Malcolm Ridgway: CMS and Preventive Maintenance

The controversy generated by the Dec. 2, 2011 “clarification” memo from CMS to the state survey agency directors has made me stop and think about just what kind of a job we, as a professional community, have (or have not) done in clearing up the mysteries and misconceptions surrounding preventive maintenance (PM) for medical devices. Ever since The Joint Commission (TJC) generously opened the door in 1989, we have developed an intellectually lazy habit of believing that since we now use a risk-based approach we don’t have to have clear, logical reasons why we include some devices and not others in our PM programs, and provide understandable justifications for the PM frequencies we use.  Although we have started to use the newly popular term “evidence-based,” we don’t yet have general agreement on just what kind of data we need to cite as evidence of reasonable risk. We don’t even have a consensus on which devices should be considered “critical.”

I believe that CMS is sincerely trying to go along with the spirit of TJC’s relaxation of the original excessively stringent “manufacturer’s recommendations” requirement. Unfortunately, they are not experts in this technically complex area, but they do have a regulatory obligation to act as the nation’s watchdog, making sure that patients are not being exposed to unreasonable risks. And, if they had asked us for technical guidance, I believe that what we currently have to offer would not have helped them understand the simple science underlying the practical aspects of preventive maintenance as it relates to medical equipment.

Although it is not going to help in the near term with sorting out the confusion created by the December memo, it is surely time for the clinical engineering community to find a way to come together to develop some kind of consensus guidelines on what constitutes a reasonable evidence-based medical device PM program. Until we have agreement on this, and can decide what constitutes appropriate evidence, we should stick with the guideline format—not a standard. Without some kind of a reference point such as this we will continue to be unable to respond to legitimate challenges that certain approaches that we advocate are either too risky or too conservative. Aside from the CMS, our clinical colleagues have a right to ask for the same reassurances, and a right to be able to comprehend what we tell them.

Malcolm Ridgway
Chief Clinical Technology Officer
ARAMARK Clinical Technology Services

2 thoughts on “Malcolm Ridgway: CMS and Preventive Maintenance

  1. Healthcare Facilities, to include both users and maintenance personnel, have a legal obligation to follow the device Mfg instructions for use (labeling). The CMS is merely requiring what is already fact, that once a Class II or III device and labeling are cleared by the FDA, it is considered safe and effective when the instructions are followed, unless a filed complaint prompts a labeling changed.

  2. This is such an interesting and challenging topic. I think that I am aligned with many people in that I firmly believe in the value of evidence-based maintenance regardless of the level of risk associated with the use of that equipment. I certainly would like the freedom to focus my work on where the evidence confirms that it would do the most good. I would love to see the data regarding equipment failures related to the lack of effective PM’s causing patient harm upon which CMS based their decision, assuming it exists.

    However, I think a reasonable, objective person would look at the CMS guidelines and ask, “what’s the problem?” Who better to establish the content and frequency of PM than the company that manufactured the product? It’s actually a reasonable approach to a STARTING POINT for a guideline. It is also reasonable in my opinion for CMS to take the next step and to allow variation based on evidence for ALL types of equipment. But only if as a field we can show that we have a consistent, documented process for the use of evidence in determining maintenance strategies. But that is the challenge as Malcolm so eloquently states. We can continue to lobby CMS to revise their recent guideline, but until we agree on a process I think it will be difficult to convince them to do so.

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