Right to Repair continues to be a hot topic in healthcare technology management. TechNation recently contacted key stakeholders within the medical device repair industry to gather their insights on the Right to Repair. Participants in this roundtable article are College of Biomedical Equipment Technology President Dr. Richard L. “Monty” Gonzales; MultiMedical Systems LLC Vice President of Operation Nicole Palmer; U.S. PIRG Campaign for the Right to Repair Senior Director Nathan Proctor; Elite Biomedical Solutions CEO and Co-Founder Jeff Smith; Innovatus Imaging Vice President of Sales and Marketing Matt Tomory; and Renovo Solutions Chief Operating Officer Andrew Ulvenes.
Q: Why is Right to Repair important for health care facilities?
Gonzales: To better address the question of why health care organizations should be concerned about the Right to Repair, we should emphasize that financial stewardship plays a crucial role in health care facilities. I have read many arguments for and against Right to Repair, but it is undeniable that the issue primarily revolves around financial aspects. By limiting health care organizations’ ability to make informed decisions about maintaining their medical devices, arbitrary restrictions can hinder their ability to exercise prudent financial judgment. The same professionals entrusted to make life and death decisions about patients, should be granted control over the maintenance and repair of their medical equipment.
Palmer: We believe when you own equipment you should have the right to access manuals, equipment, parts, tools and diagnostic equipment. This is especially critical in health care when support could be delayed days or weeks. Critical hours can pass while trying to reach tech support and booking an OEM tech to respond. The loss of revenue when some devices are not operable is affecting health care’s bottom line, patient care and patient safety.
Proctor: Right to Repair is about empowering choice. Not just the ability to choose a repair option that might involve less downtime, or less cost. It’s also about choosing the method of repair that has the best quality. Manufacturers would like us to believe that they offer the best service automatically, but that’s just not true. Sometimes, manufacturers have bought another company, and their servicing quality has taken a hit, but they still charge five times what a local ISO charges, who also does the repair in hours instead of weeks. Meanwhile, the devices fail more often when serviced by this over-stretched OEM. Facing a loss of service revenue, some OEMs would take this opportunity to lock down their service manuals, PM kits, service keys and triple the cost for their trainings – all of which would be aimed at pushing the health care facility to renew a bad service contract. Why shouldn’t the hospital be able to hire the best, fastest, safest option? Sometimes manufacturers do offer the safest service, and for some equipment a health care facility would never choose any other option given the market options right now. But even in those cases, Right to Repair is a benefit. It keeps the OEM honest, forces them to maintain that quality if they want to keep winning those contracts. This is about creating a system with good incentives.
Smith: Medical devices are integral to a health care facility’s ability to provide patient care. Unfortunately, there is shortage of repair technicians in the health care industry, and so hospitals often must outsource device repairs. One significant concern for hospitals focuses on how the Right to Repair fight will impact their ability to repair devices in a timely manner, as OEMs may not be able to repair equipment fast enough or have sufficient available parts. Based on analysis of millions of complaints, a 2018 FDA report concluded that, “the objective evidence indicates that many OEMs and third-party entities provide high quality, safe and effective servicing of medical devices,” and that “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.” Given the importance of medical devices to patient care, we, as a community, must work together for our country.
Tomory: The migration to in-house service has been going on for many years and has accelerated due to rising support costs and the increase in competency of HTM staff. With many organizations performing their own service and maintenance, it is critical they have the proper tools and documentation to comprehensively support the equipment they own and operate as well as ensure it is performing as the OEM intends.
Ulvenes: Hospitals need very responsive, high-quality and cost-effective solutions for maintaining their medical equipment. They purchase and own their assets and they should have the choice in how they manage their life cycle. Right to Repair creates healthy options for health care facilities that allows them to provide the best patient care and experience to those they care for.
Q: How can HTM professionals help the Right to Repair cause?
Gonzales: The most important thing that HTM professionals can contribute to the Right to Repair movement is to be well-informed and engaged. Being well-informed includes understanding the fundamental tenants of the argument, the legislative initiatives shaping the fight, and other trends influencing the national debate. Actively participating in trade shows, HTM associations and other professional forums is also important. Lastly, active involvement in the political process, contacting your representatives and engaging in both public and private discourse on the topic.
Palmer: Ask your local HTM management professionals and follow those working for health care on social media, such as www.prig.org. MMS has worked on initiatives with US PIRG, and many others to raise awareness on this important issue. Write or leave a voice message for your senator or representative. Provide examples of why or how the right to repair affects you and your team and, most importantly, those whom we serve – the patient. We, together as an HTM community, can be a powerful voice!
Proctor: I think there are two ways we need more biomeds and HTMs to help. Number 1 is we need your voice. We live in a democracy, where decisions are made by speaking up, and finding others who agree with you. You should join groups like the Medical Device Servicing Community, which aims at fostering a dialog and collaborative community around these topics and other important issues facing HTMs. You can sign our letter and join the more than 500 other biomeds active on this issue. Number 2 is data and facts. I know hospitals track which device servicers are more effective, faster and how much they charge. Lawmakers need to understand this data to make informed decisions. We are working hard to collect data, but we need more people who can share some of their insights with us without violating patient privacy. The FDA 2018 report is the closest we have, but it doesn’t consider downtime, price or how long a repaired device kept working before failing again. I know people track this, and this data tells a very compelling story about why Right to Repair would be common sense.
Smith: HTM professionals should demand access to the proper manuals/training/parts needed to safely repair and maintain medical equipment, and OEMs should be made to provide that information. Additionally, consumers should reach out to the Federal Trade Commission (FTC) to inform the agency of any concerning practices or statements OEMs may be utilizing, including unsupported statements regarding the safety of third-party parts or when OEMs characterize third-party parts as “counterfeit” parts or “gray market” parts. The FTC has focused on Right to Repair restrictions generally, and the Senate Judiciary Committee’s Subcommittee on Antitrust emphasized the FTC’s continued work combating repair restrictions that allegedly harm consumers, explaining that the FTC is “prioritizing action against business practices that unlawfully restrict consumers’ ability to repair their products, costing them more over the long term.”
Tomory: The HTM team should be involved in all equipment purchasing processes (in my humble opinion) to provide a post-warranty support perspective. During the purchasing process, critical items such as manuals, software (keys), proprietary test equipment, etc. should be negotiated so the health care provider may partially or fully support after the OEM warranty expires.
Ulvenes: There are several things HTM professionals can and are doing to help the cause. One of those is making sure our teams have proper training and skills to repair and support medical devices. In addition, many service providers are ISO (13485 or 9001) certified ensuring that they have quality standards in place.
Q: Can you share an example of a time when you had an issue with a device that Right to Repair could prevent?
Gonzales: I have a slightly different perspective in my current role as the president of the college and can only speak as an authority to that which I am directly responsible. Nevertheless, it is hardly likely that most technicians within the HTM industry would assert their unfamiliarity with the potential pitfalls that could have been averted had they been granted the Right to Repair a device.
Palmer: It is hard to choose just one. As a national company, MMS works with clients ranging from clinics to hospitals. We see how the Right to Repair affects our clients, especially the critical/rural access hospitals. As well as the smaller, independent health care facilities. Due to the geographical areas, they are delayed much longer than their acute care counterparts. Third-party organizations are restricted even further. Owners not only should have access to the necessary tools and diagnostic equipment, but they should be able to transfer access to their qualified and skilled third-party partners.
Smith: As a third-party service provider, I can think of multiple examples, but most recently we have learned that our customers have received letters from the OEM informing them that if they utilized third-party parts on the OEM’s devices, the OEM would not repair or upgrade the device unless the customer paid an exorbitant amount of money to remove the third-party parts. I am both dismayed and disappointed in our community of health care professionals that, instead of working together to serve our country’s patient population, they choose to make false accusations and charge significant monetary amounts that may potentially disrupt health care priorities.
Tomory: As an independent service organization, we engineer solutions to repair OEM MRI coils and ultrasound probes daily so we may serve health care providers, asset management organizations and even several OEMs. We are essentially the forefront of Right to Repair as we partner with these organizations as an OEM supplement or alternative.
Ulvenes: In my years I have seen many issues where Right to Repair has unequivocally benefited health care facilities. Supply chain resiliency is one where having multiple sources/options have proved to have better quality and faster turnaround time. In addition, service responsiveness has been lacking where in-house or third-party service providers have provided instant response because we are onsite allowing continuous operations for health care providers.
Q: How can Right to Repair legislation promote patient safety?
Gonzales: Right to Repair legislation offers tremendous potential to promote patient safety by fostering collaboration and knowledge sharing among key stakeholders, including original equipment manufacturers (OEMs), healthcare delivery organizations (HDOs), independent service organizations (ISOs) and others. By working together on a more evenly defined playing field, these stakeholders can clarify standards, establish uniform practices, and provide the necessary education and training required to ensure the safe and effective servicing of medical equipment and, ultimately, patient safety.
Palmer: The old saying “Time has a way of showing us what really matters.” Giving the device owner’s control would give them freedom to choose what is right for their facility or health care system. This would also give them the right to choose a qualified vendor who best suits their needs. Delay in service equals time lost. Time lost equals compromised care. Reducing inefficiencies in health care would be a win for all.
Proctor: First, I believe that the health care delivery organization has the best and most complete view of patient safety. Right to Repair ensures they have the ability to make choices to repair equipment faster and have more in-house capacity to keep critical devices running. We found that most hospital-based biomeds have had to delay patient procedures because of equipment downtime, downtime they say would be alleviated through Right to Repair. Secondly, there are a set of important safety issues which are caught in an impasse because they involve a false choice between repair access and safety. Manufacturers want to end device alteration, but are pushing for rules which do that by increasing their control on who does repairs. That’s just not going to work. We have a similar fear in the world of cybersecurity which clearly negatively impacts all of us. We need a solution, but one that doesn’t create more control for manufacturers over devices. Once we strike the right balance, we can move forward on all these fronts.
Smith: The momentum continues to build for the Right to Repair cause. It is my opinion that it is one of the most critical fights for patient safety. As a registered FDA company, Elite consciously chooses to certify to ISO 13485 and ISO 9001, and closely follow the FDA’s 21 CFR Part 820 guidelines. I am absolutely in favor of requirements that demand all OEMs and third-party servicers adhere to the same standards.
Tomory: HTM staff are already successfully and safely repairing and maintaining their own equipment using a variety of resources. Imagine the increase in efficiency if they are provided the same tools and documentation as the OEM.
Ulvenes: Legislation must create an even playing field for medical device service/support in order for health care facilities to deliver consistent patient care. The right equipment, at the right time, for the right patient care is critical for patient safety. Data and evidence exists that shows how delays in care create increased mortality and morbidity. Less choices and options will create patient care delays that increase risks to patients.
Q: What else do you think TechNation readers need to know about Right to Repair?
Gonzales: Ensuring the Right to Repair issue does not become overly polarizing is crucial for fostering positive and necessary change in the health care industry. By allowing individuals and health care providers access to repair, modify, or customize medical devices and equipment, we can enhance patient care, reduce costs, and expand innovation. It is essential to strike a balance between protecting proprietary information for security reasons and empowering stakeholders with the necessary tools to maintain and repair critical medical technologies. By adopting a collaborative and inclusive approach, we can address concerns from all sides and drive progress that benefits patients, health care providers and the industry.
Palmer: The Right to Repair could enhance not only patient care and patient safety but promote sustainability. Right to Repair could help reduce electronic waste and replacement costs. Legislation could provide cost savings, which is critical in today’s economy. It is especially critical to help our rural hospitals from shuttering. Skilled technicians can be easily trained to maintain and repair these devices just as the OEM techs have been trained. We should never forget that someone’s loved one is counting on this equipment to be working and ready to go 24/7 and 365!
Proctor: Right to Repair has passed in six different states for a range of devices … but so far, not medical devices. If we want that to happen, we need more people to raise their voices.
Smith: Right to Repair is everyone’s responsibility. It is imperative that we all be accountable and strive for the highest of level of patient safety. That’s why all of us chose this field.
Tomory: There is always a place for the OEM when developing and supporting a successful in-house program. I believe the best path forward for Right to Repair is cooperation between manufacturers and HTM teams to ensure safe, effective and economical equipment repair and maintenance.
Ulvenes: Everyone’s voice is important, and each person can make an impact. I encourage all to get involved and help make sure the Right to Repair effort is supported. We all have the common goal: providing safe and available medical devices for the best patient care. Let’s rally together and make sure we continue to advance this together.