Ever since the Centers for Medicare and Medicaid Services clarified its guidelines for preventive maintenance in a December 2011 directive, which requires hospitals to strictly adhere to manufacturers' recommendations, the process of maintaining clinical equipment in a hospital has received considerable attention from a host of industry players over the past few years.

The Joint Commission, ECRI Institute, the Association for the Advancement of Medical Instrumentation, the American Society for Healthcare Engineering and others in the field have been working together since the directive was issued to show CMS that the Joint Commission's accreditation process for medical equipment and facilities equipment maintenance is safe and adequate.

While CMS has remained mum on the topic, a division concerning the rule has sprung up among stakeholders.

The American Society of Radiologic Technologists (ASRT), the Intersocietal Accreditation Commission (IAC), and the American Association of Physicists in Medicine (AAPM) believe that deviating from the manufacturers recommended maintenance standards could threaten patient safety as well as put operators in harms way. In November, Rep. Tim Murphy (R-Pa.) and Rep. Allyson Schwartz (D-NY) sent a letter to CMS voicing their shared concerns with these provider and accreditation groups that weakening the requirement to follow manufacturers' recommended maintenance standards is unsafe.

"The biggest risk would be that the equipment would be calibrated incorrectly or something may not be right with an extended maintenance cycle and the technologist could be overexposing the patient," Liana Watson, chief governance and development officer at ASRT, told DOTmed News.

Not all radiologic imaging equipment falls under the directive because it's considered "critical equipment," but some does.

"It's confusing to us as operators why biomedical engineers would feel they would not have to follow manufactures recommendations because those recommendations were approved by FDA," said Watson. "It's part of what they have to submit when they are getting FDA approval for their equipment."

In fact, it came as a surprise to her and others that biomedical engineers were not adhering to the standards all this time.

"We assumed they were following the manufactures recommendations because that was what Joint Commission said they were supposed to be doing," said Watson.

However, since 1994, the Joint Commission has consistently signed off on a risk-based process to evaluate an organization's equipment inventories, preventive maintenance strategies and assignment of preventive maintenance frequencies.

Manufacturers' recommendations have always been the starting point for clinical engineering departments' maintenance process. But over the years, the Joint Commission — which accredits the majority of U.S. health care facilities — allows maintainers of equipment to deviate from these recommendations as their experience warrants. Biomedical engineers are permitted to judiciously decide if and how often they need to maintain devices that are lower-risk to patients.

In a story posted last year, George Mills, the Commission's director of engineering, told DOTmed News that the process is safe and reliable for both life support and non-life support equipment and that there has not been one adverse event associated with their protocol over the past 17 years.

Biomedical engineers are worried that if the CMS rule is enforced, it would require more manpower and present a financial burden on hospitals' already strained budgets.

CMS has not given any indication as to when it would issue a final rule, but many suspect it will happen soon.

Lawmakers who support following the manufacturer's recommendations for preventive maintenance are asking CMS to go through a formal rule-making process, which means giving the public a chance to comment before anything is official.