The reactions
Third-party companies, ISOs and HTM professionals have different opinions of the docket. Some are skeptical and see it as a sign of potential increased regulations, and others are hopeful that it will create more transparency in the industry. Leon Gugel, president of Metropolis International, a third-party diagnostic imaging equipment company, was one of the commenters on the docket. He thinks that the “various stakeholders who have expressed concern” are the OEMs, and that they “want to push the little guy out for doing a better job than they are.”

He stated that there are no aftermarket companies that make any medical device parts, so all parts come from older, decommissioned systems with one or two broken parts. “We, as smaller businesses, invest in buying broken systems and use them for parts, [which is] the same thing that the OEMs do when they take systems on trade,” he wrote. Many of the OEMs that HealthCare Business News requested an interview with declined. GE Healthcare wrote in an email that it is “pleased” that the FDA has opened the docket for comments.
“We believe the implementation of appropriate minimum standards for these activities supports the quality and effective performance of medical devices as well as patient safety. GE Healthcare is working alongside its partners to prepare comments accordingly,” a GE spokesperson wrote. Toshiba America Medical Systems is not actively involved with the docket, but wrote that it will review and comment if necessary.

“Toshiba prioritizes safety in regard to our customers and their patients. Toshiba invests in its customers and employees through extensive research and training on each product that it markets. Toshiba applauds the FDA taking action that will provide a standard of safety for all patients,” Paul Biggins, director of regulatory affairs at Toshiba, wrote in an email. Heidi Horn, vice president of clinical engineering service at SSM Health in Missouri, also commented on the docket and encouraged the FDA to look at the data instead of listening to the manufacturers’ lobbyists.

SSM Health has hired many employees who used to work for manufacturers and they have all said that they are able to better service the equipment as an employee of the hospital, versus as an employee of a manufacturer, she wrote. She believes that the FDA should focus its attention on forcing the manufacturers to make their products less prone to human error and breakage, and also adopt policies that help the owners of the equipment properly maintain it by making training, diagnostic software, parts and service manuals more accessible and economical.

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