Rebuttal: Medical Device Right to Repair is the Wrong Approach

Peter J. Pitts’ recent article offers a passionate yet fundamentally flawed critique of expanding right-to-repair policies to medical technologies. While we all share his concerns about patient safety and device complexity in the healthcare field, his argument overlooks critical facts about the profession of clinical engineering and healthcare technology management (HTM). It further misrepresents the existing safeguards and qualifications that hospital-based professionals bring to medical device servicing.

1. Clinical engineering and HTM: A proven track record of safety and competence

For over 50 years, hospitals have safely and effectively maintained, calibrated, and repaired their own medical equipment through highly trained biomedical equipment technicians (BMETs) and clinical engineers. These professionals are not hobbyists with “dusty toolboxes,” as the article implies, but rather degreed, certified, and credentialed experts, many with decades of experience working directly alongside clinicians to ensure that equipment performs safely and accurately at the point of care. Mr. Pitts’ ignorance of these professionals is unbecoming of a former FDA commissioner, and the implication that they are just some garage shop DIY tinkerers is both deeply offensive and insulting, in the extreme. 

Hospital-based HTM departments are guided by:

• Rigorous internal policies and procedures aligned with CMS Conditions of Participation and The Joint Commission standards,
• Preventive maintenance programs that often exceed manufacturer recommendations,
• Incident investigation and adverse event reporting systems, and
• Commitment to continuous professional education, including OEM training and third-party certifications.

In short, hospitals already have highly competent in-house and/or ISO teams capable of performing device maintenance at or above the level of many manufacturer service providers — and they’ve been doing so with documented success and safety for decades. Somewhat ironically and unfortunately, the better these in-house technical experts are, the more invisible they become. One reason, perhaps, that this HTM profession continues to be largely unnoticed.

2. Manufacturers that collaborate win

While some manufacturers restrict service manuals, tools, and parts under the guise of “patient safety,” others have chosen to partner constructively with clinical engineering teams. These forward-thinking companies:

• Provide device-specific training to hospital staff,
• Offer tiered and flexible service agreements,
• Support open communication and troubleshooting,
• Respect hospital autonomy while enhancing support efficiency.

These partnerships often yield faster response times, lower service costs, and better patient outcomes, particularly in remote or resource-constrained hospitals where waiting days for an OEM technician can put lives at risk. A “locked box” approach to service undermines rather than supports care delivery. 

A subtle, yet profound, additional benefit to these manufacturers of having their equipment supported in-house is often the improved perception among their clinical users that this equipment ‘always just seems to work.’ 

3. Accountability exists — and can be strengthened for all

Mr. Pitts’ assertion that independent service organizations (ISOs) and hospital teams operate without oversight ignores both the current regulatory landscape and opportunities for collaborative improvement. Hospitals are already subject to detailed accreditation audits, and any adverse event linked to equipment failure must be investigated and reported, whether caused by an OEM or in-house repair.

If additional transparency is needed, the solution is not to prohibit access, but to require all servicers, including OEMs, to:

• Adhere to minimum quality management standards,
• Participate in adverse event reporting,
• Maintain documentation on service history and personnel competency.

This approach ensures uniform accountability rather than selectively applying it to non-OEM entities.

4. Cybersecurity and software concerns: Real, but manageable

The article rightly raises concerns about cybersecurity in a digitally connected medical environment. However, denying hospitals access to diagnostic software or requiring internet-enabled “phone home” tools controlled only by OEMs is itself a security risk. Hospitals must be empowered to secure, audit, and manage their own systems without being forced to rely on remote OEM gateways or opaque firmware.

Collaborative cybersecurity frameworks — not exclusionary service restrictions — are the path forward.

5. The “Emergency Exception” fallacy

Citing the Covid-19 pandemic as an aberration is misleading. What the pandemic exposed was not that temporary policy relaxations were reckless, but rather that overly rigid OEM control of repairs placed patient care at risk. Hospitals rose to the occasion, often repairing and repurposing ventilators, infusion pumps, and monitors with ingenuity, speed, and care. This was not unsafe improvisation — it was a reaffirmation of the value and reliability of in-house HTM professionals.

Conclusion: Support hospitals, not monopolies

Hospitals should have the right to repair the equipment they depend upon daily. Doing so is not a step backward but a reaffirmation of trust in the skilled and deeply committed professionals who already maintain the integrity of our healthcare systems. It is with them and the tireless, often invisible work that they do that patient safety truly begins.

Photo: JanWillemKunnen, Getty Images

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