News Story

M-CERSI Hosts Conference on Human Reliability Analysis of Medical Devices, Aug. 26

The Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) will host a medical devices conference at the University of Maryland College Park campus on August 26, titled "Human Reliability Analysis Applied to Medical Device Use-Related Hazards." The event will take place in the Kay Boardrooms, #1107 and #1111, in the Jeong H. Kim Engineering Building from 9:00 am - 1:30 pm.

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 conference 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.

The target audience for the conference 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.

The event is free, but registration is required by August 21, 2013. To register online, visit: http://ter.ps/2wg

The M-CERSI is supported by the U.S. Food and Drug Administration (FDA) and focuses on modernizing and improving the ways drugs and medical devices are reviewed and evaluated.  This center is a collaborative partnership between the University of Maryland, College Park, and the University of Maryland, Baltimore. Researchers from both campuses work with FDA staff to support the development of new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.  

For more information about M-CERSI, visit: http://www.cersi.umd.edu.

July 23, 2013