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Critical equipment

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Critical equipment:...is the term used by the CMS to describe "biomedical equipment for which there is a risk of serious injury or death to a patient or staff person should the equipment fail.

Note: However, there is a practical problem with using this term because, to the best of our knowledge, there is still no real consensus on which types of devices the CMS intends to be considered as "critical equipment". This is also the case for the similar term used by The Joint Commission (TJC) - which is “high-risk medical equipment”. The only examples of "critical equipment" provided in the CMS regulation are ventilators, defibrillators, and robotic surgery devices.

Understanding what equipment CMS intends to cover when they use this term is important because the intent in the "clarification memo" is to disqualify such items from immediate inclusion in an AEM Program (unless the facility can provide specific justification for including them). The regulation requires the facility to conduct a formal risk analysis to identify (and label as “critical equipment”) those devices whose failure could result in such a serious risk. The CMS surveyors are also instructed in the same memo to pay particular attention to any items that the facility has labeled “critical equipment” but that are being maintained other than as recommended by the manufacturer. This implies that when such items are found the facility will be asked to explain why this has not reduced the overall level of patient safety.

In an attempt to make a best guess at what CMS intends, the Maintenance Practices Task Force (MPTF) considered the following:

There are many different causes for medical equipment failures but they can be grouped into three general categories (see Section 1.8 of HTM ComDoc 1):

  • Failures attributable to the device’s inherent reliability, including the random failure of its components, as well as poor design or poor construction of the device itself
  • Process-related failures, attributable to causes such as use errors, physical damage, environmental stress, accessory problems, tampering, and connected network issues
  • Maintenance-related failures, attributable to causes such as non-durable parts that were inadequately restored during the device's last PM or hidden failures that have occurred since the device's last PM, as well failures resulting from intrusive maintenance, and those resulting from poor initial set-up of the device itself

And there are only four ways in which such failures can become hazardous.

  1. When a device on which a patient’s continued well-being is completely dependent (such as a critical care ventilator) fails unexpectedly.
  2. When a device on which a patient’s continued well-being is dependent develops a failure that reduces its performance or safety to an unacceptable level, and the failure is not likely to be obvious to the device user (often called a “hidden” failure)
  3. When the device is used improperly.
  4. When the device is damaged in such a way that it presents some kind of direct physical threat to the safety of patients or staff. For example, if the damage leaves an exposed sharp edge.

However, the CMS "clarification memo" is focused exclusively on equipment planned maintenance (PM) and, of these four ways of becoming hazardous, only two subsets of the four are PM-preventable:

  • Unexpected failures that are caused by the premature deterioration of a critical part that is usually restored during a periodic PM
  • “Hidden” failures that reduce the device’s performance or safety below a critical level, and which would be detected by performance and/or safety verification testing recommended by the manufacturer to be performed during periodic PMs.

Keep in mind also that not all of these failures will necessarily result in outcomes that could result in serious injury or death. See entry for Level of Severity (LOS) below.

Since the objective of the AEM Program option is to allow the facility to use more efficient maintenance practices than are otherwise mandated (following the manufacturer’s PM recommendations for every single piece of medical equipment) - provided that this will not increase the risk to patients or the attending staff, a logical place to start would be to determine which devices could result in some kind of serious, life-threatening outcome if they should fail - from any cause, not just a PM-preventable cause. But this interpretation could be overly inclusive and there is considerable uncertainty about the extent to which CMS intended items that:

(a) demonstrate a relatively high level of inherent unreliability (devices that could be called reliability-critical?), or that
(b) are relatively easy to use improperly in a way that makes them hazardous (devices that could be called human factors-critical?), or that
(c) are unusually vulnerable to becoming damaged in a way that could be dangerous (devices that could be called fragility-critical?),

... be classified as "critical equipment" - and thus not eligible for inclusion in an AEM program.

The Task Force has taken the position that this ambiguity in the definition was not intended by CMS and such items should therefore not be considered to be "critical equipment". To make this interpretation absolutely clear the Task Force has chosen to use a more specific term than "critical equipment", such as PM-critical device" or potentially high PM risk device" to label devices with critical, life-threatening ways of failing (failure modes) that can be prevented by competent and timely planned maintenance. See "A rational, evidence-based approach to designing a safe and effective equipment maintenance program. Part 1: A very simple, basic AEM program" (HTM ComRef 35) for more on the Task Force's PM-focused risk analysis. The tentative result of this analysis (documented in Part 1 of the paper - HTM ComRef 35) is that there are only 20 specific device types should be considered potentially high PM risk devices.

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