Industry leaders mull actions HTM professionals can take

By Chris Hayhurst

As a clinical engineer, a technical consultant, and the director of quality and regulatory affairs with a medical device manufacturer, Binseng Wang, ScD, CCE, FAIMBE, FACCE, is a very busy man. So when he decided to sit down and write a letter last summer to a politician he’d never met but hoped to sway with his words, he knew he’d better make the best of his time.

“Dear Senator L’Italien,” Wang began, addressing the representative in the Massachusetts State Senate, “This is to provide information and comments to support the bill referenced above that is being reviewed by the Joint Committee on Consumer Protection and Professional Licensure.”

That bill, S.96, “An Act Relative to the Digital Right to Repair,” would guarantee product owners the right to repair electronics like smartphones and computers. It would also require manufacturers to give independent repair technicians reasonable access to replacement parts, security patches, and service information. The bill excluded class III implantable devices, but other medical devices would be covered if it was signed into law.

Big manufacturers had come out against the bill for all “the typical reasons,” Wang recalls now (his company specializes in sprints and braces and would be unaffected by the bill).

His letter to L’Italien focused on the manufacturers’ arguments—“(1) the need to protect proprietary information, (2) the alleged lack of regulation of medical device maintenance, and (3) the alleged risks to the safety of patients and clinical professionals due to improper maintenance”—and proceeded to make the case that each was unfounded.

On the first point, Wang wrote, a manufacturer’s proprietary information can be protected with patents and is almost never needed for maintenance anyway. Furthermore, device makers who sell their products in Europe are already required by European Union law to release maintenance information, so “there is no reason” they shouldn’t do so here, as well.

On the manufacturers’ second argument—that a lack of regulation around device maintenance meant releasing information would increase their liability risk—Wang pointed out that the FDA had investigated the need for regulation. “There is no statistically significant evidence of problems caused by maintenance to warrant such an action,” he wrote.

Wang also noted that the Centers for Medicare & Medicaid Services already oversees “the vast majority” of medical device maintenance, and that state agencies regulate such maintenance, as well.

And finally, in addressing manufacturers’ concerns around the safety risks of maintenance activities, Wang provided a list of studies and other supporting documents showing “there is no statistically significant evidence of patient safety risks caused by improper maintenance to justify withholding maintenance information.”

In fact, Wang wrote, when manufacturers keep such information out of the hands of qualified technicians, it is “more likely to induce unsafe practice that can negatively affect the well-being of Massachusetts patients and clinical professionals, in addition to almost certainly increasing the cost of healthcare.”

Make Your Voice Heard

The “right to repair” bill that had Wang’s interest, and which is still under review by the Massachusetts Senate, is one of about a dozen in states across the country, according to Gay Gordon-Byrne, executive director of The Repair Association.

Her organization, Gordon-Byrne says, advocates for anyone involved in the repair of technology, whether it’s home-garage hobbyists or biomedical equipment technicians, and maintains a website (www.repair.org) that connects people to their state representatives so they can stand up for their right to repair.

“A lot of legislators look at these bills and say, ‘We understand that this an important issue for consumers who want to repair things like home electronics and refrigerators, but we have to draw the line somewhere,’” she explains. “So where do they draw the line? At medical equipment. And it’s often because they’re misinformed about what biomeds are qualified to do.”

For that reason, Gordon-Byrne encourages other HTM professionals to follow Wang’s lead and make their voices heard. “We can’t explain it in the way a biomed can convey the issues; it really needs to be explained in a compelling way.”

Otherwise, she says, legislators will just listen to industry lobbyists arguing such bills would threaten patient safety, “when we know the real reason is they want to control their revenue.”

To be most effective, Gordon-Byrne recommends, start by calling your legislator’s office and asking for a face-to-face meeting. “Most people think, ‘There’s no way they’re going to meet with me—I’m just an ordinary person.’ But at the state level, ordinary people are individually important because elections are sometimes won by a couple hundred votes.”

If a meeting seems out of the question, she says, the next best approach is to convey your message over the phone. “Tell your story, that this is about your livelihood, to whoever it is that happens to answer. You can be sure that if you’re their constituent, they’re going to listen to what you have to say.”

Last, Gordon-Byrne says, write letters like Wang’s. “A meeting is worth at least a hundred phone calls, and a phone call is probably worth a hundred emails. But if you can write a letter, please just do it. It will be read, and if you work in a hospital and can speak to your experience, chances are it’s going to help.”

Tips from the Frontlines

One person who does work in a hospital and has spoken up for the “right to repair” is Scot Mackeil, CBET, ACCE, N1JSM, a senior anesthesia biomed with a 1,000-bed academic medical center in Boston. “For frontline biomeds and HTM professionals,” Mackeil says, “the right to repair is the key issue for us and essential to our mission.”

Like Gordon-Byrne and Wang, he implores biomeds, regional HTM societies, and “even ISO groups” to “be engaged” by becoming politically active. In his own case, Mackeil says, he’s currently focused on working locally with Gordan-Byrne, as well as the American College of Clinical Engineering’s Stephen Grimes and repair.org’s Tom Carnery to meet with Boston legislators to facilitate what could become the nation’s first right to repair bill.

He is also asking colleagues to write in opposition to a Medical Imaging & Technology Alliance-sponsored American National Standards Institute-National Electrical Manufacturers Association national servicing standard before December 18. After all, Mackeil says, if ANSI adopts the standard, it could lead to regulatory requirements that will make the compliance side of servicing imaging equipment far more burdensome and costly for the American healthcare system.

“This standard, which is tailored to the needs of global multi-national imaging device manufacturers, could be catastrophic for HTM departments and ISOs and could compromise patient safety by diverting HTM resources from providing support to caregivers and patients,” Mackeil adds.

Furthermore, he says, the industry’s current quality systems “are not broken, nor in any way in need of additional quality standards or regulatory burden,” he adds. Mackeil also suggests that biomeds work with their own facilities at the administrative level to ensure any new purchases include terms supporting their right to repair.

And last, he says, they can gain the upper hand on service manual access by insisting to vendors when a new device is initially inspected that they provide them with PDFs of the operator’s and factory service manuals. “If they refuse or make excuses, say: ‘I’m sorry, your device failed the inspection. You’re welcome back when you can provide the required documents.’”

Biomeds can use the Joint Commission standard EC.01.01.01, EP 3 “as a rationale for this requirement,” Mackeil says. “It’s a problem largely of our own making, but by insisting on service manuals up-front, it will help turn the tide. Managers can support it, and BMETs and [clinical engineers] can make it their default practice.”

Barbara Maguire, CHTM, CCE, MBA, vice president of quality and Geisinger Clinical Engineering with Langhorne, Pa.-based ISS Solutions, agrees with Mackeil that HTM departments and their leadership should speak up for their technicians’ right to repair, and that biomeds themselves “should reach out locally” to their lawmakers.

“I understand why manufacturers have certain requirements, and I think it’s reasonable that they have standards around the qualifications of those who work on their equipment. But when a manufacturer doesn’t provide a path for us to do our jobs, that’s a problem, and that’s where I think we need to be proactive.”

In her company’s case, Maguire says, many of their equipment technicians have undergone manufacturer-led training to satisfy vendors’ concerns they can service equipment as necessary. “When we call to order a part for an infusion pump, they’ll ask us, ‘Who is this part for? Who’s going to do the work?’ They want to make sure that person is qualified.”

Sometimes, however, even technicians who are clearly qualified can’t get access to the parts or service information they need.

“And that’s frustrating,” Maguire says. “When a vendor won’t give us the calibration procedure for a pump and it’s something that we could do very easily, there’s no reason they should keep it from us and delay getting that equipment back in service.”

Maguire says they’ve managed to minimize right-to-repair issues by working with their supply chain during the equipment-purchasing process. “If they have a pending order, they’ll get our input on what we need for service. And if we say, ‘yes, we want training for technicians,’ or ‘we want them to give us a shared-service contract’ or to let us do preventive maintenance, they’ll talk to the vendor and try to get them to agree.”

Sometimes, vendors will cite FDA regulations that supposedly prevent them from allowing such concessions. Maguire calls that a “poor excuse.”

“They might have to ensure that the quality of their parts are tracked, or that we have a mechanism to report any defects we see during servicing, but there are no restrictions around giving us access. There are certainly ways they can comply with any requirements while still allowing us to service the equipment.”

Put It in Writing

Patrick Lynch, CBET, CCE, CHTM, CPHIMS, FACCE, a longtime biomed now working as a consultant, thinks HTM professionals should approach the right to repair knowing that, for now, “that right does not exist.”

There are certain bills currently under consideration, including the one in Massachusetts, but so far, he notes, no laws have been passed.

“A lot of people just assume that there must be something that says, ‘you have to supply parts for x amount of time; you have to provide manuals; you have to train me.’ But unless you specifically build it into the contract or into the purchasing agreement that you have with a vendor, there’s nothing like that anywhere.”

Even an email from a salesperson stating your team will be provided access to service information means “absolutely nothing,” Lynch says. “It’s not legally binding. What is? That statement at the end of the purchase agreement that says something like, ‘This document constitutes the entire agreement between these two parties and anything outside of what’s written on this paper doesn’t matter.’”

Consequently, Lynch says, it’s imperative that HTM departments broach the right to repair with their vendors upfront. “You have to think of buying equipment as equivalent to the courtship in marriage process.”

“The right to repair is like talking about a divorce,” Lynch adds. “It’s uncomfortable to do because it’s at a time when you’re in love, you like the product and the company, and you don’t want to talk about those days when things aren’t so good. But if you don’t plan for those eventualities, no matter how hard it seems on the front end, it’s going to be even harder down the road.”

Have the “most cynical person” in your facility lead the process, Lynch recommends, “because they’re going to anticipate the worst that could happen.”

For example, what if a manufacturer who does allow repairs is suddenly unable to supply you with parts? Or if a company does all repairs itself, what happens if another company buys its service department and everyone on staff decides to quit?

He had that happen once, Lynch recalls, “and we couldn’t get any service from the company. It’s the kind of event that can cripple a hospital.” Wang, for his part, agrees with Lynch that the conversation around repair should take place in the beginning and should ensure that every detail is clearly spelled out.

Still, he says, until right-to-repair legislation is in the books, many organizations will find negotiating is an uphill battle.

“If you’re a Johns Hopkins, or a Kaiser Permanente, or if you’re a hospital system with hundreds of facilities, then you’re going to have some leverage. But if you’re a small hospital” that wants to buy a CT scanner and there are only one or two companies that have what you need, “you’re probably out of luck.”

That may change eventually, Wang says. “But until it does, we need to do everything that we can to help.”

Chris Hayhurst is a contributing writer for 24×7 Magazine. For more information, contact chief editor Keri Forsythe-Stephens at kstephens@medqor.com.