Blood supply FDA oversight and remaining issues of safety : report to the ranking minority member, Committee on Commerce, House of Representatives.DIANE Publishing, 1997 |
Common terms and phrases
52 plasma AABB accident reports analysis of EIRs antibody areas autologous bacterial contamination blood and blood Blood Banks blood establishments blood industry blood products blood safety blood transfusions blood units checklist compliance program consignees contained Department of Health determine disease district donation donor screening EAR rate EIR information EIRs and Form ensure error and accident examined facilities and transfusion FDA inspectors FDA’s Form 483 observations guidelines HBsAg Health and Human hepatitis HTLV HTLV-I Human Services identified inactivation inspection reports lookback procedures manufacturing manufacturing practices Monitoring and Investigating notify number of EARs parvovirus patients percent plasma centers platelets postdonation information problems product recall public health Quarantining recipients regulations repeatedly reactive response risk Safety Issues sample source plasma syphilis total number transfusion services transmission units collected units of blood unlicensed blood facilities unlicensed facilities Viral and Nonviral viral markers viral testing virus viruses warning letters
Popular passages
Page 128 - The Office of Inspector General (OIG) is transmitting the Department's response to this draft report in our capacity as the Department's designated focal point and coordinator for US Government Accountability Office reports.
Page 59 - H, et al. Molecular cloning and disease association of hepatitis G virus: a transfusion-transmissible agent.
Page 129 - The Department of Health and Human Services (HHS) appreciates the opportunity to comment on the US Government Accountability Office's (GAO) draft report.
Page 137 - Current Good Manufacturing Practices for Blood and Blood Components: Notification of Consignees Receiving Blood and Blood Components at Increased Risk for Transmitting HIV Infection.
Page 5 - ... vulnerabilities we identified would enhance the safety of blood products. Therefore we have recommended that the Secretary of Health and Human Services take the following actions: - Require that blood facilities notify all donors who are permanently deferred (not just those who test positive for HIV) that they have been deferred and the medical reasons for their deferral, so that they do not attempt further donation and can seek further medical care if they desire. - Require confirmatory testing...
Page 134 - Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products.
Page 12 - Chairman of the Energy and Commerce Committee of the US House of Representatives...
Page 5 - ... they have been deferred, and the medical reasons for their deferral. These people should not be attempting to continue donating blood. And they should be given the opportunity to seek further medical care if they choose. Next, we require that FDA ought to require blood facilities to notify patients when they have been transfused with blood from a donor whose subsequent donations were found to be positive, here too, not just for HIV, but for all viruses for which a confirmatory test is available....
Page 68 - June 11, 2001] §606.165 Distribution and receipt; procedures and records. (a) Distribution and receipt procedures shall include a system by which the distribution or receipt of each unit can be readily determined to facilitate its recall, if necessary. (b) Distribution records shall contain information to readily facilitate the., identification of the name and address of the consignee, the date and quantity delivered, the lot number of the unit(s), the date of expiration or the date of collection,...
Page 11 - NHLBI, National Heart, Lung, and Blood Institute; NIH, National Institutes of Health...