title: Consistency and proportionality in policy decision-making in blood safety: the case for an all-apheresis platelet supply in Germany.
abstract: Recently, German investigators presented the first mathematical model finding a significant increase in the risk of HIV, HCV, and HBV transmission when pools of 4 whole-blood-derived buffy-coat platelets, rather than 1 single-donor (apheresis) component, are used to provide one platelet dose. Based, in both cases, on mathematical models employing the incidence/window-period method, the relative risk of transmission from pooled versus apheresis platelets (2.2 or 2.75 for HIV, 2.7 or 3.375 for HCV, and 3.2 or 4.0 for HBV, with pools of 4 or 5 concentrates, respectively) is similar to the difference in risk before (versus after) introduction of HIV-1 and HCV RNA screening. The absolute increase in the risk from pools (1 to 2 HIV-, HCV-, or HBV-infectious platelet doses annually) is much smaller than the yield from HIV-1 and HCV RNA screening projected in the 1990s, but it becomes similar to that yield (with up to 88 infectious platelet doses intercepted) when we consider the next transfusion-transmitted pathogen to emerge in the future. Although pathogen reduction (PR) of platelets would eliminate the difference in risk between pooled and apheresis platelets vis-a-vis viral transmission, PR is not ready for implementation because the safety of PR needs to be investigated further. German transfusion guidelines should be revised to indicate the difference in risk associated with pooled versus apheresis platelets, and transition toward an all-apheresis platelet supply should commence. These actions are consistent with and proportionate to the action taken in the 1990s when screening for HIV-1 and HCV RNA was implemented.
authors.affiliation: Transfusion Center, University Medical Center, Johannes Gutenberg University Mainz, Germany. vamvakas@post.harvard.edu
authors.forename: E C
authors.initials: EC
authors.lastname: Vamvakas
authors.forename: W E
authors.initials: WE
authors.lastname: Hitzler
mesh_terms: D001781:Blood Component Removal; D001792:Blood Platelets / Q000382:microbiology / Q000821:virology; D005858:Germany; D015497:HIV-1 / Q000302:isolation & purification; D006291:Health Policy; D016174:Hepacivirus / Q000302:isolation & purification; D006515:Hepatitis B virus / Q000302:isolation & purification; D006801:Humans; D017713:Platelet Transfusion / Q000009:adverse effects*