Metric identification and mapping of reimbursable implant codes in Morocco to the global nomenclature (GMDN) and European (EUDAMED) of medical devices.

BACKGROUND: The list of medical devices (MD) eligible for reimbursement under the Compulsory Health Insurance in Morocco is set by Ministerial Order comprising 869 items between life-support equipment, external prostheses, and implants. The objective of the present study is to analyze the nomenclature of implantable medical devices (IMD) appearing on this list and compare them with the global nomenclature of MD (GMDN) and the European nomenclature of MD (EMDN). METHODS: The study deals with (i) the mapping of the codes of the IMD list with 170 DM per cardinality and (ii) a metric identification by Sørensen-Dice coefficient of terminological similarity of the IMD with respect to the two databases. RESULTS: The 170 IMD codes are mapped onto 493 terms in the GMDN and 344 terms in the EMDN. The 37.7% of implants are mapped to more than or equal to 2 terms of GMDN while 36.5% are mapped to more than or equal to 2 terms to the EMDN. The comparison of cardinality distributions has revealed no significant difference (P=0.430) between the two databases. The implants examined are divided into 11 categories whose strong similarity is given to active cardiovascular implants in the EMDN database with simDice=0.534. CONCLUSION: Healthcare authorities need to align with nomenclature standards to improve interoperability and rely on a more efficient and rational regulatory process.

[Optimizing the use-by date of reusable medical devices. Experience in a healthcare establishment]. / Optimisation de la date limite d'utilisation des dispositifs médicaux réutilisables. Expérience dans un établissement de santé.

OBJECTIVES: Sterilized reusable medical devices have a use-by date, after which sterility is no longer guaranteed. There is currently no consensus on how this should be determined. The aim is to re-evaluate the expiry date of reusable medical devices, by means of a risk analysis and an assessment of the maintenance of the sterile state of reusable medical devices over time. METHODS: The risk analysis focused on the stages whose malfunction could compromise the sterility of reusable medical devices over time: packaging, transport and storage. Risk mapping was carried out in accordance with the methodology recommended by the French Health Authority. Based on standard NF EN ISO 11737, the assessment of the maintenance of the sterile state was checked on reusable medical devices after two, four and six months storage and on reusable medical devices that had expired more than a year previously. RESULTS: The risk analysis identified four failures and sixty-eight potential causes. The most sensitive stage was storage, which accounted for most of the critical and major causes. Improvement actions were proposed, such as the definition of a container maintenance plan. At the same time, 256 reusable medical devices were tested. The cultures remained sterile for all the containers, for folded products tested at 6 months and more and for the sachets tested at 2 and 4 months and at more than one year of storage. CONCLUSIONS: The DLU has been extended to 4 months for sachets, 6 months for folded products and maintained at six months for containers.

ECT: An essential therapy in psychiatry.

At a time when innovations in psychiatry are booming, particularly in the field of medical devices, we thought it necessary, as members of French Society for Biological Psychiatry and Neuropsychopharmacology (AFPBN), to reconsider one of the oldest medical devices in psychiatry: the ECT apparatus. First, we recall the regulatory aspects of ECT. National guidelines define means of implementation and conditions of administration of ECT. Second, we remind of the indications and levels of evidence of ECT in the main psychiatric disorders, including catatonia. Then, we synthetize the place of ECT alongside other brain stimulation therapies, especially repetitive Trancranial Magnetic Stimulation (rTMS). Furthermore, we explain the general effects of ECT: increased neuronal plasticity and neurogenesis, enhancement of the stress axis, resistance to oxidative stress, improved vascular endothelial function, activation of microglia and astrocytes, decrease in inflammatory events by upregulation of neuroinflammatory cytokines, and production of mitochondrial ATP. These effects appear from the first sessions and continue during the course of ECT treatment, suggesting activation of endogenous neuroprotection. Finally, we remember that most patients perform as well or better on neuropsychological assessments after ECT, relative to pre-ECT results, and this improvement continues over the following months. Memory disorders reported post-ECT are not all attributable to ECT. They may be subjective in nature or linked to residual depressive (and possibly comorbid neurogenerative) symptoms later attributed to ECT, on the basis of preexisting negative representations. We urgently need to reemphasize the crucial role of ECT in psychiatric treatment strategies as well as the need to update ECT recommendations.

[Infusion sets in neonatology: What practices in France?] / Montages de perfusion en néonatologie : quelles pratiques en France ?

OBJECTIVES: Therapeutic management of ill newborns can require complex infusion practices using medical devices (MD). Currently, there does not exist any recommendations concerning these infusion practices. The objective of this work was to study and characterise French infusion methods neonatal and neonatal intensive care units. MATERIALS AND METHODS: The study was performed in 2019, during 6 months. French hospitals possessing high (type 3) or medium (type 2B) grade maternity ward were contacted and asked to complete a 5 part online survey, to gather general information about the hospital/ward, infusion methods (overall and detailed), and detailed information about the medications and MD used. RESULTS: The participation level was of 19.6 % Type 3 maternities use overall two-times more MD than those of type 2B. The vascular access device most commonly used was a single lumen catheter (80.6 % of infusion methods). 100 % of the hospitals having answered used multi-access devices (three-way tap, multiport infusion manifold, Y-extension lines) and 93.5 % used a pump-infusor. Lipidic filters for parenteral nutrition were used in 78.6 % of the hospitals. Two general standard of infusion methods were isolated: a simple version with two access points (type 2B hospitals), and a complex one with five access points (from hospitals with type 3 maternities). CONCLUSIONS: Neonatal infusion practices in France are very heterogeneous, thus exposing the patients to a degree of variability during their therapeutic management. This work is a first step forwards to help analyse and anticipate the risks of content/container interactions caused by infusion practices.

[Educational needs and implantable medical devices: How to meet the expectations of patients with coronary stents and heart valves?] / Besoins éducatifs et dispositif médical implantable : comment répondre aux attentes des patients porteurs de stents coronaires et valves cardiaques ?

At the Grenoble Alpes University Hospital Center, patients with cardiovascular disease have the opportunity to participate in a therapeutic education program in the cardiac rehabilitation department. The objective of this study is to analyze the educational needs of patients with coronary stents and heart valve prostheses. Using an exploratory qualitative method, semi-structured research interviews were conducted with 22 patients and an inductive thematic analysis was performed. We found that emergency surgery does not facilitate the assimilation of information in comparison with a scheduled procedure. The image of the "repaired heart" creates a cognitive conflict with the chronicity imposed by secondary preventive monitoring, a particularity of the implantable medical device. Patients feel that the information they receive is sometimes too voluminous and not adapted to their current needs. Thus, we propose an individualized support model based on the respect of temporality and on the psycho-behavioral functioning of the patient.

[Health technology assessment of innovative medical devices: Timing and decision at national and local level]. / Accès au marché des dispositifs médicaux innovants : articulation entre évaluations nationales et hospitalières.

INTRODUCTION: The Medical Device Committee (CODIMS) evaluates all innovative medical devices (MD) before their introduction in the hospitals of the Assistance publique-hôpitaux de Paris (AP-HP). At the national level, the Medical Device and Health Technology Evaluation Committee (CNEDiMTS) provides recommendation for MD with respects to reimbursement by the National Health Insurance Fund. The aim of this study is to compare the recommendations of both committees and to analyze their timing on a six-year period. MATERIAL AND METHOD: We selected all innovative MD assessed by the CODIMS between 2013 and 2018. We retrieved all the recommendations for these MD from the CNEDiMTS. We performed quantitative and qualitative analysis of data collected. RESULTS: On 30 innovative MD assessed by both the CODIMS and the CNEDiMTS, 11 (37%) evaluations were performed by the CODIMS before the CNEDiMTS evaluation. They occurred approximately a year before the CNEDiMTS recommendation (an average of 378 days). Among the 25 MD with a recommendation of both committees, the two opinions were consistent in 88 per cent of all cases. DISCUSSION/CONCLUSION: This study highlights that there is a good consistency between the recommendations of both committees. This suggests that the MD evaluations conducted at the hospital level are relevant and timely. Finally, a better coordination between the national and local levels should be promoted for the MD assessment.

[Medical devices used in digestive system surgical procedures: What's the cost?] / Dépenses en dispositifs médicaux stériles dans certains actes de chirurgie hépatobiliaire et digestive : que resterait-il du Groupe Homogène de Séjour ?

OBJECTIVE: Medical devices innovations and associated procedures represent a large part of health facilities budget. The aim of this work was to evaluate the cost of medical devices used during different surgical procedures. This cost was compare with the revenue collected from hospital stay pricing. METHOD: A prospective analysis of the medical devices used in operating room was carried out for different types of programmed surgeries. For five weeks, references of sterile single-use medical devices used during the interventions were collected. RESULTS: Expenditure on medical devices used during surgical procedures represented 5.7 % of the hospitalization value for an inguinal hernia repair, 12 % for a cholecystectomy, 9.35 % for a colectomy, 14.5 % for a hepatectomy and 7 % for pancreatectomy, any severity index combined. The most important correlations existed between act duration and patient's level of severity and between operating times and consumables expenditure. CONCLUSION: Cost optimization opportunities are equivalence of some medical devices ranges, purchases with national groupings and potential decreases in operating times related to the use of innovative medical devices.

[Design and assessment of a outpatient living with PICC-line support program: A pilot study]. / Étude pilote d'évaluation d'un programme d'accompagnement pour les patients quittant l'hôpital avec un PICC-line.

The peripheral insertion central catheter (PICC-Line) is indicated for long term intravenous medication administration. Some adverse events (AE) might occur, especially for patients after hospital discharge. Therefore, patient empowerment about the side effects and precaution for use is essential to prevent potential patient harm. A multidisciplinary working group met and designed support program for outpatient living with PICC-line. Pharmacy consultations (PC) were proposed to patient before and after PICC-line insertion. A strip cartoon and card game were created to facilitate patient education. The aim of the study was to assess the comprehension of patient then secondarily to follow up AE awareness. During 10 months, 30 patients of mean age 65.9±14 years were included. Thirty-sixPICC-Line were installed and followed on 1659days of catheterization. 4, 9 and 13patients received respectively no, at least one and two PCs before discharge from the hospital. Although the differences were not statistically significant, comprehension tends to improve when patients benefit from both PCs especially when it concerns complications. Twenty-fiveambulatory AEs were recorded including 9infections or suspicion of infection, 2 thrombosis and 2 displacements of PICC-line. Among the patients who had no PC, four experienced delayed care. In comparison, it occurred in only one patient in the group who received at least one PC after PICC-line insertion. Further studies are warranted to confirm this trend.

[3D printed medical devices and anatomical models: What kind of distribution and which uses in French hospitals?] / Dispositifs médicaux et modèles anatomiques produits par impression 3D : quelle diffusion et quelles utilisations dans les établissements de santé français ?

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 in French hospitals in order to its main features in surgery. By conducting a national survey, we targeted hospitals equipped with 3D printers and those using external providers to benefit from this technology. Forty-seven hospitals were identified as using 3D printing including eight equipped with in-house 3D printers. This work gives us a first picture of 3D printing for hospital use in France and it raises questions about hospital pharmacists' involvement in 3D printed medical device production.

[Review of patient-specific instrumentation for total knee prosthesis]. / Revue des guides personnalisés à usage unique dans les prothèses totales de genou.

OBJECTIVES: Single use patient-specific instruments (PSI) for total knee prosthesis are introduced as a new alternative to conventional ancillaries and computer assisted surgery by improving implants positioning. An exhaustive review was carried out to identify their specific characteristics, with their advantages and disadvantages. METHODS: Medical devices suppliers were consulted in 2015 for reviewing their PSI. Their technical, clinical and economic data were compared. The results had been submitted to an orthopaedics expert commission of our university hospital for clinical and financial opinion. RESULTS: Ten companies have provided the documentation for the analysis. PSI are manufactured by suppliers using a three dimensional printing method based on CT scans or MRI images. PSI are produced according to the surgeon's preferences after a preliminary data check, which can be performed by the suppliers' engineers, the surgeon and automatic calculation. Five suppliers can produce sterile PSI with optional delivery of 3D bone models. According to the experts, the studies failed to demonstrate the superiority of a PSI or hospital economic gain. The prices listed remain high and operating room time is not always significantly reduced. CONCLUSIONS: With the development of personalized medicine, the role of PSI grows in importance. They facilitate the surgeon's work by fully respecting the anatomy. These systems offer an interesting perspective in their technical and pedagogical aspects. But it seems premature to take them into routine use given the low number of high-level studies that were currently done.

[Introduction of Health technology assessment at hospital]. / Mise en place de l'évaluation des technologies de santé en milieu hospitalier.

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 of evidence of clinical studies used for the device evaluations by the CODIMS in 2012 and 2013 and to analyze the relationship between levels of evidence and decisions. MATERIAL AND METHOD: Executive summaries written in 2012 and 2013 about studied SMD was analyzed and the level of evidence of clinical studies used was qualified in high/low levels of evidence according to the scale of Sackett et al. Then, levels of evidence were correlated to decisions published by the CODIMS. RESULTS: Sixty-one files of SMD (72.1% of implantable MD) have been evaluated (225 clinical studies). Among them, only 28% of clinical studies had a high level of evidence (and 28.6% of MD at-risk) and 18% did not have any clinical studies. The CODIMS delivered an unfavourable opinion for 16 SMD: only 28 clinicals studies were available for evaluation. Among these, only 6 studies had a high level of evidence. DISCUSSION ET CONCLUSION: The amount and level of evidence of clinical studies is naturally correlated to admittance of SMD. These findings suggest that the clinical evidence used to demonstrate safety and efficacy for high-risk medical devices is based on clinical studies with poor quality data, making more difficult the evaluation of SMD in hospital. The development of a multi-criteria tool to help decision-making would improve the process of SMD evaluation by the CODIMS.

[Hospital-based health technology assessment in France: how to proceed to evaluate innovative medical devices?]. / Évaluation des technologies de santé en milieu hospitalier : quelle organisation pour évaluer et acquérir des dispositifs médicaux innovants ?

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. The objective of the present paper is to explore HB-HTA models for adopting innovative medical devices in France and elsewhere. Four different models have been conceptualized: "ambassador" model, "mini-HTA" model, "HTA unit" model and "internal committee". Apparently, "HTA unit" and "internal committee" (or a mixture of both models) are the prevailing HB-HTA models in France. Nevertheless, some weaknesses of these models have been pointed out in previous works. Only few examples involving hospital pharmacists have been found abroad, except in France and in Italy. Finally, the harmonization of the assessment of innovative medical devices in France needs a better understanding of HB-HTA practices.

[CamiCon study: Evaluation of a new tool for automated and connected voiding calendar]. / Étude CamiCon : évaluation d'un nouvel outil pour la réalisation d'un calendrier mictionnel automatisé et connecté.

INTRODUCTION: A voiding diary (VD) is a key element in the evaluation of patients with overactive bladder (OAB) at initial presentation and during treatment to assess its effectiveness. In order to be clinically relevant, it must be performed over 3 days according to the International Continence Society (ICS). Unfortunately, some patients find it cumbersome. We aimed to evaluate the reliability and patient satisfaction when using a connected tank device. MATERIAL AND METHOD: We conducted a single-center prospective study including 41 patients. Each patient completed a paper voiding diary and then a diary with Diary Pod® (DP) or inversely depending on the study arm. Data from 34 patients were collected. After completion of both diaries, patients completed a satisfaction questionnaire sent by email via GoogleForm. Study statistics were performed with Jamovi® and Excel® software. RESULT: Data from 34 patients were analyzed. There was a statically significant difference (P=0.046) between the mean volume calculated from the paper VD and that calculated from the connected VD (DP). There was no statistically significant difference (P=0.112) between the mean number of daytime voids, mean number of nighttime voids (P=0.156), mean water intake (P=0.183) reported on the paper VD and the connected VD. Thirteen (42%) paper VD and 1 connected VD did not include documentation of the presence or absence of urine leakage or urgency. There was no statistically significant difference between the two calendars regarding the presence or absence of urine leakage (P=0.180) and urinary urgency (P=0.564). Eighty-four percent (26/31) preferred the connected tank to the usual method (paper/pen), while 55% (17/31) and 29% (9/31) of the participants respectively answered that the DP was "very definitely" or "definitely" an aid for performing VD. Nevertheless, 39% (12/31) and 55% (17/31) considered its price to be high or fair and only 22% (7/31) were inclined to buy it. CONCLUSION: This study showed that the Diary connected reservoir Pod® is a reliable and innovative tool for voiding schedules. It facilitates data collection for the majority of patients (83%) and could, through better patient compliance, provide better quality data and help their interpretation by the physician. These factors could encourage the implementation of the connected voiding diary as a diagnostic tool. It would also be used for the assessment of treatment effectiveness in daily clinical practice as well as in research. Its cost remains a major obstacle, judged by 39% of patients to be too high, and could therefore be proposed in specific situations requiring precise data.

A brief history of contact X-ray brachytherapy 50 kVp.

Contact X ray brachytherapy 50 kVp was initiated in the 1930s with the Siemens unit and popularized with the Philips unit in the 1950s. A renaissance was seen in the early 2000s with the Intrabeam™ unit for breast IORT. Presently the Papillon™ systems thanks to its high dose rate (>10Gy/mn) can be used to treat breast (IORT), skin, eyelid and rectal cancers. Future developments are expected to consolidate the place of contact radiotherapy as a safe and efficient treatment for accessible early tumors.

[Telemonitoring by the nurse of patients equipped with an implantable heart device]. / Télésuivi par l'infirmière des patients porteurs d'un dispositif cardiaque implantable.

The nurse is at the heart of the caregiving relationship in the remote monitoring of patients with heart failure equipped with an implantable device. Her direct contact with the patient erases the distance imposed by telemonitoring and her close connection with the cardiologist-arrhythmia specialist ensures the patient follow-up is optimal. After her training in telemedicine, the nurse plays a key role in the telerhythmology activity.

[The prescribing of dressings]. / La prescription des pansements.

Dressings must be prescribed as accurately as possible, whether the prescription is written by a nurse or by a doctor. The pharmacist is then able to dispense the exact product prescribed. Knowledge of the different classes of dressings and their indications ensures the adapted management of chronic and acute wounds.

[Secondary dressings]. / Les pansements secondaires.

Wound management imposes a defined approach to each phase of healing and thereby the need for in-depth knowledge of the various medical devices available: primary and secondary dressings. Secondary dressings are essential as they have an impact on the efficacy of the primary dressing. Their role is to protect, reinforce and cover the primary dressing. In practice, it is usually nurses who have the responsibility of selecting and prescribing the most suitable dressing for the wound.

[Peripherally inserted central catheter antibiotic therapy for cystic fibrosis patients]. / Le PICC line, un nouvel accès veineux pour les cures antibiotiques de la mucoviscidose de l'adulte.

INTRODUCTION: Peripherally inserted central catheters (PICC) are more and more used for intravenous antibiotic infusions in cystic fibrosis (CF) patients in the Grenoble area (France). The aim of this study was to assess the use of this technique in this indication. METHODS: 1. Retrospective evaluation of 102 consecutive PICC insertions over 3years and the incidence of adverse events during the therapy. 2. Prospective evaluation of 12 patient's satisfaction and their nurses over a 3-month period. 3. Comparative analysis of single domiciliary treatment costs using PICC versus peripheral catheter (PC). RESULTS: 102 PICC insertions were attempted in 31 patients. Seven failures and 7 complications occurred during the treatment requiring removal of the PICC, i.e. an overall success rate of 86.2% (88/102). Pain during PICC introduction was 4.2/10 (visual analogical scale). Mean satisfaction levels during therapy were 9.3/10 for patients and 8.7/10 for nurses. Compared with PC, all the patients said that PICC was "more comfortable". Differential costs of treatment with PC and with PICC at home were estimated at 57.15€ and 590.16€ respectively. CONCLUSION: PICC is an alternative to CP for intravenous antibiotherapy in CF patients, providing better safety and comfort. PICC use should be promoted in this indication.