The Clinical Engineering Consolidated Program within the U.S. Department of Veterans Affairs (VA), New England Healthcare System, has been named a finalist for ECRI Institute's 13th Health Devices Achievement Award. The Consolidated Program, which serves eight medical centers and more than three dozen clinics across New England, was one of two groups honored for detailing its implementation of an alternative equipment maintenance (AEM) program—an approach for completing preventive maintenance (PM) activities in a more effective and efficient manner. (The other group was John Muir Health.)

The Health Devices Achievement Award recognizes outstanding initiatives undertaken by member healthcare institutions to improve patient safety, reduce costs, or otherwise facilitate better strategic management of health technology. For details about the winning submission and other finalists, see The Health Devices Achievement Award: Recognizing Exceptional Health Technology Management.

ECRI Institute congratulates the project team members: Ashley O'Mara, Michael Ambrosi, Jordan Anderson, Heather Fields, Carolyn Mahoney, Kyle Riley, Brian Taylor, Nina Warah, Rachel Wilk, and Lee Winslow.
 

The Challenge

To establish an AEM program that allows the organization to comply with the Joint Commission's medical device PM requirements more efficiently, so that clinical engineering resources can be directed toward activities that add greater value to the enterprise.
 

The Context

VA New England's Clinical Engineering Consolidated Program is responsible for maintaining all medical devices that diagnose, prevent, treat, alleviate, or monitor a disease, as well as managing increasingly complex systems and playing a larger role in strategic planning for the hospital. With an increasing workload and ever-present budgetary constraints, the organization ascertained that maintaining all its devices according to the manufacturers' instructions while achieving 100% PM completion rates would stretch the department to the breaking point. Resources that could otherwise be spent on activities that improve patient care would instead have to be diverted to conducting PM inspections that the organization had determined would add little value. For instance, the organization noted that some low-risk devices pose little risk of failure or harm, and that some manufacturer-recommended maintenance activities are overly cautious, including lengthy performance verification steps that are not proven to prevent failures from occurring after the PM.

The Clinical Engineering Consolidated Program determined that it could most efficiently meet its obligations—safeguarding patient care while complying with relevant maintenance requirements—by establishing an AEM program. As noted by the U.S. Centers for Medicare & Medicaid Services (CMS), an AEM program allows a healthcare facility to "adjust its maintenance, inspection, and testing frequency and activities for facility and medical equipment from what is recommended by the manufacturer, based on a risk-based assessment by qualified personnel."[1] Such programs can be an acceptable approach for completing PM activities in a more effective and efficient manner, provided that certain conditions are met. For details about those conditions, see What Is an Alternative Equipment Maintenance Program?

The Process

The Clinical Engineering Consolidated Program sought to establish an AEM program that would reduce the technician workload without reducing patient safety. A key step in this process was establishing a methodology for determining the appropriate level of PM for each type of medical device—that is, which equipment needs to be maintained according to the manufacturer's recommendations, and which devices can be safely maintained according to an alternate plan (e.g., by using fewer PM steps, by conducting less frequent inspections).

To make these determinations, the Clinical Engineering Consolidated Program team assigns a criticality score (from 1 to 16) to each device type. This score takes into account the following:

1. The probability of a device failure

a) The team uses the "mean time between equipment failures" concept to assess probability—that is, how often a device can be expected to fail. The mean time between equipment failures is calculated by taking the product of a chosen time interval (two years was used) and the number of devices and dividing it by the number of maintenance-related failures over those two years.

b) Depending on the value calculated, the probability will be classified as follows and assigned the value shown:

(1) Remote = 1

(2) Uncommon = 2

(3) Occasional = 3

(4) Frequent = 4

2. The severity of a failure of that device

a) Severity is assessed based on the impact to the patient if the device were to fail while in use.

b) The severity is classified into one of the following categories and assigned the value shown:

(1) Minor = 1. An event that does not result in an injury that requires more than first-aid treatment and that does not increase the duration of care or lead to a loss of staff work time.

(2) Moderate = 2. An event that may require medical intervention that increases the duration of care or that leads to a loss of staff work time.

(3) Major = 3. An event that causes permanent lessening of bodily function or disfigurement.

(4) Catastrophic = 4. An event that may cause death, or cause injury or illness that could lead to permanent loss of function.

Multiplying the probability value by the severity value yields the criticality score, which is used to determine the appropriate maintenance plan for that device. Three categories of maintenance plans were established:

1. Non-AEM, Follow Manufacturer Instructions (criticality score in the top range, from 9 to 16). Devices that are designated as high-risk are considered non-AEM-eligible. The technician must follow the manufacturer's instructions so that the device remains safe for patient use.

2. AEM (criticality score of 6 to 8). Devices that pose a moderate risk to the patient or that are found to be more likely to fail may be placed in an AEM plan that changes the inspection frequency or modifies the manufacturer recommendations in a way that does not compromise the safety of the device or the quality of the PM.

3. AEM—Upon Repair (criticality score below 6)

a) Low-risk devices that:

(1) Require minimal maintenance, as recommended by the manufacturer-—for example, requiring only visual inspection, changing batteries, performance verification, or calibration

(2) Do not have a significant history of failures

b) With such devices, the chance of a failure leading to patient harm is so small that taking the time to locate the device and then perform minimal maintenance would not be worthwhile.

c) PM steps would still be followed if there is an issue with the equipment and it is sent for repair.

The AEM determination also considers factors such as recalls, hazards, whether the device incorporates alarms (which would need to be checked according to Joint Commission requirements), and any special circumstances (such as radiation safety concerns or College of American Pathologists [CAP] requirements for lab equipment). Each device placed on AEM is to be reevaluated on a periodic basis to verify that the AEM plan has not affected the quality, performance, or safety of the device.
 

The Results

The program was still in the early stages of implementation at the time that the VA New England Healthcare System submitted its report to us. Only 5% of the devices in inventory had been assessed for AEM status. Nevertheless, the organization was beginning to realize notable benefits:

1. Decreased labor expenditures. The organization calculated labor cost savings of more than $38,000 in the first nine months of implementation. The actual saving is expected to be much higher, as this figure does not include the price of parts or PM kits saved. VA New England estimates that more than 1,100 hours of labor will be saved in one year.

2. Decreased employee burnout. In an all-employee survey for the VA New England Healthcare System Clinical Engineering Consolidated Program, the burnout rate decreased from 3.61 to 2.86 between 2017 and 2018. For this survey, employees rated burnout on a scale from 1 (not burned out at all) to 5 (feeling extremely burned out). The team suspects that some of the decrease in the burnout score can be attributed to the AEM plan decreasing the amount of non-value-added work with which staff have to contend.

3. Increased time for clinical engineering staff to work on value-added services, while still making sure that medical devices are safe to use. For instance, staff now have more time for activities such as working with clinical customers on equipment evaluations and installations, addressing medical device security, and completing corrective maintenance with shorter turnaround times.
 

Key Takeaways

The growing complexity of medical devices and systems is increasing the demands placed on clinical engineering departments. Thus, departments must identify ways to divert resources away from legacy practices that have little impact on patient care and instead direct those resources toward activities that add value to the enterprise. A well-implemented AEM program can help a department achieve this goal.
 

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[1] Centers for Medicare & Medicaid Services (CMS), U.S. Hospital equipment maintenance requirements [Survey & Certification Letter]. S&C:14-07-Hospital. 2013 Dec 20. Available from: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-07.pdf.