by Barbara Kram

As previously reported in DOTmed Business News, March 2008

The International Association of Medical Equipment Remarketers & Servicers (IAMERS) is putting a labeling system in place for used medical equipment in the U.S.

The voluntary program will issue identifying labels for equipment according to established categories. Companies selling the equipment will be required to sign documentation verifying the condition of each piece of equipment according to these categories:

-As Is, Where Is
-Refurbished
-Cosmetically Enhanced, or
-Remanufactured (See definitions below.)

The impetus for the IAMERS equipment labeling initiative is to promote quality and standards through industry controls as opposed to government regulation. IAMERS is being proactive to manage the process, according to Diana Upton, President of IAMERS.

"The FDA has been suggesting for a long time that we do something like this," she said. "My belief is that, in the absence of us doing it, they'd eventually be telling us how to do it."

The industry initiative is satisfactory to the agency, which is charged with ensuring quality despite limited resources. "They have already been briefed and they are very happy with what we've done," Upton said of the FDA response. "It is a totally unregulated situation and I believe the goal of the FDA is to get the pre-owned sector to have the same kind -- or close to the same kind -- of constraints that OEMs do."

IAMERS is striving to make the program as uncomplicated as possible. The group is ironing out the legal language on forms that members will be required to sign before getting their equipment labels. The organization will keep a database of all equipment so labeled. The topic will be discussed further, and the FDA will attend, the IAMERS annual meeting May 2-3, 2008 in Charleston, SC.


IAMERS Equipment Labeling Initiative Categories

-As Is, Where Is. "As is, where is" systems are unchanged. These systems are typically deinstalled from the hospital/clinic and are then crated and shipped to the buyer. Nothing else is done to the system.

-Refurbished. Refurbished systems retain their original identity and are essentially repaired and/or upgraded in a manner which could be achieved by field service personnel or in a facility capable of such repairs or upgrades. Refurbished systems include those systems which have received software upgrades or basic improvements consistent with the life cycle of the product. The system complies with the original level of function and at least meets the original OEM defined specifications or the OEM specified path for upgrades. This is consistent with the extended life cycle as proposed by the OEM.

-Cosmetically Enhanced. The system is basically as is, where is; but has been painted and/or cosmetically improved. However, no repairs or upgrades have been done.

-Remanufactured. Remanufactured systems would be newly built systems using rebuilt, repaired or new parts which allow the system to perform substantially different than the original system. (This category, however, will rarely apply to IAMERS members and their equipment.)