Trade group says manufacturers’ restrictions on servicing raise costs, limit choice, and are not supported by safety or cybersecurity data.
By Alyx Arnett
The International Association of Medical Equipment Remarketers and Servicers (IAMERS) is calling for legal protections to uphold hospitals’ ability to repair—and choose who repairs—their own medical devices. The organization says this right is critical to ensuring patient safety and controlling healthcare costs.
IAMERS’ statement follows mounting concerns over rising service and maintenance expenses. The American Hospital Association has warned that growing operational costs threaten the long-term financial health of the nation’s hospitals.
“When hospitals have choices for servicing and parts, hospitals enjoy competitive pricing, accountability, and, in most cases, better service,” IAMERS writes in its statement. The group emphasizes that some manufacturers still restrict access to certain repairs, arguing—without sufficient evidence, IAMERS says—that only they can perform them safely.
Oversight, Risk Data Highlighted
IAMERS points to the existing hospital infrastructure, including biomedical engineers, procurement teams, and safety committees, that already evaluates and oversees repair quality. Reports to the US Food and Drug Administration (FDA) of adverse events in the repair and service of devices are under 1%, the statement notes.
The group also cites a 2018 FDA report, which concluded that third-party repair entities are “critical to the functioning of the US healthcare system.”
On cybersecurity, IAMERS disputes arguments that independent service providers introduce unacceptable risk. The FDA has previously stated that exemptions allowing access to software for medical device repair would not “necessarily and materially jeopardize” device safety or effectiveness. The US Copyright Office agreed in its 2021 ruling that safety-based objections to repair access were not supported by evidence, IAMERS notes.
A Call for Accountability
IAMERS encourages manufacturers to adopt an industry best practice of providing servicing instructions that support routine maintenance and repair of reusable devices. It cites the FDA’s draft guidance on remanufacturing, which encourages OEMs to include labeling information, such as performance specifications, maintenance schedules, and error code descriptions.
Ultimately, the group argues that hospitals and the servicers they select should be legally entitled to access the tools and information necessary to repair the devices they own. “In the event that a manufacturer does not cooperate,” the statement reads, “…there should be legal consequences.”
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