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The hospital’s activities and frequencies for inspecting, testing, and maintaining the following items must be in accordance with manufacturer’s recommendations: • Equipment subject to federal or state law or Medicare Conditions of Participation in which inspecting, testing, and maintaining must be in accordance with the manufacturer’s recommendations, or otherwise establishes more stringent requirements • Medical laser devices • Imaging and radiologic equipment (whether used for diagnostic or therapeutic purposes) • New medical equipment with insufficient maintenance history to support the use of alternative maintenance strategies DUHS will also follow manufacturer’s recommendation for items that have been designated as highrisk.. A qualified individual(s) uses written criteria to support the determination whether it is safe to permit medical equipment to be maintained in an alternate manner that includes the following: • • • • • How the equipment is used, including the seriousness and prevalence of harm during normal use Likely consequences of equipment failure or malfunction, including seriousness of and prevalence of harm Availability of alternative or back-up equipment in the event that equipment fails or malfunctions Incident history of identical or similar equipment Maintenance requirements of the equipment The DUHS clinical engineering leadership developed a methodology, based on the above criteria, for the identification of equipment to be included in the alternative equipment maintenance (AEM) program.. Backup equipment is available for many types of equipment within the user department, through loaners or spares maintained by Clinical Engineering or through such departments as: Equipment Distribution – DUH Electronic Flow Control – DRH Patient Care Equipment Department - DRAH The Clinical Engineering department is staffed 8:00 AM - 4:30 PM Monday through Friday at Duke University Hospital and the Duke PDCs and DPCs7:00 AM- 3:30 PM at Duke Raleigh Hospita
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