By Robert J. Kerwin

The renowned New York Times columnist and bestselling author of “Thank You for Being Late”, Thomas Friedman, notes that we may be living through one of the greatest inflection points in history. “The three largest forces on the planet – technology, globalization and climate change – are all accelerating at once.”

In light of these accelerating forces, many things need to be reevaluated. For IAMERS, and other imaging equipment stakeholders, Friedman’s observation raises the question: Can the relationship between independent servicers and manufacturers be reimagined and more mutually beneficial in the modern era?

The current situation needs to be improved, and the argument that independent and in-house servicing practices are unsafe has been disproven. ECRI research has noted that servicing has been a contributing factor in less than .005 percent of incidences of maintenance-related failures.

Figuring out how to encourage market competition, while also ensuring patient safety and stronger communication across imaging stakeholders, is in the best interest of the healthcare ecosystem.

Hospitals need choices
If future manufacturer cloud-based platforms or government legislation succeeds in excluding independent and in-house teams from servicing, what happens to the ability of a hospital to choose servicers for the equipment it owns? Will there be an escalation of healthcare costs for rural and regional America? Will hospitals be able to afford to pay reported rates in some cases of almost $600 per hour with a four-hour minimum for service calls?

The cost saving that comes from market competition should not be understated when looking at hospital finances. The industry is aware of recent court and regulatory actions in both the U.S. and Europe to examine whether possible restraints of trade are occurring. Standard settings practices could possibly be scrutinized to the extent the standards exclude independent and in-house servicers. According to the FTC, trade associations are not themselves exempted from scrutiny to the extent they are determined not to be at least competitively neutral.

So how do we move forward in a way that encourages market competition and is satisfactory to all parties?

Cooperation with providing information
Some independent sellers and servicers (including in-house teams) experience constant stress over delays or refusals by equipment manufacturers to provide service keys, passwords, manuals and training. If patient safety is the top concern, then it seems that sharing this information with third-party service entities would be a way to help enhance it.

It’s not just independent servicers who are experiencing challenges in obtaining this information. The HTM community is reportedly experiencing this problem. A few years ago, I was contacted at the request of a manufacturer who was apparently frustrated that another manufacturer had reportedly declined to provide information. I forwarded the letters IAMERS had received from the FDA which helped to clarify regulatory responsibilities to turnover information for radiation-emitting devices.

For smaller companies, there is a fear that complaining to manufacturers about uncooperative practices could lead to further problems. They could find themselves in a pattern of having their requests ignored or perhaps other services affected.

Additional regulations are not the solution
It seems clear from the FOIA responses to IAMERS requests to the FDA, the FDA docket response, and statements at the October 2016 FDA workshop, that a manufacturer’s trade association was urging the FDA to further regulate independent servicers of diagnostic imaging equipment. Thereafter, legislation was filed. From financial disclosure statements filed with the Congress it also seems that significant resources have been spent advocating on Capitol Hill for greater regulation of servicers.

In my view, encouraging independent service companies is in the best interest of the already overburdened U.S. healthcare system. Voluntary adoption of quality management systems should continue. In this regard, IAMERS Best Practices Committee has prepared for its members some robust QMS templates and guidelines for its members.

Training should be available for both the HTM and independent servicer community. Indeed, some IAMERS members currently both support and train manufacturers engaged in multi-vendor servicing. Future opportunities for collaboration should be explored, as many independent servicers are intimately familiar with the equipment and some older modalities are no longer fully supported by their manufacturers.

Collaboration may occur on many levels. For example, a manufacturer’s representative contributed effectively to an IAMERS committee on the UDI regulation and assisted IAMERS in responding cooperatively to the FDA’s request for feedback.

Sometimes with a new game plan 1+1 = 3. Can’t we take to heart Friedman’s challenges and try to reimagine? Or is it time to take a closer look at whether some of these practices are impermissible restraints of trade? Did I mention I want to remain an optimist?

About the author: Robert J. Kerwin has served as general counsel to the International Association of Medical Equipment Remarketers and Servicers Inc. for over twenty years.