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Journal articles on the topic 'Medical device safety'

Author: Grafiati

Published: 4 June 2021

Last updated: 10 March 2023

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1

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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3

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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5

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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6

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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8

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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Mosley, M., and G. F. O. Tyers. "Medical Device Safety: Addressing the Issues." MD Conference Express 14, no. 9 (July 1, 2014): 30–31. http://dx.doi.org/10.1177/155989771409017.

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12

The Lancet Oncology. "Catching up on medical device safety." Lancet Oncology 20, no. 1 (January 2019): 1. http://dx.doi.org/10.1016/s1470-2045(18)30945-8.

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13

Ross, Joseph S. "Strengthening Medical Device Postmarket Safety Surveillance." JAMA Internal Medicine 175, no. 8 (August 1, 2015): 1350. http://dx.doi.org/10.1001/jamainternmed.2015.2650.

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14

Small, Stephen D. "Medical Device–Associated Safety and Risk." JAMA 291, no. 3 (January 21, 2004): 367. http://dx.doi.org/10.1001/jama.291.3.367.

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15

Cramer, Sarah D., Juliana S. Lee, Mark T. Butt, Jaime Paulin, and William C. Stoffregen. "Neurologic Medical Device Overview for Pathologists." Toxicologic Pathology 47, no. 3 (January 1, 2019): 250–63. http://dx.doi.org/10.1177/0192623318816685.

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Thorough morphologic evaluations of medical devices placed in or near the nervous system depend on many factors. Pathologists interpreting a neurologic device study must be familiar with the regulatory framework affecting device development, biocompatibility and safety determinants impacting nervous tissue responses, and appropriate study design, including the use of appropriate animal models, group design, device localization, euthanasia time points, tissue examination, sampling and processing, histochemistry and immunohistochemistry, and reporting. This overview contextualizes these features of neurologic medical devices for pathologists engaged in device evaluations.

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Friedemann, Molly C., Nicole A. Mehta, Staci L. Jessen, Fatima H. Charara, Anne-Marie Ginn-Hedman, Courtney N. Kaulfus, Breanna F. Brocklesby, et al. "Introduction to Currently Applied Device Pathology." Toxicologic Pathology 47, no. 3 (March 7, 2019): 221–34. http://dx.doi.org/10.1177/0192623319826585.

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Pathologic evaluation is crucial to the study of medical devices and integral to the Food and Drug Administration and other regulatory entities’ assessment of device safety and efficacy. While pathologic analysis is tailored to the type of device, it generally involves at a minimum gross and microscopic evaluation of the medical device and associated tissues. Due to the complex nature of some implanted devices and specific questions posed by sponsors, pathologic evaluation inherently presents many challenges in accurately assessing medical device safety and efficacy. This laboratory’s experience in numerous collaborative projects involving veterinary pathologists, biomedical engineers, physicians, and other scientists has led to a set of interrelated assessments to determine pathologic end points as a means to address these challenges and achieve study outcomes. Thorough device evaluation is often accomplished by utilizing traditional paraffin histology, plastic embedding and microground sections, and advanced imaging modalities. Combining these advanced techniques provides an integrative, comprehensive approach to medical device pathology and enhances medical device safety and efficacy assessment.

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Aballa, A. N., D. U. Ebem, O. A. Eneh, and J. A. Adeniyi. "Relevance of Requirement Engineering In Medical Devices Development." Advances in Multidisciplinary and scientific Research Journal Publication 1 (July 30, 2022): 13–16. http://dx.doi.org/10.22624/aims/rebk2022-p2.

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ABSTRACT Medical device development life cycle requires the strict adherence to the stages outlined by the regulatory bodies to ensure safety of use by patients and clinicians and to ensure high quality products. This chapter tactfully describes how introducing the process of requirement engineering into the medical device development procedures can help in creating high standard medical devices to improve health care administration. Keywords: Medical Devices, Patients, Clinician, Requirement Engineering, Health Care, Safety.

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Targhotra, Monika, Geeta Aggarwal, Harvinder Popli, and Madhu Gupta. "Regulatory aspects of medical devices in India." International Journal of Drug Delivery 9, no. 2 (October 6, 2017): 18. http://dx.doi.org/10.5138/09750215.2147.

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<p>Today millions of patients depend on medical device based treatment for the management and diagnose of several diseases. Quality and safety of device is depends upon the regulatory guidelines. Medical device manufacturing in India should be taken seriously due to large population and the potential severity of the consequences of introducing inferior and unsafe products to the market-place. Therefore a law containing adequate guidelines of rules and regulations are required for monitoring the entry of such devices into the use in public health. The regulations define requirements of medical device design, development and manufacture to ensure that products reaching market are safe and effective. Presently in India regulatory body CDSCO is governing regulation for regulation of devices which with time, amendment introducing in the law will provide safety assurance to public health. This review provides a study on different regulatory aspects of medical device implemented in India. The present review discuss about the classification of medical devices and regulations aspects in India.</p>

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Larson, Brian R., Paul Jones, Yi Zhang, and John Hatcliff. "Principles and Benefits of Explicitly Designed Medical Device Safety Architecture." Biomedical Instrumentation & Technology 51, no. 5 (September 1, 2017): 380–89. http://dx.doi.org/10.2345/0899-8205-51.5.380.

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Abstract The complexity of medical devices and the processes by which they are developed pose considerable challenges to producing safe designs and regulatory submissions that are amenable to effective reviews. Designing an appropriate and clearly documented architecture can be an important step in addressing this complexity. Best practices in medical device design embrace the notion of a safety architecture organized around distinct operation and safety requirements. By explicitly separating many safety-related monitoring and mitigation functions from operational functionality, the aspects of a device most critical to safety can be localized into a smaller and simpler safety subsystem, thereby enabling easier verification and more effective reviews of claims that causes of hazardous situations are detected and handled properly. This article defines medical device safety architecture, describes its purpose and philosophy, and provides an example. Although many of the presented concepts may be familiar to those with experience in realization of safety-critical systems, this article aims to distill the essence of the approach and provide practical guidance that can potentially improve the quality of device designs and regulatory submissions.

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20

Curfman, Gregory D., Stephen Morrissey, and Jeffrey M. Drazen. "The Medical Device Safety Act of 2009." New England Journal of Medicine 360, no. 15 (April 9, 2009): 1550–51. http://dx.doi.org/10.1056/nejme0902377.

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Jones, Paul L., and Al Taylor. "Medical Device Risk Management And Safety Cases." Biomedical Instrumentation & Technology 49, s1 (January 1, 2015): 45–53. http://dx.doi.org/10.2345/0899-8205-49.s1.45.

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22

Clark, Shannon, Divya Natesan, Morgan Walker, and Denise Forkey. "Out-of-the-Box Medical Device Safety." Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care 5, no. 1 (June 2016): 84–85. http://dx.doi.org/10.1177/2327857916051014.

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Out-of-the-box experience is an important consideration in medical device design that not only impacts the user’s impression of the product, but can also have critical safety implications. This article discusses the basic safety questions to contemplate in a use-related risk analysis pertaining to the out-of-the-box experience, and focuses on how the most critical safety risks can be reduced or eliminated by conducting a usability study related to the out-of-the-box experience.

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Pelletier, Mark G. "Improving Medical Device Alarm Safety in Hospitals." Journal of Nursing Care Quality 28, no. 4 (2013): 292–94. http://dx.doi.org/10.1097/ncq.0b013e3182a268b9.

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Miclăuş, Teodora, Vasiliki Valla, Angeliki Koukoura, Anne Ahlmann Nielsen, Benedicte Dahlerup, Georgios-Ioannis Tsianos, and Efstathios Vassiliadis. "Impact of Design on Medical Device Safety." Therapeutic Innovation & Regulatory Science 54, no. 4 (December 9, 2019): 839–49. http://dx.doi.org/10.1007/s43441-019-00022-4.

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Raheja, Dev. "System Safety in Healthcare." Journal of System Safety 51, no. 3 (October 1, 2015): 11–12. http://dx.doi.org/10.56094/jss.v51i3.142.

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Unique Device Identification (UDI) is a recent development to protect patients from hazards in medical devices. The UDI relates to adverse event reporting, identifying and analyzing devices in use. Currently, hospitals are unable to report many adverse events because the device identification has to be manually located — and often, they are not easily readable, or the person reporting makes an error in reading or documenting the identification information. If a cardiac monitor malfunctions, it’s critical for the information in the adverse event report to match the manufacturer’s product identification system; otherwise, the adverse event may go unreported to U.S. Food and Drug Administration (FDA), and the device may not be recalled as soon as it should. The same urgency holds for a product recall sent from a manufacturer to the doctor, hospital or patient. An inability to identify the device affected by the recall could have potentially disastrous results for patients. In addition, if the device is for personal use, the user may not have access to information about the hazards other users of the device have experienced. With this new system, a user can easily search for hazards.

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Jain, Achin, Neenu Ganesh, and M. P. Venkatesh. "QUALITY STANDARDS FOR MEDICAL DEVICES." International Journal of Drug Regulatory Affairs 2, no. 4 (February 13, 2018): 19–24. http://dx.doi.org/10.22270/ijdra.v2i4.149.

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Formerly with more augmented disabilities, Medical devices have become decisive device in many circumstances. As these are more perilous, the manufacturer should endow with an ideal medical device in aspects of safety & quality. To produce a homogeneous device globally, there should be some standards to be followed within an explicit country and standard throughout the globe, complying with the quality. In milieu of this resemblance of device globally, International Organization for Standard (ISO) has issued a standard, ISO 13485. This article is made to furnish the details about ISO 13485 and the Quality management system followed by United States manufacturer’s to market their devices within the country, i.e., 21 CFR Part 820.

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Manita, Aakash Deep, Vikram, Avtar C. Rana, and Prabodh C. Sharma. "Regulation and Clinical Investigation of Medical Device in the European Union." Applied Clinical Research, Clinical Trials and Regulatory Affairs 6, no. 3 (November 13, 2019): 163–81. http://dx.doi.org/10.2174/2213476x06666190821095407.

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Background:: Medical devices are the machine, tool, instrument, apparatus, implant, calibrator in vitro, software, the similar or related object intended for use by the manufacturer alone or in combination becoming increasingly important in the healthcare sector as these are used to diagnosis, control, prevention or treatment of an illness. Safety of the world population is the highest priority in order to launch new medical devices for the treatment and diagnostic of several diseases. New innovation in industries and regulations work together to provide devices for different world market and to improve quality and safety of exiting devices in the market. The main key for devices is to classify the determination of actual regulatory pathway which ensures the safety standards and other regulatory requirements in a specific country. We perform clinical trials for medical device which are quite different from the clinical trials performed for drug analysis. For any high-risk devices, the new EU law states that the manufacturer has to prepare a complete summary for their evidence. The clinical trials regulation provides more transparency on clinical trials data. Complete transparency is required for the maximum possibility of informed decisions in order to use new medical devices. Objective:: The current manuscript will provide the information regarding the regulatory framework for the approval of medical devices and clinical investigation of medical device in European Union and comparison of approval process of medical device in USA, EU and India. The aim of this paper is to provide an overview of the most suitable and emerging requirements that manufacturers need for introducing their medical devices in the market in compliance with the MDR regulations. Conclusion:: The proposal for a modified regulation of medical devices aims to ensure more robust clinical data in support of the CE marking applications of the medical device. The clinical investigation requirements will be mandatory, and there will be an obligation to demonstrate the clinical benefits of the device and provide a rigorous equivalence test if the assessment is based on comparison devices. The new European legislation should require the premarket demonstration of clinical efficacy and safety, using a randomized controlled trial if possible, and a transparent clinical review, preferably centralized.

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Mkalaf, Khelood A., and Peter Gibson. "Application the Risk-Based Maintenance for Optimizing the Overall Medical Devices Safety." Journal of Techniques 4, no. 4 (December 31, 2022): 111–18. http://dx.doi.org/10.51173/jt.v4i4.615.

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The purpose of this study was to identify risks to patients as a result of sudden device failure during the delivery of medical treatment services. Which, can affect the reputation of hospitals following the exposure of patients' lives to various risks like death, injury, and misdiagnosis. Furthermore, a sudden failure will lead to increased economic losses as a result of increased maintenance costs. Of (20) medical devices, (6) high-risk devices were selected, such as a ventilator, diathermy, anesthesia, BiPAP, oxygen concentrator, and electrosurgical devices. A quantitative statistical analysis based on risk-based maintenance is used to evaluate the effectiveness of the reliability of the medical device and its risks to patient lives. The results show that the reliability of the chosen medical device has declined, with higher maintenance costs due to excessive maintenance or the type of maintenance policy used. Therefore, this study provides evidence that hospitals must adopt a risk-based maintenance approach to prevent sudden failure while in service. In addition, these medical devices have various complex parts that must adopt a combination of maintenance schedules. Based on Risk-Based Maintenance's experience in improving patient safety in public hospitals in the 20 most successful OECD countries.

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Suzuki, K. "Pitfalls in Medical Field at Use of Medical Device(The 4th Medical Devices Safety Measures Society)." JAPANES JOURNAL OF MEDICAL INSTRUMENTATION 75, no. 11 (November 1, 2005): 828–30. http://dx.doi.org/10.4286/ikakikaigaku.75.11_828.

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Vinck, Imgard, Sabine Stordeur, Frank Hulstaert, Mattias Neyt, and Hans Van Brabandt. "Market Introduction of Innovative High Risk Medical Devices: Towards a Recast of the Directive Concerning Medical Devices." European Journal of Health Law 18, no. 5 (2011): 477–89. http://dx.doi.org/10.1163/157180911x598735.

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AbstractThe European Conformity (CE) marking grants early market introduction to innovative high risk medical devices based on safety and device performance only, without any requirement to demonstrate clinical efficacy or effectiveness. Hence healthcare providers, patients and payers are informed neither about the added clinical value compared to an existing medical device nor about the risks incurred by using such innovations. In addition there is a lack of coherence and uniformity of approach in the assessment of high risk medical devices. These gaps may put the health and safety of patients in danger. The European Commission, in concert with Competent Authorities, industry, Notified Bodies, and other stakeholders, is working on a “recast” of the directives regulating medical devices. This article identifies and discusses the critical points of the pre-market clinical evaluation of innovative high-risk medical devices in the European legal framework and compares it with the USA.

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Somberg, John. "Device Safety and Effectiveness." American Journal of Therapeutics 17, no. 4 (July 2010): 357. http://dx.doi.org/10.1097/mjt.0b013e3181ecfa67.

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Krsteva Jakimovska, Katerina, Marija Glavas-Dodov, Jasmina Tonic-Ribarska, and Suzana Trajkovic-Jolevska. "Medical device risk management and its economic impact." Macedonian Pharmaceutical Bulletin 59 (September 2013): 49–60. http://dx.doi.org/10.33320/maced.pharm.bull.2013.59.006.

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The importance of medical devices in everyday users/patients lives is imensse. This is the reason why emphasis must be put on safety during their use. Satisfactory safety level can be achived by implementation of quality and risk management standards. Medical device manufacturers must learn to deal with the potential risks by using theoretical and practical examples and measures in order to protect their users/patients and themselves from suffering huge losses arising from adverse events or recall of their products. The best moment for implementation of risk management methods and analysis begins from the device design and development through manufacturing, sales and distribution. These way medical device manufacturers will succseed in protecting their users/patients from serious adverse events and at the same time protect their brand and society status, while minimizing economic losses

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Mueller, E., R. Kammula, and D. Marlowe. "Regulation of “Biomaterials” and Medical Devices." MRS Bulletin 16, no. 9 (September 1991): 39–41. http://dx.doi.org/10.1557/s0883769400056037.

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On May 28, 1976, President Gerald R. Ford signed into law the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act. The purpose of the Amendments is to ensure that medical devices are safe and effective, and properly labelled for their intended use. In order to accomplish this mandate, the Amendments provide the Food and Drug Administration (FDA) with authority to regulate devices during most phases of their development, testing, and use. The FDA's approach to this regulation focuses heavily on both the pre- and post-market phases of a device's lifetime. During the pre-market phase, the FDA concentrates on providing a reasonable assurance that new devices are adequately evaluated for safety and effectiveness. Implicit in this assessment is the concept of balancing risk to benefit. If the benefits significantly outweigh the risks for the intended use, the device will most likely be approved for marketing in the United States. Since risk/benefit assessments for new technology involve considerable clinical judgment, the FDA utilizes expert panels composed of clinicians, engineers, toxicologists, and other experts familiar with the devices. These panels are often directed to review the data provided by the manufacturer to support claims for device safety and effectiveness. If the advisory panel believes the data support the manufacturer's claims, a recommendation for approval for marketing is made to the FDA. The Agency must ultimately decide whether the device is to receive approval for marketing.

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Green, James IJ. "The impact of medical device regulation on hospital doctors who prescribe and manufacture custom-made devices." British Journal of Hospital Medicine 81, no. 12 (December 2, 2020): 1–6. http://dx.doi.org/10.12968/hmed.2020.0596.

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The 1990s saw the implementation of three European directives that aimed to standardise medical device legislation. EU regulations replace and repeal these directives, to improve the safety, effectiveness and traceability of medical devices. This article discusses the implications of the Regulation (EU) 2017/745 (Medical Device Regulation) for hospital doctors who prescribe and manufacture custom-made medical devices.

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Resnic, Frederic S., and Arjun Majithia. "Postmarket medical device safety: moving beyond voluntary reporting." BMJ Quality & Safety 27, no. 3 (October 9, 2017): 174–75. http://dx.doi.org/10.1136/bmjqs-2017-007426.

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Lee, Sanghun, DongWoo Nam, Christopher Zaslawski, and Hongmin Chu. "Safety control of traditional medical device and manipulation." Advances in Integrative Medicine 6 (May 2019): S28—S29. http://dx.doi.org/10.1016/j.aimed.2019.03.080.

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Mojdehrakhsh, R., Wei-Tek Tsai, S. Kirani, and L. Elliott. "Retrofitting software safety in an implantable medical device." IEEE Software 11, no. 1 (January 1994): 41–50. http://dx.doi.org/10.1109/52.251205.

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Kim, Dong-Won, Jin-Young Choi, and Keun-Hee Han. "Medical Device Safety Management Using Cybersecurity Risk Analysis." IEEE Access 8 (2020): 115370–82. http://dx.doi.org/10.1109/access.2020.3003032.

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Gehlot, V., and E. B. Sloane. "Ensuring Patient Safety in Wireless Medical Device Networks." Computer 39, no. 4 (April 2006): 54–60. http://dx.doi.org/10.1109/mc.2006.125.

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Zinovyeva, E. V., A. V. Sapunova, and I. V. Ivanov. "Safety of handling of medical devices at all stages of their life cycle." Public Health 2, no. 3 (September 6, 2022): 16–24. http://dx.doi.org/10.21045/2782-1676-2021-2-3-16-24.

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The review describes the main points of the life cycle of a medical device, considers three stages of regulation of medical devices: pre-market, market and post-sale. The main attention is paid to post-sale supervision, as an activity for monitoring used medical devices, collecting information about the quality, safety and effectiveness of medical devices.

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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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Ravichandran, Rajganesh, Raveena Pachal Balakrishnan, Jaya Shree Dilli Batcha, Abarna Lakshmi Ravi, and Nikhil Cherian Sam. "Medical device: a complete overview." International Journal of Clinical Trials 7, no. 4 (October 20, 2020): 285. http://dx.doi.org/10.18203/2349-3259.ijct20204487.

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<p class="abstract">Medical device means any instrument, apparatus, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose. Medical devices are generally classified based on risks; the actual risk-based classification of the medical device depends upon its intended use and purpose.<strong> </strong>Development of an entirely new device typically begins with a concept by a physician or bioengineer for a solution to a medical problem. If the idea is determined to be workable and practical (proof of concept) an early design of the device, known as a prototype, will be built. A prototype device will undergo a cycle of preclinical testing, redesigning, preclinical testing of the redesign and so forth, until the design has been refined and tested to a point that it is ready for production and testing in humans. Preclinical animal tastings are conducted to provide reasonable evidence that novel technologies and therapies are safe and effective. When studying medical devices, clinical trials are not always required, and whether or not one will be conducted depends on a risk assessment. Post marketing surveillance is the practice of monitoring the safety of a medical device after it has been released on the market.</p>

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I.V., Ivanov. "Internal control of a medical company: safety of medical device circulation." Remedium. Journal about the Russian market of medicines and medical equipment, no. 11 (2016): 62–65. http://dx.doi.org/10.21518/1561-5936-2016-11-62-65.

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Pires, Carla, Dinah Duarte, and Afonso Cavaco. "Analysis of Medical Device Alerts Issued by the Portuguese Medicines Agency: Scoping the Purpose of New Regulatory Recommendations." Acta Médica Portuguesa 34, no. 3 (March 1, 2021): 201. http://dx.doi.org/10.20344/amp.13419.

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Introduction: Medical devices are healthcare technologies with a significantly growing market worldwide. This study aims to analyze medical device alerts issued by the Portuguese Medicines Agency, INFARMED, I.P. during 2017, as well as to identify the respective regulatory actions and to suggest additional recommendations.Material and Methods: All alerts on medical device alerts publicly available in the website of INFARMED, I.P. were identified and analyzed, including actions taken. Additionally, reports on medical devices from the Portuguese national competent authorities were compared with reports from other European Union member states such as Germany.Results: A total of 32 safety alerts were identified: 18 (56%) related with devices without identified records of commercialization in Portugal, six (19%) related with devices voluntarily withdrawn from the market, such as counterfeit products, and eight (25%) categorized as ‘other’. In both Portugal and Germany, 0.28 and 4.53 reports of national competent authorities per million inhabitants were identified, respectively. Diverse regulatory actions were taken, such as six compulsory indications to not acquire or use devices.Discussion: Considering that the European Union is an open market where citizens should have equal access to medical devices, the Portuguese system of medical device safety alerts seems to be functioning normally. The identified safety alerts seemed relevant, with Portugal registering a proportionally slightly lower number of alerts when compared with higher sales volume markets, which may be explained by an underreporting of this type of problems. Further studies are needed to confirm these preliminary results, although the development of databases comprising data on patients using medical devices is recommended in order to generate automatic email and text message alerts.Conclusion: A limited number of safety alerts on medical devices was identified in Portugal, with few reported cases of counterfeit or falsified devices. The Portuguese Medicines Agency contributes to the citizens’ access to quality medical devices, by issuing safety alerts, recommendations and mandatory market withdrawals for unsuitable or unsafe medical devices.

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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.

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Gagliardi, Anna R., Julie Takata, Ariel Ducey, Pascale Lehoux, Sue Ross, Patricia L. Trbovich, Anthony Easty, Chaim M. Bell, and David R. Urbach. "MEDICAL DEVICE RECALLS IN CANADA FROM 2005 TO 2015." International Journal of Technology Assessment in Health Care 33, no. 6 (2017): 708–14. http://dx.doi.org/10.1017/s0266462317000824.

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Objectives: Medical devices are ubiquitous in modern medical care. However, little is known about the epidemiology of medical devices in the healthcare marketplace, including the rate at which medical devices are subject to recalls or other advisories. We sought to study the epidemiology of medical devices in Canada, focusing on device recalls. In Canada, a recall may signify a variety of events, ranging from relatively minor field safety notifications, to removal of a product from the marketplace.Methods: We used data from Health Canada to study medical device recalls in Canada from 2005 to 2015. We analyzed the risks of medical device recalls according to the risk class of the device (I lowest; IV highest) and the hazard priority of the recall (Type I highest potential harm; Type III lowest potential harm).Results: During a 10-year period, there were 7,226 medical device recalls. Most recalls were for intermediate risk class (Class II, 40.1 percent; Class III, 38.7 percent) medical devices. Among recalled devices, 5.0 percent were judged to have a reasonable probability of serious adverse health consequences or death (Type I recall Hazard Priority classification). While the number of medical devices marketed in Canada is not known, over a similar 10-year period, 24,849 new Class II, II, and IV medical device licenses were issued by Health Canada.Conclusions: Several hundred medical device recalls occur in Canada each year. Further research is needed to characterize the nature of medical device recalls, and to explore how consumers use information about recalls.

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Ray, Arnab, Raoul Jetley, Paul L. Jones, and Yi Zhang. "Model-Based Engineering for Medical-Device Software." Biomedical Instrumentation & Technology 44, no. 6 (November 1, 2010): 507–18. http://dx.doi.org/10.2345/0899-8205-44.6.507.

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Abstract This paper demonstrates the benefits of adopting model-based design techniques for engineering medical device software. By using a patient-controlled analgesic (PCA) infusion pump as a candidate medical device, the authors show how using models to capture design information allows for i) fast and efficient construction of executable device prototypes ii) creation of a standard, reusable baseline software architecture for a particular device family, iii) formal verification of the design against safety requirements, and iv) creation of a safety framework that reduces verification costs for future versions of the device software.1

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Harp, Steven, Todd Carpenter, and John Hatcliff. "A Reference Architecture for Secure Medical Devices." Biomedical Instrumentation & Technology 52, no. 5 (September 1, 2018): 357–65. http://dx.doi.org/10.2345/0899-8205-52.5.357.

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Abstract We propose a reference architecture aimed at supporting the safety and security of medical devices. The ISOSCELES (Intrinsically Secure, Open, and Safe Cyber-Physically Enabled, Life-Critical Essential Services) architecture is justified by a collection of design principles that leverage recent advances in software component isolation based on hypervisor and other separation technologies. The instantiation of the architecture for particular medical devices is supported by a development process based on Architecture Analysis and Design Language. The architecture models support safety and security analysis as part of a broader risk management framework. The models also can be used to derive skeletons of the device software and to configure the platform's separation policies and an extensive set of services. We are developing prototypes of the architecture and example medical device instantiations on low-cost boards that can be used in product solutions. The prototype and supporting development and assurance artifacts are being released under an open-source license.

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Payasan, Lalu Guntur, Arthur Josias S. Runturambi, and Iqrak Sulhin. "Medical Malpractice Transformation in the Internet of Medical Things Era." Technium Social Sciences Journal 38 (December 9, 2022): 204–19. http://dx.doi.org/10.47577/tssj.v38i1.7880.

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The Internet of medical things brought changes to the practice of medicine. The change is due to the inclusion of elements of devices and networks in medical services. The device and network elements in medical devices have many vulnerabilities that can lead to losses experienced by patients when they receive medical services. Therefore, this study will examine how these changes then have an impact on losses that in criminology are considered medical malpractice. A qualitative explanatory approach to both primary and secondary data is then used by researchers to support the argumentation. The results showed that the argument for the possibility of other perpetrators besides doctors who could then be interpreted as committing crimes that cause harm to patients was proven to be good from the responsibility of other human beings (electromedicine) as guarantors of device safety and reliability; manufacture and distributor of devices both from the prototype process, to use in health care facilities; and providers and hackers in the network used by healthcare devices. The impact can be seen in the discussion

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Nalini Pandey and Mohammed Imran. "Materiovigilance: Current status in India analogous to its global status." Journal of Pharmacovigilance and Drug Research 1, no. 2 (December 1, 2020): 24–31. http://dx.doi.org/10.53411/jpadr.2020.1.2.4.

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Introduction: Medical devices are boon to the healthcare system and are available in the market since long ago. More than 500,000 different types of the medical devices are available in the international market. Thus, from the patient safety view point, assessment of the quality and safety of these medical devices is essential. Objectives: This review article discusses the classification and regulation of medical devices in India and the world with framework of adverse event reporting system for medical devices in India. Methods: To address the aforesaid issue International Medical Device Regulators Forum (IMDF) was established in 2011 was established at international Level. In India, 4 years later in 2015, Materiovoigilance Program of india (MvPI) was introduced with the prime aim of improving the protection of the health and safety of patients, healthcare professionals and others by reducing the likelihood of reoccurrence of an adverse event associated with the use of medical devices. Results: At present, there are 50 Medical Device Adverse Event Monitoring Centres (MDMCs) in India. Every country has its own regulatory body and guidelines for monitoring and reporting of adverse events due to medical devices eg: USFDA in USA, TGA in Australia, MHRA in UK, ENVISA in Brazil, CDSCO in India etc. Conclusions: In India, the provisions of regulation of safety, quality and performance of medical devices are laid down in the Drugs and Cosmetics Act, 1940 and rules 1945.

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