Posted January 11, 2017
While meeting The Joint Commission’s (TJC) new standards on medical device maintenance may not be easy for some hospitals, it is doable. This was the main message delivered by George Mills, TJC’s director of engineering, and Stephen Grimes, managing partner and principal consultant for Strategic Healthcare Technology Associations, LLC, during a webinar hosted by AAMI last Friday.
TJC has moved to a “much more aggressive, ‘see it—cite it’ practice,” according to Mills. Under the new elements of performance (EPs), hospitals are expected to complete all planned maintenance activities in line with manufacturer recommendations or an alternative equipment management (AEM) program 100% of the time.
Previously, TJC had drawn a distinction between high-risk and non-high-risk equipment in terms of the 100% rule. But following efforts to streamline its standards and input from the Centers for Medicare & Medicaid Services, the federal agency that administers several government health insurance programs, the expectation for all equipment—regardless of risk—is now the same.
During the webinar, which was attended by nearly 1,000 healthcare technology management (HTM) professionals, Mills provided the example of changing the oil in a pump, saying that you have to do all the steps to complete the job. “You’ve got to do those. No negotiation there,” he said.
The leeway comes in crafting an AEM program and departmental policies, as well as in determining the frequency of the required maintenance activities. Mills stressed the need to start with the recommendations from the device manufacturer and then use real-world evidence to decide if deviations can be made without reducing the safety of the equipment. He repeatedly underscored the need to create a comprehensive program that reflects an understanding of possible questions and challenges down the road.
“It does take some thought and time,” Mills said of developing a strong AEM program. He added that it is vital that HTM staff can explain and defend their policies when asked about them. “It always goes back to: ‘Can you defend the decision you make?’“ Mills said.
He also pointed out that a good AEM program isn’t about doing less than the manufacturer may recommend. There could be instances in which an HTM department determines there is a need to do more. “It is making the right decisions to get the right outcome,” Mills said.
As a result, a good AEM program reflects a thorough understanding of risk, hospital needs, inventory, resources, and patient safety.
Mills and Grimes emphasized that maintenance activities covered by the new 100% rule don’t apply to equipment that is either in use with a patient or missing. “We have never, ever advocated talking it off a patient to see if it’s working OK,” Mills said of medical devices that are in use at the appointed time of service. “If you were there and there on time, it’s not going to count against you.”
The key point, the two men indicated, is having the ability to document that:
- HTM staff did indeed determine the equipment was either in use or could not be located.
- There is a clear policy in place that details what will be done once the equipment becomes available or remains missing for a specified period of time.
Because, as Mills often has said at the AAMI Annual Conference & Expo: “If it isn’t documented; it isn’t done.”
For large healthcare systems with multiple facilities, both men said there is a need to recognize that some adjustments are likely necessary in AEM programs and policies to best meet the needs of each individual facility.
“You have to implement it at a local level—engaging the clinicians, engaging risk management,” Grimes said. “One size doesn’t fit all in this case.”
A recording of this one-hour webinar and PDF copies of the slides are available in the AAMI Store. On-demand access is free for AAMI members and costs $85 for non-members.