By Dennis Durmis
While COVID-19 has put immense stress on many parts of the healthcare system, one bright spot is the ongoing reliability of medical devices thanks to the expertise and service of needed experts in this field. In fact, trained and talented servicers have answered the call, keeping critical medical technologies up and running. There has been no evidence that medical devices have gone unrepaired or underserviced during the pandemic.
That is why the federal medical device right to repair bill introduced by Sen. Ron Wyden and Rep. Yvette Clark seems misplaced and ill-timed during a health crisis that requires broad focus, resources, and limited distractions. The bill purports to fix a problem that doesn’t exist. While this is hardly the first piece of legislation to serve as a solution in search of a problem, it is the unintended consequences of the Critical Medical Infrastructure Right-to-Repair Act of 2020 that is a cause for concern.
One example of creating a problem that doesn’t exist is the rhetoric from this past Spring related to ventilators. Many original equipment manufacturer (OEM) servicers did make manuals freely available to meet biomedical engineers’ immediate requests, but that didn’t stop third-party servicing and their right-to-repair allies from purporting a false narrative around a shortage of serviceable ventilators. An article published in the New England Journal of Medicine reveals the truth: In March, there were 62,000 full-featured ventilators available in the United States as well as an estimated 10,000 to 20,000 more on call in the Strategic National Stockpile.
You must ask yourself if a problem does not exist, who exactly would benefit if this bill became law? In this case, the answer is clear: the unregulated third-party service companies that are not required to register with the U.S. Food & Drug Administration (FDA), adopt quality management systems, or report medical device errors to the federal government as original equipment manufacturers are required to do.
The passage of this bill could increase risk for the very same people to whom the bill’s authors claim they are attempting to help: Patients. Even with access to manuals, third-party manufacturers lack product knowledge, rigorous training, and context to fix sophisticated equipment. Furthermore, not all Medical Device Equipment is the same, and if equipment is not fixed properly it can lead to misdiagnosis or harm.
By stripping away manufacturer copyright protections, this bill would give unregulated service businesses a free pass to copy, share, or post online service manuals and tools for anyone’s use. While that may at first sound helpful, relying only on a service manual without the proper training and experience needed to repair a complex CT scanner raises serious risks. Improperly serviced equipment could lead to, at best, a machine wearing out before it should, and at worst, a malfunction causing patient and provider harm, including over exposure to radiation, electric shock, improper dosing, or a missed diagnosis.
All devices are not the same – not even in the medical field. While you might be able to repair your mobile phone or even a basic monitor with a service manual and some engineering skills, relying solely on a service manual to repair a multimillion-dollar MRI system doesn’t sound like quality service to me nor is it in the best interests of patients or reducing healthcare costs.
Knowledge of, and compliance with, FDA regulatory requirements are essential to the performance of safe servicing activities. By refusing to adopt FDA-compliant quality management systems, third-party servicers demonstrate a failure to own their responsibilities to patients, their customers, or health workers that come with adhering to FDA regulations.
Instead of treating all medical devices the same, following the same playbook for dissimilar equipment, and trying to obtain OEM manuals without the right training or product knowledge, the third-party medical device service community should own up to their responsibilities, register with the FDA, and comply with federal regulations that advance patient safety.
Dennis Durmis is Senior Vice President Bayer Radiology, Americas Region and chair of the Medical Imaging & Technology Alliance. Mr. Durmis lives in Indianola, PA.