After 2 years of controversy and debate over its policies for the preventive maintenance of medical equipment, the Centers for Medicare and Medicaid Services (CMS) has issued an update to its December 2011 directive requiring hospitals to follow manufacturer guidelines for any equipment deemed “critical to health and safety.” The new regulations, issued December 20, allow hospitals to set their own parameters for frequency and type of maintenance based on recommendations from qualified personnel. Imaging and radiologic equipment are exempt from the new guidelines.
The original directive applied to, but was 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.” CMS received pushback from those who considered the regulations excessive. Servicing equipment can be costly for hospitals and may result in downtime. The memorandum acknowledges, “Hospitals may find that manufacturer’s recommendations for some equipment are not available to them or their contractors, or they may through experience have identified more efficient or effective maintenance activities which do not reduce the safety of the equipment.”
Under the new standards, hospitals seeking to adjust manufacturer-specified methods or frequencies must develop and strictly adhere to an Alternate Equipment Management (AEM) program based on “generally accepted standards of practice” for maintenance. Such a program must also include policies to evaluate the program’s success, including how incidents of equipment malfunction are identified and the process of removal for equipment that is no longer functional.
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