Safety concerns regarding refurbishing and servicing medical equipment by independent service organizations (ISOs), health care facilities and OEMs alike have been brought to the FDA’s attention by “various stakeholders.” The agency recently responded by opening a docket to seek comments from anyone with insights. The reactions among third-party vendors, ISOs and health technology management (HTM) professionals vary widely. Some see this as an indication that increased regulations are inevitable and will hurt their business, but other stakeholders see this action as an opportunity to educate the FDA and the OEMs on the value that they bring to hospitals.

The FDA is asking for comments regarding the service, maintenance, refurbishment and alteration of endoscopes and radiation-emitting devices including CT, X-ray and fluoroscopy. The agency also wants to know about any challenges that third-party companies face when attempting to restore the devices to their original or current specifications. There were 24 comments on the docket as of April 13, but stakeholders have until May 3, 2016, to give their input. Industry experts don’t know exactly what will come as a result of this docket, but their hope is that it will lead to improvements in patient safety.

What prompted this?
“There has been a lot more conversation in the medical device industry sector in the last year or two about concerns with adverse incidents [caused by] devices that have been poorly repaired,” says Mary Logan, president of the Association for the Advancement of Medical Instrumentation (AAMI). Bellevue Hospital Center in New York is part of the city’s Health and Hospitals Corporation and two years ago the corporation contracted with a third-party company. In a comment on the docket, a Bellevue representative stated that the third-party company doesn’t have technicians who are trained to work on most of the equipment and that they use substitute or refurbished parts from companies that buy used equipment.

The representative stated, “We are experiencing downtime and repeated calls on the same repairs. The repairs are substandard. They use parts from one machine to repair another. The contract was supposed to save money, but is costing the corporation more than when the equipment was maintained by the in-house biomedical engineering department and the manufacturer.” Some think that the docket was meant to address patient safety issues with endoscopes.

“I think that a lot of it stems from business other than purely diagnostic imaging, such as endoscopes,” says Diana Upton, president of the International Association of Medical Equipment Remarketers and Servicers (IAMERS). “The FDA [doesn’t] know [a great deal] about this [aftermarket] business because they regulate manufacturers, so they know only a slice of the business from their role of regulating manufacturers,” says Logan. “Yet they get reports of adverse incidents, so I think it’s awesome they want to understand the whole service business.”

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