Medical groups resist possible standards loosening

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The potential rule change, which has not been formally proposed or presented to the public, would allow hospitals to deviate from specific maintenance requirements approved by the Food and Drug Administration (FDA), which regulates medical devices for medical imaging equipment. Current regulations call for the devices to be maintained according to the manufacturer’s guidelines

On July 9, the president and advocacy committee chairwoman of the Society for Vascular Ultrasound wrote in a letter to the CMS that “the new standards will weaken the safety requirements that protect Medicare patients by allowing hospitals to forgo the manufacturer’s maintenance standards.”

They added, “The correct use of properly maintained and serviced ultrasound equipment not only saves Medicare dollars, but also ensures appropriate health care and reduces the risks associated with other more expensive or invasive imaging modalities, which may present more significant morbidity and mortality risks.”

The current CMS guidance was issued in 2011.

A potential new proposal would reduce those standards and allow fewer tests, inspections and maintenance than what manufacturers intended, the groups worry.

Harvey Neiman, chief executive of the American College of Radiology, wrote to the CMS in May stating that the organization “strongly supports" the current regulations.

“It is only reasonable and common sense that the manufacturer of imaging equipment would be the best judge as to the maintenance requirements for such equipment,” he wrote.

A CMS spokesperson did not respond to requests for comment about the potential change in regulation.

The agency sets standards for hospitals in order to receive federal Medicare money.