title: Alternative strategies in assuring blood safety: An overview.
abstract: Assuring transfusion safety is an essential element of health care in all countries, requiring government commitment, national policy and a legal framework. Fundamental safety strategies include selection of low risk donors, Good Manufacturing Practices in preparation of blood components, and appropriate clinical use including avoidance of unnecessary transfusions. Hemovigilance, including surveillance for known adverse events and sentinel reporting of unexpected adverse events, enhances safety through benchmarking to promote best practices and by enabling rapid responses to new threats. Preventing transmission of infectious diseases is a principal safety concern. Selection of low risk donors includes use of screening questions to elicit risk factors known to be associated with transmissible infections. Laboratory testing for specific infectious disease markers is an established strategy for interdicting contaminated donations. The sensitivity, specificity, and operational convenience of laboratory testing have improved over time and newer technologies are imminent. Donor screening and laboratory testing, while highly effective in reducing risk, cannot eliminate all risk from known agents and must be developed de novo to address emerging infections. In contrast, pathogen reduction technologies offer the possibility for robust inactivation of a broad spectrum of blood transmissible agents and provide an added safeguard against newly emerging infectious threats of most types. Current pathogen reduction methods also inactivate leukocytes, adding safety benefits similar to leukocyte removal and product irradiation. However, to date, concerns about the safety and efficacy of cellular blood components treated by pathogen reduction have prevented approval of these technologies in the U.S. and Canada. FDA is promoting clinical and basic scientific studies to clarify these issues and would consider alternative approaches to assuring blood safety if pathogen reduction technologies are proven to be safe and effective.
authors.affiliation: Office of Blood Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, HFM-300, 1401 Rockville Pike, Rockville, MD 20852, USA. jay.epstein@fda.hhs.gov
authors.forename: Jay S
authors.initials: JS
authors.lastname: Epstein
mesh_terms: D001782:Blood Donors; D001800:Blood Specimen Collection / Q000379:methods* / Q000592:standards; D001803:Blood Transfusion / Q000379:methods* / Q000592:standards*; D017848:Blood-Borne Pathogens / Q000302:isolation & purification; D019411:Clinical Laboratory Techniques / Q000592:standards / Q000639:trends; D003257:Consumer Product Safety / Q000592:standards; D046148:Donor Selection / Q000379:methods; D006801:Humans; D017751:Safety Management / Q000379:methods*; D011795:Surveys and Questionnaires; D065227:Transfusion Reaction