Should the US Food and Drug Administration (FDA) get involved in regulating the independent service providers (ISPs) and replacement parts suppliers that help hospitals and clinics keep medical imaging equipment up and running? And if so, how much government involvement is truly necessary?
It’s a question that continues to stir up heated debate even after an FDA report on the quality, safety, and effectiveness of medical imaging equipment servicing found no immediate concerns. The FDA made this conclusion following a public workshop and request for comments from the industry and medical community:
“We believe the currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing of medical devices, including by third party servicers, that would justify imposing additional/different burdensome regulatory requirements at this time.”
Instead of imposing regulations, the May 2018 report indicated the FDA would pursue the four following actions:
- Promote the Adoption of Quality Management Principles
- Clarify the Difference Between Servicing and Remanufacturing
- Strengthen Cybersecurity Practices Associated with Servicing of Medical Devices
- Foster Evidence Development to Assess the Quality, Safety and Effectiveness of Medical Device Servicing
While it’s unlikely there will be FDA inspections of parts suppliers or third party service providers in the near future, there are changes coming to the industry in terms of government oversight.
The reaction to this report has been somewhat mixed. There are those who see it as a step in the right direction and others who worry it is the beginning of government meddling in an industry that is already doing an adequate job policing itself.
Let’s take a closer look at the players in this ongoing saga, the different points of view, and how to best prepare for what may happen next.
P.O.V. #1: MITA and Medical Imaging Equipment Manufacturers
The Medical Imaging and Technology Alliance (MITA) represents original equipment manufacturers (OEMs) and works to influence policies in Washington, D.C. There are also trade associations such as AdvaMed speaking out for OEMs on these matters.
MITA works closely with the FDA on regulations connected to medical imaging, and it was supportive of the government’s decision to establish quality management principles. In addition, MITA is calling on Congress to pass legislation (H.R. 2118), which would require third party servicers to register with the FDA.
In an official response, MITA Executive Director Patrick Hope said:
“Today’s release of the FDA report on medical device servicing clearly demonstrates why Congress needs to step in and implement basic patient protection measures by requiring third-party servicers to register with the FDA and report adverse events … We agree the evidence available to the FDA is not sufficient to conclude whether or not a public health concern is warranted.”
The multibillion-dollar organizations that manufacture medical imaging systems and other devices are under a much higher degree of government scrutiny and oversight than the small third party organizations providing parts and service to medical facilities. ISPs and medical imaging replacement parts providers can be considered direct competition to the OEMs, as they also provide parts and service to the same healthcare organizations.
From the perspective of OEMs, establishing quality management principles, requiring FDA registration, and potentially enacting other types of government involvement would help ensure smaller companies follow the same rules as manufacturers that service and repair imaging systems.
One reason MITA is glad to see the FDA pursue quality management standards is that it is already developing its own set of standards for servicing medical imaging equipment. Patrick Hope seems to suggest the FDA will use those standards as a guide:
“We are encouraged by the FDA’s decision to promote the adoption of quality management principles and believe our proposed servicing standard provides the agency with a suitable framework in which to work.”
It is fair to say that the motivations of MITA and OEMs extends beyond patient safety and public health. In some respects, the FDA’s 2018 report may have been an attempt to appease MITA and the OEMs without enforcing stricter oversight and regulations, which would create more work for the agency.
P.O.V. #2: IAMERS and Third Party Parts and Service Providers
On the opposite side of the debate are third parties such as ISPs and replacement parts providers. These independent organizations are supported by the International Association of Medical Equipment Resellers and Servicers (IAMERS).
AAMI, which represents ISOs and imaging engineers as well as HTMs and other members of the medical community, has expressed that it is maintaining a neutral stance on the debate over regulations and seeks to find ways to collaborate.
Both of these organizations also agreed with the FDA’s report, although IAMERS in particular took issue with the way the other side interpreted the findings. During the AAMI annual meeting in June 2018, IAMERS general counsel Robert Kerwin made this statement:
“Unfortunately we still hear that the manufacturers and their trade associations are pressing Congressional leaders to pass legislation regulating servicing and seem to be characterizing the FDA’s conclusions as a ‘blindspot’. We do not think that the FDA report evidenced a blindspot. 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.”
Kerwin also noted that independent service providers are important partners to many healthcare organizations. And in fact, the FDA’s report concluded the same:
“The continued availability of third party entities to service and repair medical devices is critical to the functioning of the U.S. healthcare system.”
IAMERs is essentially taking the position that it is looking out for the little guys, yet it’s worth noting there are all different sizes and types of third party servicers and medical imaging parts providers. Some stick to much more stringent training requirements, quality assurance, and validation processes than others. So, the quality of the parts and level of service a healthcare organization receives will certainly depend on those it partners with.
There are also organizations, such as DirectMed Imaging, that actively pursue ways to document a commitment to quality.
P.O.V. #3: The Medical Community
The hospitals and clinics that purchase medical imaging systems from OEMs, and often rely on third parties to help maintain and service that equipment, provide yet another perspective on this topic.
Of course, the medical community is no stranger to FDA regulations, and you’d be hard-pressed to find those who would disagree with any move that has the potential to protect public health and improve patient safety.
Still, healthcare providers don’t want to see third-party servicers and parts suppliers driven out of business. These small businesses keep the market for medical imaging equipment competitive, which is to the advantage of the healthcare industry. Imaging engineers equipped with quality replacement parts help hospitals avoid system downtime and provide options for maintaining expensive equipment after an OEM service contract ends or a system reaches what the manufacturer dictates is end of life (EOL).
That may be why the medical community is among those calling for more collaboration from everyone involved. Samantha Jacques, director of clinical engineering at Penn State Health, commented that, despite the different opinions, there must be a consensus on the core issues of quality management, information gathering/sharing, and cybersecurity.
“Going forward, I hope a multi-stakeholder steering team is formed that can define and create task forces to address these priority topics and work toward defining some middle ground where all parties can agree and move forward.”
For its part, AAMI is also expressing a willingness to continue open discussions about how to implement changes and enforce standards. According to the association’s website, AAMI President Rob Jensen has offered to host a future forum and had this to say following the FDA’s December 2018 workshop.
“We at AAMI believe that continuing these productive talks and potentially establishing collaborative communities will help advance patient safety in the interest of all parties.”
What to Expect and How to Be Prepared
First of all, expect to be waiting a while to find out what happens with FDA oversight of medical imaging servicing. There is plenty that needs to be worked out.
The FDA recently extended a comment period meant to acquire feedback on the differences between the servicing and remanufacturing of medical imaging devices. The house bill that would require third parties to register with the FDA and provide reports to the agency was introduced in 2017, but it seems to have stalled. And, it’s quite apparent that disagreements among the various parties will take time to resolve.
There are still many unanswered questions that will need to be addressed and processes that must be developed before anything official is put into place. What seems very likely, however, is that eventually there will be a set of standards third-party servicers are required to follow. There will also be some sort of system for registering with the FDA and gathering and reporting complaints and issues.
The results of that reporting system may influence whether further oversight is necessary. If data collection confirms the FDA’s initial conclusion that the quality of medical imaging device servicing is not a risk to public health, then it’s less likely further rules would be imposed. On the other hand, if results indicate there are concerns, regulations could increase.
The organizations that will be best equipped for the changes ahead are those already committed to high standards of quality, safety, and expertise. The partners you choose to work with also matter. An ISP could register and become certified with the FDA only to order from a parts supplier that is not compliant with the government’s quality management principles.
At DirectMed Imaging, we focus solely on Siemens medical imaging replacement parts and equipment in order to bring you specialized expertise. We’ve created quality assurance and parts validation procedures and have a DOA rate lower than the OEM. We provide in-depth, hands-on training and 24-hour technical support for engineers because we’ve believe in backing up our customers from start to finish.
And, we’ve become ISO 9001: 2015 certified to prove our commitment to quality in every aspect of our work. The reason we’ve done all these things is so that we can be an ideal healthcare technology partner to you in times like these. Contact DirectMed Imaging today to learn more about how we can support your organization.