By Keri Forsythe-Stephens

Few, if any, topics in the healthcare technology management (HTM) field are as contentious as the right to repair.

On one side of the aisle are the original equipment manufacturers (OEMs), on the other are hospital-based HTM professionals, independent service organizations (ISOs), and repair-rights advocates. Manufacturers tend to emphasize patient safety and intellectual property rights, while servicers point to a lack of evidence for safety issues, and focus on access, affordability, and fair competition.

So, is a compromise even possible? Experts say yes — but it’s complicated.

The regulatory argument
Patrick Hope, executive director of AdvaMed, a group that advocates for OEM interests in Washington, acknowledges the sensitivity surrounding the issue. He’s also heard the criticism that restricting access to manuals and service tools amounts to a cash grab. Still, he says it comes down to patient safety.

“Medical devices are highly complex and sensitive, so even seemingly minor repairs require extensive training and expertise,” Hope says. “If improperly repaired, the equipment can pose serious risks to patients and operators. For this reason, quality service depends on more than just the possession of manuals and materials.”

Regulation, he says, is key. Simply put, the U.S. FDA keeps OEMs in check; but third-party servicers, the ones repairing and maintaining FDA-regulated devices, operate without the same level of oversight.

“A CT machine is not a cell phone,” Hope stresses. “Repairing FDA-regulated, highly sophisticated medical devices — some of which use medical radiation, others that employ gigantic magnets — carries more risk than fixing a mobile phone screen.”

The compromise, he argues, is to restrict repairs of FDA-regulated medical devices to entities that meet specific safety and quality standards.

“It has never made sense to hold OEMs to stricter standards than ISOs,” adds G. Wayne Moore, founder of Acertara Acoustic Laboratories and a fellow AdvaMed member. “If a device is used on a patient, any repair must restore it to OEM specifications.”

Certification as a way forward?
Wesley Reid, CHTM, CBET, CRES, director of technology management/ENTECH at Banner Health in Mesa, Arizona, sees room for compromise. A strong proponent of standardized certification programs, he views them as a way to balance safety with service access. Industrywide certification for all medical equipment servicers, OEM or independent, would help ensure quality without stifling competition, he says. Reid also supports a risk-based regulatory model, where oversight scales according to a device’s risk level.

Without such compromise, Reid warns, patient care, innovation, and service could suffer and cause negative downstream consequences. “Equipment downtime due to restricted repair options can disrupt care delivery and affect patient safety,” he says.

Hope disagrees. “There is no credible evidence that providers have had delays in medical device repairs,” he says, citing a 2018 FDA report that estimated more than 21,000 medical device servicers operate in the U.S. He views that number as proof of a robust and competitive repair ecosystem. “In fact, many OEMs are hired to service their competitors’ devices or contract with third-party servicers to extend their reach.”

Binseng Wang, ScD, CCE, vice president of program management for HTM at Sodexo and a prominent voice in the right-to-repair debate, doesn’t dispute this point. “Not all OEMs are against the right to repair,” Wang says. “Some have always been willing to release service materials and train HTM professionals.”

However, he highlights that some major OEMs oppose right-to-repair legislation in the U.S., even though they’ve been complying with similar regulations in Europe since 1993—without any negative impact on their profits or intellectual property.

“During the pandemic, many OEMs released service material because they were unable or prevented from sending service representatives to hospitals,” Wang says. “However, after the pandemic was over, most of those OEMs reverted to their original stance, while some became even more restrictive or decided to charge for technical support calls that were previously free or at nominal fees.”

Hope says it stems from safety. He again cites the 2018 FDA report, which flagged more than 4,300 adverse events linked to unauthorized third-party repairs, including instances of patient harm and death. “Allowing nonregulated repair companies to tinker with sophisticated FDA-regulated medical devices needlessly raises patient safety risks,” he says.

Wang disputes this rationale, pointing to the report's broader conclusion: that third-party providers often deliver safe, effective service, and that there is "insufficient evidence" to warrant further regulating them. He also cites a 2023 report from the Alliance for Quality Medical Device Servicing noting that servicers operate under hospital contracts and are indirectly regulated through the Centers for Medicare & Medicaid Services.

“Studies have shown that the U.S. has the highest healthcare per capita spending among all industrialized countries and yet has one of the worst outcomes,” Wang says. “The right to repair can help improve this situation.”

Still, he acknowledges that progress has been slow. While states like Colorado and California have enacted right-to-repair laws for powered wheelchairs, other medical devices remain off the table.

The current repair landscape
On the federal level, the push for broader right-to-repair legislation has hit a wall, Wang says—largely due to resistance from OEMs and their lobbying group, AdvaMed. The consequences, he warns, are far from abstract: “Our armed services personnel are left at risk of not being treated for serious injuries in combat zones due to defective medical equipment.”

Reid agrees the pace is frustrating, but says repair-rights advocates have won small victories. In 2021, the Federal Trade Commission (FTC) released its Nixing the Fix report, which addressed how repair restrictions affect medical device costs.

That same year, President Biden’s executive order on competition encouraged the FTC to scrutinize repair limitations across industries, including healthcare. The FDA has also begun weighing how best to balance safety with access, but has yet to issue comprehensive guidance for third-party servicers.

Wang isn’t convinced that recent efforts have moved the needle. He calls the FDA’s 2024 final guidance on remanufacturing “overly burdensome and impractical.” Among his concerns: the guidance doesn’t require OEMs to disclose key service materials — leaving third-party providers in the dark about what constitutes routine repair versus remanufacturing. “This is tantamount to requiring American citizens to obey the Constitution but not allowing them to read it,” Wang says.

He also draws a stark contrast between the U.S. and Canada. “To the best of my understanding, Canada offers a more privileged position for HTM professionals because the great majority work for public hospitals,” Wang says. “Through those organizations, they can establish provisional requirements that OEMs must comply with — or lose the ability to sell into those provinces.”

That kind of leverage doesn’t exist stateside, he explains. With most hospitals operating independently — and few tied to government systems — OEMs haven’t faced the same kind of pushback seen elsewhere. Aside from the recent removal of a right-to-repair provision in the National Defense Authorization Act, which he attributes to AdvaMed’s lobbying efforts, they’ve mostly sidestepped regulatory pressure.

Looming Medicaid cuts further complicate the issue, Wang says. “Most healthcare delivery organization leaders are focused on financial survival,” he says. “That’s why they’re not putting right to repair at the top of their lobbying agenda.”

AdvaMed’s Hope sees it differently, and argues that “money-grab” claims cut both ways. “[So-called] ‘right to repair’ advocates claim their policies promote competition, but the truth is many of these proposals are just a means of promoting one business’ interest over another,” Hope says. “Picking winners and losers is not the right way to promote competition.”

He also pushes back on the scope of some repair-rights demands, which he says go far beyond what’s necessary for routine maintenance. Advocates have called for access to OEM service manuals, software keys, schematics, and tools — materials that often include trade secrets, patents, and other proprietary information. “Releasing these resources would result in an irreversible loss of trade secret protections, ultimately harming innovation and competition,” he says.

A bright future?
As the right to repair debate rages on, one truth remains clear: the issue is complex and the stakes are high. Stakeholders may differ in their approaches, but they’re united in one principle: patient care comes first.

For right-to-repair advocates, this principle goes beyond just access to tools and parts. Ensuring safe, timely care means giving HTM professionals the resources they need — tools, parts, and service information. Without these, repair delays aren’t just a hassle; they’re a potential threat to patient safety.

Wang sees this as a tipping point. He believes it’s time for HTM professionals, whether in hospitals, ISOs, the military, or the VA, to unite for legislative reform. He points to Europe’s established framework as a model. For him, this is more than a cost issue; it’s about protecting both patients and the people who care for them.

But progress remains elusive. As Acertara’s Wayne Moore highlights, ISOs and OEMs must find common ground; something that allows ISOs to perform critical repairs in the field without violating intellectual property. Without that, the conversation stalls.

At the same time, right-to-repair advocates are raising alarms about the growing scope of HTM responsibilities. In some cases, biomeds are being asked to handle repairs well beyond the expectations of OEM engineers. This, they argue, could have serious consequences.

There, however, is room for hope. Reid sees potential for collaboration, especially if policies evolve to support both innovation and service. With thoughtful dialogue and aligned goals, he believes a balanced, patient-first solution is possible.

Because ultimately, the right-to-repair movement isn’t just about who gets to fix what. It’s about how we support care teams, safeguard patients, and shape the future of healthcare — one decision at a time.