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HFES Bulletin

June 2010
Volume 53, Number 6

Standards

Epic Medical Device HF Standard Issued

By Edmond W. Israelski

     After a long authoring and editing process, the Human Factors Engineering Committee of the Association for the Advancement of Medical Instrumentation (AAMI) has issued a landmark human factors standard for medical devices. The 460-page standard, AAMI HE-75:2009, Human Factors Engineering-Design of Medical Devices, is intended to aid medical device manufacturers in incorporating comprehensive user-interface design guidance into critical medical devices by taking advantage of the vast HF/E literature. This encyclopedic standard complements the existing HF/E process standard, AAMI HE-74:2001, Human Factors Design Process for Medical Devices, by focusing mostly on design guidance in 25 sections, including areas such as displays, alarms, documentation, hand tools, and mobility.

     The almost 10-year effort was spearheaded by Matthew B. Weinger, MD, of Vanderbilt University, the long-time cochair of the HFE Committee. He also led the process standard HE-74, which paved the way for the new standard. With myself as cochair, Matt worked with a group of more than 25 human factors and industry experts to write, review, and edit this compilation of relevant design advice containing prescriptive design requirements, examples, checklists, and illustrated case studies focused on a wide variety of medical devices. The case studies cover a range of devices, from simple injection devices to IV infusion pumps, patient monitors, and complex anesthesia workstations. The committee was international in its composition and included experts from the medical device manufacturing industry, health care providers, clinicians, and government agency representatives, including the U.S. Food and Drug Administration (FDA). Many volunteer hours and long, intense editing meetings were held to create the standard. Special comprehensive editing was provided by Carl Pantiskas of Draeger Medical, supplemented by professional technical editing.

     FDA was heavily involved in the creation of the standard, and the agency is expected to formally recognize it, as it has done with the complementary HF/E process standard, HE-74. The new standard has an extensive set of references and a bibliography for users seeking additional detail.

     This standard, in the AAMI HFE Committee's view, is not a simple design cookbook; rather, designers should begin with HE-75 for the relevant design principles and then rigorously follow the HF/E process as outlined in HE-74 to ensure good design.

     The AAMI HFE Committee also prepared a companion and supplemental textbook, Handbook of Human Factors in Medical Device Design (2010), edited by Matthew B. Weinger, Michael E. Wiklund, and Daryle J. Gardner-Bonneau, which is scheduled for publication by CRC Press in June. Its 850+ pages add more material, advice, and case studies to HE-75.

Edmond W. Israelski is human factors program manager at Abbott Laboratories in Abbott Park, Illinois.


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