Relevant bibliographies by topics / Medical device safety

Contents

  1. Journal articles
  2. Dissertations / Theses
  3. Books
  4. Book chapters
  5. Conference papers
  6. Reports

Academic literature on the topic 'Medical device safety'

Author: Grafiati
Published: 4 June 2021
Last updated: 10 March 2023

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Journal articles on the topic "Medical device safety"

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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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Piepenbrink, James. "Medical Device Safety—The Regulation of Medical Devices for Public Health and Safety." Biomedical Instrumentation & Technology 37, no. 1 (January 2003): 71. http://dx.doi.org/10.2345/0899-8205(2003)37[71:mdsrom]2.0.co;2.

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Higson, Gordon, and Lee T. Myers. "Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety." Medical Physics 30, no. 11 (November 2003): 3047. http://dx.doi.org/10.1118/1.1619134.

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Yusko, James G. "Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety." Health Physics 82, no. 5 (May 2002): 749. http://dx.doi.org/10.1097/00004032-200205000-00019.

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O'Dowd, W. J. "Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety." Physics in Medicine and Biology 47, no. 2 (January 4, 2002): 349. http://dx.doi.org/10.1088/0031-9155/47/2/701.

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Mattox, Elizabeth. "Medical Devices and Patient Safety." Critical Care Nurse 32, no. 4 (August 1, 2012): 60–68. http://dx.doi.org/10.4037/ccn2012925.

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Errors related to health care devices are not well understood. Nurses in intensive care and progressive care environments can benefit from understanding manufacturer-related error and device-use error, the principles of human factors engineering, and the steps that can be taken to reduce risk of errors related to health care devices.
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Rajan, Prashant V., Daniel B. Kramer, and Aaron S. Kesselheim. "Medical Device Postapproval Safety Monitoring." Circulation: Cardiovascular Quality and Outcomes 8, no. 1 (January 2015): 124–31. http://dx.doi.org/10.1161/circoutcomes.114.001460.

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Konecny, Cathy. "Training in Medical Device Safety." AORN Journal 77, no. 3 (March 2003): 543. http://dx.doi.org/10.1016/s0001-2092(06)61247-7.

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&NA;. "Resources for medical device safety." Nursing 44, no. 6 (June 2014): 68. http://dx.doi.org/10.1097/01.nurse.0000443328.34321.eb.

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Niemiec, Emilia. "Will the EU Medical Device Regulation help to improve the safety and performance of medical AI devices?" DIGITAL HEALTH 8 (January 2022): 205520762210890. http://dx.doi.org/10.1177/20552076221089079.

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Concerns have been raised over the quality of evidence on the performance of medical artificial intelligence devices, including devices that are already on the market in the USA and Europe. Recently, the Medical Device Regulation, which aims to set high standards of safety and quality, has become applicable in the European Union. The aim of this article is to discuss whether, and how, the Medical Device Regulation will help improve the safety and performance of medical artificial intelligence devices entering the market. The Medical Device Regulation introduces new rules for risk classification of the devices, which will result in more devices subjected to a higher degree of scrutiny before entering the market; more stringent requirements on clinical evaluation, including the requirement for appraisal of clinical data; new requirements for post-market surveillance, which may help spot early on any new, unexpected side effects and risks of the devices; and requirements for notified bodies, including for expertise of the personnel and consideration of relevant best practice documents. The guidance of the Medical Device Coordination Group on clinical evaluation of medical device software and the MEDDEV2.7 guideline on clinical evaluation also attend to some of the problems identified in studies on medical artificial intelligence devices. The Medical Device Regulation will likely help improve the safety and performance of the medical artificial intelligence devices on the European market. The impact of the Regulation, however, is also dependent on its adequate enforcement by the European Union member states.
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Dissertations / Theses on the topic "Medical device safety"

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Foe, Owono Guy. "Impact of EU Medical Device Directive on Medical Device Software." ScholarWorks, 2015. https://scholarworks.waldenu.edu/dissertations/353.

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Directive 2007/47/EC of the European Parliament amending Medical Device Directive (MDD) provides medical device manufacturers with a compliance framework. However, the effects of the amendments to the MDD on competition in the U.S. medical device software industry are unknown. This study examined the impact of this directive on the competitiveness of U.S. medical device software companies, the safety and efficacy of medical device software, employee training, and recruitment. The conceptual framework for this study included 3 dimensions of medical device regulations: safety, performance, and reliability. The overall research design was a concurrent mixed method study using both quantitative and qualitative techniques. The qualitative techniques involved case studies of 5 purposively selected companies. Data collection involved both surveys and interviews. The sample consisted of 56 employees within medical device firms with markets around the European regions. Qualitative data analysis consisted of descriptive thematic analysis along the study questions and hypotheses and summative evaluation. Quantitative data analysis included descriptive statistics and correlation to test the 4 hypotheses. The results suggested that the MDD has realigned medical device software manufacturing practices, and US medical device companies have gained global competitiveness in improving product safety and increasing sales revenue. Key recommendations to medical device manufacturers include adopting MDD 93/42/EEC, using model-based approaches, and being comprehensive in model use. Adopting the MDD will provide positive social change to patients, as human safety improves with better product quality while companies experience fewer product recalls.
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Song, Qingyang S. M. Massachusetts Institute of Technology. "A system theoretic approach to design safety into medical device." Thesis, Massachusetts Institute of Technology, 2012. http://hdl.handle.net/1721.1/76510.

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Thesis (S.M. in Engineering and Management)--Massachusetts Institute of Technology, Engineering Systems Division, System Design and Management Program, 2012.
Cataloged from PDF version of thesis.
Includes bibliographical references (p. 65-66).
The goal of this thesis is to investigate and demonstrate the application of a systems approach to medical device safety in China. Professor Leveson has developed an accident modeling framework called STAMP (Systems Theoretic Accident Modeling and Processes.) Traditional accident models typically focus on component failure; in contrast, STAMP includes interactions between components as well as social, economic, and legal factors. In this thesis, the accident of the artificial heart at a level II hospital in China was used as a test case to study whether Causal Analysis based on STAMP (CAST) is used to outline the interactions between the different medical device system components, identify the safety control structure in place, and understand how this control structure failed to prevent artificial heart accident in a Chinese hospital. The analysis suggested that further changes might be necessary to protect the Chinese public and so, based on the results of the CAST, a new set of systemic recommendations was proposed.
by Qingyang Song.
S.M.in Engineering and Management
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Shuja, Sana. "Formal Verification Techniques for Safety Critical Medical Device Software Control." Diss., North Dakota State University, 2016. http://hdl.handle.net/10365/25736.

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Safety-critical medical devices play an important role in improving patients health and lifestyle. Faulty behaviors of such devices can cause harm or even death. Often these faulty behaviors are caused due to bugs in software programs used for digital control of the device. We present a formal veri cation methodology that can be used to check the correctness of object code programs that implement the safety-critical control functions of these medical devices. Our methodology is based on the theory of Well-Founded Equivalence Bisimulation (WEB) re nement, where both formal speci cations and implementations are treated as transition systems. First, we present formal speci cation model for the medical device. Second, we develop correctness proof obligations that can be applied to validate object code programs used in these devices. Formal methods are not widely employed for the veri cation of safety critical medical devices. However, using our methodology we were able to bridge the gap between two very important phases of software life cycle: speci cation and veri cation.
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Hinrichs, Saba. "A systems approach to improving patient safety through medical device purchasing." Thesis, University of Cambridge, 2010. https://www.repository.cam.ac.uk/handle/1810/238973.

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The purchase of medical devices involves engaging various stakeholders as well as balancing clinical, technical and financial requirements. Failure to consider these requirements can lead to wider consequences in the delivery of care. This study first builds a general knowledge base of current purchasing practice in a sample of NHS Trusts, which confirms the direction and guidance given by policy documents and literature as to the extent of the challenges faced by purchasing stakeholders. This then leads to an analysis to identify inefficiencies in the purchasing process, and how such practice can lead to risks in the delivery of care. These risks range from injury to individuals, impacts to the healthcare delivery service, and financial and litigation risks. Finally, a framework that highlights these potential risks in the life-cycle of medical devices in hospitals is presented. Key policy guidance has encouraged both researchers and implementers of healthcare services to approach patient safety from a systems perspective, acknowledging that medical device errors are not only directly related to device design, but to the design of the healthcare delivery service system in which the device operates. Little evidence exists of successfully applying systems approaches specifically to medical device purchasing practice. Medical device purchasing, because of its implications to patient safety on the one hand, and the uniqueness of the healthcare context, requires a unique approach. By demonstrating the influence of purchasing practice to service delivery and patient care, the thesis made is that taking a holistic systems approach is one method to improve device purchasing practice, and hence influence better care.
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Lindholm, Christin. "Software development and risk management in the safety critical medical device domain /." Lund : Department of Computer Science, Lund University, 2009. http://www.lu.se/o.o.i.s?id=12683&postid=1304138.

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Doyle, Marc. "Comprehending the Safety Paradox and Privacy Concerns with Medical Device Remote Patient Monitoring." Diss., NSUWorks, 2019. https://nsuworks.nova.edu/gscis_etd/1090.

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Medical literature identifies a number of technology-driven improvements in disease management such as implantable medical devices (IMDs) that are a standard treatment for candidates with specific diseases. Among patients using implantable cardiac defibrillators (ICD), for example, problems and issues are being discovered faster compared to patients without monitoring, improving safety. What is not known is why patients report not feeling safer, creating a safety paradox, and why patients identify privacy concerns in ICD monitoring. There is a major gap in the literature regarding the factors that contribute to perceived safety and privacy in remote patient monitoring (RPM). To address this gap, the research goal of this study was to provide an interpretive account of the experience of RPM patients. This study investigated two research questions: 1) How did RPM recipients perceive safety concerns?, and 2) How did RPM recipients perceive privacy concerns? To address the research questions, in-depth, semi-structured interviews were conducted with six participants to explore individual perceptions in rich detail using interpretative phenomenological analysis (IPA). Four themes were identified and described based on the analysis of the interviews that include — comfort with perceived risk, control over information, education, and security — emerged from the iterative review and data analysis. Participants expressed comfort with perceived risk, however being scared and anxious were recurrent subordinate themes. The majority of participants expressed negative feelings as a result of an initial traumatic event related to their devices and lived in fear of being shocked in inopportune moments. Most of these concerns stem from lack of information and inadequate education. Uncertainties concerning treatment tends to be common, due to lack of feedback from ICD RPM status. Those who knew others with ICD RPM became worrisome after hearing about incidences of sudden cardiac death (SCD) when the device either failed or did not work adequately to save their friend’s life. Participants also expressed cybersecurity concerns that their ICD might be hacked, maladjusted, manipulated with magnets, or turned off. They believed ICD RPM security was in place but inadequate as well as reported feeling a lack of control over information. Participants expressed wanting the right to be left alone and in most cases wanted to limit others’ access to their information, which in turn, created conflict within families and loved ones. Geolocation was a contentious node in this study, with most of participants reporting they did not want to be tracked under any circumstances. This research was needed because few researchers have explored how people live and interact with these newer and more advanced devices. These findings have implications for practice relating to RPM safety and privacy such as identifying a gap between device companies, practitioners, and participants and provided directions for future research to discover better ways to live with ICD RPM and ICD shock.
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Shah, Syed Ghulam Sarwar. "Safety of medical device users : a study of physiotherapists' practices, procedures and risk perception." Thesis, Brunel University, 2011. http://bura.brunel.ac.uk/handle/2438/6360.

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Aims: To study practices and procedures with respect to electrotherapy in physiotherapy departments and to study physiotherapists’ perception of health risk, health consequences and protection of health from different risks including electromagnetic field emissions from electrotherapy devices. Methods: This cross-sectional study was conducted in three phases from June 2002 to December 2003. The first phase was an audit of the practices and procedures regarding electrotherapy in National Health Service physiotherapy departments (N = 46 including 7 departments in pilot study) located in 12 counties in the southeast and southwest of England including Greater London. The second phase comprised one observational visit to each of the same physiotherapy departments to characterise their occupational environment. The third phase was a questionnaire survey of 584 physiotherapists working in these departments. Variables concerned perception of health risk, health consequences and protection of health associated with different risk factors. Results: In the first two phases, the recruitment rate of the departments was 80.7% (46 out of 57) and response rate of those recruited was 100% (n=46). The response rate for the last phase of the study was 66.8% (390 out of 584). Results of the practices and procedures audit show that ultrasound was the most common form of electrotherapy while microwave diathermy was neither available nor used in these departments. Pulsed shortwave diathermy was used 4-5 days per week while continuous shortwave diathermy was used rarely. Electrotherapy was provided to up to 50% of patients per week in the departments. The observational visits to the departments revealed that there were metallic objects within close proximity of diathermy equipment and wooden treatment couches for treatment with PSWD and CSWD were rare. The risk perception survey showed that physiotherapists generally perceived a moderate health risk and health consequences (harm) from exposure to EMF emissions from electrotherapy devices. Protection from EMFs in physiotherapy departments was generally perceived as ‘usually’ possible. Conclusions: Physiotherapy departments report safe electrotherapy practices. Use of diathermy devices that use RF EMFs is declining. The key predictors of physiotherapists’ perception of health risk were perception of health consequences and vice versa. Gender was a significant predictor of the perception of health risks and health consequences. The main predictor of perception of protection against risk was the knowledge of environmental and health issues. Latent dimensions of perceptions of health risk, health consequences and protection from risk were identified and confirmed and their predictors were determined.
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Kyrkander, Sara. "Traceability of Single-Use Medical Devices through the Hospital Supply Chain. Reflections and Recommendations for Implementation of Single-Use Medical Devices Traceability." Thesis, KTH, Medicinteknik och hälsosystem, 2020. http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-279140.

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There is an increased need for complete medical device traceability in the healthcare industry. The two main reasons are the healthcare industry's global supply chain and decentralised adverse events reporting, where different laws apply for each country and where each country has their own database for incidents without international governance. The idea of improving traceability procedures in the surgical department at Karolinska University Hospital was formed in the light of a near miss event where guidelines regarding incident management of a Single-Use Medical Device (SUMD) were not followed properly. Hence, this thesis project will investigate the issue of finding an effective way to trace SUMDs at Karolinska University Hospital, in order to improve the incident management process and suggest improvements of patient safety at other Swedish hospitals as well. The collection of data consisted of different data sources; observations at the research site and interviews with relevant participants. By employing multiple sources to this study, a more holistic approach could be achieved. In addition to observing the current situation of device registration, it was of importance to ask individuals with competence and different perspectives on the issue of traceability of SUMDs. To answer the research questions, the acquired data was categorized into the different identified cornerstones of traceability of SUMDs. These were registration process, perioperative supply chain and incidents management. Each section was divided into an investigation of the current process, issues and suggested improvements, in order to clearly answer to the research questions. Furthermore, these acquired answers and insights, from observations and interviews, were translated and summarized to form a basis for the results. Based on the data acquisition and compilation from the different perspectives, key findings and themes are presented in the results. The thesis proposal include a visual representation that show the physical flow of a SUMD from the point of being delivered to the hospital by the distributor, through different entities where registration occur, until it is either discarded or saved for incidents reporting. In order to avoid many of the current issues and to realize the acquired suggestions from this thesis, interoperability between the systems within the healthcare organization as well as between the different entities throughout the entire supply chain is an essential part of the solution, which should be further studied.
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Murphy, Robert S. "The design of safety-critical medical infusion devices." Thesis, University of South Wales, 2007. https://pure.southwales.ac.uk/en/studentthesis/the-design-of-safetycritical-medical-infusion-devices(1557c702-3087-43f9-a399-99a9ba65ae9b).html.

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Intravenous infusion devices - commonly known as infusion pumps - provide clinicians with mechanisms to automate the accurate dosing of potent fluid therapies to critically ill patients. In critical care applications, fluid dosing must be both accurate and safe since unwanted flow disturbance can cause physiological harm to the patient. This study consists of three discrete projects based on these vital themes of safe device design and accurate fluid delivery. The first project, commissioned by Medical Magnetics Ltd during the period 1998 onwards, proposed that the fail-safe design philosophy universally used in the design of infusion pumps, and implemented in embedded software, is lengthy and provides the manufacturer with difficulties in demonstrating the exhaustive fail-safe validation needed for an instrument to be released speedily for sale. An alternative and innovative strategy employing the design of hardware modules and using re-configurable VLSI, is proposed and shown to offer a significant reduction of the design and validation phase of development with consequent financial benefit to the manufacturer. The second project conducted as part of the Manukau Institute Research Programme for 2003 examined the manner in which dosing accuracy is assessed for infusion pumps. The International Standard used by clinicians to select apparatus suitable for treatment of 'critically-ill' patients is shown to be flawed and potentially misleading - a finding of international significance. An innovative mathematical simulation model is described that enables prediction of flow accuracy for various expected operating scenarios previously impossible to investigate using current laboratory measurement techniques. Use of this simulation model indicates that various mechanical design factors influencing system compliance and hence dosing accuracy have been previously ignored by designers and suggests that contemporary infusion pump designs are far from optimum. These findings offer an explanation for instances of dosing error previously reported in the clinical literature and are of international value. The third project of the study utilises the findings of, and is subsequent to, the second project. An innovative design is proposed for an infusion therapy device in which dosing accuracy may be maintained under operating conditions such as height change and patient venous pressure variation that cause unwanted errors in conventional equipment designs. This design is the subject of patent application, commercial exploitation and further development.
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Afroze, Tonima, and Palmqvist Mia Isaksson. "Patient Safety Regarding Medical Devices at ICUs in Bangladesh." Thesis, KTH, Skolan för teknik och hälsa (STH), 2013. http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-132245.

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Accidents related to medical devices are a worldwide problem and result in many deaths each year. It affects patients, relatives, health care workers and society. Due to the complexity of intensive care units (ICUs), such accidents lead to particularly serious consequences. The aim of this thesis was to identify patient safety aspects at ICUs in public and private hospitals in Bangladesh, in order to provide a basis for improving the quality of performance of devices as well as personnel, care and cost effectiveness. The objectives were to a)      compare the conditions of medical devices at ICUs in private and public hospitals, b)      increase understanding of errors, risks and accidents related to medical devices, c)      study reporting systems and communication between staff at ICUs and d)      find ways to minimize hazards related to medical equipment to ensure effective and safe use of devices. Data was collected through interviews during field visits to six hospitals in Dhaka, Bangladesh. Interviews were held with the chiefs of the ICUs, physicians, nurses and technicians. It was noticed that the admission fees to the public hospitals were lower and had more limited resources. Differences between public and private hospitals could be seen in the aspects of finance, the existence of a Biomedical Engineering Department, maintenance and calibration of medical equipment, further education of staff, working environment and infection control. The reporting systems for adverse events and communication about patients’ conditions between coworkers were weak at all hospitals. The procurement process was lengthy at all hospitals. Access to disposable items was limited at several hospitals. The lower admission fee at the government hospitals results in the patients of these hospitals often having a lower income and status, thus less inclined to be critical of the received care. A number of suggestions have been proposed in order to improve the work in the ICU. These include a)      following up rules made by the authorities to ensure they are implemented at each hospital, b)      increasing documentation of malfunctioning devices and adverse events, c)      nurses and physicians taking part in the procurement process, d)      establishing a Biomedical Engineering Department at all hospitals, e)      organizing workshops for health care workers, f)       developing biomedical products adapted for multiple time use and with less need for calibration, g)      providing more education for health care workers in infection control, management of specific devices, solutions to common technical problems, patient safety and user safety, for example using Information and Communication Technology tools (audio and audiovisual material) and discussion platforms as well as h)      constructing an internet forum for consultation on the abovementioned subjects for technicians.
Olyckor relaterade till medicinteknisk utrustning är ett globalt problem som leder till många dödsfall varje år. Det påverkar patienter, anhöriga, sjukvårdspersonal och samhället. Den komplexa miljön på intensivvårdsavdelningar gör att olyckorna leder till allvarliga konsekvenser. Uppsatsen syftade till att identifiera patientsäkerhetsaspekter på intensivvårdsavdelningar i Bangladesh för att skapa en grund för prestandaförbättring, både gällande utrustning och gällande personal. Det ska också öka vård- och konstandseffektiviteten. Målet uppnåddes genom att a)      jämföra användandemiljön för medicinteknisk utrustning på intensivvårdsavdelningar på statliga och privata sjukhus, b)      öka förståelsen för fel, risker och olyckor relaterade till medicinteknisk utrustning, c)      studera rapporteringssystem samt kommunikation mellan personal på intensivvårdsavdelningar och d)      hitta sätt att minimera faror relaterade till medicinteknisk utrustning för att försäkra en effektiv och säker användning av utrustningen. Data samlades in genom intervjuer under en fältstudie på sex sjukhus i Dhaka, Bangladesh. Intervjuer hölls med cheferna på intensivvårdsavdelningarna, läkare, sjuksköterskor och tekniker. Det upptäcktes att patientavgiften på de statliga sjukhusen var lägre och resurserna var mer begränsade. Skillnader mellan statliga och privata sjukhus kunde ses inom ekonomiska resurser, förekomsten av medicintekniskavdelning, underhåll och kalibrering av medicinteknisk utrustning, vidareutbildning av personal, arbetsmiljö och infektionskontroll. Rapporteringssystemen för olyckor samt kommunikationen om patienters tillstånd mellan medarbetare var bristfällig på alla sjukhus. Upphandlingsprocesserna av ny medicintekniskutrustning var lång på alla sjukhus. Tillgången på engångsartiklar var begränsad på flera utav sjukhusen. Den lägre avgiften på de statliga sjukhusen resulterar i att patienterna på dessa sjukhus ofta har lägre inkomst samt status i samhället och är därför mindre benägna att vara kritiska till den mottagna vården. Ett antal ändringar föreslogs för att förbättra arbetet på intensivvårdsavdelningarna. Dessa inkluderar att a)      följa upp de av myndigheterna satta reglerna för att försäkra att de är implementerade på varje sjukhus, b)      öka dokumentationen av icke fungerande utrustning tillika olyckor, c)      sjuksköterskor och läkare skall delta i upphandlingsprocesserna, d)      starta medicintekniska avdelningar på alla sjukhus, e)      organisera workshops för vårdpersonal, f)       utveckla medicintekniska produkter som är anpassade för att användas flera gånger och som behöver kalibreras mer sällan, g)      ge mer utbildning till sjukvårdspersonal om infektionskontroll, hantering av specifika maskiner, lösningar till vanligt förekommande tekniska problem, patientsäkerhet och användarsäkerhet till exempel genom att använda information- och kommunikationsteknik-verktyg (audio och audiovisuellt material) och diskussionsplattformar samt h)      konstruera ett internetforum där tekniker kan få konsultation angående ovannämnda ämnen.
To develop patient safety system to improve the safety and quality of patient care at the Intensive Care Units
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Books on the topic "Medical device safety"

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Medical device safety: The regulation of medical devices for public health and safety. Bristol: Institute of Physics Pub., 2002.

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Lori, Brown S., Bright Roselie A, and Tavris Dale R, eds. Medical device epidemiology and surveillance. Chichester, West Sussex, England: John Wiley & Sons, 2007.

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Boggs & Blow Patton. Guide to medical device regulation. Washington, D.C: Thompson Publishing Group, 1994.

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Heller, Mark A. Guide to medical device regulation. Washington, DC: Thompson Pub. Group, 1997.

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Heller, Mark A. Guide to medical device regulation. Washington, D.C: Thompson Pub. Group, 1993.

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Schoenmakers, C. C. W. CE marking for medical devices: A handbook to the medical devices directives : Medical Device Directive 93/42/EEC : the Active Implantable Medical Device Directive 90/396/EEC. New York, NY: Standards Information Network/IEEE Press, 1997.

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Eeckhoven, Eddie F. J. van., ed. Medical device vigilance/monitoring: European device directives compliance. Buffalo Grove, Ill: Interpharm Press, 1997.

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E, Donawa Maria, ed. International medical device registration. Buffalo Grove, IL: Interpharm Press, 1996.

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Medical Device Amendments of 1992. [Washington, D.C.?: U.S. G.P.O., 1992.

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Medical device design and regulation. Milwaukee, Wis: ASQ Quality Press, 2011.

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Book chapters on the topic "Medical device safety"

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Gad, Shayne C. "Device Safety Evaluation." In Safety Evaluation of Pharmaceuticals and Medical Devices, 91–112. Boston, MA: Springer US, 2010. http://dx.doi.org/10.1007/978-1-4419-7449-5_7.

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Doyle, Peter A. "Improving Safety of Medical Device Use Through Training." In Safety of Health IT, 241–52. Cham: Springer International Publishing, 2016. http://dx.doi.org/10.1007/978-3-319-31123-4_19.

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Zusterzeel, Robbert. "Safety and Effectiveness of Medical Device Therapy." In Advances in Experimental Medicine and Biology, 107–21. Cham: Springer International Publishing, 2018. http://dx.doi.org/10.1007/978-3-319-77932-4_7.

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Kim, Cheolgi, Mu Sun, Heechul Yun, and Lui Sha. "A Medical Device Safety Supervision over Wireless." In Reliable and Autonomous Computational Science, 21–40. Basel: Springer Basel, 2010. http://dx.doi.org/10.1007/978-3-0348-0031-0_2.

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Benet, Albert Farré. "A Risk Driven Approach to testing Medical Device Software." In Advances in Systems Safety, 157–68. London: Springer London, 2010. http://dx.doi.org/10.1007/978-0-85729-133-2_10.

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Gad, Shayne C. "Introduction to Safety Assessment in Drug and Medical Device Development." In Safety Evaluation of Pharmaceuticals and Medical Devices, 1–15. Boston, MA: Springer US, 2010. http://dx.doi.org/10.1007/978-1-4419-7449-5_1.

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Gurbeta, Lejla, Almir Badnjević, and Emina Kurta. "eVerlab: Software Tool for Medical Device Safety and Performance Inspection Management." In IFMBE Proceedings, 429–35. Cham: Springer International Publishing, 2019. http://dx.doi.org/10.1007/978-3-030-17971-7_65.

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Gad, Shayne C. "Regulatory Aspects and Strategy in Medical Device and Biomaterials Safety Evaluation." In Integrated Safety and Risk Assessment for Medical Devices and Combination Products, 19–56. Cham: Springer International Publishing, 2019. http://dx.doi.org/10.1007/978-3-030-35241-7_2.

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Bezerra, F. N., V. H. B. Tsukahara, R. H. Almeida, F. S. Borges, E. Pantarotto, R. V. Martins, M. Iglesias, P. Trbovich, S. Pinkney, and S. J. Calil. "Heuristic Analysis: A Tool to Improve Medical Device Safety and Usability." In IFMBE Proceedings, 1186–89. Cham: Springer International Publishing, 2014. http://dx.doi.org/10.1007/978-3-319-00846-2_294.

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Gad, Shayne C. "Regulatory Aspects and Strategy in Medical Device and Biomaterials Safety Evaluation." In Regulatory Toxicology, 83–112. Third edition. | Boca Raton, Florida : CRC Press, [2019]: CRC Press, 2018. http://dx.doi.org/10.1201/9780429464737-4.

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Conference papers on the topic "Medical device safety"

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Murray, A. "Medical devices and patient safety." In IET Seminar on Medical Device Management - More than Maintenance. IEE, 2007. http://dx.doi.org/10.1049/ic:20070516.

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Liddle, S., L. Grover, R. Zhang, M. Khitrov, J. C. Brown, J. P. Cobb, J. Goldman, et al. "Safety evaluation of a Medical Device Data System." In 2012 34th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC). IEEE, 2012. http://dx.doi.org/10.1109/embc.2012.6347336.

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Arney, David, Miroslav Pajic, Julian M. Goldman, Insup Lee, Rahul Mangharam, and Oleg Sokolsky. "Toward patient safety in closed-loop medical device systems." In the 1st ACM/IEEE International Conference. New York, New York, USA: ACM Press, 2010. http://dx.doi.org/10.1145/1795194.1795214.

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Wei, Yuan, and Jin Qin. "Safety-driven software reliability allocation in medical device application." In 2011 International Conference on Quality, Reliability, Risk, Maintenance, and Safety Engineering (ICQR2MSE). IEEE, 2011. http://dx.doi.org/10.1109/icqr2mse.2011.5976578.

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Lindvall, Mikael, Madeline Diep, Michele Klein, Paul Jones, Yi Zhang, and Eugene Vasserman. "Safety-Focused Security Requirements Elicitation for Medical Device Software." In 2017 IEEE 25th International Requirements Engineering Conference (RE). IEEE, 2017. http://dx.doi.org/10.1109/re.2017.21.

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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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Lowndes, Bethany, Dawn Finnie, Julie Hathaway, Jennifer Ridgeway, Kristin Vickers-Douglas, Charles Bruce, and Susan Hallbeck. "Human Factors Applications to Mitigate Design Limitations of a Wearable Telemedicine Heart Rate Monitor." In 2017 Design of Medical Devices Conference. American Society of Mechanical Engineers, 2017. http://dx.doi.org/10.1115/dmd2017-3461.

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The time required to get a device to market is critical to a successful design, development, and manufacturing process [1]. Achieving status of the first device to market is often a priority for manufacturers and developers. Upon market introduction, it is well known that device performance must meet at least minimum standards in order to provide consumer satisfaction and be a successful product to prevent competitive devices from taking over the market [1]. However, if a design only meets minimum expectations, it may struggle to maintain market control. This demonstrates the tradeoffs of speed-to-market and performance, for which optimization has not been clearly defined [2]. Product performance and usability can be designed in, evaluated and enhanced in order to avoid user errors and achieve optimal profitability. For medical devices, clinical trials are a key step in preparing to take a device to market. Clinical trials can allow for analyses of the effectiveness of the device in the patient care process. For wearable medical devices, patient usability is crucial to patient adherence and safety since the device will be operated by non-medically trained individuals [3,4]. Without adequate usability, adherence and continuity of care are greatly reduced which will reduce the overall effectiveness of the device [5,6]. Human factors principles can best be incorporated in the design process to improve the usability of medical devices and patient safety [5,6,7], specifically for those used in telemedicine [4] and cardiovascular treatment [3]. The objective of this project was to evaluate a telemedicine heart rate monitoring device for patient usability in order to improve the next device’s performance and lead to greater patient adherence for the current version via an improved user manual.
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Dorin, Michael, Heather Mortensen, and Sergio Montenegro. "Open Source Medical Device Safety: Loop Artificial Pancreas Case Report*." In 2020 IEEE Symposium on Product Compliance Engineering - (SPCE Portland). IEEE, 2020. http://dx.doi.org/10.1109/spce50045.2020.9296152.

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Taktak, A. "Electrical safety testing: standards and recommendations." In IET Seminar on Medical Device Management - More than Maintenance. IEE, 2007. http://dx.doi.org/10.1049/ic:20070523.

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Cortes, Philippe-Antoine, Shankar M. Krishnan, Insup Lee, and Julian M. Goldman. "Improving the Safety of Patient-Controlled Analgesia Infusions with Safety Interlocks and Closed-Loop Control." In 2007 Joint Workshop on High Confidence Medical Devices, Software, and Systems and Medical Device Plug-and-Play Interoperability (HCMDSS-MDPnP 2007). IEEE, 2007. http://dx.doi.org/10.1109/hcmdss-mdpnp.2007.8.

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Reports on the topic "Medical device safety"

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Kim, Tae-Hun, and Jung Won Kang. The clinical evidence of effectiveness and safety of massage chair: a scoping review. INPLASY - International Platform of Registered Systematic Review and Meta-analysis Protocols, February 2023. http://dx.doi.org/10.37766/inplasy2023.2.0021.

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Review question / Objective: To evaluate current clinical evidence status of massage chair and to present evidence map for future research implication. Background: A massage chair is a furniture-type device such as a sofa or bed which provides automated massage using installed rollers and airbags. Although the market is growing and the number of users is increasing, its clinical evidence of the benefit and harm has not been clearly established yet. Because it is accepted like a furniture not a medical devices, its use is not controlled by medical personnel like other medical devices, so there is a need to pay attention to safety issues and effectiveness in terms of individual health promotion. This scoping review will assess the current evidence status of massage chair and present clinical research agenda in future.
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Budhavaram, Naresh, Vijay Damodaran, Damien Cavez, Sabrine Derkaoua, Nayla Francis, Angeline Renou, Jean-Michel Soro, et al. Implementation of Article 117 of European Union Medical Devices Regulation (EU MDR) General Safety and Performance Requirements: a position paper. BioPhorum, January 2022. http://dx.doi.org/10.46220/2022mt001.

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Evidence Synthesis and Meta-Analysis for Drug Safety. Council for International Organizations of Medical Sciences (CIOMS), 2016. http://dx.doi.org/10.56759/lela7055.

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At any point in the drug development process, systematic reviews and meta-analysis can provide important information to guide the future path of the development programme and any actions that might be needed in the post-marketing setting. This report gives the rationale for why and when a meta-analysis should be considered, all in the context of regulatory decision-making, and the tasks, data collection, and analyses that need to be carried out to inform those decisions. -- There is increasing demand by decision-makers in health care, the biopharmaceutical industry, and society at large to have access to the best available evidence on benefits and risks of medicinal products. The best strategy will take an overview of all the evidence and where it is possible and sensible, combine the evidence and summarize the results. For efficacy, the outcomes generally use the same or very similar predefined events for each of the trials to be included. Most regulatory guidance and many Cochrane Collaboration reviews have usually given more attention to assessment of benefits, while issues around combining evidence on harms have not been as well-covered. However, the (inevitably) unplanned nature of the data on safety makes the process more difficult. -- Combining evidence on adverse events (AEs), where these were not the focus of the original studies, is more challenging than combining evidence on pre-specified benefits. This focus on AEs represents the main contribution of the current CIOMS X report. The goal of the CIOMS X report is to provide principles on appropriate application of meta-analysis in assessing safety of pharmaceutical products to inform regulatory decision-making. This report is about meta-analysis in this narrow area, but the present report should also provide conceptually helpful points to consider for a wider range of applications, such as vaccines, medical devices, veterinary medicines or even products that are combinations of medicinal products and medical devices. -- Although some of the content of this report describes highly technical statistical concepts and methods (in particular Chapter 4), the ambition of the working group has been to make it comprehensible to non-statisticians for its use in clinical epidemiology and regulatory science. To that end, Chapters 3 and 4, which contain the main technical statistical aspects of the appropriate design, analysis and reporting of a meta-analysis of safety data are followed by Chapter 5 with a thought process for evaluating the findings of a meta-analysis and how to communicate these.
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