The Association for the Advancement of Medical Instrumentation (AAMI) has tapped a top executive with the Food and Drug Administration (FDA)’s national Medical Product Safety Network (MedSun) to serve in a new senior leadership role focusing on patient safety initiatives.
Marilyn Neder Flack is currently the director of the Division of Patient Safety Partnerships at the FDA’s Office of Surveillance and Biometrics in the Center for Devices and Radiological Health (CDRH). She will join AAMI in early September as senior vice president for patient safety initiatives and executive director of the AAMI Foundation. She also will serve as executive director of the foundation’s Healthcare Technology Safety Institute (HTSI), which focuses on safety initiatives that strengthen the development, management, and use of medical technology for improved patient outcomes.
“AAMI and its volunteers already have established a solid base and infrastructure for HTSI, and I look forward to continuing to build on their success,” Flack says.
The move underscores AAMI’s commitment to HTSI and the overarching goal of finding solutions to some of the most challenging technology issues in modern healthcare.
“Quite simply, we are taking HTSI to a new level,” says AAMI president Mary Logan. “In hiring Marilyn Neder Flack, we want the healthcare community to know that both AAMI and HTSI are serious about our vision of a world in which healthcare technology continually advances patient safety and does no harm.”
Flack will be responsible for implementing strategy for HTSI. Her duties will include the development of technology-related safety metrics, as well as fundraising—with an eye on building HTSI into a financially self-supporting enterprise.
Flack also will act as the primary “voice” of HTSI to articulate its mission and strategy both internally and externally, while building new professional relationships and partnerships that uphold it as a neutral venue marked by the diversity of its stakeholders.
“By stakeholders bringing their particular viewpoints, knowledge, and talents into the larger discussion, the best solutions and the best practices to ensure patient safety with medical devices can be identified and adopted,” Flack says. “It is always so rewarding to work with groups of committed individuals who bring energy and creative ideas to the table to improve the lives of patients.”
Flack brings impressive credentials to the job. She has held her current position at the FDA since 1999. In that role, she has directed all aspects of MedSun, which is the FDA’s national medical device adverse event sentinel program, and incorporated the clinical community’s perspective into the regulatory and patient-safety work of the agency. Her responsibilities also have included setting the research and special device project priorities for the division, and educating foreign governments on methods of building a successful adverse event/patient safety network.
Flack holds a BA in speech-language pathology/audiology from Douglass College/Rutgers University; an MA in audiology from the University of Maryland; and a master’s certificate in project management from George Washington University.
HTSI’s efforts started in 2010 amid concerns about one of the most widely used medical devices—infusion pumps. Many experts believed that the existing global standard on infusion pumps was not adequately addressing problems associated with their use. At the same time, the FDA was preparing a major initiative to improve the safety of infusion pumps, which had been associated with at least 56,000 reports of adverse events and 87 recalls over a five-year period.