Imaging Wire Q&A: Regulating Service with Bayer & MITA

The “Right-to-Repair” movement’s migration from iPhones to medical devices has brought service to the forefront of the medical imaging industry, and it could have major ramifications on who can service medical imaging devices and how they’re regulated.

In this Imaging Wire Q&A we sat down with Bayer Radiology’s Dennis Durmis and MITA’s Peter Weems to discuss the evolving medical device service issue and how ongoing regulation might impact patients, clinicians, and OEMs.

Tell me about yourselves and how you became involved with the Right-to-Repair movement?

Peter: I’m Peter Weems, Senior Director of Policy and Strategy with the Medical Imaging and Technology Alliance, also known as MITA. We’re the primary trade association and standards development organization representing manufacturers of medical imaging devices.

The service issue is one of our top priorities given its very serious implications for patient safety. We’ve been working on this for several years, after our member companies started flagging instances where their devices had been improperly serviced by an unregulated third-party, creating concerns for patient safety and device performance.

They were reporting situations where third-party servicers bypassed X-ray system radiation controls and instances where devices had been repaired with twist ties or duct tape or non-validated parts that you could find at the hardware store.

Clearly, this raised all sorts of concerns about patient safety and device performance, motivating us to engage the FDA and Congress to make sure all servicers were held to the same quality, safety, and regulatory requirements.

Dennis: I’m the head of Bayer Radiology in the Americas and former chair of MITA, so I’m part of the group that Peter’s been talking to. I’ve been involved with the service discussion for quite some time as well.

Peter makes all the valid arguments. These Right-to-Repair bills continue to grow broader, bringing in medical devices to some state bills. That of course creates concerns over whether these medical products are safe and efficacious, and the risks to patients or even to medical practitioners.

What made you realize how serious this issue is?

Peter: A number of our member companies have flagged instances where imaging devices were improperly serviced by an unregulated third-party servicer, creating enormous risks to patients and healthcare providers in terms of safety and the quality of the devices’ performance.

We’ve accumulated a number of these case studies over the years to the point that we eventually felt that the FDA needed to take action to ensure that everybody is held to consistent quality, safety, and regulatory requirements no matter who is servicing the device.

Dennis: I’ve viewed this as a serious issue for quite a while. At one point in time, I was the head of Bayer’s multi-vendor service business, so I’m actually very familiar with what third-party servicing is. I’d like to think that I have a good idea of the right way to manage a third-party service business.

Since we operated as part of a medical device OEM, we had very stringent quality standards. We had engineers who reverse engineered products. We drew up our own schematics. We understood how the products worked. Basically, we did everything but register a 510(k) with the FDA.

As a result of seeing that and being involved in the third-party space, it was easy to see where some of the good providers were and where some of the really bad providers were. Some servicers were just going through the motions, including not having a quality system, not having training requirements, and not guaranteeing that a product would work in the manner it was expected to work.

This goes back a number of years for me, almost ten years, and it’s continued to raise its head. This previously involved discussions with the FDA about defining repair versus remanufacturing. The Right-to-Repair language has been a more recent issue in the medical device area, and it’s in direct opposition to what we believe in: safety and efficacy.

What are the current medical device service rules?

Peter: Right now, the FDA regulates servicing of medical devices only when it’s performed by a medical device manufacturer. Manufacturers have to register with the FDA, report to the FDA whenever they encounter a death, serious injury, major malfunction, and they’re required to have a quality management system in place that dictates certain things like training and documentation requirements, verification and validation of replacement parts, etcetera.

If you’re not a manufacturer, you’re not FDA regulated. So essentially there is no oversight over the third-party servicing industry. These third-party servicing businesses are not required to register with the FDA, they don’t have to file MDRs, and they don’t have to have any quality or safety controls in place.

Our priority is to make sure that these businesses are held accountable and are registered with the FDA and follow certain basic quality, safety, and regulatory requirements.

What are the patient safety implications of these service rules?

Peter: Fundamentally, this is about patient safety from our perspective, full stop.

Given the critical role they play in our healthcare system, we need all medical devices to perform safely and effectively for their intended use in every case.

That’s why manufacturer service organizations are FDA regulated and that’s why the FDA should regulate third-party servicing businesses in this space. If one of these devices fails to perform, the risks are real. We’re talking about anything from electrical shock to overexposure to ionizing radiation to infection to air embolisms.

Never mind that as our devices become more integrated with software, the cybersecurity risks associated with improper servicing grow ever greater.

For MITA member companies specifically, we’re talking in large part about devices used for screening or diagnosis. If an imaging device fails to perform, diagnosis could be missed or patient care could be delayed. That has a real material tangible impact on the livelihood of patients.

So clearly patient safety is motivating our engagement on this issue.

Dennis: Peter said it well. A patient should never have to worry about whether the equipment that’s being used on them, either for treatment or therapy, has been properly serviced and maintained. That shouldn’t be a concern of any patient or any health professional. Unfortunately, that’s not necessarily the case today and there are multiple examples of where that isn’t happening.

I don’t think that MITA’s recommendation to the FDA is too much. It’s simply to ask the third-party service companies to register with the FDA and maintain a quality system. That’s just good business practice. That’s nothing more than doing what’s supposed to be done regardless of whether you’re in a regulated space or not, to be honest with you.

So those shouldn’t be hurdles or significant cost drivers for any company. It’s simply just good business practices and that’s really what we believe in.

What will it take for Congress to introduce more stringent medical device standards?

Peter: We’ve been working with congress for a number of years on this issue. As part of the previous user fee reauthorization cycle, Congress required the FDA to publish a report on the servicing issue. That report came out in May of 2018.

Legislation was also introduced in that congress, H.R. 2118 by Costello and Peters, which would have required servicers to register with the FDA, report MDRs, and have a complaint management system.

I fully expect that we’ll continue to engage Congress on this issue. I believe that educating Congress about the serious risks being presented to patients and to healthcare providers by unregulated third-party servicing will motivate Congress to act.

Dennis: Like Peter said, it’s all about educating Congress about the lack of third-party standards and the safety risks that creates.

There are a lot of third-party service providers out there that perform work on behalf of OEMs, so they’re considered authorized service providers. When that happens, they fall under the quality system of the OEM that they’re performing the work for.

Typically, within our quality system, we would look at supplier quality. We would perform audits on them. We would make sure that their training is to the same standards that we would expect as an OEM. They would have the latest revision levels of software schematics, antivirus updates, and the like.

So, the extension of the FDA umbrella falls through the OEM to the third-party service providers when they’re performing authorized work. When they’re not providing authorized work, as Peter said, really there are no guidelines, requirements, or standards.

Then you get into the questions about what parts are being put on? What’s the training and background of the person performing the work? What documentation are they providing, if any? All those things come to play and are really some of the big red flags that we see on our end.

Why is this topic particularly important right now?

Dennis: With regards to Right-to-Repair, there’s been increased efforts to expand service rights to third parties. These efforts mainly came from the consumer goods side, but third-party service providers who participate in the medical device space obviously jumped on that bandwagon.

This was heightened during COVID. There was some publicity suggesting that OEMs didn’t have enough bandwidth to service the ventilators required to support patients with COVID-19. We’ve unequivocally demonstrated that that is not the case and not the truth, but that triggered a lot of the recent discussion.

Peter: From our perspective, this is an important issue because we’re talking about complex devices involved in diagnosis or treatment of serious medical conditions. Making sure that these devices always perform safely and effectively for their intended use is our top priority. Action is long overdue.

Now, the other side of this issue has been very aggressive lately in pursuit of their business interests. They had their own legislation introduced in the previous Congress that would have compelled manufacturers to turn over intellectual property to their unregulated competitors. And now there are a number of Right-to-Repair bills at the state level. Many of these bills are broadly applicable to all sorts of consumer goods, but there’s also a number of these bills that are medical device-specific.

If these bills were to pass, it would be disastrous for patient safety and device performance. We’re talking about having to turn over company confidential information–intellectual property– to unregulated competitors who are not required to have quality or safety controls in place or even make themselves known to the FDA.

Uncontrolled use of proprietary, highly technical service materials by unregulated businesses could lead to improper servicing of a medical device, dramatically increasing risks to patient safety, device performance, and cybersecurity. Safe and effective medical device servicing is not merely acquisition of certain documentation or materials—it is the implementation of and adherence to a set of policies, practices, and procedures which consistently return the device to a state of safe and effective operation.

Open distribution of schematics, wiring diagrams, software, what have you, would be very damaging to the safety and performance of these devices and would have serious implications for ongoing competition and innovation in this space.

Dennis: Even if the schematics and testing equipment was provided, if the third-party service company isn’t trained on how to use the product, how to troubleshoot a product, how to ensure that the product is up in a working condition, the product might not be repaired in a way that’s expected. That’s one of the big concerns.

What advice would you give healthcare providers who are considering working with an unauthorized service company?

Dennis: Healthcare providers should ensure that any service provider has a quality system in place and they should ask a lot of questions to confirm that. Providers should ask:

  • How do they ensure that the repaired product meets performance requirements?
  • Do they have an engineering staff or team that looks at reverse engineering and creating service procedures in a controlled manner?
  • What are their training requirements and how do they stay updated in a very dynamic technological market?
  • How are they keeping products updated to recent software revisions or antivirus software requirements?
  • How do they ensure parts equivalency when they purchase or replace a part?
  • How quickly do they respond to emergency calls?
  • And will they assume liability for the products’ performance after they perform the repairs and the work is completed?

If I was evaluating a third-party service provider to work on my hospital equipment, those are some questions I would want answered before I engage with them.

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