The FDA ignited a debate across the medical equipment landscape when it opened a docket in 2016 aimed at better understanding third-party service. That investigation culminated in May with the publication of the FDA’s findings.

Some imaging stakeholders have praised the FDA’s report and see it as a conclusion to a long debate, while others think the report leaves the industry with more questions than answers, and more work needs to be done.

HealthCare Business News spoke to Dennis Durmis, senior vice president, Head of Americas Region, Bayer Radiology, to find out why he believes legislative action is needed in order to pick up where the FDA left off, ensuring safe medical device service for patients in the U.S.

HCB News: What were the key findings in the FDA's recent report on third party service?
Dennis Durmis: The FDA issued the following summary of their report:

They believe the currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing, including by third party servicers, of medical devices that would justify imposing additional/different, and in their opinion, burdensome regulatory requirements at this time.

Rather, the objective evidence indicates many OEMs and third-party entities provide high-quality, safe, and effective servicing of medical devices.

A majority of comments, complaints, and adverse event reports alleging that inadequate “servicing” caused or contributed to clinical adverse events and deaths actually pertain to “remanufacturing” and not “servicing.”

The continued availability of third-party entities to service and repair medical devices is critical to the functioning of the U.S. healthcare system.

The report describes four areas where the FDA intends to pursue action:

1. Promote the Adoption of Quality Management Principles;
2. Clarify the Difference between Servicing and Remanufacturing;
3. Strengthen Cybersecurity Practices Associated with Servicing of Medical Devices; and
4. Foster Evidence Development to Assess the Quality, Safety and Effectiveness of Medical Device Servicing.

HCB News: On June 15, there was a meeting on Capitol Hill to discuss the impact of third-party service and the implications for patient care. Can you tell us about that meeting and the viewpoints that were presented?
DD: The Capitol Hill briefing was sponsored by the Advanced Medical Technology Association (AdvaMed) and the Medical Imaging and Technology Alliance (MITA), in conjunction with Rep. Ryan Costello (R-PA) and Rep. Scott Peters (D-CA) and the House MedTech Caucus, and was chaired by Rep. Anna Eshoo (D-CA) and Rep. Erik Paulsen (R-MN). The briefing provided an overview of third party servicing of medical devices, and the implications for patient care. Specific discussion topics included an overview of the issue and a need for congressional action, from the perspective of medical device manufacturers, third-party servicers, and the patient perspective.

I was one of the OEM representatives at the hearing and advocated for the passing of the Medical Device Servicing Safety and Accountability Act in an effort to ensure that all medical device servicers are held to the same quality, safety, and regulatory requirements. During my presentation I spoke to the fact that there is no basic requirement for third-party service companies to register with the FDA, creating a gap that makes it impossible for the agency to ensure devices are correctly serviced.

Other speakers included:
• Vy Tran, Varian; senior vice president, Regulatory Affairs and Compliance
• Miguel Machuca, Medical Outfitters
• Toni Mattoch, America’s Blood Centers; director, Quality Services,

HCB News: Why do you feel there is a need for Congressional action with regard to third-party service? What might the right legislation entail?
DD: Although the FDA’s report addresses important issues, there is still work to be done to understand the patient safety impact associated with unregulated servicing. Currently, service activities are only regulated by the FDA when they are performed by the medical device’s OEM. Service activities performed by non-OEM parties are not held to any quality, safety or regulatory requirements, including FDA oversight. As a patient, who is most likely seeing a physician because of some worrisome health problem, the last thing they should have to also worry about is who performed service on hospital equipment, are they qualified to do that work, and is the product that is going to be used on me safe. At a minimum, there are minimum requirements I believe the FDA should be ensuring across all providers that will significantly improve patient safety with little to no cost to the healthcare system.

It’s important to note that many third parties are following FDA guidelines in demonstrating best practices. These companies appear not to be concerned with FDA registration and minimal reporting and equipment in the proposal.

The FDA noted in its report the evidence available to date is not sufficient to conclude whether or not a public health concern is warranted. As such, legislation is needed to ensure third-party servicers of medical devices register with the FDA and report adverse events. The Medical Device Servicing and Accountability Act would require third-party servicers to register with the FDA, report deaths and serious injuries, and maintain complaint handling systems. We are encouraged to see leaders in Congress like Rep. Ryan Costello (R-Penn.) and Scott Peters (D-Calif.) champion consistency in the regulation of medical device servicing, which is critical to ensure patient safety and the effectiveness of life-saving medical technologies.

It is pretty simple, registering with the FDA would take minutes and, if there is nothing to report, then this should not be “burdensome. The FDA’s report also raised an important distinction between servicing and remanufacturing. Overall, we feel there is more guidance that needs to be provided in this area, as there appears to be confusion from various stakeholders concerning the difference between the two. As such, clarifying the difference between the two is an important focus area as remanufacturers are regulated by the FDA as manufacturers and are subject to the Quality System Regulation. Further establishing a better understanding of the activities that are defined as remanufacturing will help to extend more oversight of these activities to protect patient safety.

HCB News: You have an extensive background with Bayer MVS (formerly Medrad) which gives you a unique insight to this conversation. What do you tell third-party stakeholders who see this type of legislation as an effort to hurt their business?
DD: While many third-party servicers perform high-quality work, the current gap in regulation isn’t in the best interest of patients. The number of unregulated and unregistered service organizations and persons servicing medical devices has dramatically increased over the last 20 years without any comparable adjustment in the regulatory framework governing these activities. As a company that actively participated and competed in the third-party service business, there are ways to create OEM alternative business models that offer quality solutions at a competitive price. However, under no circumstances should quality and/or patient safety be compromised, and some level of minimal consistent regulation would better ensure that hospitals are not unknowingly tempted by unsafe/substandard service offerings.

This is absolutely not about business, but it is about ensuring that – through consistent standards for device servicing – patient and user safety remains at the forefront. The bipartisan Medical Device Servicing and Accountability Act, if passed, would be a major first step toward solving this problem.

HCB News: What is your response to third party stakeholders who tout ECRI's analysis of the FDA's MAUDE database, which found no evidence that a safety problem exists in relation to medical device service and maintenance?
DD: In the simplest of terms, I don’t appreciate how referencing the ECRI database can be used to validate safety of third party servicing when there is no requirement for third party servicers to report any findings. Of course we would expect to see no evidence there.

Bayer has seen firsthand the type of issues that can arise due to inadequate third-party servicing of medical devices that could have posed a risk to patient and provider safety. In one case involving maintenance by a third-party company, an overhead counterpoise support system arm (accessory to a powered contrast injection system) separated and fell, striking a radiology technologist due to a support arm separation. The company providing the servicing didn’t maintain regular records, so it was unclear to Bayer’s service representative when they were called to address the incident if it had been regularly inspected and maintained appropriately.

During a recent service call for an angiographic power injector, it was observed that a third-party service vendor inappropriately substituted an OEM steel pin with a simple wood screw to hold a syringe turret in place. An OEM power injector of this class can inject fluid pressures up to 1200 psi. If the substituted screw were to break during a patient procedure the turret could break free potentially causing the turret and connected syringe to act as projectiles.

Despite these examples submitted to the FDA, the agency acknowledged in their report that extending regulations could be “burdensome.” Bayer doesn’t see extending regulations as burdensome, but as an important step to ensure the safe and effective operation of medical devices.

HCB News: Is there a template, or anything we can learn, based on how other countries have dealt with these kinds of challenges?
DD: There have been other countries struggling with third party service approaches across the globe. The most recent one is within the EU, where there are draft changes to the MDD which to my knowledge have not been implemented.

HCB News: Under the potential legislation, would OEM accountability change at all? For example, would manufacturers be held to a higher standard of sharing sensitive information, such as manuals and passcodes, with compliant third parties?
DD: While there isn’t specific language in the legislation in regard to changes in already rigorous OEM accountability standards, the May 15 FDA report referenced the possible creation of a “collaborative community” framework. We believe it is imperative for third party service providers to have certain basic information regarding the design and testing requirements of devices. Servicing of these technically advanced pieces of equipment is not a right and requires some level of investment regardless of being an OEM or a non-OEM. Whether this is reverse engineering, training, partnership, etc., I believe different products and modalities will have differing solutions in this area. However, adequate quality and regulatory performance of these activities is not dependent only on possession of these materials.

As a medical device leader, Bayer supports collaboration across the servicing industry to drive quality standards. Bayer believes the sharing of information would be productive if it’s done in a comprehensive and regulated manner. Proper training, experience operating within a quality system, and knowledge of FDA regulatory requirements are essential to the safe and effective operation of medical devices.

HCB News: What does this whole conversation boil down to? Is there a bottom line that gets lost in the discussion?
DD: Yes, the bottom line is patient safety. There are incentives for good service behaviors by OEM’s that maximize patient safety as a result of FDA QSR guidelines. There is no dispute amongst OEM’s that these guidelines yield positive outcomes. The lack of any guidelines for third party servicers allows for significant interpretation of what is right and what is wrong. The system actually incents third party service companies to test the boundaries of putting profits ahead of patient safety. Many choose the right path, and others, unfortunately, do not.