Particulates that may be present on intravenous medical devices such as guidewires, catheters, and stent delivery systems pose potential health risks to patients. This webinar is aimed toward companies that develop such products or manufacture other cardiovascular medical devices or devices that are likely to come in contact with a patient’s bloodstream. The FDA has frequently requested these devices be tested for particulate matter. General testing methods and validation techniques will be discussed as well as sources of particulate matter, particulate matter monitoring and effectively establishing limits for your device. Available standards and guidance documents such as USP <788>, EN45502/ISO14708 and AAMI TIR 42:2010, will also be a topic in the presentation. Lastly, methods for particulate matter analysis (light obscuration and microscopic) will be discussed along with the advantages and disadvantages of each.
Date:07/19/2012 - 3:37pm