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Improving medical device safety and performance: From passive reporting to active surveillance and beyond
Management in Healthcare: A Peer-Reviewed Journal,
3
(3),
250-261
(2018)
Abstract
Medical device use is expanding with the emergence of sophisticated applications to gather, store, process and communicate patient-centric data. Diversity, fast-paced technological advances and complex interfaces between users and technology complicate challenges associated with promoting medical device safety. The purpose of this conceptual paper is to evaluate strategies for improving medical device safety and performance through collaborative evidence generation and innovative analytics. Developing public–private partnerships and the infrastructure for active surveillance, evidence generation and data analytics requires engaged and enlightened institutional leadership who share a common vision and values. Integration of interprofessional initiatives may remediate the silo mentality pandemic in the healthcare community, harness the digital revolution for surveillance and promote improvements in medical device safety and performance.
Keywords: medical devices; patient safety; active surveillance; real-world evidence; informatics; registries; electronic health record
The full article is available to subscribers to the journal.
Author's Biography
Louise Underdahl earned a BA (English Literature) at the University of California, Los Angeles (UCLA), followed by Master of Science in Library Science (MSLS), Master of Public Administration and PhD at the University of Southern California. She served UCLA from 1978 to 1992, UCLA Health Risk Management from 1992 to 2017 and University of Phoenix Online since 2004. She is currently Lead Faculty Area Chair for the School of Advanced Studies Doctor of Health Administration programme and also serves as dissertation chair, committee member and active participant in the University of Phoenix Research Hub. Her research focuses on work attitudes and medical device safety.
Francine Nelson is a registered nurse with a PhD. Her professional background consists of comprehensive experience within the healthcare industry, in regulatory compliance, clinical studies and research coordination, clinical management and training, and academic practice and leadership capacities. She has worked as an investigator for state and federal compliance, an educator in higher education, a full-time researcher, a faculty member, a research consultant and a campus programmes chair. She is a retired commander of the US Navy, where she served in various capacities, ranging from senior nurse to head of Ambulatory Pediatric Nursing, Emergency and Ambulatory Care Nursing, Emergency Nursing Departments and Nursing Research Department. She has served on various healthcare and education governing bodies and councils, including Institutional Review Boards. Her areas of research include pain, pain management, activity and sleep and ageing populations.
Citation
Underdahl, Louise and Nelson, Francine (2018, December 1). Improving medical device safety and performance: From passive reporting to active surveillance and beyond. In the Management in Healthcare: A Peer-Reviewed Journal, Volume 3, Issue 3. https://doi.org/10.69554/YFXO2952.
© Henry Stewart
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