Готові списки джерел за темами / Medical Devices and Systems

Добірка наукової літератури з теми "Medical Devices and Systems"

Автор: Grafiati
Опубліковано: 6 вересня 2023

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Статті в журналах з теми "Medical Devices and Systems"

1

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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2

Arandia, Nerea, Jose Ignacio Garate, and Jon Mabe. "Embedded Sensor Systems in Medical Devices: Requisites and Challenges Ahead." Sensors 22, no. 24 (December 16, 2022): 9917. http://dx.doi.org/10.3390/s22249917.

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The evolution of technology enables the design of smarter medical devices. Embedded Sensor Systems play an important role, both in monitoring and diagnostic devices for healthcare. The design and development of Embedded Sensor Systems for medical devices are subjected to standards and regulations that will depend on the intended use of the device as well as the used technology. This article summarizes the challenges to be faced when designing Embedded Sensor Systems for the medical sector. With this aim, it presents the innovation context of the sector, the stages of new medical device development, the technological components that make up an Embedded Sensor System and the regulatory framework that applies to it. Finally, this article highlights the need to define new medical product design and development methodologies that help companies to successfully introduce new technologies in medical devices.
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3

Klein, Devorah E., and Matthew J. Jordan. "Methods of Assessing Medical Devices." Proceedings of the Human Factors and Ergonomics Society Annual Meeting 46, no. 23 (September 2002): 1890–94. http://dx.doi.org/10.1177/154193120204602305.

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While designing and validating any complex system has challenges, the medical domain has specific requirements which must be considered for a system or device to be successful. The environments, communities of use, and interactions are varied, unpredictable, uncontrolled, and ever-changing. Given the environments, communities of use, and interactions involved with medical devices, successful early and late validation of the device must be informed by the context of use itself. Building “frameworks” which represent the context of use for the device can focus validation goals, methods, and criteria and ensure that validation is directed and appropriate. In this paper we present a process and associated methods for defining the frameworks in which medical devices can be successfully assessed. The phases of the process include Phase1: Definition in which a framework of understanding is built which represents the environment of use, community of users, and the interactions between systems and users for the medical device in development. In Phase 2: Validation the framework which defines the environment of use, community of users, and the interactions between systems and users is used to develop a validation approach and criteria. The developing device is then validated against the framework itself.
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4

Connolly, Christine. "Precision assembly systems for medical devices." Assembly Automation 29, no. 4 (September 25, 2009): 326–31. http://dx.doi.org/10.1108/01445150910987736.

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5

Lin, Tzu-Wei, and Chien-Lung Hsu. "FAIDM for Medical Privacy Protection in 5G Telemedicine Systems." Applied Sciences 11, no. 3 (January 27, 2021): 1155. http://dx.doi.org/10.3390/app11031155.

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Анотація:
5G networks have an efficient effect in energy consumption and provide a quality experience to many communication devices. Device-to-device communication is one of the key technologies of 5G networks. Internet of Things (IoT) applying 5G infrastructure changes the application scenario in many fields especially real-time communication between machines, data, and people. The 5G network has expanded rapidly around the world including in healthcare. Telemedicine provides long-distance medical communication and services. Patient can get help with ambulatory care or other medical services in remote areas. 5G and IoT will become important parts of next generation smart medical healthcare. Telemedicine is a technology of electronic message and telecommunication related to healthcare, which is implemented in public networks. Privacy issue of transmitted information in telemedicine is important because the information is sensitive and private. In this paper, 5G-based federated anonymous identity management for medical privacy protection is proposed, and it can provide a secure way to protect medical privacy. There are some properties below. (i) The proposed scheme provides federated identity management which can manage identity of devices in a hierarchical structure efficiently. (ii) Identity authentication will be achieved by mutual authentication. (iii) The proposed scheme provides session key to secure transmitted data which is related to privacy of patients. (iv) The proposed scheme provides anonymous identities for devices in order to reduce the possibility of leaking transmitted medical data and real information of device and its owner. (v) If one of devices transmit abnormal data, proposed scheme provides traceability for servers of medical institute. (vi) Proposed scheme provides signature for non-repudiation.
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6

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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7

Riha, Chris. "Integrating Medical Devices to Clinical Information Systems." Biomedical Instrumentation & Technology 43, no. 5 (September 1, 2009): 385–87. http://dx.doi.org/10.2345/0899-8205-43.5.385.

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Анотація:
Abstract For this installment of IT World, I'd like to introduce Chris Riha. He brings an excellent perspective on an issue that just might call for a constant vigil for those of us in healthcare technology management. We're talking about super systems, where networked medical devices are passing patient data around the network and other, third-party systems are plugged in to collect those data as well. I think—like Chris is saying—we can sense trouble brewing. We can't wait for something to happen to validate and verify the new super system components. As the article notes, if we relying more and more on this super system, downtime becomes very important. In a 24×7 world, 98.5% uptime means you're down a week per year. If one of the feeding systems is down, how does the super system react? Does it make clinical recommendations on partial data? One example I recently heard of shows how patient data can get mixed. After working with one particular patient, a clinician found that his medical record indicated he was pregnant. That's right—a male patient. In investigating the problem, it was discovered that when data converted from an old super system to a new one, those data were misfiled. While this example is humorous and no harm done, it does show that mixing patient data happens. A multidisciplinary approach to our vigil on super systems is warranted. There are a number of things we in healthcare service can do. Provide education to the clinician on what the super system can and cannot do. Take what it's telling you with a grain of salt by understanding its limitations and boundaries. When I am a patient, I'm asked everywhere I go in a hospital what I'm there for, as a way to check that they're performing the right test on the right person. We need to ask the same question of our systems. Does this collection of data look reasonable? I also agree with the author that a multidisciplinary approach is needed to ensure not only accurate data, but also that the patient records are collecting only that particular patient's data. One way to jump in is to gain expertise on HL7 (covered in IT World in the Sept/Oct 2006 edition). This article sets the scene well—now we need to decide how we react to support our customers and our customer's customer (the patient)! —Jeff Kabachinski, IT World Columnist
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8

UEMURA, Munenori. "Development of Medical Devices and Systems for Advanced Medical Services." Proceedings of Mechanical Engineering Congress, Japan 2017 (2017): W221004. http://dx.doi.org/10.1299/jsmemecj.2017.w221004.

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9

Arandia, Nerea, Jose Ignacio Garate, and Jon Mabe. "Medical Devices with Embedded Sensor Systems: Design and Development Methodology for Start-Ups." Sensors 23, no. 5 (February 26, 2023): 2578. http://dx.doi.org/10.3390/s23052578.

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Анотація:
Embedded systems have become a key technology for the evolution of medical devices. However, the regulatory requirements that must be met make designing and developing these devices challenging. As a result, many start-ups attempting to develop medical devices fail. Therefore, this article presents a methodology to design and develop embedded medical devices while minimising the economic investment during the technical risk stages and encouraging customer feedback. The proposed methodology is based on the execution of three stages: Development Feasibility, Incremental and Iterative Prototyping, and Medical Product Consolidation. All this is completed in compliance with the applicable regulations. The methodology mentioned above is validated through practical use cases in which the development of a wearable device for monitoring vital signs is the most relevant. The presented use cases sustain the proposed methodology, for the devices were successfully CE marked. Moreover, ISO 13485 certification is obtained by following the proposed procedures.
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10

Meadows, Susan. "Human Factors Applications to Health Care Systems." Proceedings of the Human Factors Society Annual Meeting 33, no. 17 (October 1989): 1167. http://dx.doi.org/10.1518/107118189786757923.

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This demonstration program shows how human factors design and evaluation principles can be applied to the area of medical device and healthcare systems. The objective is to provide examples of evaluations and new designs for healthcare products which reduce human error and improve medical devices and instructional materials. International performance and design standards incorporating human factors principles are gaining more attention because of the efforts of the European medical device industry to standardize products.
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Більше джерел

Дисертації з теми "Medical Devices and Systems"

1

Basu, Probal, and Eun Kyun Kim. "Customer segmentation in the medical devices industry." Thesis, Massachusetts Institute of Technology, 2007. http://hdl.handle.net/1721.1/40110.

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Анотація:
Thesis (M. Eng. in Logistics)--Massachusetts Institute of Technology, Engineering Systems Division, 2007.
Includes bibliographical references (p. 73-76).
This thesis addresses Company X's concerns about its product shipment options. The company ships over 70% of its products to its customers using the primary service provider that ensures that the product is at the customer site by 10:30 AM next day. As per the understanding with its customers, the company, absorbs the cost of premium shipping and does not pass it on to most of its customers. The company believes that this priority service is a source of competitive advantage that helps it get customer loyalty and thereby increases sales. However it is not a normal industry practice to provide this service free to the customers. Keeping in mind this enormous cost burden, Company X wants to minimize this cost. Medical device sales are non-seasonal and do not show promotional effects. We analyzed data for the months of June and October, 2006 as a part of our research. The objective of our data analysis was to validate the proposed approaches we reviewed as a basis for proposing ways to segment customers for improving service while reducing cost. We proposed three types of segmentation: by region, by order method and by division. Segmentation by region looks at dividing the customers by into 4 regions based on their location.
(cont.) Segmentation by ordering method splits the customers in terms of whether they order using phone, fax or EDI while segmentation by division breaks up the customer base in terms of the various divisions the company has. Our study revealed that the company can expect to save over 3 million dollars annually by not offering this service free of charge to its customers. If customers are not convinced that the lower level of service meets their needs, they may pay for use of premium shipping. We demonstrate that the lower level of service will likely be just as effective and hence the company can guarantee that the product would reach the customer on time. Given the criticality of the parts that the company ships, it is advised to take its customers into confidence before making major policy changes.
by Probal Basu [and] Eun Kyun Kim.
M.Eng.in Logistics
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2

Hillstrom, Nichole L. (Nichole Leigh), and Renato A. Malabanan. "Strategic inventory management of externally sourced medical devices." Thesis, Massachusetts Institute of Technology, 2013. http://hdl.handle.net/1721.1/81099.

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Анотація:
Thesis (M. Eng. in Logistics)--Massachusetts Institute of Technology, Engineering Systems Division, 2013.
Cataloged from PDF version of thesis.
Includes bibliographical references (p. 59).
The purpose of this research was to determine inventory strategies for externally sourced medical devices. In the medical device industry, the desire for high levels of customer service often results in less than optimal inventory levels. In this study, we analyzed the details of the current inventory model utilized by the medical device company. In assigning appropriate inventory levels, we determined that key inputs were not regarded. When evaluating inventory levels, it was determined that pipeline inventory should be removed from the target on hand inventory levels if inventory ownership occurs upon receipt. When calculating safety stock, we determined that supply variability should be incorporated into the safety stock formula and extra buffers currently in place should be removed. In addition, a more robust measure of demand variability such as the Root Mean Squared Error (RMSE) or the Mean Absolute Percent Error (MAPE) should be incorporated into the formula instead of the use of the maximum of standard deviation of demand and standard deviation of forecast. Also, a gap was identified between the customer service safety factor used in the safety stock formula and the measurement of customer service by the company. Following the analysis of the current inventory modeling approach, we segmented the medical device SKU's based on key factors that drive inventory: demand, lead time, criticality and customer service. We also redefined the model used to determine slow moving inventory levels by incorporating the lead time of the part in setting cycle and safety stock levels and simulating the results to validate the relationships between the various inventory drivers. The application of the methodologies, concepts and findings in this research covering externally sourced medical devices can be extended to other subsidiaries and other industries.
by Nichole L. Hillstrom and Renato A. Malabanan.
M.Eng.in Logistics
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3

Arad, Ron 1973. "Sterilization resource forecasting in the medical devices industry." Thesis, Massachusetts Institute of Technology, 2005. http://hdl.handle.net/1721.1/33333.

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Анотація:
Thesis (M. Eng. in Logistics)--Massachusetts Institute of Technology, Engineering Systems Division, 2005.
Includes bibliographical references (leaf 73).
Sterilization is an example of a procedure that has been outsourced by medical device companies. Sterilization is required for all medical devices and the process used is based on product type. As demand for medical devices increases, production is ramping up, and the need for additional sterilization capacity increases. The time required to build more sterilization capacity can be between six to nine months, and therefore companies are looking into their future production to estimate when will be the right time to start building more capacity. This thesis analyzes the change in sterilization capacity utilization using a simulation model. The model replicates the current production distribution based on data provided from the sterilization facility.
y Ron Arad.
M.Eng.in Logistics
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4

Balgos, Vincent H. "A systems theoretic application to design for the safety of medical diagnostic devices." Thesis, Massachusetts Institute of Technology, 2012. http://hdl.handle.net/1721.1/76814.

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Анотація:
Thesis (S.M. in Engineering and Management)--Massachusetts Institute of Technology, Engineering Systems Division, System Design and Management Program, 2012.
This electronic version was submitted by the student author. The certified thesis is available in the Institute Archives and Special Collections.
Cataloged from PDF version of thesis.
Includes bibliographical references (p. 87-89).
In today's environment, medical technology is rapidly advancing to deliver tremendous value to physicians, nurses, and medical staff in order to support them to ultimately serve a common goal: provide safe and effective medical care for patients. However, these complex medical systems are contributing to the increasing number of healthcare accidents each year. These accidents present unnecessary risk and injury to the very population these systems are designed to help. Thus the current safety engineering techniques that are widely practiced by the healthcare industry during medical system development are inadequate in preventing these tragic accidents. Therefore, there is a need for a new approach to design safety into medical systems. This thesis demonstrated that a holistic approach to safety design using the Systems Theoretic Accident Model and Process (STAMP) and Causal Analysis based on STAMP (CAST) was more effective than the traditional, linear chain-of-events model of Failure Mode Effects and Criticality Analysis (FMECA). The CAST technique was applied to a medical case accident involving a complex diagnostic analyzer system. The results of the CAST analysis were then compared to the original FMECA hazards. By treating safety as a control problem, the CAST analysis was capable of identifying an array of hazards beyond what was detected by the current regulatory approved technique. From these hazards, new safety design requirements and recommendations were generated for the case system that could have prevented the case accident. These safety design requirements can also be utilized in new medical diagnostic system development efforts to prevent future medical accidents, and protect the patient from unnecessary harm.
by Vincent H. Balgos.
S.M.in Engineering and Management
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5

Jellen, Isabel. "Towards Security and Privacy in Networked Medical Devices and Electronic Healthcare Systems." DigitalCommons@CalPoly, 2020. https://digitalcommons.calpoly.edu/theses/2141.

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Анотація:
E-health is a growing eld which utilizes wireless sensor networks to enable access to effective and efficient healthcare services and provide patient monitoring to enable early detection and treatment of health conditions. Due to the proliferation of e-health systems, security and privacy have become critical issues in preventing data falsification, unauthorized access to the system, or eavesdropping on sensitive health data. Furthermore, due to the intrinsic limitations of many wireless medical devices, including low power and limited computational resources, security and device performance can be difficult to balance. Therefore, many current networked medical devices operate without basic security services such as authentication, authorization, and encryption. In this work, we survey recent work on e-health security, including biometric approaches, proximity-based approaches, key management techniques, audit mechanisms, anomaly detection, external device methods, and lightweight encryption and key management protocols. We also survey the state-of-the art in e-health privacy, including techniques such as obfuscation, secret sharing, distributed data mining, authentication, access control, blockchain, anonymization, and cryptography. We then propose a comprehensive system model for e-health applications with consideration of battery capacity and computational ability of medical devices. A case study is presented to show that the proposed system model can support heterogeneous medical devices with varying power and resource constraints. The case study demonstrates that it is possible to signicantly reduce the overhead for security on power-constrained devices based on the proposed system model.
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6

Amiri, Atila. "ST. JUDE MEDICAL: AN OBJECT-ORIENTED SOFTWARE ARCHITECTURE FOR EMBEDDED AND REAL-TIME MEDICAL DEVICES." DigitalCommons@CalPoly, 2010. https://digitalcommons.calpoly.edu/theses/374.

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Анотація:
Medical devices used for surgical or therapeutic purposes require a high degree of safety and effectiveness. Software is critical component of many such medical devices. The software architecture of a system defines organizational structure and the runtime characteristic of the application used to control the operation of the system and provides a set of frameworks that are used to develop that. As such, the design of software architecture is a critical element in achieving the intended functionality, performance, and safety requirements of a medical device. This architecture uses object-oriented design techniques, which model the underlying system as a set of objects that interact to achieve their goals. The architecture includes a number of frameworks comprised of a set of classes that can be extended to achieve different functionality required for a medical device. The Input/ Output (IO) framework includes a number of core classes that implement periodic and a periodic input output with varying priority requirements, provides a hardware neutral interface to the application logic, and a set of classes that can be extended to both meet the hardware IO specifics of a target platform and create new sensor and actuator types for client applications. The Devices framework provides a blueprint to develop the controller logic of the medical device in terms of abstractions that parallel the hardware components of the medical device. The Configuration framework allows creation and configuration of a medical device from an XML (Extensible Markup Specification) specification that specifies the configuration of the device based on abstract factories that can be extended to meet requirements of a specific medical device. The Controller is the component of the architecture that defines classes that implement reception of commands from and transmission of status and data to a local or remote client and dictate the structure of threads, thread priorities and policies for this purpose. The Diagnostics package of the architecture defines a framework for developing components that monitor the health of the system and detect emergency conditions. The architecture is implemented in C++ and runs on a real-time LINUX operating system. At this time, the architecture is used in development of two of the St. Jude Medical Atrial Fibrillation Division’s medical devices; one of these has FDA class III and the other class II classification.
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7

Yip, Marcus. "Ultra-low-power circuits and systems for wearable and implantable medical devices." Thesis, Massachusetts Institute of Technology, 2013. http://hdl.handle.net/1721.1/84902.

Повний текст джерела
Анотація:
Thesis (Ph. D.)--Massachusetts Institute of Technology, Department of Electrical Engineering and Computer Science, 2013.
Cataloged from PDF version of thesis.
Includes bibliographical references (pages 219-231).
Advances in circuits, sensors, and energy storage elements have opened up many new possibilities in the health industry. In the area of wearable devices, the miniaturization of electronics has spurred the rapid development of wearable vital signs, activity, and fitness monitors. Maximizing the time between battery recharge places stringent requirements on power consumption by the device. For implantable devices, the situation is exacerbated by the fact that energy storage capacity is limited by volume constraints, and frequent battery replacement via surgery is undesirable. In this case, the design of energy-efficient circuits and systems becomes even more crucial. This thesis explores the design of energy-efficient circuits and systems for two medical applications. The first half of the thesis focuses on the design and implementation of an ultra-low-power, mixed-signal front-end for a wearable ECG monitor in a 0.18pm CMOS process. A mixed-signal architecture together with analog circuit optimizations enable ultra-low-voltage operation at 0.6V which provides power savings through voltage scaling, and ensures compatibility with state-of-the-art DSPs. The fully-integrated front-end consumes just 2.9[mu]W, which is two orders of magnitude lower than commercially available parts. The second half of this thesis focuses on ultra-low-power system design and energy-efficient neural stimulation for a proof-of-concept fully-implantable cochlear implant. First, implantable acoustic sensing is demonstrated by sensing the motion of a human cadaveric middle ear with a piezoelectric sensor. Second, alternate energy-efficient electrical stimulation waveforms are investigated to reduce neural stimulation power when compared to the conventional rectangular waveform. The energy-optimal waveform is analyzed using a computational nerve fiber model, and validated with in-vivo ECAP recordings in the auditory nerve of two cats and with psychophysical tests in two human cochlear implant users. Preliminary human subject testing shows that charge and energy savings of 20-30% and 15-35% respectively are possible with alternative waveforms. A system-on-chip comprising the sensor interface, reconfigurable sound processor, and arbitrary-waveform neural stimulator is implemented in a 0.18[mu]m high-voltage CMOS process to demonstrate the feasibility of this system. The sensor interface and sound processor consume just 12[mu]W of power, representing just 2% of the overall system power which is dominated by stimulation. As a result, the energy savings from using alternative stimulation waveforms transfer directly to the system.
by Marcus Yip.
Ph.D.
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8

GOMES, LEILA CRISTINA NUNES. "PRODUCTION SYSTEMS IN THE MEDICAL IMAGE DEVICES INDUSTRY: AN ANALYSIS OF MAGNETIC RESONANCE." PONTIFÍCIA UNIVERSIDADE CATÓLICA DO RIO DE JANEIRO, 2004. http://www.maxwell.vrac.puc-rio.br/Busca_etds.php?strSecao=resultado&nrSeq=6081@1.

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Анотація:
COORDENAÇÃO DE APERFEIÇOAMENTO DO PESSOAL DE ENSINO SUPERIOR
Nas últimas décadas, vem ocorrendo uma importante revolução na área da tecnologia médica, em particular nos equipamentos de diagnóstico por imagem. O propósito central da presente tese concentra-se na análise e compreensão das estratégias e sistemas produtivos empregados na produção desses equipamentos, com enfoque específico na produção de equipamentos de Ressonância Magnética, pela importância de se dispor de dados e informações principalmente em países como o Brasil que, apesar de ainda não apresentarem produção nacional, fazem uso de toda essa tecnologia e necessitam preparar recursos humanos não só para a sua própria utilização, mas também para o desenvolvimento e produção de componentes e periféricos específicos. Um grande motivador para esta pesquisa foi o Projeto ToRM, desenvolvido pela Universidade de São Paulo. O projeto constava do desenvolvimento local de um equipamento de ressonância para que fosse possível a formação de mão-de-obra especializada e a realização de estudos para acessórios e componentes. A metodologia empregada neste estudo, o qual é de caráter exploratório, envolve uma pesquisa bibliográfica e dois estudos de casos realizados em empresas produtoras de equipamentos de diagnóstico por imagem - Philips Medical Systems e Siemens Medical. Assim, com a compreensão dos sistemas produtivos aplicados, objetiva-se subsidiar as empresas e universidades com informações atualizadas referentes a essa indústria, principalmente pela falta de material acadêmico sobre o assunto.
In the last decades, an important revolution has taken place in the medical technology field, particularly in image diagnosis equipment. The central purpose of the present thesis is to analyze and understand the strategies and productive systems used in the production of such equipment, with specific focus on the production of Magnetic Resonance equipment. It is important to make data and information available especially in countries like Brazil, which, despite still not having a national production, make use of this technology and need to prepare human resources not only for its own use but also for the development and production of specific components. A great motivation to this research was the ToRM Project, developed by the University of São Paulo. This project consisted in the local development of a resonance machine, which would allow for the preparation of specialized professionals and the development of studies about accessories and components. The methodology used in the present study, which is exploratory in character, involves a literature review and case studies performed in two major manufacturers of image diagnosis equipment - Philips Medical Systems and Siemens Medical. Thus, by understanding the productive systems applied, our goal is to provide companies and universities with updated information about this industry, especially considering the lack of academic material on this subject.
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9

Zhao, Jing. "Design and evaluation of a screen-CCD imaging system for medical radiology /." Online version of thesis, 1992. http://hdl.handle.net/1850/11253.

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Kiani, Mehdi. "Wireless power and data transmission to high-performance implantable medical devices." Diss., Georgia Institute of Technology, 2014. http://hdl.handle.net/1853/53396.

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Novel techniques for high-performance wireless power transmission and data interfacing with implantable medical devices (IMDs) were proposed. Several system- and circuit-level techniques were developed towards the design of a novel wireless data and power transmission link for a multi-channel inductively-powered wireless implantable neural-recording and stimulation system. Such wireless data and power transmission techniques have promising prospects for use in IMDs such as biosensors and neural recording/stimulation devices, neural interfacing experiments in enriched environments, radio-frequency identification (RFID), smartcards, near-field communication (NFC), wireless sensors, and charging mobile devices and electric vehicles. The contributions in wireless power transfer are the development of an RFID-based closed-loop power transmission system, a high-performance 3-coil link with optimal design procedure, circuit-based theoretical foundation for magnetic-resonance-based power transmission using multiple coils, a figure-of-merit for designing high-performance inductive links, a low-power and adaptive power management and data transceiver ASIC to be used as a general-purpose power module for wireless electrophysiology experiments, and a Q-modulated inductive link for automatic load matching. In wireless data transfer, the contributions are the development of a new modulation technique called pulse-delay modulation for low-power and wideband near-field data communication and a pulse-width-modulation impulse-radio ultra-wideband transceiver for low-power and wideband far-field data transmission.
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Книги з теми "Medical Devices and Systems"

1

1937-, Bronzino Joseph D., ed. Medical devices and systems. Boca Raton: CRC/Taylor & Francis, 2006.

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Rogers, John A., Roozbeh Ghaffari, and Dae-Hyeong Kim, eds. Stretchable Bioelectronics for Medical Devices and Systems. Cham: Springer International Publishing, 2016. http://dx.doi.org/10.1007/978-3-319-28694-5.

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Lopez, Orlando. Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation. Boca Raton : Taylor & Francis, [2018]: Productivity Press, 2018. http://dx.doi.org/10.4324/9781315174617.

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Williams, Rebecca D. Keeping medical devices safe from electromagnetic interference. [Rockville, MD: Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, 1995.

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King, Paul H. Design of biomedical devices and systems. 2nd ed. Boca Raton: Taylor & Francis, 2009.

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C, Fries Richard, ed. Design of biomedical devices and systems. New York: Marcel Dekker, 2003.

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Chelimsky, Eleanor. Medical devices: Underreporting of problems, backlogged systems, and weak statutory support. [Washington, D.C.]: U.S. General Accounting Office, 1989.

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Directorate, Great Britain Medical Devices. The medical devices vigilance system: European Commission guidelines. [London]: Department of Health, 1994.

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Materials and coatings for medical devices: Cardiovascular. Materials Park, Ohio: ASM International, 2009.

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10

M, Link David, McDonnell Edward J, and Association for the Advancement of Medical Instrumentation., eds. Current issues on medical device quality systems. Arlington, Va: Association for the Advancement of Medical Instrumentation, 1997.

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Частини книг з теми "Medical Devices and Systems"

1

Vienken, Claudia, Emanuele Gatti, and Joerg Vienken. "Reimbursement Systems for Healthcare: Considerations on “Pay for Performance”." In Medical Devices, 193–216. Cham: Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-030-85653-3_10.

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2

France, Francis H. Roger, and Gérald Santucci. "Medical Instrumentation and Devices." In Health Systems Research, 101–27. Berlin, Heidelberg: Springer Berlin Heidelberg, 1991. http://dx.doi.org/10.1007/978-3-642-84471-3_12.

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Boccato, Carlo, Sergio Cerutti, and Joerg Vienken. "The Medical Devices Promise to the Healthcare System." In Medical Devices, 3–16. Cham: Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-030-85653-3_1.

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Ramakrishna, Seeram, Lingling Tian, Charlene Wang, Susan Liao, and Wee Eong Teo. "Quality management systems for medical device manufacture." In Medical Devices, 49–63. Elsevier, 2015. http://dx.doi.org/10.1016/b978-0-08-100289-6.00003-x.

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"Electrosurgical Devices." In Medical Devices and Systems, 1095–104. CRC Press, 2006. http://dx.doi.org/10.1201/9781420003864-73.

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Eggleston, Jeffrey, and Wolf von Maltzahn. "Electrosurgical Devices." In Medical Devices and Systems, 63–1. CRC Press, 2006. http://dx.doi.org/10.1201/9781420003864.ch63.

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"Parenteral Infusion Devices." In Medical Devices and Systems, 1171–82. CRC Press, 2006. http://dx.doi.org/10.1201/9781420003864-78.

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Butterfield, Robert, and Gregory Voss. "Parenteral Infusion Devices." In Medical Devices and Systems, 68–1. CRC Press, 2006. http://dx.doi.org/10.1201/9781420003864.ch68.

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Kun, Luis, and T. Allan Pryor. "Hospital Information Systems." In Medical Devices and Systems, 40–1. CRC Press, 2006. http://dx.doi.org/10.1201/9781420003864.sec4.

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"Section IV. Medical Informatics." In Medical Devices and Systems, 797–808. CRC Press, 2006. http://dx.doi.org/10.1201/9781420003864-47.

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Тези доповідей конференцій з теми "Medical Devices and Systems"

1

Mellish, R. G. "The Medical Devices Directive." In IEE Colloquium on European Directives - Their Impact on Systems Engineering. IEE, 1996. http://dx.doi.org/10.1049/ic:19960216.

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2

Iyer, Ravishankar. "Resilience of Medical Devices and Systems." In ASIA CCS '15: 10th ACM Symposium on Information, Computer and Communications Security. New York, NY, USA: ACM, 2015. http://dx.doi.org/10.1145/2732198.2749244.

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Cristina Barbosa Medeiros, Ana, and Molly Smyth. "Usability Validation of Complex Medical Systems." In 14th International Conference on Applied Human Factors and Ergonomics (AHFE 2023). AHFE International, 2023. http://dx.doi.org/10.54941/ahfe1003471.

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The end goal of the application of Human Factors to the development of a safety-critical medical device is to validate the device’s safety and effectiveness in the hands of intended users. Generally, the complexity of validation studies varies according to the device intricacy. In the case of complex medical systems, such as a robotic surgical system which can be used for prolonged periods by multiple user groups at the same time and may interact with other devices in the operating room, the planning and execution of such studies require much more thinking, organization, and resources. Bearing that in mind, we have grouped the effort involved in validating complex medical systems into four categories for an optimized, practical approach. This paper discusses these four categories and provides essential guidance, based on our experience.
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Sango, Marc, Jean Godot, Antonio Gonzalez, and Ricardo Ruiz Nolasco. "Model-Based System, Safety and Security Co-Engineering Method and Toolchain for Medical Devices Design." In 2019 Design of Medical Devices Conference. American Society of Mechanical Engineers, 2019. http://dx.doi.org/10.1115/dmd2019-3210.

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The increasing complexity of the medical regulatory environment and the inherent complexity of medical devices, especially due to the increased use of connected devices and embedded control software, impose adoption of new methods and tools for the system design, safety and security analyses. In this paper, we propose a method and an associated toolchain to couple model-based system engineering and safety/security analyses at the design phase of medical devices. The method is compliant with ANSI/AAMI/ISO TIR57 safety and security guidance, and compatible with INCOSE Biomedical-Healthcare Model-Based Systems Engineering works. The toolchain is based on a system architecture modelling tool and supports medical device domain specific reference architecture, as well as tools for safety and security risk analyses. The proposed method and toolchain are illustrated by considering a RGB’s TOF-CUFF monitor device analyzed in the scope of the AQUAS project as a medical device use case.
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Thimbleby, Harold. "Improving Safety in Medical Devices and Systems." In 2013 IEEE International Conference on Healthcare Informatics (ICHI). IEEE, 2013. http://dx.doi.org/10.1109/ichi.2013.91.

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Abdelhalim, Ibrahim, and Omnia Hamdy. "A Low-Cost and Easy-to-Use Laser Corneal Reshaping Device for Educational, Research and Training Purposes." In 2022 Design of Medical Devices Conference. American Society of Mechanical Engineers, 2022. http://dx.doi.org/10.1115/dmd2022-1009.

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Abstract Recently, many vision disorders such as myopia and hyperopia can be corrected via LASIK refractive surgery. Based on the photo-ablation effect of UV-laser pulses (at 193 nm for most commercial devices), the shape of the treated cornea is modified in order to regain the normal vision capability. In laser corneal reshaping process, the laser parameters must be adjusted to maintain the desired photo-ablation effect. Moreover, the design of the employed device plays an important role in performing successful surgeries with optimum results. However, the commercial devices are designed for specific operations with a limited access to their optical system and software. Besides, these devices are not available for research or training. Consequently, we provide a low-cost and easy-to-use ablation device that can be utilized as an educational, research, and training tool for the specialists in corneal reshaping and related procedures at universities, research institutes, or medical centers. The device has a special opening to enable entry of external laser source for any desired experimental investigations. Moreover, the binocular in commercial devices is replaced by live view screen to decrease the device’s cost. There are no access limitations to the software or the optical system of the proposed device.
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"LIFETIME MANAGEMENT SYSTEMS FOR MEDICAL DEVICES - Specific Methods for Life Extension of Equipment and Systems in Medical Devices." In International Conference on Biomedical Electronics and Devices. SciTePress - Science and and Technology Publications, 2011. http://dx.doi.org/10.5220/0003112803010306.

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8

O'Kane, Aisling Ann, Yvonne Rogers, and Ann E. Blandford. "Concealing or Revealing Mobile Medical Devices?" In CHI '15: CHI Conference on Human Factors in Computing Systems. New York, NY, USA: ACM, 2015. http://dx.doi.org/10.1145/2702123.2702453.

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9

Longras, Ana, Henrique Oliveira, and Sara Paiva. "Security Vulnerabilities on Implantable Medical Devices." In 2020 15th Iberian Conference on Information Systems and Technologies (CISTI). IEEE, 2020. http://dx.doi.org/10.23919/cisti49556.2020.9141043.

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Karami, M. Amin. "In Vivo Energy Harvesting Using Cardiomyocytes for Implantable Medical Devices." In ASME 2018 Conference on Smart Materials, Adaptive Structures and Intelligent Systems. American Society of Mechanical Engineers, 2018. http://dx.doi.org/10.1115/smasis2018-8188.

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One major problem of implantable biomedical devices is the source of their power. Batteries, as the main source of current implantable devices, deplete after a few years and either the battery or the whole device needs to be replaced. Usually, this procedure involves a new surgery which is costly and could cause some risks for the patient. In this paper, we study the energy harvesting at small scale for powering implantable biomedical devices. The device consists of a layer of cultured cardiac muscle cells (cardiomyocytes) and a layer of piezoelectric polymer polyvinylidene fluoride (PVDF). The cardiac muscle cells with the desired thickness are grown over the PVDF layer and as the cardiac cells contract the piezoelectric layer deforms and produces electricity. The proposed device uses both piezoelectric and flexoelectric effects of the PVDF layer. At the smaller thicknesses the flexoelectric effect becomes dominant. The amount of power is on the order of multiple microwatts and is sufficient to power variety of sensors and implantable devices in the body. Unlike the battery technology, the proposed energy harvester is autonomous and lasts for the lifetime of patients. In this article, we explain the configuration of the proposed energy harvester, the natural frequency of the device is calculated, the power output is optimized with respect to the thickness of the PVDF, and a resistance sweep is performed to find the optimized resistive load.
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Звіти організацій з теми "Medical Devices and Systems"

1

Nikiforov, Vladimir. Laser technology and integrated system devices in devices and tools for dentists and other medical technologies. Intellectual Archive, June 2019. http://dx.doi.org/10.32370/iaj.2132.

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2

Nikiforov, Vladimir. Laser equipment and complex system devices in appliances and tools for dentists and other medical technologies. Intellectual Archive, August 2019. http://dx.doi.org/10.32370/iaj.2173.

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Lewis, Dustin, and Naz Modirzadeh. Taking into Account the Potential Effects of Counterterrorism Measures on Humanitarian and Medical Activities: Elements of an Analytical Framework for States Grounded in Respect for International Law. Harvard Law School Program on International Law and Armed Conflict, May 2021. http://dx.doi.org/10.54813/qbot8406.

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For at least a decade, States, humanitarian bodies, and civil-society actors have raised concerns about how certain counterterrorism measures can prevent or impede humanitarian and medical activities in armed conflicts. In 2019, the issue drew the attention of the world’s preeminent body charged with maintaining or restoring international peace and security: the United Nations Security Council. In two resolutions — Resolution 2462 (2019) and Resolution 2482 (2019) — adopted that year, the Security Council urged States to take into account the potential effects of certain counterterrorism measures on exclusively humanitarian activities, including medical activities, that are carried out by impartial humanitarian actors in a manner consistent with international humanitarian law (IHL). By implicitly recognizing that measures adopted to achieve one policy objective (countering terrorism) can impair or prevent another policy objective (safeguarding humanitarian and medical activities), the Security Council elevated taking into account the potential effects of certain counterterrorism measures on exclusively humanitarian activities to an issue implicating international peace and security. In this legal briefing, we aim to support the development of an analytical framework through which a State may seek to devise and administer a system to take into account the potential effects of counterterrorism measures on humanitarian and medical activities. Our primary intended audience includes the people involved in creating or administering a “take into account” system and in developing relevant laws and policies. Our analysis zooms in on Resolution 2462 (2019) and Resolution 2482 (2019) and focuses on grounding the framework in respect for international law, notably the U.N. Charter and IHL. In section 1, we introduce the impetus, objectives, and structure of the briefing. In our view, a thorough legal analysis of the relevant resolutions in their wider context is a crucial element to laying the conditions conducive to the development and administration of an effective “take into account” system. Further, the stakes and timeliness of the issue, the Security Council’s implicit recognition of a potential tension between measures adopted to achieve different policy objectives, and the relatively scant salient direct practice and scholarship on elements pertinent to “take into account” systems also compelled us to engage in original legal analysis, with a focus on public international law and IHL. In section 2, as a primer for readers unfamiliar with the core issues, we briefly outline humanitarian and medical activities and counterterrorism measures. Then we highlight a range of possible effects of the latter on the former. Concerning armed conflict, humanitarian activities aim primarily to provide relief to and protection for people affected by the conflict whose needs are unmet, whereas medical activities aim primarily to provide care for wounded and sick persons, including the enemy. Meanwhile, for at least several decades, States have sought to prevent and suppress acts of terrorism and punish those who commit, attempt to commit, or otherwise support acts of terrorism. Under the rubric of countering terrorism, States have taken an increasingly broad and diverse array of actions at the global, regional, and national levels. A growing body of qualitative and quantitative evidence documents how certain measures designed and applied to counter terrorism can impede or prevent humanitarian and medical activities in armed conflicts. In a nutshell, counterterrorism measures may lead to diminished or complete lack of access by humanitarian and medical actors to the persons affected by an armed conflict that is also characterized as a counterterrorism context, or those measures may adversely affect the scope, amount, or quality of humanitarian and medical services provided to such persons. The diverse array of detrimental effects of certain counterterrorism measures on humanitarian and medical activities may be grouped into several cross-cutting categories, including operational, financial, security, legal, and reputational effects. In section 3, we explain some of the key legal aspects of humanitarian and medical activities and counterterrorism measures. States have developed IHL as the primary body of international law applicable to acts and omissions connected with an armed conflict. IHL lays down several rights and obligations relating to a broad spectrum of humanitarian and medical activities pertaining to armed conflicts. A violation of an applicable IHL provision related to humanitarian or medical activities may engage the international legal responsibility of a State or an individual. Meanwhile, at the international level, there is no single, comprehensive body of counterterrorism laws. However, States have developed a collection of treaties to pursue specific anti-terrorism objectives. Further, for its part, the Security Council has assumed an increasingly prominent role in countering terrorism, including by adopting decisions that U.N. Member States must accept and carry out under the U.N. Charter. Some counterterrorism measures are designed and applied in a manner that implicitly or expressly “carves out” particular safeguards — typically in the form of limited exceptions or exemptions — for certain humanitarian or medical activities or actors. Yet most counterterrorism measures do not include such safeguards. In section 4, which constitutes the bulk of our original legal analysis, we closely evaluate the two resolutions in which the Security Council urged States to take into account the effects of (certain) counterterrorism measures on humanitarian and medical activities. We set the stage by summarizing some aspects of the legal relations between Security Council acts and IHL provisions pertaining to humanitarian and medical activities. We then analyze the status, consequences, and content of several substantive elements of the resolutions and what they may entail for States seeking to counter terrorism and safeguard humanitarian and medical activities. Among the elements that we evaluate are: the Security Council’s new notion of a prohibited financial “benefit” for terrorists as it may relate to humanitarian and medical activities; the Council’s demand that States comply with IHL obligations while countering terrorism; and the constituent parts of the Council’s notion of a “take into account” system. In section 5, we set out some potential elements of an analytical framework through which a State may seek to develop and administer its “take into account” system in line with Resolution 2462 (2019) and Resolution 2482 (2019). In terms of its object and purpose, a “take into account” system may aim to secure respect for international law, notably the U.N. Charter and IHL pertaining to humanitarian and medical activities. In addition, the system may seek to safeguard humanitarian and medical activities in armed conflicts that also qualify as counterterrorism contexts. We also identify two sets of preconditions arguably necessary for a State to anticipate and address relevant potential effects through the development and execution of its “take into account” system. Finally, we suggest three sets of attributes that a “take into account” system may need to embody to achieve its aims: utilizing a State-wide approach, focusing on potential effects, and including default principles and rules to help guide implementation. In section 6, we briefly conclude. In our view, jointly pursuing the policy objectives of countering terrorism and safeguarding humanitarian and medical activities presents several opportunities, challenges, and complexities. International law does not necessarily provide ready-made answers to all of the difficult questions in this area. Yet devising and executing a “take into account” system provides a State significant opportunities to safeguard humanitarian and medical activities and counter terrorism while securing greater respect for international law.
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Johnson, Leah, Stephanie Swarner, Ariane van der Straten, and Ginger Rothrock. Methods for Assessing the Adherence to Medical Devices. RTI Press, October 2016. http://dx.doi.org/10.3768/rtipress.2016.mr.0036.1610.

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Bates, J. B., and T. Sein. Development of Thin-Film Battery Powered Transdermal Medical Devices. Office of Scientific and Technical Information (OSTI), July 1999. http://dx.doi.org/10.2172/10434.

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George, Nicholas. Optoelectronic Materials Devices Systems Research. Fort Belvoir, VA: Defense Technical Information Center, September 1998. http://dx.doi.org/10.21236/ada358443.

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Bergman, Alon, Matthew Grennan, and Ashley Swanson. Lobbying Physicians: Payments from Industry and Hospital Procurement of Medical Devices. Cambridge, MA: National Bureau of Economic Research, December 2021. http://dx.doi.org/10.3386/w29583.

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Magomedov, I. A., and I. R. Midalishov. ANALYSIS OF MODERN MEDICAL INFORMATION SYSTEMS. PJSC GAZPROM, 2019. http://dx.doi.org/10.18411/9785-6043-2019-10010.

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Babbitt, W. R. Advanced Coherent Transient Systems and Devices. Fort Belvoir, VA: Defense Technical Information Center, July 2002. http://dx.doi.org/10.21236/ada409269.

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Drexler, Elizabeth S., William F. Regnault, and John A. Tesk. Measurement methods for evaluation of the reliability of active implantable medical devices :. Gaithersburg, MD: National Institute of Standards and Technology, 2006. http://dx.doi.org/10.6028/nist.sp.1047.

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