Judith Pineau's research while affiliated with Hôpital Européen Georges-Pompidou (Hôpitaux Universitaires Paris-Ouest) and other places

Publications (45)

Article
Aim: The evaluation of a health technology determines the clinical and non clinical value of the technology. Among the non clinical criteria, evaluation models include the organizational impact (OI) of the technology. The objective of this study is to highlight the types of OIs of 3D printing in a hospital setting. Materials & methods: A panel of 1...
Preprint
Full-text available
Background In 2020, the first mRNA COVID vaccine was approved by the with six doses from single vial. In the context of material shortages, the aim of the study was to compare different protocols to extract doses using uncrimped materials with good trueness and reproducibility. Methods To optimize the extraction of the sixth dose from a single via...
Article
Objective: We aimed to perform a systematic review of economic evaluations of drug-coated balloons (DCBs) and drug-eluting stents (DESs) in peripheral artery disease (PAD) and to assess the level of evidence of relevant studies. The purpose was not to present economic findings. Methods: A systematic review was performed using four electronic dat...
Article
Objectifs Plusieurs études ont déjà porté sur l’intérêt de l’urétéroscope souple à usage unique (URSUU) par rapport aux urétéroscopes réutilisables (URSUM). Afin de prendre en compte l’ensemble des données « en vie réelle » et déterminer la place d’une technique par rapport à l’autre, une évaluation économique comparative doit être menée mais égale...
Article
Objective Because of a lack of suitable heart donors, alternatives to transplantation are required. These alternatives can have high costs. The aim of this study was to perform a systematic review of cost-effectiveness studies of ventricular assist devices (VADs) and to assess the level of evidence of relevant studies. The purpose was not to presen...
Article
Objectives The use of three-dimensional (3D) printing in surgery is expanding and there is a focus on comprehensively evaluating the clinical impact of this technology. However, although additional costs are one of the main limitations to its use, little is known about its economic impact. The purpose of this systematic review is to identify the co...
Article
Background Transcatheter aortic-valve implantation (TAVI) has become an essential alternative to surgical aortic-valve replacement in the treatment of symptomatic severe aortic stenosis, and this procedure requires technical expertise. The aim of this study was to identify prospective studies on TAVI from the past 10 years, and then to analyze the...
Article
Résumé Introduction Le Comité des dispositifs médicaux stériles (CODIMS) de l’Assistance publique–hôpitaux de Paris (AP–HP) évalue les dispositifs médicaux stériles (DMS) innovants en vue de leur référencement à l’AP–HP. Ces mêmes DMS peuvent avoir fait l’objet ou non d’une évaluation au plan national par la Commission nationale d’évaluation des d...
Article
Background: Three-dimensional (3D) printing has changed surgical practice over the past few years, especially in maxillofacial surgery. However, little is known about its real clinical impact. The objectives of our study were to identify clinical outcomes that have been evaluated in the literature regarding 3D printing applications in jaw reconstru...
Article
Introduction The Medical Devices Regulation (MDR) 2017/745/EU will fully apply from May 2020. Interventional radiologists use medical devices on a daily basis and so must be aware of the impact that this new regulation will have on their daily practice. Materials and Methods In this paper, we describe the major transformation that the MDR brings t...
Article
Les pansements ne cessent d’évoluer grâce aux avancées technologiques pour aboutir à des dispositifs modernes d’action ciblée. Des évaluations précliniques et cliniques, selon des critères exigeants, sont nécessaires pour obtenir un marquage de conformité européenne avant commercialisation. À l’hôpital, le tarif du pansement est inclus dans le forf...
Article
Objectives The objective of the present work was to assess the level of evidence in economic evaluations of percutaneous left atrial appendage closure devices, and to test the complementarity of three different tools for assessing the quality of economic evaluations. Methods We conducted a systematic review of articles in English or French listed...
Article
Rationale, aims, and objectives There is at present no standard methodology to analyse the organizational impacts (OIs) of medical devices (MDs), and the field is still in its infancy. The aim of the present study was to assess, at a hospital level, the organizational and economic impacts of the introduction of a new MD, specifically the single‐use...
Article
3D printing plays an increasingly important role in the medical sector and particularly in surgery. Nowadays, numerous manufacturers benefit from this technology to produce their medical devices and some hospitals have also purchased 3D printers. In this context, the aim of the present study was to study the distribution and the use of 3D printing...
Article
Introduction L’utilisation croissante des dispositifs de traitement par pression négative (TPN) et l’élargissement de l’offre du marché, associés au manque de données cliniques (HAS, 2016) ont conduit le Comité des dispositifs médicaux stériles (CODIMS) de notre établissement à réunir un groupe d’experts (pharmaciens, infirmiers, médecins) pour men...
Article
Objective The aim of this study was to determine relevant items for reporting clinical trials on implantable medical devices and to identify reporting guidelines which include these items. Study design and setting A panel of experts identified the most relevant items for evaluating implantable medical devices from an initial list based on referenc...
Article
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...
Article
Introduction: The Medical Devices Committee (CODIMS) of the Assistance publique-Hôpitaux de Paris (AP-HP) is responsible for deciding whether innovative and costly sterile medical devices (SMD) should be adopted for the AP-HP network and for issuing recommendations on their proper use. The aim of this study was to qualify retrospectively the level...
Article
Background: At 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 not...
Article
Full-text available
Background: Three-dimensional (3D) printing is becoming increasingly important in medicine and especially in surgery. The aim of the present work was to identify the advantages and disadvantages of 3D printing applied in surgery. Methods: We conducted a systematic review of articles on 3D printing applications in surgery published between 2005 a...
Article
Full-text available
Context: Economic evaluations are far less frequently reported for medical devices than for drugs. In addition, little is known about the quality of existing economic evaluations, particularly for innovative devices, such as those used in vertebroplasty and kyphoplasty. Objective: To assess the level of evidence provided by the available economi...
Data
Hierarchy scale for data sources in economic evaluations from Cooper et al. (DOCX)
Article
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 (phy...
Article
Local health technology assessment (HTA) to determine whether new health technologies should be adopted is now a common practice in many healthcare organizations worldwide. However, little is known about hospital-based HTA activities in France. The objective of this study was to explore hospital-based HTA activities in French university hospitals a...
Article
Innovative medical devices offer solutions to medical problems and greatly improve patients' outcomes. Like National Health Technology Assessment (HTA) agencies, hospitals face numerous requests for innovative and costly medical devices. To help local decision-makers, different approaches of hospital-based HTA (HB-HTA) have been adopted worldwide....
Article
Objectives: Several models of hospital-based health technology assessment (HTA) have been developed worldwide, for the introduction of innovative medical devices and support evidence-based decision making in hospitals. Two such models, the HTA unit and mini-HTA models, are widespread in university hospitals and involve various stakeholders. The pu...
Article
Rationale, aims and objectives: 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 t...
Article
Innovative medical devices offer solutions to medical problems and greatly improve patients’ outcomes. Like National Health Technology Assessment (HTA) agencies, hospitals face numerous requests for innovative and costly medical devices. To help local decision-makers, different approaches of hospital-based HTA (HB-HTA) have been adopted worldwide....
Article
Related to the good practice contract implemented in hospitals, the prescription dedicated to medical devices, such as pharmaceuticals, could promote safety and good practice. We attempted to implement a computerized prescription for medical devices. In order to illustrate the method, two examples were selected: the Negative Pressure Wound Therapy...
Article
To conduct a risk analysis of the negative pressure wound therapy (NPWT) care process and to improve the safety of NPWT, a working group of nurses, hospital pharmacists, physicians and hospital managers performed a risk analysis for the process of NPWT care. The failure modes, effects and criticality analysis (FMECA) method was used for this analys...
Article
Objective The aim of our study is to evaluate seven flow rate regulators (FRR) to assess the reliability of these devices compared to standard perfuser with roller clamp.
Article
The aim of our study is to evaluate seven flow rate regulators (FRR) to assess the reliability of these devices compared to standard perfuser with roller clamp. Each FRR was tested with 5% dextrose and 0.9% sodium chloride combined with three different theoretical flow rates (30, 80 and 250 ml/h). Accuracy was compared with the theoretical value. R...
Article
The purpose of this study was to compare the cost-effectiveness of coils versus the Amplatzer Vascular Plug (AVP) for occlusion of the internal iliac artery (IAA). Between 2002 and January 2006, 13 patients (mean age 73 +/- 13 years) were referred for stent-grafting of abdominal aortic aneurysm (n = 6); type I distal endoleak (n = 3), isolated ilia...
Article
Infusion practice is of major importance in hospital because of its frequency and role for treatment outcome, and the associated iatrogenic risks (overdose, air embolism, infection). Therefore it can be considered as a true marker of good clinical practice. A survey conducted with nurses in our hospital revealed a significant prevalence of infusion...
Article
The occurrence of infusion incidents related to the misuse of medical devices recently raised concerns about patients safety in our hospital. Consequently, local infusion practices assessment were required by the pharmacy department, the medical devices committee, the care policy Direction and the infection control Unit. Two types of questionnaires...

Citations

... 3D printed models can be embedded into the curriculum of medical education within preclinical years (often the first-half of medical school years), which can allow for better anatomic visualization. Moreover, the literature on the effects of 3D visualization programs in student curriculum has shown promise in potentially improving memory recall of anatomy and spatial understanding (18)(19)(20)(21)(22)(23)(24). However, the concerns regarding cost of implementation may serve as a potential barrier towards widespread implementation in medical student curriculum (23)(24)(25). ...
... Transcatheter aortic valve implantation (TAVI) is a technically complex procedure and has a significant learning curve, training protocols being based on proctored sessions, animal models, or on dry laboratory procedures. 1,2 There is currently no consensus regarding the minimum number of procedures required for an operator to achieve expertise, nor any guidelines for initiating a TAVI program. 2 Aortic regurgitation (AR), predominantly of the paravalvular type, is considered the most common and characteristic drawback of transcatheter deployed aortic prostheses. 3 Paravalvular AR is more frequently observed after TAVI as compared to surgical aortic valve replacement (SAVR). ...
... Comprehensive implementation of medical 3D printing in oral and maxillofacial surgery (OMFS) has significantly expanded the limits of preoperative planning and intraoperative realization in recent decades [1]. In dental implantology, a multitude of applications exist that are being continuously refined, such as alveolar ridge augmentation, traumatology, orthognathic surgery, and microvascular bone reconstruction [2][3][4][5]. ...
... supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance should be significantly reinforced, whilst provisions ensuring transparency and traceability regarding MD should be introduced, to improve health and safety' [2]. As recently reported, these fundamental and necessary changes [8] will have a central implication in the development of new devices and could affect their innovation and availability, as well as discourage investment in research within Europe. Start-ups and SME might not be able to cope with the increasing complexity and the required changes in perspective [7,9]. ...
... There are only a few data concerning the economic perspective of percutaneous LAAC [5][6][7][8][9][10][11][12]. Moreover, in the existing literature, direct primary cost-utility analyses of LAAC have been performed rarely. ...
... The additional sterilisation step is costly and time consuming and requires additional capital investments for hospitals [4]. Multiple cost evaluations have been conducted to create an understanding of the cost associated with using bronchoscopes, where the cost of RFBs is typically divided into the categories of capital, repair and reprocessing [4,8,9]. In 2009, the first single-use flexible bronchoscope (SFB) was introduced as an alternative technology to the RFB while simultaneously making reprocessing and repairs redundant and potentially offering a clinical advantage by eliminating cross-infection caused by the RFB [4]. ...
... Elle s'est ensuite développée comme mode de production à part entière dans différents secteurs industriels 3 en biomécanique, en gestion de la qualité ou encore sur la réglementation du dispositif médical. C'est pourquoi la production par impression 3D au sein d'un établissement de santé reste pour le moment limitée à la conception de dispositifs relativement simples tels que des modèles anatomiques et des guides chirurgicaux 19 . La production internalisée a connu un essor important pendant l'épidémie liée au SARS-CoV-2 de 2020 où des équipements de protection tels que des visière ont pu être imprimés en 3D pour approvisionner rapidement les établissements de santé 20 . ...
... Many principles of trial design used for pharmaceutical products apply also for medical devices, but some characteristics of high-risk devices imply a need for different guidance. 19 Incremental development with short life cycles, the physical mode of action, the complexity of interventions, and dependency on contextual factors may lead to device modifications during the course of clinical investigations, hinder blinding, or imbalance recruitment to study arms due to provider and patient preferences. Individual and institutional learning curves may have to be taken into account when quantifying the effect of an intervention. ...
... In the studies conducted by Martelli et al. (2017) and Kidholm et al. (2015), the managers participating in the research stated that they needed the most information about clinical effectiveness and economic aspects when they decided to acquire a new technology. On the other hand, a review of the literature provides that HTA is defined in the broadest terms as "a multidisciplinary process that summarises information about the medical, social, economic, and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner" (Grenon et al., 2016;Kahveci and Dilmaç, 2013;Kanis and Hiligsmann, 2014;Kristensen et al., 2008;Martin et al., 2016;Nielsen et al., 2008;Yiğit and Erdem, 2016). ...
... Using computational design also changes the preparation time for surgical uses of 3D printing. Martelli et al. [48] mention the time necessary for data processing and preparing 3D models (rather than 3D printing itself) as the most time-consuming aspects of using 3D printing in surgery. The time necessary for the computational design system to produce the tool design will also affect preparation time. ...