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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 12 experts was assembled based on their knowledge of 3D-printed medical devices and then interviewed individually. Results: A strong consensus was reached for three types of impacts out of the 12 types of OIs associated with medical devices: the need for training, cooperation and communication and the logistics circuit. Conclusion: It seems very relevant to integrate these three types of impacts in future evaluations of 3D printing in healthcare.

BackgroundTranscatheter 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 quality of information reported about the learning curve.Materials and methodsA systematic review of articles published between 2007 and 2017 was performed using PubMed and the EMBASE database. Prospective studies regarding TAVI were included. The quality of information reported about the learning curve was evaluated using the following criteria: mention of the learning curve, the description of a roll-in phase, the involvement of a proctor, and the number of patients suggested to maintain skills.ResultsA total of sixty-eight studies met the selection criteria and were suitable for analysis. The learning curve was addressed in approximately half of the articles (n = 37, 54 percent). However, the roll-in period was mentioned by only eight studies (12 percent) and with very few details. Furthermore, a proctorship was disclosed in three articles (4 percent) whereas twenty-five studies (37 percent) included authors that were proctors for manufacturers of TAVI.ConclusionMany prospective studies on TAVI over the past 10 years mention learning curves as a core component of successful TAVI procedures. However, the quality of information reported about the learning curve is relatively poor, and uniform guidance on how to properly assess the learning curve is still missing.

International audience; 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 reconstruction, and to quantify the impact of this technology on operating times.Methods: A systematic review was conducted by searching PubMed and EMBASE to collect comparative studies on 3D printing applications in jaw reconstruction. A meta-analysis of operating times was then performed. A Cochran's Q test was used to determine heterogeneity, and the overall effect size was calculated using a random effects model.Results: Fourteen studies were included in our review. Eighteen clinical end-points were identified, of which the most frequently reported were operating time (n = 5; 35.7%) and the final aesthetic result (n = 4; 28.6%). Operating times were significantly lower in the 3D printing groups, with an overall estimated effect of 21.2% (95% CI 10-33%; p < 0.001).Conclusion: The use of 3D printing in jaw reconstruction was associated with a significant reduction in operating times. The end-points evaluated differed largely among the studies. More studies with higher levels of evidence are needed to confirm our results.

ObjectiveBecause 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 present economic findings.MethodsA systematic review was performed using four electronic databases to identify health economic evaluation studies dealing with VADs. The methodological quality and reporting quality of the studies was assessed using three different tools, the Drummond, Cooper, and CHEERS (Consolidated Health Economic Evaluation Reporting Standards) checklists.ResultsOf the 1,258 publications identified, thirteen articles were included in this review. Twelve studies were cost–utility analyses and one was a cost-effectiveness analysis. According to the Cooper hierarchy scale, the quality of the data used was heterogeneous. The level of evidence used for clinical effect sizes, safety data, and baseline clinical data was of poor quality. In contrast, cost data were of high quality in most studies. Quality of reporting varied between studies, with an average score of 17.4 (range 15–19) according to the CHEERS checklist.ConclusionThe current study shows that the quality of clinical data used in economic evaluations of VADs is rather poor in general. This is a concern that deserves greater attention in the process of health technology assessment of medical devices.

ObjectivesThe 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 costs associated with its use and highlight the first quantitative data available.MethodsA systematic literature review was conducted in the PubMed and Embase databases and in the National Health Service Economic Evaluation Database (NHS EED) at the University of York. Studies that reported an assessment of the costs associated with the use of 3D printing for surgical application and published between 2009 and 2019, in English or French, were included.ResultsNine studies were included in our review. Nine types of costs were identified, the three main ones being printing material costs (n = 6), staff costs (n = 3), and operating room costs (n = 3). The printing cost ranged from less than U.S. dollars (USD) 1 to USD 146 (in USD 2019 values) depending on the criteria used to calculate this cost. Three studies evaluated the potential savings generated by the use of 3D printing technology in surgery, based on operating time reduction.ConclusionThis literature review highlights the lack of reliable economic data on 3D printing technology. Nevertheless, this review makes it possible to identify expenditures or items that should be considered in order to carry out more robust studies.

Objectives The aim of this study was to determine relevant items for reporting clinical trials on implantable medical devices (IMDs) and to identify reporting guidelines which include these items. Study Design and Setting A panel of experts identified the most relevant items for evaluating IMDs from an initial list based on reference papers. We then conducted a systematic review of articles indexed in MEDLINE. We retrieved reporting guidelines from the EQUATOR network's library for health research reporting. Finally, we screened these reporting guidelines to find those using our set of reporting items. Results Seven relevant reporting items were selected that related to four topics: randomization, learning curve, surgical setting, and device information. A total of 348 reporting guidelines were identified, among which 26 met our inclusion criteria. However, none of the 26 reporting guidelines presented all seven items together. The most frequently reported item was timing of randomization (65%). On the contrary, device information and learning curve effects were poorly specified. Conclusion To our knowledge, this study is the first to identify specific items related to IMDs in reporting guidelines for clinical trials. We have shown that no existing reporting guideline is totally suitable for these devices.

Objectives: 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 and to provide a picture of organizational approaches to the assessment of new and innovative medical devices.Methods: Eighteen semi-structured interviews with hospital pharmacists were conducted from October 2012 to April 2013. Six topics were discussed in depth: (i) the nature of the institution concerned; (ii) activities relating to innovative medical devices; (iii) the technology assessment and decision-making process; (iv) the methodology for technology assessment; (v) factors likely to influence decisions and (vi) suggestions for improving the current process. The interview data were coded, collated and analyzed statistically.Results: Three major types of hospital-based HTA processes were identified: medical device committees, innovation committees, and “pharmacy & management” processes. HTA units had been set up to support medical device and innovation committees for technology assessment. Slow decision making was the main limitation to both these committee-based approaches. As an alternative, “pharmacy & management” processes emerged as a means of rapidly obtaining a formal assessment.Conclusions: This study provides an overview of hospital-based HTA initiatives in France. We hope that it will help to promote hospital-based HTA activities in France and discussions about ways to improve and harmonize practices, through the development of national guidelines and/or a French mini-HTA tool, for example.

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.

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.

International audience; We describe here recent modifications to the French Coverage with Evidence Development (CED) scheme for innovative medical devices. CED can be defined as temporary coverage for a novel health product during collection of the additional evidence required to determine whether definitive coverage is possible. The principle refinements to the scheme include a more precise definition of what may be considered an innovative product, the possibility for device manufacturers to request CED either independently or in partnership with hospitals, and the establishment of processing deadlines for health authorities. In the long term, these modifications may increase the number of applications to the CED scheme, which could lead to unsustainable funding for future projects. It will also be necessary to ensure that the study conditions required by national health authorities are suitable for medical devices and that processing deadlines are met for the scheme to be fully operational. Overall, the modifications recently applied to the French CED scheme for innovative medical devices should increase the transparency of the process, and therefore be more appealing to medical device manufacturers.

Resume Depuis l’arret DocMorris rendu par la Cour de Justice des Communautes europeennes (CJCE) le 11 decembre 2003, il n’est pas possible a un Etat membre d’interdire de facon absolue la vente de medicaments sur Internet. Or, aucune disposition n’a ete adoptee par le legislateur francais pour tirer les consequences de la jurisprudence communautaire, afin d’encadrer cette vente a partir de sites pharmaceutiques francais. Les auteurs envisagent cette necessaire evolution et proposent des modifications du code de la sante publique visant a securiser les nouvelles pratiques de vente virtuelle.

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 and 2015 and identified using a PubMed and EMBASE search. Studies dealing with bioprinting, dentistry, and limb prosthesis or those not conducted in a hospital setting were excluded. Results A total of 158 studies met the inclusion criteria. Three-dimensional printing was used to produce anatomic models (n = 113, 71.5%), surgical guides and templates (n = 40, 25.3%), implants (n = 15, 9.5%) and molds (n = 10, 6.3%), and primarily in maxillofacial (n = 79, 50.0%) and orthopedic (n = 39, 24.7%) operations. The main advantages reported were the possibilities for preoperative planning (n = 77, 48.7%), the accuracy of the process used (n = 53, 33.5%), and the time saved in the operating room (n = 52, 32.9%); 34 studies (21.5%) stressed that the accuracy was not satisfactory. The time needed to prepare the object (n = 31, 19.6%) and the additional costs (n = 30, 19.0%) were also seen as important limitations for routine use of 3D printing. Conclusion The additional cost and the time needed to produce devices by current 3D technology still limit its widespread use in hospitals. The development of guidelines to improve the reporting of experience with 3D printing in surgery is highly desirable.

A legal anachronism : the notion of medical weight in the definition of medicine, from the germinal Act to the ordinance of September 1967. From 1941 to 1967, during a quarter of century, the legal definition of medicine refered to a conditioning for a medical weight. This precision had not a literal meaning. So, the case-law, specially the «Cour de cassation», said, several times, which bearing to give to this amazing legal anachronism., Un anachronisme juridique : la notion de poids médicinal dans la définition du médicament, de la loi de germinal à l'ordonnance du 23 septembre 1967. De 1941 à 1967, pendant plus d'un quart de siècle, la définition juridique du médicament a fait référence à un conditionnement en vue de l'usage au poids médicinal. Cette précision étant dépourvue de toute signification littérale, c'est la Cour de cassation qui a indiqué à plusieurs reprises quelle portée il convenait de conférer à cet étonnant anachronisme juridique., Van den Brink Hélène, Fouassier Éric. Un anachronisme juridique : la notion de poids médicinal dans la définition du médicament de la loi germinal à l'ordonnance du 23 septembre 1967. In: Revue d'histoire de la pharmacie, 89ᵉ année, n°330, 2001. pp. 215-221.

The indivisibility of the ownership and the running of pharmacy. The indivisibility of the ownership and the running of a pharmacy is one of the basic principles of the pharmaceutical profession and find its origin in two ancient texts: The Royal Declaration of April 25th, 1777 and some twenty-six years later, the well-known law of 21st Germinal, year XI. The spirit of the law should have done with the competitors, but it did not. The principle was stretched many times until a Court Decision in June 23rd, 1859. Since then the rule was progressively confirmed and many conventions relative to the ownership and the running have been forbidden. Yet certain derogations do exist. Nevertheless, the publication of a law in December 11th, 2001, called « law MURCEF » overthrows deeply the principle because it could allow for reconsideration., Le principe de l'indivisibilité de la propriété et de l'exploitation est un des principes de base de la profession pharmaceutique qui trouve ses origines dans deux textes anciens : la Déclaration royale du 25 avril 1777 et, vingt-six ans plus tard, la fameuse loi du 21 germinal an XI. L'esprit de la loi aurait dû écarter les concurrents et pourtant il n'en fut pas ainsi. Le principe connut de nombreuses entorses jusqu'à un arrêt de la Cour de cassation du 23 juin 1859. Puis, au fur et à mesure que cette règle s'affirmait, de nombreuses conventions relatives à la propriété et à l'exploitation ont été prohibées, en laissant place, toutefois, à certaines dérogations. Néanmoins, la publication de la loi du 11 décembre 2001, dite loi MURCEF, bouleverse profondément ce principe puisqu'il pourrait fort bien être remis en cause., Van den Brink Hélène. Le principe d'indivisibilité de la propriété et de l'exploitation de l'officine. In: Revue d'histoire de la pharmacie, 91ᵉ année, n°339, 2003. pp. 407-416.

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.

3D printing is a technology that allows the production of an object by additions of materials layers by layers. This technology has many applications in healthcare: bio-printing of tissues and organs, manufacture of medicines or production of customised medical devices. Over the last fifteen years, the production of anatomical models, surgical guides and implants adapted to the patient's anatomy has grown exponentially in all surgical domains. Nevertheless, the question of its clinical and economic evaluation remains unanswered. The objective of this work is to propose several recommendations for designing an economic evaluation model that would take into account the numerous specificities of this technology. We underlined that existing models are not suitable for evaluating a 3D printed device, in particular by highlighting the importance of organisational impact assessment. Thus, we suggested ten key recommendations to be taken into account when designing a study model for 3D printed medical devices., L’impression 3D est une technologie permettant la fabrication d’un objet par additions successives de couches de matériaux. Cette technologie trouve de nombreuses applications dans le domaine de la santé : bio-impression de tissus et d’organes, fabrication de médicaments ou encore production de dispositifs médicaux sur mesure. Ces quinze dernières années, la production de modèles anatomiques, de guides chirurgicaux et d’implants adaptés à l’anatomie du patient s’est développée de façon exponentielle dans toutes les spécialités chirurgicales. Néanmoins, la question de son évaluation clinique et médico-économique reste entière. L’objectif de ce travail est de proposer des recommandations visant à élaborer un modèle d’évaluation médico-économique qui prendrait en compte les spécificités de cette technologie. Nous avons pu démontrer que les modèles médico-économiques existants ne conviennent pas pour évaluer un dispositif imprimé en 3D, en mettant notamment en avant l’importance de l’évaluation de l’impact organisationnel. Ainsi, nous proposons dix recommandations essentielles à prendre en compte pour la conception d’un modèle d’étude de dispositifs médicaux imprimés en 3D.