Right before the start of the year, the Centers for Medicare and Medicaid Services spoke out about an issue that had clinical engineers in health care facilities across the country worried for almost two years: Whether they were going to have to revise long-established protocols on how often they perform preventive maintenance for medical devices.

When CMS cleared up the equipment maintenance guidelines on Dec. 23, 2013, the clinical engineering community was mostly relieved. In the updated directive, CMS announced that it will allow health care facilities to follow an alternative equipment maintenance (AEM) program based on accepted standards of practice for maintenance. In other words, clinical engineers can continue doing what they have been doing to maintain medical equipment — a practice that has been endorsed and approved by the Joint Commission for over 10 years — except when it comes to imaging equipment, lasers, and new equipment without a long enough history to establish an adequate risk-based assessment for maintenance. In those cases, facilities will now have to follow what the OEMs recommend.

“If I’m the clinical engineering director, I’m very happy to receive this memo, I’ve gotten most of my flexibility back, not all of it,” says Jonathan Gaev, business line manager of BioMedicalBenchmark at ECRI Institute.

Overall, Gaev says the memo was wellreceived by the clinical engineering community — but with a little less cheer in those areas where the directive still holds.

Exceptions to the rule
In November 2013 — before CMS had cleared up the directive — Rep. Tim Murphy (R-Pa.) and Rep. Allyson Schwartz (D-NY) sent a letter to CMS voicing their concerns, which were shared by dozens of industry stakeholders, including the Medical Imaging & Technology Alliance (MITA), an industry lobby, that in essence said that weakening the requirement to follow manufacturers’ recommended maintenance standards on imaging equipment is unsafe.

The imaging community said that deviating from the manufacturer’s recommended maintenance standards could threaten safety as well as put the operators in harm’s way, and the outcry from the industry is what likely prompted CMS to include the AEM exception for imaging equipment.

Since 1994, the Joint Commission has consistently allowed for 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 — allowed clinical engineers to deviate from the recommendations as the experience of the facility maintaining the equipment warranted.

The Joint Commission fully supports the new CMS directive, even the exceptions.

“Because imaging/radiologic and medical laser devices typically are serviced according to manufacturers’ recommendations, the Joint Commission agrees with exception language,” says George Mills, the Joint Commission’s director of engineering.

He says he doesn’t anticipate that the exception for imaging equipment will be an issue. Others see a different scenario. “The general reaction from the field, from my observation, is a sense of frustration with that distinction,” says Karen Waninger, director of clinical engineering at Community Hospitals Indianapolis.

While Waninger can’t speak for everyone, she brings up a few problems she has with the distinction. In many ways, she doesn’t see it being that necessary because if there is evidence to indicate the need for specific maintenance activities on any device, the AEM program will certainly include those activities regardless of what the manufacturer recommends.

Further, she said she can cite specific examples where the manufacturer’s recommended procedures couldn’t be performed due to revisions and updates that the manufacturer made to the equipment, without making corresponding updates to the procedures.

“Therefore I must ask the question, what is expected of whom in those instances? I believe many members of the HTM profession have similar experiences. What we lack is the political clout to offset the messages of the large organizations who see it to their advantage to have imaging equipment excluded from the AEM process,” she said.

The exception applies to all imaging equipment, even for modalities such as ultrasound that don’t emit harmful radiation.

Gaev said he can understand the concern around radiation-emitting equipment and erring on the side of safety by following manufacturer’s recommendations. But he doesn’t understand the need to include ultrasound and MRI because radiation is not a factor.

“I believe that manufacturers are responsible people who want to bring safe equipment to the marketplace, however, there is no law, rule or regulation to my knowledge that requires manufacturers of imaging equipment or lasers to submit any data to any agency that demonstrates their inspection and preventative maintenance frequencies are the appropriate ones,” says Gaev.

Supporters of AEM programs also say that the established protocol of allowing maintainers of equipment to deviate from these recommendations by utilizing evidence-based maintenance schedules has never resulted in an adverse event.

“We’ve been doing this for a long time and we don’t see patient safety issues. In other words, where we do use our experience and we back off manufacturers’ requests, it hasn’t caused any additional hazard for patients,” says Matt Baretich, president of Baretich Engineering in DOTmed’s original story about the maintenance directive back in 2012.

A brief history
For several years, there was built-in conflict between what CMS and the Joint Commission required as far as medical equipment maintenance. When CMS clarified its standing in 2011, asking hospitals to strictly adhere to manufacturers’ recommendations, the clinical engineering community reacted strongly because it went against their long-established practices.



But there was more: It also created the potential for more work and an even greater financial burden to hospital budgets, and with that, the issue of patient safety.

“Hospitals are under big budget constraints so if a department has to do more work, they probably won’t get a budget increase to hire more people. So that means something else won’t get done and that’s what we’re afraid of. Those other things have more impact on patient safety than some of the maintenance activity,” says Gaev.

We still have questions
Experts say that many parts of the December 2013 clarification from CMS need further clarification. On that priority list is how CMS defines “critical equipment.”

“The problem is that if you take any piece of medical equipment, you can come up with a reason that it’s critical,” says Gaev. Clinical engineers are asking for a list of critical equipment from CMS that would hopefully clear up the confusion.

Besides clearly defining critical equipment, professionals in the field would also like CMS to explain what they mean when they say “a sufficient” amount of information. For example, one device category was excluded from being put on an alternative equipment management program because new equipment without “a sufficient” amount of maintenance history had been acquired.

And even bigger-picture questions remain, for instance, does the evidence-based risk assessment for preventive maintenance have to be knowledge from within a certain hospital or can a facility get its knowledge from other hospitals?

The clinical engineering community will be trying to find answers to these questions and more in the months ahead.