Mike Busdicker: Is ‘Right to Repair’ the Core Issue?

This year, I had the opportunity to attend a conference and take part in panel discussions with the main topic of “the customer comes first.” A number of the questions posed to the panel centered on what service organizations could provide to their customers. This is not a new subject—this has been an area of focus for my entire 35-year career in healthcare technology management (HTM). Unfortunately, technology has advanced at a much quicker pace than the ability of service organizations to work together to meet the needs of our customers.

In fact, I believe we as an industry have lost the true identity of the actual customer. We need to get back to the basics and understand that the real customer is the patients being serviced by our healthcare organizations. In the pursuit of revenue generation and market share, service organizations in HTM have developed an “us and them” mentality. This way of doing business is not breaking down the barriers for collaborative relationships. It is creating obstacles that potentially drive up costs and adds to the mistrust between service organizations.

People in the HTM industry are aware of the ongoing discussion about the “right to repair” medical equipment. The decisions around this very important topic could have a significant impact on healthcare organizations that will filter down to the patients. In my opinion, we must consider the potential effect on our patients before restricting service organizations from the right to repair.

To be clear, I am not just talking about considering the potential impact on costs. We must ensure that patient and caregiver safety is included in the evaluation process. I believe most of these areas could be addressed through full adoption of current standards developed by regulatory agencies and guidance from organizations like AAMI. Of course, there are some areas requiring further clarification and these could be covered through the development of a quality service standard or quality measurements system.

Most people within the HTM industry have an opinion about the right to repair, development of a quality measurement system, and certification of personnel, processes, and companies outside of the original equipment manufacturer. I believe there is a place in the market for all service providers, but we do need to implement a system of checks and balances. In doing this, we must make sure we are keeping our patients and caregivers safe but not driving up healthcare costs. All service providers (including independent service organizations, manufacturers, third party, and in-house programs) must work together to create a “win-win” for all parties.

In the long run, this will benefit healthcare as a whole and also create a win for our patients. It’s time to stop working against each other and start working together for the benefit of our “true” customers.

Mike Busdicker, MBA, CHTM, is system director of clinical engineering at Intermountain Healthcare, which is based in Salt Lake City, UT.

3 thoughts on “Mike Busdicker: Is ‘Right to Repair’ the Core Issue?

  1. This is just my thought… Electronics are electronics are electronics… every device that has patient connections are electrically isolated via opto-isolators and transformers. Meaning that the data from the patient side of the device is transmitted by light to the main part of the main board. The power for the patient side is provided by a transformer from the main side of the board isolating the patient side.. Non-electronic techs have no idea what that means and think that patient safety is a concern on monitoring equipment… even though the patient is completely isolated from any wall power. The OEMs know that unless you have a electronic degree you would have no clue to this fact and use this misconception as leverage to overcharge and downplay our intelligence using fear of patient safety as their motive. Their fight is not about patient safety its about monopolizing the market and lets face it when they charge $27.00 for a .05 cent spring all they are doing is driving up costs.

  2. I wish the author had provided some specifics about what he considers to be patient interests that aren’t being met (in the context of this topic, of course), citing either published sources or even his own or people he knows’ experiences as a patient. Even a hypothetical scenario depicting the issues that right to repair implies for patients would be helpful.

    I have one: Imagine a hospital with no in house repair capability or availability of a third party that services the full spectrum of medical devices. Imagine all service being provided by each manufacturer’s service organizations. Set aside cost and equipment management issues and just focus on what that would mean for the point of delivery of care.

    I have worked with numerous manufacturer engineering and technical professionals over decades, and one thing I feel quite comfortable asserting is they don’t appreciate how their equipment fits as a participating component in the device menagerie that is a bedside system. They don’t. Because they can’t. Because they necessarily have to focus on the devices for which they are trained to provide service. And as the point of care becomes increasingly complex, that matters.

    For a complex system problem, which manufacturer should the hospital call? Should the hospital call all the manufacturers with devices at the point of care? How will they work together? How will caregivers work with them? How will they schedule their arrivals? What should be done to maintain the quality of patient care delivery while all of that is going on?

    This is not simply a hypothetical concern but one a diverse group representing manufacturers, providers, and regulators worked on when I was active in the development of the Responsibility Agreement guidance document for the 80001 standard. It was very difficult for that group to come to consensus, primarily because manufacturers were hesitant to share information with a “Responsible Organization” (typically a hospital risk managing its networks) that other manufacturers might need to see to jointly resolve a problem (I left the process before the document was completed and do not know how it was resolved).

    I could cite other scenarios, but I’ll leave that to others who bring different perspectives. I see the seemingly never ending “right to repair” argument as one of a larger set of broad medical technology systems issues. The author is spot on in stating that patient and caregiver safety issues are crucial in the discussion, hence my challenge to the field to explicitly identify as broad a set as possible. And I challenge the field to further broaden the scope to broader system and technology management concerns, e.g., applying system safety engineering principles to the design of the point of care, in part because what is going on at the point of care while one of its components is being serviced is more important than who provides that service.

  3. Mike raises a lot of good points. to me it is all about serving my caregivers, I am never happy when an OEM chooses to put their needs to drive their service revenue, above my mission to support my caregivers and their patients. If you or a family member were undergoing surgery, would you want your surgeon using a piece of equipment on you that the surgeon’s Biomed staff were intentionally kept in the dark about by a medical equipment manufacturer? What if the only answer you can give the MD is “sorry doctor, if you say its broken, the only thing we can do is ship it to the factory for service” (And yes I have been told exactly this by an a major OEM rep earlier this week.)

    Most people have no context to even understand the issue. put another way… Would you want to fly on an airliner if you knew that the builder of that airliner had a installed a software key that intentionally turned off many of the gages and indicators for the engines and flight systems so the pilots and flight engineers could not monitor their performance and would have to bring the plane to the factory hangar for any problem? Can you imagine a pilot in flight calling the factory and saying “there is a funny sound in my left engine and I need to see the fuel pressure, oil pressure and temperature”, and the factory guy comes back on the radio and says, “well we cant turn that on for you or tell you what you need to know, but if you land at our hanger in new York our techs can come out on the ramp next Tuesday and check it for you and let you know if we find something” coming from an airline family, I know this is not the case but…. We would never tolerate airliner manufacturers doing what many medical equipment manufacturers are doing routinely. Airlines would never buy jets from a company that did this.

    In most if not all hospitals, HTM departments either purchase the equipment or play a major role in purchasing. Why are “WE” not doing a better job of curbing the worst practices of the OEMs that don’t want to support us?

    Pilot – “There is smoke coming from the engine, I need to access fire suppression !” OEM guy – “I’m sorry, that’s proprietary, I cant give you the access code to use that menu.”
    Pilot – Mayday – Mayday – Mayday

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