What it means and what we should expect
By Jeremy Probst
It’s been more than a year since the U.S. FDA chose not to set new regulations on the servicing of medical imaging devices—yet, the debate over how much oversight is actually needed to ensure patient safety continues. In its original May 2018 report, the FDA claimed that there was not enough evidence “to conclude whether there is a widespread public health concern related to servicing medical imaging devices.”
The FDA, along with other leaders in the medical imaging field, set their sights on other goals, including clarification around the differences between servicing and remanufacturing devices and the establishment of quality management principles.
Today, most of the ongoing conflict continues between third-party service providers and medical imaging system manufacturers (OEMs), as well as the entities that represent the two sides. Unfortunately, that leaves healthcare providers—who often rely on independent service organizations (ISOs) but must also put patient health and safety first—stuck in the middle. And even if new regulations were implemented, the FDA would need to determine how to enforce them. To better understand the situation, it helps to take a closer look at these four different perspectives.
1. The Medical Imaging OEMs Medical device manufacturers are represented by the Medical Imaging Technology Alliance (MITA) and its parent organization, the Association of Electrical Equipment and Medical Imaging Manufacturers (NEMA). OEMs do face more regulatory scrutiny than third parties, so, from their point of view, increasing regulations on independent service providers would simply level the playing field. In fact, in response to the effort to establish quality management principles for the servicing of medical imaging systems, MITA offered up its own set of standards for consideration in March.
“It is important to have sound processes—such as training, verification, and validation—in place to ensure that servicing activities are performed in a manner that protects patient safety and device integrity,” maintains Dennis Durmis, chair of the MITA Board of Directors and vice president of Bayer Radiology, Americas region. MITA also wants to ensure that the work of field service engineers (FSEs) working for ISOs does not cross over from servicing equipment into remanufacturing. There’s been discussion surrounding the definition of these two activities, but in simple terms, servicing an imaging device returns it to its original use while remanufacturing would alter that use or significantly change performance and safety specifications.
2. The Third-Party Service Organizations The FDA scrutinized third-party ISOs under the microscope in its 2018 report—not only did the agency determine there was insufficient evidence to support additional oversight, but it also concluded that independent parts and service providers are “critical to the functioning of the U.S. healthcare system.” Many hospitals and clinics trust ISOs to perform preventive maintenance procedures and keep older, yet still valuable, imaging systems in operation after an OEM service contract ends or the manufacturer decides the system has reached end of life.
The International Association of Medical Equipment Resellers and Servicers (IAMERS) represents the service organizations. IAMERS general counsel Robert Kerwin expressed frustration on behalf of ISOs when OEMs cited FDA “blindspots” and continued seeking oversight after the May report was released. “We do not think that the FDA report evidenced a blindspot,” says Kerwin. “To the contrary, we feel the 27-page report was a careful analysis of the empirical evidence that there is not a safety problem as suggested by some.” Essentially, IAMERS believes independent parts and service providers are already doing an acceptable job of regulating themselves. Some question whether imposing federal oversight only benefits large OEMs while restricting the smaller organizations, which could be seen as competition to equipment manufacturers that also provide parts and service.
3. The FDA If ISOs are to receive additional oversight, the FDA must figure out how to enforce and monitor the rules while it is already struggling to keep up with its existing responsibilities. Words such as “overwhelmed,” “under-resourced” and “understaffed” are often used to describe the agency’s current situation, which doesn’t bode well for the addition of new responsibilities. Among the FDA’s many other responsibilities are the enforcement of the new Food Safety Modernization Act, concerns surrounding vaping products, generic drug risks, and more.
For example, the FDA is responsible for monitoring the health claims made by nutritional supplement manufacturers, including the still unproven CBD products hitting the market. If the FDA does not see a need to take immediate action on the servicing of medical imaging equipment, it could table the federal oversight topic for now. But pressure from NEMA, MITA, and the OEMs will likely continue.
4. The Healthcare Providers Every healthcare organization is unique, and healthcare technology managers (HTMs) and medical imaging directors have their own way of handling the servicing and maintenance of devices. As the FDA noted, ISOs and third-party replacement parts providers fill a vital need in the servicing and maintenance of medical equipment. While the OEM’s sales tactic may be to push a provider toward updating its imaging systems to the newest model, that’s not always a viable option.
For example, many financially-strained rural hospitals and clinics may not have the finances to upgrade imaging equipment often, but they still need affordable ways to maintain and repair those systems even after the OEM stops providing parts and service. Moreover, the medical community’s top concern is protecting the patients being scanned on imaging equipment. And the FDA’s report indicated that there are as many as 20,000 companies servicing medical imaging devices across the country. So, can all of them be trusted to provide quality parts and service?
Making Quality Assurance a Priority
Patient health and safety should truly be the goal of everyone in the medical imaging industry. We’re all part of a system that allows some hospitals to pursue the latest and greatest technology, while other providers offer valuable imaging services using high-quality systems that happen to be a bit older. It’s not unlike the way some people purchase a new vehicle every three years, while others drive a car for more than a decade. You wouldn’t like being forced to buy a new car when your 36,000-mile warranty expires and, chances are, you wouldn’t take your car to a mechanic you didn’t trust, either.
That’s why it’s smart for ISOs and healthcare providers to make quality assurance for replacement parts—as well as ongoing training for FSEs and in-house imaging engineers—a top priority. While it may take some time to develop and approve a set of consistent quality management principles that all sides agree upon, the most significant action third-party service organizations and HTMs can take now is to ensure they’re following reliable standards of their own. That includes a reliable parts supply chain, ongoing education for FSEs, and access to technical support for troubleshooting issues, all while guaranteeing proper on-site procedures.
Let’s hope that out of the contentious debate come solutions and processes that provide benefits not just to one side, but to all people who rely on medical imaging for accurate diagnoses and treatment.
Jeremy Probst is president and CEO of Technical Prospects. Questions and comments can be directed to 24×7 Magazine chief editor Keri Forsythe-Stephens at email@example.com. Editor’s Note: This story was edited to adjust an earlier version which mentioned AAMI in regards to the perspective of third-party parts and service organizations. AAMI has clarified its position on the topic in a comment connected to this opinion piece.
The OEMs of course have a huge vested interest in controlling service and in particular limiting it to themselves. This is anti-competitive and not proven to be necessary. Poorly documented anecdotes where they exist are not proof. This position is like any other manufacturer who claims that only they can service what ever it is. Of course the ISO also have self interest, but their position is pro-competitive and to the degree that they are less expensive they help hospitals control costs.
We, at Afya, have been active vocal participants in the FDA discussions regarding repair, refurbishing, and manufacturing of medical devices over the past five years. Through attendance at all of the workshops and conferences the FDA have held, and empanelment on the meeting at the Silver Lakes campus, I have spoken up and presented our case for the absolute necessity of “third party” activities for the most under represented segment of the industry.
The Afya Foundation of America is but one of many charitable, non-profit organizations receiving used medical equipment for redistribution to areas of the world underseved by the medical community. Our very lifeblood is the ability to make this equipment safe and effective for use in less developed areas of the world and areas hard hit by disaster and conflict. At Afya, we bring our used devices up to the same standards applied to hospitals in the US. We are hampered by some who restrict access to even user manual for certain equipment and I urge all parties to act as partners to the relief organizations instead of adversaries.
I agree with bill Hyman
While the article focuses on imaging equipment, all the issues raised apply to other medical instruments just as strongly.
Please note the following information from AAMI’s president and CEO, Rob Jensen:
I read with interest the “Soapbox” piece titled Perspectives on Potential FDA Servicing Oversight, published by 24×7 on June 21. I’m writing in response to that article because it characterizes AAMI’s role and position on this issue incorrectly, and it also omits a current and significant endeavor that is central to the finding of common ground among the various stakeholders and developing solutions to this complex issue.
The article indicates that AAMI “represents the service organizations.” It also attributes to AAMI a position on the issue of device servicing that did not in fact come from AAMI.
To clarify, AAMI is not an advocacy organization representing any single perspective. Our membership and non-member stakeholders come from all positions in this debate, and we remain neutral. AAMI’s focus is on bringing the expertise of often divergent stakeholders together to find common ground and solutions that best promote the welfare of patients.
Over the last several years, AAMI welcomed the FDA’s interest in the servicing of devices and lent its expertise to the various FDA workshops on the issue. Without a preconceived position, AAMI was, and remains, open to working with all relevant stakeholders to ensure high quality of device servicing that assures device efficacy and safeguards patient safety.
This leads me to an important and more contemporary endeavor than those addressed in the 24×7 piece. In its May 2018 report on device servicing, the FDA discusses the establishment of “Collaborative Communities”—the hallmark of which is a continuing forum where public and private sector members work together to solve problems in an environment of trust and openness. The FDA report notes that a Collaborative Community “to address the challenges associated with delivering high quality, safe, and effective servicing of medical devices” may have value.
Such a Collaborative Community is in its very early formative stages and has begun with a shared spirit of collegiality and cooperation. AAMI has participated in this nascent effort. I am optimistic that this more open approach will overcome the challenges of the past and will successfully and meaningfully move this community forward.