13 results on '"MESH: Equipment and Supplies"'
Search Results
2. Effects of flow rate on the migration of different plasticizers from PVC infusion medical devices
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Lise Bernard, Teuta Eljezi, Hélène Clauson, Céline Lambert, Yassine Bouattour, Philip Chennell, Bruno Pereira, Valérie Sautou, ARMED Study Group, Institut de Chimie de Clermont-Ferrand (ICCF), SIGMA Clermont (SIGMA Clermont)-Institut de Chimie du CNRS (INC)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), CHU Clermont-Ferrand, Service Pharmacie [CHU Clermont-Ferrand], CHU Louise Michel [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], and CHU Clermont-Ferrand-CHU Louise Michel [Clermont-Ferrand]
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Contact time ,Polymers ,[SDV]Life Sciences [q-bio] ,lcsh:Medicine ,02 engineering and technology ,010501 environmental sciences ,MESH: Plasticizers ,01 natural sciences ,Mass Spectrometry ,Analytical Chemistry ,chemistry.chemical_compound ,Spectrum Analysis Techniques ,Plasticizers ,Infusion Procedure ,Medicine and Health Sciences ,lcsh:Science ,Polyvinyl Chloride ,Flow Rate ,Multidisciplinary ,Chemistry ,Pharmaceutics ,Organic Compounds ,Physics ,Chromatographic Techniques ,Classical Mechanics ,MESH: Equipment and Supplies ,021001 nanoscience & nanotechnology ,Hospitals ,3. Good health ,Volumetric flow rate ,Intensive Care Units ,Macromolecules ,Equipment and Supplies ,Physical Sciences ,Chloroform ,0210 nano-technology ,Research Article ,Biotechnology ,Drug Administration ,Patients ,Materials by Structure ,Materials Science ,MESH: Polyvinyl Chloride ,Fluid Mechanics ,Research and Analysis Methods ,Continuum Mechanics ,Gas Chromatography-Mass Spectrometry ,Drug Therapy ,Intensive care ,Humans ,0105 earth and related environmental sciences ,Inpatients ,MESH: Humans ,lcsh:R ,Significant difference ,Organic Chemistry ,Plasticizer ,Chemical Compounds ,Biology and Life Sciences ,Fluid Dynamics ,Polymer Chemistry ,Pvc matrix ,Health Care ,Polyvinyl chloride ,Health Care Facilities ,lcsh:Q ,Medical Devices and Equipment ,MESH: Intensive Care Units ,Biomedical engineering - Abstract
International audience; Infusion medical devices (MDs) used in hospitals are often made of plasticized polyvinylchloride (PVC). These plasticizers may leach out into infused solutions during clinical practice, especially during risk-situations, e.g multiple infusions in Intensive Care Units and thus may enter into contact with the patients. The migrability of the plasticizers is dependent of several clinical parameters such as temperature, contact time, nature of the simulant, etc… However, no data is available about the influence of the flow rate at which drug solutions are administrated. In this study, we evaluated the impact of different flow rates on the release of the different plasticizers during an infusion procedure in order to assess if they could expose the patients to more toxic amounts of plasticizers. Migration assays with different PVC infusion sets and extension lines were performed with different flow rates that are used in clinical practice during 1h, 2h, 4h, 8h and 24h, using a lipophilic drug simulant. From a clinical point of view, the results showed that, regardless of the plasticizer, the faster the flow rate, the higher the infused volume and the higher the quantities of plasticizers released, both from infusion sets and extension lines, leading to higher patient exposure. However, physically, there was no significant difference of the migration kinetics linked to the flow rate for a same medical device, reflecting complex interactions between the PVC matrix and the simulant. The migration was especially dependent on the nature and the composition of the medical device.
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- 2018
3. HARMONIZING HEALTH TECHNOLOGY ASSESSMENT PRACTICES IN UNIVERSITY HOSPITALS: TO WHAT EXTENT IS THE MINI-HTA MODEL SUITABLE IN THE FRENCH CONTEXT?
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Judith Pineau, Hélène van den Brink, Isabelle Borget, Mathilde Billaux, Nicolas Martelli, Capucine Devaux, Patrice Prognon, Groupe de Recherche et d'Accueil en Droit et Economie de la Santé (GRADES), and Université Paris-Saclay
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Decision support system ,Technology Assessment, Biomedical ,education ,MEDLINE ,Context (language use) ,Technology assessment ,Decision Support Techniques ,Danish ,Hospitals, University ,03 medical and health sciences ,Hospital ,0302 clinical medicine ,MESH: Technology Assessment, Biomedical ,Agency (sociology) ,parasitic diseases ,Medicine ,Humans ,030212 general & internal medicine ,Innovation ,MESH: Hospitals, University ,Medical education ,MESH: Humans ,business.industry ,030503 health policy & services ,Health Policy ,Environmental resource management ,Health technology ,MESH: Decision Support Techniques ,MESH: Equipment and Supplies ,language.human_language ,Purchasing ,Mini-health technology assessment ,Equipment and Supplies ,language ,Medical devices ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,0305 other medical science ,business - Abstract
Background: The number of new medical devices for individual use that are launched annually exceeds the assessment capacity of the French national health technology assessment (HTA) agency. This has resulted in hospitals, and particularly university hospitals (UHs), developing hospital-based HTA initiatives to support their decisions for purchasing innovative devices. However, the methodologies used in such hospitals have no common basis. The aim of this study was to assess a mini-HTA model as a potential solution to harmonize HTA methodology in French UHs.Methods: A systematic review was conducted on Medline, Embase, Health Technology Assessment database, and Google Scholar to identify published articles reporting the use of mini-HTA tools and decision support-like models. A survey was also carried out in eighteen French UHs to identify in-house decision support tools. Finally, topics evaluated in the Danish mini-HTA model and in French UHs were compared using Jaccard similarity coefficients.Results: Our findings showed differences between topics evaluated in French UHs and those assessed in decision support models from the literature. Only five topics among the thirteen most evaluated in French UHs were similar to those assessed in the Danish mini-HTA model. The organizational and ethical/social impacts were rarely explored among the surveyed models used in French UHs when introducing new medical devices.Conclusions: Before its widespread and harmonized use in French UHs, the mini-HTA model would first require adaptations to the French context.
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- 2017
4. Special funding schemes for innovative medical devices in French hospitals: The pros and cons of two different approaches
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Hélène van den Brink, Nicolas Martelli, Groupe de Recherche et d'Accueil en Droit et Economie de la Santé (GRADES), and Université Paris-Saclay
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Technology Assessment, Biomedical ,Transparency (market) ,MESH: Financing, Organized ,Hospital ,03 medical and health sciences ,0302 clinical medicine ,MESH: Technology Assessment, Biomedical ,Inventions ,MESH: European Union ,National health policy ,European market ,Medicine ,European Union ,030212 general & internal medicine ,Health technology assessment ,Innovation ,Reimbursement ,Coverage with evidence development ,Supplementary data ,Actuarial science ,business.industry ,030503 health policy & services ,Health Policy ,Financing, Organized ,MESH: Equipment and Supplies ,Public relations ,MESH: Hospitals ,Hospitals ,3. Good health ,MESH: France ,Social security ,MESH: Inventions ,Equipment and Supplies ,Clinical evidence ,Medical devices ,MESH: Health Policy ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,France ,0305 other medical science ,business - Abstract
International audience; Financing innovative medical devices is an important challenge for national health policy makers, and a crucial issue for hospitals. However, when innovative medical devices are launched on the European market there is generally little clinical evidence regarding both efficacy and safety, both because of the flaws in the European system for regulating such devices, and because they are at an early stage of development. To manage the uncertainty surrounding the reimbursement of innovation, several European countries have set up temporary funding schemes to generate evidence about the effectiveness of devices. This article explores two different French approaches to funding innovative in-hospital devices and collecting supplementary data: the coverage with evidence development (CED) scheme introduced under Article L. 165-1-1 of the French Social Security Code; and national programs for hospital-based research. We discuss pros and cons of both approaches in the light of CED policies in Germany and the UK. The CED policies for devices share common limitations. Thus, transparency of CED processes should be enhanced and decisions need to be made in a timely way. Finally, we think that closer collaboration between manufacturers, health authorities and hospitals is essential to make CED policies more operational.
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- 2014
5. Organisational impact: Definition and assessment methods for medical devices
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Karine Szwarcensztein, Christophe Roussel, Antoine Audry, André Tanti, Hubert Méchin, Nicolas Martelli, Sandrine Fare, Stéphane Burtey, Emmanuel Luigi, Frédéric Rupprecht, François Langevin, Stéphane Laroche, Cédric Carbonneil, Grégoire Mercier, Sébastien Woynar, Catherine Zaidman, Institut des Sciences Moléculaires de Marseille (ISM2), Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS)-École Centrale de Marseille (ECM)-Institut de Chimie du CNRS (INC), Chirurgie urologique et transplantation rénale [Hôpital de la Conception - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Vascular research center of Marseille (VRCM), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), École des Hautes Études en Santé Publique [EHESP] (EHESP), Institut du Management (IDM), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Groupe de Recherche et d'Accueil en Droit et Economie de la Santé (GRADES), Université Paris-Saclay, and Aix Marseille Université (AMU)-École Centrale de Marseille (ECM)-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS)
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Value (ethics) ,Technology Assessment, Biomedical ,Organisational innovation ,Biomedical ,Computer science ,Process (engineering) ,Cost-Benefit Analysis ,[SDV]Life Sciences [q-bio] ,Guidelines as Topic ,Efficiency ,Technology assessment ,030226 pharmacology & pharmacy ,Organizational ,03 medical and health sciences ,0302 clinical medicine ,MESH: Technology Assessment, Biomedical ,Humans ,Pharmacology (medical) ,MESH: Humans ,Cost–benefit analysis ,030503 health policy & services ,MESH: Guidelines as Topic ,Health technology ,MESH: Equipment and Supplies ,Benchmarking ,Risk analysis (engineering) ,Work (electrical) ,Equipment and supplies ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,0305 other medical science ,Medical literature ,MESH: Cost-Benefit Analysis - Abstract
International audience; Health technology assessment (HTA) is a rapidly developing area and the value of taking non-clinical fields into consideration is growing. Although the health-economic aspect is commonly recognised, evaluating organisational impact has not been studied nearly as much. The goal of this work was to provide a definition of organisational impact in the sector of medical devices by defining its contours and exploring the evaluation methods specific to this field. Following an analysis of the literature concerning the impact of technologies on organisations as well as the medical literature, and also after reviewing the regulatory texts in this respect, the group of experts identified 12 types of organisational impact. A number of medical devices were carefully screened using the criteria grid, which proved to be operational and to differentiate properly. From the analysis of the practice and of the methods described, the group was then able to derive a few guidelines to successfully evaluate organisational impact. This work shows that taking organisational impact into consideration may be critical alongside of the other criteria currently in favour (clinically and economically). What remains is to confer a role in the decision-making process on this factor and one that meets the economic efficiency principle.
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- 2016
6. Innovative medical devices and hospital decision making: a study comparing the views of hospital pharmacists and physicians
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Nicolas Martelli, Isabelle Borget, Mathilde Billaux, Judith Pineau, Patrice Prognon, Groupe de Recherche et d'Accueil en Droit et Economie de la Santé (GRADES), and Université Paris-Saclay
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Male ,MESH: Pharmacists ,medicine.medical_specialty ,Health Knowledge, Attitudes, Practice ,MESH: Health Knowledge, Attitudes, Practice ,MESH: Medical Staff, Hospital ,Population health ,Pharmacists ,Interviews as Topic ,03 medical and health sciences ,0302 clinical medicine ,Nursing ,Inventions ,MESH: Decision Making, Organizational ,Health care ,Medical Staff, Hospital ,Medicine ,Humans ,030212 general & internal medicine ,MESH: Qualitative Research ,Decision Making, Organizational ,Qualitative Research ,Government ,Health economics ,MESH: Purchasing, Hospital ,MESH: Humans ,business.industry ,030503 health policy & services ,Health Policy ,Public health ,Health technology ,MESH: Equipment and Supplies ,Viewpoints ,MESH: Interviews as Topic ,MESH: Male ,3. Good health ,MESH: Inventions ,Equipment and Supplies ,Purchasing, Hospital ,Female ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,0305 other medical science ,business ,MESH: Female ,Qualitative research - Abstract
International audience; Objectives Many university hospitals have developed local health technology assessment processes to guide informed decisions about new medical devices. However, little is known about stakeholders’ perceptions and assessment of innovative devices. Herein, we investigated the perceptions regarding innovative medical devices of their chief users (physicians and surgeons), as well as those of hospital pharmacists, because they are responsible for the purchase and management of sterile medical devices. We noted the evaluation criteria used to assess and select new medical devices and suggestions for improving local health technology assessment processes indicated by the interviewees. Methods We randomly selected 18 physicians and surgeons (nine each) and 18 hospital pharmacists from 18 French university hospitals. Semistructured interviews were conducted between October 2012 and August 2013. Responses were coded separately by two researchers. Results Physicians and surgeons frequently described innovative medical devices as ‘new’, ‘safe’ and ‘effective’, whereas hospital pharmacists focused more on economic considerations and considered real innovative devices to be those for which no equivalent could be found on the market. No significant difference in evaluation criteria was found between these groups of professionals. Finally, hospital pharmacists considered the management of conflicts of interests in local health technology assessment processes to be an issue, whereas physicians and surgeons did not. Conclusions The present study highlights differences in perceptions related to professional affiliation. The findings suggest several ways in which current practices for local health technology assessment in French university hospitals could be improved and studied. What is known about the topic? Hospitals are faced with ever-growing demands for innovative and costly medical devices. To help hospital management deal with technology acquisition issues, hospital-based health technology assessment has been developed to support decisions. However, little is known about the different perceptions of innovative medical devices among practitioners and how different perceptions may affect decision making. What does this paper add? This paper compares and understands the perceptions of two groups of health professionals concerning innovative devices in the university hospital environment. What are the implications for practitioners? Such a comparison of viewpoints could facilitate improvements in current practices and decision-making processes in local health technology assessment for these medical products.
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- 2016
7. Clinical studies of innovative medical devices: what level of evidence for hospital-based health technology assessment?
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Boudard, Aurélie, Martelli, Nicolas, Prognon, Patrice, Pineau, Judith, Groupe de Recherche et d'Accueil en Droit et Economie de la Santé (GRADES), and Université Paris-Saclay
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Clinical Trials as Topic ,clinical trials ,hospital-based health technology assessment ,Technology Assessment, Biomedical ,evaluation ,MESH: Humans ,MESH: Clinical Trials as Topic ,medical device ,Cost-Benefit Analysis ,education ,MESH: Equipment and Supplies ,level of evidence ,MESH: Evidence-Based Practice ,innovation ,Equipment and Supplies ,Hospital Administration ,MESH: Technology Assessment, Biomedical ,Evidence-Based Practice ,Humans ,MESH: Hospital Administration ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,health care economics and organizations ,MESH: Cost-Benefit Analysis - Abstract
Like health technology assessment (HTA) agencies, hospitals are faced with requests for innovative and costly medical devices. However, local decision makers are frequently confronted with a lack of high-quality clinical data when assessing the effectiveness of innovative medical devices. The aim of this study was to quantify the level of evidence available for innovative medical devices in the context of hospital-based HTA.We searched the Medline, Embase and Cochrane Library databases for articles, letters and reports relating to 32 innovative medical devices requested at our hospital between January 2008 and March 2012. All clinical studies retrieved were screened and classified according to the Sackett 5-point level-of-evidence scale.We screened and classified 217 studies: 215 clinical trials and 2 cost-effectiveness studies. Only 47 of the 215 clinical studies (22%) provided high-level clinical evidence (levels 1-2); 33 (15%) were randomized controlled trials (RCTs). More than half of the 215 studies (52.1%) included fewer than 30 patients. Only 14 of the 47 high-quality studies reported the amount of missing data. For implantable medical devices, 84 (71.8%) studies specified the follow-up period and the mean follow-up period was 18.9 months. Finally, methodological quality did not increase with the risk level of the medical device.Our findings confirm that only a few studies of innovative medical devices provide high-level clinical evidence. Nevertheless, RCT may be the 'gold standard' for drugs, but it is not always appropriate for medical devices. Changes to the European regulation of medical devices, with the requirement for a demonstration of clinical efficacy and safety before release onto the European market, have raised expectations.
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- 2013
8. Consensus document regarding cardiovascular safety at sports arenas: position stand from the European Association of Cardiovascular Prevention and Rehabilitation (EACPR), section of Sports Cardiology
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Borjesson, M, Serratosa, L, Carre, F, Corrado, Domenico, Drezner, J, Dugmore, Dl, Heidbuchel, Hh, Mellwig, Kp, Panhuyzen Goedkoop NM, Papadakis, M, Rasmusen, H, Sharma, S, Solberg, Ee, van Buuren, F, Pelliccia, A, writing group on behalf of the EACPR Section of Sports Cardiology, Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de médecine du sport et d'explorations fonctionnelles, CHU Pontchaillou [Rennes], University of Washington [Seattle], Department of Cardiology [K.U.Leuven], Catholic University of Leuven - Katholieke Universiteit Leuven (KU Leuven)-University Hospital Gasthuisberg [Leuven], EACPR section of sports cardiology, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Catholic University of Leuven - Katholieke Universiteit Leuven (KU Leuven)-University Hospital Gasthuisberg
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Emergency Medical Services ,medicine.medical_treatment ,MESH: Cardiopulmonary Resuscitation ,030204 cardiovascular system & hematology ,Medical Records ,0302 clinical medicine ,Mass gathering ,MESH: Health Planning ,030212 general & internal medicine ,MESH: Quality of Health Care ,Rehabilitation ,Cardiovascular diseases [NCEBP 14] ,biology ,Communication ,MESH: Equipment and Supplies ,Checklist ,3. Good health ,Transportation of Patients ,Equipment and Supplies ,Action plan ,Cardiology ,MESH: Emergency Medical Services ,MESH: Communication ,[SDV.IB]Life Sciences [q-bio]/Bioengineering ,Medical emergency ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,Sports ,MESH: Medical Records ,medicine.medical_specialty ,Health Personnel ,Interprofessional Relations ,MESH: Emergency Treatment ,Sudden death ,MESH: Checklist ,03 medical and health sciences ,[SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system ,Internal medicine ,MESH: Interprofessional Relations ,medicine ,Humans ,Chain of survival ,Emergency Treatment ,Quality of Health Care ,MESH: Humans ,business.industry ,Athletes ,Sudden cardiac arrest ,MESH: Death, Sudden, Cardiac ,medicine.disease ,biology.organism_classification ,Cardiopulmonary Resuscitation ,Health Planning ,Death, Sudden, Cardiac ,Life support ,MESH: Transportation of Patients ,MESH: Health Personnel ,MESH: Defibrillators ,MESH: Sports ,business ,human activities ,Defibrillators - Abstract
Item does not contain fulltext Mass gathering events in sports arenas create challenges regarding the cardiovascular safety of both athletes and spectators. A comprehensive medical action plan, to ensure properly applied cardiopulmonary resuscitation, and wide availability and use of automated external defibrillators (AEDs), is essential to improving survival from sudden cardiac arrest at sporting events. This paper outlines minimum standards for cardiovascular care to assist in the planning of mass gathering sports events across Europe with the intention of local adaptation at individual sports arenas, to ensure the full implementation of the chain of survival.
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- 2011
9. Interest of the preliminary risk analysis method in a central sterile supply department
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Alain Desroches, Damien Talon, Brigitte Bonan, Florence Vincent, Patrice Prognon, Nicolas Martelli, Juliette Niel-Lainé, Groupe de Recherche et d'Accueil en Droit et Economie de la Santé (GRADES), Université Paris-Saclay, MINES ParisTech - École nationale supérieure des mines de Paris, and Université Paris sciences et lettres (PSL)
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Safety Management ,Quality management ,MEDLINE ,MESH: Sterilization ,[QFIN.RM]Quantitative Finance [q-fin]/Risk Management [q-fin.RM] ,MESH: Risk Assessment ,Risk Assessment ,Hospitals, University ,MESH: Quality Improvement ,03 medical and health sciences ,0302 clinical medicine ,Hazardous waste ,Health care ,Humans ,Medicine ,Operations management ,030212 general & internal medicine ,MESH: Hospitals, University ,0303 health sciences ,MESH: Humans ,030306 microbiology ,business.industry ,Health Policy ,Reproducibility of Results ,Sterilization ,MESH: Equipment and Supplies ,Prospective risk ,Quality Improvement ,3. Good health ,IT risk management ,MESH: Reproducibility of Results ,MESH: Safety Management ,Equipment and Supplies ,Risk analysis (engineering) ,Public university ,business ,Risk assessment - Abstract
Objectives In order to improve its quality-assurance programme based on ISO 9001, the Central Sterile Supply Department of a public university hospital has performed a prospective risk analysis using the Preliminary Risk Analysis method (PRA). The objectives were the achievement of a global risk mapping related to the whole process of sterilising medical devices, and second, the implementation of corrective measures to reduce identified risks. Methods A multidisciplinary team, formed in January 2008, validated results at each step of the study. During the analysis, 416 hazardous situations were identified, among which 81 were quoted first in priority and led to the description of 141 risk scenarios. The PRA team assessed 42 scenarios with risk ranking assessed as ‘acceptable under control’ or ‘unacceptable.’ They adopted 23 follow-up actions measures and 13 safety parameters. Results and discussion The PRA constitutes an appropriate tool for assessing quality-improvement policy and safety in healthcare facilities that can be easily integrated into standard quality-management systems.
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- 2011
10. Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform: Report of a policy conference of the European Society of Cardiology
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Fraser AG, Daubert JC, Van de Werf F, Estes NA 3rd, Smith SC Jr, Krucoff MW, Vardas PE, Komajda M, Anker S, Auricchio A, Bailey S, Bonhoeffer P, Borggrefe M, Brodin LA, Bruining N, Buser P, Butchart E, Calle Gordo J, Cleland J, Danchin N, Degertekin M, Demade I, Denjoy N, Derumeaux G, di Mario C, Dickstein K, Dudek D, Farb A, Flotats A, Gueret P, Israel C, James S, Kautzner J, Lombardi M, Marwick T, Mioulet M, O'Kelly S, Rosano G, Rosenhek R, Sabate M, Swahn E, Tavazzi L, van der Velde E, van Herwerden L, Voigt JU, Weaver D, Wilmshurst P., PERRONE FILARDI, PASQUALE, Fraser, Ag, Daubert, Jc, Van de Werf, F, Estes NA, 3rd, Smith SC, Jr, Krucoff, Mw, Vardas, Pe, Komajda, M, Anker, S, Auricchio, A, Bailey, S, Bonhoeffer, P, Borggrefe, M, Brodin, La, Bruining, N, Buser, P, Butchart, E, Calle Gordo, J, Cleland, J, Danchin, N, Degertekin, M, Demade, I, Denjoy, N, Derumeaux, G, di Mario, C, Dickstein, K, Dudek, D, Farb, A, Flotats, A, Gueret, P, Israel, C, James, S, Kautzner, J, Lombardi, M, Marwick, T, Mioulet, M, O'Kelly, S, PERRONE FILARDI, Pasquale, Rosano, G, Rosenhek, R, Sabate, M, Swahn, E, Tavazzi, L, van der Velde, E, van Herwerden, L, Voigt, Ju, Weaver, D, Wilmshurst, P., Société Européenne de Cardiologie (ESC), and Société Européenne de Cardiologie (ESC)-The European Heart House
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Legislation, Medical ,Health Care Sector ,MESH: Equipment Failure ,Regulatory reform ,030204 cardiovascular system & hematology ,Premarket approval ,0302 clinical medicine ,Medicine ,030212 general & internal medicine ,Post-marketing surveillance ,MESH: Equipment and Supplies ,Equipment Design ,MESH: Cardiology ,3. Good health ,Equipment and Supplies ,MESH: Patient Safety ,Medical devices ,Engineering ethics ,Professional association ,Equipment Failure ,[SDV.IB]Life Sciences [q-bio]/Bioengineering ,Patient Safety ,Cardiology and Cardiovascular Medicine ,Clinical evaluation ,Diagnostic Imaging ,medicine.medical_specialty ,Process (engineering) ,Interprofessional Relations ,Biomedical Technology ,Cardiology ,Postmarketing surveillance ,Legislation ,Context (language use) ,MESH: Diffusion of Innovation ,European device directives ,03 medical and health sciences ,[SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system ,MESH: Interprofessional Relations ,MESH: United States ,MESH: European Union ,Humans ,European Union ,Psychiatry ,Pace ,MESH: Humans ,business.industry ,MESH: Diagnostic Imaging ,MESH: Health Care Sector ,MESH: Legislation, Medical ,United States ,Recast of legislation ,Diffusion of Innovation ,business ,MESH: Biomedical Technology ,MESH: Equipment Design - Abstract
International audience; The European Commission announced in 2008 that a fundamental revision of the medical device directives is being considered in order to clarify and strengthen the current legal framework. The system for testing and approving devices in Europe was established >20 years ago as a 'New Approach' to a previously little-regulated industry. It is recognized by many that the regulatory system has not kept pace with technological advances and changing patterns of medical practice. New legislation will be drafted during 2011, but medical experts have been little involved in this important process. This context makes it an opportune time for a professional association to advise from both clinical and academic perspectives about changes which should be made to improve the safety and efficacy of devices used in clinical practice and to develop more appropriate systems for their clinical evaluation and post-marketing surveillance. This report summarizes how medical devices are regulated and it reviews some serious clinical problems that have occurred with cardiovascular devices. Finally, it presents the main recommendations from a Policy Conference on the Clinical Evaluation of Cardiovascular Devices that was held at the European Heart House in January 2011.
- Published
- 2011
11. An assessment of interactions between global health initiatives and country health systems
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Mark Dybul, Jean-Paul Moatti, Tim Evans, Rifat Atun, Justine Hsu, Ruairi Brugha, Badara Samb, Carissa F. Etienne, Asia Russell, Jim Yong Kim, Francesca Celletti, Anna Wright, Sania Nishtar, Chauvin, Pierre, World Health Organisation (WHO), Organisation Mondiale de la Santé / World Health Organization Office (OMS / WHO), O'Neill Institute, Georgetown University [Washington] (GU), Imperial College London, Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM - U912 INSERM - Aix Marseille Univ - IRD), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Heartfile, Harvard School of Public Health, Royal College of Surgeons, Health GAP, World Health Organization Maximizing Positive Synergies, Georgetown University, and Institut de Recherche pour le Développement (IRD)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Aix Marseille Université (AMU)
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Budgets ,Economic growth ,MESH: Delivery of Health Care ,Global Health ,Health Services Accessibility ,0302 clinical medicine ,Global health ,Medicine ,MESH: Health Planning ,030212 general & internal medicine ,Health Workforce ,MESH: Quality of Health Care ,MESH: Healthcare Disparities ,MESH: Developing Countries ,MESH: Health Services Accessibility ,MESH: Program Evaluation ,030503 health policy & services ,Health Policy ,Environmental resource management ,Financing, Organized ,1. No poverty ,MESH: Equipment and Supplies ,General Medicine ,Millennium Development Goals ,3. Good health ,MESH: Health Priorities ,Equipment and Supplies ,MESH: Health Manpower ,MESH: Information Systems ,MESH: Health Policy ,0305 other medical science ,Goals ,Information Systems ,MESH: Health Services Needs and Demand ,medicine.medical_specialty ,MESH: Health Expenditures ,Health Personnel ,Developing country ,MESH: International Agencies ,MESH: Financing, Organized ,03 medical and health sciences ,Humans ,Healthcare Disparities ,Developing Countries ,Health policy ,Quality of Health Care ,Health Services Needs and Demand ,Equity (economics) ,MESH: Humans ,MESH: Budgets ,business.industry ,Health Priorities ,Public health ,International health ,International Agencies ,Health Planning ,[SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie ,MESH: Goals ,Global Health Initiatives ,MESH: Health Personnel ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,Health Expenditures ,business ,Delivery of Health Care ,MESH: World Health ,Program Evaluation - Abstract
International audience; Since 2000, the emergence of several large disease-specific global health initiatives (GHIs) has changed the way in which international donors provide assistance for public health. Some critics have claimed that these initiatives burden health systems that are already fragile in countries with few resources, whereas others have asserted that weak health systems prevent progress in meeting disease-specific targets. So far, most of the evidence for this debate has been provided by speculation and anecdotes. We use a review and analysis of existing data, and 15 new studies that were submitted to WHO for the purpose of writing this Report to describe the complex nature of the interplay between country health systems and GHIs. We suggest that this Report provides the most detailed compilation of published and emerging evidence so far, and provides a basis for identification of the ways in which GHIs and health systems can interact to mutually reinforce their effects. On the basis of the findings, we make some general recommendations and identify a series of action points for international partners, governments, and other stakeholders that will help ensure that investments in GHIs and country health systems can fulfil their potential to produce comprehensive and lasting results in disease-specific work, and advance the general public health agenda. The target date for achievement of the health-related Millennium Development Goals is drawing close, and the economic downturn threatens to undermine the improvements in health outcomes that have been achieved in the past few years. If adjustments to the interactions between GHIs and country health systems will improve efficiency, equity, value for money, and outcomes in global public health, then these opportunities should not be missed.
- Published
- 2009
12. There is something out there: distal attribution in sensory substitution, twenty years later
- Author
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Sylvain Hanneton, Charles Lenay, Kevin O'Regan, Malika Auvray, Laboratoire de psychologie expérimentale (LPE - UMR8581), Centre National de la Recherche Scientifique (CNRS)-Université Paris Descartes - Paris 5 (UPD5)-École pratique des hautes études (EPHE), Neurophysique et physiologie du système moteur (NPSM), Université Paris Descartes - Paris 5 (UPD5)-Centre National de la Recherche Scientifique (CNRS), Connaissance Organisation et Systèmes TECHniques (COSTECH), Université de Technologie de Compiègne (UTC), Hanneton, Sylvain, Laboratoire de psychologie expérimentale ( LPE - UMR8581 ), École pratique des hautes études ( EPHE ) -Université Paris Descartes - Paris 5 ( UPD5 ) -Centre National de la Recherche Scientifique ( CNRS ), Neurophysique et physiologie du système moteur ( NPSM ), Université Paris Descartes - Paris 5 ( UPD5 ) -Centre National de la Recherche Scientifique ( CNRS ), Connaissance Organisation et Systèmes TECHniques ( COSTECH ), Université de Technologie de Compiègne ( UTC ), and Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)
- Subjects
MESH : Movement ,[ SCCO.PSYC ] Cognitive science/Psychology ,MESH: Movement ,Space (commercial competition) ,perception ,MESH : Auditory Perception ,0302 clinical medicine ,MESH : Neuronal Plasticity ,MESH: Neuronal Plasticity ,media_common ,learning ,Neuronal Plasticity ,General Neuroscience ,05 social sciences ,MESH: Equipment and Supplies ,General Medicine ,sensory substitution ,Object (philosophy) ,Degree (music) ,Sensory substitution ,Equipment and Supplies ,[SCCO.PSYC]Cognitive science/Psychology ,[SCCO.PSYC] Cognitive science/Psychology ,Auditory Perception ,Visual Perception ,[SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC] ,Psychology ,MESH : Visual Perception ,Cognitive psychology ,Auditory perception ,media_common.quotation_subject ,Movement ,050105 experimental psychology ,03 medical and health sciences ,MESH: Auditory Perception ,Perception ,Sensation ,MESH : Equipment and Supplies ,Humans ,0501 psychology and cognitive sciences ,Communication ,MESH: Humans ,MESH: Visual Perception ,business.industry ,MESH : Humans ,[ SDV.NEU ] Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC] ,physiology ,prosthesis ,Attribution ,business ,030217 neurology & neurosurgery - Abstract
Sensory substitution constitutes an interesting domain of study to consider the philosopher's classical question of distal attribution: how we can distinguish between a sensation and the perception of an object that causes this sensation. We tested the hypothesis that distal attribution consists of three distinct components: an object, a perceptual space, and a coupling between subjects' movements and stimulation. We equipped sixty participants with a visual-to-auditory substitution device, without any information about it. The device converts the video stream produced by a head-mounted camera into a sound stream. We investigated several experimental conditions: the existence or not of a correlation between movements and resulting stimulation, the direct or indirect manipulation of an object, and the presence of a background environment. Participants were asked to describe their impressions by rating their experiences in terms of seven possible "scenarios". These scenarios were carefully chosen to distinguish the degree to which the participants attributed their sensations to a distal cause. Participants rated the scenarios both before and after they were given the possibility to interrupt the stimulation with an obstacle. We were interested in several questions. Did participants extract laws of co-variation between their movements and resulting stimulation? Did they deduce the existence of a perceptual space originating from this coupling? Did they individuate objects that caused the sensations? Whatever the experimental conditions, participants were able to establish that there was a link between their movements and the resulting auditory stimulation. Detection of the existence of a coupling was more frequent than the inferences of distal space and object.
- Published
- 2005
13. Combining multi-criteria decision analysis and mini-health technology assessment: A funding decision-support tool for medical devices in a university hospital setting
- Author
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Isabelle Borget, Hélène van den Brink, Anne-Laure Cordonnier, Patrice Prognon, Aurélie Boudard, Judith Pineau, Paul Hansen, Nicolas Martelli, Capucine Devaux, Groupe de Recherche et d'Accueil en Droit et Economie de la Santé (GRADES), and Université Paris-Saclay
- Subjects
Technology Assessment, Biomedical ,Health Informatics ,Technology assessment ,Hospitals, University ,03 medical and health sciences ,Hospital ,0302 clinical medicine ,MESH: Technology Assessment, Biomedical ,Multi-criteria decision analysis ,Humans ,Medicine ,030212 general & internal medicine ,MESH: Hospitals, University ,MESH: Humans ,business.industry ,Management science ,030503 health policy & services ,MESH: Equipment and Supplies ,Health technology ,Decision Support Systems, Clinical ,Multiple-criteria decision analysis ,Elicitation technique ,Purchasing ,3. Good health ,Test (assessment) ,Computer Science Applications ,Mini-health technology assessment ,MESH: Medical Informatics ,Engineering management ,Equipment and Supplies ,MESH: Decision Support Systems, Clinical ,Medical devices ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,Pairwise comparison ,0305 other medical science ,business ,Medical Informatics ,Decision analysis - Abstract
Display Omitted Mini-health technology assessment (HTA) is increasingly used in hospitals.We develop a mini-HTA/multi-criteria decision analysis decision-support tool.We test the tool for purchasing new medical devices in a hospital setting.Our tool would help to promote a more transparent approach in decision-making. BackgroundAt the hospital level, decisions about purchasing new and oftentimes expensive medical devices must take into account multiple criteria simultaneously. Multi-criteria decision analysis (MCDA) is increasingly used for health technology assessment (HTA). One of the most successful hospital-based HTA approaches is mini-HTA, of which a notable example is the Matrix4value model. ObjectivesTo develop a funding decision-support tool combining MCDA and mini-HTA, based on Matrix4value, suitable for medical devices for individual patient use in French university hospitals - known as the IDA tool, short for 'innovative device assessment'. MethodsCriteria for assessing medical devices were identified from a literature review and a survey of 18 French university hospitals. Weights for the criteria, representing their relative importance, were derived from a survey of 25 members of a medical devices committee using an elicitation technique involving pairwise comparisons. As a test of its usefulness, the IDA tool was applied to two new drug-eluting beads (DEBs) for transcatheter arterial chemoembolization. ResultsThe IDA tool comprises five criteria and weights for each of two over-arching categories: risk and value. The tool revealed that the two new DEBs conferred no additional value relative to DEBs currently available. ConclusionsFeedback from participating decision-makers about the IDA tool was very positive. The tool could help to promote a more structured and transparent approach to HTA decision-making in French university hospitals.
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