The American College of Clinical Engineering offered that there was a lack of real-world evidence to support MITA’s advocacy for additional regulation. The respected scientific research institute, ECRI, after review of, among other things, the FDA MAUDE reports, offered that there was no evidence to date that a patient safety problem exists.

Several independents at the FDA workshop noted they were having difficulty obtaining resources from device manufacturers (passwords, manuals and software) that would hasten the repair of equipment. One gentleman from a major Boston hospital asked, "if this is about patient safety, shouldn’t the hospital be provided a copy of the equipment manual?"

The FDA advised that it would be preparing a summary of the information gathered. In the last few months the FDA has contacted stakeholders to clarify and confirm the takeaways from the workshop. Even as this new legislation goes to Congress, stakeholders continue to await the FDA's report.

MITA's pursuit of device servicing standards
In February 2017, MITA announced that it was forming an effort to develop an American National Standard for servicing of medical imaging devices. The "Consensus Body" formed by MITA was announced as open to all materially-affected interested parties.

When I inquired as to whether issues such as access to Assemble-Install-Adjust-Test (AIAT) information and manuals would also be discussed, I was informed that it was not likely to find its way into a servicing standard. My takeaway: MITA was working on a Servicing Standard but wouldn’t be addressing whether independent servicers would be receiving AIAT or other information that is required by 21 C.F.R. Parts 820.170 and 21 CFR 1020.30.

The MITA Servicing Standard’s forward begins with stating there are “gaps in quality” at provider facilities which lead to performance and safety issues. Presumably all who would agree to the standard would be adopting this unsubstantiated claim.

Also disconcerting is the "Expected Service Life" provision, which leaves the manufacturer to determine when the "end of life" of equipment occurs. “Time period specified by the manufacturer during which the medical electrical equipment or medical electrical system is expected to remain safe for use.” This provision has important implications for rural hospitals, which may not be in a position to purchase new equipment and yet might well maintain older equipment.

The secretaries to the MITA Servicing Standards consensus committee were also MITA’s advocates for independent servicer regulation at the FDA workshop in October. It is troubling to have one’s advocates now presiding over the consensus body encouraging openness and due process.

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