Should Blood Centers be using enhanced visual inspection for particulates?
Blood establishments are required under the regulations to do visual inspections. As a result of the finding of particulate matter, FDA became aware that some blood organizations were enhancing their visual inspection procedures. In light of the uncertainty surrounding the particulates, FDA stated that it considered such procedures to be an appropriate interim step. Based on information from a number of sources in the blood and health industries, FDA is reminding blood collection establishments to inspect all blood and blood components using an enhanced procedure.