Blood component recalls in the United States

Transfusion

Volumn 39, Issue 5, 1999, Pages 473-478

  Ramsey, Glenn ^a   Sherman, L A ^b  

^a NORTHWESTERN MEMORIAL HOSPITAL   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ACCREDITATION; ARTICLE; BLOOD BANK; BLOOD COMPONENT; BLOOD DONOR; FOOD AND DRUG ADMINISTRATION; MARKET; SCREENING TEST; UNITED STATES; VIRUS TRANSMISSION;

BLOOD COMPONENT TRANSFUSION; COMMUNICABLE DISEASES; DRUG AND NARCOTIC CONTROL; HUMANS; RETROSPECTIVE STUDIES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0032900732     PISSN: 00411132     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1537-2995.1999.39050473.x     Document Type: Article

References (14)

1. AuBuchon JP, Birkmeyer JD, Busch MP. Safety of the blood supply in the United States: opportunities and controversies. Ann Intern Med 1997;127:904-9.
2. Title 21 CFR 210-211 and 600-640. Washington: Government Printing Office, 1997 (revised annually).
3. Vengelen-Tyler V, ed. Technical manual. 12th ed. Bethesda: American Association of Blood Banks, 1996:1-23.
4. Title 21 CFR 7.1-7.59. Washington: Government Printing Office, 1997 (revised annually).
5. FDA Enforcement Report. Rockville, MD: Food and Drug Administration, http://www.fda.gov (updated weekly).
6. Wallace EL, Churchill WH, Surgenor DM, et al. Collection and transfusion of blood and blood components in the United States, 1994. Transfusion 1998;38:625-36.
7. FDA Talk Paper. T93-51. Rockville, MD: CBER Office of Communication, Training, and Manufacturers Assistance, December 29, 1993.
8. Swami VK, Sazama K. Reasons for biological recalls and market withdrawals: a moving target (abstract). Transfusion 1997;37(Suppl):42S.
9. Lackritz EM, Satten GA, Aberle-Grasse J, et al. Estimated risk of transfusion of the human immunodeficiency virus by screening blood in the United States. N Engl J Med 1995;333:1721-5.
10. Ramsey G, Fryxell LM, Russell DL, Sherman LA. Three-year hospital experience with a system for tracking blood supplier notifications about blood products (abstract). Transfusion 1998;38(Suppl):123S.
11. Smith DM Jr, Lipton KS. Consignee/recipient notification guidelines. Association Bulletin #97-3. Bethesda, MD: American Association of Blood Banks, April 23, 1997.
12. Menitove JE, ed. Standards for blood banks and transfusion services. 18th ed. Bethesda: American Association of Blood Banks, 1997.
13. Eichenwald K. Shortage of plasma drug creates health care crisis. New York Times 1998;April 26:Sect A, p 1.
14. Change to the guidance entitled "Revised precautionary measures to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) by blood and blood products. FDA Information Sheet. Rockville, MD: CBER, September 8, 1998.