The safety and availability of blood and tissues - Progress and challenges

New England Journal of Medicine

Volumn 351, Issue 8, 2004, Pages 819-822

  Goodman, Jesse L ^a  

^a CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BACTEREMIA; BLOOD TRANSFUSION; EDITORIAL; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFECTION PREVENTION; PRIORITY JOURNAL; SAFETY; THROMBOCYTE TRANSFUSION; TISSUE TRANSPLANTATION; VIRUS INACTIVATION; VIRUS TRANSMISSION;

BLOOD BANKS; BLOOD DONORS; BLOOD-BORNE PATHOGENS; HUMANS; NUCLEIC ACID AMPLIFICATION TECHNIQUES; RNA, VIRAL; TISSUE BANKS; TISSUE DONORS; VIREMIA;

EID: 4143109213     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJMe048146     Document Type: Editorial

References (15)

1. Stramer SL, Glynn SA, Kleinman SH, et al. Detection of HIV-1 and HCV infections among antibody-negative blood donors by nucleic acid-amplification testing. N Engl J Med 2004;351:760-8.
2. Jackson BR, Busch MP, Stramer SL, AuBuchon JP. The cost-effectiveness of NAT for HIV, HCV, and HBV in whole-blood donations. Transfusion 2003;43:721-9.
3. Marshall DA, Kleinman SH, Wong JB, et al. Cost-effectiveness of nucleic acid test screening of volunteer blood donations for hepatitis B, hepatitis C and human immunodeficiency virus in the United States. Vox Sang 2004;86:28-40.
4. Hillyer CD, Josephson CD, Blajchman MA, Vostal JG, Epstein JS, Goodman JL. Bacterial contamination of blood components: risks, strategies, and regulation: Joint ASH and AABB Educational Session in transfusion medicine. Hematology (Am Soc Hematol Educ Program) 2003;1:575-89.
5. Leiby DA, Herron RM Jr, Read EJ, Lenes BA, Stumpf RJ. Trypanosoma cruzi in Los Angeles and Miami blood donors: impact of evolving donor demographics on seroprevalence and implications for transfusion transmission. Transfusion 2002;42:549-55.
6. Update: cutaneous leishmaniasis in U.S. military personnel - Southwest/Central Asia, 2002-2004. MMWR Morb Mortal Wkly Rep 2004;53:264-5.
7. Llewelyn CA, Hewitt PE, Knight RS, et al. Possible transmission of variant Creutzfeldt-Jakob disease by blood transfusion. Lancet 2004;363:417-21.
8. Second case of vCJD "via blood." BBC News, UK edition. July 22, 2004. (Accessed July 30, 2004, at http://news.bbc.co.uk/1/hi/health/3916285. stm.)
9. Food and Drug Administration, Center for Biologics Evaluation and Research. Guidance for industry: revised preventive measures to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood products. January 2002. (Accessed July 30, 2004, at http://www.fda.gov/cber/gdlns/cjdvcjd.pdf.)
10. Pealer LN, Marfin AA, Petersen LR, et al. Transmission of West Nile virus through blood transfusion in the United States in 2002. N Engl J Med 2003;349:1236-45.
11. Zou S, Dodd RY, Stramer SL, Strong DM. Probability of viremia with HBV, HCV, HIV, and HTLV among tissue donors in the United States. N Engl J Med 2004;351:751-9.
12. Kainer MA, Linden JV, Whaley DN, et al. Clostridium infections associated with musculoskeletal-tissue allografts. N Engl J Med 2004;350:2564-71.
13. Food and Drug Administration, Center for Biologics Evaluation and Research. Guidance for industry: eligibility determination for donors of human cells, tissues, and cellular and tissue-based products: final rule and notice. May 25, 2004. (Accessed July 30, 2004, at http://www.fda.gov/cber/rules/ suitdonor.pdf.)
14. Idem. Current good tissue practice for manufacturers of human cellular and tissue-based products: inspection and enforcement: proposed rule. January 8, 2001. (Accessed July 30, 2004, at http://www.fda.gov/cber/rules/gtp010801pr. pdf.)
15. Food and Drug Administration. Innovation or stagnation: challenge and opportunity on the critical path to new medical products. (Accessed July 30, 2004, at http://www.fda.gov/oc/initiatives/criticalpath/.)