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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.
Повний текст джерелаАнотація:
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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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.
Повний текст джерелаАнотація:
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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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.
Повний текст джерелаАнотація:
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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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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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.
Повний текст джерелаАнотація:
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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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.
Повний текст джерелаАнотація:
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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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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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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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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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.
Повний текст джерелаАнотація:
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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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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Di Marco, Mariagrazia, and Laure Vallotton. "Medical devices: Regulatory environment forecasts." Regulatory Affairs Watch 1, no. 2 (October 2019): 3–8. http://dx.doi.org/10.54920/scto.2019.rawatch.2.3.
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The regulatory landscape of medical devices is currently undergoing tremendous changes in the EU – changes that will directly affect Switzerland. Following numerous serious incidents resulting from medical devices (most notably, hip prostheses and defective silicone breast implants), a searchlight has been cast on the manufacturing, marketing, and surveillance of medical devices, as they stand in the EU. The systems in place contained many loopholes and shortcuts, which allowed some poor-quality and risk-compromising devices to be authorised. Consequently, the EU decided to tighten the regulatory procedures and two new EU regulations entered into force in 2017. They will apply, starting in 2020 and 2022, respectively. These changes set out in the regulations seek to improve medical device safety and performance and will carry consequences in terms of clinical evaluations and investigations on the devices, and how they are conducted. Switzerland is currently adapting its legislation on medical devices, to ensure that Swiss-based patients will also benefit from the improvements made. At the same time, only by aligning its own legislation to EU developments, will Switzerland be able to maintain its position as an equal partner in the EU internal market for medical devices. Nevertheless, some issues still need to be solved urgently for a smooth transition to take place.
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Paulsen, Benjamin Alexander, Sandra Henn, Georg Männel, and Philipp Rostalski. "Functional Safety Concept EGAS for Medical Devices." Current Directions in Biomedical Engineering 7, no. 2 (October 1, 2021): 739–42. http://dx.doi.org/10.1515/cdbme-2021-2189.
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Abstract For patient safety, it is important that a medical device can safely and reliably perform its intended purpose. The challenge in medical technology is that medical devices are heterogeneous systems and thus no widely applicable standard concepts for functional safety exist in medical technology. This is also reflected in the regulatory landscape, with its rather generally applicable standards. Patient safety is currently achieved by performing continuous risk management with an acceptable level of residual risk. Functional safety and its design concepts, as applied in other industries, have so far found little application in the field of medical technology. In this paper, the automotive safety concept "EGAS" is analyzed with regard to its applicability for medical devices. Based on the investigated example of a medical ventilator, important parallels were found between the automotive and the medical device sector, indicating the possibility of successfully applying the EGAS safety concept to medical devices.
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B.V., Chandan, Balamuralidhara V, Gowrav M.P, and Vishakharaju Motupalli. "Applications of Medical Devices in Healthcare Industry." Journal of Evolution of Medical and Dental Sciences 10, no. 38 (September 20, 2021): 3419–23. http://dx.doi.org/10.14260/jemds/2021/692.
Повний текст джерелаАнотація:
In the health-care industry, use of medical devices is becoming increasingly significant. There are currently over 8000 generic medical device categories, with some containing pharmaceutical active ingredients. The potential growth of the medical devices in the healthcare industry helps the healthcare system stupendously in diagnosis, treatment, pathogen tracking, patient monitoring and many more aspects of serving the human race in healthcare terms. Medical device utilization is becoming an increasingly crucial part of a healthcare professional's job. Personal users of medical devices must be taught and educated regularly to guarantee that they are proficient in the usage of equipment. Medical gadgets are becoming increasingly important in the health-care market. Keeping up with regulatory regulations and incorporating them into the process is one of the most difficult elements of creating and manufacturing medical devices. Tighter regulatory systems are needed to ensure that products entering the market are both safe and effective. Keeping up with regulatory regulations and incorporating them into the process is one of the most difficult elements of creating and manufacturing medical devices. A company that fails to succeed in this endeavour could lose thousands of dollars due to the amount of time it takes to do it. KEY WORDS Medical Device, Artificial Intelligence, Machine Learning, Design and Development, Diagnosis, Disease Management.
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Senders, J. W. "On the complexity of medical devices and systems." Quality in Health Care 15, suppl 1 (December 2006): i41—i43. http://dx.doi.org/10.1136/qshc.2005.015990.
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How does one design something that is complex? Or something that is simple? Why should one try to reduce or increase complexity? What is complexity? There are a large number of different uses of the word, including many in mathematics and physics. Most of these are not useful in attempting to fit the word to the problems of the design of systems and devices for medicine. In this paper the concept has been defined to apply to health care, which has led to some conclusions about the future development of medical systems and devices.
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IRNICH, WERNER. "Electronic Security Systems and Active Implantable Medical Devices." Pacing and Clinical Electrophysiology 25, no. 8 (August 2002): 1235–58. http://dx.doi.org/10.1046/j.1460-9592.2002.01235.x.
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Sathyabhama, B., and B. Siva Shankari. "An Ultra-Low Power Implantable Medical Devices: An Engineering Perspective." Journal of University of Shanghai for Science and Technology 23, no. 12 (December 6, 2021): 46–59. http://dx.doi.org/10.51201/jusst/21/11920.
Повний текст джерелаАнотація:
Implantable Medical Devices (IMDs) reside within human bodies either temporarily or permanently, for diagnostic, monitoring, or therapeutic purposes. IMDs have a history of outstanding success in the treatment of many diseases, including heart diseases, neurological disorders, and deafness etc.,With the ever-increasing clinical need for implantable devices comes along with the continuous flow of technical challenges. Comparing with the commercial portable products, implantable devices share the same need to reduce size, weight and power. Thus, the need for device integration becomes very much imperative. There are many challenges faced when creating an implantable medical device. While this paper focuses on various techniques adapted to design a reliable device and also focus on the key electronic features of designing an ultra-low power implantable medical circuits for devices and systems.
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Gupta, Sonali. "A Systems Theoretic Approach to Safety Analysis in Medical Cyber Physical Systems." Turkish Journal of Computer and Mathematics Education (TURCOMAT) 9, no. 3 (December 17, 2018): 1130–35. http://dx.doi.org/10.17762/turcomat.v9i3.13903.
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The concept of a Cyber-Physical System (CPS) has been gaining traction as a promising new field of study in recent years. It integrates digital processing and data transfer with the real environment. Healthcare, aircraft, automobiles, chemicals, civil infrastructure, energy, manufacturing, transportation, and biological systems are just a few of the many applications of cyber-physical systems. Medical Safe, context-aware, and interconnected networks of medical equipment are what we call Medical Cyber-Physical Systems (MCPS). More and more hospitals are installing these systems in order to give their patients with round-the-clock, high-quality treatment. Systems theory is an umbrella term for the study of how various parts of a system interact to provide a unified whole. Bio-electronic systems (implantable medical devices) are a common kind of MCPS. Bionic ear and eye implants, deep brain stimulators for neurological disorders, and bionic arms for amputees are all examples of computer-based bio-electronic systems designed to replace impaired human body parts. There is a lot of work being done to boost the efficiency of bionic systems so that they can operate at near 100% efficiency, at cheap cost, and in smaller, safer packages. Avoiding risks to property and human life caused by uncontrolled interactions in implanted devices of CPS makes the design of bug-free and safe medical device software in MCPS both crucial and difficult.
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Brenner, Michael J., Jared A. Shenson, Austin S. Rose, Tulio A. Valdez, Masayoshi Takashima, Omar G. Ahmed, Philip A. Weissbrod, et al. "New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review 2020." OTO Open 5, no. 4 (October 2021): 2473974X2110570. http://dx.doi.org/10.1177/2473974x211057035.
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Objectives To evaluate new drugs and devices relevant to otolaryngology–head and neck surgery that were approved by the US Food and Drug Administration (FDA) in 2020. Data Sources Publicly available device and therapeutic approvals from ENT (ear, nose, and throat), anesthesia, neurology (neurosurgery), and plastic and general surgery FDA committees. Review Methods Members of the American Academy of Otolaryngology–Head and Neck Surgery’s Medical Devices and Drugs Committee reviewed new therapeutics and medical devices from a query of the FDA’s device and therapeutic approvals. Two independent reviewers assessed the drug’s or device’s relevance to otolaryngology, classified to subspecialty field, with a critical review of available scientific literature. Conclusions The Medical Devices and Drugs Committee reviewed 53 new therapeutics and 1094 devices (89 ENT, 140 anesthesia, 511 plastic and general surgery, and 354 neurology) approved in 2020. Ten drugs and 17 devices were considered relevant to the otolaryngology community. Rhinology saw significant improvements around image guidance systems; indications for cochlear implantation expanded; several new monoclonal therapeutics were added to head and neck oncology’s armamentarium; and several new approvals appeared for facial plastics surgery, pediatric otolaryngology, and comprehensive otolaryngology. Implications for Practice New technologies and pharmaceuticals offer the promise of improving how we care for otolaryngology patients. However, judicious introduction of innovations into practice requires a nuanced understanding of safety, advantages, and limitations. Working knowledge of new drugs and medical devices approved for the market helps clinicians tailor patient care accordingly.
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Gassmann, Stefan, and Lienhard Pagel. "High Throuput Fluidic PCBs for Medical Devices." Additional Conferences (Device Packaging, HiTEC, HiTEN, and CICMT) 2011, DPC (January 1, 2011): 000539–54. http://dx.doi.org/10.4071/2011dpc-ta21.
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Printed circuit boards (PCBs) perform normally wiring, holding and cooling tasks in electronic systems. But with the request for integration of more and more functionality in the devices the PCBs have to take over more and more tasks in a system and will become a functional device and not only the carrier for electronic devices. One of these functions can be fluidics. The usage of PCBs for micro fluidic devices such as pumps and sensors was already reported. In this talk a new research area of the fluidic PCB group at the University of Rostock is presented: The usage of a fluidic PCB technology for the realization of medical fluidic devices with high throughput. The problems to overcome are the creation of high pressure proof channels with a low flow resistance and of course the biocompatibility. In the talk a medical device developed in such a technology will be described. It is a support device for the minimal invasive surgery which has to regulate the pressure in the pneumoperitonaeum, a so called insufflator. For this device flow rates of up to 45l/min CO2 has to deliver and the channel must withstand a pressure of up to 3.5 Bar. The focus in the talk will be the technological challenge of building pressure proof channels in the PCB. The requirements for the usage in medical devices will be explicitly described and the measurement results will be demonstrated. As a conclusion a comparison to a device build in a conventional technology device is given. The criterias are the functional parameters and the production and maintainance costs.
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Mildner, Alexander, Armin Janß, Jasmin Dell’Anna-Pudlik, Paul Merz, Martin Leucker, and Klaus Radermacher. "Device- and service profiles for integrated or systems based on open standards." Current Directions in Biomedical Engineering 1, no. 1 (September 1, 2015): 538–42. http://dx.doi.org/10.1515/cdbme-2015-0128.
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AbstractIntegrated OR systems nowadays are closed and proprietary, so that the interconnection of components from third-party vendors is only possible with high time and cost effort. An integrated operating theatre with open interfaces, giving clinical operators the opportunity to choose individual medical devices from different manufacturers, is currently being developed in the framework of the BMBF (Federal Ministry of Education and Research) funded project OR.NET [1]. Actual standards and concepts regarding technical feasibility and accreditation process do not cope with the requirements for modular integration based on an open standard. Therefore, strategies as well as service and device profiles to enable a procedure for risk management and certifiability are in the focus of the project work. Amongst others, a concept for User Interface Profiles (UI-Profiles) has been conceived in order to describe medical device functions and the entire user interface regarding Human-Machine-Interaction (HMI) characteristics with the aim to identify human-induced risks of central user interfaces. The use of standardized device and service profiles shall allow the manufacturers to integrate their medical devices in the OR.NET network, without disclosing the medical devices’ risk analysis and related confidential knowledge or proprietary information.
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Vadia, Rucha, and Katharina Blankart. "Regional Innovation Systems of Medical Technology." REGION 8, no. 2 (September 27, 2021): 57–81. http://dx.doi.org/10.18335/region.v8i2.352.
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We investigated the role of external funding in cardiovascular device innovation across 31 countries in Europe. We rely on the knowledge production function (KPF) framework that establishes the knowledge output of a region as a function of innovatory effort and other characteristics of that region. In a cross-sectional analysis, we investigated regional variation in knowledge production by the number of publications in cardiovascular device research obtained from the bibliometric data of the world’s largest biomedical library, the US National Library of Medicine, 2014‒2017. We mapped these publications to product categories of medical devices approved for cardiovascular diseases by the US Food and Drug Administration. Considering spatial correlation across regions of Europe in our estimates of the KPF, we investigated the impact of two types of funding mechanisms: grants reported in the publications and the volume of European Union Horizon 2020 funding received by the innovating regions. We obtained 123,487 cardiovascular device-related publications distributed across 1,051 (75% of total) regions (NUTS-3 level). Receiving external funding strongly contributes to a region’s knowledge output. The estimated elasticities of innovatory effort range between 0.51 and 0.64. These estimates were consistently larger than the elasticities of other characteristics in the region measured by gross domestic product (0.14‒0.56). We also documented spillover effects from neighboring regions when the funding was measured by the grants reported in the publications, concluding that innovatory efforts in the form of external research investments are effective for promoting innovation in the medical device industry at the regional level.
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Pozza, Giuliano. "Healthcare SCACA Systems and Medical Devices Data Systems Governance and Security." Journal of Clinical Engineering 39, no. 3 (2014): 136–41. http://dx.doi.org/10.1097/jce.0000000000000042.
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Altenstetter, Christa. "EU AND MEMBER STATE MEDICAL DEVICES REGULATION." International Journal of Technology Assessment in Health Care 19, no. 1 (January 2003): 228–48. http://dx.doi.org/10.1017/s0266462303000217.
Повний текст джерелаАнотація:
This article examines European Union (EU) and member state regulation of medical devices, particularly: a) the similarities and differences between medical devices and prescription drugs, including the respective industries, market authorization pathways, and boundary issues between the two sectors; b) the political background, current nature, and future prospects for EU medical device regulation; and c) regulatory responsibilities of the member states. Included are definitions of medical devices and in vitro diagnostics, and a brief history of their treatment by European law. The erosion of boundaries between exclusive and shared responsibilities of the EU and member states will be addressed, especially as it affects market approval of medical devices, clinical investigations, labeling and instructions for use, price setting and reimbursement, and evidence-based medicine and healthcare technology assessment. Finally, the article discusses medical device reporting and surveillance systems, which may be the weakest link in the EU integrative process. If patient safety is as important to the EU regulatory scheme as free movement and competitiveness, then both Brussels and member states will require additional resources, as well as measures to overcome obstacles to implementation, evaluation, and accountability.
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Manoharan, Iswarya, Jeslin Libisha J, Sowmiya E C, Harishma S., and John Amose. "Medical Data Analytics and Wearable Devices." EAI Endorsed Transactions on Smart Cities 6, no. 4 (October 11, 2022): e2. http://dx.doi.org/10.4108/eetsc.v6i4.2264.
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Clinical decision-making may be directly impacted by wearable application. Some people think that wearable technologies, such as patient rehabilitation outside of hospitals, could boost patient care quality while lowering costs. The big data produced by wearable technology presents researchers with both a challenge and an opportunity to expand the use of artificial intelligence (AI) techniques on these data. By establishing new healthcare service systems, it is possible to organise diverse information and communications technologies into service linkages. This includes emerging smart systems, cloud computing, social networks, and enhanced sensing and data analysis techniques. The characteristics and features of big data, the significance of big data analytics in the healthcare industry, and a discussion of the effectiveness of several machine learning algorithms employed in big data analytics served as our conclusion.
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Clemente, Fabrizio, Gian Franco Ferrari, Claudio De Lazzari, and Giancarlo Tosti. "Technical standards for medical devices. Assisted circulation devices." Technology and Health Care 5, no. 6 (December 1, 1997): 449–59. http://dx.doi.org/10.3233/thc-1997-5604.
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RAMSHAW, JOHN A. M., PAUL R. VAUGHAN, and JEROME A. WERKMEISTER. "APPLICATIONS OF COLLAGEN IN MEDICAL DEVICES." Biomedical Engineering: Applications, Basis and Communications 13, no. 01 (February 25, 2001): 14–26. http://dx.doi.org/10.4015/s1016237201000042.
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Collagen is the most abundant natural protein found in living systems. While there is a whole family of different collagen types, each differing in sequence, the properties that make this protein so attractive as the building blocks for medical devices, are reflected largely by the unique fibrillar structure of the molecule, as well as defined functional regions that interact with the surrounding cells and other matrix components. As a commercial medical product, collagen can be part of the natural tissue used in the device, or it can be fabricated as a reconstituted product from animal or recombinant sources. Both types of uses have distinct properties that convey advantages and disadvantages to the end product. This review examines the chemistry and biology of collagen and describes some well-documented examples of collagen-based medical devices produced in one or other of these formats.
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Anghel, Sanziana, Muhammad Arif Mahmood, Consuela Elena Matei, and Anita Ioana Visan. "Polymeric Coatings for Drug Delivery by Medical Devices." Journal of Nanotechnology in Diagnosis and Treatment 7 (October 31, 2021): 33–48. http://dx.doi.org/10.12974/2311-8792.2021.07.4.
Повний текст джерелаАнотація:
An analysis of the current landscape of therapeutics and delivery methods was conducted, aiming the field of drug delivery systems. Drug delivery biodistribution characteristics should be systematically understood, in order to maximize the function of these delivery systems. As a result, this review covers a history of the drug delivery systems, as well as the basic terminology associated with them, with a focus on the usage of polymers in the drug administration systems (particularly in form of coatings) and their application.
New trends in nanomaterials-based drug delivery systems, primarily for cancer treatment, were presented, involving a technology designed to maximize therapeutic efficacy of drugs by controlling their biodistribution profile.
There is a justified need to investigate drug delivery systems in form of thin films because, in comparation to bulk drug delivery system, which have a long and comprehensive history, there is still insufficient and fragmented understanding about the delivery of thin polymeric films, with research limited in general to very specific cases. Our efforts have been concentrated on these specifically polymeric drug delivery systems in the form of coatings. Understanding the dynamic changes that occur in a biodegradable polymeric thin film can aid in the prediction of the future performance of synthesized films designed to be used as implantable medical devices.
Extensive research is required to continuously develop new therapeutic systems in order to achieve an optimal concentration of a specific drug at its site of action for an appropriate duration.
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Powers, Jeff, and Frederick Kremkau. "Medical ultrasound systems." Interface Focus 1, no. 4 (May 18, 2011): 477–89. http://dx.doi.org/10.1098/rsfs.2011.0027.
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Medical ultrasound imaging has advanced dramatically since its introduction only a few decades ago. This paper provides a short historical background, and then briefly describes many of the system features and concepts required in a modern commercial ultrasound system. The topics addressed include array beam formation, steering and focusing; array and matrix transducers; echo image formation; tissue harmonic imaging; speckle reduction through frequency and spatial compounding, and image processing; tissue aberration; Doppler flow detection; and system architectures. It then describes some of the more practical aspects of ultrasound system design necessary to be taken into account for today's marketplace. It finally discusses the recent explosion of portable and handheld devices and their potential to expand the clinical footprint of ultrasound into regions of the world where medical care is practically non-existent. Throughout the article reference is made to ways in which ultrasound imaging has benefited from advances in the commercial electronics industry. It is meant to be an overview of the field as an introduction to other more detailed papers in this special issue.
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Wolfberg, Douglas M., Vincent P. Verdile, and Richard D. Flinn. "Incorporating Drugs and Devices into Emergency Medical Services Systems." Prehospital and Disaster Medicine 10, no. 3 (September 1995): 189–94. http://dx.doi.org/10.1017/s1049023x00041996.
Повний текст джерелаАнотація:
AbstractThe proliferation of new medical technology and pharmacology forces the medical community to ensure the efficacy and safety of new drugs and devices before their use in patient care. Although traditional medical practices have a fairly consistent means to achieve this end, prehospital medical practice often does not. In addition, it often appears that the emergency medical services marketplace does not always follow conventional supply/demand and cost/quality paradigms. This article describes a process implemented in Pennsylvania to standardize the mechanism by which new drugs and devices are introduced into prehospital medical practice.
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Pietzsch, Jan B., Lauren M. Aquino, Paul G. Yock, M. Elisabeth Paté-Cornell, and John H. Linehan. "Review of U.S. Medical Device Regulation." Journal of Medical Devices 1, no. 4 (October 19, 2007): 283–92. http://dx.doi.org/10.1115/1.2812429.
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Medical device regulation plays a significant role in the design, development, and commercialization of new medical technologies. A comprehensive understanding of the various regulatory requirements and their practical implementation is thus an essential cornerstone of successful medical device innovation. In this paper, we review the background, mission, and statutory requirements of medical device regulation in the United States. As opposed to pharmaceuticals, which have been regulated since the early 1900s, medical device regulation was not enacted before 1976, when Congress signed into law the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act of 1938. The U.S. Food and Drug Administration (FDA) has implemented a risk-based classification system, which is essential in determining the regulatory pathway for a given device. Our review of the different regulatory pathways discusses the specific steps and requirements associated with each pathway, and their implications for development and testing of different types of devices. The differences in these pathways are significant, and thus require careful consideration and analysis already at early stages of development. The FDA’s Quality Systems Regulation, which outlines specific requirements for development, testing, production, and postmarket surveillance, is another important aspect of device regulation. We present its elements and relationship to design controls and other operating procedures implemented by device manufacturers, and discuss their relevance in ensuring the safety and effectiveness of marketed devices. A summary of recent additions to device regulation, implemented by the FDA to allow for adequate regulation of products that combine drugs and devices or biologics and devices (so-called combination products), completes our review. Because of the significance of device regulation for medical device innovation, we strongly support increased efforts to educate the various stakeholders involved in the medical device development process, both at the academic and professional level.
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Khan, Sadeque Reza, Sumanth Kumar Pavuluri, Gerard Cummins, and Marc P. Y. Desmulliez. "Wireless Power Transfer Techniques for Implantable Medical Devices: A Review." Sensors 20, no. 12 (June 19, 2020): 3487. http://dx.doi.org/10.3390/s20123487.
Повний текст джерелаАнотація:
Wireless power transfer (WPT) systems have become increasingly suitable solutions for the electrical powering of advanced multifunctional micro-electronic devices such as those found in current biomedical implants. The design and implementation of high power transfer efficiency WPT systems are, however, challenging. The size of the WPT system, the separation distance between the outside environment and location of the implanted medical device inside the body, the operating frequency and tissue safety due to power dissipation are key parameters to consider in the design of WPT systems. This article provides a systematic review of the wide range of WPT systems that have been investigated over the last two decades to improve overall system performance. The various strategies implemented to transfer wireless power in implantable medical devices (IMDs) were reviewed, which includes capacitive coupling, inductive coupling, magnetic resonance coupling and, more recently, acoustic and optical powering methods. The strengths and limitations of all these techniques are benchmarked against each other and particular emphasis is placed on comparing the implanted receiver size, the WPT distance, power transfer efficiency and tissue safety presented by the resulting systems. Necessary improvements and trends of each WPT techniques are also indicated per specific IMD.
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Panescu, Dorin. "Emerging Technologies [wireless communication systems for implantable medical devices]." IEEE Engineering in Medicine and Biology Magazine 27, no. 2 (March 2008): 96–101. http://dx.doi.org/10.1109/emb.2008.915488.
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Chinzei, Kiyoyuki, Akinobu Shimizu, Kensaku Mori, Kanako Harada, Hideaki Takeda, Makoto Hashizume, Mayumi Ishizuka, et al. "Regulatory Science on AI-based Medical Devices and Systems." Advanced Biomedical Engineering 7 (2018): 118–23. http://dx.doi.org/10.14326/abe.7.118.
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Touahria, Imad Eddine, and Abdallah Khababa. "A Component Based Framework to Enable Medical Devices Communication." Ingénierie des systèmes d information 26, no. 3 (June 30, 2021): 295–302. http://dx.doi.org/10.18280/isi.260306.
Повний текст джерелаАнотація:
The interconnection of medical devices is emerging as a new requirement in modern medicine. The final goal of connecting heterogeneous medical devices in a wider network of computational servers is to monitor and improve patient safety, where it also constitutes a major goal in the Integrated Clinical Environment (ICE) framework. The heterogeneity of medical devices provided by different suppliers is a key challenge in ICE-based systems, where interoperability and data communication across devices is still under study and specification. ICE aims to create a standard interface that covers medical devices heterogeneity, hence, achieving interoperability in a safe way. It focuses on defining an interoperable bus between the patient, medical devices, software applications, and the clinician. Given the lack of realization of ICE standard, this paper presents a component-based framework for making ICE usable for medical applications. This work illustrates the component model in detail and validates it with a prototype implementation that focuses on the integration of heterogeneous medical devices as the most relevant requirements faced by ICE.
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Pietzsch, Jan B., and M. Elisabeth Paté-Cornell. "Early technology assessment of new medical devices." International Journal of Technology Assessment in Health Care 24, no. 01 (January 2008): 36–44. http://dx.doi.org/10.1017/s0266462307080051.
Повний текст джерелаАнотація:
Objectives:In the United States, medical devices represent an eighty-billion dollar a year market. The U.S. Food and Drug Administration rejects a significant number of applications of devices that reach the investigational stage. The prospects of improving patient condition, as well as firms' profits, are thus substantial, but fraught with uncertainties at the time when investments and design decisions are made. This study presents a quantitative model focused on the risk aspects of early technology assessment, designed to support the decisions of medical device firms in the investment and development stages.Methods:The model is based on the engineering risk analysis method involving systems analysis and probability. It assumes use of all evidence available (both direct and indirect) and integrates the information through a linear formula of aggregation of probability distributions. The model is illustrated by a schematic version of the case of the AtrialShaper, a device for the reduction of stroke risk that is currently in the preprototype stage.Results:The results of the modeling provide a more complete description of the evidence base available to support early-stage decisions, thus allowing comparison of alternative designs and management alternatives.Conclusions:The model presented here provides early-stage decision-support to industry, but also benefits regulators and payers in their later assessment of new devices and associated procedures.
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Wei, Lili, Sujuan Hou, and Qiuxia Liu. "Clinical Care of Hyperthyroidism Using Wearable Medical Devices in a Medical IoT Scenario." Journal of Healthcare Engineering 2022 (February 23, 2022): 1–10. http://dx.doi.org/10.1155/2022/5951326.
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This paper presents an in-depth study and analysis of clinical care of patients with hyperthyroidism using wearable medical devices in the context of medical IoT scenarios. According to the use scenario of the gateway and the connectivity of the equipment, the hardware architecture, hardware interfaces, functionality, and performance of the gateway were briefly designed, so as to monitor patients with hyperthyroidism more comprehensively and save labor costs. The gateway can provide access to different devices and adaptation functions to different hardware interfaces and provide hardware support for the subsequent deployment of the proposed new medical communication protocols and related information systems. A medical data convergence information system based on multidevice management and multiprotocol parsing was designed and implemented. The system enables the management and configuration of different medical devices and access to data through the targeted parsing of the underlying medical device communication protocols. The system also provides the automatic adaptation of multiple types of underlying medical device communication protocols and automatic parsing of multiple versions and can provide multiple devices to process fused data streams or device information and data from a single device. The use of event-driven asynchronous communication eliminates the tight dependency on service invocation in the synchronous communication approach. The use of a metadata-based data model structure enables model extensions to accommodate the impact of iterative business requirements on the database structure. Real-time patient physiological data transmission for intraoperative monitoring based on the MQTT protocol and video transmission for intraoperative patient monitoring based on the RTMP protocol were implemented. The development of the intelligent medical monitoring service system was completed, and the system was tested, optimized, and deployed. The functionality and performance of the system were tested, the performance issue of slow query speed was optimized, and the deployment of the project using Docker containers was automated.
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Abdulsalam, Yousef, Dari Alhuwail, and Eugene S. Schneller. "Adopting Identification Standards in the Medical Device Supply Chain." International Journal of Information Systems and Supply Chain Management 13, no. 1 (January 2020): 1–14. http://dx.doi.org/10.4018/ijisscm.2020010101.
Повний текст джерелаАнотація:
The U.S. Food and Drug Administration has recently mandated that medical device manufacturers adopt Unique Device Identification (UDI) standards on their medical devices. The benefits that UDI brings to hospitals and patients is relatively obvious, including inventory transparency, product safety, product equivalency, business intelligence. However, adoption by manufacturers, who face the mandate, has been slow in part because the benefit to them is not as readily perceived. This study focuses on the incentives, barriers, and benefits that medical device manufacturers perceive in UDI adoption. This study seeks to understand which adoption pressures are driving manufacturers to act, and attempts to gauge the benefits to manufacturers from UDI adoption. Through survey methods, the evidence suggests that medical device manufacturers implement UDI largely as a response to the coercive and normative pressures they face. There continues to be a high level of uncertainty regarding the return on investment for the medical device manufacturers, particularly from the late adopters.
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Demosthenous, Andreas. "Advances in Microelectronics for Implantable Medical Devices." Advances in Electronics 2014 (April 29, 2014): 1–21. http://dx.doi.org/10.1155/2014/981295.
Повний текст джерелаАнотація:
Implantable medical devices provide therapy to treat numerous health conditions as well as monitoring and diagnosis. Over the years, the development of these devices has seen remarkable progress thanks to tremendous advances in microelectronics, electrode technology, packaging and signal processing techniques. Many of today’s implantable devices use wireless technology to supply power and provide communication. There are many challenges when creating an implantable device. Issues such as reliable and fast bidirectional data communication, efficient power delivery to the implantable circuits, low noise and low power for the recording part of the system, and delivery of safe stimulation to avoid tissue and electrode damage are some of the challenges faced by the microelectronics circuit designer. This paper provides a review of advances in microelectronics over the last decade or so for implantable medical devices and systems. The focus is on neural recording and stimulation circuits suitable for fabrication in modern silicon process technologies and biotelemetry methods for power and data transfer, with particular emphasis on methods employing radio frequency inductive coupling. The paper concludes by highlighting some of the issues that will drive future research in the field.
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Schoenmakers, Coen. "CE marking of medical devices." Technology and Health Care 6, no. 4 (October 1, 1998): 271–74. http://dx.doi.org/10.3233/thc-1998-6406.
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Malovecká, Ivona, Daniela Mináriková, and Viliam Foltán. "PATIENT SATISFACTION WITH ORTHOPEDIC AND PROSTHETIC MEDICAL DEVICES." CBU International Conference Proceedings 3 (September 19, 2015): 419–26. http://dx.doi.org/10.12955/cbup.v3.632.
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Collecting information about patient satisfaction with orthopedic and prosthetic medical devices in terms of utility, tolerance, and compliance is essential for verifying and improving the quality of these devices. In addition, such information is useful for improving the patients’ quality of life, and the quality management systems of health care providers. This study assessed patient satisfaction with these devices from a sample of patients with orthopedic, neurologic, and rheumatic diseases at the Specialized Hospital for Orthopedic Prosthetics and at the premises of the Dispenser of Orthopedic and Prosthetic Medical Devices, both in Bratislava in the Slovak Republic. The assessment involved a translated and validated questionnaire about patient satisfaction with orthopedic and prosthetic medical devices to evaluate key factors of weight, fit, appearance, comfort, pain free, free of abrasiveness, ease of application, and durability of each device. The study samples consisted of patients with lower limb problems (42.5%), spine problems (26.9%), and a combination of leg and spine issues (25.9%). Orthopedic disease occurred in 73.6% of these patients, a combination of orthopedic and neurologic disease in 13.5%, and neurologic disease in 7.3%. Orthopedic insoles (36.3%), hip belts (17.6%), and the corset on the spine (5.2%) were the most used devices. Overall, the medical devices rated highly, with a high proportion of patients voting “strongly satisfied” in five of the eight key factors (range 51.8 to 63.2%), followed by a moderately lower proportion for durability (43.5%), comfort (37.3%), and appearance (31.1%). The comfort in wearing the device received the greatest patient dissatisfaction (22.8% of patients), followed by appearance (12.4%), and then fit (7.3%).
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Vallet-Regí, María, and Francisco Balas. "Silica Materials for Medical Applications." Open Biomedical Engineering Journal 2, no. 1 (January 29, 2008): 1–9. http://dx.doi.org/10.2174/1874120700802010001.
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The two main applications of silica-based materials in medicine and biotechnology,i.e.for bone-repairing devices and for drug delivery systems, are presented and discussed. The influence of the structure and chemical composition in the final characteristics and properties of every silica-based material is also shown as a function of the both applications presented. The adequate combination of the synthesis techniques, template systems and additives leads to the development of materials that merge the bioactive behavior with the drug carrier ability. These systems could be excellent candidates as materials for the development of devices for tissue engineering.
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Clausen, J. D., V. K. Goel, K. Sairyo, and M. Pfeiffer. "A Protocol to Evaluate Semi-Rigid Pedicle Screw Systems." Journal of Biomechanical Engineering 119, no. 3 (August 1, 1997): 364–66. http://dx.doi.org/10.1115/1.2796102.
Повний текст джерелаАнотація:
The objective of the current study was to develop an in vitro testing protocol to evaluate semi-rigid pedicle screw devices. A corpectomy model protocol exists to evaluate rigid spinal implants; however, semi-rigid devices are contraindicated for this condition. This paper describes a technique that simulates more closely the conditions a semi-rigid device would see in vivo. Finally, the new testing protocol is used to evaluate the DDS® pedicle screw-cable system. Benefits and shortcomings of the new protocol are discussed.
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Cheong, Sok Teng, Jian Li, Carolina Oi Lam Ung, Daisheng Tang, and Hao Hu. "Building an innovation system of medical devices in China: Drivers, barriers, and strategies for sustainability." SAGE Open Medicine 8 (January 2020): 205031212093821. http://dx.doi.org/10.1177/2050312120938218.
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Objectives: This article aimed to discuss the emergence of medical device sector in China from a sectoral innovation system perspective, to explore the drivers and barriers to the successful building of an innovation system of medical devices, and to highlight the policy implications and suggestions for sustainable innovation of medical devices. Methods: A theoretical framework of sectoral systems of innovation was applied in the analysis of data, and materials were collected from multiple sources with particular attention paid to the evolutionary phases, structure, and function of the innovation system. Results: The evolution of medical device sector in China could be divided into four phases: initialization (1960s–1970s); exploration (1980s); steady growth (1990s); and rapid growth (since 2000). Through analyzing the innovation system’s structural components of technology, actors, and networking, as well as institutions, this study indicated that the government policy decision was the most important driver that affected the virtuous cycle of the Chinese medical device innovation system, followed by market demand and entrepreneurial activities. However, barriers against the innovation cycle such as knowledge base development and diffusion, legitimacy, and resource mobilization still remained. Conclusion: In its endeavor to build an innovation system, the Chinese medical device sector had made some progress in meeting the local medical demands and improving its industrial competence. Although a Chinese innovation system for medical devices was initiated under the guidance of the government, knowledge advancement and diffusion had become the main challenges for the sustainability of innovation in this sector. The future development depends on China’s effort and ability to establish education and health research systems specific to medical devices.
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Jensen, Maria Lund, and Jayme Coates. "Planning Human Factors Engineering for Development of Implantable Medical Devices." Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care 7, no. 1 (June 2018): 156–60. http://dx.doi.org/10.1177/2327857918071037.
Повний текст джерелаАнотація:
Development of implantable medical devices is becoming increasingly interesting for manufacturers, but identifying the right Human Factors Engineering (HFE) approach to ensure safe use and effectiveness is challenging. Most active implantable devices are highly complex; they are built on extremely advanced, compact technology, often comprise systems of several device elements and accessories, and they span various types of user interfaces which must facilitate diverse interaction performed by several different user groups throughout the lifetime of the device. Furthermore, since treatment with implantable devices is often vital and by definition involves surgical procedures, potential risks related to use error can be severe. A systematic mapping of Product System Elements and Life Cycle Stages can help early identification of Use Cases, and for example user groups and high-level use risks, to be accounted for via HFE throughout development to optimize Human Factors processes and patient outcomes. This paper presents a concrete matrix tool which can facilitate an early systematic approach to planning and frontloading of Human Factors Engineering activities in complex medical device development.
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Stelmasiak, Katarzyna, Marek Świerczyński, and Zbigniew Więckowski. "Badania kliniczne wyrobów medycznych wykorzystujących inteligentne algorytmy – wstęp do dyskusji." Prawo w Działaniu 50 (2022): 112–29. http://dx.doi.org/10.32041/pwd.5005.
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The authors of the paper carry out a preliminary assessment of the new regulation on clinical trials of medical devices in the context of software based on intelligent algorithms (so-called AI systems). The primary source of law here is the EU Medical Device Regulation (MDR). The study highlights the need to take into account the regulations on artificial intelligence systems when conducting clinical trials. It is justified by their close relationship with the EU provisions on medical devices. The main difficulty in making a legal and ethical assessment of new solutions used in medical devices is the application of various, sometimes divergent, regulations in the field of new technologies and medical law. The study contains preliminary, necessarily balanced and careful, bearing in mind the need to protect patients - research participants (and other people), conclusions on the application of the above provisions in the conduct of clinical trials.
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Andersen, Björn, Martin Kasparick, Hannes Ulrich, Stefan Franke, Jan Schlamelcher, Max Rockstroh, and Josef Ingenerf. "Connecting the clinical IT infrastructure to a service-oriented architecture of medical devices." Biomedical Engineering / Biomedizinische Technik 63, no. 1 (February 23, 2018): 57–68. http://dx.doi.org/10.1515/bmt-2017-0021.
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AbstractThe new medical device communication protocol known as IEEE 11073 SDC is well-suited for the integration of (surgical) point-of-care devices, so are the established Health Level Seven (HL7) V2 and Digital Imaging and Communications in Medicine (DICOM) standards for the communication of systems in the clinical IT infrastructure (CITI). An integrated operating room (OR) and other integrated clinical environments, however, need interoperability between both domains to fully unfold their potential for improving the quality of care as well as clinical workflows. This work thus presents concepts for the propagation of clinical and administrative data to medical devices, physiologic measurements and device parameters to clinical IT systems, as well as image and multimedia content in both directions. Prototypical implementations of the derived components have proven to integrate well with systems of networked medical devices and with the CITI, effectively connecting these heterogeneous domains. Our qualitative evaluation indicates that the interoperability concepts are suitable to be integrated into clinical workflows and are expected to benefit patients and clinicians alike. The upcoming HL7 Fast Healthcare Interoperability Resources (FHIR) communication standard will likely change the domain of clinical IT significantly. A straightforward mapping to its resource model thus ensures the tenability of these concepts despite a foreseeable change in demand and requirements.
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Elson, Ila J. "Designing Diagnostic Medical Devices for Your Lab Tests." Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care 6, no. 1 (May 15, 2017): 143–49. http://dx.doi.org/10.1177/2327857917061031.
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Diagnostic medical devices used in homes, hospitals, reference labs, blood banks, and physician offices and clinics generate laboratory data that provide critical information needed to make medical decisions. This article profiles the product development process and sciences used to design these advanced diagnostics systems to be human-centered. Systems are becoming smarter, faster and friendlier for users. Specific benefits are identified along with the methods, challenges and design tradeoffs to achieve them. Users of diagnostic devices will be able to recognize and understand the impact of ergonomics in the design from this product development history.
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Natu, Rucha, Luke Herbertson, Grazziela Sena, Kate Strachan, and Suvajyoti Guha. "A Systematic Analysis of Recent Technology Trends of Microfluidic Medical Devices in the United States." Micromachines 14, no. 7 (June 24, 2023): 1293. http://dx.doi.org/10.3390/mi14071293.
Повний текст джерелаАнотація:
In recent years, the U.S. Food and Drug Administration (FDA) has seen an increase in microfluidic medical device submissions, likely stemming from recent advancements in microfluidic technologies. This recent trend has only been enhanced during the COVID-19 pandemic, as microfluidic-based test kits have been used for diagnosis. To better understand the implications of this emerging technology, device submissions to the FDA from 2015 to 2021 containing microfluidic technologies have been systematically reviewed to identify trends in microfluidic medical applications, performance tests, standards used, fabrication techniques, materials, and flow systems. More than 80% of devices with microfluidic platforms were found to be diagnostic in nature, with lateral flow systems accounting for about 35% of all identified microfluidic devices. A targeted analysis of over 40,000 adverse event reports linked to microfluidic technologies revealed that flow, operation, and data output related failures are the most common failure modes for these device types. Lastly, this paper highlights key considerations for developing new protocols for various microfluidic applications that use certain analytes (e.g., blood, urine, nasal-pharyngeal swab), materials, flow, and detection mechanisms. We anticipate that these considerations would help facilitate innovation in microfluidic-based medical devices.
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Lakshminarayanan, V., and N. Sriraam. "Proposed Solution to the Problem of Thermal Stress Induced Failures in Medical Electronic Systems." International Journal of Biomedical and Clinical Engineering 3, no. 2 (July 2014): 33–41. http://dx.doi.org/10.4018/ijbce.2014070103.
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The concept of miniaturization has propagated to all types of electronic applications. The complexity of electronic systems has been increasing due to increase in the number of functions and features offered to the users. At the same time the number of devices working per unit volume of the system has increased enormously, due to which the power density per unit volume has increased. Dissipating high power in small volumes has increased the thermal problems in all types of electronic systems, including medical gadgets. Thermal stress has been identified to be the major cause of failure of electronic devices in electronic systems, based on the analysis of failures, based on research work. The causative mechanism of failure of semiconductor device package due to thermal overstress in medical electronic systems is the differential expansion between plastic and metal parts of the device which causes a differential strain and package failure. Selection of materials with similar coefficient of thermal expansion is important to prevent thermal overstress caused failures. In this paper, we discuss a technique which uses mathematical analysis to provide a solution to this problem of selecting the suitable material to prevent differential thermal stress failures in medical electronics systems.
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Sackner-Bernstein, Jonathan. "Design of Hack-Resistant Diabetes Devices and Disclosure of Their Cyber Safety." Journal of Diabetes Science and Technology 11, no. 2 (November 11, 2016): 198–202. http://dx.doi.org/10.1177/1932296816678264.
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Background: The focus of the medical device industry and regulatory bodies on cyber security parallels that in other industries, primarily on risk assessment and user education as well as the recognition and response to infiltration. However, transparency of the safety of marketed devices is lacking and developers are not embracing optimal design practices with new devices. Achieving cyber safe diabetes devices: To improve understanding of cyber safety by clinicians and patients, and inform decision making on use practices of medical devices requires disclosure by device manufacturers of the results of their cyber security testing. Furthermore, developers should immediately shift their design processes to deliver better cyber safety, exemplified by use of state of the art encryption, secure operating systems, and memory protections from malware.