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Abstract: Pathogen inactivation of blood products represents a global and major paradigm shift in transfusion medicine. In the next near future, it is likely that most blood products will be inactivated by various physicochemical approaches. The concept of blood safety will be challenged as well as transfusion medicine practice, notably for donor selection or biological qualification. In this context, it seems mandatory to develop analytical economic approaches by assessing costs-benefits ratio of blood transfusion as well as to set up cohorts of patients based on hemovigilance networks allowing rigorous scientific analysis of the benefits and the risks of blood transfusion at short- and long-term. [Copyright &y& Elsevier]

Summary: Hemapheresis is made up of a set of essential methods for modern medical practices. Applicated to donors, they allow production of labile blood products as well as raw material for plasma products industrial manufacturing; applicated to patients, they are indispensable for the treatment of many pathologies. Conditions for their implementation are very variable according to the teams who have few tools at their disposal to access, standardize and make reliable their activity. Therefore, an approach has been initiated by the Institut National de la Transfusion Sanguine and the Hemapheresis French Society to develop a guide which primary goal is to help teams evaluate themselves in different areas of their responsabilities. The generalization of the evaluation of professional practices in all activities and specialities required recently by the third iteration of the certification procedure of health institutions and a new law about French health system reinforce us in our approach. Finally, hemapheresis is not whithout risks, neither for donors nor for patients, which now encourages us to analyze sharply our procedures, to identify risk situations and develop means of prevention. This second step is already a current news for us. [ABSTRACT FROM AUTHOR]

Abstract: The Alps-Mediterranean division of the French blood establishment (EFS Alpes-Mediterranée) has implemented a risk management program. Within this framework, the labile blood product distribution process was assessed to identify critical steps. Subsequently, safety measures were instituted including computer-assisted decision support, detailed written instructions and control checks at each step. Failure of these measures to prevent an incident underlines the vulnerability of the process to the human factor. Indeed root cause analysis showed that the incident was due to underestimation of the danger by one individual. Elimination of this type of risk will require continuous training, testing and updating of personnel. Identification and reporting of nonconformities will allow personnel at all levels (local, regional, and national) to share lessons and implement appropriate risk mitigation strategies. [Copyright &y& Elsevier]