Infantile hemangioma (IH) is the most common benign vascular tumor in infants. Clinically, the lesion may have a superficial (red) and/or deep (flesh-colored–underlying bluish appearance) component and may be located in all areas of the body, including the mucosa. It is important to be familiar with this entity, given its frequency, in order to quickly reassure parents. This makes it easier to know when to refer the child to an expert Centre in order to introduce treatment, or when a syndromic form is suspected.
Most IH do not require treatment as they resolve spontaneously. Those at risk for significant sequelae must be treated. Until 2008 the first-line treatment was high-dose systemic corticosteroid. The French discovery of the spectacular efficacy of propranolol in preventing the growth of this tumor has changed the recommendations and propranolol is now proposed as the first-line treatment to be started as soon as possible.
{"title":"Diagnosis and management of infantile hemangiomas: Tremendous advances over the last 15 years","authors":"Dorine Canu , Sorilla Mary-Prey , Christine Leauté-Labreze","doi":"10.1016/j.lpm.2025.104291","DOIUrl":"10.1016/j.lpm.2025.104291","url":null,"abstract":"<div><div>Infantile hemangioma (IH) is the most common benign vascular tumor in infants. Clinically, the lesion may have a superficial (red) and/or deep (flesh-colored–underlying bluish appearance) component and may be located in all areas of the body, including the mucosa. It is important to be familiar with this entity, given its frequency, in order to quickly reassure parents. This makes it easier to know when to refer the child to an expert Centre in order to introduce treatment, or when a syndromic form is suspected.</div><div>Most IH do not require treatment as they resolve spontaneously. Those at risk for significant sequelae must be treated. Until 2008 the first-line treatment was high-dose systemic corticosteroid. The French discovery of the spectacular efficacy of propranolol in preventing the growth of this tumor has changed the recommendations and propranolol is now proposed as the first-line treatment to be started as soon as possible.</div></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"54 3","pages":"Article 104291"},"PeriodicalIF":3.2,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144187826","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-09DOI: 10.1016/j.lpm.2025.104279
Cédric Carbonneil , Corinne Collignon , Hubert Galmiche , Andrea Lasserre , Charlotte Masia , Floriane Pelon
Background
In France, health technologies can be reimbursed by the national health insurance system. However, not all are eligible, and several steps are required. This article aims at deciphering the various procedures involved.
Methods
We first described the most common steps for reimbursement procedures, from authorisation to health technology assessment, including clinical evaluation and reimbursement decision. We then discussed certain specificities related to the nature of the health technologies (for example, vaccines among drugs, or digital medical devices (DMDs) among medical devices), and to the status of the procedure (derogatory vs. standard).
Findings
France benefits from several procedures aimed at reimbursing health products, and their number is increasing over time. They all share one common step, assessment, which is systematically performed from a clinical perspective and sometimes includes an organisational or an economic viewpoint, by a single actor: the French National Authority for Health (Haute Autorité de santé, HAS).
Conclusion and relevance
HAS evaluations are essential tools for informing healthcare decision-making, and ensuring that patients have access to safe, effective, and affordable treatments. The system will have to face new challenges in the coming years: the European regulation will pool certain procedural steps, there will be more self-directed DMDs on the market and new organizations set up to support innovation as well as scarce human and financial resources. Ultimately, it is all about constantly adapting to meet patients' needs, introducing new health technologies that offer added value and limited risks, while making the best possible use of available resources.
背景在法国，医疗技术可以由国家医疗保险系统报销。然而，并不是所有的都符合条件，需要几个步骤。本文旨在解读所涉及的各种程序。方法我们首先描述了报销程序中最常见的步骤，从授权到卫生技术评估，包括临床评估和报销决策。然后，我们讨论了与卫生技术的性质（例如，药物中的疫苗，或医疗设备中的数字医疗设备（dmd））以及程序状态（贬损与标准）相关的某些特殊性。调查结果：法国受益于几项旨在报销医疗产品的程序，而且这些程序的数量正随着时间的推移而增加。它们都有一个共同的步骤，即评估，这是从临床角度系统地进行的，有时包括组织或经济观点，由一个行动者：法国国家卫生管理局（Haute autorit de sant， HAS）。结论和相关has评估是告知医疗保健决策的重要工具，并确保患者获得安全、有效和负担得起的治疗。该系统将在未来几年面临新的挑战：欧洲法规将汇集某些程序步骤，市场上将出现更多自主的dmd，建立新的组织来支持创新以及稀缺的人力和财政资源。最终，这一切都是为了不断适应以满足患者的需求，引入提供附加值和风险有限的新卫生技术，同时尽可能充分利用现有资源。
{"title":"French reimbursement of health technologies: assessment is at the heart of the procedure","authors":"Cédric Carbonneil , Corinne Collignon , Hubert Galmiche , Andrea Lasserre , Charlotte Masia , Floriane Pelon","doi":"10.1016/j.lpm.2025.104279","DOIUrl":"10.1016/j.lpm.2025.104279","url":null,"abstract":"<div><h3>Background</h3><div>In France, health technologies can be reimbursed by the national health insurance system. However, not all are eligible, and several steps are required. This article aims at deciphering the various procedures involved.</div></div><div><h3>Methods</h3><div>We first described the most common steps for reimbursement procedures, from authorisation to health technology assessment, including clinical evaluation and reimbursement decision. We then discussed certain specificities related to the nature of the health technologies (for example, vaccines among drugs, or digital medical devices (DMDs) among medical devices), and to the status of the procedure (derogatory vs. standard).</div></div><div><h3>Findings</h3><div>France benefits from several procedures aimed at reimbursing health products, and their number is increasing over time. They all share one common step, assessment, which is systematically performed from a clinical perspective and sometimes includes an organisational or an economic viewpoint, by a single actor: the French National Authority for Health (Haute Autorité de santé, HAS).</div></div><div><h3>Conclusion and relevance</h3><div>HAS evaluations are essential tools for informing healthcare decision-making, and ensuring that patients have access to safe, effective, and affordable treatments. The system will have to face new challenges in the coming years: the European regulation will pool certain procedural steps, there will be more self-directed DMDs on the market and new organizations set up to support innovation as well as scarce human and financial resources. Ultimately, it is all about constantly adapting to meet patients' needs, introducing new health technologies that offer added value and limited risks, while making the best possible use of available resources.</div></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"54 2","pages":"Article 104279"},"PeriodicalIF":3.2,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143916741","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
To accelerate the availability of innovative healthcare technologies for patients with the potential for significant clinical benefits in a context of high unmet needs, derogatory programs have been elaborated. The aim of this paper is to describe the different pathways developed in France to accelerate access to innovation, efficiently handle uncertainties while controlling the risks for patients.
Methods
We first describe the different early and temporary accesses to innovation in France involving the HAS. Feedback on these pathways based on the decisions provided by the HAS up until June 2024, is summarised and discussed. Subsequent emphasis is placed on the challenges of the evaluation process.
Findings
French derogatory pathways for innovation distinguish between medicinal products, medical devices (MDs) and procedures, as well as the funding mechanism. Early funding is dedicated to MDs, in vitro diagnostic MDs and procedures. Later fast-track access is dedicated to medicinal products but also to (digital) MDs. Based on the submitted files from 2015 to 2021, the derogatory access was approved about 70% for medicinal products and 30% for MDs/procedures.
Conclusions and Relevance
While fast-track processes appear widely used and understood for medicinal products, the different pathways available for MDs and procedures remain under-used and sometimes misunderstood. Whichever the product, the main limitation factor of approval was data quality and maturity, in concordance with reports on accelerated approvals from the FDA. The main challenge is to find the right balance between rapid access to innovation and patient safety, while addressing ethical challenges posed by new therapeutic approaches.
{"title":"French evaluation of innovative health technologies: Early access and fundings","authors":"Capucine Serain , Sylvie Chevret , Yann Chambon , Vanessa Hernando , Françoise Lucet , Samuel Seksik , Hassan Serrier , Elodie Velzenberger Maquart , Pierre Cochat","doi":"10.1016/j.lpm.2025.104284","DOIUrl":"10.1016/j.lpm.2025.104284","url":null,"abstract":"<div><h3>Background</h3><div>To accelerate the availability of innovative healthcare technologies for patients with the potential for significant clinical benefits in a context of high unmet needs, derogatory programs have been elaborated. The aim of this paper is to describe the different pathways developed in France to accelerate access to innovation, efficiently handle uncertainties while controlling the risks for patients.</div></div><div><h3>Methods</h3><div>We first describe the different early and temporary accesses to innovation in France involving the HAS. Feedback on these pathways based on the decisions provided by the HAS up until June 2024, is summarised and discussed. Subsequent emphasis is placed on the challenges of the evaluation process.</div></div><div><h3>Findings</h3><div>French derogatory pathways for innovation distinguish between medicinal products, medical devices (MDs) and procedures, as well as the funding mechanism. Early funding is dedicated to MDs, in vitro diagnostic MDs and procedures. Later fast-track access is dedicated to medicinal products but also to (digital) MDs. Based on the submitted files from 2015 to 2021, the derogatory access was approved about 70% for medicinal products and 30% for MDs/procedures.</div></div><div><h3>Conclusions and Relevance</h3><div>While fast-track processes appear widely used and understood for medicinal products, the different pathways available for MDs and procedures remain under-used and sometimes misunderstood. Whichever the product, the main limitation factor of approval was data quality and maturity, in concordance with reports on accelerated approvals from the FDA. The main challenge is to find the right balance between rapid access to innovation and patient safety, while addressing ethical challenges posed by new therapeutic approaches.</div></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"54 2","pages":"Article 104284"},"PeriodicalIF":3.2,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143924138","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-07DOI: 10.1016/j.lpm.2025.104283
Maxence Lyonnet , Robert Gelli , Hubert Galmiche
The HAS is unique in France due to its status as an independent public authority. Its closest equivalent is the National Institute for Health and Care Excellence (NICE) in England and Wales. It stands out from other French health agencies by its independence and wide scope, covering health and the social and medico-social sectors. Its independence, guaranteed by law, is combined with regular dialogue with public authorities and external partners. Independence does not come without accountability; it must report its actions to the state and its control bodies (Parliament ant Justice in particular) and more broadly to society and health actors. Scientific rigor, independence, and transparency are at the heart of its values. The 2011 health law, adopted following the French Mediator scandal, established a common legal framework for preventing conflicts of interest in health. The has also developed its own complementary prevention tools. It ensures that the composition of its expert committees balances different schools of thought. In terms of transparency, the HAS publishes all its opinions and decisions, as well as methodological and practical guides. In a demanding context where scientific expertise is particularly scrutinized and the risk of a health crisis, such as Covid-19, is imminent, the HAS must maintain the highest standards of conflict of interest prevention and transparency. This is essential for the quality of expertise and public trust.
{"title":"Taking ethics into account: the HAS perspective","authors":"Maxence Lyonnet , Robert Gelli , Hubert Galmiche","doi":"10.1016/j.lpm.2025.104283","DOIUrl":"10.1016/j.lpm.2025.104283","url":null,"abstract":"<div><div>The HAS is unique in France due to its status as an independent public authority. Its closest equivalent is the National Institute for Health and Care Excellence (NICE) in England and Wales. It stands out from other French health agencies by its independence and wide scope, covering health and the social and medico-social sectors. Its independence, guaranteed by law, is combined with regular dialogue with public authorities and external partners. Independence does not come without accountability; it must report its actions to the state and its control bodies (Parliament ant Justice in particular) and more broadly to society and health actors. Scientific rigor, independence, and transparency are at the heart of its values. The 2011 health law, adopted following the French Mediator scandal, established a common legal framework for preventing conflicts of interest in health. The has also developed its own complementary prevention tools. It ensures that the composition of its expert committees balances different schools of thought. In terms of transparency, the HAS publishes all its opinions and decisions, as well as methodological and practical guides. In a demanding context where scientific expertise is particularly scrutinized and the risk of a health crisis, such as Covid-19, is imminent, the HAS must maintain the highest standards of conflict of interest prevention and transparency. This is essential for the quality of expertise and public trust.</div></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"54 2","pages":"Article 104283"},"PeriodicalIF":3.2,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143924137","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-07DOI: 10.1016/j.lpm.2025.104282
Judith Fernandez, Paul de Boissieu, Margaret Galbraith
Health Technology Assessment (HTA) is a multidisciplinary process that evaluates the medical, social, economic, legal, and ethical aspects of health technologies to determine their value throughout their lifecycle. With rising healthcare costs in Europe, robust HTA processes are crucial for making informed decisions that promote an equitable and efficient health system. HTA practices date back to 1967 in France and have expanded across Europe, with most countries adopting HTA models to guide pricing and reimbursement decisions. An analysis of European Health Technology Assessment bodies (HTAb) was conducted through an online survey to showcase the diversity of HTA systems while highlighting their shared goals. The survey, sent to 33 HTAb from July 8 to August 25, 2024, included 11 multiple-choice questions about their organization and processes, allowing for optional free text responses. Data collected were self-reported and analysed using descriptive statistics, with minimal verification of responses. Despite some differences in remit and scope, European HTAb remain steadfast in their resolve to collaborate. The European Commission and EU member states have fostered collaboration among HTA bodies through initiatives like EUnetHTA, culminating in the adoption of the HTA Regulation (EU) 2021/2282, which will be implemented starting January 12, 2025 with the production on joint clinical assessment and joint scientific consultation for some medicinal products and high-risk medical devices. The HTAR offers numerous opportunities for collaboration. Joint productions will foster a culture of mutual learning, allowing countries to benefit from shared expertise and data while ensuring the rigorous and transparent assessment of new health technologies. Moreover, a more unified approach to HTA could accelerate the adoption of new and effective technologies at the continental level, ultimately improving patient outcomes across Europe.
{"title":"Health technology assessment in Europe: A comparison of organizations and introduction to the European regulation","authors":"Judith Fernandez, Paul de Boissieu, Margaret Galbraith","doi":"10.1016/j.lpm.2025.104282","DOIUrl":"10.1016/j.lpm.2025.104282","url":null,"abstract":"<div><div>Health Technology Assessment (HTA) is a multidisciplinary process that evaluates the medical, social, economic, legal, and ethical aspects of health technologies to determine their value throughout their lifecycle. With rising healthcare costs in Europe, robust HTA processes are crucial for making informed decisions that promote an equitable and efficient health system. HTA practices date back to 1967 in France and have expanded across Europe, with most countries adopting HTA models to guide pricing and reimbursement decisions. An analysis of European Health Technology Assessment bodies (HTAb) was conducted through an online survey to showcase the diversity of HTA systems while highlighting their shared goals. The survey, sent to 33 HTAb from July 8 to August 25, 2024, included 11 multiple-choice questions about their organization and processes, allowing for optional free text responses. Data collected were self-reported and analysed using descriptive statistics, with minimal verification of responses. Despite some differences in remit and scope, European HTAb remain steadfast in their resolve to collaborate. The European Commission and EU member states have fostered collaboration among HTA bodies through initiatives like EUnetHTA, culminating in the adoption of the HTA Regulation (EU) 2021/2282, which will be implemented starting January 12, 2025 with the production on joint clinical assessment and joint scientific consultation for some medicinal products and high-risk medical devices. The HTAR offers numerous opportunities for collaboration. Joint productions will foster a culture of mutual learning, allowing countries to benefit from shared expertise and data while ensuring the rigorous and transparent assessment of new health technologies. Moreover, a more unified approach to HTA could accelerate the adoption of new and effective technologies at the continental level, ultimately improving patient outcomes across Europe.</div></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"54 2","pages":"Article 104282"},"PeriodicalIF":3.2,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143942793","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-05DOI: 10.1016/j.lpm.2025.104281
Joachim Baba , Nathan Guerrier , Irena Guzina , Vanessa Hernando , Vassilia Ressencourt , Ivana Spasojevic , Dominic Thorrington , Charlotte Masia
Context
The Haute Autorité de Santé (HAS) is an independent body responsible for advising the government on the appropriateness of national funding for healthcare technologies and interventions. To fulfil this role, HAS evaluates their efficacy and safety, especially in comparison to existing alternatives.
Methods
We first described how the HAS is organised to carry out this mission, then outlined the different stages of the evaluation process, highlighting specific features according to the type of health technology being assessed We also reviewed the HAS's activities for 2023.
Results
The HAS relies on international methodological standards to assess health technologies and interventions, on the expertise of healthcare professionals and patient experiences, and input from various stakeholders where appropriate and necessary.
Conclusion
Through this rigorous, independent, and transparent scientific evaluation process, the HAS aims to ensure that patients have access to the best available treatments and care, and, when relevant, to the most efficient options for the French healthcare system, while guaranteeing patient safety.
{"title":"The French way of HTA: Between scientific rigor, independence and transparency","authors":"Joachim Baba , Nathan Guerrier , Irena Guzina , Vanessa Hernando , Vassilia Ressencourt , Ivana Spasojevic , Dominic Thorrington , Charlotte Masia","doi":"10.1016/j.lpm.2025.104281","DOIUrl":"10.1016/j.lpm.2025.104281","url":null,"abstract":"<div><h3>Context</h3><div>The Haute Autorité de Santé (HAS) is an independent body responsible for advising the government on the appropriateness of national funding for healthcare technologies and interventions. To fulfil this role, HAS evaluates their efficacy and safety, especially in comparison to existing alternatives.</div></div><div><h3>Methods</h3><div>We first described how the HAS is organised to carry out this mission, then outlined the different stages of the evaluation process, highlighting specific features according to the type of health technology being assessed We also reviewed the HAS's activities for 2023.</div></div><div><h3>Results</h3><div>The HAS relies on international methodological standards to assess health technologies and interventions, on the expertise of healthcare professionals and patient experiences, and input from various stakeholders where appropriate and necessary.</div></div><div><h3>Conclusion</h3><div>Through this rigorous, independent, and transparent scientific evaluation process, the HAS aims to ensure that patients have access to the best available treatments and care, and, when relevant, to the most efficient options for the French healthcare system, while guaranteeing patient safety.</div></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"54 2","pages":"Article 104281"},"PeriodicalIF":3.2,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143804102","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Heath Technology Assessment (HTA) is mainly used for reimbursement/disinvestment and access to innovation purposes. In addition, HTA is a useful tool to promote appropriateness of care, as it describes the updated level of validation of assessed health technologies. Thus, several tools (proper use sheets, drug-indexed decision support systems, supervision of practices or use) based on HTA are developed to promote the appropriateness of use of drugs, medical devices or diagnostic and therapeutic procedures among healthcare professionals.
HTA can also support the development and the update of clinical practice guidelines (CPG) which are the main tool of clinical practice improvement. In addition, HTA can increase CPG implementation through reimbursement of recommended health technologies. Therefore, HTA and CPGs can be perfectly articulated to enable synergistic synchronic or asynchronic action to improve the relevance of care by enabling more dynamic and efficient actions, particularly in terms of robustness and updating.
However, HTA shares with CPGs the same difficulties of implementation in the field. To face them, whatever the implementation strategy defined, it requires a multifaceted approach involving iterative communication and the involvement of healthcare professionals, patients and stakeholders, both upstream and downstream of the HTA stages.
{"title":"French HTA and appropriateness of care: Beyond reimbursement","authors":"Sophie Blanchard , Valérie Lindecker-Cournil , Bertrand Mussetta , Fréderic Nahmias , Cédric Carbonneil","doi":"10.1016/j.lpm.2025.104280","DOIUrl":"10.1016/j.lpm.2025.104280","url":null,"abstract":"<div><div>Heath Technology Assessment (HTA) is mainly used for reimbursement/disinvestment and access to innovation purposes. In addition, HTA is a useful tool to promote appropriateness of care, as it describes the updated level of validation of assessed health technologies. Thus, several tools (proper use sheets, drug-indexed decision support systems, supervision of practices or use) based on HTA are developed to promote the appropriateness of use of drugs, medical devices or diagnostic and therapeutic procedures among healthcare professionals.</div><div>HTA can also support the development and the update of clinical practice guidelines (CPG) which are the main tool of clinical practice improvement. In addition, HTA can increase CPG implementation through reimbursement of recommended health technologies. Therefore, HTA and CPGs can be perfectly articulated to enable synergistic synchronic or asynchronic action to improve the relevance of care by enabling more dynamic and efficient actions, particularly in terms of robustness and updating.</div><div>However, HTA shares with CPGs the same difficulties of implementation in the field. To face them, whatever the implementation strategy defined, it requires a multifaceted approach involving iterative communication and the involvement of healthcare professionals, patients and stakeholders, both upstream and downstream of the HTA stages.</div></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"54 2","pages":"Article 104280"},"PeriodicalIF":3.2,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143804101","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-04DOI: 10.1016/j.lpm.2025.104277
Patrick Berche
The occurrence of laboratory-associated infections, which are caused by the handling of human or animal pathogens, represents a significant threat to the health and safety of laboratory workers and the general population. Such risks are present in clinical diagnostic and research laboratories, including those utilizing biotechnology on pathogenic organisms and industrial laboratories engaged in vaccine production. The investigation of these incidents is based on a retrospective analysis of published reports and voluntary questionnaires. The precise level of risk is challenging to ascertain, given the lack of a mandatory reporting system in the majority of countries. This indicates that many event involving exposure to contamination are not reported. The pathogens encountered in the primary published series include bacteria (e.g., Brucella spp., Mycobacterium tuberculosis, Salmonella spp., Shigella spp., Neisseria meningitidis, Coxiella burnetii), viruses (e.g., HBV, HCV, HIV, SARS-CoV-1, VEEV), and particularly dangerous viruses (e.g., hantavirus, filovirus, arenavirus), and less frequently fungi, parasites, and prions. Approximately 70% of these incidents are attributable to human errors. The primary modes of contamination are inhalation of aerosols and accidental parenteral injections. Additionally, contamination may occur during the handling of pathogens and the decontamination of waste, as well as during the inactivation processes of mass cultures utilized in vaccine production. It is therefore imperative that any incident or accident linked to contact with pathogens in laboratories be made compulsory to report. This will facilitate the systematic monitoring of these infections and data analysis for educational purposes, thereby enhancing prevention of laboratory accidents and leaks.
{"title":"Laboratory-associated infections and biosafety","authors":"Patrick Berche","doi":"10.1016/j.lpm.2025.104277","DOIUrl":"10.1016/j.lpm.2025.104277","url":null,"abstract":"<div><div>The occurrence of laboratory-associated infections, which are caused by the handling of human or animal pathogens, represents a significant threat to the health and safety of laboratory workers and the general population. Such risks are present in clinical diagnostic and research laboratories, including those utilizing biotechnology on pathogenic organisms and industrial laboratories engaged in vaccine production. The investigation of these incidents is based on a retrospective analysis of published reports and voluntary questionnaires. The precise level of risk is challenging to ascertain, given the lack of a mandatory reporting system in the majority of countries. This indicates that many event involving exposure to contamination are not reported. The pathogens encountered in the primary published series include bacteria (<em>e.g., Brucella</em> spp.<em>, Mycobacterium tuberculosis, Salmonella</em> spp.<em>, Shigella</em> spp.<em>, Neisseria meningitidis, Coxiella burnetii)</em>, viruses (<em>e.g.,</em> HBV, HCV, HIV, SARS-CoV-1, VEEV), and particularly dangerous viruses (<em>e.g.,</em> hantavirus, filovirus, arenavirus), and less frequently fungi, parasites, and prions. Approximately 70% of these incidents are attributable to human errors. The primary modes of contamination are inhalation of aerosols and accidental parenteral injections. Additionally, contamination may occur during the handling of pathogens and the decontamination of waste, as well as during the inactivation processes of mass cultures utilized in vaccine production. It is therefore imperative that any incident or accident linked to contact with pathogens in laboratories be made compulsory to report. This will facilitate the systematic monitoring of these infections and data analysis for educational purposes, thereby enhancing prevention of laboratory accidents and leaks.</div></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"55 3","pages":"Article 104277"},"PeriodicalIF":3.4,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143796219","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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