By Dave Francoeur
Our people are in the clinical engineering business because they know that what we do every day to keep medical technology working effectively is critical a piece of our hospital partner’s ability to live their mission and provide the highest-quality patient care.
If something’s broken or not working at its best, our instinct is to fix it.
So, you can imagine how strongly we feel about potentially losing our opportunity to take care of hospital equipment in the ways we’ve done for years. For those of you who haven’t been following industry news over the past two decades, many Original Equipment Manufacturers (OEMs) are pushing to have maintenance and repairs of their devices limited to only their technicians. This issue is known in our industry as “right to repair” – and we’re obviously arguing that we should continue to have that right. This isn’t a new issue just in HTM, indeed we’ve seen similar battles have taken place in the airline and other manufacturing industries. Think of it this way, are you forced to take your car to the dealership every time you need an oil change? No, you can take it to a certified mechanic at your local service station – or even a quick-lube shop.
Already, external service contracts – usually required for a medical center’s most-sophisticated imaging and surgical equipment – take select devices out of the scope of an HTM program, whether a hospital has an in-house team or engages an external partner, like TKA. If the OEMs win the right-to-repair battle, that would potentially make all service out of our reach – something that we’re starting to see happen in some health systems. In the early months of the pandemic, which brought operational stress to the nation’s healthcare system, a survey of 222 biomeds revealed half had been denied access to “critical repair information, parts or service keys.”
If proponents are successful in this quest to restrict the right to maintain and repair work to only OEM technicians, healthcare networks and hospitals risk expediency in keeping equipment clean and ready – representing a significant risk to their mission to save lives and improve patient outcomes. They also risk having to invest significantly more cost in service contracts for this limited pool of OEM-qualified technicians.
Think about it: Say you have 50 devices from 50 different manufacturers. Is it feasible to negotiate – and then manage repeatedly throughout the year – 50 separate service contracts to ensure each device is covered for repairs and maintenance? (Especially if your in-house or current HTM partner is already a mostly one-stop shop in taking care of most of that equipment and supporting your patient needs.)
TKA Taking a Stance
For years, I personally have been invested in ensuring our HTM industry remains a level playing field for everyone, where we all equally share in the right to repair – and no one holds a monopoly. Our TKA leadership has embraced this belief as well and has supported my current outreach with our peers as we look to find the best solution.
Before going a little deeper, let me share a little more background on the issue, which first began to surface in 1996. The Medical Imaging and Technology Alliance got the ear of federal legislators, raising questions about whether service not provided by manufacturers was safe.
A decade later, the issue surfaced again, with OEMs now focused on trying to claim another piece of the broad HTM market, which currently is worth about $17 billion. They argued they were losing market share and having difficulty in selling their products. Again, nothing was decided.
That led to a two-day U.S. Food and Drug Administration session in 2016 where both sides presented their cases, leading the FDA to give merits to each argument with no ruling. Instead, the agency that oversees the approval of medical technology created a collaborative community, bringing together 25 individuals from each of five core subsets of our industry, to help develop an informed solution. Nothing was decided.
Fast forward to today, where the OEM push to have sole right to repair focuses on quality, safe medical equipment repairs – which is exactly what TKA and our peers advocate every single day. The FDA has relaunched the medical device servicing community, with a set of five-person subgroups: Healthcare Delivery Organizations (HDO), ISOs, OEMs, associations and patient advocates. I’m one of the five ISO representatives with voting power. Will anything be decided this time?
Advocating Our Approach
Our opponents have questioned the caliber of HDOs and ISOs, of which TKA is one, on many fronts, but you don’t have to dig very long to find out these don’t bear up in the marketplace:
- Training: TKA is committed to hiring qualified biomeds, and we pay for coursework and testing for our people to gain additional certifications. Through our central procurement group, we look for top-tier training in every type of device, which doesn’t always mean we opt for the OEM program if it doesn’t provide the desired level of instruction and ongoing support. As HTM professionals, we’re dedicated to putting patients first and ensuring our work meets every standard.
- Responsiveness: OEMs claim they can build a network that delivers timely response, as they do to service cutting-edge imaging and surgical devices. But they are very infrequently based in the hospital, at the ready to fix equipment as soon as it’s reported out of service? A front-line HTM team also can strategically refine your required preventive maintenance schedule to maximize your biomeds and their time. On the flip side, if the pool is narrowed to the OEM-sponsored techs, the scarcity will make it difficult for hospital leadership to drive efficiencies.
- Costs: Hiring outside service will always come at a higher cost, both in the actual cost of service and lost revenue as you await that repair and have to pause an important revenue stream in patient care.
Always Being Ready for Patient Care
Significant investments in research and development are what OEMs do best. They are transforming medical technology with out-of-the-box thinking that is leading to the production of amazing devices that are improving patient care. For that, we applaud them.
As it is, devices with cutting-edge technology will always require OEM-led maintenance at the outset as the industry masters the upkeep and repair on these machines, including access to specialty parts.
However, when it comes down to the day-in, day-out need to keep these devices at the ready, the OEMs aren’t positioned to deliver what healthcare organizations need. There’s a tremendous leap from development to service. Just because they designed and built certain equipment doesn’t mean OEMs are the only people with the right to repair and maintain it. Some OEMs have stepped back from this push, perhaps for this very reason.
What we should collectively be pushing for is the adoption of quality management principles across our practice. We need to work together to foster the development of evidence that validates the quality, safety and effectiveness of medical device servicing, which can lead to operational standards.
Some tangential efforts include strengthening related cybersecurity practices, as well as clarifying the difference between servicing (our daily work to clean, repair and maintain equipment) and remanufacturing (which alters a finished device and changes its intended delivery), which is a real risk across our industry.
We want to be partners with everyone across this industry, which will drive the best service solutions to ensure devices are ready and working properly so that patients benefit. When we allow on-site teams to be supported by OEMs, that creates a value chain where hospital leaders see high-caliber products with high-caliber support. When it’s time to replace a device, those same healthcare administrators view the current manufacturer a viable option for the new equipment. We should all work together to provide the best possible outcomes for our clients – our hospitals, who want the best scenarios for their patients.
At the end of the day, we share a commitment to ensuring that the people working on medical technology have the skills and knowledge – not to mention access to manuals, tools and parts – to meet the right qualifications for this critical role. We know there’s always room for improvement, which is why we promote continuing professional development for our biomeds.
We’re even applying those same strong expectations to the company itself. TKA is incorporating an industry-leading ISO-9001 initiative that will elevate the level of our entire program, including procurement processes, technician preparedness and quality management.
We encourage every HTM provider and hospital to take time to explore and truly understand that if we fail in our efforts to keep the right to repair, that will create upheaval in how we work together on our shared missions of quality patient care. Reach out to me with your thoughts and ideas for how we can navigate a solution that keeps the best outcomes for our patients at its core.
Take this moment to discuss this important topic with your hospital administrators. Don’t hesitate to contact me with any questions; I’m eager to keep everyone across our industry informed.