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

Leiss, William; Tyshenko, Michael G.; Krewski, Daniel

doi:10.1016/j.tmrv.2007.09.002

Cited by 45 publications

(54 citation statements)

References 21 publications

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“…They might not accept the donor selection criteria because they consider them to be discriminatory, especially for MSM. The question whether the permanent deferral from blood donation for MSM should be changed to a temporary deferral leading to a better compliance with the deferral criteria and eventually to higher safety of the blood supply has been discussed intensively on an international level [33][34][35]. Offergeld/Hamouda/Burger analyses.…”

Section: Resultsmentioning

confidence: 99%

Epidemiological Data – an Important Part of the Hemovigilance System

Offergeld

Hamouda²,

Bürger³

2010

Transfus Med Hemother

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Epidemiological data are essential for monitoring trends and outbreaks of infectious diseases in the general population. The reporting system pursuant to the Infection Protection Act in Germany results in a very good quality of timely nationwide data on all reportable diseases including those relevant for the blood supply: HIV, hepatitis C, hepatitis B and syphilis. Notifications of acute hepatitis B and first-time diagnosed hepatitis C infections in the general population showed a declining trend in the past years, but the number of reports of HIV and syphilis infections increased until 2007 especially among men who have sex with men. New preventive strategies should also address changes in sexual behavior. The specific surveillance of blood donors is an important part of the hemovigilance system. The highly effective donor selection process results in a small number of confirmed infections among donors in Germany. The surveillance data enable us to identify specific trends that might challenge blood safety like the increase in HIV infections among repeat donors. Specific evaluations are performed when needed. These additional studies can be used to modify guidelines or recommendations and to (re)evaluate the need for or the effect of further testing.

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Section: Resultsmentioning

confidence: 99%

Epidemiological Data – an Important Part of the Hemovigilance System

Offergeld

Hamouda²,

Bürger³

2010

Transfus Med Hemother

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“…Experts mostly favor exclusion of MSM due to the following reasons: 1) they take into account low-quality evidence such as extrapolations from infectious disease incidence in MSM groups, often extrapolating on data from outside the field of transfusion medicine, and there is much circumstantial evidence to support an increased risk of HIV and other sexually transmitted diseases in at least a subpopulation of gays; 2) the risk of transmission of infectious diseases, not tested for or which are (as yet) unknown, is also higher in this population; 75,76 3) laboratory tests cannot guarantee total safety (a recent study reported an error rate of 0.01% of third-and fourth-generation HIV tests); 77 and 4) the instinct and tradition of the sector experts is to make blood ever safer, with zero risk as the ultimate goal. 78,79 This is partly the result of the AIDS epidemic of the early 1980s which led to the infection of thousands of people after receiving a blood transfusion or blood products before HIV antibody testing became available. Although this situation is not comparable to the current scientific and health climate, the scare (and medicolegal consequences) of that episode still resides in many minds.…”

Section: Discussionmentioning

confidence: 99%

Blood donor deferral: time for change? An evidence-based analysis

Borra¹,

Vandewalle²,

Remoortel³

et al. 2016

IJCTM

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Donor selection remains an important part in the safety of the blood supply all over the world. Yet, donor deferral criteria seem to be strongly based on the precautionary principle protecting safety and quality, and on supply and expense considerations. This review therefore provides an overview of the available evidence on donor exclusion criteria, as well as on their cost-effectiveness, for the most frequent reasons of donor deferral in our region. PubMed was queried to retrieve primary research studies, systematic reviews, and health technology assessments (HTAs) concerning donor exclusion criteria. With a similar approach, HTAs about the different blood-banking safety interventions were included. Reasons for donor deferral were recorded via the blood bank information system of the Belgian Red Cross-Flanders. Seven systematic reviews were identified: four on donor safety (hypotension, hypertension/type 2 diabetes, epilepsy, and higher age) and three on recipient safety (hemochromatosis, men who have sex with men, and endoscopy). Forty-three lowquality observational studies were included, as well as 16 HTAs: three about donor exclusion criteria and 13 cost-utility analyses about blood-banking safety interventions. In general, the available evidence for deferral reasons was of low quality, and for 60% of the top 30 reasons for excluding donors, no evidence was found. Blood banking shows its unique position as many safety measures far exceed the normally accepted cost of €50,000/quality-adjusted life-years. The historical model based on the precautionary principle and on supply and expense considerations provides adequate supplies of safe blood at a reasonable price. More and better primary research and evidence-based analyses are required, however, before this model can be replaced by an evidence-based approach. Meanwhile, policy makers should provide guidance at the level of principles, not at the level of technical measures, about the balance between patient and donor rights, and about the acceptable cost-effectiveness implications of these choices.

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“…[6][7][8] The precautionary principle and the ban The precautionary principle is implemented in situations in which public health is in danger, and no conclusive scientific information is available. 1 Under this principle, authorities responsible for public health may choose to act cautiously, without necessarily having robust scientific evidence on which to rely. 8 However, the precautionary principle may be relied upon only to the extent that no new scientific evidence regarding the spread and origin of a disease becomes available.…”

Section: History Of the Banmentioning

confidence: 99%

“…1 In Canada, donations from people considered to be at higher risk for a transfusion-transmissible viral infection are permanently deferred. Reasons for permanent deferral include injection drug use, possible exposure to Creutzfeldt-Jakob disease, exchange of sex for money or drugs, and sex between men.…”

mentioning

confidence: 99%