Safety and Efficacy of Seven Day Platelets
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چکیده
Concerns over bacterial proliferation in room temperature–stored platelet concentrates prompted the US Food and Drug Administration on June 02 1986 to issue a memorandum to blood establishments directing a reduction in the allowable storage time of platelet concentrates from 7 to 5 days. In this memorandum, the FDA called attention to several cases of fatal post-transfusion sepsis from platelet transfusions that had been reported to the agency and stated that “significant levels” of bacteria may be seen in platelets after 5-7 days of storage. At that time, no FDA cleared bacterial detection devices were available for use with platelet concentrates. The platelet storage period had been increased from three days to 5 days in 1981 with the introduction of new plastics and further increased to 7 days in 1984 using the same container materials. The temporal whiplash in the permissible storage times for platelets that collection establishments and hospitals experienced in the 1980s abated as the 5-day permissible storage period was unchanged until recently, with the exception of one aborted clinical trial described below.
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