Lawmakers increase pressure on device maintenance standards

Members of the House want to prevent the Centers for Medicare and Medicaid Services (CMS) from changing the rules for maintaining medical equipment that perform MRIs and other procedures.

The lawmakers say that a potential change in the CMS’s standards could put patients at risk.

{mosads}“We’re not dealing with an automobile or refrigerator here,” Rep. Tim Murphy (R-Pa.) said on Friday. “The consequences can be pretty deadly.”

He added that the “weakening of equipment maintenance standards could have some severe consequences for health and safety.”

In order to receive money under the federal Medicare program, hospitals currently have to follow the equipment maintenance standards recommended by the manufacturer and approved by the Food and Drug Administration (FDA).

A potential proposal from the CMS, which has not yet been unveiled to the public, would allow hospitals to deviate from those standards.

Murphy was one of five members of Congress who wrote to the CMS this week warning that the change “may put patients and health care personnel at unnecessary and avoidable risk.”

The lawmakers asked the agency to go through a formal rule-making process, including a chance for the public to comment, before issuing any changes to its maintenance rules.

“We are concerned the agency is meeting and speaking with those organizations that support loosening current guidelines, while largely ignoring the many stakeholders who have substantial patient safety concerns about this approach,” they wrote.

A number of medical trade groups that have opposed the possible change have said that the CMS has been unwilling to meet with them. 

Testifying before the House Energy and Commerce subcommittee on Health, of which Murphy is a member, the head of the FDA’s medical device center shared its concerns.

“Our concern is that the maintenance schedule is really part of assuring that the device is safe and effective,” Jeffrey Shuren said.  

“These are technologies that may be making radiation. … We want to make sure [patients are] getting the right amount of radiation, not too much,” he said.

Shuren added that the FDA has “raised concerns” with the CMS.

In addition to Murphy, Reps. Allyson Schwartz (D-Pa.), Chris Gibson (R-N.Y.), Mike Kelly (R-Pa.) and Keith Rothfus (R-Pa.) signed the letter to the CMS.  

— This story was updated on Nov. 18 to correct Jeffrey Shuren’s identity.