TRIMEDX Senior Vice President of Cybersecurity Scott Trevino was recently featured in an article published in TechNation on the latest developments with Right to Repair and what individuals in the healthcare industry can do to make their voices be heard. The published article, as it appeared April 1, 2023, is below.
Maytag once used commercials to brag in about how long their products lasted. Today, planned obsolescence has led many products to saturate landfills, instead of offering years of use to consumers.
Part of the problem that has led to this situation is the lack of repairability of so many of these items by consumers or local repair shops. Instructions, tools, easy access and replacement parts are all missing in action. This doesn’t seem to be a simple oversight, but a determined decision by the manufacturers.
Many products are just not created to be sustainable. Others are not built to be repairable. The profitability of a company may best be increased or maintained if its products need to be replaced regularly.
The debate has waged for several years now over right to repair within the medical device servicing community. Manufacturers claim that it is a patient safety issue. HTM professionals point out that they are also focused on patient safety, and can repair or service the equipment confidently and safely. There is no argument that anyone is ignoring patient safety. The FDA has already determined that there is not quantitative proof that non-OEM service providers compromise the quality of devices in a way that results in measurable harm.
The manufacturers are entitled to earn revenues and also have rights to intellectual property. To what extent those rights are protected versus providing outside service providers with information needed to service devices is up for discussion. The problem is that there is no discussion going on because there are opposing views and the arbitrators for now are state legislatures and the U.S. Congress.
It appears, to some degree, that some OEMs are getting the message; at least one. The new Apple iPhone 14 is said, by tech insiders, to be substantially easier to repair than previous generations. It appears that Apple has done this purposefully.
Both the screen, and the back panel of the phone, are much easier for a third-party repair shop to achieve. The iPhone has traditionally been a difficult phone to repair because of the need for proprietary tools and the arrangement and construction of internals.
Yet, it is not all wine and roses. Apple has incorporated software that prevents the replacement of components with after-market parts. The changes the company did make came out of pressure from the government and the company’s own customers and investors.
According to The Repair Association (Repair.org), as of January 2023, there were right to repair bills, or public filings, in 16 states, including Vermont, Colorado, Connecticut, Missouri, Montana, Oklahoma, New Hampshire, Texas, Washington, Delaware, Florida, New Jersey, Tennessee, Hawaii, Massachusetts and Oregon.
There are already bills that passed in Colorado and New York.
An investigation by the Public Interest Research Group (PIRG), Repair.org and iFixit of 50 appliance makers found that 86 percent did not supply full repair instructions. It is evidence such as that which mandates more effort in this campaign.
Wesley Reid, CHTM/CRES/CBET, director of Technology Management/ENTECH at Banner Health; Kevin O’Reilly, right to repair campaign director for PIRG and Kelly Starman, chief marketing officer at PartsSource, co-presented a TechNation Webinar Wednesday session last year titled: “Reclaiming Our Right to Repair: Understanding Challenges and Taking Back Control.”
The webinar looked at the current state of right to repair as it impacts the HTM profession and suggested ways for biomeds to address the issue.
Who Holds the Power?
While the right to repair movement has pitted consumers and public-interest groups against manufacturers, it has also caused tension between the HTM community and OEMs.
“There is a shortage of repair technicians in the health care industry and the main concern for our customers is around how right to repair will impact their ability to repair devices in a timely manner to maintain uptime and positive patient outcomes. Not all OEMs contribute to the right to repair challenges, which we emphasize as partners with both providers and OEMs to improve the availability, quality and affordability of patient care,” Starman says.
She says that one of her firm’s most passionate customer HTM leaders explains this situation as a continuum.
“At one end are manufacturers that collaborate with providers and willingly supply the information and tools to uphold the shared focus on patient safety. Manufacturers with no options for providers appear at the other end of this continuum, which is the focus of this movement,” Starman says.
The manufacturers who offer no options believe that non-OEM repair is inferior and presents a danger to patients. They also believe that providing diagnostic tools or replacement parts could result in trade secret theft.
The pandemic pointed to one downside of depending on outside service and repair, when many field service engineers (FSEs) were either not available or their presence provided a concern for either hospital safety or the safety of the FSE. Many of the FSEs were sick or hospitals had to put new infection control protocols into place that limited visitors.
Similar problems can present themselves outside of the extraordinary circumstances of a pandemic, such as when adverse weather conditions, weekends or supply chain issues provide obstacles to the availability of an outside source for repairs or service. There are often problems with availability of the OEM service person with substantial premiums for expedited service.
Within the tug-of-war that often exists between medical device OEMs and HTM professionals, as it relates to the right to repair issue, the OEM often wields more political persuasion.
“Industry groups that oppose expanding the right to repair have significant access to federal policymakers, which has been one of the most significant obstacles to action at that level of government. These groups represent manufacturers and have found success advancing claims that the right to repair presents safety risks. While data has thoroughly debunked these claims, we need to build support and spread awareness among those most impacted to make sure that legislators hear and understand this message. This includes the public as well as the hospitals and care facilities that rely on advanced medical technology every day to treat patients,” says Scott Trevino, senior vice president at TRIMEDX.
He says that despite challenges at the federal level, there are encouraging developments.
“Many state legislatures have been introducing bills focusing on right to repair. Advocacy groups are more vocal than ever in protecting the right to repair, and even the rise in popularity of the term ‘right to repair’ among the public shows progress in advancing the cause,” Trevino adds.
Challenges for Biomeds
There is little gained by HTM professionals complaining about right to repair and the barriers and frustration they may experience when confronting this issue. The only way any change can come about is if HTM professionals use a collective voice to address their concerns to state legislatures and their U.S. House and Senate representatives.
If the representatives at the state and federal levels hear from enough constituents with the same concerns, then they will have incentive to advance those concerns when crafting new legislation.
What information is often withheld by OEMs that is required for servicing or repairing medical equipment?
“First the basics of a service manual with PM procedures and checklists are required to properly perform preventive maintenance and calibration verification in accordance with CMS, TJC, DNV, state and/or hospital regulations and policies,” Reid says.
He says that sometimes there are specialty tools such as calibration keys, phantoms, and passwords or dongles to bypass OEM software locks that are needed as well, depending on the nature and complexity of the device or system.
“Schematics, circuit theory, and part breakouts with parts identification are necessary on the repair side of the house. These are required to first understand and reference the circuit theory in order to intelligently troubleshoot the device or system. Then, by utilizing the schematics as a physical map of sorts, while measuring the inputs and outputs of the actual components with our test equipment, we can isolate the faulty component, board or assembly,” Reid adds.
He says that circuit theory in service manuals used to be the way we became proficient in understanding the operation of the device. Currently, the OEMs mostly omit that from the service literature provided to non-OEM technicians.
“At the DoD BMET school, students are taught to read and interpret circuit theory so that they do not need to attend manufacturer schools on every device and can troubleshoot down to the component level if necessary,” Reid says.
Even trained biomeds face roadblocks.
“Imaging modalities are at the front as the imaging-specific OEMs have led the way of taking away the rights of the equipment owners. Sometimes the access of local BMETs, when they have OEM training, is limited to the serial number and has an expiration. This has caused delays to bringing the equipment back on line even though the technician has had a proven track record of solving similar problems,” says Tony Cody, CHTM, tech management/ENTECH director at Banner Health in Colorado.
Cody says that the lack of right to repair help has increased the cost of ownership, thereby taking away an opportunity to acquire additional/better equipment. He says that it has also increased the downtime of equipment.
“BMETs are spending more time doing administration and less time maintaining and repairing equipment. It is causing frustration and disengagement of the BMETs,” he adds.
Make Your Voices Heard
What can the HTM community do to support right to repair? Every member of HTM should contribute to making their voices heard and taking action.
Sign a letter to state legislators to voice your support for right to repair. Document incidents expeditiously as they occur. Join the Linkedin Medical Device Servicing Community group.
Negotiation at the point of a capital purchase provides a strong bargaining position. Bring concerns to leadership in HTM so that those concerns can be relayed to the C-suite.
“Biomedical technicians can act in many ways to help stakeholders who can affect change understand their challenges. Even at the individual level, technicians can keep colleagues and leaders in their health systems informed of how access to materials, technical information and repair services affects day-to-day operations,” Trevino says.
He points out that there is strength in numbers, so getting more involved with professional groups and associations is a great way for biomedical technicians to amplify their message and reach the public and policymakers who are not as directly connected to health care operations.
“Educating others on the real-world experience that technicians have in such a vital sector builds a compelling case for the benefits that right to repair legislation could have throughout the health care system, from providers to patients,” Trevino says.
There are real budgetary considerations as well.
“The patient is the one that ultimately suffers. In-house BMETs can respond quicker than an OEM FSE. This allows the clinicians to have resources they need to provide the best care,” Cody says.
He says that having a fully supported OEM-based service model is not sustainable.
“The financial expense is much higher. The likely COSR increase would be 15 percent or greater instead of an industry average 4 to 6 percent. The infrastructure for supporting the increase volume of work is not in place for the OEMs to provide quality and timely repairs,” Cody says.
“I have seen survey responses from biomeds who feel like they are not able to make a difference, and that is not the case. Every biomed can be part of the change in right to repair. They can make valuable contributions by: staying informed, following the conversation, recognizing when their rights are violated, documenting these situations, and sharing their stories internally and with peers,” Starman says.
She says thanks to TechNation for providing the incident tracker to make documentation a convenient process.
“It is also important for biomeds to share this data with their leaders and upstream in their organizations. They can impact change when they speak up and ask vendors for the repair materials needed to uphold patient safety,” Starman adds.
“To build momentum further, staying informed on legislative developments is essential. Policy proposals are often complex and affect people and industries in ways that are not always apparent at first glance,” Trevino says.
He says that the level of advocacy that has helped advance the right to repair in recent years is only possible with informed, vocal stakeholders.
“Helping policymakers understand the real impact on patient safety and efficiency in health care puts into context what is truly at stake. Hospitals can’t depend on legislation alone and should also focus on making progress within their organizations. Taking full advantage of the right to repair means making sure that biomedical technicians have access to the best possible training to deliver reliable service and maintenance across medical device inventories that are constantly growing in size and complexity,” Trevino adds.
Reid says that Medwatch form 3500 can also be used to voluntarily report adverse equipment related events to the FDA.
“Let your supervisor know if you see something that doesn’t look right, such as charging twice or more for travel when multiple devices are co-located on a repair quotation. Or perhaps, you are unable to get basic parts for a device well within your capabilities of repair due to claims from the OEM that you are not qualified. As a director, I am oftentimes successful at getting fair and reasonable results from the regional service and sales managers when these issues are brought to my attention from my team of professionals,” Reid says.
“I implore each of you reading this to join the resistance and fight for your right to repair. Because we’re not going to take it, anymore,” Reid adds.
TechNation, an advocate for right to repair in health care, offers a web form where biomeds can report incidents where an OEM has declined to provide keys, parts or technical assistance.
Find it at 1technation.com/right-to-repair-incident.