The News Room

The Association for the Advancement of Medical Instrumentation (AAMI) is inviting comments and recommendations from interested parties on a recent U.S. Centers for Medicare and Medicaid Services (CMS) announcement that manufacturer-recommended maintenance frequencies are required for all equipment critical to patient health and safety.

The comments, which can be submitted here, will be used to guide the next steps of an informal coalition of interested parties that was formed to discuss the Dec. 2 announcement, which was greeted with dismay by many hospital-based healthcare technology management professionals.

The announcement also calls for hospitals to follow manufacturer-recommended maintenance frequencies on any new equipment until a sufficient amount of maintenance history for that equipment has been acquired. And the announcement flatly rules out any alternatives to the manufacturer’s methods for maintaining equipment, “even if the hospitals alter the frequency of maintenance activities.”

The coalition includes various medical equipment users and others, including representatives from The Joint Commission (TJC), AAMI, ECRI Institute, and healthcare facilities.

AAMI would like to know how affected parties would be impacted by the announcement. Specific data and/or examples encouraged in the comments.

The CMS announcement came in the form of a memo distributed to state survey agency directors and described as a “clarification of hospital equipment maintenance requirements.” It came about 18 months after TJC, the largest healthcare accrediting organization in the country, announced at the AAMI 2010 Annual Conference & Expo that CMS had accepted the organization’s approach of granting hospitals more leeway in setting their PM schedules.  The CMS “clarification” grants hospitals far less latitude with maintenance than what TJC had announced.

According to CMS, biomeds and clinical engineers can adjust the PM schedule for noncritical equipment by using strategies different from what the manufacturer recommends. But the hospital must create an evidence-based assessment that shows “the frequency adjustment will not adversely affect patient or staff health and safety.”

The full CMS memorandum is available here (PDF).

Founded in 1967, the Association for the Advancement of Medical Instrumentation (AAMI) is a nonprofit organization representing a unique alliance of over 6,000 members from around the world united by one mission to increase the understanding and beneficial use of medical instrumentation through effective standards and educational programs, and publications.