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Colloquium Addresses Medical Device IncidentsOn March 8, a diverse group of stakeholders—including medical technology manufacturers, hospital personnel, and industry regulators—met in Houston to develop an integrated action plan for improving patient safety through an effective and fair system for reporting device-related failures. Moderated by Yadin David, EdD, PE, CCE, president of the Health Technology Foundation, and director, biomedical engineering, at Texas Children’s Hospital, Houston, and Professor William Hyman, and sponsored by the American College of Clinical Engineering (ACCE) Healthcare Technology Foundation, Texas Children’s Hospital, Texas A&M University, and the FDA Medical Device Industry Coalition, the one-day colloquium offered a unique opportunity for the audience of over 75 to hear and interact with representatives of the above organizations and others. “There are number of challenges associated with investigating a medical device’s adverse event,” David said. “Prime among these is the fact that it is often difficult to reconstruct what exactly happened in the surrounding environment. We must find a framework to facilitate the sharing of, and encourage the contribution to such important information.” The first half of the program consisted of formal presentations, followed by an audience Q&A session. The second half of the program provided the faculty and the audience with breakout sessions where each was asked to respond to a specific set of questions. David and Hyman facilitated the interactive program and encouraged discussions of perspectives, ideas, and concerns. “One of the major colloquium successes was the fact that such a varied range of stakeholders agreed to publicly debate these issues and hear each other’s perspective,” David said. One area covered concerned errors due to design, use, and the plethora of device alarms that have created confusion, and what is now being termed alarm immunity or alarm fatigue. Some future directions discussed included the need to better organize the reporting system, adopt an integrated approach, a standard operating procedure for users and maintainers of medical devices, to investigate the potential benefits from the creation of a national board of unbiased cross-disciplined experts in adverse event investigation, and change the legal system to facilitate national blame-free sharing of data collected. “We, in the clinical engineering profession, should support the direction outlined at the colloquium and take steps to prepare to claim a seat at the table,” David said.
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