AAMI’s Medical Equipment Management Committee is developing a new standard on the acquisition of healthcare technology, with the goal of creating a consistent process for healthcare delivery organizations (HDOs) and a uniform set of topics that should be covered during the requisition process.
Capital equipment planning is becoming a bigger issue, and many hospitals are finding they are not making optimum decisions about medical equipment, facts that are detailed in the July/August cover story of AAMI’s peer-reviewed journal, BI&T.
Patrick Bernat, AAMI’s director of HTM, said there is a need to establish clear protocols and policies. “Without a formal process in place for acquiring healthcare technology, and without involving the necessary players in the process, healthcare technology acquisition can become disorganized and disjointed,” he said.
A formalized, streamlined approach to technology acquisition could help HDOs make more appropriate decisions, save time and money, and reduce end-user error.
“The industry would greatly benefit from a referenceable standard on healthcare technology acquisition that identifies the benefits/need for an effective acquisition process to HDO leadership, lays out an effective process with appropriate stakeholders engaged, and provides examples of tools that can help facilitate the acquisition process,” said Stephen Grimes, managing partner of Strategic Health Care Technology Associates and a member of the Medical Equipment Management Committee.
The new standard is expected to cover service documentation, risk management files, processes for making purchasing decisions (including who should be involved in those decisions), depreciation schedules, monitoring of hazard alerts and product recalls, and identifying technical specifications. The committee is also aiming to develop a standardized request for proposals.
A Call for Papers
AAMI will devote the spring 2017 edition of its award-winning supplement Horizons to clinical alarm management. Proposals are being accepted until November 2.
Those interested in submitting a research article, systematic review, case study, commentary, or other type of paper should email Senior Editor Gavin Stern at gstern@aami.org. Authors should specify in 200 words or less the topic of the proposed manuscript and describe how it will advance the literature on the subject.
Once submitted, manuscripts will undergo peer review. The content of Horizons is indexed and searchable on various healthcare and scientific databases, including PubMed.
Like Those It Serves, Human Factors Course Evolves with Times
Over the course of seven years and 1,200 students, AAMI’s Human Factors for Medical Devices course has continued to evolve. This year, the three-day program, which offers an introduction to regulatory requirements as they relate to the discipline of understanding how humans interact with devices, is undergoing another refresh.
The most recent evolution of the course – which is aimed at quality and design engineers, research and development managers, and risk managers – includes an increased focus on combination products and ties in with changes stemming from the Food and Drug Administration’s (FDA) February 2016 guidance document, Applying Human Factors and
Usability Engineering to Medical Devices, as well as revisions to ANSI/AAMI/IEC 62366-1, Medical Devices—Part 1: Application of usability engineering to medical devices.
“Many participants were coming to our course with the new guidance in their hands, and we know they want us to be up to date with the FDA’s published position on human factors,” said Bob North, chief scientist at Human Centered Strategies in Colorado Springs, Colorado, who directs the course. “We also present material from the newly updated international guidance, IEC 62366, which has undergone an upgrade to make it harmonize more with the FDA’s guidance. The course now has an integrated agenda that includes both of the FDA’s devices and drug centers. We now have officials from both of those FDA centers giving co-presentations.”
Since 2009, AAMI’s human factors course has seen an increasing number of participants from the pharmaceutical industry – thanks to greater integration of drugs and devices – which North described as “game changing.” As a result, the course has gradually incorporated the unique human factors requirements for participants seeking clearance on combination products. Today, it includes instructors from the pharmaceutical industry as well.
The completely revised program will launch in November and will incorporate additional investigation techniques, including class exercises where participants use data to identify device design flaws. To register for an upcoming session, please visit the AAMI Store at www.aami.org/store.
Pack a ‘Brown Bag’ for Free Young Professional Webinar Series
AAMI’s Next Gen Task Force has launched a free “brown bag” style webinar series for students and young professionals. These sessions are intended to spark conversations around the issues facing those who are just starting out in the field.
“AAMI’s Next Gen Brown Bag webinars are the big kickoff for our initiative to get more young professionals involved in healthcare technology. Our goal is to help launch our members’ early careers by providing resources and networking opportunities,” said Allison Rafti, director of membership marketing at AAMI and the staff manager for the Next Gen Advisory Task Force. “This supports AAMI’s strategic priority to help young professionals develop in their careers, climb the ladder, and hopefully stay and find success in the healthcare technology field.”
This month, the webinars will focus on the armed forces. Jonathan Richardson, a federal government service sales manager at Siemens Healthcare, will provide advice on transitioning from military healthcare technology management to the private sector. On October 31, Danielle McGeary, director of clinical engineering for the VA Boston Healthcare System, will talk about working for the VA.
In November, Inhel Rekik, a clinical engineer at the University of Maryland Medical Center, will focus on how women in engineering can overcome challenges. Angela Spillane, a consultant with Mainspring Healthcare Solutions, an Accruent Company in Boston, Massachusetts, will discuss taking on projects to advance your career.
For a complete listing of webinars and resources to help career advancement, visit www.aami.org/nextgen.