In the medical device industry, risk assessment is required for product development and support, regulatory compliance, and manufacturing support. The risk assessment process can be divided into four major steps. The first step, hazard identification, involves determining whether exposure to an agent can cause an increased incidence of an adverse health condition (e.g., acute toxicity, cancer, birth defects, etc.). The next step in the risk assessment process is to characterize the dose-response relationship. Virtually all chemicals are toxic at some dose, and toxicity is dependent upon the circumstances of exposure, including the amount of substance available, the nature of contact with the substance, and the duration of contact. For both hazard identification and dose-response assessment, the use of scientifically valid data from any source, including data from published literature, is a central feature. Exposure assessment is the determination or estimation of the frequency and duration of human exposure to an agent. The last step in the risk assessment process is risk characterization. Risk characterization uses information from all three previous steps to estimate the probability of an adverse effect under the various conditions of described human exposure. All the components of risk assessment provide the framework for a working paradigm used in evaluating the safety of new or modified medical devices.
A Review of Perfluoroalkyl Acids (PFAAs) in terms of Sources, Applications, Human Exposure, Dietary Intake, Toxicity, Legal Regulation, and Methods of Determination
