Imagine a scenario: a critical piece of diagnostic equipment in a rural hospital goes down. The screen flickers and dies. Procedures are canceled, and patients are told they must wait—not for a part, but for a specialized technician from the original manufacturer, who might be days away and charge a premium for the visit. The hospital’s own highly skilled biomedical equipment technician (BMET) is standing right there, fully capable of fixing the issue, but is legally and technically locked out. They have no repair manuals, no diagnostic software, and no access to the necessary replacement parts. This isn’t a hypothetical; it’s the central battleground for one of the most high-stakes “Right to Repair” debates happening today: the right to repair medical devices.
The broader Right to Repair movement has gained significant traction, successfully tackling everything from smartphones to tractors. The core argument is simple: if you own something, you should have the right to fix it yourself or hire a technician of your choice. But when the “something” is an MRI machine, a ventilator, or an infusion pump, the stakes are exponentially higher. This debate isn’t just about consumer rights and monopolies; it’s about patient safety, healthcare costs, and operational efficiency.
The Core of the Conflict: Control vs. Access
At the heart of the issue is a fundamental disagreement between the Original Equipment Manufacturers (OEMs) and a coalition of independent repair organizations (ISOs), hospital BMETs, and patient advocates. On one side, manufacturers argue that medical devices are complex, highly regulated systems where a single incorrect repair could have catastrophic consequences. On the other side, hospitals and independent technicians argue that manufacturer-controlled repair creates dangerous delays, inflates costs, and renders perfectly good equipment obsolete.
Proponents of the right to repair are not asking for untrained hobbyists to start soldering circuit boards on life-support machines. They are advocating for professional access. Their key demands typically include:
- Access to service manuals and schematics.
- Availability of OEM-grade replacement parts.
- Access to the diagnostic software and security keys required to troubleshoot, calibrate, and “handshake” new parts with the machine.
Without these tools, a simple repair—like replacing a certified battery or a failing sensor—becomes impossible for anyone outside the manufacturer’s closed loop.
The Manufacturer’s Case: Patient Safety is Non-Negotiable
Why would companies like Siemens, Medtronic, or Philips fight so hard to maintain control? Their argument hinges on two powerful pillars: safety and liability.
Medical devices are not toasters. They are rigorously tested and approved by regulatory bodies like the U.S. Food and Drug Administration (FDA) as a complete, closed system. Manufacturers argue that allowing third-party access introduces unknown variables. An independent technician might use a non-validated part, or incorrectly calibrate a scanner, leading to a misdiagnosis. They might inadvertently disable a critical safety alarm or introduce a cybersecurity vulnerability into the hospital’s network.
Liability is the other major concern. If a patient is harmed by a device that was serviced by a third party, who is responsible? The hospital? The technician? Or will the OEM, whose name is on the front of the machine, be pulled into a lawsuit? Manufacturers argue that the only way to guarantee a device functions exactly as it was designed and approved is to ensure that every service event is handled by a technician they have personally trained, using parts they have validated.
Original Equipment Manufacturers (OEMs) stress that these devices are sophisticated, integrated systems, not just collections of parts. They contend that unauthorized third-party repairs could lead to device malfunction, incorrect calibration, or compromised cybersecurity. Because these devices are critical to patient outcomes, manufacturers insist that only their certified technicians, using proprietary parts and software, can guarantee the safety and regulatory compliance mandated by bodies like the FDA. This “closed loop” approach, they argue, is essential for mitigating risk and protecting patients.
The Cybersecurity Dimension
In our hyper-connected world, the risk of cyberattacks is no longer theoretical. Many modern medical devices are connected to hospital networks and the internet. OEMs argue that diagnostic software ports are a potential gateway for bad actors. By keeping their service tools proprietary and secure, they are not just protecting their intellectual property; they are protecting patients and their data from being hacked. They claim that widespread distribution of service keys and diagnostic software would be a security nightmare.
The Hospital’s Rebuttal: Repair Delays Are Also a Patient Safety Issue
Hospital administrators and BMETs find the manufacturers’ arguments frustrating, and sometimes, disingenuous. They argue that delayed care is also a form of patient harm.
Downtime and Deserts
When a critical device fails, the hospital doesn’t have the luxury of waiting. An OEM technician might not be available for 24, 48, or even 72 hours, especially at a rural or under-resourced facility. During that time, patients are not being diagnosed, treatments are postponed, and emergency rooms may have to divert ambulances. Hospital technicians, who are on-site 24/7, could often diagnose and fix the problem in minutes—if they only had the manual and the parts.
This creates what some call “repair deserts.” Major hospitals in big cities might get prompt service, but smaller clinics are left waiting, forcing them to either over-invest in redundant equipment or send patients elsewhere.
The Cost and Waste Equation
The financial argument is just as compelling. OEM service contracts are notoriously expensive. When manufacturers are the only game in town, they can set any price they want for service calls and replacement parts. This drives up the cost of healthcare for everyone.
Furthermore, this system creates incredible waste. Often, a manufacturer will refuse to service an “end-of-life” machine, even if it’s mechanically sound. They may no longer offer the specific part or software update, forcing the hospital to dispose of a $500,000 piece of equipment because a $500 part failed. An independent technician, if given access, could often source the part or find a workaround, extending the life of valuable assets and saving the healthcare system millions.
Advocates also point out that BMETs are not amateurs; they are highly trained, certified professionals often specialized in diagnostic imaging or anesthetic equipment. The idea that they are less capable of performing a safe repair than an OEM technician is, in their view, an insult to their profession.
The Pandemic Effect: A Turning Point?
The debate was supercharged by the COVID-19 pandemic. As hospitals scrambled to get their hands on every available ventilator, a shocking problem emerged: many of the devices in their reserves couldn’t be used. They were locked by manufacturer software or had failed simple calibration tests that required a proprietary tool to fix. BMETs and independent repairers found themselves “hacking” their own equipment, desperately trying to get it online to save lives.
This crisis provided a powerful, real-world example of how repair restrictions could directly impede patient care in an emergency. It lent a new urgency to the legislative push, with lawmakers starting to see this less as a niche commercial dispute and more as a matter of national resilience and public health.
The Path Forward: Legislation and Compromise
This fight is now moving from hospital hallways to statehouses. Several states have introduced or are considering “Right to Repair” bills that specifically include medical equipment. These bills aim to level the playing field by mandating that OEMs make parts, manuals, and diagnostic tools available to asset owners and independent shops at a fair price.
The battle is far from over. Manufacturers are lobbying hard, armed with their potent arguments about patient safety and FDA regulations. But the momentum, for the first time, seems to be on the side of repair. A potential compromise may not be an all-or-nothing solution. It might involve tiered access, where BMETs are given tools for common, low-risk repairs (like replacing power supplies or monitors) while more complex, high-risk calibrations remain with the OEM. Or it could involve a standardized, secure certification process for independent technicians.
Ultimately, the debate is a search for balance. It’s a complex triangle connecting intellectual property, patient safety, and healthcare accessibility. While manufacturers must be held accountable for the safety and security of their devices, healthcare providers argue they must have the power to maintain their own equipment efficiently and affordably. Finding that balance is one of the most pressing, and least seen, challenges in modern medicine.
