By Kevin O’Reilly
The most compelling arguments for medical Right to Repair I hear are the ones that show its impact on patients.
Nader Hammoud, the biomedical engineering manager at John Muir Health, puts it in particularly stark terms. “If the iPhone isn’t fixed, you’re not going to have a phone,” Hammoud told WIRED. “If you don’t fix a vent[ilator], the patient is dead.”
Hammoud has had to rush into the hospital in the middle of the night to fix a broken device – often using parts harvested from other devices – multiple times over the course of his career. The urgency is all too real; if “you don’t get that device up and running in an hour or two hours, that patient will die,” he said.
While patient safety is a critical consideration related to medical Right to Repair, it’s not the only important factor. In the BMJ, a peer-reviewed medical journal, authors Shuhan He, Debbie Lai, Grace Jin and Jarone Lee argue that we should adopt a SAFER framework – one that accounts for issues surrounding safety and security, adaptability, fiscal responsibility, environmental impact and regulatory compliance – for advancing such legislation.
Each of these aspects are critical to make sure that the laws we pass are ones that improve our health care system. How does medical Right to Repair legislation measure up to these categories?
Safety
In addition to stories such as Hammoud’s, that show how repair limits limit hospitals’ ability to deliver effective care, it’s important to look at empirical evidence. Both highlight the need for medical Right to Repair.
Based on analysis of millions of complaints, a 2018 FDA report concluded that, “the objective evidence indicates that many OEMs and third-party entities provide high quality, safe and effective servicing of medical devices,” and that, “the continued availability of third-party entities to service and repair medical devices is critical to the functioning of the U.S. health care system.”
Security
Cyber attacks on health care organizations are both costly – the average total cost for the most expensive cyber attack experienced was $4.4 million – and dangerous for patients, with 57% of healthcare IT and security practitioners surveyed reporting that the attacks caused poor patient outcomes.
These risks, however, should not be used as an excuse to lock out independent repair. Medical device cybersecurity expert Billy Rios told U.S. PIRG that accepted best practices for addressing cyber issues do not impact independent maintenance or repair. Rather, equipment makers misrepresent repair as a cybersecurity concern to limit competition in the repair market.
“The manufacturers’ concerns are not the most important,” Rios said. “This is about safety and saving lives. The doctors and the patients need to have a say in that calculation as well.”
The BMJ article authors also note that, “Key security features of any Medical Internet of Things include authentication, encryption and secure storage which should not be manipulable. Functionality that ensures security includes data logging and monitoring of any repair that is made.” None of these measures are at odds with medical Right to Repair.
Adaptability
The paper states Right to Repair, “should not impede product improvements and innovation,” and I couldn’t agree more. Ensuring that we continue to invent and improve upon medical device technology is critical to two of Right to Repair’s key goals – promoting patient safety and reducing health care costs.
The authors note that “There may at times be trade-offs between product designs that render medical devices easier to use, rather easier to repair.”
Repairability is an important design consideration, and I’d argue OEMs can do better. But model Right to Repair legislation does not impose any design requirements on manufacturers. Again, these goals can be balanced.
Fiscal Responsibility
Hospitals have faced financial challenges in the wake of the pandemic, and the cost of health care in the United States is too damn high: it’s nearly twice the average of other wealthy countries. Roughly $1.1 trillion of hospital costs are related to medical equipment.
Repair and maintenance is a significant portion of those costs – and repair restrictions make it more expensive. Without medical Right to Repair, hospitals can be forced into pricey OEM service contracts. Biomeds estimate that OEM repair services run roughly 10-15 percent of the original cost of the device. That’s roughly double the cost of independent service, and as much as three times the cost of in-house repair.
For example, a single $1 million dollar MRI machine, ensuring repair options could save a hospital as much as $100,000 a year. Imagine the possible savings across other modalities – not to mention our whole health care system.
Environmental Impact
When OEMs restrict repair materials, hospitals don’t have complete control of the repair of medical devices, and refurbishers aren’t able to restore them for future use. That means too many are destined to end up in the landfill, when they could be used by other hospitals in the U.S. or around the world.
In addition to disposal problems, the production and transportation of medical devices contributes to the overall greenhouse gas emissions of the health care industry, which are estimated to be as much as 10% of total U.S. emissions.
Repair materials enable refurbishment, which together can reduce e-waste, emissions and the squandering of medical equipment that could be saving lives. That sounds like a win-win-win to me.
Regulatory compliance
The final section of the BMJ paper hones in on the importance of balancing intellectual property rights with repair access.
The Federal Trade Commission’s “Nixing the Fix” report states that it is possible: “the assertion of IP rights does not appear to be a significant impediment to independent repair.” Another significant governmental body, the U.S. Copyright Office, recently ruled that the repair and maintenance of medical devices does not amount to a copyright crime.
Right to Repair is SAFER than repair restrictions
This doctor-developed framework is an important way to evaluate the potential impact of medical Right to Repair legislation. Based on our evaluation, the results seem clear – the SAFER option is to give hospital and independent biomeds access to the repair materials they need.
