This article originally appeared in the July 2012 edition of DOTmed Business News.

During a May 18 webinar hosted by the Joint Commission, George Mills, the Commission’s director of engineering, made a plea with attendees in the field of clinical engineering. He urged them to fill out a questionnaire that would be used to explain to the Centers for Medicare and Medicaid Services that there’s already a safe medical equipment maintenance process in place to inspect, test and maintain equipment and utility systems in health care facilities around the country.

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. But ever since CMS clarified its guidelines in a December 2011 directive, which requires hospitals to strictly adhere to manufacturers’ recommendations, the process of maintaining clinical equipment has received considerable attention from a host of industry players.

“CMS has always said that if you receive funds from us,you will maintain equipment in your facility according to manufacturers’ recommendations,” says Tim Ritter, senior project engineer at ECRI Institute. “A lot of people didn’t know that, it wasn’t widely recognized.” (ECRI Institute held a similar webinar on the subject in mid February with the title: Should the Centers for Medicare & Medicaid Services revise its new directive on the preventive maintenance of medical devices?)

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.

“If over the years, they found that certain technologies weren’t failing in certain ways, they could reduce their testing or expand the interval for testing,” says Ritter.

The Joint Commission, officially deemed by CMS to conduct testing certification on their behalf, backs an evidence based approach. While placing a higher priority on life-support devices, like defibrillators, clinical engineering personnel are permitted to judiciously decide if and how often they need to maintain devices that are lower-risk to patients.

“Over the past 17 years, there has not been an adverse event associated with the Joint Commission methodology for servicing both life support and non-life support equipment. The process that we have set in place for hospitals to follow is reliable and provides safe outcomes for patients,” says Mills.

Experts working in the field second this. Matt Baretich, president of Baretich Engineering, says he’s followed the Joint Commission’s lead successfully through the years.

“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 Baretich.

People like Baretich want to demonstrate to CMS that the Joint Commission’s accreditation process for medical equipment and facilities equipment maintenance is safe and should be allowed to continue without interruption.

The costs of the rule
Experts agree that the CMS directive significantly changes the amount of maintenance work for biomeds.


“When you look at clinical engineering work, 80 percent of a technician’s time is spent on preventative maintenance and repair, split evenly. So if you figure 40 percent of the time is spent on maintenance, anything that changes the amount of maintenance they have to do greatly affects the work load,” says Jonathan Gaev, ECRI Institute’s business line manager for BiomedicalBenchmark.

Baretich says it adds an even greater financial burden to hospital budgets. “Some estimates have been developed in the billions of dollar per year range for the impact of say, adding additional staff and time, and there’s some stringent documentation required that would add to the paperwork.”

Clinical engineering departments within facilities are also wary about going to their bosses and asking for a budget increase, especially as hospitals are trying to cut back on spending. For third party providers, it’s a similar story.

“They are saying: we don’t want to go to our clients and say we’re going to have to charge you more,” says Baretich.

According to the Joint Commission’s Mills, experts in the field have estimated that the exact cost of maintaining clinical engineering and facilities equipment will be increased from the CMS guidelines by two to five billion dollars for hospitals participating in CMS funding based on additional full-time equivalents, service contracts and man-hours.

“This would amount to an estimated total of $4 to 10 billion in increased costs to the industry,” he says.

But of greater concern is how this could affect 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.

Some hospitals are in the middle of reviewing their programs to make room for these changes, while a few anticipate minimal impact because they’ve been following manufacturers’ guidelines all along.

But Ritter speculates that some hospitals may risk not taking any action, in part because they are hopeful that organizations like ECRI Institute will be able to convince CMS that the Joint Commission’s process works well.

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

“We have some maintenance data from the Biomedical- Benchmark product we have developed over the last several years that will help support this position,” says Ritter.

Further, ECRI Institute is looking into developing a study with the Joint Commission comparing equipment maintained strictly according to the manufacturers’ recommendations with maintenance that has deviated from manufacturers’ recommendations.

ECRI also recommends developing an outside advisory board for CMS.

“It would be very desirable for people who work in the field to review not only this directive but future regulations that CMS might be considering, to determine how we can best ensure the safety and reliability of equipment,” says Ritter.

Although it’s uncertain at this point if CMS will amend the rule, Baretich says they have been receptive to discussion, and open to seeing the data.

DOTmed Registered 2012 - July DMBN: Test Equipment Companies

Names in boldface are Premium Listings.
Domestic
Julio Castro, Pronk Technologies, CA
Bruce Smith, Medical Systems Technologies, CO
DOTmed Certified
TOM GRAHAM, CLINICAL RESOURCES INC, MD
Michael Minch, BiCOM Inc., NY

International
Cicero Oliveira, Kuf Electronics, Brazil
Juan Manuel Esquivel Martinez, X-Ray Sistemas Medicos, Mexico
moito maekawa, medicalserv, Brazil