Designing Out Harm — Leveraging a Human Factors-Engineered Value Analysis and Risk Management Program to Improve Outcomes, Mitigate Preventable Harm, and Reduce Unnecessary Cost

Event Schedule by Time Zone: 
Pacific: 10 AM to 11 AM | Mountain: 11 AM to 12 PM | Central: 12 PM to 1 PM | Eastern: 1 PM to 2 PM

The majority of medical device-related adverse events are not caused by devices that failed — they are caused by predictable mismatches between how products are designed and how real humans use them in real clinical environments. Human factors engineering (HFE), grounded in FDA guidance, offers a systematic approach to surfacing these use-related risks before products are adopted. In this capstone session, AHVAP experts demonstrate how embedding HFE principles into an integrated value analysis and risk management program prevents use errors, improves clinical outcomes, mitigates preventable harm, and reduces the unnecessary costs that flow from workarounds, waste, rework, adverse events, and litigation. Participants will leave with a replicable HFE-integrated VA/RM workflow and tools they can deploy immediately.

Learning Objectives:

1. Describe the core principles of human factors engineering and their application to medical device evaluation, selection, and post-adoption surveillance.
2. Analyze how use-related risks surfaced through an HFE-informed evaluation translate into measurable improvements in clinical outcomes, reductions in preventable harm, and avoidance of downstream cost.

3. Construct an HFE-integrated value analysis and risk management workflow incorporating task analysis, simulated-use testing, structured end-user input, and risk-informed scoring prior to product adoption.

    

Speaker:

Dr. Hudson Garrett Jr. is a healthcare executive, infection prevention expert, and Assistant Professor of Medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine. He specializes in healthcare-associated and community-associated infection prevention, healthcare epidemiology, patient safety, and medical affairs. A recognized leader in the field, Dr. Garrett collaborates with major organizations including the CDC, WHO, FDA, APIC, AORN, and SHEA, and is widely respected for his expertise in infectious diseases, antimicrobial resistance, healthcare quality, and leadership development.

Member: $39.00
Non-Member: $99.00