By Patrick Flaherty and Joseph Haduch
Many of you have seen references in some of our more recent articles to two organizations that represent the interests of many major clinical equipment OEMs. They are Advanced Medical Technology Association (AdvaMed) and Medical Imaging and Technology Alliance (MITA), which is a part of National Electrical Manufacturers Association (NEMA). Some of you have asked, “Why, as HTM leaders and representatives, should I have any concern about either of the organizations and the messages they are delivering to Congress and the public at large?” Allow us to provide some easily verifiable background information and you can decide for yourself what, if any, concern is warranted from our industry.
AdvaMed is a global trade association that advocates the interests of over 400 technology companies ranging in size from global-market companies to small clinical equipment and device startups. Some of the common organizations that participate in either or both of these organizations that you might recognize include GE Healthcare, Philips, Fuji, J&J, Siemens, Medtronic and Cardinal. AdvaMed actively engages policy makers in Washington, D.C. to advance the interests of its members through legislation and public policy.
MITA, as part of NEMA, represents companies that make up over 90 percent of the global market for imaging technologies. The participants include medical imaging equipment and radiopharmaceutical manufacturers. I’ll spare you the list of members but, as you can imagine, given MITA is representing over 90 percent of the industry, pretty much any imaging company you’re working with belongs to MITA.
Both organizations have recently gained notice within our industry because of their positions on right to repair, publication of service documentation through public platforms and their withdrawal from the FDA’s Collaborative Community, known as the Medical Device Servicing Collaborative Community (MDSCC). Unlike MITA, who only represents OEMs, the MDSCC is a diverse group of service professionals that includes hospital service groups, ISOs and OEMs.
For the purpose of this column we will concentrate on MITA primarily because, based on their web page, their number one strategic priority is to adopt uniform standards for imaging service providers. In the interest of context, their number two strategic priority is patient access to imaging. How they reconcile this with their stated mission “to reduce regulatory barriers” is beyond the scope of this article. If you believe or if you’re being told that MITA’s position only affects third-party ISOs or equipment remanufacturers you are being actively misled. MITA’s position, as a representative for the majority of imaging OEMS, is for the FDA to implement “regulatory requirements for everyone who services a medical device, including requiring all servicers to register with the FDA, file medical device reports and implement a quality management system.” Please take special note of the focus on the quality management system (QMS) implementation as, in addition to being expensive, a QMS is more commonly associated with a manufacturer, not an exclusively service-focused department or business. Adding a QMS to an in-house solution adds no additional quality control over an effective CMMS and it would only increase costs for the provider … hardly a recipe for increased patient access. One of the speaking tracks of OEMs is that in-house service organizations are not the point of the MITA message. Do you see a carve out for in-house organizations in the quoted MITA statement above?
For those of you unfamiliar with MITA’s history, allow us to provide some background. MITA developed a servicing standard NEMA/MITA 2-201x. Although this is a NEMA adopted standard, keep in mind MITA is part of NEMA, so this “standard” has an innate bias toward OEMs, a bias that was highlighted when it failed to gain acceptance through ANSI, a much more diverse standards organization. After failing to gain ANSI acceptance, MITA attempted to use this as the basis for driving additional regulatory standards through the FDA. In 2018, after much hype and months of public input, the FDA issued a report on the quality, safety and effectiveness of servicing medical devices. It found the following:
- 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, burdensome regulatory requirements at this time;
- Rather, the objective evidence indicates that 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”; and
- The continued availability of third-party entities to service and repair medical devices is critical to the functioning of the U.S. health care system.
Insufficient evidence to implement burdensome regulatory requirements; the conclusion from the objective evidence available was that both OEMs and third-party organizations provide a high level of service and third-party entities are “critical” to the U.S. health care systems. In addition, the FDA believed there would be value in creating a collaborative community forum to “address the challenges associated with … effective servicing of medical devices.” The FDA also agreed to facilitate the creation of this community if there was sufficient interest, hence the MDSCC. In May MITA and AdvaMed decided to remove themselves from the Collaborative Community citing they “did not feel the group made sufficient progress” and that “progress is unlikely any time soon.” Other reports claim that “AdvaMed, supported by MITA, would only accept 100% unanimity” on voting and ratifying positions. Essentially, they wanted the ability to veto any policy or position this group would take. Hardly collaborative and inclusive of a provider’s needs and thoughts but entirely consistent with each organization’s commitment to unilateral behavior.
Everything you have just read is easily verified and cannot be objectively disputed. The point and the impact for HTM is that your OEMs, through government lobbying groups, are looking to create burdensome regulation that will directly impact in-house service organizations, increase service costs and limit patient access to imaging by increasing costs to providers. Unlike ISOs HTM groups are uniquely qualified to hold OEMs responsible for their political position as HTM organizations are not seeking highly margined revenue streams. Ask for data that supports their position, but do not hold your breath waiting for their response. Inform your administration of the impact the OEM will have on you and your organization. Hospitals have lobbying groups, too. It’s cliché, but call your congressman. Get involved, before your OEM dangerously stretches their oligopoly powers further into equipment service.
Patrick Flaherty is the vice president of operations for UPMC BioTronics. Joseph Haduch, MBA, MS, is the senior director of clinical engineering for UPMC BioTronics. The views expressed here are those of the authors and do not necessarily represent or reflect the views of TechNation or MD Publishing.