NEMA drafts standard for mammography equipment QA

Lawmakers in five states are developing legislation to regulatemammography facilities, prompting the National Electrical ManufacturersAssociation to draft performance standards for mammography equipment.

Bills pending in Michigan, California, New York, Ohio and Utahconcern quality assurance aspects of mammography equipment. Nearlyall of these affect mammography equipment manufacturers, saidVicki Schofield, a NEMA staffer who manages the agency's x-raysubcommittee.

On the federal level, legislators have proposed more than 50bills in the last year that concern breast cancer, many of whichwould impose national mammography quality assurance standards.

NEMA, which represents 85% of the U.S. x-ray manufacturers,has been working on its own set of mammography standards to ensurethat manufacturers have their say when it comes to rules and regulations.The standard would apply to performance and engineering aspectsof new equipment being developed.

"If no standard exists, you end up having a free-for-all,with regulatory and legislative people developing their own requirements,"Schofield said. "Often these bills have an incredible impacton manufacturers. We feel that if the industry wants to establisha standard, NEMA should be the one to do it."

The standard is in the outline stage, but after meetings withthe x-ray subcommittee, the text is beginning to take shape, Schofieldsaid. In the interim, the group is providing direction to legislatorson pending bills by submitting written comments.

"The legislators we've spoken with have said they willseriously consider our comments," she said. "But inthe case of Michigan, for example, sometimes the proposed rulesare already cast in concrete. We're hoping that once our standardsare developed they can be used as an information base."