A critical look at the meaning of critical
A second hurdle was cleared when CMS conceded to only apply the requirements to critical equipment. This meant a clear definition of "critical equipment" needed to be agreed upon. The working definition of critical equipment is now defined as equipment whose failure could reasonably run the chance of causing death or serious injury, or whose misuse or failure to operate under normal circumstances could cause death or serious injury.

According to Mills, CMS declined to give a list of medical devices falling under the "critical equipment" umbrella out of the concern that medical professionals would "put on blinders" and not look beyond that list as new equipment is introduced.
As for new equipment, facilities will need to follow manufacturer suggested maintenance -- whether the equipment is critical or non-critical -- until it's determined the organization has a sufficient amount of information to determine the value of maintaining the manufacturer's inspection and testing frequencies. They may adjust the schedule of non-critical equipment based on the assessment of qualified personnel specializing in staff health and patient safety.

If methodology is wrong, "where are the bodies?"
Still, the key argument, as more than one person serving on the committee stated, is that hospitals have been using different methodologies to determine maintenance schedules for decades. If the methodologies are wrong, where are the bodies?

AAMI and ASHE teamed up to survey members about that question. After three surveys and a response of more than 1,500 medical professionals representing more than a quarter of all U.S. hospitals, the anecdotal evidence suggests that there have been no deaths caused by maintenance frequencies maintained by facilities using outcome-based planning. Ultimately, it's rare for failures of equipment from wear and tear -- what maintenance can prevent. Instead, it's increasingly a failure of user process -- something that increased maintenance schedules would have little impact on.

No greased palms here
Mills admitted that his first thought when hearing the changes to the maintenance schedules by CMS was that some independent service organizations or manufacturers bent the ear of someone to get this put into place. He quickly determined that wasn't the case. "CMS was really trying to make everyone's jobs easier by creating a set of standards that everyone would be using across the board," he said.

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