AAMI/FDA Voluntary Plan for Servicers, Refurbishers, and Remarketers Moves Forward

AAMI/FDA voluntary task force is a few steps closer to finalizing a joint industry proposal that would establish a system of voluntary controls for servicers, refurbishers and remarketers.

Task force members are Robert Kerwin, attorney for the International Association of Medical Equipment Remarketers; Bernie Liebler, director, Technology and Regulatory Affairs, Health Industry Manufacturers Association; Elliot Sloane, vice president, Quality and Regulatory Assurance, Mediq/PRN; and Jim Keller, director, Health Devices Group, ECRI. The task force met with Kathy Warye, AAMI's senior vice president, Education and Government Programs, in late February to begin drafting the proposal based on the recommendations of the full task force.

The proposal includes the creation of a voluntary registry of servicers, refurbishers and remarketers; labeling provisions for certain types of activities; and a mechanism for distribution of recall and hazard notices.

The draft proposal was presented to the full task force, which includes representatives from servicing, refurbishing, remarketing, manufacturing, FDA and other health care professions, at its meeting March 19. The final proposal will be submitted to FDA this spring.

FDA plans to publish the task force's recommendations and a summary of its activities in the preamble to the agency's proposal for ensuring the safety of servicing, refurbishing, and remarketing, says Wes Morgenstern, deputy director, Division of Program Operations.