Word Play: The debate over terms in the equipment aftermarket

Marketing language or layers of meaning? When professionals in the medical field see these words, what’s the takeaway?

From the perspective of equipment vendors, these words are chosen for a reason. They can have legal implications. They can inform branding strategy. And they certainly can change over time with consumer attitudes, market trends and corporate philosophy.

To stakeholders such as hospitals and group service providers, this language is left to interpretation. The simplest meaning these phrases all communicate is “not new.” But beyond that, nuance takes hold, and the question persists: Is there a critical difference when it’s time to buy?

The letter of the law
The FDA defines a remanufacturer as “any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use.”

Defining at what point—if at all—the work done to renovate a pre-owned piece of equipment constitutes remanufacturing is as subjective a question as exists in the secondary market today.

“The Federal Food, Drug, and Cosmetic Act has not provided a specific definitional basis for the word ‘remanufactured,’” says Robert J. Kerwin, Esq. The regulation doesn’t specify how much modification the FDA considers significant, he says.

Kerwin is an attorney with Tarlow, Breed, Hart and Rogers P.C. of Boston, Mass. He is legal counsel for IAMERS, the International Association of Medical Equipment Remarketers and Servicers, and a regular contributor to MD Publishing.

“This is a complicated area,” he says. “The FDA does not regulate remarketers of third-party services and devices the same way it regulates original equipment manufacturers and remanufacturers, and the FDA also does not countenance remarketers from implying that they’re FDA-approved.”

“It was thought, perhaps, that best way to get an instant product recall is if you have a bar code or an alphanumeric arrangement on a device,” he says. “We’re supposed to have the original equipment manufacturer’s unique device identification on all medical equipment.

“Well, along comes Company X, who is doing some repairs to the equipment. At what point do you put a new UDI in versus an old UDI—and indirectly, at what point is something remanufactured versus existing equipment? “The IAMERS-UDI working group has a number of members addressing best practices for implementation of a UDI system. But the matter remains a work in progress even now.”

If the FDA chooses to establish that...

Read this complete article by clicking here.