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Sharma, Damini, and Amrish Chandra. "Medical Device Rules - 2017, India: An Insight." Applied Clinical Research, Clinical Trials and Regulatory Affairs 7, no. 2 (July 14, 2020): 126–34. http://dx.doi.org/10.2174/2666255813666190912114043.
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According to “Medical Device Rules-2017” (MDR-2017), “Medical Devices (MDs) are the substances which are used for in-vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood, and blood component collection bag with or without anticoagulant and substances including mechanical contraceptives, disinfectants and insecticides and devices notified from time to time under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940”. According to this definition, MDs are classified into four classes: - class A, class B, class C and class D. The purpose of this review article is to present an overview of the regulatory registration requirement of MD in India according to the new MDR-2017.
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Owens, Brian. "Stronger rules needed for medical device cybersecurity." Lancet 387, no. 10026 (April 2016): 1364. http://dx.doi.org/10.1016/s0140-6736(16)30120-9.
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Миронова, Анфиса, and Anfisa Mironova. "Developments in Rules of state registration of medical devices." Vestnik Roszdravnadzora 2019, no. 3 (June 26, 2019): 24–27. http://dx.doi.org/10.35576/article_5d135f4a159e30.48455158.
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This article dedicated to analysis of the key developments in the legal and regulatory environment in a circulation of medical devices in the Russian Federation in regard to procedure of state registration of medical devices, as well as amending documents of the registration dossiers of the medical device, which have to be taken into account by the applicant in the process of submission of documents to Roszdravnadzor.
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Targhotra, Monika, Geeta Aggarwal, Harvinder Popli, and Madhu Gupta. "Regulatory aspects of medical devices in India." International Journal of Drug Delivery 9, no. 2 (October 6, 2017): 18. http://dx.doi.org/10.5138/09750215.2147.
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<p>Today millions of patients depend on medical device based treatment for the management and diagnose of several diseases. Quality and safety of device is depends upon the regulatory guidelines. Medical device manufacturing in India should be taken seriously due to large population and the potential severity of the consequences of introducing inferior and unsafe products to the market-place. Therefore a law containing adequate guidelines of rules and regulations are required for monitoring the entry of such devices into the use in public health. The regulations define requirements of medical device design, development and manufacture to ensure that products reaching market are safe and effective. Presently in India regulatory body CDSCO is governing regulation for regulation of devices which with time, amendment introducing in the law will provide safety assurance to public health. This review provides a study on different regulatory aspects of medical device implemented in India. The present review discuss about the classification of medical devices and regulations aspects in India.</p>
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Peter, Lukas, Ladislav Hajek, Petra Maresova, Martin Augustynek, and Marek Penhaker. "Medical Devices: Regulation, Risk Classification, and Open Innovation." Journal of Open Innovation: Technology, Market, and Complexity 6, no. 2 (June 10, 2020): 42. http://dx.doi.org/10.3390/joitmc6020042.
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In the Czech Republic, the medical device industry is an important sector with a strong tradition and has high added value and perspectives in demand under changing demographic and social structures. The aim of this article is to describe and analyze the complex issues of the new European Commission Medical Device Regulation (MDR) 2017/745 from the perspective of the strategic decisions of companies that have to comply with the requirements imposed on them by the new legislation and at the same time fulfill their own business needs and goals. The legislative changes significantly affect the standards, processes, and certifications in the medical device sector. The classification system of medical devices has been revised to more appropriately reflect the possible health risks associated with use of modern high-end technology in healthcare. The requirement is to categorize each device under the highest possible risk class, which means for the medical device manufacturers to carefully review the new rules and regulations and classify their devices accordingly.
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Keutzer, Lina, and Ulrika SH Simonsson. "Medical Device Apps: An Introduction to Regulatory Affairs for Developers." JMIR mHealth and uHealth 8, no. 6 (June 26, 2020): e17567. http://dx.doi.org/10.2196/17567.
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The Poly Implant Prothèse (PIP) scandal in France prompted a revision of the regulations regarding the marketing of medical devices. The new Medical Device Regulation (MDR [EU]) 2017/745 was developed and entered into force on May 25, 2017. After a transition period of 3 years, the regulations must be implemented in all EU and European Economic Area member states. The implementation of this regulation bears many changes for medical device development and marketing, including medical device software and mobile apps. Medical device development and marketing is a complex process by which manufacturers must keep many regulatory requirements and obligations in mind. The objective of this paper is to provide an introduction and overview of regulatory affairs for manufacturers that are new to the field of medical device software and apps with a specific focus on the new MDR, accompanying harmonized standards, and guidance documents from the European Commission. This work provides a concise overview of the qualification and classification of medical device software and apps, conformity assessment routes, technical documentation, clinical evaluation, the involvement of notified bodies, and the unique device identifier. Compared to the previous Medical Device Directive (MDD) 93/42/EEC, the MDR provides greater detail about the requirements for software qualification and classification. In particular, rule 11 sets specific rules for the classification of medical device software and will be described in this paper. In comparison to the previous MDD, the MDR is more stringent, especially regarding the classification of health apps and software. The implementation of the MDR in May 2020 and its interpretation by the authorities will demonstrate how app and software manufacturers as well as patients will be affected by the regulation.
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Shaik, Ayesha bi, and G. Ramakrishna. "Registration Process of Medical Devices in CIS Countries." International Journal of Drug Regulatory Affairs 9, no. 2 (June 16, 2021): 35–42. http://dx.doi.org/10.22270/ijdra.v9i2.468.
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The Commonwealth of Independent States (CIS) is a region with constant, and often quite radical, changes in medical device regulations. This article summarizes the most significant new regulations in the largest CIS countries in order to provide a clearer picture of the regulatory requirements for medical devices in the region. The article also examines the new registration procedure for medical devices placed on the common market within the Eurasian Economic Union (EAEU) in accordance with the International Treaty within the EAEU. This Treaty defines the common principles and rules of circulation of medicinal products and medical devices.
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Gomez, Ann Lydia, D. Nagasamy Venkatesh, and Niveditha Neelakandan. "A comparative study of medical device regulations in India: Before and after the implementation of medical device rules 2017." Research Journal of Pharmacy and Technology 13, no. 9 (2020): 4423. http://dx.doi.org/10.5958/0974-360x.2020.00782.9.
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Mukhtar, Hamid, Saeed Rubaiee, Moez Krichen, and Roobaea Alroobaea. "An IoT Framework for Screening of COVID-19 Using Real-Time Data from Wearable Sensors." International Journal of Environmental Research and Public Health 18, no. 8 (April 12, 2021): 4022. http://dx.doi.org/10.3390/ijerph18084022.
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Experts have predicted that COVID-19 may prevail for many months or even years before it can be completely eliminated. A major problem in its cure is its early screening and detection, which will decide on its treatment. Due to the fast contactless spreading of the virus, its screening is unusually difficult. Moreover, the results of COVID-19 tests may take up to 48 h. That is enough time for the virus to worsen the health of the affected person. The health community needs effective means for identification of the virus in the shortest possible time. In this study, we invent a medical device utilized consisting of composable sensors to monitor remotely and in real-time the health status of those who have symptoms of the coronavirus or those infected with it. The device comprises wearable medical sensors integrated using the Arduino hardware interfacing and a smartphone application. An IoT framework is deployed at the backend through which various devices can communicate in real-time. The medical device is applied to determine the patient’s critical status of the effects of the coronavirus or its symptoms using heartbeat, cough, temperature and Oxygen concentration (SpO2) that are evaluated using our custom algorithm. Until now, it has been found that many coronavirus patients remain asymptomatic, but in case of known symptoms, a person can be quickly identified with our device. It also allows doctors to examine their patients without the need for physical direct contact with them to reduce the possibility of infection. Our solution uses rule-based decision-making based on the physiological data of a person obtained through sensors. These rules allow to classify a person as healthy or having a possibility of infection by the coronavirus. The advantage of using rules for patient’s classification is that the rules can be updated as new findings emerge from time to time. In this article, we explain the details of the sensors, the smartphone application, and the associated IoT framework for real-time, remote screening of COVID-19.
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Chauhan, Pratibha, and Rahul Chauhan. "CONDUCIVE ENVIROMENT FOR FOSTERING INDIA SPECIFIC INNOVATION: NEW MEDICAL DEVICE RULES 2017." International Journal of Drug Regulatory Affairs 5, no. 3 (September 16, 2017): 20–26. http://dx.doi.org/10.22270/ijdra.v5i3.203.
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Cho, Su-Jin, Jung Ae Ko, Lee Yo Seb, Eun Ji Yun, and Rang Kyoung Ha. "PP011 Covering New Medical Devices With Low Cost-Effectiveness Evidence." International Journal of Technology Assessment in Health Care 33, S1 (2017): 71–72. http://dx.doi.org/10.1017/s0266462317002045.
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INTRODUCTION:The Korea National Health Insurance (K-NHI) has covered medical devices with low cost-effectiveness evidence by what is known as the Selective Benefit (SB) since December of 2013 as a type of conditional coverage. Most medical devices in the SB category are new technology and have higher levels of clinical effectiveness and/or functions than those in the benefit category, but they are characterized as being expensive. We compare the K-NHI medical device coverage system to those in Japan and Taiwan so as to be more informed about how to cover and set prices for new medical devices.METHODS:We searched for materials related to medical device coverage or the reimbursement systems of three countries (Korea, Japan, and Taiwan). National health insurance laws, policy reports, and the websites of the Ministries of Health of the respective countries, for instance, were also reviewed.RESULTS:The NHI systems of Korea, Japan, and Taiwan have several similarities with regard to their medical device benefit lists. They reimburse listed medical devices separately although they cover them basically by including procedures or a diagnosis-related group (DRG) fee. The K-NHI reimburses for medical devices with low cost-effectiveness using the actual market medical price, similar to other medical devices in the benefit category. However, there are no detailed rules regarding how to set prices for these devices. Every listed medical device is covered at the notified price in Japan, but the prices of new medical devices with improved functions can add 1 -100 percent of the price to the notified price. The prices of devices related to new medical procedures are determined by cost-accounting methods. The NHI service in Taiwan compensates for medical devices which are alternates but clinically improved types through a balance billing method.CONCLUSIONS:The NHI systems in Japan and Taiwan set prices with regard to reimbursements for new medical devices separately, specifically for devices which are advanced clinically or functionally but expensive. The K-NHI must consider establishing a pricing or reimbursement system for new medical devices through the discussion with stakeholders for reasonable reimbursements and decreasing the financial burden on the K-NHI.
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Bulygin, V. P., and A. G. Chepaikin. "Determination of Sensitivity and Specificity Parameters of Interpretation Rules in Medical Device Testing." Biomedical Engineering 37, no. 6 (November 2003): 309–14. http://dx.doi.org/10.1023/b:bien.0000020121.69491.14.
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Can, H., S. Erdol, and AZ Ozdemir. "Medical Device Reimbursement Rules In Turkey: With Past And Current Practices, Looking Forward." Value in Health 18, no. 7 (November 2015): A371. http://dx.doi.org/10.1016/j.jval.2015.09.753.
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Cox, Kate. "Ergonomic Design is the Best Weapon to Reduce Risk." Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care 9, no. 1 (September 2020): 196–98. http://dx.doi.org/10.1177/2327857920091009.
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“Do it by Design” written by Dick Sawyer and the CDRH work group is a premiere reference and introduction to human factors in medical devices published by HHS, FDA CDRH. In this publication, the relationship of device design to safe and effective use is described and then built upon in subsequent key industry standards such as ANSI/AAMI HE 75. Yet the importance of completing good design and considering all the possible usability aspects continues to be overlooked or under-represented in the design process. Information for safety is required to be provided to medical device users (MDR 2017, FDA 21 CFR 801). However, risk mitigations in the form of training, labeling and instructions for use (IFU) are required to be used as a last resort, avoided or used sparingly (MDR 2017 and ISO 14971). Instead devices should be inherently safe by design and construction as well as implement adequate protection measures, such as alarms, for those risks that cannot be eliminated. As often observed in usability studies, users disregard labeling and instructional information or do not even realize it is provided to them. In cases where information for safety is the risk control method, can it be considered effective in reducing risk and should they be acceptable to medical device manufacturers? This article discusses rules of thumb in good product design that limit or eliminate the reliance on instructions and when that’s not possible, the rules of design for instructional materials that provide solid support for users.
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Aguwa, Celestine C., Leslie Monplaisir, and Prasanth Achuthamenon Sylajakumari. "Rules modification on a Fuzzy-based modular architecture for medical device design and development." IIE Transactions on Healthcare Systems Engineering 2, no. 1 (January 2012): 50–61. http://dx.doi.org/10.1080/19488300.2012.666630.
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Iadanza, Ernesto, Samuele Cerofolini, Chiara Lombardo, Francesca Satta, and Monica Gherardelli. "Medical devices nomenclature systems: a scoping review." Health and Technology 11, no. 4 (May 28, 2021): 681–92. http://dx.doi.org/10.1007/s12553-021-00567-1.
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AbstractInventory is a fundamental process throughout the life cycle of medical devices. The maintenance program for each piece of equipment must comply with current regulations that are constantly evolving. The need to set up an evidence based management of the inventory of thousands of medical devices hosted in the Careggi University Hospital (AOUC), in Florence (Italy), has suggested to conceive a method to group medical devices in sub-classes, in order to monitor their performances and maintenance. The starting point to reach this goal is to establish a suitable nomenclature, a complex system of rules, codes, and definitions employed by healthcare systems and organizations to identify sets of medical devices. This paper describes the literature search performed on both Ovid and Scopus databases, that made it possible to identify several classifications and nomenclatures for medical devices. On the basis of this search, only a few works fulfil the requirement of classifying medical devices for management purposes (e.g., inventories, database, and supply chains). The analysis has shown that it is possible to reduce the number of classes into macro groups when applying the Italian National Classification of Medical Devices (CND). Although the CND nomenclature shows inconsistencies for complex groups it is an effective and successful choice, in terms of efficiency and optimization, also considering that it is the basis for the European Medical Device Nomenclature (EMDN).
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Richards, E. P. "Engineering and the law. The Supreme Court rules on medical device liability-or does it?" IEEE Engineering in Medicine and Biology Magazine 16, no. 1 (January 1997): 87–88. http://dx.doi.org/10.1109/51.566160.
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Noury, Norbert, Karima Bourquard, Didier Bergognon, and Jean-Bernard Schroeder. "Regulations Initiatives in France for the Interoperability of Communicating Medical Devices." International Journal of E-Health and Medical Communications 4, no. 2 (April 2013): 50–64. http://dx.doi.org/10.4018/jehmc.2013040104.
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Telemedicine has introduced new challenges in health delivery with the introduction of advanced information communication technologies in home care medicine. To meet the high standard of quality in health service delivery, the data flow of medical data must be maintained, which implies harmonization and standardization frameworks within the field of the communicating medical devices. Those medical devices must be certified to prove their effectiveness and compliance with the requirements on health and safety of patients, before to be brought into service or used. But there is no requirement concerning the interoperability of these communicating medical devices. A group of French experts have anticipated the need in developing projects to define communication medical device in the home and by taking part in standardization projects on the interoperability of data and systems in health. They first identified the standardization rules at European and national level and confirmed that most guides and directives are well available. They based their study on three specialties, commonly using medical devices and telemedicine and covering various use cases. Then, they defined a methodology following the IHE International and Continua Alliance approach in order to define the integration profile. Eventually, they defined a generic workflow and an inventory of the integration profiles, norms and standards that can support this generic workflow.
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Flouchi, Rachid, Abderrahim Elmniai, Mohamed El Far, Ibrahim Touzani, Naoufal El Hachlafi, and Kawtar Fikri-Benbrahim. "Microbiological Monitoring of the Environment Using the “Association Rules” Approach and Disinfection Procedure Evaluation in a Hospital Center in Morocco." Journal of Environmental and Public Health 2021 (July 5, 2021): 1–9. http://dx.doi.org/10.1155/2021/7682042.
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Background. The hospital environment, especially surfaces and medical devices, is a source of contamination for patients. Objective. This study carried out, to the best of our knowledge, for the first time at Taza Hospital in Morocco aimed to assess the microbiological quality of surfaces and medical devices in surgical departments and to evaluate the disinfection procedure in time and space. Methods. Samples were taken by swabbing after cleaning the hospital surface or medical device, to isolate and identify germs which were inoculated on semiselective culture media then identified by standard biochemical and physiological tests, using the analytical profile index (API) galleries. Moreover, the association rules extraction model between sites on the one hand and germs on the other hand was used for sampling. Results. The study showed that 83% of the samples have been contaminated after biocleaning. The most contaminated services have been men’s and women’s surgeries. 62% of isolated germs have been identified as Gram-positive bacteria, 29% as Gram-negative bacteria, and 9% as fungi. Concerning the association rules extraction model, a strong association between some contaminated sites and the presence of germ has been found, such as the association between wall and nightstand and door cuff, meaning that the wall and nightstand contamination is systematically linked to that of the door cuff. The disinfection procedure efficacy evaluation has enabled suggesting renewing it each 4 h. Conclusion. Microbiological monitoring of surfaces is necessary at hospital level through the use of the association rule extraction model, which is very important to optimize the sampling, cleaning, and disinfection site scenarios of the most contaminated ones.
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Kander, Mark, and Steve White. "Coding for Evaluation and Treatment." Perspectives on Voice and Voice Disorders 18, no. 1 (March 2008): 9–20. http://dx.doi.org/10.1044/vvd18.1.9.
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Abstract This article explains the development and use of ICD-9-CM diagnosis codes, CPT procedure codes, and HCPCS supply/device codes. Examples of appropriate coding combinations, and Coding rules adopted by most third party payers are given. Additionally, references for complete code lists on the Web and a list of voice-related CPT code edits are included. The reader is given adequate information to report an evaluation or treatment session with accurate diagnosis, procedure, and supply/device codes. Speech-language pathologists can accurately code services when given adequate resources and rules and are encouraged to insert relevant codes in the medical record rather than depend on billing personnel to accurately provide this information. Consultation is available from the Division 3 Reimbursement Committee members and from reimbursement@asha.org .
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Watson, R. "Europe is updating rules on medical devices after implant fiasco." BMJ 344, jan30 3 (January 30, 2012): e766-e766. http://dx.doi.org/10.1136/bmj.e766.
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Lee, Sang-Soo, and Eugene Salole. "Medical Device Reimbursement Coverage and Pricing Rules in Korea: Current Practice and Issues with Access to Innovation." Value in Health 17, no. 4 (June 2014): 476–81. http://dx.doi.org/10.1016/j.jval.2014.03.1719.
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Almpani, Sofia, Petros Stefaneas, Harold Boley, Theodoros Mitsikas, and Panayiotis Frangos. "A Rule-Based Model for Compliance of Medical Devices Applied to the European Market." International Journal of Extreme Automation and Connectivity in Healthcare 1, no. 2 (July 2019): 56–78. http://dx.doi.org/10.4018/ijeach.2019070104.
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There is a growing producer and consumer interest in medical devices and the commensurate need for regulatory frameworks to ensure the quality of medical devices marketed locally and globally. This work focuses on formalizing the clauses enacted by Regulation (EU) 2017/745 for risk-based classification and class-based conformity assessment regarding marketability of medical devices. The resulting knowledge base (KB) represents clauses in Positional-Slotted Object-Applicative (PSOA) RuleML by integrating F-logic-like frames with Prolog-like relationships for atoms used as facts and in the conclusions and conditions of rules. Rules can apply polyadic functions, define polyadic relations, and augment conclusions with actions and conditions with events. The PSOA RuleML-implemented Medical Devices Rules KB was tested by querying in the open-source Java-implemented PSOATransRun system, which has provided a feedback loop for refinement and extension. This prototype can contribute to the licensing process of stakeholders and the registration of medical devices with a CE conformity mark.
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Kondo, Kenya, Hiroki Tamura, and Koichi Tanno. "Proposal and design methodology of switching mode low dropout regulator for Bio-medical applications." International Journal of Electrical and Computer Engineering (IJECE) 9, no. 6 (December 1, 2019): 5046. http://dx.doi.org/10.11591/ijece.v9i6.pp5046-5059.
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<p>The switching operation based low dropout (LDO) regulator utilizing on-off control is pre-sented. It consists of simple circuit elements which are comparator, some logic gates, switched capacitor and feedback circuit. In this study, we target the application to the power supply circuit for the analog front end (AFE) of bio-medical system (such as daily-used bio-monitoring devices) whose required maximum load current is 50 A. In this paper, the design procedure of the proposed LDO has been clarified and actual circuit design using the procedure has been done. The proposed LDO has been evaluated by SPICE simulation using 1P 2M 0.6 m CMOS process device parameters. From simulation results, we could confirm that the low quiescent current of 1 A with the output ripple of 5 mVpp. The circuit area is 0.0173 mm2 in spite of using 0.6 m design rules. The proposed circuit is suitable for adopting to the light load and low frequency applications.</p>
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Rechul, D., and K. Rechul. "0708 A Study To Determine Efficacy Of A Device In Anticipating Obstructive Sleep Apnea Events." Sleep 43, Supplement_1 (April 2020): A269—A270. http://dx.doi.org/10.1093/sleep/zsaa056.704.
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Abstract Introduction Current treatment options for obstructive sleep apnea pose multiple challenges ranging from issues with therapy adherence (i.e. PAP) to partial effectiveness (i.e. MAD) or invasiveness (i.e. implantable nerve stimulation devices). SleepMethods, Inc. designed a device that proposed to solve these issues. It consisted of two integrated mechanisms; one to anticipate the development of an obstructive event and the other to deliver therapeutic intervention to abort the process of airway collapse before it ensued. A clinical trial was conducted to test the efficacy of the system designed to anticipate obstructive sleep apnea events. Methods Ten adults (7M;3F) aged 18-80y/o (avg. 54.7y/o) with a known AHI ≥ 15/hr (avg. AHI = 42.6/hr) underwent 1 overnight PSG recording while wearing the device. Patients were required to forego their usual CPAP therapy on the night of study in efforts to expose the device to an adequate number of total obstructive events (defined as apneas and hypopneas; RERAs and snores were excluded). Standard PSG analysis was performed. Scoring rules were applied to determine whether signals were true/false positives and/or true/false negatives based on pre-clinical data showing anticipation accuracy for up to 45 seconds prior to an obstructive airway event. Results Preliminary results suggest the device functions with 96.9% sensitivity and about 67.1% PPV. Data analysis is ongoing to determine specificity, statistical significance, etc. Conclusion The device has shown promise in pre-clinical and clinical trials to accurately and consistently anticipate airway collapse; a possible breakthrough in designing more targeted therapies aimed at aborting obstructive sleep apnea events before they ensue to a clinically significant degree. Support N/A
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Bowes, Lorna. "Labelling for cosmetic products and medical devices: rules, regulations and requirements." Journal of Aesthetic Nursing 2, no. 10 (January 2014): 491–94. http://dx.doi.org/10.12968/joan.2013.2.10.491.
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Maassen, Oliver, Sebastian Fritsch, Julia Gantner, Saskia Deffge, Julian Kunze, Gernot Marx, and Johannes Bickenbach. "Future Mobile Device Usage, Requirements, and Expectations of Physicians in German University Hospitals: Web-Based Survey." Journal of Medical Internet Research 22, no. 12 (December 21, 2020): e23955. http://dx.doi.org/10.2196/23955.
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Background The use of mobile devices in hospital care constantly increases. However, smartphones and tablets have not yet widely become official working equipment in medical care. Meanwhile, the parallel use of private and official devices in hospitals is common. Medical staff use smartphones and tablets in a growing number of ways. This mixture of devices and how they can be used is a challenge to persons in charge of defining strategies and rules for the usage of mobile devices in hospital care. Objective Therefore, we aimed to examine the status quo of physicians’ mobile device usage and concrete requirements and their future expectations of how mobile devices can be used. Methods We performed a web-based survey among physicians in 8 German university hospitals from June to October 2019. The online survey was forwarded by hospital management personnel to physicians from all departments involved in patient care at the local sites. Results A total of 303 physicians from almost all medical fields and work experience levels completed the web-based survey. The majority regarded a tablet (211/303, 69.6%) and a smartphone (177/303, 58.4%) as the ideal devices for their operational area. In practice, physicians are still predominantly using desktop computers during their worktime (mean percentage of worktime spent on a desktop computer: 56.8%; smartphone: 12.8%; tablet: 3.6%). Today, physicians use mobile devices for basic tasks such as oral (171/303, 56.4%) and written (118/303, 38.9%) communication and to look up dosages, diagnoses, and guidelines (194/303, 64.0%). Respondents are also willing to use mobile devices for more advanced applications such as an early warning system (224/303, 73.9%) and mobile electronic health records (211/303, 69.6%). We found a significant association between the technical affinity and the preference of device in medical care (χs2=53.84, P<.001) showing that with increasing self-reported technical affinity, the preference for smartphones and tablets increases compared to desktop computers. Conclusions Physicians in German university hospitals have a high technical affinity and positive attitude toward the widespread implementation of mobile devices in clinical care. They are willing to use official mobile devices in clinical practice for basic and advanced mobile health uses. Thus, the reason for the low usage is not a lack of willingness of the potential users. Challenges that hinder the wider adoption of mobile devices might be regulatory, financial and organizational issues, and missing interoperability standards of clinical information systems, but also a shortage of areas of application in which workflows are adapted for (small) mobile devices.
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Gupta, Rajkumar M. "REVIEW OF MARKETING AUTHORIZATION OF MEDICAL DEVICES IN INDIA." International Journal of Drug Regulatory Affairs 2, no. 4 (February 13, 2018): 25–32. http://dx.doi.org/10.22270/ijdra.v2i4.150.
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Marketing authorization of medical devices in India is given under heading “Registration Certificate and it is as per the regulatory processes in other countries. The foreign companies marketing of medical devices require either own office or an agent to receive, store and distribute the devices. The marketing Authorization (Registration Certificate) is considered valid for three years from the date of its issue. Only the Notified Medical Devices, New medical Devices and the devices classified under drug rules require marketing Authorization from DCGI. The other medical devices e.g. Non-notified devices do not require manufacturing, sales, import registration and can be marketed freely.
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Rodrigues, Pedro, Manuel João Ferreira, and João Luís Monteiro. "Quantum Computation Perspectives in Medical Image Processing." International Journal of Nanotechnology and Molecular Computation 2, no. 2 (April 2010): 16–46. http://dx.doi.org/10.4018/978-1-61520-670-4.ch006.
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The need to increase the complexity of computational methods to produce improvements in functional performance, particularly in medical image processing applications, leads to find suitable physical devices. This chapter describes two ways of adapting the techniques of image processing to quantum devices. This kind of computing can achieve, for some problems, unparalleled performance as compared to classic computing. In the first method, using the quantum Grover’s algorithm how to implement image processing techniques under quantum rules is shown. In the second method, using diffraction and interference, the possibility of using less complex quantum devices for processing digital images is treated. Using leucocytes images, that mode is tested.
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Callens, Stefaan. "Legal Aspects of Personalized Health Monitoring." European Journal of Health Law 19, no. 5 (2012): 503–13. http://dx.doi.org/10.1163/15718093-12341241.
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Abstract Personal health monitoring (PHM) can be defined as comprising all technical systems, processing, collecting, and storing of data linked to a person. PHM involves several legal issues that are described in this article. This article analyses firstly the short term actions that are needed at the European level to allow personal health monitoring in respect of the interests and rights of patients such as the need to have more harmonized medical liability rules at the EU level. Introducing PHM implies also legal action at the EU level on the long run. These long-term actions are related to e.g., the way in which hospitals are organized in their relation with healthcare professionals and with other hospitals or healthcare actors. The paper will finally analyse also how health monitoring projects may change the traditional (non-) relationship between patients and pharmaceutical/medical device industry. Today, the producers and distributors of medicinal products have no specific contact with patients. This situation may change when applying telemonitoring projects and may require to new legal rules.
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Skałkowski, Kornel, and Krzysztof Zieliński. "Applying formalized rules for treatment procedures to data delivered by personal medical devices." Journal of Biomedical Informatics 46, no. 3 (June 2013): 530–40. http://dx.doi.org/10.1016/j.jbi.2013.04.005.
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Mattamal, George J. "Recent U.S. FDA Reclassification on the Regulation of Tissue Adhesives for Skin Approximation in Clinical Applications." Materials Science Forum 638-642 (January 2010): 624–28. http://dx.doi.org/10.4028/www.scientific.net/msf.638-642.624.
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Since the Medical Device Amendments of 1976 were enacted, the FDA considers Tissue Adhesives as “Transitional Devices” that are classified as Class III medical devices and are marketed in the United States subsequent to the approval of a Pre-market Approval Application (PMA). On February 9, 2006, Regulatory & Clinical Research Institute, Inc. submitted a petition to FDA to reclassify tissue adhesive transitional medical devices for skin approximation from Class III to Class II (special controls). FDA consulted with the General and Plastic Surgery Devices Advisory Panel, and on August 25, 2006, in a public meeting, the panel unanimously recommended that the tissue adhesive transitional medical devices for topical approximation of skin be classified from class III into Class II. Consequently, since June 30, 2008, following the effective date of the FDA Final Rule [1] that reclassified tissue adhesive transitional medical devices for skin approximation, any firm submitting a Premarket Notification [510(k)] for a tissue adhesive for the topical approximation of skin will need to address the issues covered in the published “Class II Special Control Guidance Document: Tissue Adhesive for the Topical Approximation of Skin, dated May 30, 2008” [2]. Accordingly, the firm needs to show that its device meets the recommendations of the published Class II guidance document or in some other way provides equivalent assurances of safety and effectiveness. Also, the author provides a short regulatory description of US FDA, under what laws its operates, how FDA evaluates new medical devices for marketing as Class I, Class II, and Class III [3].
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Von Eiff, C., W. Kohnen, K. Becker, and B. Jansen. "Modern Strategies in the Prevention of Implant-Associated Infections." International Journal of Artificial Organs 28, no. 11 (November 2005): 1146–56. http://dx.doi.org/10.1177/039139880502801112.
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The application of medical devices either for temporary or permanent use has become an indispensible part of almost all fields of medicine. However, foreign bodies are associated with a substantial risk of bacterial and fungal infections. Implant-associated infections significantly contribute to the still increasing problem of nosocomial infections. To reduce the incidence of such infections, specific guidelines providing evidence-based recommendations and comprising both technological and nontechnological strategies for prevention have been established. Strict adherence to hygienic rules during insertion or implantation of the device are aspects of particular importance. Besides such basic and indispensable aspects, the development of new materials which could withstand microbial adherence and colonization has become a major topic in recent years. Modification of surface by primarily physico-chemical methods may lead to a change in specific and unspecific interactions with microorganisms and, thus, to a reduction in microbial adherence. Medical devices made out of a material that would be ideally antiadhesive or at least colonization-resistant would be the most suitable candidates to avoid colonization and subsequent infection. However, it appears impossible to create a surface with an absolute “zero”-adherence due to thermodynamical reasons and due to the fact that a modified material surface is in vivo rapidly covered by plasma and connective tissue proteins. Therefore, another concept for the prevention of implant-associated infections involves the impregnation of devices with various antimicrobial substances such as antibiotics, antiseptics, and/or metals. In fact, already commercially available materials for clinical use such as antimicrobial catheters have been introduced, in part with considerable impact on subsequent infections. However, future studies are warranted to translate the knowledge on the pathogenesis of device-associated infections into applicable prevention strategies.
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Unruh, Gregory. "Circular Economy, 3D Printing, and the Biosphere Rules." California Management Review 60, no. 3 (March 13, 2018): 95–111. http://dx.doi.org/10.1177/0008125618759684.
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This article applies the Biosphere Rules—a biomimicry-inspired management framework for circular economy initiatives—to the emerging field of additive manufacturing and three-dimensional (3D) Printing, which are revolutionizing industrial sectors from medical devices to spare parts. They are also potentially keys in the emergence of a true circular economy that will bring about environmentally sustainable manufacturing. This article lays out an established strategy that can guide managers and policy makers in pursuit of a cradle-to-cradle economy.
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Almpani, Sofia, Theodoros Mitsikas, Petros Stefaneas, and Panayiotis Frangos. "ExosCE: A legal-based computational system for compliance with exoskeletons’ CE marking." Paladyn, Journal of Behavioral Robotics 11, no. 1 (October 7, 2020): 414–27. http://dx.doi.org/10.1515/pjbr-2020-0026.
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AbstractWearable robots are devices intended to improve the quality of users’ life by augmenting, assisting, or substituting human functions. Exoskeletons are one of the most widespread types of wearable robots, currently used extensively in medical applications (and also for industrial, assistive, or military purposes), thus governed by regulations for medical devices and their conformity assessment. On top of that, manufacturers must also specify if their exoskeletons can be categorized as machines and, therefore, additionally apply a number of requirements mandated from machinery regulations. This work focuses on capturing both the abovementioned requirements enacted by the Medical Devices Directive 2017/745 and the Machinery Directive 2006/42 into a single framework. It formalizes into Rules the Conformity Assessment procedures regarding the marketability of exoskeletons indicated by the CE marking (“Conformité Européene”). These Rules, expressed in the Positional-Slotted Object-Applicative (PSOA) RuleML code, were complemented by representative Facts based on real-life cases of commercialized exoskeletons. Additional Exoskeletons Facts can be included by users from other forms (such as MS Excel) and translated into the PSOA RuleML code through the provided Python script. The open-source Exoskeletons’ CE mark (ExosCE) Rules KB was tested by querying in the open-source PSOATransRun system. The ExosCE Rules prototype can assist in the compliance process of stakeholders and in the registration of exoskeletons with a CE mark.
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Dezhurny, L. I., and A. Yu Zakurdaeva. "PROBLEMS RELATED TO FIRST AID EQUIPMENT: ORGANIZATIONAL AND LEGAL ASPECT." Social Aspects of Population Health 66, no. 5 (2020): 10. http://dx.doi.org/10.21045/2071-5021-2020-66-5-10.
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The article examines organizational and legal problems related to state registration, production, procurement and use of medical devices for first aid. The study significance is accounted for by the need to find solutions to problems related to equipping first aid activities with medical devices, which is becoming extremely important for the modern Russian society. Moreover, a comprehensive study of these issues has not been undertaken so far. The purpose of the study is to develop a set of proposals of an organizational and legal nature to improve quality of medical devices for first aid and equipping all potential participants of first aid delivery with such devices. To eliminate the problem of low equipment of potential participants of first aid delivery with the means of delivery, the composition of first-aid kits, packs, sets, and packages for all categories of participants have to be approval by the Ministry of Health of the Russian Federation. The authors also propose organizational and legal measures to improve interdepartmental and intradepartmental cooperation in this direction with the Russian Ministry of Health playing the coordinating role. The authors have also identified the need for improving the procedure for state registration of the production of first aid devices either though amending the Federal Law "On the Basics of Public Health Protection in the Russian Federation" regarding the provision that first-aid kits, packs, sets, and packages equipped with medical devices registered in the prescribed manner are not subject to state registration. As an alternative, the authors propose amendments and additions to the Rules of the state registration of medical devices, providing for a simplified state registration of first-aid kits, packs, sets, and packages. In addition, the authors name arguments in favor of improving the clinical trial procedure for first aid medical devices and propose changes to Article 38 of the Federal Law “On the Basics of Public Health Protection in the Russian Federation” in terms of eliminating the problems of legal techniques in the definition of the term “medical device” regarding first aid. Keywords: First aid; first aid kits; first aid equipment; medical devices.
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Cassuto, Daniel, Mara Delledonne, Giovanna Zaccaria, Immacolata Illiano, Andrea Maria Giori, and Gilberto Bellia. "Safety Assessment of High- and Low-Molecular-Weight Hyaluronans (Profhilo®) as Derived from Worldwide Postmarketing Data." BioMed Research International 2020 (June 22, 2020): 1–9. http://dx.doi.org/10.1155/2020/8159047.
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Background. At present, dermal fillers based on hyaluronic acid (HA) represent the most popular intervention of dermoesthetic medicine for the treatment of skin aging. Recent studies have shown that the combination of HA chains of different lengths and molecular weights improves tissue repair and regeneration through a synergistic mechanism. Profhilo® is a product available that has been on the market since 2015 and is based on stable, hybrid, and cooperative complexes (HyCoCos) produced by means of NAHYCO® Hybrid Technology, which is an innovative thermal process that rules out the use of any chemical reagents. The result is a filler with high biocompatibility and low viscosity that favors optimal diffusion at the tissue level to obtain the target bioremodeling of the facial contour. The objective of this review is to provide data from the overall postmarketing experience after 3 years of use and more than 40,000 patients treated with the medical device. Methods. All spontaneous postmarketing adverse event (AE) reports received from physicians and healthcare professionals worldwide between February 9, 2015, and February 8, 2018, associated with the use of the studied medical device and sent to the IBSA global safety database were analyzed. Results. In total, 12 adverse event reports were logged in the global database, and none were considered serious. Early-onset injection site reactions, i.e., swelling, edema, redness, ecchymosis, and erythema, were the most frequently observed. Late-onset local reactions (e.g., swelling, nodules) followed. The genesis of these reactions was considered, both by the reporting physician and IBSA, as being local reactions of hypersensitivity and/or due to inappropriate injection techniques. In no case was the product held liable for direct damage. All events resolved without any complications according to the treatment guidelines. Two late-onset reactions were collected. Conclusions. Although underreporting of minor events cannot be ruled out, the overall number of reports is very low, thereby supporting the high tolerability and safety of the product. After 3 years of postmarketing experience, the safety profile of the studied medical device is favorable and consistent with the product information.
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Hatfield, Laura A., Christine M. Baugh, Vanessa Azzone, and Sharon-Lise T. Normand. "Regulator Loss Functions and Hierarchical Modeling for Safety Decision Making." Medical Decision Making 37, no. 5 (January 23, 2017): 512–22. http://dx.doi.org/10.1177/0272989x16686767.
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Background. Regulators must act to protect the public when evidence indicates safety problems with medical devices. This requires complex tradeoffs among risks and benefits, which conventional safety surveillance methods do not incorporate. Objective. To combine explicit regulator loss functions with statistical evidence on medical device safety signals to improve decision making. Methods. In the Hospital Cost and Utilization Project National Inpatient Sample, we select pediatric inpatient admissions and identify adverse medical device events (AMDEs). We fit hierarchical Bayesian models to the annual hospital-level AMDE rates, accounting for patient and hospital characteristics. These models produce expected AMDE rates (a safety target), against which we compare the observed rates in a test year to compute a safety signal. We specify a set of loss functions that quantify the costs and benefits of each action as a function of the safety signal. We integrate the loss functions over the posterior distribution of the safety signal to obtain the posterior (Bayes) risk; the preferred action has the smallest Bayes risk. Using simulation and an analysis of AMDE data, we compare our minimum-risk decisions to a conventional Z score approach for classifying safety signals. Results. The 2 rules produced different actions for nearly half of hospitals (45%). In the simulation, decisions that minimize Bayes risk outperform Z score–based decisions, even when the loss functions or hierarchical models are misspecified. Limitations. Our method is sensitive to the choice of loss functions; eliciting quantitative inputs to the loss functions from regulators is challenging. Conclusions. A decision-theoretic approach to acting on safety signals is potentially promising but requires careful specification of loss functions in consultation with subject matter experts.
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Demidov, P. A. "Dry disposal technology in transportation and processing of reusable medical devices." Medical alphabet 3, no. 32 (January 23, 2020): 45–49. http://dx.doi.org/10.33667/2078-5631-2019-3-32(407)-45-49.
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The processing of multiple-use medical devices (MD) between patient use is an integral part of anti-epidemic measures in a medical organization (MO) and directly affects the safety of medical services. Based on the requirements of the Sanitary Rules and Regulations 2.1.3.2630–10 it is possible to use washing and disinfecting machines for disinfection purposes. At the same time, there remains the problem of organizing the operation of the operating unit and the central medical department of the medical organization for transportation and work with MD contaminated with blood and other biological fluids.
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Duarte, Ricardo, Jean-Pierre Nadeau, Antonio Ramos, and Michel Mesnard. "Design Method to Structure Orthosis Design: Camptocormia Postural Brace Case Study." Journal of Healthcare Engineering 2019 (February 3, 2019): 1–9. http://dx.doi.org/10.1155/2019/3513947.
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The orthosis is considered a class 1 medical device which often originates from a nonstructured development process. As these devices are mainly developed by small- and medium-sized enterprises, with no standard research method, the result can be an unadapted device which may not respond to the user’s needs and which in the short term may be abandoned. One way to solve this problem is to define and apply standard rules and procedures throughout the development/design process. Although methodologies may solve the “empiricism” in orthosis design problems, these design strategies are not applied during orthosis development due to the particularities of this field and the difficulties in linking the required knowledge and the actors that may be present during the orthosis development. The objective of this work is to develop a methodology to structure the orthosis design process that takes into account both the device life cycle and the different stakeholders involved in the design process. A case study was used to validate the proposed methodology. It was applied to the development of an orthosis to treat a specific postural disorder called camptocormia, also known as bent spine syndrome. This disorder is characterized by the anteroflexion of the trunk and especially affects elderly people. Contrary to scoliosis, the characteristics of camptocormia are not permanent, which means that the patient is able to straighten his posture. A postural brace is used to treat this disorder which enables the patient to redress and maintain the correct upright posture of the trunk.
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Furrow, Barry R. "The Problem of Medical Misadventures: A Review of E. Haavi Morreim's Holding Health Care Accountable." Journal of Law, Medicine & Ethics 29, no. 3-4 (2001): 381–93. http://dx.doi.org/10.1111/j.1748-720x.2001.tb00355.x.
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Health-care provider liability has again taken center stage in American political debate, but with an ironic twist. In the seventies, physicians wanted tort reform, but they measured such reform solely by a reduction in both the risk of being sued and the size of any judgment a plaintiff could win. Malpractice reforms in many states in the seventies therefore capped damages, reduced contingency awards to lawyers, and restricted other tort rules to limit plaintiff success. Today physicians are conflicted. They want an increase in liability exposure — not for themselves, but for managed care plans. We have therefore ended up with a series of overlapping debates, with the same debaters taking contradictory positions. Should managed care organizations—until now protected by ERISA preemption from liability—be liable? Physicians say yes. But should physicians be protected from the threat of suit, which they argue acts as an in terrorem device that drives disclosure of medical errors into hiding?
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Tsyganchuk, O. M. "State sanitary and anti-epidemic rules and norms of medical waste management." Infusion & Chemotherapy, no. 3.2 (December 15, 2020): 300–302. http://dx.doi.org/10.32902/2663-0338-2020-3.2-300-302.
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Background. Hands are a favorable environment for bacterial colonization. The microflora of skin is divided into resident and transient. The latter gets to the hands of healthcare workers (HCW) by the contact during professional activities during various diagnostic and treatment procedures, as well as by the contact with contaminated objects. General requirements for hand hygiene include short nails, absence of false nails, absence of infected skin injuries (or covered injuries) on the hands and forearms, absence of jewelry or watch. If there is visible dirt, the hands should be washed with usual soap. As for disinfection, it is divided into focal (current and final) and preventive (planned and according to the epidemic indications). Not only the hands of the HCW, medical devices, surfaces and furniture, but also medical waste (MW) should be disinfected.
Objective. To describe the features of disinfection and MW management.
Materials and methods. Analysis of the literature on this issue.
Results and discussion. After use, the syringes are disinfected together with the needles without caps and collected in waterproof and puncture-proof containers. When using containers for sharp objects, it is allowed to fill them for 3 days. Medical devices should be immersed in a disinfectant solution immediately after use; the solution should cover the tools at least 1 cm above their surface. Containers with disinfectant solutions must be marked with the name of the solution, its concentration, purpose, exposure time, date of preparation and expiration date. Disinfectants are divided into halide-containing, alcohol-containing, aldehyde-containing, oxidizing, detergent and composite. Decamethoxine – an antiseptic and antifungal drug for topical use – is widely used for disinfection. The mechanism of action of this solution is to disrupt the permeability of the cytoplasmic membrane of bacteria and fungi by binding to phosphatide groups of membrane lipids. The problem of MW is a major problem in the domestic health care system. Ukraine annually produces about 400 thousand tons of MW, 100-120 thousand of which are dangerous. The risks caused by MW are divided into infectious, chemical and radiation-associated. Categories of MW include category A – epidemically safe MW, B – epidemically dangerous MW, C – toxicologically dangerous MW, D – radiologically dangerous MW. The waste management system includes its collection and sorting; marking; disinfection; transportation within the institution; utilization or disposal (category A only). For each type of waste there are special types of containers and markings regulated by normative documents. Category A waste include household waste of all departments of the hospital, except infectious; waste that have not had contact with biological fluids of the body; food waste of all departments of the hospital, except infectious. Food waste is collected separately from other waste. When collecting MW of B category (used medical instruments; items contaminated with blood or other biological fluids; organic MW of patients; food waste of infectious departments), it is forbidden to cut or destroy this waste, to remove needles from syringes, to spill or compact MW, to install containers for waste collection at a distance of less than 1 m from heating appliances. Category C waste includes drugs, substances for diagnostics, and disinfectants; batteries; items containing mercury and heavy metals; wastes generate as a result of operation of transport, lighting systems, etc. Collection and temporary storage of waste, associated with cytostatics and genotoxic drugs, as well as all MW produced as a result of their preparation (category C), is not allowed without decontamination. It is also needed to decontaminate the workplace. Any work with such waste should be carried out with the use of personal protective equipment in the special ventilated rooms. Category D waste management is implemented in accordance with the requirements of the legislation of Ukraine on radioactive waste management and radiation safety standards.
Conclusions. 1. The problem of MW is a significant problem of the domestic health care system. 2. Categories of MW include category A – epidemically safe MW, B – epidemically dangerous MW, C – toxicologically dangerous MW, D – radiologically dangerous MW. 3. The waste management system includes their collection and sorting; marking; disinfection; transportation within the institution; utilization or disposal (category A only).
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Tarricone, R., O. Ciani, S. D'Acunto, and S. Scalzo. "The rise of rules: Will the new EU regulation of medical devices make us safer?" European Journal of Internal Medicine 80 (October 2020): 117–20. http://dx.doi.org/10.1016/j.ejim.2020.07.012.
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HADIYOSO, SUGONDO, NURSANTO NURSANTO, and ACHMAD RIZAL. "Implementasi Regulator Oksigen Otomatis berdasarkan Tingkat Pernapasan menggunakan Logika Fuzzy." ELKOMIKA: Jurnal Teknik Energi Elektrik, Teknik Telekomunikasi, & Teknik Elektronika 3, no. 1 (January 1, 2015): 52. http://dx.doi.org/10.26760/elkomika.v3i1.52.
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ABSTRAKOtomasi perangkat kesehatan saat ini banyak dikembangkan dengan tujuan untuk mempermudah kerja manusia sekaligus efisiensi utilitas perangkat. Pada penelitian ini, diusulkan desain prototipe sebuah regulator oksigen otomatis pada sebuah alat bantu pernafasan yang berfungsi untuk mengatur tekanan atau kadar oksigen yang dikeluarkan. Kondisi ini disesuaikan dengan tingkat pernafasan pasien. Jika tingkat pernafasan pasien diatas ambang batas maka tekanan oksigen akan dinaikkan. Melaui sensor, pernafasan pasien dideteksi yang selanjutnya diolah oleh mikrokontroler untuk dihitung rate pernafasannya. Melalui logika fuzzy, perhitungan tersebut diolah untuk proses pengambilan keputusan berapa banyak oksigen yang harus dikeluarkan. Setelah dilakukan pengujian, regulator otomatis dapat mengatur volume oksigen yang dikeluarkan sesuai dengan jumlah pernafasan pasien. Terdapat 9 buah aturan yang diimplementasikan pada sistem dalam pengaturan volume oksigen. Dimana setiap logika tersebut dapat dijalankan dengan baik oleh sistem. Tingkat akurasi yang dicapai perangkat untuk menghitung rate pernafasan mencapai 92,73%.Kata kunci: otomasi, regulator, oksigen, logika fuzzy. ABSTRACTAutomatic medical device currently developed with the aim to help the work and efficiency of the device utilities. In this research, proposed to prototype design an automatic oxygen regulator to regulate pressure or levels of oxygen. This condition is adjusted by the respiratory rate of patient. If the respiratory rate of the patient above the threshold then the oxygen pressure would be raised. Sensor detect the patient's breathing then processed by a microcontroller to count breathing rate. Through fuzzy logic, that calculations are processed for the decision process to determine how much oxygen should be given. After testing, the automatic regulator can control the volume of oxygen according with the patient's respiratory condition. There are 9 rules that are implemented on the system for setting the volume of oxygen. Each logic rules can be run well by the system. The level accuracy of device to compute respiration rate, reached 92.73%.Keywords: automation, regulator, oxygen, fuzzy logic.
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Adiguzel, Yekbun, Kristel P. Ramirez Valdez, and Gulkizilca Yurur. "Medical Use of Sensor-Based Devices, the Debates Around and Implementation in Education." Reports in Advances of Physical Sciences 02, no. 01 (March 2018): 1850001. http://dx.doi.org/10.1142/s2424942418500019.
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Sensor-based diagnostics are increasing rapidly and in clinics, they can transform the health care as they will be in use out of clinics as well, namely, by the non-clinicians and people without expertise. The trade-off between the advantages and disadvantages of their implementation into the clinical settings should be decisive in their use, at the current state. Yet, disadvantages must be carefully worked out and tried to be eliminated in any case, while keeping the inborn benefits. Therefore, we would like to draw attention to the reliability and security risks of personal health data and associated concerns. We further discuss the related issues of sensor-based diagnostics, mobile health (mHealth) and eHealth. The debate starts with the current states of the rules and regulations. It is argued that there is prompt need for internationally consolidated solutions for vast device types and uses onto which the local needs may have to be implemented without violating the basic assets such as the inherent privacy rights of the users/patients. The resistance factors against the sensor-based healthcare devices and applications are also conferred. There are additionally data quality and assessment issues, and in relation to the data assessment, concerns that are associated with the psychological responses of the layman to the health data are mentioned. For these and more reasons, and finally for proper use and implementation of sensor-based tests and devices in the clinical settings, education of both professionals and non-professionals seems to be the key. All these require much work and maybe even more workforces to be allocated for the emerging, associated tasks. However, there are economic benefits, and beyond those, they bring new features in the health care that were deemed to be impossible. Besides, despite the apparent unethical use risks, they can result in better ethical practices, e.g., possible prevention of unnecessary tests on animals when similar test on organ-on-chips would be failing.
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Maras, Marie-Helen, and Adam Scott Wandt. "State of Ohio v. Ross Compton: Internet-enabled medical device data introduced as evidence of arson and insurance fraud." International Journal of Evidence & Proof 24, no. 3 (June 4, 2020): 321–28. http://dx.doi.org/10.1177/1365712720930600.
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The data generated by Internet of Things devices is increasingly being introduced as evidence in court. The first US case involving the introduction of medical data from a pacemaker as evidence of arson and insurance fraud was State of Ohio v Compton. The purpose of this article is three-fold. First, the article explores this case, looking in particular at the facts of the case and the charges brought against the defendant. Second, the article critically examines the decision of the trial court judge during the suppression hearing for the evidence from the pacemaker. In this hearing, the judge ruled that the search and seizure did not violate the Fourth Amendment rights of the defendant and allowed the pacemaker data to be entered as evidence against him. Third, the article considers the implications of this decision for future cases involving Internet-of-Things (IoT) medical data. Ultimately, the constitutional protections of IoT medical device data and the circumstances under which the data from these devices will be collected and used as evidence, are issues that currently demand the attention of legal and digital forensics professionals and warrant public debate.
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Taran, O. V., and O. G. Sandul. "Criminal Liability for Illicit Trafficking of Radioactive Materials." Nuclear and Radiation Safety, no. 3(79) (August 28, 2018): 66–70. http://dx.doi.org/10.32918/nrs.2018.3(79).10.
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The nuclear energy use progressively becomes part of the life of every modern person, who more and more faces radioactive materials in medical institutions, in industry. Half of all electricity generated in Ukraine is generated by nuclear power plants. The peculiarities of the nuclear energy use generate appropriate rules for people dealing with radioactive materials. The article analyzes the standards of the Criminal Code of Ukraine, which provides for liability for acts related to the illegal handling of radioactive materials, for violation of the nuclear and radiation safety rules, violation of radiation safety requirements, the threat of theft of radioactive materials, the illicit manufacturing of a nuclear explosive device, abduction or capture of radioactive materials, attack on radioactive materials transportation means. The grounds and peculiarities for bringing to criminal liability have been reviewed, the range of persons who can be prosecuted has been defined. Conditions and grounds for exemption from criminal liability in the absence of a person's criminal intent to use radioactive material are considered. It has been demonstrated that the Criminal Code of Ukraine, by prohibiting certain actions on the illegal radioactive materials handling, ensures protection of the most important social relations and social benefits.
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Rechul, D., and K. Rechul. "0164 Evidence Suggesting Early Airway Collapse as Cause of Spontaneous Arousals." Sleep 43, Supplement_1 (April 2020): A64. http://dx.doi.org/10.1093/sleep/zsaa056.162.
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Abstract Introduction Spontaneous arousals can occur in response to a number of stimuli like noise, movement, hypoxia, or airway obstruction. Some arousals occur “spontaneously” and in individuals donning a hyper-arousable phenotype, spontaneous arousals can dominate the sleep architecture. While arousal mechanisms for some stimuli have been well described, there is a profound lack of knowledge to explain spontaneous arousals. During clinical testing of a device that was designed by SleepMethods, Inc. to anticipate obstructive sleep apnea events by the ability to sense minute airway caliber changes, it was noted, incidentally that the device would signal impeding airway collapse but a spontaneous arousal followed the signal before an obstructive airway event ever developed. This phenomenon was observed many times within and between subjects, suggesting the possibility that very early airway changes are causing “spontaneous arousals” Methods Ten adults (7M;3F) aged 18-80y/o (avg. 54.7y/o) with a known AHI ≥ 15/hr (avg. AHI = 42.6/hr) underwent 1 overnight PSG recording while wearing the device. Patients were required to forego their usual CPAP therapy on the night of study in efforts to expose the device to an adequate number of total obstructive events (defined as apneas and hypopneas; RERAs and snores were excluded). Standard PSG analysis was performed. Scoring rules were applied to determine whether signals were true/false positives and/or true/false negatives based on pre-clinical data showing anticipation accuracy for up to 45 seconds prior to an obstructive airway event. Signals designed to herald obstructive events were noted, incidentally, appearing prior to spontaneous arousals. Results Preliminary results suggest that early phases of airway collapse, as the airway progresses from patency to clinically significant obstruction, are causing EEG arousals which, by current standards, are considered “spontaneous”. Because these findings were incidental to another primary purpose of the clinical study, data analysis is in early stages but currently suggesting at least an associative relationship. Conclusion If final data analysis shows statistically significant correlation between early airway collapse and “spontaneous arousals”, it may have tremendous implications for patients with hyper-arousability, insomnia, and/or pathologically elevated spontaneous arousal indices by proposing therapies aimed at airway patency maintenance. Support N/A
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Koreerat, Nicholas R., and Russell Giese. "An Observation of Application of Structural Brain Injury Devices for Traumatic Brain Injury Evaluation in Austere Military Prehospital Settings." Military Medicine 186, Supplement_1 (January 1, 2021): 579–83. http://dx.doi.org/10.1093/milmed/usaa397.
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ABSTRACT Introduction Military units lack the ability to quickly, objectively, and accurately assess individuals that have suffered a closed head injury for structural brain injury and functional brain impairments in forward settings, where neurological assessment equipment and expertise may be lacking. With acute traumatic brain injury patients, detached medical providers are often faced with a decision to wait and observe or medically evacuate, both of which have cascading consequences. Structural brain injury assessment devices, when employed in forward environments, have the potential to reduce the risk of undiagnosed and/or mismanaged traumatic brain injuries given their high negative predictive value and suggested increased specificity compared to common subjective clinical decision rules. These handheld devices are portable and have an ease of use, from combat medic to physician, allowing for use in austere environments, safely keeping soldiers with their teams when able and suggesting further evaluation via computed tomography (CT) scan when warranted. Methods Data collected on 13 encounters at 5 locations were retrospectively analyzed using descriptive statistics. Results A total number of 13 examinations were performed using the BrainScope One device during the 9-month deployment. The Structural Injury Classification was negative for 11 of the patients. Two of the 11 patients underwent head CT scans, which confirmed the absence of intracranial hemorrhage. Of the two positive Structural Injury Classification exams, one was CT negative and no CT was performed for the other based on clinical judgment. Conclusion The data from this study suggest that structural brain injury devices may provide value by ruling out serious brain injury pathology while limiting excessive medical evacuations from austere settings, where neurological assessment equipment and expertise may be lacking, reducing unnecessary head CT scans.
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Chen, Guo Ping, Jun Lin Tao, Dai Quan Zhang, and Lang Tang. "Experimental Investigation on the Embracing Force of Medical Ni-Ti Memory Alloy Arm-Embracing Fixator." Advanced Materials Research 79-82 (August 2009): 55–58. http://dx.doi.org/10.4028/www.scientific.net/amr.79-82.55.
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The unique memory function of Ni-Ti alloy makes it unique durative self-press function as the orthopaedics internal fixator devices, the durative embracing force provides a good mechanical condition for the bone healing in clinical orthopaedics. Through the special embracing force testing device and using self-designed experiment device which arms at this kind of arm-embracing Internal fixator experiment to observe the effect of the extended distance of arms on the embracing force when Ni-Ti shape memory alloy arm-embracing fixes fractures. It is researched that the state affected embracing force under the resistance effect, and fully realizes the law of embracing force’s variety. The investigation has been done to the clutching internal fixator which frequently used in clinical treatment of orthopedic and find that the embracing force increases with time and stabilizes finally, when the open end of arm-embracing internal fixator is in the equal temperature and opening under the resistive effect; it observes the character of embracing force which increasing along with the opening degree of the arms when the open end is at the same temperature and different opening degree; it also researches that the embracing force has the rule of change that it will reduce in repeated experiment at the same temperature, at the same place of the memory alloy arm-embracing clip. The research provides the instructions and references based on mechanics for clinical treatment.