Now that right-to-repair legislation is proposed in all 50 states; healthcare organizations are gaining more flexibility to decide how medical equipment is serviced.

While more repair options — including internal teams and third-party providers — may help reduce costs and address service delays, they also present new risks. Without robust internal QMS in place, this added flexibility can lead to gaps in oversight and, ultimately, impact patient safety.

Heidi Drafall, SVP of Quality at Agiliti, noticed this gap early. Not only did she lead the internal development of the company’s QMS, but she also drafted a right-to-repair bill aimed at ensuring safe, fair access to repair tools and OEM parts.
HCB News: Right-to-repair laws are creating new service options across many industries. As medical right-to-repair laws gain attention and traction in states across the country, what are the top actions healthcare organizations must take now to use this flexibility effectively and safely? What key opportunities or challenges are often overlooked?
Heidi Drafall: The right-to-repair legislation is progressing across the country—momentum that was evident during discussions in Washington, D.C. with members of congress just last week. This shift provides healthcare organizations with options for more affordable and timely medical device service. This potential change will require providers to make informed decisions when selecting a service provider. As a first step, it is critical that providers implement a robust assessment process, which includes ensuring the service providers operate within a proven, certified quality framework.

Simply proving an organization's ability to complete a repair is not sufficient. Healthcare teams should ask about the documentation of repairs, the training of technicians and the safeguards in place to maintain the long-term integrity of a given device. A common mistake is assuming all third-party providers offer the same level of service. Preventive maintenance intervals, replacement part selection and methods for performance verification testing should all be scrutinized through a risk-based approach centered on patient safety.

HCB News: As someone who has implemented a QMS and has drafted a right-to-repair bill, how do these two critical areas come together to redefine medical equipment service and patient safety in the years ahead?
HD: What brings these two areas together—policy and quality—is the shared goal of safe, equitable access. Right-to-repair laws remove unnecessary barriers; however, without proper quality oversight, increased accessibility can result in greater risks. That is where a strong Quality Management System (QMS) becomes crucial. It establishes the processes, traceability and accountability required to make sure the expanded options available under right-to-repair do not introduce variability or compromise device safety or performance.

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