From the August 2016 issue of HealthCare Business News magazine


Will new regulations hurt the health system?
Faced with the FDA’s concerns, third-party providers and their representative associations have vigorously defended their safety record, their value proposition, and the importance of a competitive market.

“Much like automobiles, aircraft or other complex machinery, the OEM isn’t the only one that is capable to repair the equipment,” writes Jeffrey Little, who describes himself as a 25-year veteran of health care operations, in his docket comment.



“At the end of the day, items like this definitely have a place for debate, however they are typically spawned from OEM vendors feeling a decline in dollars coming in from repairs, and finding fault with someone else’s work,” he writes.

In 1998, the FDA decided to exclude refurbishers and servicers from the requirement to comply with the 1997 Quality System Regulation under part 820, according to Diana Upton, president of the International Association of Medical Equipment Remarketers and Servicers, Inc. (IAMERS). Since the issues being raised in the current docket are the same, she argues, the agency would need compelling reasons to reverse its prior position.

For the FDA to make a judgment in the best interest of the entire health system, David Francoeur, senior director of brand and quality at Sodexo, says it needs to stick to the data. “Whatever the outcome, it has to be based on the impact of safety and not anything else – if it isn’t broken, why fix it?” he asks.

But, according to MITA's Hope, there may not be sufficient evidence either way. “It is impossible to provide a statistically valid analysis of the extent of problems that have occurred when there has been no prior scrutiny or any regulatory oversight of non-OEM service providers and other third parties, which would require reporting of problems,” he writes.

Although wary of lobbyists and the private interests of big business, many third-party stakeholders agree that some degree of increased oversight might not be such a bad idea, as long as it is implemented in a way that doesn’t unfairly undermine the value they bring to a health system that is already strapped for cash.

For Francoeur, that means new standards to ensure levels of technical competency, oversight and management. “I’m not necessarily advocating certification or registration,” he says, “but I do think it’s reasonable for the FDA to require some form of assurance that technicians possess the skill sets needed to work on medical equipment.”

Little also acknowledges the need for some kind of common requirements. “Not all third-party repair vendors are created equal, so standards must be established so that [everyone is] on the same level playing field,” he writes.

August 2016 Magazine

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