What constitutes an effective and compliant clinical equipment planned maintenance (PM) program? Ask 100 HTM professionals, and you’ll get 100 different answers.
By Steven Martinez
Planned maintenance (PM) is a necessary job function for all healthcare technology management (HTM) organizations—whether they are hospital employees, part of an independent service organization (ISO), or the service arm for an original equipment manufacturer (OEM). Effective PM programs not only help ensure the medical equipment is safe and reliable, but they’re also required in some cases by regulatory and accrediting organizations.
Like many things in the HTM industry, there is little consensus over what constitutes an effective and compliant PM program—or even whether to call it planned maintenance, preventive maintenance, or preventative maintenance—because the terms are commonly used (albeit incorrectly) interchangeably.
The Association for the Advancement of Medical Instrumentation (AAMI) has published several standards and guidebooks that reference PM definitions. ANSI/AAMI EQ89 defines planned maintenance as “a general term that is applied to maintenance strategies that take place before a device experiences a loss of function.” Different types of planned maintenance activities can include:
- Preventive maintenance: This involves disassembling the device, cleaning, lubricating, adjusting, and/or automatically replacing non-durable parts at specified time intervals to prevent failures.
- Predictive maintenance: This is similar to preventive maintenance, but it only focuses on replacing heavily worn components.
- Diagnostic or detective maintenance: This involves verifying that the equipment functions correctly, detects any incidental damage, and ensures secondary functions and performance are up to standard via calibration, electrical safety tests, and software version control.
- Evidence-based maintenance: This relies on the organization’s past experience with similar devices to predict the performance and maintenance needs of comparable equipment.
The Centers for Medicare & Medicaid Services (CMS) and its most-used accrediting organization, The Joint Commission (TJC), require that all imaging/radiologic equipment, medical laser devices, and “new equipment without a sufficient amount of maintenance history” be maintained per manufacturer’s recommendations, which almost always calls for regular PMs. However, those devices only account for a very small percentage of a typical hospital’s clinical equipment inventory. It’s up to each individual HTM organization to decide what it believes is the best maintenance strategy for the thousands of devices that don’t fall into those three categories—the choices being either the manufacturer’s documented guidelines or an alternative equipment maintenance (AEM) program.
An AEM program diverges from OEM recommendations, allowing HTM organizations to use evidence-based maintenance analytics for equipment safety and reliability. By its very definition, if every manufacturer-recommended task is not performed within the time frame documented in the service manual, then the device is on an AEM. While this may seem straightforward, policies and real-world practices don’t always align.
Heidi Horn, president of Heidi Horn HTM Consulting LLC, says that although policies and regulations may require strict adherence to the manufacturer’s PM procedures and frequencies in some cases, most in-house, ISO, and OEM HTM technicians take a more practical approach.
“I can tell you with complete certainty that the manufacturers themselves are not performing every task documented in their service manuals every single time they do a PM,” says Horn. “Like all competent in-house and third-party HTM organizations, the manufacturers know what tasks are superfluous, and they skip them sometimes. Otherwise, it would take a half-day or more to perform the simplest of PMs. Not only is it not practical in the real world, performing PM tasks that do not contribute to the safety and reliability of the equipment wastes precious time and money—both of which are in very short supply these days.”
AEM programs offer HTM shops the greatest flexibility under CMS/TJC rules for maintaining equipment and improving the efficiency of staying compliant, but they also must be managed properly. And that, insiders say, is not always easy.
Christopher Nowak, CBET, CHP, CSCS, the director of clinical engineering for Arkansas Children’s Hospital, sees an opportunity for efficiency through AEM programs. With more than 40 years in biomedical technology, including 29 years overseeing HTM for 29 acute-care facilities at Universal Health Services, Nowak believes that some industry professionals miss opportunities because they’re hesitant to trust their expertise or embrace change.
“I’ve had the opportunity to go into situations around the country, and I’ve seen how different leaders manage their programs and planned maintenance,” says Nowak. “Some of them are still stuck in the 1980s, even younger leaders. They’re doing planned maintenance on thermometers, and blood glucose meters, which are devices that are touched maybe 50 or 100 times a day.”
Nowak explains that devices like these have self-testing features, where the devices automatically check their functionality every time they are turned on. To perform the manufacturer’s PM procedures would mean regularly locating these hard-to-find devices and pulling them out of service, and he’s found that inevitably, the self-test makes the PM unnecessary.
“Why don’t you use those resources that you’re deploying to do that type of planned maintenance to attack something that’s very meaningful and much more effective to your program?” Nowak muses.
Different Interpretations of TJC Standards
The debate over whether it’s better to follow the manufacturer’s PM recommendations or opt for an evidence-based AEM is just one of the many longstanding “PM controversies” in the HTM industry. Horn and other industry leaders say the primary cause for the confusion and inconsistency can be attributed to a lack of industry standards and the vagueness of the CMS and TJC requirements—which leave a lot open for interpretation.
For example, TJC mandates a 100% PM completion rate. But does that mean you have to touch the device and perform every task in the PM checklist before the PM due date? If you can’t find the device or it’s in use, can you still document it as completed? What if you do the PM after the due date? Should it be calculated in your completion rate?
Ask 100 different people in HTM these questions, and you’ll likely get 100 different answers.
Horn contends that it’s time for regulating agencies to work with HTM experts to develop more practical and clear standards – based on evidence-based best practices – that promote medical equipment safety and reliability. “For too long, HTM organizations—and I’m including in-house departments, ISOs, and OEM service divisions in this bucket—have operated as ‘unique and special’ snowflakes,” Horn says. “They’re really not. They’re all working on pretty much the same equipment, trying to follow the same regulations in a healthcare setting. By leaving it up to every organization to interpret the rules and create policies for themselves, it is creating a tremendous amount of additional work and cost for every organization to manage those unique programs.”
“Think about the customized configurations needed for your CMMS in order to document adherence to your policies, or how much time you spend trying to write and justify your procedures,” Horn adds. “If we can standardize industry best practices, it will raise the performance levels of the entire HTM industry.”
Nowak begs to differ. “The clinical engineering field is all about managing risk, whether it’s a cybersecurity risk—somebody hacking into your medical device—or if it’s a risk associated with planned maintenance,” says Nowak. “So, the beauty with managing the PM risk is it yields a lot of opportunities for a leader who is very strategic,” he says.
Nowak says he appreciates the freedom allowed by TJC’s requirements to develop his own planned maintenance program. “And then I have to live by it,” Nowak says, “and that’s what Joint Commission holds my feet to the fire on.”
Bringing Clarity and Standardization to the Field
Despite the perceived flexibility, Horn and many of her colleagues think its time for more HTM standards to reduce the differing interpretations, procedures, and performance levels in CMS and TJC requirements.
Horn, who has spent over 20 years in the HTM field, currently serves as treasurer of AAMI’s Board of Directors Executive Committee and was the previous chair of AAMI’s Technology Management Council (TMC). She is also an inaugural member of the AAMI Fellow program.
In her time on AAMI’s TMC, Horn and her colleagues spent a lot of time pondering what it means to comply with CMS and TJC standards and created the Planned Maintenance Compliance and Definitions Guide. According to Horn, the guide aims to enhance clarity and standardization by outlining TJC’s standards and establishing best practices for HTM organizations to follow. Created by six HTM experts and reviewed by TJC, Horn says that arriving at definitions and procedures that everyone could agree upon required much debate, emphasizing the need for a shared starting point in collaboration.
The AAMI PM guide includes a list of definitions for terms like “PM Complete” versus “PM Compliant” and includes formulas for calculating PM completion percentage and PM compliance percentage. It then runs through a series of scenarios that might be confusing while staying compliant.
One common procedural variation among HTM organizations is whether to label equipment that can’t be located for maintenance or is currently in use as “PM Complete,” even though the device never received a PM. Some organizations identify the work order as complete and close it to comply with TJC’s 100%-completion rule. Others leave the work order open until the PM can be performed, but then must explain to TJC why they aren’t at 100% completion. AAMI’s PM guide recommends creating a new status in the CMMS of “PM-Compliant” to identify that the HTM organization did their due diligence to locate the device and perform the PM. The guide then suggests using “PM-Complete” on the PM work order only when the appropriate PM tasks have been performed on the device.
Another often-debated issue that the guide addresses is how many times a technician should look for a device that can’t be found for its PM, as well as when the device should be considered missing or lost.
Per the AAMI PM guide, shops should search for the device at least two times before the PM due date—at least once in person and another time via message to a clinical point of contact. Crucially, instead of marking the PM work order of a missing device as “complete,” the guide advises closing the work order with a code indicating that maintenance couldn’t be performed due to the device not being located after two attempts.
“I’ll speak for my own hospital system,” Horn says. “When we started really looking at our ‘PM Not Performed, Not Found’ process, we found work orders for devices that had not been found for years that the technicians just marked ‘complete,’ and the PM work order would generate every six months. Most likely, that device was not even in the hospital. It was long gone, but we were still creating that work for ourselves over-and-over again to run around the hospital looking for it.”
Missing and lost equipment is a fact of life for hospitals, particularly when it comes to mobile equipment, which is constantly being shifted around the facility. Even when presumed they are no longer in the facility, devices sometimes have a way of popping up again at the least opportune moment, according to Nowak.
“At my former employer, we had an ultrasound system that went through two PM cycles, and we were never able to find it. During a Joint Commission survey, one of the surveyors walked the floors and saw an ultrasound system. [The surveyor] then took down the number, sent it to me and the clinical engineering director, and [asked for the] planned maintenance data history on this device,’” says Nowak.
Of course, it turned out to be the lost ultrasound system. “That was a little bit of a ‘gotcha,’” says Nowak. “It was a great learning experience for the staff in clinical engineering because when we retire equipment, we cut the plug off so that it can’t be used. But, yeah, it happens.”
While the situation was frustrating at the moment, ultimately, Nowak and his facility were saved by the thoroughness of their procedures. The situation was resolved, and the Joint Commission surveyor observed how the hospital documented the lost device and its return to service.
“We were upfront with the surveyor; we did a post-mortem, and then we PM’d the device and put it back in service,” says Nowak. “The surveyor was fine with everything. When you comply with your policy, and you’ve shown by your documentation to the surveyor that you’ve complied with your policy, you met all aspects. You were 100% compliant.”
The Importance of Time Management
Given the shortage of clinical equipment technicians, proper time management needs to be a priority for a hospital when creating a PM program, insiders say. Every manager will prioritize things differently based on the needs and resources at their facility. That prioritization will determine how hard it is to maintain PM compliance. Horn says the hospitals she works with spend about 30%-40% of their time on PMs, roughly 30% on administrative work and projects, and the remaining time on corrective maintenance.
Nowak estimates that at Arkansas Children’s Hospital, which has 350 beds split between a large and small facility, technicians spend 50%-65% of their time on PMs compared to corrective maintenance. He says the smaller facility, with only two full-time techs, spends more time on PMs because equipment breaks down less frequently. But Nowak also emphasizes that good planning is crucial to maintaining that balance, especially with such a small staff.
And planning ahead is something the AAMI PM Guide encourages HTM departments to do. This means ordering parts for upcoming PMs, balancing workloads and schedules for techs, identifying priority PMs on high-risk devices in the month before they are due, and looking for hard-to-locate devices before a PM due date. Also, ensuring that when priority tasks come up, there are enough people scheduled so it isn’t a surprise when someone is on vacation or attending a service school.
Staying on top of a PM schedule, especially when dealing with outside service, is of the utmost importance, says Nowak. “A pitfall is not staying ahead of your outside service PMs and making sure you have your documentation in when you say you’re supposed to have your documentation,” He adds.
Nowak opens his PMs on the 15th of the month before a PM is due and closes them out on the 15th of the month after they are scheduled. He does this because outside service engineers have their own schedule that is outside of his control. Even if they complete their service before the PM is due, it will still take time for them to complete and send in their paperwork. With proper planning and enough of a buffer, Nowak allows enough leeway to stay compliant with his own PM program, he says.
Yes, facilitating a PM program may seem like a never-ending juggling act. But if you stay organized, document well, and follow efficient procedures, you can attain 100% compliance.