CMS Reverses Course on Maintenance Activities

Posted December 20, 2013

A key federal agency has announced that hospitals have some latitude in setting their maintenance activities for medical equipment, revising an earlier stance that manufacturer’s recommendations must be followed in almost all cases.

News of the change came in a memorandum from the Centers for Medicare & Medicaid Services (CMS). The agency sent an e-mail with the memo to many individuals and groups, including AAMI. The document, written for state survey agency directors and dated Dec. 20, is described as an update of a memo issued two years ago.

The latest memo would appear to be welcome news for healthcare technology management (HTM) departments, many of whom bristled when CMS in December 2011 had narrowed their ability to set alternate maintenance schedules and had completely restricted their ability to set alternate methods.

The CMS memo opens the door to both, as long as some safeguards are followed and some exceptions are honored.

“Under certain circumstances it also may be consistent with the regulatory requirements for a hospital to use maintenance activities or frequency of facility or medical equipment which may not be the same as those recommended by the manufacturer,” CMS says in the new memo. “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.”

If a hospital elects to follow maintenance practices that are different than those recommended by the manufacturer, CMS stresses that they must be “based on a risk-based assessment by qualified personnel” and that such policies must be documented in the facility’s alternate equipment management (AEM) program.

The agency now says critical equipment may even be part of a hospital’s AEM program, a big change from the December 2011 memo.

The memo points to ANSI/AAMI EQ 56:1999/(R) 2008, Recommended Practice for a Medical Equipment Management Program as having an example of standards for a medical equipment program.

Importantly, CMS also specifies that a hospital may not deviate from a manufacturer’s recommendations when:

  • 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.
  • The equipment is a medical laser device.
  • New equipment without a sufficient amount of maintenance history has been acquired.

“It’s obvious from a first read of the material that a lot of thought and solid research went into this revised memo—thankfully,” said AAMI President Mary Logan. “CMS did its homework and appeared to listen to all of the input it received. Imaging manufacturers should be pleased with the exceptions, and the HTM community should be pleased with the recognition that a risk-based approach is appropriate.”

The agency’s 2011 memo caused an uproar in the HTM community. The agency agreed to revisit the directive after reviewing of a 244-page packet of information and data from AAMI and the American Society for Healthcare Engineering (an American Hospital Association group).

According to the new memo, hospitals must have policies in place to evaluate the effectiveness of an AEM program that address certain factors, including how malfunctions are identified and investigated. They also must address how a malfunction could have been prevented, as well as what they will do to prevent a recurrence. Finally, facilities must address whether the malfunction was the result of the use of an AEM strategy.

The memo directs CMS surveyors to focus their review on pieces of critical equipment that are part of the AEM program, as well as “the hospital’s documentation of the factors and evidence it considered in developing an AEM strategy for that equipment.”

Karen Waninger, director of clinical engineer at Community Health Network in Indianapolis, hailed the new policy.

“We are appreciative of CMS’ attention to the concerns of the HTM profession, and ultimately to the needs of our healthcare organizations and our patients,” said Waninger, who had been at the forefront of the effort asking CMS to reconsider the 2011 memo. Waninger sits on AAMI’s Technology Management Council (TMC).

Read the complete CMS memo.