Nasal cannula and face mask gas flow rates when connecting to the Y-piece of the anesthesia circuit.

STUDY OBJECTIVE: To determine the relationship between the delivered gas flows via nasal cannulas and face masks and the set gas flow and the breathing circuit pressure when connecting to the Y-adapter of the anesthesia breathing circuit and using the oxygen blender on the anesthesia machine, relevant to surgery when there is concern for causing a fire. The flow rates that are delivered at various flow rates and circuit pressures have not been previously studied. DESIGN: Laboratory investigation. SETTING: Academic medical center. PATIENTS: None. INTERVENTIONS: The gas flows from each of 3 anesthesia machines from the same manufacturer were systematically increased from 1 to 15 L/min with changes to the adjustable pressure limiting valve to maintain 0-40 cm water pressure in the breathing circuit for nasal cannula testing and at 20-30 cm water circuit pressure for face masks. MEASUREMENTS: The delivered gas flows to the cannula were determined using a float-ball flowmeter for combinations of set gas flows and circuit pressures after connecting the cannula tubing to the Y-piece of the anesthesia circuit via a tracheal tube adapter. Decreasing the supply tubing length on the delivered flow rates was evaluated. MAIN RESULTS: There was a highly linear relationship between the anesthesia circuit pressure and the delivered nasal cannula flow rates, with 0 flow observed when the APL valve was fully open (i.e., 0 cm water). However, even under maximum conditions (40 cm water and 15 L/min), the delivered nasal cannula flow rate was 3.5 L/min. Shortening the 6.5-ft cannula tubing increased the flow at 20 and 30 cm water by approximately 0.12 L/min/ft. The estimated FiO2 assuming a minute ventilation of 5 L/min and 30% FiO2 ranged from 21.7% to 27.0% at nasal cannula flow rates of 0.5 to 4.0 L/min. When using a face mask and the APL fully closed, delivered flow rates were 0.25 L/min less than the set flow rate between 1 and 3 L/min and equal to the set flow rate between 4 and 8 L/min. CONCLUSIONS: When using a nasal cannula adapted to the Y-piece of the anesthesia circuit, the delivery system is linearly dependent on the pressure in the circuit and uninfluenced by the flow rate set on the anesthesia machine. However, only modest flow rates (≤ 3.5 L/min) and a limited increase in the inspired FiO2 are possible when using this delivery method. When using a face mask and the anesthesia circuit, flow rates close to the set flow rate are possible with the APL valve fully closed. Patients scheduled for sedation for head and neck procedures with increased fire risk who require more than a marginal increase in the FiO2 to maintain an acceptable pulse oximetry saturation may need general anesthesia with tracheal intubation.

Experience-based Modifications of the Bed Band ReAlised through Co-dEsign (EMBRACE).

BACKGROUND: Upper body limitations are a common disability in neurological conditions including stroke and multiple sclerosis. Care of patients with upper body limitations while in bed involves positioning techniques to maximise comfort and independence. The Bed Band is a nurse-led innovation to support people with limited mobility to maintain a comfortable position in bed, thereby promoting comfort and independence with activities of daily living. AIM: To co-design and implement adaptations to the Bed Band prototype with recommendations for user instructions towards enhanced product design and future development. METHODS: A co-design approach involving collaboration between academic and industry partners. Expert stakeholders provided feedback on the Bed Band via an online focus group before healthy volunteers tested the product in a healthcare simulation suite. Data were thematically analysed and findings sense checked by expert stakeholders who then prioritised adaptations to the Bed Band using a modified Delphi technique. RESULTS: Three themes resulted from the analysis: (1) reaction to the Bed Band; (2) potential risks and mitigation; and (3) product adaptations. Simplicity was a strength of the innovation which easily enabled positional support. Adaptations to the Bed Band informed the development of an enhanced prototype for testing in future studies. CONCLUSION: Co-design of the Bed Band prototype involving experts and healthy volunteers enabled early identification of potential risks with recommendations to mitigate them and priority adaptations. Further studies are required in hospital patients and community populations with upper mobility issues to determine the efficacy of the Bed Band and optimal duration of use.

Working Hours and Personal Protective Equipment Effect on Blood Cholinesterase Levels of Tobacco Plantation Workers

@#Introduction: Tobacco production is increasing in certain regions of Indonesia due to its high economic value. Tobacco and its products can have harmful effects on the health of consumers, producers and processing workers. Analysis of blood samples has shown that tobacco farmers are at risk of developing occupational diseases related to pesticide exposure and nicotine absorption through the epidermis of wet tobacco leaves. The aim of this study was to compare blood cholinesterase levels in tobacco plantation workers in relation to their working hours and use of personal protective equipment (PPE). Methods: This cross-sectional observational study was conducted in ten subdistricts in Jember district, Indonesia, and included 50 participants selected using proportional sampling. Spearman’s test was used to analyse the relationship between variables. Results: The significance value of the relationship based on Spearman’s test between working hours and blood cholinesterase levels of tobacco farmers in Jember was 0.058 > α (0.05). Meanwhile, the significance value of the relationship between working hours and complete blood count, specifically mean corpuscular haemoglobin concentration (MCHC), was 0.00 < α (0.05), and between PPE use and blood cholinesterase levels was 0.035 < α (0.05). Conclusion: Working hours were not associated with blood cholinesterase levels, but were associated with blood MCHC levels. Meanwhile, the use of PPE was found to be associated with cholinesterase levels in tobacco farmers.

Spinal cord injury without radiological abnormality due to a fall while using an abdominal roller: A report of two cases.

Background: In recent years, various home-use health devices have gained popularity. The abdominal roller is one of these. Spinal cord injury without radiological abnormality is known to occur even with relatively minor injuries, but there are few reports of such injuries caused by a roller. Case Presentation: Two cases of spinal cord injuries caused by a roller are reported. In both cases, injuries occurred during the standing rollout by a patient in an inebriated state, and the patients were rushed to an emergency department. Conclusion: Because the use of abdominal rollers may result in extremely serious disabilities, it is necessary to emphasize the appropriate use of such equipment.

Recreational windsurfing-related acute injuries: a narrative review. Part 2: injury prevention and a proposal for a set of potential prevention strategies with a holistic approach.

Objective: The purpose of this review was to identify existing prevention strategies for recreational windsurfing-related acute injuries and provide clinicians with a practical overview of current evidence supporting proposed potential prevention strategies. Methods: A literature search was conducted through March 8, 2023, using relevant keywords with Boolean operators, such as "windsurfing" AND "injury prevention" and "windsurfing" AND "exercise interventions," from the PubMed and Google Scholar databases. Only peer-reviewed English-articles were included. Results: Existing prevention strategies, right-of-way rules, a new proposed set of eight potential primary to tertiary prevention strategies for windsurfing-related acute injuries, and proposed definitions of injury prevention levels equivalent to Haddon's matrix were identified and tabled. Conclusions: The proposed potential prevention strategies may facilitate clinicians in preventing recreational windsurfing-related acute injuries. Injury prevention for recreational windsurfing is under-researched. Future studies should focus on large prospective clinical trials evaluating the efficacy of prevention strategies for recreational windsurfing-related injuries.

Objectif: Le but de cette étude était d'identifier les stratégies de prévention existantes pour les blessures aiguës liées à la pratique récréative de la planche à voile et de fournir aux cliniciens une vue d'ensemble pratique des preuves actuelles soutenant les stratégies de prévention potentielles proposées. Méthodologie: Une recherche documentaire a été effectuée jusqu'au 8 mars 2023, en utilisant des mots clés pertinents avec des opérateurs booléens, tels que "windsurfing" AND "injury prevention" (planche à voile ET prévention des blessures) et "windsurfing" AND "exercise interventions ¼ (planche à voile ET prescriptions d'exercices) à partir des bases de données PubMed et Google Scholar. Seuls les articles en anglais examinés par des pairs ont été retenus. Résultats: Les stratégies de prévention existantes, les règles de droit de passage, un nouvel ensemble proposé de huit stratégies potentielles de prévention primaire à tertiaire pour les blessures aiguës liées à la pratique de la planche à voile, et les définitions proposées des niveaux de prévention des blessures équivalentes à la matrice de Haddon ont été déterminés et présentés. Conclusions: Les stratégies de prévention potentielles proposées peuvent aider les cliniciens à prévenir les blessures aiguës liées à la pratique récréative de la planche à voile. La prévention des blessures liées à la pratique récréative de la planche à voile n'est pas suffisamment étudiée. Les études futures devraient se pencher sur de vastes essais cliniques prospectifs évaluant l'efficacité des stratégies de prévention des blessures liées à la pratique récréative de la planche à voile.

Towards cost saving in surgery without compromising safety: stapleless laparoscopic splenectomy in a developing country-a prospective cohort study.

BACKGROUND: Minimally invasive surgery has been steadily growing in popularity. Control of splenic hilar vessels is the most delicate step during laparoscopic splenectomy (LS). In the earlier eras of LS, hilar vessels were controlled using clips and/or ligation. Laparoscopic staples were later introduced and have arguably led to an increase in popularity of LS. They do not abolish potential complications of splenectomy and theoretically represent an added operative cost.In this study, we aimed to assess the safety and efficacy of stapleless LS (using knots, haemostatic devices and clips) compared with the now more conventional stapled LS. METHODS: A pilot randomised prospective study was conducted in a university hospital between September 2018 and April 2020. It included 40 patients randomly assigned to two equal groups: (1) 20 patients: stapleless LS and (2) 20 patients: LS using laparoscopic staples.We compared operative time, intra and postoperative complications and postoperative recovery. RESULTS: There was no statistically significant difference between both groups across all comparative outcomes. CONCLUSION: Both techniques are comparable in terms of safety and operative time. In terms of cost efficiency, we recommend more comprehensive analyses of hospital costs.

Novel solutions to old problems: improving the reliability of emergency equipment provision in critical care using accessible digital solutions.

Reliable provision of emergency equipment in Critical Care is key to ensure patient safety during medical emergencies and transfers. A problem was identified in incident reports and external inspections of processes that ensured the provision of such equipment for use by critical care teams in non-critical care areas in the form of grab bags. A comprehensive project was undertaken to tackle this including the provision of a bespoke digital system.Existing systems were reliant on staff remembering to check equipment and document checks on paper and there was no formal ability to hand over ongoing problems. A local project management approach, '7 Steps to Quality Improvement', which integrated many of the philosophies and tools from Healthcare Improvement was used. A bespoke digital system was designed and implemented with integrated improvements in equipment stocking ergonomics.The reliability of documented equipment checks improved significantly, there was a significant reduction in the number of incident reports regarding emergency equipment and the time spent by staff doing equipment checks was reduced substantially with significant cost and resource improvements. This was so successful the format has been rapidly translated and spread to other areas such as operating theatres' difficult airway trolleys.Undertaking a structured quality improvement approach, using appropriate stakeholder engagement, digitalisation of systems and improvements in basic system ergonomics can have a substantial impact on the reliability and safety of emergency equipment provided for use by members of the critical care team.

Assessment of pre-anesthesia machine check and airway equipment preparedness: A cross-sectional study.

Background: Anesthesia Equipment malfunction is one of the most common factors contributing to intraoperative surgical patient morbidity and mortality. It is impossible to give anesthesia without proper anesthesia machine checks and airway equipment preparation. Therefore, all anesthesia professionals should make sure that the anesthetic machine and equipment are working correctly. Method: An institutional-based prospective observational study was conducted at the University Comprehensive Specialized Hospital, Operation rooms, from April 10, 2020 to May 10, 2020. About 90 anesthetists were working regularly in the operation theater both emergency and elective patients. Those include; 26 Msc holders, 17 MSc students, 7 BSc anesthetists, and 40 graduating BSc students. These descriptive data were presented with frequency, percentage, and table. Result: The overall compliance rate was 87%. Whereas; 12.46% of clinicians have not met the standard. Out of standards that were not performed, 25.81% were not available from the setup. Conclusion: The result shows that there was poor compliance with anesthesia machine check and equipment preparation before anesthesia in the operation theater according.

Remote Programming in Patients With Parkinson's Disease After Deep Brain Stimulation: Safe, Effective, and Economical.

Objective: The purpose of this study was to evaluate the safety, efficiency, and cost expenditure of remote programming in patients with Parkinson's disease (PD) after deep brain stimulation (DBS). Methods: A total of 74 patients who underwent DBS at the Department of Neurosurgery, Zhongnan Hospital of Wuhan University between June 2018 and June 2020 were enrolled in this study. There were 27 patients in the remote programming group and 47 patients in the outpatient programming group. Clinical data, programming efficiency, adverse events, expenditure, and satisfaction were compared between the two groups. Results: A total of 36 times of remote programming were performed on the 27 patients in the remote programming group, and four had mild adverse events during programming, and the adverse events disappeared within 1 week. The satisfaction questionnaire showed that 97.3% of the patients were satisfied with the surgical effect. The patients in the remote programming group (88.9%) were more likely to receive long-term programming after DBS than the patients in the outpatient programming group (74.5%). The Parkinsonism symptoms improved in both programming groups. The majority (18/27) of patients in the remote programming group lived away from the programming center, while the majority (27/47) of patients in the outpatient programming group lived in Wuhan, where the programming center was located (P = 0.046). The cost per patient per programming was US$ 43.5 in the remote programming group and $59.5 (56-82.7) in the outpatient programming group (P < 0.001). The median time cost for each visit was 30 min (25-30) in the remote programming group and 150 min (135-270.0) in the outpatient programming group (P < 0.001). Conclusion: Remote programming is safe and effective after DBS in patients with Parkinson's disease. Moreover, it reduces expenditure and time costs for patients and achieves high satisfaction, particularly for patients living far from programming centers.

Impact of monoplane to biplane angiography upgrade on diagnostic angiography procedures: A retrospective cross-sectional study.

The radiation dose during digital subtraction angiography (DSA) examination is determined on the basis of many factors. The aim of this study was to evaluate the dose-area product, air kerma, and fluoroscopy time on monoplane and biplane DSA of the cerebral arteries. Our results show that biplane angiography offered lower DAP, cumulative air kerma at the reference point and fluoroscopy time despite comparable procedure time.. Further research in this area and personnel training warrant the improvement of the radiosafety of angiographic interventional procedures and further development of angiographic technology.

Same-day discharge percutaneous coronary intervention. Where are we? / Intervenção coronária percutânea com alta no mesmo dia. Onde estamos?

With the evolution of percutaneous coronary intervention techniques and their greater safety, the use of radial access, the greater need to optimize resources in health management and the greater demand from patients for an agile service to solve their problems, the discharge on the same day after percutaneous coronary interventions have been gaining ground in the global scenario as a feasible strategy. The objective of this article was to demonstrate that there is already a scientific basis for this, which extends from the financial aspect, and the patient's experience, to the technical details related to the safety of the strategy. A structured protocol based on evidence and on the most recent recommendations from two major medical societies is also proposed. Selecting patients well, training the multidisciplinary team and educating the patient are fundamental parts for the success of the strategy.

Com a evolução das técnicas de intervenção coronária percutânea e sua maior segurança, o uso do acesso radial, a maior necessidade de otimização dos recursos na gestão em saúde e a maior cobrança por parte dos pacientes por um serviço ágil para resolução de seus problemas, a alta no mesmo dia após as intervenções coronárias percutâneas vem ganhando espaço no cenário global como uma estratégia factível. O objetivo deste artigo foi demonstrar que já há base científica para o assunto, a qual se estende desde a aspectos financeiros, à experiência do paciente até à questão técnica relacionada à segurança da estratégia. Propõe-se, ainda, um protocolo estruturado baseado em evidências e nas recomendações mais recentes de duas grandes sociedades médicas. Selecionar bem os pacientes, treinar a equipe multiprofissional e educar o paciente são partes fundamentais para o sucesso da estratégia.

Analysis and suggestion on adverse events of active medical devices in Shandong province / 中华医院管理杂志

Objective:To analyze the characteristics of adverse events of active medical devices in Shandong province, as well as the impact of device use duration on the risk rate of adverse events, for reference in improving the monitoring system of active medical device adverse events in China and the level of hospital medical quality management.Methods:The data came from the adverse event reporting data of active medical devices collected by Shandong Adverse Drug Reaction Monitoring Center from January 2019 to October 2021. The R software was used to analyze the distribution, cause and severity of adverse events, and a linear regression model of adverse event risk rate(Y) and adverse event time point(X) was established.Results:A total of 35 254 adverse events of active devices were included, of which 3 059 were serious injuries. The province/municipality with the largest number of reported adverse events was Shanghai(8 006 cases), and the least was Hainan province(4 cases); The majority of adverse events were reported by hospitals, with 34 056(96.60%). The medical devices reporting a higher number of adverse events were ventilators(688 cases), monitors(4 623 cases), infusion pumps(1 079 cases), syringe infusion pumps(1 995 cases), medical electron accelerators(529 cases)and infant incubators(513 cases). In the linear regression model, the risk rate of adverse events increased with the useduration of the device when 0.00%≤ X<14.14%; the risk rate of adverse events decreased with the increase of service time when 14.14%≤ X<100.00%. Conclusions:The number of adverse events reported in each province is different, and hospitals are the main reporting units.The causes of adverse events of different medical devices indicate different correlation strengths with the product itself. The use duration of medical devices poses a great impact on the risk rate of adverse events.

Pilot Study of an e-Cohort to Monitor Adverse Event for Patient with Hip Prostheses from Clinical Data Warehouse.

Hip arthroplasty represents a large proportion of orthopaedic activity, constantly increasing. Automating monitoring from clinical data warehouses is an opportunity to dynamically monitor devices and patient outcomes allowing improve clinical practices. Our objective was to assess quantitative and qualitative concordance between claim data and device supply data in order to create an e-cohort of patients undergoing a hip replacement. We performed a single-centre cohort pilot study, from one clinical data warehouse of a French University Hospital, from January 1, 2010 to December 31, 2019. We included all adult patients undergoing a hip arthroplasty, and with at least one hip medical device provided. Patients younger than 18 years or opposed to the reuse of their data were excluded from the analysis. Our primary outcome was the percentage of hospital stays with both hip arthroplasty and hip device provided. The patient and stay characteristics assessed in this study were: age, sex, length of stay, surgery procedure (replacement, repositioning, change, or reconstruction), medical motif for surgery (osteoarthritis, fracture, cancer, infection, or other) and device provided (head, stem, shell, or other). We found 3,380 stays and 2,934 patients, 96.4% of them had both a hip surgery procedure and a hip device provided. These data from different sources are close enough to be integrated in a common clinical data warehouse.

SAFETY AND EFFECTIVENESS OF A STATIC WEARABLE CHAIR FOR PATIENTS REQUIRING REHABILITATION: A PRELIMINARY REPORT.

OBJECTIVE: To evaluate the acceptability of using a static wearable chair for patients requiring rehabilitation. METHODS: The acceptability of use of a static wearable chair during rehabilitation was assessed via static balance and subjective evaluation of 7 healthy subjects and 3 patients during standing training. Participants performed 1 standing task in free mode (in which the knee could bend freely) and 1 in support mode (in which the user could sit on the wearable chair with the knee slightly bent) for 3 min. For balance evaluation, the skeletal coordinates were measured. For subjective evaluation, a visual analogue scale questionnaire was administered before and after each task. RESULTS: Balance assessment revealed that patients had less head sway during support, whereas subjective evaluation showed that the device support created a positive psychological state in terms of stability, comfort, satisfaction, interest in usage, and motivation for rehabilitation. However, patients reported feeling strangeness, fear, or restraint during support. CONCLUSION: The static wearable chair improved the static balance of 3 patients and created a more positive psychological state. Use of the device is considered acceptable for use with rehabilitation patients. However, patients might feel strangeness, fear, and restraint during support. Familiarization with the static wearable chair may make it more acceptable among rehabilitation patients.

Navigating the shifting sands of filtering facepiece respirator provision during the COVID-19 pandemic: a system response for maximising staff safety.

INTRODUCTION: Personal protective equipment is essential to protect health workers and patients and to ensure confidence when dealing with aerosolised disease transmission. We describe the process for ensuring adequate filtering facepiece respirator (FFR) qualitative fit testing at a local level during the COVID-19 pandemic. METHODS: Cascaded training is described, which allowed rapid spreading of the testing process, with supervision allowing quality assurance throughout. Testing consisted of subjective 'fit checking', checking for leaks, followed by qualitative hood testing. RESULTS: The original respirators (3M 1870) had a hood test pass rate of 87.5%. Following identification of this as a non-renewable and unsustainable option, a domestically manufactured and sustainable Help-It P2 duckbill-type respirator was adopted as the primary FFR. The hood test pass rate for this respirator was only 54%. A third respirator was made available (3M 1860), with a high pass rate of 80% but also a limited and non-renewable resource. Algorithms were constructed highlighting different proportional use of the respirators depending on the most limited resource. CONCLUSION: The testing format used is simple, reproducible and can be used by any hospital organisation when occupational health and safety departments are unable to provide the service during overwhelming demand. Qualitative fit testing is a scalable and effective method for ensuring appropriately sized and shaped FFRs, minimising resource consumption in the process. The use of a product with appropriate filtration capacity but a lower fit test pass rate (domestic duckbill respirator) as a replaceable resource facilitated adequate respirator availability for staff that would otherwise not have been possible. The provision of an FFR fit registry allows an organisation to make appropriate respirators available to staff from different sources as supply and demand changes.

Sustained Use of the Impella 5.0 Heart Pump Enables Bridge to Clinical Decisions in 34 Patients.

We studied whether sustained hemodynamic support (>7 d) with the Impella 5.0 heart pump can be used as a bridge to clinical decisions in patients who present with cardiogenic shock, and whether such support can improve their outcomes. We retrospectively reviewed cases of patients who had Impella 5.0 support at our hospital from August 2017 through May 2019. Thirty-four patients (23 with cardiogenic shock and 11 with severely decompensated heart failure) underwent sustained support for a mean duration of 11.7 ± 9.3 days (range, ≤48 d). Of 29 patients (85.3%) who survived to next therapy, 15 were weaned from the Impella, 8 underwent durable left ventricular assist device placement, 4 were escalated to venoarterial extracorporeal membrane oxygenation support, and 2 underwent heart transplantation. The 30-day survival rate was 76.5% (26 of 34 patients). Only 2 patients had a major adverse event: one each had an ischemic stroke and flail mitral leaflet. None of the devices malfunctioned. Sustained hemodynamic support with the Impella 5.0 not only improved outcomes in patients who presented with cardiogenic shock, but also provided time for multidisciplinary evaluation of potential cardiac recovery, or the need for durable left ventricular assist device implantation or heart transplantation. Our study shows the value of using the Impella 5.0 as a bridge to clinical decisions.

Role of real-world digital data for orthopedic implant automated surveillance: a systematic review.

INTRODUCTION: Data collection automation through the reuse of real-world digital data from clinical data warehouses (CDW) could represent a great opportunity to improve medical device monitoring. For instance, this approach is starting to be used for the design of automated decision support systems for joint replacement monitoring. However, a number of obstacles remains, such as data quality and interoperability through the use of common and regularly updated terminologies, and the use of a Unique Device Identifier (UDI). AREAS COVERED: To present the existing models of automated surveillance of orthopedic devices, a systematic review of initiatives using real-world digital health data to monitor joint replacement surgery was performed following the PRISMA 2020 guidelines. The main objective was to identify the data sources, the target populations, the population size, the device location, and the main results of studies on such initiatives. EXPERT OPINION: Analysis of the identified studies showed that real-world digital data offer many opportunities for improving the automation of monitoring in orthopedics. The contribution of real-world data, especially through natural language processing, UDI use in CDW and the integration of device databases, is needed for automated and more robust health surveillance.

[Regulatory path of the medical device]. / Parcours réglementaire du dispositif médical.

Regulatory path of the medical device. The safety of medical devices (MD) is recognized by the CE marking allowing their free circulation on the European market. The new European regulation will reinforce the application and the survey of MD. For implantable MD, clinical data will be required, and the traceability will be facilitated by the implementation of a unique identifier. The safety of MD is under the European governance responsibility, while the circulation, the reimbursement and the survey of MD is under the responsibility of each country. In France, the evaluation of the clinical benefit and conditions of use of MD reimbursed is under the responsibility of a specific commission of the HAS, while their surveillance is under the responsibility of the ANSM.

"Parcours réglementaire du dispositif médical. Le marquage CE médical garantit la sécurité des dispositifs médicaux et permet sa libre circulation sur le marché européen. Les exigences de ce marquage CE vont se renforcer grâce à la mise en application du nouveau règlement européen tant à l'obtention que dans son suivi. Les investigations cliniques pour les dispositifs médicaux implantables deviennent une règle. La mise en place de l'identifiant unique du dispositif médical va faciliter sa traçabilité. Si la sécurité du dispositif médical relève d'une gouvernance européenne, la prise en charge et la surveillance relève de la compétence de chaque pays. En France l'évaluation du bénéfice clinique et des conditions d'utilisation des dispositifs médicaux relève de la HAS alors que leur surveillance est sous la responsabilité de l'ANSM."

[Connected health objects and medical devices]. / Objets de santé et dispositifs médicaux connectés.

Connected health objects and medical devices.A clear distinction is required between connected devices which change patient's care and those intended to im¬prove his well-being. Connected devices with a medical objective must obtain a CE mark assessing the technical reliability of both the physical piece and the associated software, but also ensuring the control of the hosting of data. Those who demonstrate individual or collective improvement in the diagnosis or treatment of a disease may be financed by the community. This reimbursement is the main tool in France expecting to reduce the digital divide.

Objets de santé et dispositifs médicaux connectés.L'expansion des objets connectés impose de distinguer ceux qui modifient la prise en charge d'un malade, à finalité médicale et ceux destinés à améliorer son bien-être. Les dispositifs connectés ayant une finalité médicale doivent obtenir un marquage CE pour évaluer la fiabilité technique de l'objet physique et du logiciel associé mais aussi pour garantir le contrôle de l'hébergement des données. Ceux qui démontrent une amélioration indivi¬duelle ou collective du diagnostic ou du traitement d'une maladie peuvent être pris en charge par la collectivité. Ce soutien financier représente en France le principal outil pour limiter la fracture numérique.

Comparison of Knowledge Databases to Be Used in Automated Monitoring of Orthopedic Medical Devices.

Surveillance and traceability of medical devices (MD) is a challenge in health care systems. In the perspective of reusing EHR data to automate the monitoring of medical devices, we carried out a comparison of the main MD knowledge bases (MD-KDB) currently available in France. Four MD-KDBs (ANSM, Gudid, Exhausmed and CIOdm) were compared quantitatively and through an example of a shoulder prosthesis. The number of MDs registered differs from one MD-KDB to another. Domain terminologies used in MD-KDBs differ in terms of granularity and in the ease of querying. Waiting EUDAMED, the European MD-KDB, it seems necessary so far to use and combine information coming from several MD-KDBs to address MD monitoring.