Meeting third-party stakeholders halfway: Service after the FDA report

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Meeting third-party stakeholders halfway: Service after the FDA report

por Gus Iversen, Editor in Chief | August 07, 2018
HTM Parts And Service
From the August 2018 issue of HealthCare Business News magazine


HCB News: For hospitals and other medical industry stakeholders, what are the concerns regarding new legislation being introduced on behalf of OEM organizations?
Rob Kerwin: Hospitals and healthcare systems welcome choices. Independent and in-house servicers offer choices. Regional and rural hospital representatives with whom we have spoken are concerned that manufacturer supported legislative and regulatory efforts may increase costs and reduce competition from third-party servicers without evidence of increased public safety.

In an era of smart regulation, is there really a basis to add to the costs of third party and in-house servicers? Will these costs, if allowed, necessarily be eventually passed along to the patient, or will there be fewer choices? Is this press for further legislation and regulation really about patient safety?

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Scot Mackeil: The FDA report brought important issues into the sunlight, but the FDA is in the business of implementation and enforcement of laws and regulations that protect the public health. Were the FDA to be presented with new legislation to enforce, they would do so. Therefore, if any new legislation is to be presented, HTM and ISOs need to have helped craft it in a fair and balanced manner.

HTM and ISO stakeholders need to work diligently at state and local levels with their state and federal legislators. We need a grassroots counter campaign to write and call our representatives on the issue of 2118 as well as state level R2R bills. The message needs to get into new channels, it needs to get out to caregivers and healthcare supply chain managers in their journals and media.

Up until now, when we think about service legislation, HTM/ISO has been reacting to initiatives enacted by the medical equipment manufacturers’ paid lobbyists and trade associations. What if we collaborated with the manufacturer trade groups to address the issues on our own terms, prior to having them dictated to us from a play book written by others?

Instead of legislation that leaves certain groups out in the rain, we ought to develop high-quality collaborative regulations, standards and practices that make supporting the hospital BMET, CE, the ISO, the hospital, caregivers, patients, manufacturers and America's healthcare system the common goal.

HCB News: Is a greater level of standardization needed in equipment service? If so, how do we get there in a way that promotes a level playing field and competitive options for hospitals?

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