A quantitative approach for medical device Health Hazard Analysis

Health Hazard Analysis (HHA) is one major type of patient health risk assessment for medical device field performance issue. U.S. Food and Drug Administration (FDA) has an online form, listing the needed information for HHA. In this paper, we will illustrate a quantitative HHA approach, which is structured in a rigorous risk assessment framework, with several critical steps, concepts and some key statistical reliability techniques embedded. We will also propose a method using Bayesian approach in patient health risk assessment due to medical device field failure. This approach is very useful for issues identified in the manufacturing process or supply chain, when there have been no field returns yet out of the current product sales. Our work may assist the medical device industry by offering an enhanced HHA approach for patient health risk assessment.