The FDA has issued a letter to Congressional representatives in which the agency spells out its authority to enforce disclosure of information about diagnostic x-ray systems to third-party installers. Importantly, the FDA also indicted that another, broader regulation also requires OEMs to make installation and inspection instructions available for a wide array of medical equipment.

The letter, dated September 18, 2006, came in response to efforts by IAMERS, the International Association of Medical Equipment Remarketers & Servicers, to lobby for stiffer enforcement of applicable regulations that require OEMs to disclose information to third-party technicians.

DOTmed News saw a recent IAMERS communication about their progress in lobbying the government and we followed up on the story.


The performance standard includes a specific information disclosure provision in Title 21, Code of Federal Regulations (CFR), section 1020:30(g). This regulation requires, upon the request of a third party, the disclosure of information concerning the assembly, installation, adjustment, and testing (AIAT) for each certified component in a diagnostic x-ray system, according to the letter from FDAs Assistant Commissioner David W. Boyer to Representatives Sherrod Brown (D-OH) and Tammy Baldwin (D-WI).

The letter also clarifies that the standard applies to software and to other equipment, under a separate regulation (21 CFR 820.170[b]).

This really is a big change it also extends to [other equipment]. It is saying you not only have a bow and arrow in terms of regulation, you have a shotgun, said Casper E. Uldriks, special assistant to the director of the office of compliance at the FDAs Center for Devices and Radiological Health.

Its important to note that the FDA is only concerned with installation of the equipment and not servicing or deinstallation. The rules are really more directed at OEMs when they are first putting [equipment] into commerce and installing it for the first time, Uldriks said. In terms of third-party servicers and refurbished deviceswe dont regulate that activity. While the standards and regulations werent designed for ongoing servicing, FDA maintains jurisdiction over the devices themselves.

In terms of third-party refurbishers for remarketing the device or even for dealers who are remarketing the device, its very difficult, Uldriks said. Refurbishers have been unhappy for a long time and its just not something that the agency is going to take on given all the other things its trying to do right now.

Ultimately, its up to the used medical equipment industry to regulate itself through programs including DOTmeds rating system and the DOTmed Certified program. FDA acknowledged that this approach works. That means a lot to me if you have an industry that is willing to self-regulate, Uldriks said. He said he knows its working because he doesnt hear many complaints. OEMs arent telling me about bad things and Im not hearing bad things from nurses, doctors and hospitals. Everybody in the agency knows if something happens it will come to us.

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