Over 1100 Total Lots Up For Auction at Two Locations - WI 07/09, NJ Cleansweep 07/10

Spanish SpanishPortuguese PortugueseEnglish English

To regulate or not? Medical device servicing debate heats up (again)

June 27, 2025
HTM Parts And Service
Share
By Keri Forsythe-Stephens

The 2025 AAMI eXchange in New Orleans played host to one of the most anticipated — and spirited — sessions of the conference: Medical Device Servicing: To Regulate or Not? The Rematch. Centered on what many consider healthcare technology management’s (HTM’s) most contentious issue — the Right to Repair (RtR). The session featured two leading voices in the ongoing debate: long-time repair advocate Binseng Wang, ScD, CCE, and industry veteran Wayne Moore, CHTM.

InterMed chief operating officer Larry Hertzler moderated the conversation, framing it as “talking about regulating the unregulated.” And true to that theme, the discussion cut deep into complex questions surrounding safety, access, and fairness in the servicing of today’s increasingly sophisticated medical equipment.
stats
DOTmed text ad

Your Trusted Source for Sony Medical Displays, Printers & More!

Ampronix, a Top Master Distributor for Sony Medical, provides Sales, Service & Exchanges for Sony Surgical Displays, Printers, & More. Rely on Us for Expert Support Tailored to Your Needs. Email info@ampronix.com or Call 949-273-8000 for Premier Pricing.

stats
A question of access
One of the central issues raised: whether independent servicers should be required to register, just as original equipment manufacturers (OEMs) are, especially if they’re being asked to meet the same service standards. Moore pointed out the nuance: “It depends on what type of service we are talking about.” For example, component-level repairs might cross the line from servicing into remanufacturing, a distinction that becomes crucial under FDA scrutiny.

Wang underscored the challenge with a stark metaphor: “If I’m required to abide by the Constitution but can’t read it, how can I abide by it?” Without access to necessary service manuals, parts, or diagnostics, he argued, even experienced HTM professionals are left to “go at it blindly.”

The FDA’s role — and limitations
Both speakers addressed the FDA’s longstanding reluctance to regulate third-party servicing more aggressively. “The FDA has had the opportunity but hasn’t acted, perhaps because they haven’t seen a compelling reason to,” Wang said.

Wayne Moore
Moore agreed that the agency’s position is complex. While it does differentiate between servicing and remanufacturing, and has authority to inspect entities performing either, it doesn’t define “bad servicing.” As Moore put it, “There’s no such thing as bad service. It’s either service or remanufacturing.”

That lack of regulatory clarity raises practical concerns. For instance, installing a non-OEM part that hasn’t been validated could shift the activity into remanufacturing territory. But as Wang noted, HTM professionals often lack the information needed to make that call accurately. “We are now guessing,” he quipped. “And guessing is not a good situation.”

Right to repair: A national or local solution?
Another point of contention was whether the U.S. needs a federal RtR law to create uniformity in access to service materials. Moore nixed the idea, saying it simply won’t happen. “You can’t even get 100% of people to agree that puppies are cute,” he remarked. “Getting Congress to fully agree on something is tantamount to impossible.” He foresees it being a state-by-state issue.

Binseng Wang
Wang held a different view, stating: “In theory, we should have a single, nationwide law.” Even so, he points to existing state-level RtR laws in California and Colorado that include provisions for medical devices, though limited to wheelchairs. He likened the current opportunity to the automotive industry’s approach: “If we can fix over 80% of the issues and get the equipment back to service quickly [without going to the manufacturer], that’s what we want.”

Who should have the right?
Importantly, Wang clarified that he wasn’t advocating for unrestricted access to service materials. Instead, he argued that the owner of the medical device — not the manufacturer — should decide who can access those resources. “We are not saying anyone under the sun should have access to service materials,” he emphasized. “But if you buy a medical device, you should have the right to the information.”

That point resonated with many in the audience, especially those working in hospital-based HTM departments who often struggle with access to critical documentation, even when servicing devices they legally own.

In the end, there was no resolution, only the acknowledgment that servicing debates remain far from settled. Yet the AAMI session provided a vital space for airing opposing views, challenging assumptions, and reinforcing a shared goal: ensuring that safe, effective care is not delayed by regulatory or commercial gridlock.

As Wang noted, medical devices are getting smarter, “and we need to be sure we can safely handle the equipment.” But whether that means federal regulation, smarter standards, or broader cooperation remains to be seen.
Sign up for Weekly Top stories

You Must Be Logged In To Post A Comment

Sign up for Weekly Top stories

 

advertisement

U.S. Healthcare Homepage

Patient engagement technology only works if patients use It
Why QMS matters more than ever in the era of right-to-repair
Siemens Healthineers receives FDA clearance for its first helium-free 1.5T MR scanner
SUNY Downstate in Brooklyn to receive $1 billion for hospital modernization, service preservation
Vandalia Health breaks ground on $30 million West Virginia hospital
Ratio Therapeutics secures isotope supply deal with Nusano for radiopharmaceutical development
Siemens Healthineers, Mass General launch theranostics research center
Ascension to acquire AMSURG, expanding national outpatient surgery network
North Kansas City Hospital, Meritas Health rebrand under unified NKC Health name
Duke Health expands Cary campus with new inpatient facility