Foundations of Safety Engineering Part I Sept 30 2025

Welcome to a new series of lectures on Safety Engineering for Medical Systems, hosted by the  Center for Smart and Autonomous Medical Systems (SaAMS), at the MGB Anesthesia MD PnP Program This is part of a series of lectures: Special Topics in Smart and Autonomous Medical Systems https://mdpnp.mgh.harvard.edu/saams-center/ Posted to YouTube https://bit.ly/SaAMS_YouTube Course Director: Julian M. Goldman, MD Foundations of Safety Engineering for Medical Systems Part I Sept 30, 2025 4:00-5:10 ET Part II - Oct 9, 2025 4:00-5:30 ET Developing safe medical device systems requires good engineering—a disciplined process combined with sound decision-making at every step. In this opening lecture series, Dr. Weininger will introduce the foundational concepts that support the assurance of safety in complex medical technologies. He will describe how safety emerges from the synergy of a robust design and development framework and consistent, informed choices throughout the lifecycle. Topics will include the FDA regulatory framework, the landscape of medical equipment safety standards, and the principles of risk management. Dr. Weininger will also introduce practical tools such as failure mode and fault tree analyses that help structure decision-making and control the chaos of system development. By the end of these sessions, participants will have a clear view of the standards, processes, and analytical tools that form the foundation of safety engineering in medical systems. Inaugural Lecturer: Sandy Weininger, Ph.D. Senior Electrical/Biomedical Engineer Division of Biomedical Physics Office of Science and Engineering Laboratories Center for Devices and Radiological Health U.S. Food and Drug Administration U.S. Department of Health and Human Services Learning Objectives 1. Define how medical devices are classified within the U.S. regulatory framework. 2. Describe how international standards support medical device safety. 3. Distinguish between common system safety tools and their intended uses. 4. Recognize how interprofessional collaboration among clinicians, engineers, and informaticists contributes to safer medical device systems. Accreditation: In support of improving patient care, Mass General Brigham is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Mass General Brigham designates this live activity for a maximum of 2.50 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.