scholarly journals A Web Based Application for Investment Evaluation of Medical Devices Development

2020 ◽  
Author(s):  
Maresova Petra ◽  
Sobeslav Vladimir
Keyword(s):  
Medical Devices ◽  
Web Based ◽  
Investment Evaluation

scholarly journals Efficacy of a web-based self-help tool to reduce problem gambling in Switzerland: study protocol of a two-armed randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e032110 ◽  
Author(s):  
Christian Baumgartner ◽  
Elena Bilevicius ◽  
Yasser Khazaal ◽  
Sophia Achab ◽  
Susanne Schaaf ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Problem Gambling ◽  
Medical Devices ◽  
Controlled Trial ◽  
Intervention Programme ◽  
Web Based ◽  
Related Disorder ◽  
Self Help ◽  
Study Results ◽  
Randomised Controlled

IntroductionThe past-year prevalence of problem gambling worldwide averages 2.3%. Switzerland exhibits a slightly lower past-year prevalence rate, of 1.1%, among adults. Only a minority of these adults attend outpatient treatment. Surveyed problem gamblers have explained that they wanted to handle the problem on their own. The option of a web-based self-help programme could potentially reach those users who hesitate to approach treatment centres and help them to reduce or stop their problem gambling. The effectiveness of such web-based interventions has been shown in other countries.Methods and analysisThis two-armed randomised controlled trial (RCT) will examine the efficacy of a web-based self-help intervention, relative to an active control condition with a self-help manual, at reducing problem gambling. The active intervention programme, spanning 8 weeks, consists of nine modules developed to reduce gambling and attenuate psychopathological comorbidity, including depression, anxiety and stress-related disorder symptoms, relying on motivational interviewing and cognitive behavioural therapy. With a target sample size of 352, questionnaire data will be collected at baseline, and at 8 and 24 weeks after baseline. Primary outcomes will be the number of days one has gambled in the last 30 days. Secondary outcomes will include money and time spent on gambling activities, changes in gambling-related problems (Problem Gambling Severity Index, Gambling Symptom Assessment Scale), use of alcohol and cigarettes, and psychopathological comorbidity. All data analysis will comply with the intention-to-treat principle.Ethics and disseminationThe RCT will be conducted in accordance with the Declaration of Helsinki; the consort eHealth Guidelines for studies on medical devices; the European Directive on medical devices 93/42/EEC, Swiss Law and Swiss Regulatory Authority requirements. The study was approved by the ethics committee of the Canton of Zurich. Results will be published in a scientific peer-reviewed journal. Participants will be informed via e-mail about study results via a lay-person-friendly summary of trial findings.Trial registration numberCurrent Controlled Trials registry (ISRCTN16339434).

An automated computational tool to study MRI safety of implanted passive cardiovascular medical devices

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Baretta ◽  
R Bursi ◽  
A Palazzin ◽  
L Emili
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
In Silico ◽  
Test Method ◽  
Rf Heating ◽  
Implantable Medical Devices ◽  
Web Based ◽  
Computer Aided ◽  
Simulation Results ◽  
Rf Energy

Abstract Introduction The absorption of radiofrequency (RF) energy during an MRI procedure may cause tissue heating in the vicinity of an implanted device, such as a stent or a stented valve, potentially causing patient harm. Computational modeling and simulation (M&S) can be used by medical device manufacturers to assess the RF-induced heating of implanted devices during an MRI scan and identify worst-case configurations within a given line of implants. However, despite the use of in-silico tools, a standard for in-silico testing of such problematic is still missing; The tool here proposed is a web-based application that automates the set-up and solution of RF-heating analysis, in line with existing standards for in-vitro testing. Methods The presented tool is part of a commercial web-based platform. The tool was developed in collaboration with the market leader of computer-aided engineering software and as part of a Research Collaboration Agreement with the American regulatory body. Commercial software was used to compute RF energy absorption and thermal heating of implantable medical devices replicating the directives of the ASTM F2182–11a Standard Test Method. The model is integrated in an automated workflow. Each simulation submitted by the user is sent to the cloud infrastructure for solution. Simulation results are stored in a database for later retrieval and report generation. Results The tool consists of a web-interface where the user can: i) upload the medical device computer-aided design (CAD) or select a simplified geometry from a library; ii) define the material properties of the device; ii) specify the desired input parameters specific to an MRI exposure scenario. Specifically, it is possible to study the device exposure: i) at different field frequencies (i.e., 64 MHz and 128 MHz); ii) at different powers (i.e., 2, 4 and 10 W/kg Whole body Specific Absorption Rate - SAR); iii) at different field polarizations (i.e., two circular and two linear); and iv) for different exposure time (i.e., form 240 s to 900 s). The presented tool allows the users to view and export results for each simulation, including electromagnetic fields, local SAR, and the temperature rise over time. Finally, the simulation results are summarized in an automatically generated report that follows regulatory guidance on M&S reporting. Conclusion The presented web-based M&S tool allows users to perform the thermal safety assessment of implantable medical devices during an MRI procedure following established good simulation practices. Minimal training or background in computer modeling is required to use the tool. Specific potential applications of the tool include RF-heating assessment of cardiovascular devices (e.g., stents, stented valves, stent retrievers). The proposed platform promotes the broader adoption of digital evidence in preclinical trials for RF safety analysis, supporting the device submission process and pre-market regulatory evaluation. Stent safety simulation result interface Funding Acknowledgement Type of funding source: None

New Perspectives on Sustainable Healthcare Delivery Through Web of Things

2018 ◽  
pp. 166-187 ◽  
Author(s):  
Cristina Elena Turcu ◽  
Corneliu Octavian Turcu
Keyword(s):  
Social Networks ◽  
Patient Care ◽  
Medical Devices ◽  
Healthcare Delivery ◽  
Healthcare Providers ◽  
Web Based ◽  
Web Of Things ◽  
The Social ◽  
Health Sensors ◽  
The Web

This chapter focuses on examining the adoption of the web of things paradigm in healthcare in order to facilitate the development of new web-based systems in more effective and efficient ways. Nowadays, the increasing number of personal health sensors and medical devices present the opportunity for healthcare providers to interact with patients in entirely new ways. In this context, the WoT paradigm could be closely linked to patient care and has the potential to generate changes in healthcare. WoT could also be applied in the social and insurance fields, etc. The social web of things (SWoT) further extends WoT in order to facilitate continued interaction between physical devices and humans, allowing the integration of smart objects with social networks. Although it opens new social possibilities, it was less applied in the delivery of healthcare. Nevertheless, its successful adoption depends on overcoming some open challenges.

Registry for Medical Devices

2014 ◽  
Vol 3 (1) ◽  
pp. 19-31
Author(s):  
George Pappous ◽  
Tarsi Giannouli ◽  
Evi Saratsioti
Keyword(s):  
Medical Devices ◽  
Healthcare Professionals ◽  
Close Collaboration ◽  
Web Based ◽  
The Past ◽  
Mature Phase ◽  
Digital Convergence ◽  
Accurate Picture ◽  
System Interoperability ◽  
Management Issues

Through the past two decades numerous efforts were undertaken towards a digital convergence in the Greek National Healthcare system. E-Health in Greece was initially perceived and developed locally (per healthcare institution) without accrediting the capability of digital technology. This together with the lack of a unified coding and classification system for medical devices not only created system interoperability failures, but also procurement, financial and BIT management issues. Registry of medical devices is a web based application, which has been developed by the National Evaluation Center of Quality & Technology in Health to fill the existing gap and is continuously updated during the last five years in close collaboration with medical device's market and healthcare professionals. Today the Registry is in a mature phase and ready for widespread use. By this way, it is possible to conduct electronic auctions widely, gained complete and accurate picture of the types, quantities and prices of products and mainly made possible the real needs assessment and early planning

A Web-based searchable system to confirm magnetic resonance compatibility of implantable medical devices in Japan: a preliminary study

2017 ◽  
Vol 10 (3) ◽  
pp. 340-348 ◽  
Author(s):  
Yasuhiro Fujiwara ◽  
Hitoshi Fujioka ◽  
Tomoko Watanabe ◽  
Maiko Sekiguchi ◽  
Ryuji Murakami
Keyword(s):  
Magnetic Resonance ◽  
Medical Devices ◽  
Implantable Medical Devices ◽  
Web Based ◽  
Preliminary Study

Ultrastructural changes in murine lymphoma cells exposed to ultraviolet-A radiation

1991 ◽  
Vol 49 ◽  
pp. 104-105
Author(s):  
Delma P. Thomas ◽  
Dianne E. Godar
Keyword(s):  
Medical Devices ◽  
Blood Cells ◽  
White Blood Cells ◽  
Consumer Products ◽  
Ultrastructural Changes ◽  
Ultraviolet A ◽  
Uv Spectrum ◽  
Lymphoma Cells ◽  
Murine Lymphoma ◽  
Transmission Electron

Ultraviolet radiation (UVR) from all three waveband regions of the UV spectrum, UVA (320-400 nm), UVB (290-320 nm), and UVC (200-290 nm), can be emitted by some medical devices and consumer products. Sunlamps can expose the blood to a considerable amount of UVR, particularly UVA and/or UVB. The percent transmission of each waveband through the epidermis to the dermis, which contains blood, increases in the order of increasing wavelength: UVC (10%) < UVB (20%) < UVA (30%). To investigate the effects of UVR on white blood cells, we chose transmission electron microscopy to examine the ultrastructure changes in L5178Y-R murine lymphoma cells.

Bacterial biofilm behavior in water-supply lines of dental units

1992 ◽  
Vol 50 (1) ◽  
pp. 882-883
Author(s):  
B.D. Tall ◽  
K.S. George ◽  
R. T. Gray ◽  
H.N. Williams
Keyword(s):  
Water Supply ◽  
Medical Devices ◽  
Biofilm Formation ◽  
Bacterial Biofilm

Studies of bacterial behavior in many environments have shown that most organisms attach to surfaces, forming communities of microcolonies called biofilms. In contaminated medical devices, biofilms may serve both as reservoirs and as inocula for the initiation of infections. Recently, there has been much concern about the potential of dental units to transmit infections. Because the mechanisms of biofilm formation are ill-defined, we investigated the behavior and formation of a biofilm associated with tubing leading to the water syringe of a dental unit over a period of 1 month.

The PBL-Evaluator: a web-based tool for assessment in tutorials

1998 ◽  
Vol 62 (9) ◽  
pp. 671-674
Author(s):  
JF Chaves ◽  
JA Chaves ◽  
MS Lantz
Keyword(s):  
Web Based

Using Popular Mobile Devices in Voice Therapy

2013 ◽  
Vol 23 (3) ◽  
pp. 82-87 ◽  
Author(s):  
Eva van Leer
Keyword(s):  
Exercise Behavior ◽  
Voice Therapy ◽  
Pure Oxygen ◽  
Mobile Platforms ◽  
Self Monitoring ◽  
Web Based ◽  
Motivational Messages ◽  
Related Information ◽  
Health Related ◽  
Tailored Approach

Mobile tools are increasingly available to help individuals monitor their progress toward health behavior goals. Commonly known commercial products for health and fitness self-monitoring include wearable devices such as the Fitbit© and Nike + Pedometer© that work independently or in conjunction with mobile platforms (e.g., smartphones, media players) as well as web-based interfaces. These tools track and graph exercise behavior, provide motivational messages, offer health-related information, and allow users to share their accomplishments via social media. Approximately 2 million software programs or “apps” have been designed for mobile platforms (Pure Oxygen Mobile, 2013), many of which are health-related. The development of mobile health devices and applications is advancing so quickly that the Food and Drug Administration issued a Guidance statement with the purpose of defining mobile medical applications and describing a tailored approach to their regulation.

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