have to purchase a replacement because they are not able to repair or upgrade what they have?
Push-back against these restrictions have mostly originated with organizations founded to represent the rights of consumers, self-employed repair technicians and independent service organizations (ISOs).
Only through legislation would OEMs be compelled to release schematics and manuals or other documentation, make parts, diagnostic tools or software available to independent service businesses, qualified technicians or to consumers.
When the home auto mechanic, with a consumer-level OBD-ll scanner attempts to diagnose an issue with their vehicle, the data needed from the onboard computer may be restricted, and only read, by the auto manufacturers’ specialty scanners.
By restricting access to all of the available data, the manufacturer is assured that only their technicians can fully diagnose problems with their products. The independent service shop, or the home auto mechanic, is left without other options.
This problem has impacted farmers who often need to get farm equipment back into service as soon as possible. The problem has also obstructed HTM professionals from moving ahead with repairs that might need to be expedited.
Organizations that are consumer-advocates, along with ISOs within the medical equipment repair and maintenance business, have traditionally been advocates for change. These groups have brought the issue before state legislatures and the U.S. Congress to promote change in the laws.
The effort has seen small victories in some states. But it hasn’t been enough to put the effort and achievements solidly into the win-column.
The start of 2025 and beyond is a time that the biomed community, the C-suite and HTM state associations should come out en masse and push the issue over the finish line. If legislators at the state and federal levels heard from thousands of HTM professional, state associations and societies, along with ISOs, the importance of the problem would be driven home. New legislation would be passed and a new day would dawn.
“I worry that we haven’t yet been able to ‘crack the code’ of fighting for medical right-to-repair in state legislatures. We have had only some action led by legislators with hospital administration experience – Illinois and Delaware – but that alone hasn’t been enough to get bills beyond the filing stage. It takes commitment from legislative leadership – party doesn’t matter – and leadership won’t fight battles they don’t believe they can win; catch 22,” says Gay Gordon-Byrne, executive director of The Repair Association.
The Fight for Medical Equipment Right to Repair
There are thousands of biomeds who have been impacted by the right-to-repair issue in recent decades. With the ever-evolving high-tech nature of medical equipment, the intensity and frustration of the struggle can be experienced even more in the future.
“I definitely hear hospital-based biomeds talking about how important it is to get access to the repair materials as a condition of starting the bidding process for new equipment. Clearly, this is where the hospitals have leverage, with the bigger hospitals having more purchasing power. Two different attendees to the keynote talk at MD Expo raised this point,” says Nathan Proctor, senior director at U.S. PIRG Campaign for the Right to Repair, referring to a townhall discussion at the April 2024 Las Vegas MD Expo.
But, has the issue been demanding enough to lead to a widespread mobilization of the biomed community?
“I don’t think the average in-house biomed sees/feels the debate quite the same way that the primary players do. Most do not support the OEM side of the debate as that side is seen as interference and restriction to what they do. However, when a paycheck comes from the health system itself, there is possibly a sense of false comfort that they are outside of the real debate itself – almost to the point where they don’t feel that they are going to be affected by it – not at least in the same way that an ISO/third party or an individual entrepreneur would,” says Perry Kirwan, executive, clinical engineering, eQuip-Center for Clinical Technology Management at Sutter Health.
He says that added to this is the introverted nature of most biomeds.
“With the exception of a few vocal and dynamic leaders, the profession is largely composed of individuals that will talk about issues around the water cooler but that doesn’t necessarily translate into activism. One has to put oneself out there with activism and the gravity of the debate hasn’t quite hit a trigger to motivate a majority to action. Sprinkle a little bit of the ‘my vote doesn’t really matter’ mentality and that’s a good recipe for passivism,” Kirwan says.
He believes that state associations can be a good way to motivate people because there is strength in numbers.
“If individuals can be around other like-minded individuals that educate on the topic, what’s important in the debate, and what’s at risk if owners lose their ability to make maintenance and support decisions around the equipment they own, they might be a little more motivated to act,” Kirwan says.
He says that is the primary reason that people tend to respond to things that are bigger than just themselves. He added that it also helps to feel supported and that they are not alone.
“Associations solve that by being a place where individuals network with other individuals in the same industry. One opportunity for state associations is to align with other associations outside of HTM, but hopefully aligned in the interests of quadruple aim – most of which is affordability. The American Hospital Association (AHA) is a much larger lobbying group than the state association and each state has their own chapter,” Kirwan says.
He says that getting the state AHA involved provides access and a voice to local and state legislators as well as federal equivalents.
“State legislators are much more important to persuade along the lines of this argument as state laws that favor right-to-repair may be attenable to achieve while the much slower federal process grinds along,” Kirwan adds.
He says that in addition, there is an emerging but growing trend of HTM leaders becoming members of the American College of Healthcare Executives (ACHE).
“This organization provides HTM leaders access to administrative and C-suite members that lead healthcare delivery organizations who would see impact should right-to-repair be lost to their organizations. These forums are invaluable in informing decision makers of what’s at stake and how those decisions would impact patient care, safety and affordability,” Kirwan says.
What Steps Can Biomeds Take to Contribute?
The HTM community – from the individual biomed to health care systems and state associations – can make a difference and encourage lawmakers to push forward legislation that promotes right to repair.
“Biomeds can provide the facts, but we have to first make sure legislators are interested in listening to them. A good crisis would be helpful, such as the OEM flubs on ventilators during the pandemic, but that momentum has dissipated,” Gordon-Byrne says.
Third parties and ISOs have led the fight for right-to-repair in past years, but they could use the help of the HTM community to further gains.
“If I could waive a magic wand and speak to every biomed, or rad tech, and the associations which represent them, I would ask that they request that those in charge of purchasing/procurement insist when purchasing equipment from a manufacturer that they include in the procurement offer an obligation for the winning manufacturer to provide service access information for good safety practices and to advance right to repair,” says Robert Kerwin, general counsel at the International Association of Medical Equipment Remarketers and Servicers (IAMERS).
He says that the 2024 FDA Remanufacturing Guidance sets forth on Page 21 a good description of what is needed to service the equipment and conduct periodic maintenance.
“When/if there is pushback or some unwelcome tactics (i.e., conditioning updates and upgrades or cybersecurity protections on the hospital’s agreement for a long-term servicing contract) let IAMERS know. We consider these kinds of tactics as a competition concern. Remember: when the hospital has choices, the hospitals and their patients are better off,” Kerwin adds.
IAMERS is a trade organization that actively participates in regulatory and legislative advocacy in the U.S., E.U. and worldwide.
“I think it’s an excellent idea to try and secure access to repair materials at the bidding stage, but I did offer a word of warning. Some hospitals, such as small rural hospitals, don’t have the kind of purchasing power that moves the needle, first of all. The other is that this problem will not be solved unless there are rules to protect all equipment owners. We have a lot of experience in all manner of marketplaces, and ‘voting with your dollars’ doesn’t work very well in highly consolidated markets,” Proctor says.
He says that for some equipment, hospitals have a range of vendors, but others are limited in terms of choice.
“In-house HTM departments need to ensure the word is out and everyone is educated on the issue. This includes the HTM caregivers, but just as important and maybe more importantly, they need to educate organizational leadership on the issue. I would expect that every organization has a leadership council of some sort; legal counsel, and government relations. These personnel need to know and be educated on the issue,” says Mike Busdicker, MBA, CHTM, AAMIF, FACHE, senior director of clinical engineering at Intermountain Health.
He says that state associations should be involved at the local politician level along with bringing the HTM caregivers in the area together.
“They should be actively engaged with an education effort at the state political level and at the same time encouraging the local HTM caregivers to be involved within their sites. This could be somewhat of a delicate issue if they have non-inhouse or ISOs organizations involved in their local association,” Busdicker says.
Calling All Biomeds
Those who have been consumer-advocates also look to biomeds for support to change the status quo.
“So, what is the best way hospitals can help reach a more open repair ecosystem for equipment? They can speak up for rules like the right-to-repair, that require all manufacturers to provide access to the parts, tools and information needed to fix equipment. I fundamentally believe that selling someone equipment, and then preventing them from repairing it without paying more for a special contract, is an unfair practice,” Proctor says.
Which equipment should we allow to be sold unfairly, he asks?
Proctor says that over the last year, right-to-repair has continued to make progress.
“We passed three more laws in 2024, a consumer Right to Repair law in Oregon and a consumer and business electronics repair law in Colorado and a new wheelchair Right to Repair law in California. So far, making progress on medical repair issues has been challenging, which is why it is so important for hospitals to engage with the process,” he adds.
Gordon-Byrne suggests holding meetings with the top hospital administration and impress upon them the excessive costs that limit their budgets without any improvement in quality of care.
“Money does talk, once quality of care is out of the picture. If hospital admins/leadership wants Right to Repair – its far more likely to happen than without. Large hospital chains have the power of the purchase order and can at least try to demand better terms and conditions in exchange for a large P.O. The larger the chain; the bigger their leverage,” she says.
Gordon-Byrne says that legislators react to consumers as voters, and that’s where we’ve had results. If we can drill down to the cost per person in excessive medical costs which drive personal insurance rates, that’s another way we can push voters to complain to their legislators.
“It is crucial that health care system leaders, facility leaders, physician leaders and other influencers within the industry understand what ‘right to repair’ is, how it can impact their organization, and how it can impact health care. Also, leaders should understand the findings of the 2018 FDA Report on Medical Device Servicing, what states have introduced and/or passed legislation and the organizations involved with the process,” Busdicker says.
He says that biomeds can participate in moving this issue forward by ensuring that they are educated on the issue and understand how their support can drive the process forward.
“They need to understand how to become involved, why their involvement is so important, and we need to provide them with materials and information that makes the process easier for them,” Busdicker adds.
Gordon-Byrne says that “maybe we should be asking biomeds to tell their horror stories to us and allow us to use our media friends to get consumers angry. We can take anonymous complaints on our complaint collector repair.org/repair-complaints.”
It’s time for HTM to unite, organize and lend its collective voice to the right-to-repair issue. Some in the field have done so for years, but when lawmakers hear from voters in large numbers, and when associations and organizations decide to provide focus to an issue, mountains can be moved. The time is ripe.
