AEM eligibility check

Can a piece of equipment be maintained on your own risk-based schedule instead of the manufacturer's? Screen it against the CMS rules and get the documentation checklist.

Reference only. Summarized from CMS's public memo S&C 14-07-Hospital (December 20, 2013) and the State Operations Manual Appendix A, tag A-0724. Check the current CMS manual and your accreditor's standards, which can add requirements. Not a substitute for your facility's HTM program, manufacturer service manuals or employer procedures.

Equipment type (optional, shown on the printout)

Does any of these apply? (any yes = not eligible) Imaging or radiologic equipment (diagnostic or therapeutic) Medical laser device New equipment without enough maintenance history to support a risk-based decision Another federal law or a state law requires the manufacturer's schedule or stricter maintenance A Life Safety Code provision covers this maintenance (e.g. alcohol-based hand-rub dispensers)

Risk assessment Failure could cause serious injury or death to a patient or staff member ("critical equipment") The decision is made by qualified staff (e.g. a biomedical technician or engineer), and we keep their qualification records We have incident and service history for identical or very similar equipment A backup device or system is available in time if it fails

What CMS allows

Hospitals must keep facilities, supplies and equipment at an acceptable level of safety and quality (42 CFR 482.41(c)(2)). Following the manufacturer's recommended maintenance always complies. A hospital may instead use different maintenance activities or frequencies through a documented alternate equipment management (AEM) program, based on a risk assessment by qualified personnel, and it must then follow its own AEM schedule strictly (CMS S&C 14-07-Hospital).

Never eligible

Imaging and radiologic equipment: maintain per the manufacturer (42 CFR 482.26(b)(2)).
Medical lasers.
New equipment until enough maintenance history exists.
Equipment where other federal or state law, or another Condition of Participation such as the Life Safety Code provisions at 42 CFR 482.41(b), requires the manufacturer's maintenance or stricter rules.

Risk factors CMS lists

How the equipment is used and how serious and widespread the harm from a failure would be (CMS's example: a slightly miscalibrated scale is a small risk in an adult outpatient clinic but serious in a neonatal ICU); the manufacturer's recommendations and their rationale; how simple or complex the maintenance is and whether you can validate an alternate method; whether backup equipment is available in time; and the incident history of identical or very similar equipment. CMS gives no scoring formula, so this tool doesn't invent one: it records your answers for the decision your qualified staff make.

Sources

CMS S&C 14-07-Hospital: Hospital Equipment Maintenance Requirements (PDF with SOM Appendix A text)
42 CFR 482.41 Condition of participation: Physical environment
FDA Medical Device Recalls database and MAUDE (public failure and recall history for the risk assessment)

Logic checked against the sources above and our test cases on 2026-10-17. Planning aid, not legal, engineering or clinical advice.

AEM eligibility check

What CMS allows

Never eligible

Risk factors CMS lists

Sources

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