TRIMEDX

Since 2014, healthcare technology management (HTM) professionals have been adjusting to the Centers for Medicare & Medicaid Services (CMS) clarification memo regarding the strict requirements for implementation of an Alternative Equipment Management (AEM) program. A common area of accreditation and state survey focus directly involves the AEM program. The key components and requirements of this program are clients’ understanding and acceptance of the program and appropriate implementation of the program on behalf of the HTM professionals.

As a point of reference, The Centers for Medicare & Medicaid Services (CMS) distributed a memorandum in 2014 clarifying that “hospitals may implement an Alternative Equipment Management program electing to adjust facility or medical equipment maintenance must develop policies and procedures and maintain documentation supporting their Alternate Equipment Management (AEM) program. They must adhere strictly to the AEM activities and/or frequencies they establish. Hospitals must be able to demonstrate that qualified personnel― whether employees or contractors―are making the decisions to place equipment in the AEM program, performing the risk-based assessments, establishing the alternate equipment maintenance requirements, managing the AEM program and performing the maintenance in strict accordance with the AEM policies and procedures.”

The AEM, as defined in hospital accreditation programs (HAP) and critical access hospital programs (CAP), is classified as Alternative Equipment Maintenance program rather than “management program.”For the sake of this article, AEM will reference it as applicable to CMS and accreditation requirements.

Before diving into how to implement a compliant and effective AEM program, it is important to note the medical equipment that is not eligible for an AEM program, as these devices must follow Manufacturer PM frequencies:

• Imaging & Radiological equipment

• Laboratory equipment (due to federal lab regulatory requirements)

• Medical equipment lasers

• Any new equipment model brought into the medical equipment inventory without a minimum of one year of service history available to determine eligibility of an AEM program and frequency

• State-specific regulations must be considered, as some states do not allow AEM strategies to be implemented

Compliant AEM programs must consider the following as a requirement:

• Risk assessment and patient safety

• Manufacturer frequencies and service documentation

• Qualified personnel

• Hospital stakeholder adoption

Risk assessment

A risk assessment must be conducted on each medical device within the inventory and any/all safety risks associated with the equipment’s function and consequence of failure should be considered, as well as the acuity of the patients utilizing said medical device. This process involves creation of a risk score matrix and collaboration with the hospital clinical, patient safety and Environment of Care committee (EOC).

"A risk assessment must be conducted on each medical device within the inventory and any/all safety risks associated with the equipment’s function and consequence of failure should be considered, as well as the acuity of the patients utilizing said medical device"

Examples of risk considerations include:

• How the equipment is used (equipment function examples, but not limited to)

• Intensive care

• Physiological monitoring

• Surgical

• General care

• Non-medical equipment

• Based upon the type of equipment, how should the device be classified in the equipment inventory database? Definitions of regulatory and accreditation agencies below are for reference and consideration:

• CMS does not provide a detailed list of devices considered as critical equipment, however, they do provide the following guidance: “At a minimum such critical equipment includes, but is not limited to, life-support devices, key resuscitation devices, critical monitoring devices, equipment used for radiologic imaging and other devices whose failure may result in serious injury or death of patients or staff.”  These medical devices must be indicated as such in the medical equipment inventory database.

• The FDA’s definition of Life Support devices states that Life Support devices are those devices that are “essential to, or that yield information essential to, the restoration of a body function important to the continuation of human life.”

• The Joint Commission (TJC) defines a Life Support device as “any device used for the purpose of sustaining life and whose failure to perform its primary function, when used according to manufacturers’ instructions and clinical protocol, will lead to patient death in the absence of immediate intervention.”This definition aligns with most other accreditation agencies as well.

• What is the likely impact of equipment failure or malfunction (consequence of failure), and how serious is harm likely to be?(severity examples but not limited to)

• Potential death

• Potential permanent injury

• Inaccurate diagnosis

• Major treatable injury

• Minor treatable injury

• Delay in treatment or diagnosis

• What is the acuity of patient using this device? (examples but not limited to)

• Pediatric/neonatal patient

• Critical patient

• Surgical patient

• General patient

• Is there back up or alternative equipment for the device? (redundancy)

Manufacturer frequencies and service documentation

Service documentation, equipment history and incidents are all inputs to consideration of AEM eligibility.

• Is a copy of the manufacturer’s service manual available? What are the defined PM frequencies?

• If the manufacturer’s service manual is not available, how are the AEM frequencies determined outside of risk assessment? (i.e. Are there similar equipment models within the inventory that can be considered for a baseline?)

• What is the nature of equipment failures and service requests as consideration to setting an AEM frequency? (High rate of failures or repairs need consideration as input to AEM strategy decision. AEM strategy cannot deteriorate the performance of the equipment.)

• What is the history of medical device alert and recall on the device?

• Is there potential incident history related to device that needs consideration?

• Documented maintenance strategies that may be considered as an input to AEM are but not limited to:

• Preventive (time interval-based) maintenance: Regularly scheduled maintenance performed on a piece of equipment to lessen the likelihood of failures.

• Predictive (condition-based) maintenance: Monitoring the performance and condition of the equipment during its normal operation to reduce the likelihood for failures.

• Reactive (corrective, repair-based): Maintenance completed after equipment has already broken down and focuses on restoring the equipment to normal operating conditions. This is also considered for devices that are ‘run to fail.’

• Reliability-centered maintenance: Structured and analytical process that identifies which maintenance methods work best for the specific equipment.

• Written documentation that evaluates the effectiveness of the AEM program is required annually. It is understood that a minimum of 12months of the AEM program is needed to develop an annual evaluation. Adjustments must be documented and made to ensure continued effectiveness of the program.

• The use of performance data is critical to determining if modifications of the AEM program are required. This may mean modifications of PM frequencies are increased or decreased based upon performance data.

Qualified personnel

The hospital must have records and documentation that qualify the individual(s) to determine whether it is safe to perform maintenance on plant or medical equipment without following the manufacturer’s recommendations.

• This applies to both hospital employees and contracted individuals.

• A qualified individual is someone for example are HTM professionals (i.e. biomedical engineers) or other qualified maintenance personnel.

• Highly specialized or complex equipment may require specialized knowledge or training for personnel to be considered a qualified decision maker regarding the placement of such equipment in an AEM program.

• Individuals also qualified as decision makers in the AEM decision-making process can be clinicians and/or regulatory compliance personnel, as it relates to the patient safety aspect of risk.

Hospital stakeholder adoption

It is critical that hospital clinicians, risk management and the Environment of Care Committee have awareness and adoption to the AEM program. Appropriate communication processes must be established and documented throughout the organization.

This can be accomplished by the following:

•Environment of Care Committee meeting minutes for approval of AEM.

• Departmental clinician education and communication regarding medical equipment included on the AEM program. These key stakeholders must be included in the decision-making process and adoption of the AEM program, as it has impact to their patients.

• AEM program evaluation results must be shared and reviewed on a designated cadence regarding the effectiveness of the program and appropriate adjustments made accordingly. This should be documented within the AEM policies and procedures.

In summary, the AEM program is a set of PM strategies that allows for adjustments to preventive maintenance, inspection and testing activities for facility and medical equipment from what is recommended by the equipment manufacturer.

The key advantage of adopting an AEM program is it can save significant maintenance resources while maintaining―or even enhancing―patient safety. HTM professionals can redirect their resources toward other critical activities that have a greater impact to patient safety and care.

The execution of an AEM program requires creation, implementation and adoption of policies & procedures to ensure adherence to 42 CFR 485.623(b)(1) and accreditation standards while minimizing the risk to patient safety. Additionally, continual monitoring and measurement of the AEM program effectiveness is critical to ensure device maintenance activity adjustments are made in a timely manner.

It is important HTM professionals understand what the AEM program is and what it is not, as well as how it impacts their daily work and equipment performance. This should be done in conjunction with collaboration and input from hospital risk management and key clinical personnel.

Denisa Lambert is vice president of quality & regulatory compliance at TRIMEDX,the largest independent, technology-enabled clinical asset management company in the United States. TRIMEDX provides strategic planning and management of clinical assets to drive operational cost savings, free up capital for new strategic initiatives and deliver improved risk management and cyber protection.