Development and Implementation of the Alternate Equipment Management (AEM) Program October 5 th, 2017 1:00 PM JP Stewart, Operations Manager, Tech Knowledge Associates Kimberly Rossig, National Program Specialist, Tech Knowledge Associates D.J. Fingerlos, Director of Biomedical Engineering, Tech Knowledge Associates Marc Bedard, PMP System Data Analysis & Support Manager, Tech Knowledge Associates Ernest Oates, CBET, CHTM, Director of Biomedical Engineering, Tech Knowledge Associates
In April 2016, our organization formed an AEM committee, leading to the development of a template risk assessment process and an AEM program that started in March 2017.
AEM Program Background 100,381 assets were included in the risk assessment process. 94,573 corrective maintenance work orders were included in the risk assessment process. 212,889 preventive maintenance work orders were included in the risk assessment process. The process of developing and applying the risk assessment took approximately 6 months, with another two months to get our CMMS updated.
Background In the stone age, prior to 2011, HTM professionals used a mix of manufacturer s recommendations and whatever seemed appropriate based on past experiences.
Background In 2011, CMS released a memorandum requiring hospitals to follow manufacturers recommended activities for maintaining medical equipment. (S&C: 12-07-Hospital) In December 2013, CMS updated previously provided guidance allowing for testing frequencies AND activities for medical equipment to be changed from what s recommended by the manufacturer. (S&C: 14-07-Hospital) Changes must be based on a risk-based assessment by qualified personnel
Background Certain types of equipment must be excluded from an AEM program: Other Federal or state law, or hospital Conditions of Participation (CoPs) require adherence to manufacturer s recommendations and/or set specific requirements. For example, imaging/radiologic equipment, whether used for diagnostic or therapeutic purposes, is governed by 42 CFR 482.26 and must be maintained per the manufacturer s recommendations. The equipment is a medical laser device. New equipment without a sufficient amount of maintenance history has been acquired.
Background Types of Maintenance Strategies Preventive Maintenance (Time-Based Maintenance) A maintenance strategy where activities are performed at scheduled time intervals to minimize equipment degradation and reduce loss of performance. Most preventive maintenance is performed at fixed intervals. The primary focus of preventive maintenance is reliability, not optimization of cost-effectiveness. Maintenance is performed systematically, regardless of whether or not it s needed at the time.
Background Types of Maintenance Strategies Predictive Maintenance (Condition-Based Maintenance) A maintenance strategy that involves periodic or continuous equipment condition monitoring to detect the onset of equipment degradation. For example, replacing a battery one year after the manufacturer s recommended replacement interval, based on historical monitoring that has determined the battery capacity doesn t tend to fall below the required performance threshold before this extended time.
Background Types of Maintenance Strategies Reactive Maintenance (Corrective, Breakdown, or Run to Fail Maintenance) A maintenance strategy based upon a run it until it breaks philosophy, where maintenance or replacement is performed only after equipment fails or experiences a problem. This strategy may be acceptable for equipment that is disposable or low cost, and presents little or no risk to health and safety if it fails.
Background Types of Maintenance Strategies Reliability-Centered Maintenance A maintenance strategy that not only considers equipment condition, but also considers other factors unique to individual pieces of equipment, such as equipment function, consequences of equipment failure, and the operational environment. Maintenance is performed to optimize reliability and cost effectiveness. For example, replacing a battery in an ambulance defibrillator more frequently than the same model used at a nursing station, since the one in the ambulance is used more frequently and is charged by an unstable power supply.
The Risk Assessment Process Points to consider: How the equipment is used, including the seriousness and prevalence of harm during normal use. Likely consequences of equipment failure or malfunction. Availability of backup equipment in the event of equipment failure or malfunction. Maintenance history of the medical equipment. Incident history of identical and similar equipment. Maintenance requirements of the equipment.
The Risk Assessment Process For our process, the decision was made to use the mean time between failure (MTBF) as the tool to determine probability of failure, and the basis for an annual assessment our AEM program would be graded on. Probable was defined as a MTBF of less than five years. Occasional was defined as a MTBF between five years and ten years. Remote was defined as a MTBF between ten years and twenty years. Improbable was defined as a MTBF of greater than 20 years. For the severity of a potential failure, categories of Negligible, Marginal, Critical, and Catastrophic were selected.
The Risk Assessment Process In order for the MTBF data to be meaningful, a decision on what repairs should be part of the MTBF should be determined at the onset of the AEM program, and adhered to throughout it Device recalls and alerts? Repair work orders due to damage/abuse? Repair work orders due to operator error? Repair work orders for an upgrade/configuration change?
The Risk Assessment Process There are multiple ways to calculate the mean time between failure. It s important to choose a formula that can be easily explained, and don t change the process unless you also change the way your baseline MTBF was calculated. Easy Method: (Number of devices x time period) / Number of repairs in the time period For example: 8,500 infusion pumps with 2,833 in a 5 year period (8,500 x 5) / 2,833 = a MTBF of 15 years A more complex method of determining MTBF would include the start of downtime and the start of uptime.
The Risk Assessment Process
The Risk Assessment Process
The Risk Assessment Process
The Risk Assessment Process
The Risk Assessment Process Once a risk assessment has been completed, a decision needs to be made on what to do with that information. AEM ineligible Change in PM activities Change in PM frequency Change to a run to fail (no PM required) strategy
The Risk Assessment Process For our program, the cumulative AEM Eligibility Score determined which AEM category the equipment was placed in. AEM categories were developed for: No AEM allowed, manufacturer s recommended PM procedures must be followed (activities and frequencies) PM activities and/or frequencies may be adjusted from what the manufacturer recommends. PM frequencies are changed to biennial (once every two years) Equipment is removed from the PM program (reactive maintenance)
The Risk Assessment Process
The Risk Assessment Process
The Risk Assessment Process
The Risk Assessment Process
The Risk Assessment Process For ISO s that are responsible for multiple facilities, it would be helpful to determine a way in the CMMS to easily remove assets from the AEM program that may have otherwise been in it as a result of the AEM risk assessment process. For example, certain facilities may want a particular type of equipment or department excluded from the AEM program. For our program, we added a selection within our risk assessment process that can cause an individual asset to be excluded from the AEM program very easily by either that account director or the system support manager.
AEM Program Assessment A regular assessment of an AEM program needs to be performed in order to ensure the reliability and safety of medical equipment in that program hasn t been negatively affected. In our program, we made the decision to use MTBF as the gauge to evaluate the AEM program s safety and effectiveness. If a device s MTBF decreased in a year by more than the extent of deviation within the years used to develop the baseline MTBF (standard deviation), then an assessment of that device s maintenance history is performed.
AEM Program Assessment Some additional data points may need to be added to scheduled and corrective maintenance work orders in order to make the information more relevant to the program s assessment. At a minimum, PM work orders that require some corrective action be taken in order to pass need to be easily identifiable. Similarly, those PM work orders that pass with no additional action required other than what s in the PM procedure should be easily identifiable. Corrective maintenance work orders (repairs) should be qualified as whether the fault would have been preventable had the manufacturer s PM recommendations been followed (PM preventable).
AEM Program Assessment MTBF Let s assume a thermometer has a MTBF of 10 years and a standard deviation of 3 years
AEM Program Assessment MTBF Is the current year s MTBF less than 7 years? No Yes No additional assessment necessary Additional assessment required to remain in AEM program
AEM Program Assessment MTBF Do the work orders from the current year contain PM preventable repairs? No Yes Acceptable to remain in AEM program Not acceptable to remain in AEM program at current level
References S&C: 14-07-Hospital, Centers for Medicare & Medicaid Services ANSI/AAMI EQ56:2013, Recommended Practice for a Medical Equipment Management Program. Ridgeway, M., Clark, M., Bettinardi, C, (2016, November) Reliability- Centered Maintenance: A Took for Optimizing Medical Device Maintenance. Biomedical Instrumentation & Technology Stephen L Grimes (2015) Evolution of a Risk-Based Approach to Effective Healthcare Technology Management. Biomedical Instrumentation & Technology Stephen L. Grimes (2014, November) Two Steps Forward and One Step Back How the Industry Must Take in Stride New CMS and TJC Requirements. Biomedical Instrumentation &Technology
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