By Rich Sable

New regulations shape how HTM is conducted.

As we prepare for AAMI 2018, healthcare technology management (HTM) reflects on the top issues and concerns of our community. While these concerns continue to be, as they always have been, those of meeting regulatory compliance and providing patient safety, they require a new perspective. HTM evolved because of the patient safety issues associated with widespread use of new medical devices.

Today, medical devices are safer due to engineering advances such as optical isolation and insulated cases. With devices becoming ever more sophisticated we now face new issues from operator errors, software failures, repair difficulty and cybersecurity. So while regulatory compliance and patient safety are still the top issues, they present a far more complex challenge than in the past.

The regulations and resultant new requirements
With respect to regulatory compliance, the rules became stricter during the last several years, as concerns were raised by medical device manufacturers. Because of these changes, preventative maintenance (PM) requirements centered around manufacturers’ recommended procedures, and these procedures placed increased demands on both human and capital resources of the clinical engineering departments. Unfortunately, these increases of departmental resources came at a time when hospital budgets have been reduced due to external pressures on the health care industry.

In the past, many HTM departments utilized risk-based PM to alleviate the burden of this workload. Further, most clinical engineers used this opportunity to perform tasks on equipment that they regarded as needing more attention, while saving time on the devices they determined not to present a risk to patient safety.

In fact, many devices with a low risk score did not have a manufacturer-based PM procedure to begin with, or only required an operational check which the device’s user performed prior to patient use. Using sophisticated algorithms, the CMMS (computerized maintenance management system) performed the device stratification for risk-based PM, and the reasoning for PM exclusion was easy to demonstrate to regulatory inspectors or the environment of care committee.

Due to recent changes, screening devices based on risk alone is no longer permitted. Further, all patient care devices need to be inspected 100 percent of the time regardless of the device’s risk score, causing a pain point for many HTM departments. Most departments were unable to expand their human resources and the need for an expansion would need to be demonstrated to administration.

Fortunately, another exception was created: Alternative Equipment Maintenance/Management (AEM). Because of AEM, the clinical engineering department can potentially reduce costs associated with staff overtime and/or on contracted services for PM assistance, in order to meet regulatory compliance.

AEM and what It can mean to your hospital
AEM, when executed properly, can ease the burden on an HTM department’s budget while continuing to assure patient safety.

Of course, implementing an AEM program is not as easy as it first appears, since it has many rules and restrictions set forth by both the Joint Commission and CMS (Centers for Medicare and Medicaid Services). In fact, the exceptions are one of the easier aspects of an AEM program.

For instance, medical device lasers, imaging devices, and radiologic devices are all prohibited from being on an AEM program. Thus, these medical device categories must have the manufacturers’ PM performed on them always, and at a 100 percent completion rate. In addition to the three taboo device types, HTM is not allowed to place medical devices that are new to them on an AEM program without a sufficient history (PM history or device years). New devices are defined as equipment types that are new to the organization and not just another infusion pump from the same manufacturer. In order to determine a medical device history that would be considered to be sufficient, HTM departments can set a policy as to a required amount of PM history, or a set level of device years. For example, if you have five equivalent devices for eight years, you have 40 device years for that device type. If your policy states that the number of device years required is 35, then this type is eligible for your AEM program.

Likewise, you may specify a PM history of 6 PMs before a device is placed into an AEM program. Other factors include setting a specified limit on failure rate (e.g., < 2%) and/or having backup devices available for use (e.g., > 5). Furthermore, AEM devices must also be maintained at 100 percent compliance.

AEM policies and acceptable equipment types
To implement an AEM program at your facility, HTM leadership must develop a clearly written plan in their department policies, and these policies will be presented to regulatory agencies when requested. Equally, your AEM program must not reduce the risk to patient safety as you modify your PM procedures.

For instance, you may increase the interval between inspections (say every two years versus annually), but you will perform the manufacturer’s steps completely during the 2-year inspection interval. On the other hand, you may choose to modify a step to inspect a component and replace if necessary, as opposed to replacement-only method on a PM task. Likewise, your history might determine that you want to perform a unique additional step to the manufacturer’s PM procedure that will improve patient safety and reduce the failure rate. Again, implementing an AEM program requires additional work and planning, along with a continual monitoring of the program: monthly, quarterly, etc.

With your AEM policies in place, you can begin to evaluate which equipment types you are going to place into your AEM program. Knowing the rules of AEM, you can easily eliminate the taboo devices from the inventory, along with unfamiliar device types that are new to you or your organization. But what about high-risk medical devices that are not on the taboo list and you have a documented history for?

According to the rules, you may place these device types into an AEM program, but you must not lower patient safety and you must complete these PMs at a 100 percent rate all of the time. Nevertheless, do you want to assume the risk of deviating from the manufacturer’s procedure? In my opinion, high-risk medical devices should also be taboo equipment and high-risk medical devices should not be placed on an AEM program. Even with these exclusions, there are many device types that can be placed into an AEM program and these devices are normally found in large quantities such as vital signs monitors.

Maintaining your AEM program with CMMS
After you have determined which medical device types will be considered for your AEM program, you must develop a process to review the eligibility of the devices that you place into the program. For many HTM departments, the tool of choice will be their Computerized Maintenance Management System (CMMS), so they can review the documented PM failures and failure rate of devices placed on the program. Also, they can begin to document a medical device history for those new equipment types that were added to the CMMS over the years.

More robust CMMS systems incorporate an AEM dashboard or tool that can automate the process for both determining device type eligibility and continued candidacy. In short, implementing an AEM program will require a continued assessment of the program to ensure that patient safety has not been jeopardized or equipment failure rate and downtime increased.

Which PM procedures are you going to use in your AEM program? We know that the manufacturer’s procedures are the gold standard, and they can easily be used for your task steps with a modified PM frequency. For instance, changing your vehicle’s oil every 6000 miles as opposed to every 3000 miles. In either case, you perform the same PM tasks, but augment the frequency at which the PM tasks are performed. Other organizations supply PM procedures (ECRI and ASHE), but they won’t authorize their procedures for AEM use. While this does not prevent you from using these alternative procedures for your PM program, you will need to document and be prepared to prove that your use of these alternative procedures did not reduce patient safety. Without question there is a managerial effort required to implement a successful AEM program.

The critical role of standardization
Data standardization in your CMMS is vital for a well-managed AEM program and for regulatory compliance in general. It is imperative that device types be standardized to ensure that the PM procedures, risk scores, and device recalls are used effectively. For example, if two similar device types are named differently in the CMMS, you will miss one or the other during comparison for equipment replacement or moving devices into an AEM program. Furthermore, your CMMS may contain specialized reports or dashboards that rely on data fields to stratify your equipment inventory.

To maintain standardization, many departments limit the number of users that can add key data elements such as device type, equipment class or system, vendor, and model numbers. These fields drive many different reports in CMMS programs, and they are used for device recalls or for equipment replacement planning. Furthermore, all of your data elements need to be standardized for proper reporting on all metrics within the CMMS. For example, using proper coding on work orders to track PM failures or devices in use which will be used for your AEM and regulatory compliance monitoring, is key. Thus, many HTM departments identify one individual or a committee before entering new data elements into the CMMS, and this control ensures standardization and proper reporting.

Effectively using an advanced CMMS can assure that both compliance and safety are achieved
In the end, we see that adhering to regulatory compliance requirements, including for AEM, is essential for both minimizing equipment failure rates and for patient safety. Using an advanced CMMS, we can set the proper intervals and procedures, and use the reports and dashboards to monitor our adherence to our department policies that meet the needs of regulatory agencies: Federal, State, Medicare, the Joint Commission, or DNV. We can also use an advanced CMMS to move equipment into an AEM program with reports and dashboards ensuring that program eligibility as well as regulatory compliance are adhered to.

Finally, a standardized CMMS is essential for following our department policies, and for proper reporting of our department’s KPIs (key performance indicators). We can also gather timely information on these topics at AAMI 2018. Additionally, AAMI offers a new textbook titled, AEM Program Guide: Alternative PM for Patient Safety, written by Matthew F. Baretich, PE, Ph.D., which can provide additional guidance in developing your own AEM program.

About the author: Rich Sable has over 35 years professional HTM (healthcare technology management) experience in the hospital setting, and has degrees in both Biomedical Engineering and Information Technology and Management. He also is ACI (AAMI Credential Institute) certified as a CBET (Certified Biomedical Equipment Technician). Currently he is product manager at EQ2 LLC where he manages the customer experience and product planning for the company’s HEMS® CMMS (Computerized Maintenance Management System).