Inside AAMI

Abstract

The U.S. Food and Drug Administration (FDA) has formally recognized the AAMI version of an international standard on medical electrical equipment.The recognition of ANSI/AAMI ES60601-1:2005—Medical electrical equipment, Part 1: General requirements for basic safety and essential performance and other collateral standards—comes as welcome news to the medical technology community.The standard—which is the U.S. adoption of IEC 60601-1/Ed.3:2006—contains national deviations needed to comply with the National Electrical Safety Code, says Charles Sidebottom, director of corporate standards for Minneapolis-based Medtronic and secretary of IEC/Subcommittee 62A, which developed the IEC standard.The third edition of IEC 60601-1 has been recognized and harmonized in Europe for several years. The AAMI Electrical Safety Committee, which developed the U.S. adoption, is working to harmonize it with NFPA 99, the standard from the National Fire Protection Association (NFPA) on healthcare facilities, says Mike Schmidt, cochairman of the committee.AAMI's Benchmarking Solution now includes more detailed questions on a department's device inventory and associated costs.Launched last year, AAMI's Benchmarking Solution helps clinical engineering departments measure their practices, policies, and procedures against others, and monitor their progress through the year. The online tool can be used to measure staffing, budgeting, inspections, and other issues.Subscribers answer a series of questions about their department and operation; and they can then see how their facility compares to others. The clinical engineering experts who drafted the questions made the enhancements in response to subscriber requests.For example, the experts broke down two questions about the total number of devices in an inventory into four categories: imaging, laboratory, general biomedical equipment, and non-patient care equipment.This will help subscribers compare certain types of equipment at other facilities. For more information about AAMI's Benchmarking Solution, visit www.aami.org/abs.