A hotly anticipated document intended to help healthcare technology management (HTM) professionals keep medical devices functioning efficiently and effectively has made its debut, announces the Association for the Advancement of Medical Instrumentation (AAMI).
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.
“Work on the standard got underway with the recognition that facilities were creating inconsistent preventive maintenance, or PM, procedures across the country,” says Paul Kelley director of biomedical engineering, the Green Initiative and Asset Redeployment at Washington Hospital, in Fremont, Calif. “Our work evolved over time to include not only PM, but a whole maintenance strategy.” Kelley is co-chair of the Medical Equipment Management Committee, which developed the document.
The development of EQ89 started several years ago and picked up steam after the Centers for Medicare & Medicaid Services (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 adopted a more flexible posture, giving HTM departments some latitude in setting their maintenance activities.
ANSI/AAMI EQ89:2015 Guidance for the use of medical equipment maintenance strategies and procedures is available top AAMI members for $60. To order, call 1-877-249-8226 or purchase online.
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 are made, facilities should check the maintenance recommendations of original equipment manufacturer (OEM), if they are available. It also names several considerations HTM professionals should take into account when determining a maintenance strategy: the process used to determine the strategy for similar devices; fail safes; the availability of back-up critical devices; and the available evidence and rationale.
In addition, the document names factors to consider when there is 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 and portable versus fixed location).
Kelley says 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—everyone’s ultimate goal. EQ89 was put together well, gathering input from OEMs, in-house biomedical equipment technicians, accreditation agencies, and third-party providers.”