We have all witnessed the intense strain the COVID-19 pandemic has placed on our healthcare system and its supply chain.
This pressure was perhaps best exemplified early on when a diminished supply of specific medical devices such as ventilators led to a wild scramble by many hospitals to source new, used, or even broken devices.
Broken ventilators were purchased in the hope that the hospital biomedical engineer, or the Original Equipment Manufacturers (OEM) field service engineer, or perhaps an Independent Service Organization (ISO) could repair the device and put it back into service. Many ventilator manufacturers stepped up and went above and beyond in terms of providing service materials for these products.
This, however, also led to unregulated non-OEM servicers demanding immediate access to all manufacturer-developed service-related materials, including proprietary software and service manuals, even for devices unrelated to the immediate demands of the pandemic.
Now, roughly six months into the public health crisis, lawmakers have introduced legislation in Congress that would give the non-regulated service businesses exactly what they want: Unfettered access to service manuals and tools by suspending OEM copyright protections, which would allow manuals and other tools to be copied, transmitted, posted online and used by servicers who are not held to the same federal regulations as OEM servicers.
While the intent of the federal medical “right to repair” legislation seems to be helping broken medical devices needed to care for COVID-19 patients, the fact of the matter is there is no evidence of any shortage of technicians servicing medical devices. In fact, many ventilator manufacturers went above and beyond in partnering with servicers early in the pandemic. This legislation is a solution in search of a problem that will have unintended consequences, including increasing the risk to patient safety.
As an OEM of test equipment for diagnostic ultrasound systems and probes and a certified third-party ultrasound probe repair company serving hospitals, OEMs, regulatory agencies, and ISOs globally, I have the unique position of distinguishing, first-hand, what is breathless hyperbole and what is relevant and factual.
Unfortunately, instead of fostering collaboration, this legislation pushed by non-medical Right-to-Repair (R2R) advocacy groups such as iFixit and Repair.org only serves to further divide the medical device service community. These groups and the businesses they represent have decided to capitalize on the COVID-19 public health emergency to make expansive demands for OEM-developed materials, such as proprietary service manuals that would do more harm than good, while continuing to refuse such basic responsibilities as making themselves known to the FDA, much less implementing appropriate quality controls.
Medical devices, as defined by the FDA, range from the simple to the dazzlingly complex. While it might be possible to use a service manual and basic engineering skills to repair an ECG Holter or a patient monitor, the requirements to repair a CT or an MRI system responsibly can be orders of magnitude more complex.
With an unsuccessful or botched repair on an ECG Holter, one can throw it away at relatively minimal risk or expense. Not so with a multimillion-dollar 3T MRI system where a mishandled repair can lead to a quenched magnet, or worse yet an injured patient. An incomplete or ineffective repair can also result in a more insidious failure wherein the device appears to be functioning while the operators are unaware that it is producing incorrect or incomplete results.
OEM service is heavily regulated by the FDA and is answerable to all the mandatory Quality System requirements. Currently, third-party service providers are not held to the same standard—they’re not held to any standard by the FDA. The best-in-class third-party service providers voluntarily operate with an internationally recognized quality management system in place (e.g., ISO 13485:2016), but they are in the minority of the approximately 20,000 third-party medical device servicers the FDA estimates exist around the country. The fact that there is no clear sense of the number of these servicers further underscores the need for the FDA to enforce transparency and a level quality playing field.
Despite what disingenuous advocacy and lobbying groups claim, in my experience, OEMs have never contended that ISOs do not have a “right-to-repair” complex medical imaging systems. They do believe, however, that with that right comes an inherent responsibility to have a well-implemented quality management system, file Medical Device Reports, and register with the FDA.
This legislation would put the cart miles ahead of the horse by granting demands for service manuals, wiring diagrams and software access without fully appreciating and implementing everything that is required to safely and effectively service a medical device, including advanced and on-going device-specific service training, peer mentoring, stringent process and environmental controls, continuous improvement and corrective and preventive action strategies and verification and validation processes for replacement parts.
With unregulated servicers refusing to comply with these requirements, it will be incumbent on the FDA to require all third-party medical device servicers to register with the Agency and be compliant to a recognized quality management system standard, such as 21 CFR 820, ISO 13485, or NEMA/MITA 2.
More broadly, after seeing the heroic actions of healthcare workers across the country, it will also be incumbent on all interested parties—including the FDA, OEMs and third-party servicers—to come together to collaborate on solutions to ensure that mission-critical medical devices continue to function safely and effectively during a public health emergency.
This legislation is an unfortunate step in the wrong direction.
G. Wayne Moore is the CEO of Acertara and the 2020 Ultrasound Chair for the Medical imaging &Technology Alliance Ultrasound Section.