Approbation, mise en marché et surveillance après mise en marché des dispositifs médicaux à risque élevé : examen des enjeux socio-éthiques

La littérature abordant les enjeux socio-éthiques et réglementaires associés aux médicaments est relativement abondante, ce qui n’est pas le cas des dispositifs médicaux (DM). Ce dernier secteur couvre une très large diversité de produits qui servent à de multiples applications: diagnostic, traitement, gestion des symptômes de certaines conditions physiques ou psychiatriques, restauration d’une fonction débilitante, chirurgie, etc. À tort, on a tendance à croire que les DM sont réglementés de la même manière que les médicaments, que ce soit pour les exigences concernant leur mise en marché ou des pratiques de surveillance après mise en marché. Or, au cours des dernières années, leur usage élargi, leur impact sur les coûts des soins de santé, et les rappels majeurs dont certains ont fait l’objet ont commencé à inquiéter la communauté médicale et de nombreux chercheurs. Ils interpellent les autorités réglementaires à exercer une plus grande vigilance tant au niveau de l’évaluation des nouveaux DM à risque élevé avant leur mise en marché, que dans les pratiques de surveillance après mise en marché. Une stratégie plus rigoureuse d’évaluation des nouveaux DM permettrait d’assurer un meilleur suivi des risques associés à leur utilisation, de saisir la portée des divers enjeux socio-éthiques découlant de l’utilisation de certains DM, et de préserver la confiance du public. D’emblée, il faut savoir que les autorités nationales n’ont pas pour mandat d’évaluer la portée des enjeux socio-éthiques, ou encore les coûts des DM qui font l’objet d’une demande de mise en marché. Cette évaluation est essentiellement basée sur une analyse des rapports risques-bénéfices générés par l’usage du DM pour une indication donnée. L’évaluation des impacts socio-éthiques et l’analyse coûts-bénéfices relèvent des agences d’Évaluation des technologies de santé (ÉTS). Notre recherche montre que les DM sont non seulement peu fréquemment évalués par les agences d’ÉTS, mais l’examen des enjeux socio-éthiques est trop souvent encore incomplet. En fait, les recommandations des rapports d’ÉTS sont surtout fondées sur une analyse coûts-bénéfices. Or, le secteur des DM à risque élevé est particulièrement problématique. Plusieurs sont non seulement porteurs de risques pour les patients, mais leur utilisation élargie comporte des impacts importants pour les systèmes de santé. Nous croyons que le Principisme, au cœur de l’éthique biomédicale, que ce soit au plan de l’éthique de la recherche que de l’éthique clinique, constitue un outil pour faciliter la reconnaissance et l’examen, particulièrement par les agences d’ÉTS, des enjeux socio-éthiques en jeu au niveau des DM à risque élevé. Également, le Principe de Précaution pourrait aussi servir d’outil, particulièrement au sein des agences nationales de réglementation, pour mieux cerner, reconnaître, analyser et gérer les risques associés à l’évaluation et l’utilisation de ce type de DM. Le Principisme et le Principe de Précaution pourraient servir de repères 1) pour définir les mesures nécessaires pour éliminer les lacunes observées dans pratiques associées aux processus de réglementation, et 2) pour mieux cerner et documenter les enjeux socio-éthiques spécifiques aux DM à risque élevé.

Managing the risks of medical technology: Do hazard surveillance systems provide an early warning of medical device problems?

The Food and Drug Administration (FDA) is responsible for risk assessment and risk management in the post-market surveillance of the U.S. medical device industry. One of the FDA regulatory mechanisms, the Medical Device Reporting System (MDR) is an adverse event reporting system intended to provide the FDA with advance warning of device problems. It includes voluntary reporting for individuals, and mandatory reporting for device manufacturers. ^ In a study of alleged breast implant safety problems, this research examines the organizational processes by which the FDA gathers data on adverse events and uses adverse event reporting systems to assess and manage risk. The research reviews the literature on problem recognition, risk perception, and organizational learning to understand the influence highly publicized events may have on adverse event reporting. Understanding the influence of an environmental factor, such as publicity, on adverse event reporting can provide insight into the question of whether the FDA's adverse event reporting system operates as an early warning system for medical device problems. ^ The research focuses on two main questions. The first question addresses the relationship between publicity and the voluntary and mandatory reporting of adverse events. The second question examines whether government agencies make use of these adverse event reports. ^ Using quantitative and qualitative methods, a longitudinal study was conducted of the number and content of adverse event reports regarding breast implants filed with the FDA's medical device reporting system during 1985–1991. To assess variation in publicity over time, the print media were analyzed to identify articles related to breast implant failures. ^ The exploratory findings suggest that an increase in media activity is related to an increase in voluntary reporting, especially following periods of intense media coverage of the FDA. However, a similar relationship was not found between media activity and manufacturers' mandatory adverse event reporting. A review of government committee and agency reports on the FDA published during 1976–1996 produced little evidence to suggest that publicity or MDR information contributed to problem recognition, agenda setting, or the formulation of policy recommendations. ^ The research findings suggest that the reporting of breast implant problems to FDA may reflect the perceptions and concerns of the reporting groups, a barometer of the volume and content of media attention. ^

Tuoteturvallisuusriskien hallinta suorituskyvyn johtamisen tukena sähkö- ja elektroniikkateollisuudessa

Eurooppalaisia ja suomalaisia markkinavalvontatilastoja tutkimalla havaitaan, ettei tuoteturvallisuuden hallinta ole itsestään selvää sähkö- ja elektroniikka-alalla. Vuodesta 2000 maaliskuuhun 2006Euroopan markkinoilla havaittiin 3040 vaarallista kuluttajien käyttöön tarkoitettua sähkötuotetta. Työn päätavoitteena on selvittää, miten tuoteturvallisuusriskien hallinta kytkeytyy yrityksen suorituskyvyn johtamiseen. Työssä on käytetty konstruktiivista tutkimusotetta. Aineistopohjaisen analyysin avulla kartoitetaan suorituskyvyn johtamisen teoriaa, suorituskyvyn käytännön mittaamista pienissä ja keskisuurissa yrityksissä sekä tuoteturvallisuusriskejä jariskienhallinnan periaatteita. Lisäksi kartoitetaan lainsäädännön vaatimuksia, tuotesuunnittelua, valmistusta ja osaamista sekä tarkastellaan tuoteturvallisuuden viranomaisvalvonnan tuloksia. Tutkimuksessa analysoidaan kirjallisuutta ja tilastoja etsien tuoteriskien hallinnan ja suorituskyvyn johtamisen välistä yhteyttä. Analyysiä täydennetään tutkimuksen tekijän kokemuksella tuoteturvallisuuden testauksesta ja sertifioinnista, standardisoimistyöstä sekä tuoteturvallisuuden viranomaisvalvonnasta. Riskienhallinta muodostaa parhaimmillaan osan yrityksen johtamis- ja hallintakäytäntöä. Tuoteturvallisuusriskien hallinta on yrityksen strateginen päätös, joka tukee suorituskyvyn johtamista. Työssämallinnetaan kolme toimintatapaa, joilla eri kehitysvaiheessa olevat sähkö- ja elektroniikkateollisuuden valmistajat voivat hallita tuoteturvallisuusriskejään.Työssä kootaan yhteen tuoteturvallisuuden tekijöitä, jotka suorituskyvyn mittareissa monitoroivat tuoteriskien tilaa. Lisäksi kootaan yhteen riskienhallinnan kustannuksia, joilla yritys voi arvioida etukäteen kokonaiskustannuksia.

Vers un marché du carbone au Québec : éléments de réflexion à la lumière de l'analyse économique du droit

Dans le cadre de la Western Climate Iniative, le Québec a déployé en 2012, un système de plafonnement et d’échange de droits d’émission de gaz à effet de serre (SPEDE). Il s’agit de l’un des premiers régimes de ce type en Amérique du Nord et celui-ci pourrait à terme, constituer l'un des maillons d’un marché commun du carbone à l’échelle du continent. Toutefois, le SPEDE appartient à une catégorie d’instruments économiques de protection de l’environnement encore peu connue des juristes. Il s’inscrit en effet dans la régulation économique de l’environnement et repose sur des notions tirées de la théorie économique, dont la rareté, la propriété et le marché. La thèse s’insère donc dans le dialogue entre juristes et économistes autour de la conception et de la mise en œuvre de ce type d’instrument. Afin d’explorer son architecture et de révéler les enjeux juridiques qui le traversent, nous avons eu recours à la méthode de l’analyse économique du droit. Celle-ci permet notamment de montrer les dynamiques d'incitation et d’efficacité qui sont à l'œuvre dans les règles qui encadrent le SPEDE. Elle permet également à donner un aperçu du rôle décisif joué par la formulation des règles de droit dans l’opérationnalisation des hypothèses économiques sous-jacentes à cette catégorie d’instrument. L’exploration est menée par l’entremise d’une modélisation progressive de l’échange de droits d’émission qui prend en compte les coûts de transaction. Le modèle proposé dans la thèse met ainsi en lumière, de manière générale, les points de friction qui sont susceptibles de survenir aux différentes étapes de l'échange de droits d'émission et qui peuvent faire obstacle à son efficacité économique. L’application du modèle aux règles du SPEDE a permis de contribuer à l’avancement des connaissances en donnant aux juristes un outil permettant de donner une cohérence et une intelligibilité à l’analyse des règles de l’échange. Elle a ainsi fourni une nomenclature des règles encadrant l’échange de droits d’émission. Cette nomenclature fait ressortir les stratégies de diversification de l’échange, d’institutionnalisation de ses modalités ainsi que les enjeux de la surveillance des marchés, dont celui des instruments dérivés adossés aux droits d’émission, dans un contexte de fragmentation des autorités de tutelle.

Regulations on E-Commerce Consumer Protection Rules in China and Europe Compared – Same Same but Different?

This article provides a comprehensive overview of the regulations on e-commerce protection rules in China and the European Union. It starts by giving a general overview of different approaches towards consumer protection in e-commerce. This article then scrutinizes the current legal system in China by mainly focusing on SAIC’s “Interim Measures for the Administration of Online Commodity Trading and Relevant Service Activities”. The subsequent chapter covers the supervision of consumer protection in e-commerce in China, which covers both the regulatory objects of online commodity trading and the applied regulatory mechanisms. While the regulatory objects include operating agents, operating objects, operating behavior, electronic contracts, intellectual property and consumer protection, the regulatory mechanisms for e-commerce in China combines market mechanism and industry self-discipline under the government’s administrative regulation. Further, this article examines the current European legal system in online commodity trading. It outlines the aim and the scope of EU legislation in the respective field. Subsequently, the paper describes the European approach towards the supervision of consumer protection in e-commerce. As there is no central EU agency for consumer protection in e-commerce transactions, the EU stipulates a framework for Member States’ institutions, thereby creating a European supervisory network of Member States’ institutions and empowers private consumer organisations to supervise the market on their behalf. Moreover, the EU encourages the industry to self- or co-regulate e-commerce by providing incentives. Consequently, this article concludes that consumer protection may be achieved by different means and different systems. However, even though at first glance the Chinese and the European system appear to differ substantially, a closer look reveals tendencies of convergence between the two systems.

Ensayos de seguridad eléctrica orientados a la vigilancia del mercado

El presente estudio recopila los diferentes bancos de pruebas de EMC, Radio, SAR y seguridad eléctrica que se utiliza en la vigilancia del mercado. Describe las pruebas realizadas por el Estado español para llevar a cabo el seguimiento y control de los equipos vendidos. En primer lugar se presenta una descripción cualitativa de los ambientes clasificados por requisitos que explica en qué consisten las pruebas que se hacen, cómo se configura el entorno de medida y cuáles son los equipos que se deben utilizar. Está ilustrado con fotografías de los bastidores, antenas, amplificadores, generadores y otros equipos que la SETSI tiene en su laboratorio en El Casar (Guadalajara). La vigilancia de los equipos se realiza periódicamente en los estados miembros de la Unión Europea. Los funcionarios responsables también se reúnen periódicamente a nivel europeo para sacar conclusiones y hacer proyecciones futuras. El equipo adquirido en centros comerciales de venta al público, después de poco más de un mes, en el que se pasan las pruebas, vuelve a la cadena de comercialización, por lo que los dispositivos no se puedan dañar. Las pruebas realizadas en el laboratorio no pueden ser perjudiciales para los dispositivos por lo que es necesario tomar precauciones en la ejecución de las pruebas. El centro del PFC es el área de la Seguridad Eléctrica. El capítulo 4 es una reproducción de la Norma internacional IEC 60950-1:2007/A11 sobre seguridad en equipos de tecnología de la información adaptada a los requisitos de la vigilancia de mercado. Las autoridades competentes se basan en este estándar para evaluar y garantizar la seguridad del usuario en los equipos de consumo. Diseñados los procedimientos de ensayo y montado un banco de acuerdo a estos ensayos, se ha preparado un manual de operador, capítulo 5, en el que se recogen cada una de las pruebas y controles visuales que deben realizarse para probar que el equipo es conforme. Para finalizar, en el capítulo 6, se ejecutan ensayos de ejemplo sobre tres dispositivos de prueba y se elaboran las correspondientes hojas de ensayo. El propósito es proporcionar al operador un manual completo del banco de seguridad eléctrica, es por ello que en el manual de operador se han repetido muchos fragmentos de la norma para facilitar al operador el objetivo concreto de las pruebas y el acceso fácil a la información. This dissertation presents the different test benches of EMC, Radio, SAR and Electrical Safety that are used in market surveillance. Describes the tests performed by the Spanish State to carry out the monitoring and control of equipment sold. First a qualitative description of the environments classified by requisites that explains in that consist the tests that are make it, how it configures the measure environment and which are the equipment that it should use. It is illustrated with photographs of the racks, antennas, amplifiers, generators and other equipment that the S.E.T.S.I has in its laboratory on El Casar (Guadalajara). The surveillance of equipment is performed periodically in the member states of the European Union. Responsible officials also periodically meet at European level to draw conclusions and make future projections. The equipment purchased in malls public sale, after little more than a month, in which the tests are passed, returned to the trade chain, which is why the devices cannot be damaged. The tests done in the laboratory may not be harmful for devices are thus necessary to take precautions in the execution of the tests. The center of this dissertation is the area of Electrical Safety. Chapter 4 is a reproduction of the International Standard IEC 60950-1:2007/A11 safety in teams of information technology, adapted to the requirements of market surveillance. The competent authorities are based on this standard to assess and ensure the user's safety in the consumption equipment. Designed test procedures and mounted on a bench according to these tests, it has prepared a manual operator, in Chapter 5, with each of the tests and visual inspections in order to prove that the equipment complies. Finally, in Chapter 6, such tests run on three devices are developed test and test some leaves. The purpose of this book is to provide an operator manual of the bench of electrical safety, which is why the operator manual have been repeated fragments of the standard, in chapter 5, to facilitate the operator to test execution and access to information.

Evaluation of seafood quality market in Baixada Santista/SP

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

The Privacy Paradox: Privacy, Surveillance, and Encryption

Thesis (Master's)--University of Washington, 2016-08

The Burden Of Eclampsia: Results From A Multicenter Study On Surveillance Of Severe Maternal Morbidity In Brazil.

Maternal mortality (MM) is a core indicator of disparities in women's rights. The study of Near Miss cases is strategic to identifying the breakdowns in obstetrical care. In absolute numbers, both MM and occurrence of eclampsia are rare events. We aim to assess the obstetric care indicators and main predictors for severe maternal outcome from eclampsia (SMO: maternal death plus maternal near miss). Secondary analysis of a multicenter, cross-sectional study, including 27 centers from all geographic regions of Brazil, from 2009 to 2010. 426 cases of eclampsia were identified and classified according to the outcomes: SMO and non-SMO. We classified facilities as coming from low- and high-income regions and calculated the WHO's obstetric health indicators. SPSS and Stata softwares were used to calculate the prevalence ratios (PR) and respective 95% confidence interval (CI) to assess maternal characteristics, clinical and obstetrical history, and access to health services as predictors for SMO, subsequently correlating them with the corresponding perinatal outcomes, also applying multiple regression analysis (adjusted for cluster effect). Prevalence of and mortality indexes for eclampsia in higher and lower income regions were 0.2%/0.8% and 8.1%/22%, respectively. Difficulties in access to health care showed that ICU admission (adjPR 3.61; 95% CI 1.77-7.35) and inadequate monitoring (adjPR 2.31; 95% CI 1.48-3.59) were associated with SMO. Morbidity and mortality associated with eclampsia were high in Brazil, especially in lower income regions. Promoting quality maternal health care and improving the availability of obstetric emergency care are essential actions to relieve the burden of eclampsia.

Applying The Maternal Near Miss Approach For The Evaluation Of Quality Of Obstetric Care: A Worked Example From A Multicenter Surveillance Study.

To assess quality of care of women with severe maternal morbidity and to identify associated factors. This is a national multicenter cross-sectional study performing surveillance for severe maternal morbidity, using the World Health Organization criteria. The expected number of maternal deaths was calculated with the maternal severity index (MSI) based on the severity of complication, and the standardized mortality ratio (SMR) for each center was estimated. Analyses on the adequacy of care were performed. 17 hospitals were classified as providing adequate and 10 as nonadequate care. Besides almost twofold increase in maternal mortality ratio, the main factors associated with nonadequate performance were geographic difficulty in accessing health services (P < 0.001), delays related to quality of medical care (P = 0.012), absence of blood derivatives (P = 0.013), difficulties of communication between health services (P = 0.004), and any delay during the whole process (P = 0.039). This is an example of how evaluation of the performance of health services is possible, using a benchmarking tool specific to Obstetrics. In this study the MSI was a useful tool for identifying differences in maternal mortality ratios and factors associated with nonadequate performance of care.

[strategies For Integration Of Health Care Practices And Sanitary Surveillance In The Context Of The Implementation Of Rede Cegonha - A Brazilian Mother And Infant Health Care Network].

Mother and infant mortality has been the scope of analysis throughout the history of public health in Brazil and various strategies to tackle the issue have been proposed to date. The Ministry of Health has been working on this and the Rede Cegonha strategy is the most recent policy in this context. Given the principle of comprehensive health care and the structure of the Unified Health System in care networks, it is necessary to ensure the integration of health care practices, among which are the sanitary surveillance actions (SSA). Considering that the integration of health care practices and SSA can contribute to reduce mother and infant mortality rates, this article is a result of qualitative research that analyzed the integration of these actions in four cities in the State of São Paulo/Brazil: Campinas, Indaiatuba, Jaguariúna and Santa Bárbara D'Oeste. The research was conducted through interviews with SSA and maternal health managers, and the data were evaluated using thematic analysis. The results converge with other studies, identifying the isolation of health care practices and SSA. The insertion of SSA in collectively-managed areas appears to be a potential strategy for health planning and implementation of actions in the context under scrutiny.

Burden Of Focal Cryoablation Versus Brachytherapy Versus Active Surveillance In The Treatment Of Very Low-risk Prostate Cancer: A Preliminary Head-to-head Comprehensive Assessment.

Focal cryoablation (FC), brachytherapy (B) and active surveillance (AS) were offered to patients diagnosed with very low-risk prostate cancer (VLRPC) in an equal access protocol. Comprehensive validated self-report questionnaires accessed patients' erectile (IIEF-5) and voiding (IPSS) functions, Beck scales measured anxiety (BAI), hopelessness (BHS) and depression (BDI), SF-36 reflected patients' quality of life added to the emotional thermometers including five visual analogue scales (distress, anxiety, depression, anger and need for help). Kruskal-Wallis or ANOVA tests and Spearman's correlations were obtained among groups and studied variables. Thirty patients were included, median follow-up 18 months (15-21). Those on AS (n = 11) were older, presented higher hopelessness (BHS) and lower general health perceptions (SF-36) scores than patients opting for FC (n = 10) and B (n = 9), P = 0.0014, P = 0.0268 and P = 0.0168 respectively. Patients on B had higher IPSS scores compared to those under FC and AC, P = 0.0223. For all 30 included patients, Spearman's correlation (rs ) was very strong between BHS and general health perceptions (rs  = -0.800, P < 0.0001), and weak/moderate between age and BHS (rs  = 0.405, P = 0.026) and age and general health perceptions (rs  = -0.564, P = 0.001). The sample power was >60%. To be considered in patients' counselling and care, current study supports the hypothesis that even VLRPC when untreated undermines psychosocial domains.

Contribution Of Antepartum And Intrapartum Hemorrhage To The Burden Of Maternal Near Miss And Death In A National Surveillance Study.

To evaluate the occurrence of severe obstetric complications associated with antepartum and intrapartum hemorrhage among women from the Brazilian Network for Surveillance of Severe Maternal Morbidity. Multicenter cross-sectional study. Twenty-seven obstetric referral units in Brazil between July 2009 and June 2010. A total of 9555 women categorized as having obstetric complications. The occurrence of potentially life-threatening conditions, maternal near miss and maternal deaths associated with antepartum and intrapartum hemorrhage was evaluated. Sociodemographic and obstetric characteristics and the use of criteria for management of severe bleeding were also assessed in these women. The prevalence ratios with their respective 95% confidence intervals adjusted for the cluster effect of the design, and multiple logistic regression analysis were performed to identify factors independently associated with the occurrence of severe maternal outcome. Antepartum and intrapartum hemorrhage occurred in only 8% (767) of women experiencing any type of obstetric complication. However, it was responsible for 18.2% (140) of maternal near miss and 10% (14) of maternal death cases. On multivariate analysis, maternal age and previous cesarean section were shown to be independently associated with an increased risk of severe maternal outcome (near miss or death). Severe maternal outcome due to antepartum and intrapartum hemorrhage was highly prevalent among Brazilian women. Certain risk factors, maternal age and previous cesarean delivery in particular, were associated with the occurrence of bleeding.

Severe Maternal Morbidity And Near Miss Due To Postpartum Hemorrhage In A National Multicenter Surveillance Study.

To assess the occurrence of severe maternal complications owing to postpartum hemorrhage (PPH) and its associated factors. A secondary analysis of data from a multicenter cross-sectional prospective surveillance study included 9555 cases of severe maternal morbidity at 27 centers in Brazil between July 2009 and June 2010. Complications of PPH, conditions of severity management, and sociodemographic and obstetric characteristics were assessed. Factors independently associated with severe maternal outcome (SMO) were identified using multiple regression analysis. Overall, 1192 (12.5%) of the 9555 women experienced complications owing to PPH (981 had potentially life-threatening conditions, 181 maternal near miss, and 30 had died). The SMO ratio was 2.6 per 1000 live births among women with PPH and 8.5 per 1000 live births among women with other complications. Women with PPH had a higher risk of blood transfusion and return to the operating theater than did those with complications from other causes. Maternal age, length of pregnancy, previous uterine scar, and cesarean delivery were the main factors associated with an increased risk of SMO secondary to PPH. PPH frequently leads to severe maternal morbidity. A surveillance system can identify the main causes of morbidity and could help to improve care, especially among women identified as being at high risk of PPH.

Contribution Of Antepartum And Intrapartum Hemorrhage To The Burden Of Maternal Near Miss And Death In A National Surveillance Study

Objective To evaluate the occurrence of severe obstetric complications associated with antepartum and intrapartum hemorrhage among women from the Brazilian Network for Surveillance of Severe Maternal Morbidity.Design Multicenter cross-sectional study.Setting Twenty-seven obstetric referral units in Brazil between July 2009 and June 2010.Population A total of 9555 women categorized as having obstetric complications.Methods The occurrence of potentially life-threatening conditions, maternal near miss and maternal deaths associated with antepartum and intrapartum hemorrhage was evaluated. Sociodemographic and obstetric characteristics and the use of criteria for management of severe bleeding were also assessed in these women.Main outcome measures The prevalence ratios with their respective 95% confidence intervals adjusted for the cluster effect of the design, and multiple logistic regression analysis were performed to identify factors independently associated with the occurrence of severe maternal outcome.Results Antepartum and intrapartum hemorrhage occurred in only 8% (767) of women experiencing any type of obstetric complication. However, it was responsible for 18.2% (140) of maternal near miss and 10% (14) of maternal death cases. On multivariate analysis, maternal age and previous cesarean section were shown to be independently associated with an increased risk of severe maternal outcome (near miss or death).Conclusion Severe maternal outcome due to antepartum and intrapartum hemorrhage was highly prevalent among Brazilian women. Certain risk factors, maternal age and previous cesarean delivery in particular, were associated with the occurrence of bleeding.