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Medical Device Specialty Section Webinar Featuring Thomas Hartung

Friday, May 24th, 2013
12:00 Noon EDT

Abstract:

In vitro methodologies are only slowly embraced by the field of medical device safety testing. The Limulus amebocyte lysate assay might be considered a forerunner for non animal tests here as it is applied to eluates from medical devices in order to determine microbiological contaminations. However, this test is limited to Gram-negative bacterial endotoxin. More recently, assays based on the human fever reaction were developed. They make use of human white blood cells, which respond to many further stimuli. Especially the whole blood pyrogen assay allows to measure directly on the surface of the medical devices avoiding pyrogen eluation. Its adaptation to medical devices showed, that both eluation and depyrogenation by standard methodologies are not adequate to determine and remove pyrogen burden of medical devices. This test case is used to discuss opportunities and limitations for in vitro medical device testing in general. The webinar will benefit toxicologists involved with the safety assessment of medical devices, drugs, and combination devices.

WEBINAR ACCESS INSTRUCTIONS:

Date and Time: Friday, May 24, 2013, 12:00 at Noon, EDT (New York, GMT-04:00)
Event number: 660 328 534
Event password: MDSS
Click here to join event.

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