Healthcare facilities must consider a number of factors when creating a solid alternative equipment maintenance (AEM) plan, including balancing patient safety with optimizing HTM talent.

By Aine Cryts

A successful AEM program at any healthcare facility has to balance two realities at the same time, according to Matt Baretich, PE, PhD, president of Fort Collins, Colo.-based Baretich Engineering. These two realities must prioritize patient safety and the need to make the best use of the members of the HTM team, he says. 

“We all want to make sure the medical device is safe, but we also need to do it economically and reduce the amount of time spent by techs on maintenance,” Baretich says. “That means we save money and techs can save time.” 

Blake Collins, director of clinical engineering at Wilmington, Del.-based ChristianaCare, agrees. He says biomed leaders must face the reality that they have a limited number of employees on their team, which is one reason creating an AEM program is worthwhile. 

Planned maintenance includes the inspection and maintenance procedures conducted at scheduled times for medical devices, according to Baretich, who provides these four key operating principles for a successful AEM program:

  1. The planned maintenance for a particular medical device can adjust activities or frequencies or both.For example, the planned maintenance can mean a defibrillator’s output is tested at two settings rather than four, or the device is tested once a year rather than twice a year. 
  2. With good data, it may be appropriate to reduce the planned maintenance frequency to zero, which means no planned maintenance is scheduled, sometimes referred to as a “run-to-failure” schedule. Typical equipment for this approach: otoscope/ophthalmoscope units. Some manufacturer’s requirement is for a tech to turn on the otoscope to make sure the light comes on, says Baretich, who questions the value of sending an HTM team member, a valuable resource, to perform that task. Even if the light burns out, there are other otoscopes available and there’s no negative impact on patient safety, he says.
  3. Data drives all AEM program decisions and everything has to be thoroughly documented. While a variety of risk assessment methodologies are appropriate, the best is based on the following: Risk (of equipment failure) equals severity (or impact of failure) multiplied by probability.
  4. An effective metric for planned maintenance program performance is a must. Baretich recommends the following: MTBF-PM, which equates mean time between PM-related failures. 

Create the Right Governance Structure for the AEM Program  

Samantha Jacques, PhD, FACHE, AAMIF, vice president of clinical engineering services at Grand Blanc, Mich.-based McLaren Health Care, insists biomed leaders have to get the governance structure right in order to achieve success. The role of a governance structure is to ensure clinical and technical decision-makers are reviewing and approving devices for the program, she says.  

Getting the right number of people on the team is important. “You can’t have eight, 10 or 15 people on the team —that fundamentally makes it hard to come to (a) consensus,” says Jacques, who suggests including between three to six people on the team. “Fundamentally, you want to have enough different perspectives on the team that they’re challenging each other. You don’t want one person running the program,” she says. “You want team members to serve as ‘checks on each other’ and remove internal biases.” 

Jacques’ definition of bias is “any one person’s judgment about an outcome.” That’s why having team members from different disciplines and departments are valuable. It also keeps the biomed team from getting “very regimented about its decision-making (with AEM programs),” she adds. 

Approximately 95% of the clinicians at McLaren Health Care using medical devices are nurses, which is why they’re generally a good fit for the team, according to Jacques. Including nurses in the governance structure helps ensure the biomed team fully understands how clinicians are using these devices during care delivery. In addition, including a representative from the risk management department encourages the governance team to consider risk-ranking criteria. In addition, biomed staff members bring to the governance structure an understanding of how these devices work, Jacques says.  

AEM Tip: Use Professional Judgment and Make Incremental Changes 

Baretich says you can’t reduce the safety of the equipment in an AEM program, according to CMS’ rules. His guidance is to collect historical data about the performance of the device and use that data to decide the appropriate devices to include.

It’s even possible, with good data, to put critical equipment like defibrillators into an AEM program, according to Baretich. While the manufacturer may recommend testing at 10 output levels, it’s a good idea to review the data to determine if there have been historical issues. If not, the biomed team can try testing the defibrillator at less than 10 levels. That’s where HTM professionals are using data to support decision-making, he maintains.

“You have to put in place a metric to show you the decisions are good ones,” Baretich says. Then it’s important to check on the reliability of that data in the future to determine if the right choice was made to include the defibrillator in the AEM program. It’s also important to pay attention to “red flags” that make you revisit that decision, he adds.  

In addition, biomed leaders need to rely on their professional judgment when deciding on the devices to add to or remove from AEM programs, according to Baretich. Helping to inform that insight is inspecting the healthcare organization’s records for the repair history on a particular device.  

He also suggests making incremental changes. For example, if the defibrillator manufacturer recommends doing maintenance each year and there have been no issues, consider testing it every six months and then monitor the data. What biomed leaders shouldn’t do is take a device where the manufacturer recommends maintenance every six months and stretch that out to five years, Baretich says.   

His advice is straight-forward: Make little changes and learn from making those small changes.  

Be Open to Suggestions from Staff 

Jacques advises biomed leaders to encourage team members and clinicians to suggest medical devices for inclusion in AEM programs. Her one key piece of advice: Always keep patient safety as your “North Star.” A Forbes commentary defines a “North Star” metric as one that provides “direction that is in line with the value you offer to your customers.” 

Throw it out to your staff to come up with ideas for devices to include in the AEM program and then run the numbers, she says. For example, one of Jacques’ colleagues suggested including treadmills. The initial thought process was most people use their treadmills at home two or three times a week, which means they don’t experience much wear and tear. But Jacques pulled the data and ran the analysis.  

Her findings? The healthcare system’s treadmills were in use eight to 10 hours a day, which meant they faced a great deal more wear and tear than a similar machine in someone’s home. For example, the belts in treadmills wear out as a result of use. “A failure could happen when a patient falls off (the treadmill) and breaks their arm.” 

At Kansas City, Mo.-based Saint Luke’s Health System, it incorporates treadmills as part of its cardiac rehabilitation program that uses aerobic exercise to help patients improve their use of oxygen. In most healthcare facility-based programs, the patient’s heart rate and blood pressure are monitored during exercise. 

While falling off a treadmill likely won’t result in a patient’s death, it’s a serious clinical outcome, which meant the machines wouldn’t be included in the health system’s AEM program, Jacques says.  

Hire The Right Team Members and Trust and Empower Them 

Technical knowledge and skills are a requirement, Baretich says. But he counsels biomed leaders to pursue job candidates who share the healthcare facility’s values. At the top of that list is a commitment to serving patients. The right people to hire for AEM programs or biomeds, in general, are those who aren’t looking to “cut corners” in their workload, he says. “If anything, the way some of us in the tech world see it—we’re likely to do more than is necessary. But if you have good data, you can say that (planned maintenance) doesn’t make a patient safer.” 

Team members who are designing and managing the AEM program “need to have a deep understanding of AEM principles and the hospital’s policy,” Baretich says. “They need to understand how the various medical devices work and, equally important, what their foreseeable failure modes are.” 

A basic understanding of the AEM program’s principles and purpose is a must for team members who are implementing it, he adds. “They need to be able to explain that information to equipment users who might be concerned about the safety of their equipment. They also need to be able to explain that information to (The Joint Commission) surveyors during accreditation surveys.” 

Collins’ approach at ChristianaCare is to “hire for attitude, train for skill.” Job candidates need to have the attitude of being willing to accept the training and guidance, which is really important given the amount of cross-training done within his team.

What’s the other attitude he’s looking for? That future team members are “here for the right reason and that’s to support patient safety.” Collins knows that he’ll need to empower his team members to make the right moral and ethical decisions related to the AEM program and other challenging situations as they occur. 

Meanwhile, Baretich says, “People who really, really care about doing well for patients” is one of the things that has always impressed him during his 40 years in the biomed field. “I have heard hundreds of times about people saying that they’re imagining one of their kids or their spouse or someone they love (when they think about the patients they serve).” 

That’s why he’s not concerned AEM programs will lead to inferior outcomes for patients. Instead, as he sees it, a well-run program allows biomed leaders to focus the time and resources of team members productively. “That lets you focus on the important work (of patient safety),” he adds.

Aine Cryts is a contributing writer for 24×7 Magazine. 

Sidebar: 10-15 Million Medical Devices in Use at U.S. Hospitals 

In 2016, there were between 10 to 15 million medical devices in U.S. hospitals, according to Healthcare IT News. Here’s how that breaks out across each hospital: 

  • 10 to 15 devices per bed. 
  • 7,500 devices at a 500-bed hospital, most of them are networked. 
  • A 2,000-bed health system could have as many as 1,500 infusion pumps in operation. 

Stephen Grimes, principal consultant at Strategic Healthcare Technology Associates, said during a session on cybersecurity and medical devices that this is a stark difference from 10 to 20 years ago when medical devices were “one device, one patient.”