CMS Requirements for Hospital Equipment Maintenance

Where can I find information on the CMS clarification of hospital equipment maintenance requirements?

CMS Conditions of Participation 482.41(c)(2) requires that hospital facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality. CMS issued a memorandum on December 2, 2011 updating the guidance in Appendix A of the State Operations Manual related to hospital facility and medical equipment maintenance.

Memorandum Summary:

Alternate equipment maintenance schedules permitted in some instances:

  • Hospitals may adjust maintenance, inspection, and testing frequencies for some facility and medical equipment below those recommended by the manufacturer, based on an assessment by qualified personnel of the risk to patient and staff health and safety.
    • Manufacturer-recommended maintenance frequency is required for:
      • All equipment critical to patient health and safety; and
      • Any new equipment until a sufficient amount of maintenance history has been acquired.

Alternative equipment maintenance methods are not permitted:

  • Hospitals must continue to follow the manufacturer’s recommended techniques for maintaining equipment, even if the hospitals alter the frequency of maintenance activities

Hospitals are expected to maintain equipment inventories and documentation of their maintenance activities. Federal or State laws and regulations (including Life Safety Code requirements adopted as part of Federal regulations) may require that equipment maintenance activities (i.e., maintenance, inspection and testing) be performed in accordance with the manufacturer’s recommendations, or may establish other maintenance requirements. In these instances, the hospital must be in compliance with the most stringent maintenance requirements mandated. Absent such mandated requirements, it is acceptable for the hospital to follow the manufacturer’s recommended maintenance schedule, to schedule more frequent maintenance than the manufacturer recommends, or, in some cases of non-critical equipment, to schedule less frequent equipment maintenance than the manufacturer calls for.

Equipment that is critical to patient health and safety is not a candidate for an alternative, less frequent maintenance activity schedule. Such equipment must be maintained at least as often as the manufacturer recommends. 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 to or death of patients or staff.

The manufacturer’s recommended maintenance frequency must be utilized for all new equipment until a sufficient amount of maintenance history has been acquired to safely adjust the maintenance frequency below that recommended.

If a hospital is adjusting non-critical equipment maintenance frequencies to be below those recommended by the manufacturer, such adjustments must be based upon a systematic, evidence-based assessment. The hospital must document the assessment for all equipment with less frequent maintenance than what the manufacturer recommends, including the selected maintenance strategy that led to the lower adjusted frequency, and supporting evidence. The evidence must provide support that the frequency adjustment will not adversely affect patient or staff health and safety.

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