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Résumé Sur la base évidente, d’une part, de l’existence de risques (de différentes natures) en transfusion sanguine et, d’autre part, de l’attente d’une transfusion sans « vice » ni risque, trois niveaux de sécurisation ont pu être proposés ces dernières années : une politique d’analyse de risques généralisée ; des procédures de maîtrise des risques ; une politique généralisée de qualité. Ces constructions sécuritaires ont néanmoins des impacts multidirectionnels, sur les organisations, les coûts et l’économie en général, la disponibilité des produits, et – in fine – possiblement sur l’éthique. Ce sont ces points qui sont analysés dans le présent essai, ainsi que la place éventuelle dans ces dispositifs des procédés d’inactivation/réduction de pathogènes.

The mistake-proofing concept often refers to physical devices that prevent actors from making a wrong action. In anaesthesiology, one immediately thinks to specific design of outlets for medical gases. More generally, the principle of mistake-proofing is to avoid an error, by placing knowledge in the world rather than knowledge in the head. As it often happens in risk management, healthcare has received information transfers from the industry. Computer is changing the concept of mistake-proofing, initially based on physical design, such as aerospace and automotive industry. The mistake-proofing concept may be applied to prevention, detection, and mitigation of errors. The forcing functions are a specific part of mistake-proofing: they prevent a wrong action or they force a virtuous one. Grout proposes a little shortcut to identify mistake-proofing devices: "If it is not possible to picture it in action, it is probably not a mistake-proofing device".

Failures may occur in each part of the medication use process. This study aimed to evaluate the barriers existing in hospital pharmacies in order to prevent medication errors and to help institutions to make improvement actions.Within the framework of the SECURIMED project, risk assessment visit (interviews, observations, analysis of adverse event scenario by professionals...) were conducted in volunteer hospital pharmacies. A restitution meeting, after visit in each pharmacy permitted exchanges between visitors and professionals on barriers and weaknesses and then on solutions to reduce identified risks.Twenty-one hospital pharmacies participated. Despite presence of safeguards in some pharmacies, many weaknesses were retrieved (multiplicity of process, lack of resources...) and clinical pharmacy was not enough developed.This project has led to an overview of the situation in Aquitaine, and created a regional dynamic to improve the medication system safety.

The organisations' performance is not restricted to economic criteria, it integrates other dimensions: social, safety, quality, environmental, ethical, scientific... There are few multicriteria design and management methods for organisations. In this article, we propose an analysis and modelling method of the values creation based on systematic approach. This method enables to integrate all the stakeholders' points of view and expectations in order to have a global vision of the performance. We have applied this method to one French Blood Establishment process.

Radiation therapy was one of the first medical specialties to implement quality assurance (QA) programs in clinical practice. These QA programs have mainly focused on equipment performance, neglecting human factors. Risk management is a relatively new approach in medical disciplines. Methods of evaluation and risk management must be identified, applied and adapted to the specificities of this domain. Based on the experience of industry, risk management will allow us to substantially improve safety and develop our own models of management. Recent experiences use these approaches to implement risk management in radiation therapy departments.

To deploy an inductive process for radiotherapy risk management in a regional cancer centre and to infer the actions required to solve the situations of criticality.Close collaboration between the department of radiation oncology-biophysics and the department of quality and risk management in the same institution allowed to create a multiprofessional and multidisciplinary task force and to make the experience feedback easier. A preliminary risk analysis method was used to identify the generic dangers, the mapping of risks and the specification of the scales of criticality. This method helped to evaluate and to rate each apprehended event. Four scales have been defined: seriousness scale in five levels, likelihood scale in five classes, endeavour scale in four levels and criticality scale in three categories: acceptable (criticality 1) tolerable under control (criticality 2) and unacceptable (criticality 3).Fifty-seven level 1 dangerous situations linked to 78 scenarios of criticality acceptable, tolerable and unacceptable in 24, 44 and 10 cases respectively have been identified in the department of radiotherapy leading to carry out 28 risk reduction actions.The performed risk analysis offered an original frame for a collective thinking among the care providers and contributed to modify their mode of conceiving both security and radioprotection. The study allowed us to give a relevant answer to the High Authority of Health and the Authority of Nuclear Security demands either in terms of efficient management of the risks in radiotherapy or regarding the daily concerns of the caregivers.

The Morbidity-Mortality Conference is a formalized exercise validated by the Haute Autorité de Santé (HAS) whose aim is to improve the quality and safety of care through periodic (weekly or monthly) analysis of deaths and complications. In France, no data is available concerning the implementation of the MMC methodology despite the interest of the National Institute of Healthcare Quality (HAS) in using the MMC as part of the physician recredentialling process and of hospital accreditation (mandatory in France since the laws of 2005 and 1997 respectively). We aimed to study the experience and perceptions of physicians with this specific methodology in the context of a large regional project aimed to improve clinical risk management.A one page questionnaire with eight confidential questions and a space for free commentary was sent to 150 hospitals in the north of France.We received 83 responses from 29 hospitals (range: 1-14 responses per hospital). Analysis of unexpected adverse events is performed mainly in informal meetings (76%) and mandatory reports (77%); the MMC methodology is rarely used (11%). The analysis of adverse events is considered to be an important tool for the improvement of patient care and safety (90%) and continuing education (61%), and it results in modification of care protocols (70%) or organizational change (71%). Lack of knowledge of the MMC methodology (66%) and lack of available time (50%) are the main obstacles to the adoption of the MMC. Fear that the findings of the MMC could be available for use in litigation (1%) was not an obstacle. Physicians interested in implementing the MMC are motivated by a desire for improved patient safety (86%) and care management on the surgical service (54%). Self-responsibility is more important than the mandatory process for re-credentialing.The implementation of the MMC requires specific measures such as teaching and support.

In medicine, as in oncological radiotherapy, as elsewhere, the precept of quality has no meaning if it is not defined. In France as everywhere radiotherapy has its forces and its weaknesses. As in every country, its future seems assured by its character cost effective as by its capacity to make progress in the triple point of view of its equipment, its professions and its organization. However, the French radiotherapy is in crisis. The professionals saw clearly. For more than 10 years they had recalled the medical authorities to their responsibilities concerning the demographic trends for the radiotherapists and the physicists, the renovation of the equipment, the modernization of the organizations, the promotion of the evaluation of procedures and outcomes and the development of a greater fairness in the financings. But the delay taken, the setting under pressure of the professionals by the State, its services, its agencies and the media following the recent accidents cause numerous perverse effects and worried the staff. The accident of Epinal was the starting fact of an effort of professionalisation of the risk management, but also of a disturbed period favourable with a certain confusion of minds, discouragement and protective behaviors. The risks felt by the professionals then seem especially to come from the authorities and the media. It appears that the topic of quality is at the center of all these speeches. Under this vocable, it is in fact the respect of the procedures related to the requirement of security which is privileged by the State and its representatives. The apparent security seems to override the real quality of the practices. Thus, time came for a clarification of the quality and security concepts, of organizations which contribute to it and for the development of a clear strategy bringing together the interprofessionnal actors. In this context, the implication of the College and especially of the Société française de radiothérapie oncologique is a requirement.

The recent increase in the incidence of severe anaphylaxis calls for continual assessment of risk factor and dangers associated with food allergy, keeping abreast of changes in the food industry. Allergologists, regulatory bodies and the food industry are all responsible for food safety. The Allergy Vigilance Network, founded by a university research team and comprising 398 French and Belgian allergologists, has developed a three-point strategy. First, reporting cases of severe anaphylaxis of document allergic origin makes it possible to monitor the prevalence of food allergens and to evaluate the quality of management of allergy-related emergencies, thus providing data suitable for estimating the economic burden of anaphylaxis. The second objective of the network is to set up multicenter trials to determine the prevalence of sensitization to risk allergens, such as peanut, lupin and plant pollen, of which transgenic varieties will soon emerge. The third objective is screening and long-term monitoring of dangers related to new foods, ingredients and adjuvant sensitizing factors. Post-marketing monitoring of potential allergic risks arising from genetically modified food is another aim of the network, together with the establishment of a serum bank, following WHO/FAO recommendations. The Allergy Vigilance Network, together with the French National Institute for Food Safety (AFSSA), the Ministry of Consumer Affairs (DGCCRF) and various patient associations, is striving to analyse and deal with dangers related to the allergenicity of natural and modified food proteins.

Safety of blood and its derivatives, with regards to the risk of transmission of infectious agents such as viruses or non conventional agents, relies on a series of general principles for which national and European guidance and regulations have been drawn and regularly updated. Three main criteria contribute to the safety of these products: knowledge and control of the quality of blood or plasma as the starting material, the efficiency of the manufacturing process to remove/inactivate adventitious agents, and the testing done during the production process. In addition, vigilance routinely exercised on the products used in daily practice increases the confidence in these health products.

The nosocomial pathology concept includes all the complications taking place while performing a prevention diagnosis or during a medical treatment, proved in relation with the treatment but independent from the original pathology and its course. This notion is acknowledged in the 2002-303 law which concerns the "medical accidents, iatrogenous disease and nosocomial infections" which aetiology and damages are being assessed in the same way by registered medical experts at country level Public and administrative liability relies on the proof of a prejudicial mistake. This mistake being a failure to comply with commitments and means to identify and limit potential risks as well as to limit access to the proved damage while complying with best practice rules and regulations in force. The security chain can be altered less by human failure (20%) than by a bad system organisation (80%). Security management is every one's concern among the medical team, the forensic mistake being a risk management failure.

International marketing of animals, animal products and food stuffs and the emergence or re-emergence of food poisoning has raised the risk of international transmission of certain infectious agents. Risk analysis, with its three components, assessment, management, and information, constitutes a new approach to state health policies. To guarantee health safety of the human, animal and plant populations, states can prohibit importation or marketing of food products if their decisions are based on open scientific evidence. Risk assessment is a structured open process evaluating available data designed to modelize transmission of the infectious agent integrating the different elements of the food chain from production to consumption. The assessment process involves four phases, The results of risk assessment depend on the pertinence and the quality of the data used for each of these four phases. Data required to implement risk assessment are unfortunately widely dispersed. The food and agriculture industry, official regulatory agencies, consumer watch organizations, and the scientific community all have useful information for risk assessment. The lack of standard methods to collect, process and diffuse data further complicates the problem.

As suggested by the National Blood Council, a Hemovigilance Committee was set up in the University Hospital of Liège in 1995. A multidisciplinary discussion takes place on any action aiming at the improvement of transfusion safety, and the follow-up of its implementation. The first issue to be discussed was the set up of a detailed documentation of all blood transfusions. The data are now recorded on a single document allowing proper identification of people and products involved, and of the eventual incidents. This document has lead to a better transfusion safety and to an improved administrative management of blood transfusion. The Commission has been coordinating two multi-centric studies analyzing the consumption of fresh blood products and the incidence of transfusion reactions. Among blood-saving policies, autologous transfusion and volume reduction of samples drawn for laboratory purposes have been discussed. Other measures were taken to improve the labeling of samples for cross-mach and to actively follow-up transfusion reactions. By its actions and advises, the Commission aims to direct strategies towards a safe and rational use of blood products.

To analyze retrospectively the data base of the French national vigilance reporting system concerning infusion devices during the year 1998.Each report has been reviewed and classified, except implantable catheter ports.The study included 309 reports. Among them, 28% concerned infusion pumps and 72% single use devices, i.e. catheters, infusion lines, taps, connectors, etc. We observed six deaths and 23 severe incidents. Only 25% of devices could be formally investigated by manufacturers. The origins of incidents were very different between infusion pumps and single use devices. The first showed simple failures, software errors, maintenance omissions or errors, and problems related to obsolescence of the device. The second revealed manufacturer quality insurance failures, design and utilization errors, and problems related to the technique itself rather than device.Our findings are similar to the few data available in international literature. They address the need to obtain an adequacy between the performances of devices which vary with generations of devices and the clinical risks: newest and safest devices should be preferred for the infusion of the most critical drugs.

A NEW DISCIPLINE: On January 4, 1993, the French parliament voted a law on Blood Transfusion Safety, creating a monitoring and warning system operating through a complex network and aimed at guaranteeing permanent efficacy, safety and efficiency of blood transfusion in France. A new discipline, blood monitoring was born. FUNDAMENTAL PRINCIPLES: Basically, blood monitoring is organized around two fundamental principles: blood products trackability from the donor to the recipient and mandatory reporting of all transfusion incidents. After a laborious development phase, the early results point out the immunological risk, particularly by ABO error, and the risk of bacterial contamination. AN EARLY WARNING SYSTEM: This blood monitoring system, whose primary purpose is to serve as an early warning device, must have the necessary tools to monitor, verify and analyze all available epidemiological data. Coordination of the blood monitoring system within the framework of the AFSSaPS (the French Agency for Sanitary Safety of Health Products) should enable it to fully reach this goal.

Les organisations de nature temporaire sont de plus en plus présentes dans le paysage industriel, y compris au sein d’environnements présentant des risques d’accidents majeurs. Or les recherches portant sur ce type d’organisation et leur sécurité s’avèrent rares dans la littérature en sciences de gestion. S’appuyant sur l’analyse qualitative du projet de rénovation d’un site classé Seveso, cet article tente de comprendre dans quelle mesure les organisations temporaires présentent des caractéristiques organisationnelles qui peuvent peser sur la sécurité industrielle et quelles réponses peuvent y être apportées., Temporary organizations are increasingly present in the industrial landscape, including in dangerous environments. However, little research in Management Sciences has been done on them and on their relative safety. This article presents the results of a qualitative analysis carried out on a gas storage renovation project, located on an industrial site classified as Seveso. It attempts to understand to what extent temporary organizations have organizational characteristics that can impact industrial safety and what responses can be made to them., Las organizaciones temporales están cada vez más presentes en la industria, incluso en entornos donde los riesgos de accidentes pueden ser muy graves. Sin embargo, hay poca investigación en Ciencias de la Gestión sobre este tipo de organización y su seguridad. Basado en el análisis cualitativo de un proyecto de renovación en un sitio clasificado como Seveso, este artículo intenta comprender cuáles son las características organizativas de las organizaciones temporales, cómo esas podrían afectar la seguridad industrial y qué tipo de respuestas se les puede dar.