HCB News sought input on this issue from a wide range of organizations. Among third-party stakeholders we were repeatedly told that independent auditors and medical physicists should be charged with XR-29 certification.

“They visit the hospitals once a year to make sure the machine is safe to use on patients,” said one ISO. “There is no reason these people cannot say ‘yes, this machine meets all the guidelines.'"


But according to MITA it's not that simple.

“There are portions of the standard where it would be difficult for an on-site medical physicist to make a determination,” Megan Hayes, director of Regulatory and Standards Strategy at MITA, told HCB News. “The scope of the standard is directly related to the design of the CT equipment and ultimately, a physicist is a user of the equipment.”

HCB News sought comment on this issue from ACR, but it deferred to CMS.

Over two weeks ago, CMS acknowledged receiving our inquiries into XR-29 certification, but has not yet responded to multiple requests for feedback. We have directed our inquiries to three different sources.

“I think that the main problem is the fact that CMS refrains from defining the specific requirements from a system that can be accepted,” said Aharon. “CMS and ACR claim rightfully that they can't verify if a certain solution meets all XR-29 requirements or not — this would be the case for any independent auditor.”

The third-party medical equipment industry has matured over the last several years, and keeping the playing field level in the interest of competition is more important than ever. As with the FDA's examination of equipment refurbishing and servicing, XR-29 may have significant implications for independent service organizations and the providers they do business with.

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