Implementing An AEM Program

Jason Gibson, Director of Quality & Compliance for Sodexo CTM, provides insight on how an AEM Program would benefit your HTM team. Have a question for the expert or want to find out more? Fill out the form at the bottom of the page to ask Jason Gibson a question directly.

Implementing An AEM Program

Implementing an Alternative Equipment Maintenance (AEM) program is one of the best ways we can reduce or eliminate Planned Maintenance (PM) frequencies and tasks. The Centers for Medicare and Medicaid Services (CMS) provides us with guidelines on how to implement an AEM program and which devices are excluded from AEM programs.

What is an AEM program?

An AEM program is simply equipment maintenance activities and frequencies that differ from those recommended by the manufacturer. An AEM program must develop, implement and maintain a documented AEM program to minimize risk to patients and others in the hospital associated with the use of medical equipment. One example CMS points to as an example is the ANSI/AAMI EQ56:1999/(R) 2013 – Recommended Practice for a Medical Equipment Management Program.

What devices are not eligible to be placed in an AEM program?

As outlined by CMS, the following equipment may not be eligible for placement in an AEM program:

• Other Federal or State law may require that a medical equipment's maintenance, inspection and testing be performed strictly in accordance with (IAW) the manufacturer’s recommendations, or may establish other, more stringent maintenance requirements.
• Other Conditions of Participation (CoPs) require adherence to manufacturer’s recommendations and/or set specific standards which preclude their inclusion in an AEM program
• The National Fire Protection Association (NFPA) Life Safety Code (LSC) requirements incorporated by reference at 42 CFR 482.41(b) has some provisions that are pertinent to equipment maintenance, and compliance with these requirements are assessed on federal surveys.
• Imaging/radiologic equipment, whether used for diagnostic or therapeutic purposes, is governed by 42 CFR 482.26(b)(2) and must be maintained per manufacturer’s recommendations.
• The equipment is a medical laser device.
• New equipment for which sufficient maintenance history, either based on the hospital’s own or its contractor’s records, or available publicly from nationally recognized sources, is not available to support a risk-based determination must not be immediately included in the AEM program.
  
  

Who makes the determination to place a device on an AEM?

The determination to place a device on an AEM must be made by a qualified person; in our case a clinical engineer or biomedical technician would be considered qualified. Also note, it may be necessary to use a team approach when determining to place a device on an AEM program due to the complexity of certain medical devices. The credentials of all involved in these determinations must be kept on file to demonstrate qualifications.

What factors should I consider when evaluating the risk of placing a device in an AEM program?

Some of the factors to consider when evaluating the risk associated with types of equipment include:

• How equipment is used and the likely consequences of equipment failure or malfunction?
• OEM recommendations, if available.
• Maintenance requirements of the equipment
• Appropriate accessibility of a backup system in the event of equipment failure
• Incident history of identical or similar equipment (documented, evidence-based experience or another credible source).
  
  

What documentation do I need for my devices covered under an AEM program?

For each device (or for groups of like devices) covered under the AEM program, there must be documentation indicating:

• The types and level of risk to patient or staff and safety.
• Alternate maintenance activities, the maintenance strategy and any other rationale used to determine those activities.
• Alternate maintenance frequencies to be used, if any, and the maintenance strategy and any other rationale used to determine those frequencies.

Note: Items with a very low risk to safety could use interval date ranges instead of specific time based; i.e. every 12 to 24 months or employ periodic department sweeps.

• Date when maintenance activities were performed and, if applicable, further actions required
• Documentation of any equipment failures (excludes operator error), including whether there was resulting harm to an individual.
  
  

Note: Per CMS, hospitals may choose to perform maintenance more frequently than the manufacturer recommends, however they must use the manufacturer recommended maintenance activities in such cases.

How do you evaluate the AEM program’s effectiveness?

Evaluating safety and effectiveness of the AEM program provides the opportunity for the HTM professional to examine how well the program is working. As part of the continual improvement process, this AEM program evaluation should occur no less than annually and include the following:

• How devices are evaluated to ensure there is no degradation of performance and safety.
• How incidents of device malfunction are investigated
• Could the malfunction have been prevented by additional tasks or increased frequency
• Determine if the malfunction resulted from the use of an AEM strategy
• The process for removal from service those devices determined to be unsafe or no longer suitable for their intended application
• The use of performance data to determine if modifications in the AEM program procedures are required (i.e. meantime between failure, failure rate, incident history, etc.).
  
  

How Does an AEM Program benefit me?

An AEM program is not intended to reduce the safety nor degrade equipment performance.  The guidelines CMS places forth follow a scientific process method in determining what works for your unique settings and provides for a continual improvement process to ensure quality and safety.  The use of an AEM program has the potential to reduce labor hours when dealing with low-risk items such as otoscopes and exam table planned maintenance, thus allowing for greater labor utilization for high-risk items and focusing on the customer experience.