In the United States, the Centers for Medicare & Medicaid Services (CMS) requires that healthcare facilities maintain, inspect, and test all inventoried medical equipment "in accordance with manufacturers' recommendations or with strategies of an alternative equipment maintenance (AEM) program" (Joint Commission 2014). With some exceptions, an AEM program allows a healthcare facility to "adjust its maintenance, inspection, and testing frequency and activities for facility and medical equipment from what is recommended by the manufacturer, based on a risk-based assessment by qualified personnel" (CMS 2013).

For many types of equipment, healthcare facilities find that the manufacturer-recommended maintenance activities are more onerous than is warranted, based on their own history of using and maintaining the device. On the other hand, for certain devices, a facility may determine that maintenance steps that exceed or otherwise differ from those recommended by the manufacturer are warranted to protect patients. In circumstances such as these, an AEM program allows the healthcare facility to deviate from strict adherence to manufacturer-recommended maintenance activities.

For such deviations to be acceptable, certain conditions must be met. CMS outlines these conditions in its Hospital Equipment Maintenance Requirements survey and certification letter. The following is an excerpt from the letter's Memorandum Summary (CMS 2013):

• A hospital may adjust its maintenance, inspection, and testing frequency and activities for facility and medical equipment from what is recommended by the manufacturer, based on a risk-based assessment by qualified personnel, unless:
• Other federal or state law or hospital Conditions of Participation (CoPs) require adherence to manufacturer's recommendations and/or set specific requirements. For example, all imaging/radiologic equipment must be maintained per manufacturer's recommendations; or
• The equipment is a medical laser device; or
• New equipment without a sufficient amount of maintenance history has been acquired.
• Hospitals electing to adjust facility or medical equipment maintenance must develop policies and procedures and maintain documentation supporting their AEM program. They must adhere strictly to the AEM activities and/or frequencies they establish.

A key advantage of AEM programs, when the above conditions can be met, is that they reduce the inspection and preventive maintenance burden for certain devices. This allows clinical engineering departments to direct their time and resources toward other activities that have a greater impact on patient safety. The Joint Commission cautions, however, that the "strategies of an AEM program must not reduce the safety of equipment and must be based on accepted standards of practice" (Joint Commission 2014).

References

Centers for Medicare & Medicaid Services (CMS), U.S.:

Critical access hospital (CAH) equipment maintenance requirements [Survey & Certification Letter]. S&C: 14-41-CAH. 2014 Aug 8. Available from: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-41.pdf.

Hospital equipment maintenance requirements [Survey & Certification Letter]. S&C:14-07-Hospital. 2013 Dec 20. Available from: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-07.pdf.

ECRI Institute. Complying without crying: how the new CMS requirements impact your equipment maintenance processes [webinar]. 2014 Apr 16. Available from: https://www.ecri.org/components/HDJournal/Pages/Complying-without-Crying.aspx.

Joint Commission. Revised equipment maintenance standards for critical access hospitals. Jt Comm Perspect 2014 Nov;34(11):7-10. Available from: https://www.jointcommission.org/assets/1/18/Revised_Equipment_Maintenance_Standards_for_Critical_Access_Hospitals.pdf.​