By Binseng Wang, ScD, CCE
Recently, I’ve heard some colleagues say that the purpose of AEM is to save maintenance costs (while preserving equipment safety). Not only does this statement concern me, but so does this line of reasoning. Cost-saving is not the primary purpose of AEM—and it is a slippery slope that CE/HTM professionals must avoid at all costs.
Let’s first remind ourselves how AEM came about. Soon after gaining oversight authority over the Joint Commission (TJC) in 2008, the Centers for Medicare & Medicaid Services (CMS) discovered that TJC had accreditation standards that differed significantly from their requirements. To eliminate such discrepancies, in 2011 CMS issued a memorandum mandating that all equipment must be maintained per manufacturers’ recommendations. Realizing that this mandate was not only impractical to implement but would also seriously degrade patient safety, the CE/HTM community rallied behind George Mills—the TJC Director of Engineering at the time—to seek relief.
Binseng Wang
The industry provided CMS with extensive evidence showing that medical equipment has been properly maintained for several decades without strictly following manufacturers’ recommendations. Furthermore, to do so would divert CE/HTM professionals’ attention from other more critical patient-safety-related activities (e.g., equipment planning/selection, user training, CE-IT integration, cybersecurity, etc.). After reviewing the overwhelming evidence, CMS relented and issued another memorandum in 2013, which allowed AEM for most equipment.
Therefore, AEM was not granted for saving costs. Hospitals did not lay off staff or reduce service contracts by implementing it. Any “savings” were virtual (i.e., “cost avoidance”) by not hiring more staff to fully comply with the new CMS mandate. By alleging cost-savings, CE/HTM and outsourcing managers run the risk of being asked by their supervisors or contract administrators to reduce staff or contract prices.
Worse yet, lawyers could exploit the cost-saving justification for AEM in the event of an equipment-related patient injury. Imagine how a jury of laypersons would react to learning that the hospital reduced maintenance activities in order to “save costs.” At that point, it would not matter even if you could prove that the equipment failed in an unpredictable and unpreventable manner. It would be a dream come true for any ambulance-chasing lawyer.
So, what is the purpose of AEM? In my humble opinion, the purpose of AEM is to optimize the use of limited resources to better distribute attention to areas that most benefit patients and caregivers. This is not just sophism, but an honest answer and actually what good CE/HTM professionals have been doing all along.
Another concern that I have regarding recent AEM discussions is the recycling of the old “risk-based criteria” originally proposed by Dr. Larry Fennigkoh for equipment inclusion into a scheduled maintenance (SM) program. Despite George Mills repeatedly saying that, “Just because [a device is] high-risk doesn’t automatically mean it’s high PM,” many people still think that changing SM on high-risk equipment is taboo.
For example, ICU patient monitors are obviously critical for patient safety. However, nothing can be done to prevent their failures since they’re built with solid-state electronic components. Consequently, SM is completely useless if it cannot reduce the probability of failure by replacing wearable parts or sensors, or detecting failures hidden from the users or the machine itself (“self-test”). Please understand that I am not saying risk should be completely ignored—only that it should not be a primary parameter. A detailed discussion on AEM inclusion criteria is beyond this article.
Finally, one CMS requirement for implementing AEM that has been frequently overlooked is the need to evaluate its safety and effectiveness. A simplistic and erroneous evaluation method is to monitor the failure rate or mean time between failures. Unless those failures are related to SM planning, such data is meaningless. Therefore, the cause of the work-order failures should be determined so that indicative analyses can be performed.
Even if only patient incidents caused by maintenance-related equipment failures are monitored and analyzed, it’s important to remember that clinicians often take prompt actions when they notice something wrong. However, these “close calls” are seldom documented and much less investigated. So some AEM deficiencies could go unnoticed until someone is truly harmed.
Instead of just evaluating patient incidents, one should analyze all actual and potential failures found to be predictable and preventable, hidden from users, in progress, and induced by service. Any unusual surge of these failure causes should trigger a review of the respective AEM, even if OEM recommendations were followed. Actually, the evaluation may suggest increasing the SM frequency or adding SM tasks, proving again that AEM is not for saving costs.
The biggest challenge of AEM is the lack of data to support both initial planning and post-implementation evaluation, particularly for small CE/HTM teams. It would be highly desirable for regional and national HTM organizations and/or CMMS providers to collaborate by polling together data for statistical analyses that everyone can use.
Binseng Wang, ScD, CCE, is a principal consultant with health technology consulting firm BSI. Questions and comments can be directed to chief editor Keri Forsythe-Stephens at [email protected].
References:
- While the Centers for Medicare & Medicaid Services (CMS) calls it the Alternate Equipment Management program, The Joint Commission (TJC) prefers the name Alternative Equipment Maintenance program. Information available at http://www.cms.gov/Surveycertificationgeninfo/downloads/SCLetter12_07.pdf and https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-07.pdf
- Fennigkoh L & Smith B. Clinical equipment management. JCAHO PTSM Series, 2:5-14, 1989.
- Lower J. Joint Commission’s Mills to AAMI: Use Common Sense for Alternative Equipment Maintenance Available at https://24x7mag.com/2015/06/joint-commission-mills-common-sense-alternative-equipment-maintenance-still-top-issue-for-biomeds/ Accessed Aug. 22, 2015.
- Wang B. Pinpointing the Root Cause of Equipment Failures. Available at https://24x7mag.com/2018/07/viewpoint-pinpointing-root-cause-equipment-failures/
I’ve been immersed in AEM-related activities for a while now (see my AEM Program Guide: Alternate PM for Patient Safety published by AAMI) and I agree with everything Dr. Wang says in this piece. I will admit to sometimes highlighting the PM time savings that come from a good AEM program, but (as Frank Painter and I emphasize in the AEM workshops we’ve been presenting around the country) a well-designed AEM methodology helps us make smarter decisions about how we use our maintenance resources and, as a result, improve patient care. Binseng is right; it’s not just about saving money.
I am nearing the end of a 40 year career, at various times buzzing in and out of this never-ending discussion. The article is spot on but restates topics that have been beat to death since I jumped into the rabbit hole that is clinical engineering.
For all practical purposes, the last paragraph is the one that suggests a (if not the only realistic) path out of this tar pit. Realizing it will present a known challenge: Ensuring that the data provided from multiple independent sources can be combined, i.e., is not apples and oranges. It’s doable, and the ROI will almost certainly more than justify the effort, both initial and ongoing. I would also suggest that the risks of not doing it are worthy of consideration. Good luck.
Right. We need to rely enough on standardized data to be able to set AEM based on data from outside the owner’s organization. This should include data on the components of the device if known. In a fashion similar to the drug industry, component data should be available and linked to the device.
There is a gap between “not for saving money” (Wang) and “not just for saving money (Baretich). If there was nothing to be saved then the manufacturer’s method could be followed. But the widespread belief (if not evidence) is that doing so would squander both human and fiscal resources. This is pretty close to saving money. This is the same issue as alternative parts. We think they save money, or there would be little reason to use them. Unless you want to argue you found a better part.
The legal quandary exists whether or not you are saving resources. “Did you follow the manufacturer’s procedures?”, “No”, “Why not?”
A proper risk management approach just asks a slightly different question. It isn’t inherent risk, its maintenance related risk.
Guess Prof. Hyman missed an important sentence in the article that says “Actually, the evaluation may suggest increasing the SM frequency or adding SM tasks, proving again that AEM is not for saving costs.” This actually happened when I was assisting a hospital that found numerous hidden failures on their oxygen concentrators despite following strictly OEM recommendations. The evaluation showed they had to increase the frequency of sieve bed replacements instead of following OEM recommendations. Ultimately, AEM is to provide safe and reliable equipment for patient care using resources available. Sometimes this means reducing unnecessary tasks, while other time, increasing tasks.
At first, I thought there was finally a detail where I did not agree with Binseng Wang. Ah, but I was corrected. I was saying you save money to apply it elsewhere. But the right wording is the redistribution of resources. The overall cost of resources is hopefully what is needed, though in some locations it may only be what can be afforded or what is allocated. It should not be related to AEM.