Equipment has to work when called upon, especially life support or life saving devices. This is not a topic of debate within the halls of any hospital. Patient safety is a driving force behind clinical engineering (CE) procedures and initiatives, a priority that is echoed by every segment of health care. The ability to fix a broken piece of equipment is important; the ability to prevent a life-saving piece of equipment from breaking when it’s needed is imperative. Even more critical is to ensure that equipment that appears to be working is actually working safely.

Questions about how you approach maintenance, whether scheduled or based on some other set of criteria, have garnered a lot of attention in recent years. It is no longer a new question, nor is it surprising to see the question asked. PM means different things to different CE departments, and some simple realities have changed the equation. Many medical devices are just engineered differently and more reliably today than they were when scheduled maintenance practices were first developed.

The original intent of this article was to examine the debate between the more traditional approach to scheduled maintenance and the newer evidence-based approach, but there may not be an enormous difference in opinion that favors the old way. The collective conscious of biomed professionals tends to recognize the evolution in medical devices because they see it every day. Technology has changed the equation.

Instead, we can compare the two schools of thought as the approach evolves. Drawing a contrast between existing PM protocols and an evidence-based approach is also difficult because recommendations for preventive maintenance have come from so many sources that different shops approach it differently. There is no industry-wide standard definition that can be found, even in different hospitals in the same city.

There is a general consensus for the goals of preventive maintenance: relaibility and safety. These goals also maximize clinician satisfaction while minimizing revenue loss due to down time. These precepts are generally taken for granted. While the center of the debate is on strategy (i.e., frequency and coverage), sometimes the PM tasks are also questioned.

PM the way it’s been done

The Joint Commission (TJC) offers flexibility in strategy selection. EC.02.04.01 says, “The hospital identifies, in writing, frequencies for inspecting, testing and maintaining medical equipment on the inventory based on criteria such as manufacturers’ recommendations, risk levels or current hospital experience.” Furthermore, it says, “Note: Hospitals may use different strategies for different items as appropriate. For example, strategies such as predictive maintenance, reliability-centered maintenance, interval-based inspections, corrective maintenance or metered maintenance may be selected to ensure reliable performance.”
The CMS rule says that equipment needs to be maintained “according to manufacturers’ recommendations.”

In a meeting between CMS and TJC in 2010 last year, CMS asked TJC to justify their flexibility and ended accepting TJC’s explanation but asked TJC to train their surveyors to scrutinize the effectiveness of maintenance strategies more closely.

For hospitals accredited by an organization other than TJC, the manufacturer’s recommended maintenance schedule may still be the sole guiding source (although DNV Healthcare has also received CMS approval to allow more flexibility). Manufacturers may have a self-serving and survival motivation when designing their frequency recommendations which don’t always recognize the limited resources and strained budgets that are a reality today in most hospitals and, more importantly, what the equipment truly requires.

If you could get the managers from 500 clinical engineering departments together in one big room and ask for a show of hands on which preventive maintenance approach they prefer, what would we learn? If we could get each one of those managers to complete a survey describing their department’s service interval for each piece of equipment, would we find 85 percent agreement on a set of intervals? Would there then be a way to standardize this consensus? More than 20 years of continual debates suggest that this is unlikely to happen.
In the meantime, some CE professionals decided to try a different approach by examining a large amount of maintenance data and comparing the outcomes of different strategies They call this approach evidence-based maintenance.

PM based on loads of experience

The adoption of the evidence-based maintenance approach should not require a leap of faith within the health care culture. Evidence-based medicine was accepted by clinicians a long time ago. Evidence-based medicine seeks the best clinical evidence from systematic research and injects that evidence into the decision-making process while treating an individual patient. Evidence-based medicine relies on sound methodologies. It requires the clinician to have the skills to judiciously review the clinical literature, including randomized, controlled clinical trials and cohort studies, and apply what is learned to the treatment of their patient. A physician must determine if the results of a study apply to their patient and consider the secondary effects of the treatment and the costs.

Evidence-based maintenance is a systematic method for determining maintenance effectiveness. It relies on a small set of codes to classify failures found during repairs and scheduled maintenance (PMs and SPIs). The CE professional then determines the effectiveness of different maintenance strategies in much the same way that the clinician determines a treatment regimen. In both cases, the end beneficiary is the patient, while another goal is to provide proof of the effectiveness of the approach to the regulators. It measures the outcome instead of just providing a check mark on a maintenance schedule.

The approach relies on historical evidence tailored to the usage and care of devices in a particular institution. Critical life support equipment may always remain under more frequent inspection and maintenance schedules, but other high tech devices could be reliable and safe enough to warrant reconsideration.

One of the thought leaders is Dr. Binseng Wang, Sc.D., fAIMBE, fACCE, CCE. Wang is vice president of performance management and regulatory compliance at ARAMARK Healthcare’s Clinical Technology Services. He and his colleague, Jim Fedele, AAS, CBET, CE Director at Susquehanna Health System, have spoken extensively about the evidence-based approach to preventive maintenance.

Wang draws an analogy between the vacuum tube TV of days gone by and the LCD TV of today when describing advances in medical equipment. The owner of a vacuum tube-based television could take the set into a shop or have a service person come to his home and have a tube replaced for around $50. The pre-solid state circuit technology lent itself to a number of problems that required repairs. The LCD TV of today is more reliable and does not so easily succumb to problems like overheating as the more archaic TVs did.

As Wang puts it, “We need to save money by not doing unnecessary things, but to use that resource to do the necessary things to help treat the patients more quickly, better and more effectively, because at the end of the day, we all have the same goal. We want to provide the best value in terms of health care.” “Value meaning good quality care with the lowest cost. This is not by saying, I did my preventative maintenance or I did my so many visits to the patient, but it’s really the outcome that counts.”

In evidence-based medicine, we don’t assume that any benefit is derived by the number of visits the clinician has had with the patient. Success is measured in marked improvement; if the patient is getting better, leaving the hospital and getting back home. “Maintenance is the exact same thing,” says Wang. “The only difference for us is that our patient is the equipment. We want the equipment to get good soon and remain well for as long as possible. We should invest as much of our resources as possible on the right things that the equipment needs and save the rest.”

Another thing that has changed over time is the accumulated wisdom and experience of the people who service these devices and their ability to aggregate much of that experience into databases that provide some tell-tale histories of every medical device found in a modern hospital; in their hospital.

This takes advantage of some of the software already found in the CE department. We can now very easily extrapolate the results from large data sets and derive a greater understanding of the experience of clinical engineering departments across the country or around the world. With the availability of large amounts of information about the performance and failure rates of every type of medical equipment, shared among biomed professionals from dozens of hospitals, the standard protocols of yesterday give way to the technological capabilities of today. Now, it is not just the experience of one clinical engineering department in one hospital with one inventory of devices, but potentially thousands.

A change for the CE department and clinicians

The complexity of modern medical equipment can confound even the sharpest health care professional.

The user of a piece of medical equipment is a variable that has to be considered when reviewing the devices functioning. It may never have occurred to the engineer who designed a device that just because it is intuitive to him or her, it is not just as intuitive to another smart person with different background and training.

“Things are getting more complicated,” Wang says. “Equipment is getting more challenging to use. We are having more use errors – not user errors, but use errors. Sometimes it is not very intuitive to the user how a computer or program or car should be operated.”

To this end, the evidence-based maintenance approach finds these use errors and provides a training opportunity to link the clinician with the original thinking of the engineer.

“It’s really the outcome that counts,” Wang says. “Maintenance is the exact same thing. The only difference for us is that the patient is the equipment. We want the equipment to get well soon. We should invest as many resources as possible on the right things that the equipment needs and save the rest. It’s going to cost somebody something, and it’s not benefiting anybody.”

Evidence-based maintenance measures outcomes and, thus, provides a measure of effectiveness. When a third-party wants to understand the rationale behind a preventative maintenance strategy, it gives the appropriate answer. “We are proving to you what we are doing is just as good if not better than what the manufacturer had recommended,” Wang says.

Wang draws an analogy to the education of children. Do you want your kids to go to school and earn a diploma by class attendance? Or do you really want them to prove to society, not just you, that they have really learned something? Schools systems around the country are also measuring the effectiveness of teachers and schools by student achievement tests.
There is no figure that definitively states how many clinical engineering departments have adopted the evidence-based approach. The number of departments nationally that have adopted this as a protocol or who are transitioning to this methodology is not currently quantifiable.

“There is something that has changed over the last three or four years is that more and more people are now looking into maintenance effectiveness, so much so that they are now participating in our internal studies or doing their own studies at their own institutions,” Wang says. “It’s a grassroots movement that is growing.”

This approach is designed to save on the hospital’s budget by freeing up human resources in the clinical engineering department. It is not designed to make any member of the department obsolete. Creating more time in a biomed’s day by reducing the time spent performing unnecessary PMs can be better allocated doing something else valuable to the hospital, such as helping users understand and use properly new equipment, care better for accessories and batteries, and check equipment status before putting it on a patient. “In the end, we are trying to reduce the cost of health care and improve the quality at the same time.”