Changing laws is often a grass-roots effort. The Founding Fathers believed that the political-legislative machine should be as close to the people as possible. That is why there are city councils and state legislatures. Keeping all the power vested in Washington, D.C. separates it from local decision-making.
There is a balance instead, a result of federalism.
The nature of the American system is that new laws, and changes to existing laws, can be initiated at the grass-roots level. When laws are needed to protect or support the average citizen, then an effort can be made to influence lawmakers.
This benefits taxpayers and consumers. The consumer exchanges hard-earned wages for products. If the product breaks, a resourceful consumer can often repair it without incurring too much additional cost.
When the ability to make a repair is withheld by a manufacturer, using the argument that restrictions on repair information and parts are meant to limit who can repair things to those the manufacturer deems qualified, then the consumer is left with few options.
Manufacturers claim this is a safety and quality issue. More recently, they have expressed concerns about cybersecurity vulnerabilities if an unqualified person makes a repair.
While many initiatives were put on hold during 2020, the right to repair movement gained more traction with legislation in 22 states. Indeed, the movement gained momentum.
Changes in laws to support the right to repair have not been limited to the U.S. It has also been a focus of legislation in the European Union.
In Europe, manufacturers are now mandated to make many common household appliances more easily repairable and long-lasting. In 2018, Apple customers in Australia won a right-to-repair lawsuit against the big brand when it told customers, who had devices that were inoperable, that they were not entitled to a fix because they had their devices previously serviced by non-Apple entities.
While the right-to-repair topic was covered previously in TechNation cover stories, and the issues that impact the HTM community have remained largely the same, the attention on the topic has increased.
By the beginning of 2020, there were 15 states with active bills addressing the concerns of consumers focusing on all kinds of products.
The issue has garnered substantial attention outside the HTM community also, as farmers, backyard mechanics and consumers have all found fault with the premises that handcuffed them in regards to self-service or repair.
For HTM professionals, the questions often asked include “Why don’t I have easier access to operation and service documentation and special tools? Why are these things proprietary? If it is required, why is it not provided? How are you ensuring recommended procedures are followed if you do not have them? What is the effect on cost to the consumer of health care?”
“There are roughly 22 to 25 bills expected to be active in states this winter. Of these, roughly half will focus on categories of equipment other than medical – ranging from bills for home appliances, farm equipment, mobile devices and batteries. The other half are more ambitious and include everything with a chip; including medical equipment,” says Gay Gordon-Byrne, executive director of The Repair Association.
“We won’t know for another few weeks which bills will include the medical equipment category but we are prepared to discuss how existing regulations should already prevent right-to-repair monopolies in medical equipment but lack enforcement,” she adds.
Byrne says that right to repair for medical equipment is being fought in Congress, led by Senator Ron Wyden of Oregon.
“We think the bill has great merit but will dip deeply into the patents and copyrights that already legally protect manufacturers. I doubt he’ll be able to move the bill with these provisions,” she says.
“Right to repair in states is being led by our Repair.org coalition – which now includes more biomeds and ISPs advocating with us in front of legislators. IAMERS has been a long-term member of Repair.Org and is engaged as well,” Byrne adds.
The year 2020 brought a renewed focus on the right to repair issue for several reasons. The ability of repair persons to interact with customers, or enter homes or businesses, was hampered in many ways.
When Ralph Waldo Emerson first said, “build a better mousetrap and the world will beat a path to your door,” he was probably not thinking about creating a database of repair manuals, but that concept has proven successful.
The website iFixit hosts 69,539 free repair manuals. The service was started in 2003 by two Cal Poly students in San Luis Obispo. It has 52 categories of brands/makes/models of ICU, transport, neonatal, and PAP ventilator repair documents.
When OEM documents are not available, the website offers the potential for useful information.
“Twenty-twenty was quite the year for right to repair. Our medical ventilator project was definitely a highlight, but here are a few other milestones we hit in the last half of the year,” says Olivia Webb of iFixit.
“France announced that they are requiring repairability scores to be published on the packaging of specific products, and we started offering consulting services to help manufacturers comply,” Webb says.
She says that a few months later, the European Parliament voted to make repairability and product lifetime labels mandatory
“In the November election, Massachusetts passed the world’s most advanced right to repair legislation; a law that requires car manufacturers to allow consumers access to their car repair data,” Webb says.
“We submitted requests to the Copyright Office to let us repair software-locked game consoles,” Webb adds.
iFixit is just one online resource that provides technical information to help biomeds and others maintain and repair equipment. Another is MedWrench.
MedWrench, available at MedWrench.com, is a product-focused support network where medical professionals, purchasing administrators, manufacturers, dealers and industry experts can provide opinions, share ideas and gather relevant information on medical technology and equipment.
MedWrench has more than 111,000 registered users who help provide valuable information to the HTM community. It includes a service directory, forums and a link between medical equipment sellers and buyers. It covers topics such as calibration, training, preventative maintenance and technical support.
Many of the site’s “gurus” provide advice, tips and more to help HTM professionals regarding a variety of topics such as PM tips, strategies, troubleshooting tips and ideas for career advancement.
With a renewed focus on right to repair, and alternatives to OEM-reliance availablity, the needs of the HTM department continue while being exacerbated by the impact of a pandemic.
“When a caregiver’s needs, perceptions and/or expectations of a technology fails to be in alignment with the clinical situation, biomed is called in to solve the issue. For this we rely on our relationships with our caregivers, our training and education, our knowledge of hospital and clinical systems, context and practices, our clinical engineering teammates and countless other things that one will never see in a factory service manual,” says J. Scot Mackeil, CBET, a senior anesthesia BMET at an academic medical center in Boston.
He says that the biomeds of today are far more diverse in their capabilities and roles than they were in the past.
“Having access to service manuals, procedures and parts are important to us for many reasons. We are capable of rising above challenges. BMETs and CEs are not defined or limited by what we have or don’t to work with. Our first priority is to the caregivers we serve and their need to have functional technologies to deliver safe, effective and equitable care for all our organization’s patients,” Mackeil says.
He says that in a perfect world, all OEMs would collaborate with biomeds in this work but you can’t have it all.
“Hopefully, things will change thanks to all those involved in the right-to-repair movement,” Mackeil adds.
“Access to manufacturers’ service documentation and materials (e.g., troubleshooting guides, schematic diagrams, parts lists, etc.) has been a problem for in-house HTMs and independent service organizations (ISOs) for as long as I’ve been in the industry (more than 45 years),” says Stephen L. Grimes, FACCE, FHIMSS, FAIMBE, AAMIF, principal consultant at Strategic Healthcare Technology Associates LLC.
“In-house HTMs and ISOs who are trying to ensure quality and safe support services (e.g., scheduled maintenance and repair) benefit when they have access to manufacturers’ service documentation and materials. With this kind of information, they can both judge which services they are capable of delivering safely and effectively themselves [and] have the guidance they need on when and how to deliver those services,” Grimes says.
He says that, unfortunately, many manufacturers (particularly the large, national medical device manufacturers) are very protective of this information. These medical device manufacturers (MDMs) variously claim that this information is 1) proprietary or 2) that it encourages non-qualified servicers to attempt to conduct scheduled maintenance and repairs.
“Not surprisingly, most in-house HTMs and ISOs have a different view of MDMs’ actual motives for restricting access to these materials. Most HTMs and ISOs believe MDMs’ concerns (regarding proprietary material and risks of service materials falling into the hands of unqualified servicers) are disingenuous and that the MDMs’ reasons for not sharing are more often than not fear of perceived competition for service revenue from the in-house HTMs and ISOs,” Grimes adds.
He says that the bottom line is that service materials are required for effective service. Failure by MDMs to supply the necessary tools, service keys, test equipment (including software) and education will undoubtedly compromise, or at least limit, servicers abilities.
Not everyone in HTM believes the issue of right to repair is focused on a bilateral contest of thought. Maybe there are other factors to consider.
“Maybe this is a slightly different take than most when it comes to the right to repair issue – of which I’m supportive by the way – however I’ll share it nonetheless. Sorry if it comes across more like a blog, however I’m sort of tired of how this issue is being debated because I’m not seeing many people support patient care/outcome advocacy and that should be front and center in my opinion. Maybe this belongs in an op-ed piece; however, I believe that most of us have it all wrong,” says Perry Kirwan, vice president of technology management at Banner Health.
“This issue (I guess like most issues these day) tends to be one of polarization. Supporters of ‘right to repair’ galvanize around the shortage of qualified repair personnel, access/restriction (tools, passwords, service personnel, etcetera), choice (the ability of the technology owner to make decisions on managing/supporting that technology), and the inherent costs of what that means,” Kirwan says.
He says that opponents of right to repair typically cite patient safety/risk, that it’s giving unregulated, third-party medical device service companies unfettered access to proprietary service materials and tools to maintain and repair sophisticated, highly regulated medical devices, medical device cybersecurity implications, disparities in accountability (FDA oversight, adopting/adhering to quality management systems, etc.) between original equipment manufacturers and non-OEM service providers, and denial of a labor shortage of qualified personnel.
“What is seemingly missing in the discussion is who it is that we are all trying to collectively serve – and that is the patient. Many of us profess to engage in the concept of patient-centered care, however most issues cited by either side get tainted by things other than that. My supposition is that if the support of medical technology was evaluated through that all important lens – we wouldn’t be debating and, frankly, squabbling about that the things that we are, as they do not have much to do about the patient in the end analysis,” Kirwan says.
“But the problem is that the patient doesn’t make for an easy punching bag. Who is against optimal patient care? And so, both sides conjure up other points in the interest of sounding like they are championing patient care. These points make good soundbites, however, in the end they allow the larger discussion to completely reset based on how we choose sides to fight each other,” Kirwan adds.
Kirwan asks; “And, what is the collective we are fighting for?”
He says that if one didn’t know better, it appears to be revenue generation, market share, property rights, who gets it, who doesn’t, and the list goes on.
“What we don’t hardly see is a discussion that is patient-centric, because if we did; sides would be sitting down with each other designing solutions that actually help realize the triple/quadruple aim for health care,” he says.
In 2016, the FDA put out feelers to get a reading from the medical device manufacturer and repair communities. Responses came from OEMs, HTM professionals, ISOs, The Joint Commission and other stakeholders. The agency’s updated perspective is as follows.“The FDA’s authority to regulate the servicing of medical devices by any entity, including original equipment manufacturers (OEMs) and independent service organizations (ISOs), is grounded in the agency’s authority to regulate medical devices and radiation-emitting electronic products under the Federal Food, Drug and Cosmetic Act,” says FDA spokesperson Shirley Simson.
She says that the act mandates that all devices have a reasonable assurance of safety and effectiveness.
“The applicability and enforcement of regulatory requirements by the FDA depends largely on the specific activities performed by an entity. FDA generally has not enforced requirements for servicing activities, including those performed by hospital biomedical engineers and technicians, as long as they don’t significantly change the device’s performance or safety specifications, or intended use,” Simson says.
She says that while FDA is responsible for the oversight of servicing of medical devices, several other organizations play an important complementary role in the safe and effective servicing of medical devices, including the Centers for Medicare and Medicaid Services (CMS) (conditions for receiving federal payments for health services), state regulations for repair of medical equipment, standards development organizations such as the Association for the Advancement of Medical Instrumentation (AAMI) and the American National Standards Institute (ANSI) and health care facility accreditation by organizations such as The Joint Commission which operate independently.
“The May 2018, FDA Report on the Quality, Safety and Effectiveness of Servicing of Medical Devices summarizes perspectives and needs of stakeholders based on FDA’s evaluation of the available objective evidence related to the quality, safety and effectiveness of medical device servicing, including information received via the 2016 public workshop and nearly 200 written public comments. Further, as indicated on CDRH’s Proposed Guidance A-List, FDA intends to issue draft guidance on Remanufacturing of Medical Devices in 2021,” Simson adds.
During an otherwise dismal year, the right-to-repair issue gained some traction and that can’t hurt the overall effort. If victories are won for auto repair, cellphone repair or even harvester repairs, in state legislatures, it can help build the foundation for more access for medical device repair.
It is all about momentum. There has to be a give and take which satisfies all parties. In the end, as Kirwan points out, the “true customer” must be the focus.
“From the lens of the patient – we are actually stronger and more effective working together rather than against each other. So, if the voice of the true customer, the patient, says work together – how do we expect to further advanced patient care and outcomes doing the opposite?” he asks.
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