Regulations regarding listed substances in articles are continuing challenges for product stewardship professionals. Multiple regulations across the globe require proper, effective management tools for listed substances in articles. Addressing these varied and changing regulations requires robust strategies and methods to ensure compliance now and in the future. A case study on the complexity of assessing and managing cobalt in medical devices will highlight varying strategies for managing listed substances in articles and their advantages and disadvantages. Cobalt is a particularly challenging case because it is an impurity within stainless steel, a material used extensively in the medical device field. As with many impurities, the available data is very limited and requires multiple strategies to obtain. Examining the methods and strategies used in this case study will emphasize the need for a well-documented yet flexible process to address listed substances in articles. Participants will leave this session with a wider awareness of effective tools and practices to aid in the complex assessments of listed substances in articles.
0.75 Contact Hours