Bacterial endotoxin testing (BET) regulations for the United States are outlined in chapters <85> and <161> of the United States Pharmacopeia (USP). Changes to Chapter <161>, “Transfusion and Infusion Assemblies and Similar Medical Devices,” will alter current testing guidelines for medical devices that come into contact with cerebrospinal fluid or the cardiovascular and lymphatic systems. The revisions to Chapter <161> are included as part of the first supplement to USP 38-NF 33, and take effect August 1, 2015. This webinar educates manufacturers by reviewing the changes and exploring the potential impact on bacterial endotoxin testing for these devices.
- Ben Fischer, Technical Service Coordinator, Charles River