The U.S. Army Western Regional Medical Command (WRMC), headquartered at Joint Base Lewis-McChord (WA), spearheaded a pilot project to fill a gap that existed across the U.S. Department of Defense (DOD): the lack of a standard medical equipment identification methodology for commercially available capital medical equipment. For this project, WRMC was selected as a finalist for the 2014 Health Devices Achievement Award.
The absence of an equipment identification methodology affected the integrity of each medical treatment facility's equipment management data. For instance:
- Without a standardized nomenclature to work from, technicians commonly would use different terms and identification numbers when adding identical items to the equipment management system, resulting in duplicate entries.
- Without a structured process defining the information to include and the sources to use, equipment records varied in terms of their completeness and accuracy.
All of the Tricare services—the Army, Air Force, and Navy—use the same equipment management system, explained Curtis Clay, regional equipment manager at WRMC, "but everybody uses it differently."
More than just an administrative headache, the lack of complete and consistent equipment records had real patient safety and asset management implications: It complicated the process of identifying, locating, and remediating devices that were subject to manufacturer or FDA recalls or corrective actions. And it hindered the military's ability to shift assets to the locations where they were needed most (e.g., during disaster response operations).
Led by Colonel James Shields, chief of logistics, WRMC personnel identified the need for the DOD to (1) implement a standardized medical equipment nomenclature and methodology and (2) institute a sustainable process supporting the use of the nomenclature to accurately identify and catalog commercially available capital medical equipment that was procured for use at the DOD's medical treatment facilities. In response to these needs, they designed a Nomenclature Standardization Initiative, or NSI. The initiative was approved for implementation at a pilot location in 2011, has since expanded to all WRMC facilities, and is in the process of being expanded to all Army medical treatment facilities.
At the heart of the NSI is a searchable database—called the "Master Catalog"—developed by Benjamin Lewis, web developer at WRMC. The catalog, which uses ECRI Institute's Universal Medical Device Nomenclature System™ (UMDNS™) taxonomy, contains a profile for each medical device model procured for DOD medical treatment facilities. Each profile includes:
- An item ID number.
- The manufacturer and model name—an auto-fill capability incorporates the company code, device code, and nomenclature from UMDNS.
- A photo of the device.
- Fields for the attachment of service literature or documentation related to recalls and safety alerts.
Development of the NSI also included establishing business rules requiring that all new commercially available medical equipment adhere to the NSI catalog standardization process. When logistics and medical maintenance personnel at a medical treatment facility need to enter a new item into their equipment management system, they initiate a request for an NSI profile (if one does not yet exist in the catalog). To facilitate consistency, additions to the catalog database are made only by specialists trained in proper NSI cataloging procedures. Additions are then reviewed and approved by a quality manager, who serves as a "gatekeeper" to ensure the integrity of each profile. Once an NSI profile has been created, staff at the medical treatment facility incorporate information from the catalog into their equipment management records.
WRMC reports that its implementation of this standardized naming and identification methodology for capital medical equipment items has (1) improved the quality of each facility's equipment management data and (2) provided more accurate and faster responses to FDA and manufacturer recalls, thereby improving patient safety. WRMC cited its use of ECRI Institute databases to obtain and validate equipment data and its implementation of the Alerts Tracker system to more effectively manage safety alerts related to the equipment in its inventory.
"Patient safety was the driving force behind this project," said Clay. With many treatment facilities and different management structures, there was a real need to institute a more effective system for identifying and locating equipment that was the subject of a safety alert, and to do so quickly and reliably.
But the additional benefits associated with the initiative were significant as well. "It's hard to adequately articulate the magnitude of this project," noted Clay, citing the size of the inventories across all the services, the work required in making the NSI functional, and the value that the NSI brings to each facility. As Clay explains, the ready availability of standardized data opens up a range of life-cycle management capabilities, allowing for more efficient equipment planning, device purchasing, and asset allocation.
The WRMC initiative highlights how the use of a standard nomenclature can improve operational efficiency and patient safety.
Furthermore, it illustrates the kinds of measures that can be implemented to preserve the integrity of the data in such a system. ECRI Institute considers the approach that WRMC is using to control how new model profiles are added to the Master Catalog to be a best practice: New models can be added or approved only by users who have been given the appropriate level of access permissions. When users at different facilities need to enter a new piece of equipment into the equipment management system, they select from the model profiles already in the Master Catalog, or they request the addition of a new one; business rules stipulate that new profiles be created within a specified, short time frame.
With the success of the NSI pilot program and approval to expand the program to other medical treatment facilities, WRMC outlined a five-step process to support a successful transition at each new facility:
Step 1. The facility completes a physical inventory of all capital medical equipment. "This is one of the hardest parts of the transition because of the manpower required," explained Clay; but it is essential that the facility identify all the devices that need to be represented in its equipment management system.
Step 2. A remote informational/training session, involving the WRMC NSI team and personnel at the medical treatment facility, is conducted via audio/video teleconference. The purpose of this session, which takes place approximately 30 to 60 days before the NSI team visits the facility, is to introduce key staff, provide an overview of the NSI, discuss the implementation schedule, and outline key tasks and required actions.
Step 3. One week before the NSI team visits the medical treatment facility, a follow-up briefing is conducted to provide updates, review documentation, and finalize project tasks and schedules.
Step 4. During the site visit, the NSI team guides the medical treatment facility through its implementation of the NSI. At the conclusion of the visit, the NSI team meets with the facility leadership to review accomplishments.
Step 5. Following the site visit, the WRMC NSI team tracks and monitors the facility's compliance on a monthly basis. Facilities are required to provide the team with monthly updates, and project review meetings are conducted semiannually to discuss problems, issues, and success stories.
Despite the well-structured process, Clay concedes that implementations often prove challenging. "Culturally, the switch is tough for users who had been doing things the old way for years."
Clay's sentiment is echoed by Kelly Nix, who manages the NSI database and works with Clay on NSI implementations: "We have to get staff to understand that the NSI team is there to help; we aren't looking for the 'gotcha.'"
In some cases, even leadership has been reluctant to implement the system because of the work involved. "But once they see their data inside the system"—data that is clean and complete—"they get excited," remarked Clay. The system provides a much clearer view of the facility's inventory than had existed before.
In addressing the success of the initiative, Clay explained, "We started with a small pilot project, proved that the system worked, and then established a process for expanding the system outward to other facilities." Discussing its value, Clay concluded, "A small staff in one little region" looked at a problem that affected all the services, decided to take action, "and did something huge."
Congratulations and thanks to Curtis Clay, Kelly Nix, Benjamin Lewis, Helena Digby, Sgt. Kelly Risley, and the rest of the WRMC NSI team for submitting this application for the Health Devices Achievement Award.