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AAMI Unveils Guide for Maintenance Strategies

AAMI Unveils Guide for Maintenance Strategies

Thu Jul 02 2015By AAMI

 

 

Breaking new ground, AAMI has released an ambitious standard written specifically for healthcare technology management (HTM) professionals to help them keep medical equipment functioning effectively and safely.

ANSI/AAMI EQ89:2015, Guidance for the use of medical equipment maintenance strategies and procedures, identifies commonly used practices. It is intended to help HTM departments standardize and document their maintenance procedures, as well as provide guidance to select the most appropriate maintenance strategy for a given type of device.

“It’s a good document,” said George Mills, director of engineering at The Joint Commission, the nation’s largest accrediting body for healthcare. Participating in an AAMI roundtable discussion on preventive maintenance (PM), Mills commented on the new standard. “We get a lot of blank stares” when we ask how facilities get their PM strategies and activities in place, Mills said. “The field should really benefit from the guidance that’s provided in this document.” More of Mills’ comments and a transcript of the entire roundtable discussion appear in the March/April issue of BI&T (Biomedical Instrumentation & Technology). Stephen Grimes, chief technology officer of ABM Healthcare Support Services in Boston, explained that regulatory action in recent years underscored the need for this kind of standard.

“Recent changes made by the U.S. Centers for Medicare & Medicaid Services (CMS) and accreditation authorities to their medical equipment maintenance-related requirements have had hospitals and HTM professionals scrambling to evaluate and revise their medical equipment management programs to bring them into compliance,” said Grimes, who served on the Medical Equipment Management Committee, which developed the document. “The new standard is intended to help ensure those hospitals and HTM professionals apply effective strategies when updating their maintenance procedures. By following those concepts and strategies laid out in EQ89, they will be demonstrating the use of best practices.”

The development of EQ89 started several years ago and picked up steam after CMS announced in December 2011 that hospitals should adhere to the manufacturer’s recommendations on PM activities for medical equipment in almost all instances. That move ignited an uproar in the HTM community, with many professionals saying it would be impractical, expensive, and that it failed to recognize the value of some alternative strategies with a proven history of safety and success.

Two years later, CMS reconsidered its stance, adopting a more flexible posture that gave HTM departments some latitude in setting their maintenance activities.

“Work on the standard got underway with the recognition that facilities were creating inconsistent preventive maintenance, or PM, procedures across the country,” said Paul Kelley director of Biomedical Engineering, the Green Initiative and Asset Redeployment at Washington Hospital, in Fremont, CA.

“Our work evolved over time to include not only PM, but a whole maintenance strategy,” said Kelley, who also is co-chair of the Medical Equipment Management Committee.

As EQ89 notes, “A maintenance strategy is not a one-size-fits-all approach. HTM departments should develop a plan that will keep the devices functioning and available without expending resources unnecessarily.” However, HTM professionals should be able to provide documentation on why they have chosen certain procedures, and ensure that procedures comply with any applicable authorities having jurisdiction.

The document also advises that before any changes to maintenance practices are made, HTM staff should check the maintenance recommendations of the original equipment manufacturer (OEM), if they are available. It names several considerations HTM professionals should take into account when determining a maintenance strategy: the process used to determine the strategy for similar devices; a plan if something goes wrong; the availability of back-up critical devices; and the evidence and rationale used. In addition, the document names factors to keep in mind when considering a potential change to a maintenance strategy, including the consequences of a device failure, the clinical environment in which the device will operate, and the impact of the physical environment on the device (e.g., temperature and humidity, portable versus fixed location).

Kelley said that although the road to finishing the work was winding, the experience was positive and resulted in a product that reflects the collective knowledge of the group. “There was a range of people on the committee: representatives from hospitals, lobbying organizations, manufacturers, and regulators. It was very exciting to get this document together. The finished product is easy to follow, and there’s some real meat to it.”

Fellow co-chair Michael Angel, senior manager of customer relationship management and integration programs at GE Healthcare, agreed.

“This document will allow facilities to set up their maintenance program in a compliant, efficient manner that champions patient safety. EQ89 was put together well, gathering input from OEMs, in-house biomedical equipment technicians, accreditation agencies, and third-party providers.”

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