[Methologic contribution to blood transfusion materials surveillance]. / Contribution méthodologique aux pratiques de matériovigilance en transfusion sanguine.

To reduce seriousness and frequency of iatrogenic risk implies prevention policies and efficient operational systems for vigilance. This risk management implies definition of precise organizations and procedures able to locate and to notify quickly undesirable events. This is the case about single use medical devices (SUMD) used in blood transfusion. This article is a contribution to the organisation of the implemented material vigilance in blood transfusion, collectively carried out with actors concerned (users, manufacturers, National Commission for Material Vigilance). It presents a lot of tools and methods to favour practices harmonization, as well as preventive a curative (specifications before purchase, main part of the quality contract between customer and supplier; internal control plan; index for medical device used in transfusion; illustrated glossaries for three main families of medical devices; index about symptomatic events; definitions of seriousness levels with their operational consequences; methods to manage a single use medical device judged as defective; tool for the review of incidents according to reference and batch). Then, the management of incidents about SUMD is presented within a material vigilance system integrated into the quality system of the institution, for user as for manufacturer. This is done in a chronological order with successively description of the incident, the assessment of the impact, the management of the associated risk, the periodical review of incidents and management of matters in dispute.

[Quality control of labile blood products. Why and howto properly take a specimen? Labile Blood Products Group of the French Blood Transfusion Society]. / Le contrôle de qualité des produits sanguins labiles. Pourquoi et comment bien prélever un échantillon? Groupe de produits sanguins labiles de la Société française de transfusion sanguine.

This article reviews the various techniques of sampling used for the quality control of blood cell products. The importance of this stage for the validity of quality control results is emphasized. Three sampling methods, i.e., stripping, the sterile connection of sampling bag and the destructive method, are described in the form of operating modes and analyzed according to their advantages and drawbacks. The results of a comparative study carried out by the working group 'Blood Cell Products' of the French Society of Blood Transfusion are presented, showing that each method is valid and permits one to obtain a representative sample of the product to be controlled. Thus the diversity of the sampling methods allows us to select the one most adapted to the product to be controlled and to the analyses to be carried out afterward.