3.2 Alternative Equipment Maintenance (AEM) Programs & Regulatory Compliance

3.2 Alternative Equipment Maintenance (AEM) Programs & Regulatory Compliance

Quick Answer: Under CMS Survey & Certification memo S&C 14-07-Hospital, a hospital may use maintenance activities or frequencies that differ from the manufacturer's recommendations if qualified personnel make a documented, risk-based determination and the hospital runs a documented Alternative Equipment Maintenance (AEM) program. Imaging/radiologic equipment (diagnostic or therapeutic), medical lasers, new equipment without sufficient maintenance history, and equipment whose maintenance is set by other federal or state law are not eligible. The hospital must follow the AEM activities and frequencies it sets and must evaluate the program's effectiveness.

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Regulatory Foundation and Evolution of AEM

In December 2011, CMS memo S&C 12-07-Hospital told surveyors that hospital equipment had to be maintained according to manufacturer recommendations. Many manufacturer schedules are conservative, and the clinical engineering community pushed back. On December 20, 2013, CMS replaced that guidance with S&C 14-07-Hospital, which interprets the physical environment Condition of Participation — then codified at 42 CFR §482.41(c) and, since CMS's 2016 renumbering, at §482.41(d)(2): "Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality."

S&C 14-07 establishes that:

• Hospitals comply when they follow manufacturer recommendations and keep documentation of those recommendations and of the maintenance performed.
• Hospitals may adjust maintenance activities and frequencies for facility and medical equipment based on a risk-based assessment by qualified personnel (employees or contractors), unless the equipment is ineligible.
• Hospitals that do so must maintain policies, procedures, and documentation for the AEM program, base it on generally accepted standards of practice (the memo cites ANSI/AAMI EQ56 for medical equipment), and adhere strictly to the activities and frequencies they establish.
• The hospital must identify any critical equipment in the AEM program — equipment whose failure could seriously injure or kill a patient or staff member — and surveyors focus their AEM review on that critical equipment.

How The Joint Commission Mirrors CMS

• Through 2025 (legacy EC chapter): EC.02.04.01 EP 4 required written maintenance activities and frequencies following either manufacturer recommendations or AEM strategies, with notes that AEM strategies must not reduce safety, must be based on accepted standards such as ANSI/AAMI EQ56, and that scheduled maintenance must have a 100% completion rate. EP 5 listed equipment that must follow manufacturer recommendations, and EP 6 required a qualified individual to use written criteria — how the equipment is used, likely consequences of failure, availability of backup equipment, incident history, and maintenance requirements.
• Since January 1, 2026 (Accreditation 360): The Joint Commission retired the Environment of Care chapter for hospitals and consolidated these requirements into PE.04.01.01 EP 2 ("The hospital maintains essential equipment in safe operating condition"). Its note requires inspection, testing, and maintenance documented according to manufacturer recommendations or the AEM activities and frequencies defined in the AEM program. The survey process now mirrors CMS's §482.41(d)(2) procedures.
• DNV (NIAHO PE.7) and other accrediting organizations with deeming authority apply the same CMS boundaries.

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Equipment That Is Not Eligible for AEM

S&C 14-07 lists four situations in which equipment must be maintained according to manufacturer recommendations (or a stricter legal requirement):

1. Other federal or state law, or another Condition of Participation, sets the maintenance. CMS's example: imaging and radiologic equipment, whether used for diagnostic or therapeutic purposes, is governed by §482.26(b)(2) and must be maintained per manufacturer recommendations. Mammography under the Mammography Quality Standards Act (MQSA) and state radiation-control rules are further examples.
2. Medical lasers. CMS notes that FDA requires laser manufacturers to provide a maintenance schedule and service instructions.
3. New equipment without sufficient maintenance history. History can come from the hospital's own records, a contractor's records, or nationally recognized public sources. Until enough history exists, the manufacturer's program applies; before switching, the hospital must document that it evaluated the maintenance track record and risks and tested the alternate regimen.
4. Life Safety Code items incorporated into the CoPs (and, since 2016, Health Care Facilities Code items) keep their required testing where those codes set it.

[!IMPORTANT] Life-support equipment is not automatically excluded. CMS does not bar life-support or other critical equipment from AEM. Instead, the hospital must identify critical equipment in its AEM program, and surveyors concentrate their sample on it (the 2026 Joint Commission survey guide tells surveyors that critical equipment such as ventilators, defibrillators, and robotic surgery devices should make up most of the sample). Many hospitals keep life-support equipment on manufacturer schedules as a policy choice because the evidence burden is high.

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Developing an Evidence-Based AEM Justification

Moving equipment into AEM requires an auditable engineering process:

1. Policy and governance: A written AEM policy, approved through the hospital's governance process (commonly the EOC or safety committee), defines entry criteria, analysis methods, qualified decision-makers, and review frequency.
2. Qualified personnel: CMS requires the determination to be made by qualified personnel. Document their qualifications (education, experience, certifications such as CBET or CCE, and training).
3. Maintenance history and failure analysis: Use enough CMMS history to be meaningful (many programs use two to three years) for the make and model, including:
   • Failure rates and Mean Time Between Failures (MTBF).
   • Preventable versus random failures: PM can prevent wear-out failures (batteries, seals, filters), but not drops, fluid spills, or random electronic failures.
   • Corrective work orders, incident reports, and recalls.
4. Manufacturer literature review: Understand why the manufacturer set its interval. For example, if a semi-annual PM exists mainly to check a battery that has since been redesigned for longer life, an annual interval may be defensible.
5. Documented risk assessment: Consider how the equipment is used, the likely consequences of failure, backup availability, incident history, and maintenance requirements (the Joint Commission's legacy EP 6 criteria), often organized as an FMEA-style analysis.

Each enrolled device must be identifiable as AEM in the inventory. The 2026 Joint Commission survey guide checks that AEM equipment is "readily identified," that the inventory contains no ineligible imaging or radiologic equipment, and that documentation shows the risks, the alternate activities and frequencies with their rationale, the dates maintenance was performed, and any equipment failures (other than operator error), including whether harm resulted.

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Monitoring, Re-evaluation, & Reversion

S&C 14-07 requires policies and procedures addressing the effectiveness of the AEM program, including:

• How incidents of equipment malfunction are identified;
• How malfunctions are investigated — whether they could have been prevented, what will prevent recurrence, and whether the malfunction resulted from the AEM strategy;
• How equipment found unsafe or no longer suitable is removed from service;
• How performance data are used to decide whether AEM procedures need to change.

Most programs review each AEM category at least annually and define triggers that require immediate review:

• Rising failure rates — more corrective work orders, calibration drift, or wear findings than the justification predicted.
• An adverse event or near miss in which maintenance or the maintenance interval may have contributed.
• A manufacturer safety notice or recall that changes service requirements.

When a trigger occurs, the HTM manager investigates, removes unsafe units from service, and — if the AEM strategy may have contributed or safety is uncertain — restores the manufacturer's activities and frequencies (or a stricter interval) while the analysis is completed, then reports the findings and corrective actions to the EOC or safety committee.