As HTM professionals continue to take on a more important role in overseeing hospital technology and devices, alternative equipment maintenance (AEM) programs provide a unique opportunity for them to take matters into their own hands.

HealthCare Business News spoke to Shane Kearney, senior business analyst for corporate imaging business services at Fairview Health Services in Minnesota, to find out what AEM programs entail, what their limitations are, and what advantages they can offer over manufacturer maintenance protocols.

HCB News: Alternative equipment maintenance seems to be a growing trend in the biomedical engineering space. For people who don't know, how did all this AEM talk get started?
Shane Kearney: Back in 2011, CMS and Joint Commission expressed some concern around inconsistency in the way that in-house and third-party maintenance programs were supporting medical equipment. In an effort to standardize these programs they announced their expectation that hospitals should follow manufacturers’ preventive maintenance requirements when caring for medical equipment.

The biomedical engineering and Healthcare Technology Management community had largely not been following manufacturer recommendations, based on their experience and professional judgement. Adopting the CMS practice would have caused a significant shift in the resources needed and the effectiveness of hospital maintenance programs. AAMI and ASHE released a response that provided evidence that alternatives to the manufacturer's maintenance recommendations would have not caused harm to patients, and in 2012 the agencies took a step back to solicit feedback and discuss. In 2014, CMS released "S&C 14-07", allowing hospital equipment support groups to employ alternative equipment maintenance (AEM) programs, with some exceptions.

HCB News: What are some of the basic rules that all AEM policies must adhere to?
SK: To paraphrase CMS 42 CF 482.41(c)(2) a bit, if a hospital chooses to employ a deviation to the preventive maintenance frequency or procedure dictated by the original equipment manufacturer, the hospital must develop, implement, and maintain a documented AEM program. This is to ensure that risks to patients and others in the hospital are minimized when using the facility or medical equipment. In an effort to unpack that a bit we can take it step by step:

1. Developing an AEM involves a few key foundations, such as recognizing a definition of medical equipment, defining what is critical equipment, identifying who is qualified to make the decisions, establishing a risk scoring method, and constructing a policy that clearly states the approach. Taking it a step further involves establishing your AEM review cycle and what metrics would be measured to indicate the success or need for reevaluation. Some of the key indicators you would want to look at in the future may not be in place today and would have to be established. If you plan on having an alternative to the procedure, regardless if the frequency will be adjusted or not, document this procedure for communication during implementation.

2. Implementing depends a lot on the organization and its culture. Does the CMMS system allow for risk scoring to be integrated into the appropriate module (PM, asset, device category, model, etc.)? Does the hospital's Environment of Care committee require that they sign off before any proposed AEM is enabled? Are you only applying this to one shop of five technicians, to thirty technicians across six hospitals, or hundreds that cross state lines in multiple care settings? Communication is critical, and not just within the department but between senior leadership in the organization and subject matter experts. If you have done thorough research in developing the AEM program, the communication about your direction and approach to implementing should be less demanding.

3. Maintaining the AEM program can be one of the easiest or hardest steps, depending on the diligence for standardizing the workflow in the previous two steps. If you have already objectively established the risk scoring, review cycle, and key indicators for the evaluation then maintaining can be just short of autonomous. If there is a lot of subjective input to the program it will be much more difficult to maintain, and likely more stressful when it is evaluated by an internal or external audit, or during a survey. From my conversations with biomed leadership, this is where the biggest opportunity currently lies, with the workflow and procedure for evaluating, but even more so with technology. To have a CMMS flag devices that are crossing certain established thresholds would make maintaining an AEM simple and effective, and avoid the risk of gaps in reviewing.

It is almost mentioned in passing in the CMS requirement, but one of the biggest challenges is to keep all of this work thoroughly documented along the way. Making some of these decisions can come easily, especially to seasoned biomedical engineering and HTM leaders, but keeping it documented, standardized, and organized for presentation and regular review should be at the center of developing and AEM program.

HCB News: What types of equipment are best suited for AEM? Is there anything that is prohibited from AEM?
SK: A couple classifications of equipment first come to mind for items that are best suited for evaluation. An AEM on devices that are found in large quantities in the hospital could have a significant impact if they are found to have minimal risk to patients and others if placed on a lower preventive maintenance frequency or simpler procedure.

Another would be items that are simply so low-risk that there would be next to no risk for an incident if they failed, such as thermometers, fingertip oximeters, otoscopes, etc. These are “low-hanging fruit” items, simply due to freeing up resources that would otherwise be spent performing the preventive maintenance. Less obvious candidates are devices that might undergo undue stress with repeated preventive maintenance or devices that have part of their scheduled maintenance already performed by other hospital staff during regular, documented rounding. These devices differ between hospitals but can include devices such as gas machines or defibrillators.

Prohibited items include imaging/radiology equipment (used for diagnostic or therapeutic purposes), medical laser devices, new equipment, and critical equipment. Equipment maintenance must also comply with any other state or federal agency laws. If one of these governing bodies requires maintenance according to manufacturer's recommendation it must be followed, even if an AEM is allowed under CMS guidelines.

HCB News: When successful, what benefits does AEM bring to maintenance?
SK: If implemented effectively and correctly an AEM program can lead to cost savings through reduced equipment downtime and more effective resource management. It also gives the department and care facility a standard approach to measuring and mitigating risk. An AEM can also prolong the life of an asset and prevent failures if done successfully.

If a manufacturer's procedure calls for having something like a gasket or filter removed, inspected, cleaned, and replaced on a regular basis, that handling could shorten the lifespan of that component significantly. Altering the procedure to remove that task, or reduce the frequency with which it takes place, could maintain the integrity of the part and reduce the number of times it, and the device, fails. It also shows a level of involvement that goes beyond the manufacturer. Developing an AEM program should take into consideration the manufacturer's maintenance recommendations and layer on top another level of objective data on how the device handles all the real-world interactions in a hospital environment. Coupled with a regular review it solidifies the focus on maintaining the highest possible level of safety for patients and staff.

HCB News: Can HTM departments implement AEM policies developed at other hospitals?
SK: In short, yes. Policies can be adopted from other organizations, either hospitals or third party healthcare support organizations. The decision to place something on an AEM can only be adopted from other hospitals by sharing the underlying data that supports the AEM. It's not enough to say "hospital X does an AEM on these, so we are too," you have to be able to have the information on hand that shows your due diligence in assessing the risk mitigation and decision to apply maintenance procedures or frequency in a way that differs from manufacturer's recommendation. This is a space where professional organizations like the NCBA can provide incredible opportunity, helping facilitate the discussion and exchange of ideas and information that can help biomed and HTM leaders make confident decisions quicker than if they were left to their individual healthcare facility's data and expertise.

HCB News: What is the relationship between AEM and the hospital's computerized maintenance management system (CMMS)?
SK: A CMMS provides the objective data, both about the asset and the maintenance activity, needed to support any decision related to an AEM program. This includes the initial decision to move something to an AEM, as well as the constant monitoring and validation needed to support keeping the devices on an AEM or to alter or remove it. The data leveraged out of the CMMS can be different based on the organization's policy and procedures; PM failure rates, mean time between failures, age of new medical equipment, and risk scoring within the AEM program are just some of the aspects of supporting information that I have seen biomedical engineering and HTM departments indicate as their AEM criteria.

HCB News: Last time we spoke, you mentioned alternative equipment maintenance was going to a big topic at the annual NCBA conference. What did attendees have to say?
SK: The AEM topic crept into a lot of discussions across the conference, both in classes and networking conversations. One big focus on it was a panel discussion from four leaders at different healthcare organizations. While goals for the organizations were similar, especially around patient safety, risk mitigation, and effective resource planning, approaches proved to be unique in their workflows, hospital committee engagement, and scoring criteria/thresholds. However, a common theme among them was a desire to the leverage the knowledge from each other and the rest of the NCBA organization. While they have all thought through how to best implement these policies and procedures in their own environments they welcomed challenges to their methods in order to correct mistakes and increase the dependability of their programs.