Transfusion Medicine Reviews
Volume 22, Issue 1 , Pages 35-57 , January 2008

Men Having Sex With Men Donor Deferral Risk Assessment: An Analysis Using Risk Management Principles

References 

  1. United States, Food and Drug Administration . Workshop on Behavior-Based Donor Deferrals in the NAT Era. Transcript, minutes of meeting, Bethesda, MD, 8 March 2006. http://www.fda.gov/cber/minutes/nato30806t.pdf
  2. King SM, AuBuchon J, Barrowman N, et al. Consensus statement from the consensus conference on blood-borne HIV and hepatitis. Vox Sang. 2002;83:188–193
  3. Chiavetta JA, Deeks S, Goldman M, et al. Proceedings of a Consensus Conference: Blood-Borne HIV and Hepatitis—Optimizing the Donor Selection Process. Transfus Med Rev. 2003;17:1–30
  4. Damesyn MA, Glynn S, Schreiber G, et al. for the NHLBI Retrovirus Epidemiology Donor Study Behavioral and infectious disease risks in young blood donors. Transfusion. 2003;43:1596–1603
  5. Sanchez AM, Schreiber GB, Nass CC, et al. for the Retrovirus Epidemiology Donor Study The impact of male-to-male sexual experience on risk profiles of blood donors. Transfusion. 2005;45:404–413
  6. Sellors JW, Hayward R, Swanson G, et al. Comparison of deferral rates using a computerized versus written blood donor questionnaire. BMC Public Health. 2002;2:14
  7. Rugege-Hakiza SE, Glynn S, Hutching S, et al. for the Retrovirus Epidemiology Donor Study Do blood donors read and understand screening educational materials?. Transfusion. 2003;43:1075–1083
  8. O'Brien S, Yi Q-L, Fan W, et al. Current incidence and estimated residual risk of transfusion-transmitted infections in donations made to Canadian Blood Services. Transfusion. 2007;47:316–325
  9. McColl RS, Hicks J, Craig L. Environmental health risk management: a primer for Canadians. Waterloo, ON: Institute for Risk Research, 2002. http://www.irr-neram.ca/pubs/reports/reports.html#primer
  10. Hrudey S, Leiss W. Risk management and precaution: insights on the cautious use of evidence. Environ Health Perspect. 2003;111:1577–1581
  11. United States, Office of Management and Budget . Proposed risk assessment bulletin 2006. http://www.whitehouse.gov/omb/inforeg/proposed_risk_assessment_bulletin_010906.pdf
  12. United States, National Research Council . Science and judgment in risk assessment. Washington, DC: National Academy Press; 1994;
  13. United States, National Research Council . Understanding risk. Washington, DC: National Academy Press; 1996;
  14. Tyshenko M, Krewski D. Public perception and acceptable levels of health risk among Canadians. Unpublished paper, McLaughlin Centre, University of Ottawa, 2005
  15. Wilde GJS. Target risk 2. Toronto, ON: PDE Publications; 2001;
  16. Health Canada . Assessment and management of cancer risks from radiological and chemical hazards, 1998. http://www.hc-sc.gc.ca/ewh-semt/pubs/radiation/98ehd-dhm216/index_e.html
  17. Krever . The honourable Mr. Justice Horace. Commission of Inquiry on the Blood System in Canada: Final Report, vol. I. Ottawa: Government of Canada; 1997;
  18. In:  Harremoës P,  Gee D,  MacGarvin M, et al. editor. The precautionary principle in the 20th century. London: Earthscan; 2002;
  19. Germain M, Remis RS, Delage G. The risks and benefits of accepting men who have had sex with men as blood donors. Transfusion. 2003;43:25–33
  20. Spencer B, Rios J, Cable R. Marginal recruitment impact of potential alterations to FDA deferral criteria for men who have had sex with men. [letter] Transfusion. 2006;46:869–870
  21. New Zealand, Environmental Risk Management Agency . Ethics framework, Dec. 2005. http://www.ermanz.govt.nz/resources/publications/pdfs/ER-PR-05-1.pdf
  22. World Health Organization . World Health Report 2002, Chapter 6, Section 6: “Ethical considerations in risk prevention”. http://www.who.int/whr/2002/chapter6/en/index5.html
  23. Beauchamp TL, Childress JF. Principles of medical ethics. ed 5. New York: Oxford University Press; 2001;
  24. Wilson K, Hebert PC. The challenge of an increasingly expensive blood system. CMAJ. 2003;168:1149–1150
  25. Kleinman S, Chan A, Robillard P. Risks associated with transfusion of cellular blood components in Canada. Transfus Med Rev. 2003;17:120–162
  26. United States, Food and Drug Administration, Blood Products Advisory Committee . Transcript, minutes of meeting, Bethesda, MD, 9 March 2006. http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4206t1.pdf
  27. Boulos D, Yan P, Schanzer D, et al. Estimates of HIV prevalence and incidence in Canada, 2005. Can Commun Dis Rep. 2006;32:165–175http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/06vol32/dr3215
  28. Myers T, Allman D. 2004 Ontario Men's Survey. HIV Social, Behavioural and Epidemiological Studies Unit, University of Toronto, Toronto, ON, 2004. http://cbr.cbrc.net/files/1126039797/Ontario%20Mens%20Survey%20Final%20Report.pdf
  29. Germain M, Sher G. Men who have had sex with men and blood donation: is it time to change our deferral criteria?. J Int Assoc Physicians AIDS Care. 2002;1:86–88
  30. In:  Flynn J,  Slovic P,  Kunreuther H editor. Risk, media and stigma. London: Earthscan; 2001;
  31. Dollard C. Transmission of HHV-8 by blood transfusion. In: FDA Workshop (Ref 1)
  32. Blajchman MA, Vamvakas EC. The continuing risk of transfusion-transmitted infections. N Engl J Med. 2006;355:1303–1305
  33. Hladik W, Dollard SC, Mermin J, et al. Transmission of human herpesvirus 8 by blood transfusion. N Engl J Med. 2006;355:1331–1338
  34. Chiavetta JA, Escobar M, Newman A, et al. Incidence and estimated rates of residual risk for HIV, hepatitis C, hepatitis B and human T-cell lymphotropic viruses in blood donors in Canada, 1990-2000. CMAJ. 2003;169:767–773
  35. Soldan K, Davison S, Dow B. Estimates of the frequency of HBV, HCV, and HIV infectious donations entering the blood supply in the United Kingdom, 1996 to 2003. Eurosurveillance. 2005;10:17–19
  36. Dodd RY, Notari EP, Stramer SL. Current prevalence and incidence of infectious disease markers and estimated window-period risk in the American Red Cross blood donor population. Transfusion. 2002;42:975–979
  37. Busch MP, Glynn SA, Stramer SL, et al. for the NHLBI-REDS NAT Study Group A new strategy for estimating risks of transfusion-transmitted viral infections based on rates of detection of recently infected donors. Transfusion. 2005;45:254–264
  38. Soldan K, Sinka K. Evaluation of the de-selection of men who have had sex with men from blood donation in England. Vox Sang. 2003;84:265–273
  39. Galt V. It's okay to be gay on Bay. The Globe and Mail, Toronto, ON, July 12, 2006, p. C1
  40. Hewitt PE, Llewelyn CA, Mackenzie J, et al. Creutzfeldt-Jakob disease and blood transfusion: Results of the UK Transfusion Medicine Epidemiological Review study. Vox Sang. 2006;91:221–230
  41. Burnouf T, Padilla A. Current strategies to prevent transmission of prions by human plasma derivatives. Transfus Clin Biol. 2006;13:320–328
  42. Rai SN, Krewski D, Bartlett S. A general framework for the analysis of uncertainty and variability in risk assessment. Hum Ecol Risk Assess. 1996;2:972–989

 Additional support to this study was provided by PrioNet Canada, University of British Columbia, Vancouver, BC, Canada, a Network of Centres of Excellence for research on prion diseases.

PII: S0887-7963(07)00085-5

doi: 10.1016/j.tmrv.2007.09.002

Transfusion Medicine Reviews
Volume 22, Issue 1 , Pages 35-57 , January 2008