The FDA recommends that health care facilities using refurbished medical devices should be sure their vendor knows the OEM's specifications for the product, and suggests that facilities "establish quality assurance procedures to be sure that reprocessed or refurbished devices fulfill these specifications." It's good advice - even if it's not a specific mandate.

According to the U.S. Nuclear Regulatory Commission, "regulatory authority over the medical use of radioactive material and other sources of ionizing radiation (such as X-ray machines) is shared among several government agencies at the federal, state and local levels. Radioactive material is regulated by either the NRC or an Agreement State." To date, 36 states have entered agreements with the NRC to regulate the use of certain radioactive materials.


Hazard awareness

Clinical imaging practice specialist Wayne Webster shepherds hospitals and diagnostic imaging facilities through the maze of choosing the best equipment for their uses while avoiding risky and costly missteps. As the president of ProActics Consulting in Melrose, Mass., he works with organizations of all sizes to match their development goals with their available budgets, and has ready advice for moving through the used equipment minefield.

"Where people make the most mistakes is with the removal of the old equipment. People will routinely go to vendors who say they can do it without getting all the details," he says. "It's like hiring a home improvement contractor - you need to be ready to ask all the right questions. You have to know what they're going to do and how they're going to do it, especially with big equipment."

Webster suggests a 'reverse walkthrough' of a facility to discover exactly what changes may have occurred in the intervening years between purchasing the earlier round of equipment. Figuring out the best way to get the equipment out is essential, including freight elevator capacity, doorway sizes, and the availability of a loading dock.

In the case of larger facilities, it's not uncommon to have to destroy the equipment just to get it out of the building. Webster advises a survey of the environmental hazards that cutting up the old equipment may pose, from flying particulates, dust, noise and smoke to potential radiation exposure and workflow or care disruption.

His questions include, "How is the company going to deal with that, and what internal mechanisms do I have to deal with? If you're in a hospital you routinely have a safety group or radiation safety that may need to be consulted. What internal mechanisms exist so that you aren't doing the wrong things and potentially stopping the project?"

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