Medical Device Conference: Human Reliability Analysis Applied to Medical Device Use-Related Hazards

Monday, August 26, 2013
9:00 a.m.
1107 & 1111 Kim Engineering Building, UMD Campus
Ann Anonsen

Human Reliability Analysis (HRA) is a human factors tool that can be proactively used to elucidate and quantify human error through three stages:
1) Identify use-related hazards;
2) Evaluate their impact on user safety and performance; and
3) Mitigate the hazards through the user-centric modification of device hardware, software, and intended use environment.

The Exchange will focus on the role of HRA in fulfilling the design control requirements of the Quality System Regulation and the risk management of medical devices. The conference will have three case-study driven learning modules: 1) An overview of human behavior modeling techniques for use-related hazards; 2) Empirical data collection, predictive modeling, and validation for data related to behavioral use-related hazards; and 3) Risk mitigation procedures and design intervention evaluation.

Target Audience is intended to be product safety and compliance engineers, product designers, regulatory affairs professionals, and others interested in integrating HRA in device design decision making.


Dr. Monifa Vaughn-Cooke, an Assistant Professor in the Design and Reliability of Systems Divisions in the UMD Department of Mechanical Engineering, will lead the workshop. She received a Ph.D. in Industrial Engineering with a minor in Human Factors and Ergonomics from the Pennsylvania State University, focused on the application of human reliability tools to the healthcare system. Dr. Vaughn-Cooke's interdisciplinary research aims to identify the behavioral mechanisms associated with system risk propagation to inform the design of user-centric products and systems, with the ultimate goal of improving productivity and safety. She currently teaches courses at UMD in Human Reliability Analysis, Risk and Reliability in Health Care, and Integrated Product and Process Development through the Mechanical and Reliability Engineering Programs.

The event is free, but registration is required by August 21, 2013.

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