tag:blogger.com,1999:blog-8066238290370557389.post7943587537950589908..comments2024-03-20T04:44:15.540-05:00Comments on Controversies in Hospital Infection Prevention: Secondhand woesDan Diekemahttp://www.blogger.com/profile/10231929371552334184noreply@blogger.comBlogger1125tag:blogger.com,1999:blog-8066238290370557389.post-23113448198815220332010-03-01T17:27:17.192-06:002010-03-01T17:27:17.192-06:00I wonder how this can be acceptable to the FDA whe...I wonder how this can be acceptable to the FDA when the product has not been funtionally tested after exposure to the sterilization method. For example, I know that balloon's become embrittled after exposure to gamma radiation. Who will perform the ASTM testing after a series of exposures to be sure the device will not harm a patient? It sounds like the hospital is manufacturing a medical device without having the authority or data to do so?Anonymousnoreply@blogger.com