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Journal articles on the topic 'Medical devices certification'
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Glinski, Carola, and Peter Rott. "Regulating Certification Bodies in the Field of Medical Devices: The PIP Breast Implants Litigation and Beyond." European Review of Private Law 27, Issue 2 (April 1, 2019): 403–28. http://dx.doi.org/10.54648/erpl2019021.
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This article uses the breast implants scandal around the French producer Poly Implant Prothèse (PIP) to discuss the regulation of medical devices in EU law. Thereby, the specific focus is on the role of tort liability of certification bodies in complementing the public law regime of medical devices law. As tort law has not been harmonized yet at the level of EU law, national legal systems may produce different results; which indeed the PIP case demonstrates, with diverging judgments from French and German courts. Showing the deficiencies of the public law system of the Medical Devices Directive of 1993 as well as of the new Medical Devices Regulation of 2017, the article argues that tort liability is a necessary regulatory instrument to ensure that certification bodies live up to their duties under medical devices law and therefore a necessary instrument for the protection of the health and safety of patients.
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Geremia, Fabio. "Quality aspects for medical devices, quality system and certification process." Microchemical Journal 136 (January 2018): 300–306. http://dx.doi.org/10.1016/j.microc.2017.04.018.
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Umamaheswara Rao, Ganne. "“Made in India”: How’s that for an indigenous medical device?" Indian Journal of Neurosurgery 02, no. 02 (May 2013): 151–53. http://dx.doi.org/10.4103/2277-9167.118115.
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Abstract With increasing costs of imported equipment, there is a need for Indigenization of medical devices in India. The resources including skilled manpower to develop equipment of a good standard are available in the country. What plagues the developmental process is the lack of adequate interaction between the medical profession and the technologists and reluctance of the industry to venture into the medical device manufacturing. A much bigger and more serious road-block is the lack of formal certification and regulatory processes for these devices. Medical practitioners should be open to evaluating and accepting indigenous equipment that pass the requisite standards. Formal mechanisms should be developed to orient both physicians and engineers to the technical and commercial issues of device development.
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Kaule, Sebastian, Andrea Bock, Ariane Dierke, Stefan Siewert, Klaus-Peter Schmitz, Michael Stiehm, Ernst Klar, et al. "Medical Device Regulation and current challenges for the implementation of new technologies." Current Directions in Biomedical Engineering 6, no. 3 (September 1, 2020): 334–37. http://dx.doi.org/10.1515/cdbme-2020-3086.
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AbstractThe European Parliament and the European Council on May 26, 2017 decided to introduce the new regulatory framework for medical devices. The transitional period of the so called Medical Device Regulation (EU 2017/745, MDR) should end on May 26, 2020. Currently the European Commission is working on a proposal to postpone the application for one year to relieve pressure from all stakeholders allowing them to fully focus on priorities related to the coronavirus crisis. From this date or most likely from May 26, 2021, manufacturers must present a CE-certificate according to the new MDR requirements not only for novel medical devices, but also for approved medical devices which are already on the market. The MDR will significantly complicate the process of bringing medical devices into market due to the increased requirements for the CE-certification process, particularly concerning increased documentation effort. This involves a risk for the translation of innovative products due to an overload of the overall system (manufacturers, Notified Bodies, experts) and might lead to shrinkage of the product range of existing products. Thankfully, adaption of transitional periods, special regulations, extensions of deadlines and most probably postponement of the MDR application date will ensure that there will be no gaps in medical supply that endanger patients. Establishing and keeping the relevant regulatory expertise up to date and devoting the necessary financial, time and human resources that is the biggest immediate challenge the medium-sized medical technology sector is facing in the near future. The current article, written about one month before the initially expected end of the first transition period on May 26, 2020, summarized the main aspects of the current state of MDR implementation with respect to regulatory novelties, the current legal basis in Germany, transition periods and changes in the requirements of CE-certification relevant technical documentation. Furthermore, challenges for existing and innovative medical devices were shortly discussed using a new stent based therapy of the proximal Fallopian tubal stenosis and transcatheter aortic valve implantation as two examples.
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Janß, Armin, Johannes Thorn, Malte Schmitz, Alexander Mildner, Jasmin Dell’Anna-Pudlik, Martin Leucker, and Klaus Radermacher. "Extended device profiles and testing procedures for the approval process of integrated medical devices using the IEEE 11073 communication standard." Biomedical Engineering / Biomedizinische Technik 63, no. 1 (February 23, 2018): 95–103. http://dx.doi.org/10.1515/bmt-2017-0055.
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AbstractNowadays, only closed and proprietary integrated operating room systems (IORS) from big manufacturers are available on the market. Hence, the interconnection of components from third-party vendors is only possible with increased time and costs. In the context of the German Federal Ministry of Education and Research (BMBF)-funded project OR.NET (2012–2016), the open integration of medical devices from different manufacturers was addressed. An integrated operating theater based on the open communication standard IEEE 11073 shall give clinical operators the opportunity to choose medical devices independently of the manufacturer. This approach would be advantageous especially for hospital operators and small- and medium-sized enterprises (SME) of medical devices. Actual standards and concepts regarding technical feasibility and the approval process do not cope with the requirements for a modular integration of medical devices in the operating room (OR), based on an open communication standard. Therefore, innovative approval strategies and corresponding certification and test procedures, which cover actual legal and normative standards, have to be developed in order to support the future risk management and the usability engineering process of open integrated medical devices in the OR. The use of standardized device and service profiles and a three-step testing procedure, including conformity, interoperability and integration tests are described in this paper and shall support the manufacturers to integrate their medical devices without disclosing the medical devices’ risk analysis and related confidential expertise or proprietary information.
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Mijares, Rodrigo, Néstor Utrera, Zhayda Sierra, Sara González, Rubén Lugo, María Rincón, and Raquel Mijares. "Quality Certification of Medical Devices in Venezuela: Process Developed by Simón Bolívar University, Caracas-Venezuela." Global Clinical Engineering Journal 2, no. 3 (May 4, 2020): 8–14. http://dx.doi.org/10.31354/globalce.v2i3.83.
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Background and objective: medical devices and supplies increase productivity in health institutions, contributing to the reduction of morbidity and mortality rates. However, the use of medical devices has an associated level of risk. A third party must guarantee the safety and effectiveness of the medical team to grant a quality certification. In Venezuela, one of the institutions authorized by the regulatory entity (Ministry of Popular Power for Health) that grants quality certification is the Health Technology Management Unit (UGTS) attached to the Research and Development Foundation (FUNINDES ) from the Simón Bolívar University (USB). The objective of this work is to show the certification protocol by the UGTS and its results.
Material and Methods; It based on the ISO 9001 standard for the processes. Five activities were determined: Prepare the teaching, technical and administrative staff as ISO auditors. Carry out an external audit, in order to make proposals for improvement; Plan changes in our quality management system and processes and Qualify as a supplier guided by the ISO 9001 philosophy by a prestigious international company.
Results: Based on the results, general and particular proposals were proposed to improve the process. These were adopted by the group and later in the evaluation of an international company the USB was qualified as an approved supplier for the analysis of medical devices by the company Johnson & Johnson Medical S.C.S. when complying with ISO 9001 Standard.
Conclusions: The UGTS is authorized by the Ministry of Popular Power for Health (MPPS) through the Sanitary Comptroller's Office to issue quality certificates to medical teams since 1999. Approximately 55 companies that have received service are registered in its database. In the period audited (2012 - 2014), 25 files were created. Its processes comply with ISO 9001.
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Foo, Jong Yong Abdiel, and Xin Ji Alan Tan. "Limited Awareness of the Essences of Certification or Compliance Markings on Medical Devices." Science and Engineering Ethics 23, no. 3 (November 28, 2016): 653–61. http://dx.doi.org/10.1007/s11948-016-9836-4.
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Abela, E., P. Farrugia, M. V. Gauci, P. Vella, G. Cassar, and E. Balzan. "A Novel User-Centred Framework for the Holistic Design of Therapeutic Medical Devices." Proceedings of the Design Society 2 (May 2022): 1199–208. http://dx.doi.org/10.1017/pds.2022.122.
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AbstractNumerous and complex sequence of activities in medical device development often result in time consuming and expensive engineering processes. In this study, patient and designer requirements were identified and integrated within a novel framework which supports medical device design through a consolidated understanding of user-experience whilst directly coalescing the applicable regulatory requirements in terms of product compliance and certification. This assists in the development of safe and reliable products which reflect the need for increased usability considerations during design.
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Zarmani, Nur Farhani, Mohd Anuar Ramli, Shaikh Mohd Saifuddeen Shaikh Mohd Salleh, Mohd Zaid Daud, and Mohd Amzari Tumiran. "ANALYSIS ON THE HALAL STATUS OF A MEDICAL DEVICE: A STUDY ON THE SURGICAL SUTURE." International Journal of Halal Ecosystem and Management Practices 1, no. 1 (September 15, 2021): 01–07. http://dx.doi.org/10.35631/ijhemp.11001.
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There is a recent demand for halal certification from another healthcare sector which is medical devices, which cover all types of medical equipment used in hospitals from simple equipment such as bandages to complex equipment such as ventilators. This matter has been raised by the industry as halal labelling is a requirement to penetrate the market of Islamic countries such as Saudi Arabia, Turkey, and Pakistan. Even it seems critical to proving halal status for the medical devices that incorporate animal tissues, in contact with or invasive to the body, and produce a reaction to the body, this does not deny the demand for other types of devices. This study will focus on the halal issues related to medical devices which are widely used to stitch and close the wounds of patients after surgery or injury, namely sutures. This study seeks to identify the status of suture usage from the perspective of Islamic ruling. To achieve this objective, a qualitative research method through library research, as well as field studies involving in-depth interviews with the industry players, both medical device and religious authorities, Islamic scholars, and medical practitioners. The interviews were recorded, transcribed, translated, coded, and reconciled with the aid of Atlas.ti software (version 7) to identify themes and subthemes for this study. The results show that with regard to the status of resources and processes, and the application of al-darurah (necessity) concept.
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Maresova, Petra, Ladislav Hajek, Ondrej Krejcar, Michael Storek, and Kamil Kuca. "New Regulations on Medical Devices in Europe: Are They an Opportunity for Growth?" Administrative Sciences 10, no. 1 (March 12, 2020): 16. http://dx.doi.org/10.3390/admsci10010016.
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Increasing demand for modern treatments and significant profit margins are strong incentives for investors and producers. However, the production and use of medical devices is subject to a number of laws, regulations, strict standards, and certification processes. Therefore, the aim of this paper is to analyze patent activity based on the example of the selected country (Czech Republic), compare it with selected foreign countries, and discuss the development of this industry in the context of new medical device regulation (MDR) implementation. The paper is based on the theoretical concept of the relationship between regulation and innovation. The main challenge in the implementation of the new medical device regulations lies in the area of innovation. This is because most innovative research in the medical device sector is undertaken by small to medium enterprises (SMEs) rather than by large companies. SMEs are more vulnerable than big companies when it comes to development because the accompanying administrative costs can be so high that it may force the company to leave the market. Given that the main reason for the existence of economic regulations are various forms of market failure, which occurs when market mechanisms do not lead to results that benefit society, any attempts to redress this situation should naturally lead to greater benefits for society and hence benefits for the given industry as well.
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Grossmann, Swen, Stefan Siewert, Robert Ott, Klaus-Peter Schmitz, Stefanie Kohse, Wolfram Schmidt, and Niels Grabow. "Standardized technique of water permeability measurement for biomedical applications." Current Directions in Biomedical Engineering 4, no. 1 (September 1, 2018): 633–36. http://dx.doi.org/10.1515/cdbme-2018-0152.
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AbstractStandardized methods and measures are ubiquitous in biomedical engineering and a key factor for the successful development and certification of novel biomaterials, implants or other medical devices. Hence, the development of standardized measurement techniques, which can be applied to nearly every material and device is of crucial importance. Within the current work, we introduce a method to evaluate the water permeability according to ISO/FDIS 7198. The setup was designed to determine the volumetric flow through a test sample for a given hydraulic pressure. One key feature is the effortless replacement of the chamber containing the test sample. The measurement technique can thus be applied to a variety of materials and medical devices. To demonstrate the functionality of the setup we fabricated nanofiber membranes using the process of electrospinning. Nonwovens with comparable thickness and varying morphology were analyzed with regard to water permeability. In particular the different fiber diameters as well as the modified inter-fiber distances result in large deviations of the water permeability. Furthermore, there are hints for a rearrangement of the nanofibers due to the applied hydraulic pressure. The developed measurement technique provides a powerful tool for the standardized quantification of the water permeability and can be applied to a variety of biomaterials and medical devices.
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Kinney, Eleanor D. "The Corporate Transformation of Medical Specialty Care: The Exemplary Case of Neonatology." Journal of Law, Medicine & Ethics 36, no. 4 (2008): 790–802. http://dx.doi.org/10.1111/j.1748-720x.2008.00338.x.
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With new, effective, and expensive health care services, the American health care sector has become an even greater source of business and wealth opportunities. All kinds of health care providers and suppliers are competing for patients and dollars. The key to wealth in today’s health care sector is the physician. Only physicians can certify to third-party payers that health care services, medical devices, or pharmaceutical products are necessary for patient care. That certification initiates the process by which the item, service, or treatment modality is ordered, delivered, and paid for. Thus, organizations that can exert control over physicians stand to gain financially.
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du Preez, W. B., and G. J. Booysen. "Qualification of Customised Medical Implants Produced by Ti6Al4V(ELI) Additive Manufacturing." MATEC Web of Conferences 321 (2020): 03012. http://dx.doi.org/10.1051/matecconf/202032103012.
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Although many cases of medical implants produced through additive manufacturing (AM) in Ti6Al4V have been reported in literature, most of these processes had not been qualified. To enable certification and commercialisation of medical implants and devices an ISO 13485:2016 quality management system was successfully implemented in the Centre for Rapid Prototyping and Manufacturing (CRPM) at the Central University of Technology, Free State in South Africa. This certification covers qualification of both design, development and production of patient specific custom made titanium implants, as well as preoperative models, jigs and cutting guides in nylon by means of AM and supports commercialisation. With this quality management system as framework for ensuring the reliability and repeatability of the AM performed at the CRPM, the generation of data to validate the individual processes in the AM process chain was pursued. Sufficient research data has been produced and published to prove that medical implants produced through AM can fully comply with the international standards for material, physical, chemical and mechanical properties. In this paper the research performed towards the qualification of AM of Ti6Al4V medical implants is discussed. Examples are given of internationally leading work on utilising these implants in maxillofacial and orthopaedic surgeries.
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Di Nardo, Matteo, Leen Vercaemst, Justyna Swol, Nicholas Barret, Fabio S. Taccone, Maximilian V. Malfertheiner, Lars M. Broman, et al. "A narrative review of the technical standards for extracorporeal life support devices (pumps and oxygenators) in Europe." Perfusion 33, no. 7 (May 24, 2018): 553–61. http://dx.doi.org/10.1177/0267659118772452.
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This review summarizes the European rules to control the market when introducing new products. In particular, it shows all the steps to achieve the European Conformity (CE Mark), a certification that all new medical products must achieve before being used in Europe. Extracorporeal membrane oxygenation (ECMO) devices are exposed to the same procedures. Hereby, we present some regulatory issues regarding pumps and oxygenators, providing technical details as released by the manufacturers on their websites and information charts.
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Kost, Gerald J. "Preventing Medical Errors in Point-of-Care Testing." Archives of Pathology & Laboratory Medicine 125, no. 10 (October 1, 2001): 1307–15. http://dx.doi.org/10.5858/2001-125-1307-pmeipo.
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Abstract Objective.—To prevent medical errors, improve user performance, and enhance the quality, safety, and connectivity (bidirectional communication) of point-of-care testing. Participants.—Group A included 37 multidisciplinary experts in point-of-care testing programs in critical care and other hospital disciplines. Group B included 175 professional point-of-care managers, specialists, clinicians, and researchers. The total number of participants equaled 212. Evidence.—This study followed a systems approach. Expert specifications for prevention of medical errors were incorporated into the designs of security, validation, performance, and emergency systems. Additional safeguards need to be implemented through instrument software options and point-of-care coordinators. Connectivity will be facilitated by standards that eliminate deficiencies in instrument communication and device compatibility. Assessment of control features on handheld, portable, and transportable point-of-care instruments shows that current error reduction features lag behind needs. Consensus Process.—Step 1: United States national survey and collation of group A expert requirements for security, validation, and performance. Step 2: Design of parallel systems for these functions. Step 3: Written critique and improvement of the error-prevention systems during 4 successive presentations to group B participants over 9 months until system designs stabilized into final consensus form. Conclusions.—The consensus process produced 6 conclusions for preventing medical errors in point-of-care testing: (1) adopt operator certification and validation in point-of-care testing programs; (2) implement security, validation, performance, and emergency systems on existing and new devices; (3) require flexible, user-defined error-prevention system options on instruments as a prerequisite to federal licensing of new diagnostic tests and devices; (4) integrate connectivity standards for bidirectional information exchange; (5) preserve fast therapeutic turnaround time of point-of-care test results; and (6) monitor invalid use, operator competence, quality compliance, and other performance improvement indices to reduce errors, thereby focusing on patient outcomes. (Arch Pathol Lab Med. 2001;1307–1315)
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Reich, Norbert. "Product Liability and Beyond: An Exercise in Gap-Filling." European Review of Private Law 24, Issue 3/4 (June 1, 2016): 619–43. http://dx.doi.org/10.54648/erpl2016038.
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Abstract: This article discusses the impact of product liability law on product safety regulation, with special reference to ‘medical devices’. Four aspects are highlighted in particular: first, a short reference to the experiences of and controversies in the United States on this subject; second, an analysis of the recent case law of the Court of Justice of the European Union (CJEU), which interprets product liability law under Directive 85/374/EEC as a supplementary instrument of product safety regulation; third, an examination of the limits of product liability in cases of bankruptcy of the manufacturer, as in the case of the ‘affaire PIP’; and fourth, a discussion of the attempt to hold a so-called ‘notified body’ (i.e., the EU certification agency) liable for defective medical devices in the litigation concerning defective breast implants in terms of Directive 93/42/EEC and the relevant rules of national law. The German Federal Supreme Court has recently decided to refer the matter to the CJEU for a preliminary ruling and has argued that, under the EU effectiveness principle, product liability law has a regulatory function, especially when sensitive health issues, raised by defective medical devices implanted into the human body, are at stake – as in the ‘affaire PIP’.
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Caldicott, Catherine V. "A ‘Period of Maladjustment’:." Journal of Medical Regulation 103, no. 4 (January 1, 2017): 24–31. http://dx.doi.org/10.30770/2572-1852-103.4.24.
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Rapid changes in the medical practice environment pose novel ethical challenges for clinicians. As during any time of great innovation, unanticipated conflicts, problems, or ethical questions may arise, creating a “period of maladjustment” between the introduction of the innovation or technological advancement and the point at which society achieves consensus on the appropriate use of that innovation or advancement. This article reports examples of physicians and physician assistants who exercised poor judgment — often in the absence of systems or structural supports — when faced with novel ethical dilemmas involving advancements such as electronic health records, social media, medical marijuana certification, and access to an international marketplace for drugs and devices. It suggests areas for intervention for licensing boards, educators, and other oversight entities that may better equip licensees to address these novel ethical dilemmas. Finally, because the primacy of patient welfare cannot be the responsibility of individual providers alone, this article supports a call to action for organizations to develop structures to support a culture of professionalism dedicated to safeguarding patients, clinicians, and the profession of medicine itself in this new medical environment.
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Hentschel, Lukas, Frank Kynast, Sandra Petersmann, Clemens Holzer, and Joamin Gonzalez-Gutierrez. "Processing Conditions of a Medical Grade Poly(Methyl Methacrylate) with the Arburg Plastic Freeforming Additive Manufacturing Process." Polymers 12, no. 11 (November 12, 2020): 2677. http://dx.doi.org/10.3390/polym12112677.
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The Arburg Plastic Freeforming process (APF) is a unique additive manufacturing material jetting method. In APF, a thermoplastic material is supplied as pellets, melted and selectively deposited as droplets, enabling the use of commercial materials in their original shape instead of filaments. The medical industry could significantly benefit from the use of additive manufacturing for the onsite fabrication of customized medical aids and therapeutic devices in a fast and economical way. In the medical field, the utilized materials need to be certified for such applications and cannot be altered in any way to make them printable, because modifications annul the certification. Therefore, it is necessary to modify the processing conditions rather than the materials for successful printing. In this research, a medical-grade poly(methyl methacrylate) was analyzed. The deposition parameters were kept constant, while the drop aspect ratio, discharge rate, melt temperatures, and build chamber temperature were varied to obtain specimens with different geometrical accuracy. Once satisfactory geometrical accuracy was obtained, tensile properties of specimens printed individually or in batches of five were tested in two different orientations. It was found that parts printed individually with an XY orientation showed the highest tensile properties; however, there is still room for improvement by optimizing the processing conditions to maximize the mechanical strength of printed specimens.
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du Preez, W. B., D. J. de Beer, and G. J. Booysen. "Establishing a Quality Management System for Production of Certified Customised Titanium Medical Implants through Additive Manufacturing." MRS Advances 5, no. 26 (2020): 1387–96. http://dx.doi.org/10.1557/adv.2020.192.
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ABSTRACTVarious cases of medical implants produced through additive manufacturing (AM) in Ti6Al4V have been reported in literature. Not all manufacturing processes used, were qualified. In striving to deliver certified AM medical implants and devices, an ISO 13485:2016 quality management system was implemented in the Centre for Rapid Prototyping and Manufacturing (CRPM) of the Central University of Technology, Free State (CUT) in Bloemfontein, South Africa. This certification is valid for design, development and production of patient-specific custom-made titanium implants, preoperative models, jigs and cutting-guides in nylon through AM, and contract-production of these products. For maintaining this quality management system, the generation of data to validate the individual processes in the AM process-chain is crucial to prove the DMLS product-quality of CRPM’s products. During the past five years, directed research data was produced and published to prove that medical implants produced through DMLS can fully comply with the accepted international standards for material, physical, chemical and mechanical properties of such parts. The paper discusses the quality management system’s establishment; materials research projects executed to generate validation data are mentioned; and examples of customised titanium implants for restoring the quality of life of patients are shown.
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Peel, Sean, Dominic Eggbeer, and Peter Dorrington. "Standardizing the patient-specific medical device design process via a paper-based pro-forma." Journal of Design, Business & Society 6, no. 2 (October 1, 2020): 233–58. http://dx.doi.org/10.1386/dbs_00013_1.
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Purpose/audience: this study targets designers, clinicians and biomedical engineers who are involved in digital surgical planning and patient-specific medical device design, either in hospitals, universities or companies. A commonly accepted, standardized design process does not exist in this specialized but highly variable field, and this can make regulatory compliance via the implementation of quality standards more difficult. Methodology/approach: an article-based design pro-forma was created based on needs identified in previous work. It was structured in order to broadly standardize the design process; consolidate planning and modelling behaviours into discrete clusters; anticipate decision-making on key product requirements; facilitate focused discussion with clients (surgeons); create a pleasurable experience for the designer; and encourage detailed reporting of design decisions and therefore to lower barriers to Quality Management System (QMS) implementation and adherence. The performance of the pro-forma was verified using observation, simultaneous verbalization and semi-structured interviews. Three participants across two contexts were observed designing without and then with the pro-forma. Their behaviours and comments were recorded, their designed outcomes evaluated and their quality compliance assessed. Findings: The design workflow was shown to be segmented and contained within distinct and repeatable steps when using the pro-forma. Reported participant confidence increased and stress decreased. Contact time between participants and clients was consolidated. Designed outputs and documented records successfully complied with generalizable aspects of the International Organization for Standardization (ISO) 13485 standard. However, it did not, and by definition could never, wholly implement a complete certifiable QMS, which must be tailored to a specific organization. Implications for practice, society or research: as demand for patient-specific devices continues to rise, and as regulatory requirements about QMS adherence extend to cover all contexts, organizations will need to react accordingly. This pro-forma offers a clear direction for how to introduce evidence-based best practices, and a starting point for full QMS certification. Originality/value: this research marks the first attempt to standardize this highly specialized design process across users, tools and contexts.
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Pecchia, Leandro, Davide Piaggio, Alessia Maccaro, Claudio Formisano, and Ernesto Iadanza. "The Inadequacy of Regulatory Frameworks in Time of Crisis and in Low-Resource Settings: Personal Protective Equipment and COVID-19." Health and Technology 10, no. 6 (May 2, 2020): 1375–83. http://dx.doi.org/10.1007/s12553-020-00429-2.
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Abstract COVID-19 pandemic is plaguing the world and representing the most significant stress test for many national healthcare systems and services, since their foundation. The supply-chain disruption and the unprecedented request for intensive care unit (ICU) beds have created in Europe conditions typical of low-resources settings. This generated a remarkable race to find solutions for the prevention, treatment and management of this disease which is involving a large amount of people. Every day, new Do-It-Yourself (DIY) solutions regarding personal protective equipment and medical devices populate social media feeds. Many companies (e.g., automotive or textile) are converting their traditional production to manufacture the most needed equipment (e.g., respirators, face shields, ventilators etc.). In this chaotic scenario, policy makers, international and national standards bodies, along with the World Health Organization (WHO) and scientific societies are making a joint effort to increase global awareness and knowledge about the importance of respecting the relevant requirements to guarantee appropriate quality and safety for patients and healthcare workers. Nonetheless, ordinary procedures for testing and certification are currently questioned and empowered with fast-track pathways in order to speed-up the deployment of new solutions for COVID-19. This paper shares critical reflections on the current regulatory framework for the certification of personal protective equipment. We hope that these reflections may help readers in navigating the framework of regulations, norms and international standards relevant for key personal protective equipment, sharing a subset of tests that should be deemed essential even in a period of crisis.
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Kielo-Viljamaa, Emilia, Eva Collanus, Janne Lahtiranta, and Antti Tuomisto. "Maturity of health care testbeds – A qualitative mapping at the Nordic context." Finnish Journal of eHealth and eWelfare 14, no. 1 (April 14, 2022): 92–103. http://dx.doi.org/10.23996/fjhw.111734.
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This qualitative mapping aimed to report health care testbed activities in Finland and two other Nordic countries and describe the maturity of these testbeds. The data were collected in 2021 with semi-structured interviews from twelve organizations, of which seven were university hospitals, four universities of applied sciences and one primary health care organization. The data were analyzed using deductive content analysis based on previously identified maturity factors: resources, facilities, marketing and communications, repeatability, contract models, certification and standards compliance and time at the market area. According to the results, there were testbed activities in all participating organizations. The testbed activities mainly were funded from various projects, and the staff mainly consisted of single employees. The testbed facilities were both real-life environments and test or simulation labs. The marketing and communications were based on web pages, social media, events and networks. The repeatability was ensured primarily with usability testing, and the contract models were under development in most organizations. Certification and standards of compliance were rare. Time at the market area was relatively short in many organizations as the activities were mainly testing single products or services rather than continuous co-creation. Testbed activities in the health care and higher education organizations are merging with the daily operations in Nordic countries. Specialization within the organizations was seen, for example, robotics, rehabilitation or medical devices. Testbed organizations highlighted the need for more structured and coordinated processes and activities in order to ensure the management, quality and effectiveness of their testbed services.
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Pereira Azevedo, Nuno, Stavros Gravas, and Jean de la Rosette. "Mobile Health in Urology: The Good, the Bad and the Ugly." Journal of Clinical Medicine 9, no. 4 (April 3, 2020): 1016. http://dx.doi.org/10.3390/jcm9041016.
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Our aim is to present the current position of mobile health (mHealth) and the delivery of healthcare services via mobile communication devices in urology. We conducted a literature review of urology mHealth papers on PubMed. Results indicate that mHealth is becoming ubiquitous in contemporary healthcare systems. Although its potential has been shown, urology lags behind other areas, representing just 0.1% of the 300,000 available medical apps in the Apple App Store and Google Play Store. Furthermore, there is a lack of expert healthcare professional involvement in app development. To avoid harm, it is critical that the scientific accuracy, patient privacy, and user safety of urology mHealth applications are assured. This is because there is no globally enforced medical app regulation, compulsory scientific guidelines, nor mandatory industry standards. Urologists, either individually or via scientific organizations, should have a pivotal position in the design, development, review, certification, and recommendation of apps. mHealth holds great potential in urology, as it can aid multiple stakeholders: citizens, patients, healthcare professionals, health organizations, and public authorities (e.g., Ministry of Health). Even though it is mostly used to improve existing medical activities at present, the future will include revolutionary and ground-breaking technology solutions. This innovative field should be seen by urologists as an opportunity to provide greater care to our patients and better tools and knowledge to our peers.
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Hossain, Md Anwar, Mohiuddin Ahmad, Md Rafiqul Islam, and Yadin David. "Evaluation of Performance Outcomes of Medical Equipment Technology Management and Patient Safety: Skilled Clinical Engineer’s Approach." Global Clinical Engineering Journal 1, no. 2 (March 21, 2019): 4–16. http://dx.doi.org/10.31354/globalce.v1i2.46.
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With the rapid development of medical equipment technology, the quality of patient care becomes under the spotlight of clinical engineering management of medical equipment since the past 4 decades and it is continually. Researchers give in-depth attention to minimize undesired incidents which are associated with medical and surgical equipment such as patients' unnatural deaths and injuries. This proposed research work investigates the relationship between performance outcomes of medical equipment technology management/patient-care technology and the reduction in undesired events like injury and even unnatural deaths. This proposed research work investigates the effect of varying levels of performance on quality of patient care and uses an indicator such as patient safety (PS) and cost-effective care by applying mathematical modeling of clinical engineering approach methodology to medical equipment technology management. In this study the quality model of Clinical Engineering Departments is determined by educational qualification, Clinical Engineering (CE) certification, training, and duration of experiences in this field. The standard performance of patient-care technology management is determined by the parameters of medical devices and the outcomes performance of medical equipment is determined. Data for this study was collected from 18 countries including from high, upper and lower-middle income regions. We were able to collect and analyze data of different performance levels of CE and biomedical engineering programs. The analysts' report measures the performance outcomes of Medical Equipment Technology Management System (METMS) and its impact on patient-care outcomes specifically impact on the reduction of patient risk factors associated with medical and surgical equipment. The findings should encourage researchers and healthcare stakeholders to better integrate the clinical engineering professionals in a hospital in order to achieve a safe functional condition of medical equipment to keep its scheduled life span in compliance with recommended span declared by manufactures. Cost-effective Clinical Engineering Department (CED) model can be designed and monitored through the methodology of this study. We hope that this study will motivate the deployment of senescence methodology for conventional electro-medical assets, by biomedical engineering and medical professionals, healthcare policymakers, equipment users, and vendors to improve outcomes as proposed by the research work described in this paper.
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Oh, Jai-woo, Jin-Kyu Kang, and Og-Woo Yoo. "A Study on the Automatic Control System for Quality Assurance of Clinical Pathology Examination Applying Machine Learning Technology." Webology 19, no. 1 (January 20, 2022): 4459–81. http://dx.doi.org/10.14704/web/v19i1/web19294.
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The object of research is a study on a machine learning-based integrated quality control system to provide accurate test results quickly by improving the accuracy of test results and improving the utilization rate of test equipment by analyzing clinical pathology Examination data. As for the development method for research, IEC 62304, the international standard for medical S/W life cycle used in medical software development, was applied, and the S/W life cycle rule was applied to all processors by integrating agile methodology. Random Forest, XGboost (extreme Gradient Boosting), LightGBM (Light Gradient Boosting Machine), and DNN (Deep Neural Networks) to improve Rule Check accuracy to predict abnormality of inspection results, and to monitor abnormal results in real time by rule check calculation method technique was applied. In addition, to improve user convenience, automatic control and user interface technology using a dashboard function applied with machine learning technology, and automatic interlocking interface technology for various heterogeneous inspection devices were applied. Validation and verification were conducted through a qualified testing body (TTA) to ensure reliability. The following results were found through this study. As a result of implementing a module that applied big data-based machine learning technology to the algorithm used for quality control judgment of the first knowledge-based expert system, it was possible to implement a module with more than 95% accuracy. there was. Second, in order to determine whether a real-time alarm function was provided, the development module was linked to the clinical pathology information system and as a result of the experiment, it was found that it was operating normally. In addition, reliability was secured through certification by an accredited certification body. Third, as a communication support method for the interface of the inspection equipment, stability and various technologies were secured through a number of communication tests and certification tests such as RS232C, TCP/IP, and Serial HL7. Fourth, through multiple database tests (Oracle, MSSQL, MySQL, MS Access, etc.), cost savings were secured by resolving duplicate investment by providing database neutrality and interface with other systems. Fifth, utility and user satisfaction were enhanced by providing program functions for outputting the result report in various formats and configuring the UI settings, and the UI settings were modularized to reduce the program development costs and allow the modules to be reused. Through the results of research, small and medium hospitals can improve the reliability of inspection results through the machine learning-based quality control module, and through real-time monitoring of the inspection equipment, it is possible to quickly determine whether there is a failure and improve the operation rate of the inspection equipment. In addition, by providing a module that can be linked with the existing information system, it was made easy to link, and the convenience of the user was improved by providing various UI environments. As a result, it can be expected that the hospital's competitiveness and medical service will be improved by resolving the difficulties of quality control that small and medium-sized hospitals had and providing prompt and accurate test results.
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Peter, Lukas, Ladislav Hajek, Petra Maresova, Martin Augustynek, and Marek Penhaker. "Medical Devices: Regulation, Risk Classification, and Open Innovation." Journal of Open Innovation: Technology, Market, and Complexity 6, no. 2 (June 10, 2020): 42. http://dx.doi.org/10.3390/joitmc6020042.
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In the Czech Republic, the medical device industry is an important sector with a strong tradition and has high added value and perspectives in demand under changing demographic and social structures. The aim of this article is to describe and analyze the complex issues of the new European Commission Medical Device Regulation (MDR) 2017/745 from the perspective of the strategic decisions of companies that have to comply with the requirements imposed on them by the new legislation and at the same time fulfill their own business needs and goals. The legislative changes significantly affect the standards, processes, and certifications in the medical device sector. The classification system of medical devices has been revised to more appropriately reflect the possible health risks associated with use of modern high-end technology in healthcare. The requirement is to categorize each device under the highest possible risk class, which means for the medical device manufacturers to carefully review the new rules and regulations and classify their devices accordingly.
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Lenters-Westra, Erna, and Robbert J. Slingerland. "Three of 7 Hemoglobin A1c Point-of-Care Instruments Do Not Meet Generally Accepted Analytical Performance Criteria." Clinical Chemistry 60, no. 8 (August 1, 2014): 1062–72. http://dx.doi.org/10.1373/clinchem.2014.224311.
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Abstract BACKGROUND In 2009, we investigated the conformance of 8 hemoglobin A1c (Hb A1c) point-of-care (POC) instruments. Since then, instruments have improved and new devices are available on the market. In this second study, we evaluated the performance of DCA Vantage, Afinion, InnovaStar, Quo-Lab, Quo-Test, Cobas B101, and B-analyst Hb A1c POC instruments. METHODS Clinical and Laboratory Standards Institute protocols EP-5 and EP-9 were applied to investigate imprecision, accuracy, and bias. We assessed bias using the mean of 3 certified secondary reference measurement procedures (SRMPs). Assay conformance with the National Glycohemoglobin Standardization Program (NGSP) certification criteria was also evaluated. Interference of common Hb variants was investigated for methods that could work with hemolysed material. RESULTS The total CVs for all instruments, except for the DCA Vantage at a high Hb A1c value, were ≤3.1% in SI units and ≤2.1% in Diabetes Control and Complications Trial (DCCT) units. Afinion, DCA Vantage, B-analyst, and Cobas B101 instruments passed the NGSP criteria with 2 different reagent lot numbers. Quo-Test, Quo-Lab, and InnovaStar instruments had a negative bias compared to the mean of the 3 SRMPs and failed NGSP criteria. Most of the common Hb variants did not interfere with the investigated instruments, except Hb AE for the Cobas B101. CONCLUSIONS Afinion, DCA Vantage, Cobas B101, and B-analyst instruments met the generally accepted performance criteria for Hb A1c. Quo-Test, Quo-Lab, and InnovaStar met the criteria for precision but not for bias. Proficiency testing should be mandated for users of Hb A1c POC assays to ensure quality.
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Huhn, Sophie, Miriam Axt, Hanns-Christian Gunga, Martina Anna Maggioni, Stephen Munga, David Obor, Ali Sié, et al. "The Impact of Wearable Technologies in Health Research: Scoping Review." JMIR mHealth and uHealth 10, no. 1 (January 25, 2022): e34384. http://dx.doi.org/10.2196/34384.
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Background Wearable devices hold great promise, particularly for data generation for cutting-edge health research, and their demand has risen substantially in recent years. However, there is a shortage of aggregated insights into how wearables have been used in health research. Objective In this review, we aim to broadly overview and categorize the current research conducted with affordable wearable devices for health research. Methods We performed a scoping review to understand the use of affordable, consumer-grade wearables for health research from a population health perspective using the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) framework. A total of 7499 articles were found in 4 medical databases (PubMed, Ovid, Web of Science, and CINAHL). Studies were eligible if they used noninvasive wearables: worn on the wrist, arm, hip, and chest; measured vital signs; and analyzed the collected data quantitatively. We excluded studies that did not use wearables for outcome assessment and prototype studies, devices that cost >€500 (US $570), or obtrusive smart clothing. Results We included 179 studies using 189 wearable devices covering 10,835,733 participants. Most studies were observational (128/179, 71.5%), conducted in 2020 (56/179, 31.3%) and in North America (94/179, 52.5%), and 93% (10,104,217/10,835,733) of the participants were part of global health studies. The most popular wearables were fitness trackers (86/189, 45.5%) and accelerometer wearables, which primarily measure movement (49/189, 25.9%). Typical measurements included steps (95/179, 53.1%), heart rate (HR; 55/179, 30.7%), and sleep duration (51/179, 28.5%). Other devices measured blood pressure (3/179, 1.7%), skin temperature (3/179, 1.7%), oximetry (3/179, 1.7%), or respiratory rate (2/179, 1.1%). The wearables were mostly worn on the wrist (138/189, 73%) and cost <€200 (US $228; 120/189, 63.5%). The aims and approaches of all 179 studies revealed six prominent uses for wearables, comprising correlations—wearable and other physiological data (40/179, 22.3%), method evaluations (with subgroups; 40/179, 22.3%), population-based research (31/179, 17.3%), experimental outcome assessment (30/179, 16.8%), prognostic forecasting (28/179, 15.6%), and explorative analysis of big data sets (10/179, 5.6%). The most frequent strengths of affordable wearables were validation, accuracy, and clinical certification (104/179, 58.1%). Conclusions Wearables showed an increasingly diverse field of application such as COVID-19 prediction, fertility tracking, heat-related illness, drug effects, and psychological interventions; they also included underrepresented populations, such as individuals with rare diseases. There is a lack of research on wearable devices in low-resource contexts. Fueled by the COVID-19 pandemic, we see a shift toward more large-sized, web-based studies where wearables increased insights into the developing pandemic, including forecasting models and the effects of the pandemic. Some studies have indicated that big data extracted from wearables may potentially transform the understanding of population health dynamics and the ability to forecast health trends.
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Sarradon-Eck, Aline, Tiphanie Bouchez, Lola Auroy, Matthieu Schuers, and David Darmon. "Attitudes of General Practitioners Toward Prescription of Mobile Health Apps: Qualitative Study." JMIR mHealth and uHealth 9, no. 3 (March 4, 2021): e21795. http://dx.doi.org/10.2196/21795.
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Background Mobile health (mHealth) apps are a potential means of empowering patients, especially in the case of multimorbidity, which complicates patients’ care needs. Previous studies have shown that general practitioners (GPs) have both expectations and concerns regarding patients’ use of mHealth apps that could impact their willingness to recommend the apps to patients. Objective The aim of this qualitative study is to investigate French GPs’ attitudes toward the prescription of mHealth apps or devices aimed toward patients by analyzing GPs’ perceptions and expectations of mHealth technologies. Methods A total of 36 GPs were interviewed individually (n=20) or in a discussion group (n=16). All participants were in private practice. A qualitative analysis of each interview and focus group was conducted using grounded theory analysis. Results Considering the value assigned to mHealth apps by participants and their willingness or resistance to prescribe them, 3 groups were defined based on the attitudes or positions adopted by GPs: digital engagement (favorable attitude; mHealth apps are perceived as additional resources and complementary tools that facilitate the medical work, the follow-up care, and the monitoring of patients; and apps increase patients’ compliance and empowerment); patient protection (related to the management of patient care and fear of risks for patients, concerns about patient data privacy and security, doubt about the usefulness for empowering patients, standardization of the medical decision process, overmedicalization, risks for individual freedom, and increasing social inequalities in health); doctor protection (fear of additional tasks and burden, doubt about the actionability of patient-gathered health data, risk for medical liability, dehumanization of the patient-doctor relationship, fear of increased drug prescription, and commodification of patient data). Conclusions A deep understanding of both the expectations and fears of GPs is essential to motivate them to recommend mHealth apps to their patients. The results of this study show the need to provide appropriate education and training to enhance GPs’ digital skills. Certification of the apps by an independent authority should be encouraged to reassure physicians about ethical and data security issues. Our results highlight the need to overcome technical issues such as interoperability between data collection and medical records to limit the disruption of medical work because of data flow.
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Paricharak, Sukanya, Atul Baravkar, Apeksha Masal, Sushma Chougule, Pooja Deshmane, and Sachin Kulkarni. "A comprehensive synopsis on cognizance of Regulatory Affairs in different sectors of Pharmacy." International Journal of Drug Regulatory Affairs 9, no. 4 (December 26, 2021): 20–32. http://dx.doi.org/10.22270/ijdra.v9i4.495.
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A pharmaceutical drug regulatory Affairs is mainly involved in registration process parameters of different pharmaceutical products and new drug application. Regulatory affairs (RA) professionals play vital roles in a pharmaceutical field as, it is related to healthcare products. It provides strategic, operational direction and support for working within regulations to expedite the development of pharmaceutical, biological and medical devices. Also, it is principally concern with safety and efficacy, low risk/high benefit and quality assessment of healthcare drug products throughout the world. Regulatory system of each and every country has different regulatory agencies which govern certification and good manufacturing practices. Regulatory Affairs also has a very specific importance within the formulation and marketing of drug product in pharmaceutical industries. Current abstract reports for the first time and emphasizes on studies concerning awareness and knowledge testing in regulatory affair field by the various pharma professionals. This is completely certified online survey of quiz questionnaire based on important concepts in RA and circulated via google form to different social medias to more than 1000 pharma professionals (Academics, Students, Industrials area). The systematic analysis of received responses reveals awareness and knowledge of the participants about RA in selected pharma professionals. It shows that, participants form industrial area having more knowledge than academics and students. This survey comes out with conclusion that, there is more need to raise RA information sources by the inclusion of this subject in syllabus for academics via various courses to fulfill more RA professional demands in future.
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Nistor, Cristina, and Catherine Tucker. "Certification Intermediaries: Evidence from the Medical Device Industry." Academy of Management Proceedings 2016, no. 1 (January 2016): 14314. http://dx.doi.org/10.5465/ambpp.2016.14314abstract.
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Malvehy, Josep. "Risks and Benefits of Artificial Intelligence in Teledermatology." Iproceedings 8, no. 1 (February 18, 2022): e36891. http://dx.doi.org/10.2196/36891.
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Background Recently, deep convolutional neural networks (DCNNs) became of interest as decision support systems for dermoscopic and clinical analysis of skin diseases. Application of artificial intelligence in teledermatology (TD) has been recently reported in several studies as a tool for augmented intelligence. Objective In this session, a critical discussion of the opportunities, limitations, and risks of AI in TD will be presented with special attention to recent published studies. Methods We reviewed the literature in PubMed and EMBASE databases in the period of January 2018 to November 2021 with the search terms of dermatology, skin cancer, deep learning, and AI (review of the Regulation of Medical Devices, EU 2017/745). Results A clear definition of the clinical use of AI in TD has to be considered: primary TD from patients to nurses, primary care physicians or general dermatologists; secondary TD from primary care physicians or nurses to dermatologists; or tertiary TD from dermatologists to hospital dermatologists. In some health models of TD for nurses or primary care physicians, AI assistance can lower the rates of recommending a biopsy or specialist referral, increase self-reported diagnostic confidence, and help to achieve higher diagnostic agreement rates (with dermatologists) in nonreferred cases. The main limitations of the use of AI in TD are the lack of large longitudinal studies, the lack of interpretability of the CNN, biases in the databases and unrepresented dermatological conditions for training, limited representation of different ethnicities, standardization of clinical information and of the images, liability, and privacy issues. How to implement the concept of augmented intelligence in clinical practice with referral TD consultations including structured clinical information and good-quality images will need further research and education among end users. Even if the interface is used for either store-and-forward or live TD, interactive TD is, in principle, straightforward for AI systems, and different TD modalities have particular technological requirements that can reduce their efficacy. Finally, AI systems in TD are under the umbrella of medical device regulatory frames, and specific certification is compulsory. This regulation has the benefit of assuring the quality of the new AI systems and diminishing their risks, but it can simultaneously delay the incorporation of AI tools in clinical practice. Conclusions AI has the potential to improve the results of the technology in different aspects in multiple modalities of TD. However, the evidence is weak, and several barriers and limitations have to be resolved for their integration in clinical practice. Conflicts of Interest None declared.
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Matsuhama, Maki, Tomoko Takishita, Ryosuke Kuribayashi, Kazunori Takagi, Rika Wakao, and Kenichi Mikami. "Similarities and Differences of International Practices and Procedures for the Regulation for Active Substance Master Files/Drug Master Files of Human Use: Moving Toward Regulatory Convergence." Journal of Pharmacy & Pharmaceutical Sciences 19, no. 2 (August 8, 2016): 290. http://dx.doi.org/10.18433/j37g80.
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Purpose. A gap analysis survey of international practices for Active Substance Master Files (ASMFs)/Drug Master Files (DMFs) of human use was conducted as a project of the ASMF/DMF working group of the International Generic Drug Regulators Pilot (IGDRP) to identify similarities and differences among ASMF/DMF procedures of 10 IGDRP members and 2 observers. Methods. We conducted a questionnaire survey and compared the following aspects: overall ASMF/DMF procedures, submission requirements for ASMFs/DMFs, assessment processes for ASMFs/DMFs, the technical requirements for active pharmaceutical ingredients (APIs), generation of assessment reports for ASMFs/DMFs, procedures for changing ASMF/DMF details, and Good Manufacturing Practice (GMP) inspection/certification of API manufacturers. Twelve organizations participated in this project: the Brazilian Health Surveillance Agency (Anvisa), the European Union (EU), Health Canada (HC), the Singapore Health Sciences Authority (HSA), the South African Medicines Control Council (MCC), the South Korean Ministry of Food and Drug Safety (MFDS), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), the Swiss Agency for Therapeutic Products (Swissmedic), the Taiwan Food and Drug Administration (TFDA), the Australian Therapeutic Goods Administration (TGA), the European Directorate for the Quality of Medicines & HealthCare (EDQM) (Observer) and the Prequalification Team (PQT) of the World Health Organization (WHO), which includes the PQT–Medicines (Observer). Results. Although there were many similarities among the participating agencies surveyed, there were also differences that should be discussed such as assessment processes of ASMFs/DMFs and Technical requirements for APIs. Conclusions. These differences revealed by this survey will be key considerations in order to facilitate the filing of ASMFs/DMFs globally and to establish a framework for sharing and utilizing information related to ASMFs/DMFs among IGDRP members in the future. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.
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Matsuhama, Maki, Tomoko Takishita, Ryosuke Kuribayashi, Kazunori Takagi, Rika Wakao, and Kenichi Mikami. "Similarities and Differences of International Practices and Procedures for the Regulation for Active Substance Master Files/Drug Master Files of Human Use: Moving Toward Regulatory Convergence." Journal of Pharmacy & Pharmaceutical Sciences 19, no. 2 (August 8, 2016): 290–300. http://dx.doi.org/10.18433/jpps.v19i2.27066.
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Purpose. A gap analysis survey of international practices for Active Substance Master Files (ASMFs)/Drug Master Files (DMFs) of human use was conducted as a project of the ASMF/DMF working group of the International Generic Drug Regulators Pilot (IGDRP) to identify similarities and differences among ASMF/DMF procedures of 10 IGDRP members and 2 observers. Methods. We conducted a questionnaire survey and compared the following aspects: overall ASMF/DMF procedures, submission requirements for ASMFs/DMFs, assessment processes for ASMFs/DMFs, the technical requirements for active pharmaceutical ingredients (APIs), generation of assessment reports for ASMFs/DMFs, procedures for changing ASMF/DMF details, and Good Manufacturing Practice (GMP) inspection/certification of API manufacturers. Twelve organizations participated in this project: the Brazilian Health Surveillance Agency (Anvisa), the European Union (EU), Health Canada (HC), the Singapore Health Sciences Authority (HSA), the South African Medicines Control Council (MCC), the South Korean Ministry of Food and Drug Safety (MFDS), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), the Swiss Agency for Therapeutic Products (Swissmedic), the Taiwan Food and Drug Administration (TFDA), the Australian Therapeutic Goods Administration (TGA), the European Directorate for the Quality of Medicines & HealthCare (EDQM) (Observer) and the Prequalification Team (PQT) of the World Health Organization (WHO), which includes the PQT–Medicines (Observer). Results. Although there were many similarities among the participating agencies surveyed, there were also differences that should be discussed such as assessment processes of ASMFs/DMFs and Technical requirements for APIs. Conclusions. These differences revealed by this survey will be key considerations in order to facilitate the filing of ASMFs/DMFs globally and to establish a framework for sharing and utilizing information related to ASMFs/DMFs among IGDRP members in the future. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.
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&NA;. "Applied Imaging Receives Certification to the International Medical Device Standard." Journal of Clinical Engineering 31, no. 2 (April 2006): 76. http://dx.doi.org/10.1097/00004669-200604000-00017.
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Oehme, L., O. Lindner, D. Hellwig, and J. Kotzerke. "Positron emission tomography 2008 in Germany." Nuklearmedizin 49, no. 02 (2010): 58–64. http://dx.doi.org/10.3413/nukmed-0203.
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Summary Aim: The working group on positron emission tomography (PET) of the DGN (German Society of Nuclear Medicine) initiated this first survey to collect and analyse information on the practise of PET in Germany in the year 2008. Methods: A questionnaire was sent to PET performing facilities (medical practices, hospitals, university hospitals and others) for retrospective data acquisition. Details regarding the equipment and examination procedures were examined as well as indications and number of studies. In addition, the role of PET within the diagnostic process was evaluated. Results: Responses from 65 sites were analysed. Their technical equipment consisted of 77 PET scanners (40 of them were combined PET/CT devices). About 63 500 PET studies had been performed with 86% in the field of oncology, 8% in neurology and 3% in cardiology. The radiotracers were labelled with 18F in 91% of the studies, whereas 68Ga was used in 4% and 11C in 3%. The analyses revealed lung tumours as the most investigated tumour entity, followed by malignant lymphoma, tumours of the gastro-intestinal tract and prostate cancer (about 14 000, 6000, 5000 and 2000). Corresponding to the new scanners and software procedures, the number of studies with attenuation correction by CT was high (68%) and nearly all studies were reconstructed iteratively (99%). The PET images were analysed quantitatively in the majority of cases (91%). The clinical reports, which included image documentation for the greater part, were posted regularly within 3 days. However, in 70% of the sites electronic transfer possibilities were used additionally to speed up the diagnostic process. The high standard of quality was demonstrated by the fact, that 40 facilities were engaged in a tumour board. Further on, one third of the physicians had gained a PET certification awarded by the DGN. Conclusion: Relative to the high general standard of diagnostic instrumentation in Germany, PET is less established, in particular when compared with other industrialised countries such as USA and Switzerland.
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Draman, Wan Mohd Ashraf Adlin Wan, Jeong Chun-Phuoc, and Mohd Shukri Ab Yajid. "Halal certification of medical device in Malaysia: A shariah analysis into the compliance process and legal requirements." International Journal of Medical Toxicology & Legal Medicine 22, no. 3and4 (2019): 94. http://dx.doi.org/10.5958/0974-4614.2019.00066.4.
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Mendonça, José Manuel, Nuno Cruz, Daniel Vasconcelos, Carla Sá-Couto, António P. Moreira, Paulo Costa, Hélio Mendonça, Ariane Pereira, Zakaria Naimi, and Vladimiro Miranda. "Pneuma: entrepreneurial science in the fight against the COVID-19 pandemic - a tale of industrialisation and international cooperation." Journal of Innovation Management 8, no. 4 (February 13, 2021): 3–25. http://dx.doi.org/10.24840/2183-0606_008.004_0002.
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When the COVID-19 pandemic hits Portugal in early March 2020, medical doctors, engineers and researchers, with the encouragement of the Northern Region Health Administration, teamed up to develop and build, locally and in a short time, a ventilator that might eventually be used in extreme emergency situations in the hospitals of northern Portugal. This letter tells you the story of Pneuma, a low-cost emergency ventilator designed and built under harsh isolation constraints, that gave birth to derivative designs in Brazil and Morocco, has been industrialized with 200 units being produced and is now looking forward to the certification as a medical device that will possibly support a go-to-market launch. Open intellectual property (IP), multidisciplinarity teamwork, fast prototyping and product engineering have shortened to a few months an otherwise quite longer idea-to-product route, clearly demonstrating that when scientific and engineering knowledge hold hands great challenges can be successfully faced.
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HUANG, HUNG-CHUN, CHIA-HUNG CHIEN, CHENG-YI WANG, and FOK-CHING CHONG. "EVALUATING THE UNCERTAINTY OF MEASUREMENT ON BLOOD'S GLUCOSE LEVEL." Biomedical Engineering: Applications, Basis and Communications 17, no. 02 (April 25, 2005): 91–96. http://dx.doi.org/10.4015/s1016237205000147.
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Judging from the continuous increase in population suffering from chronic illnesses in the past 30 years in Taiwan, we can predict that the number of diabetes victims will reach 1.5 million in 15 years. This increase is global. According to an estimate provided by WTO, one out of two diabetes sufferers is not identified as the illness victim. An estimate of 100 million people in the world are diabetes patients. Although there is currently no way to completely cure diabetes, this disease can be controlled, monitored, and improved through education, research and development of new medication and techniques. However, the quality control of glucose monitoring has posed a stubborn problem to all fields related to the medical realm in Taiwan. By contrast, there is already a well-developed management system of blood glucose measurement in the West. All the standard-setting organizations, such as NCCLS and ISO, have published relevant Standard Operation Procedure (SOP). In Taiwan, we haven't had any similar certification mechanism. It is urgent for Taiwan to establish such standards specifically for the yellow race. Now, CNLA has introduced ISO 17025 in clinical test. Although it offers a general guideline, it doesn't specify detailed operation steps. As a result, it cannot offer an accurate result in blood glucose measurement. This paper is focused on ways to evaluate the uncertainty of measurement on blood glucose level based on the standard environment lab for medical device testing in the biomedical engineering department of National Taiwan University Hospital, so as to establish a function of uncertainty of measurement on blood glucose level and make it a stepping stone for certification of the measurement.
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Adham, Khairul Akmaliah, Mohd Fuaad Said, Saida Farhanah Sarkam, and Nur Sa’adah Muhamad. "GranuLab: Strategies for Growth." Asian Case Research Journal 19, no. 02 (December 2015): 443–71. http://dx.doi.org/10.1142/s0218927515500169.
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GranuLab Sdn. Bhd. (GranuLab) was in the business of manufacturing patented synthetic bone graft substitute made from limestones and pure chemicals called GranuMaS. The bone graft substitute industry in Malaysia was a growing market with many large multinational players. In December 2010, the company began selling GranuMaS to several Malaysian hospitals. It had also completed the construction of its new production facility in Shah Alam, about 30 km from Malaysia’s capital city of Kuala Lumpur. With the facility’s pending operation in January 2011, the company had to find ways to leverage its high-volume production capacity. GranuLab’s approval for the CE Mark certification for GranuMaS’ exporting as well as the ISO certification to operate as an OEM contract manufacturing provider were still pending. Therefore, it was unable to export GranuMaS to Europe and other international markets, forcing the company to restrict its sales within Malaysia. Each day, the need to bring in revenue from sales of GranuMaS was mounting for Mr. Romli Ishak, the Managing Director of GranuLab particularly with the manufacturing facility due to begin its operation soon. Mr. Romli and his management team began to ponder on the appropriate strategies to adopt in order to achieve the company’s objective of high profitability. This teaching case is designed to stimulate discussion regarding strategic posturing of a young medical device company with aspirations for high growth.
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Snyder, Marion L., Alexis Carter, Karen Jenkins, and Corinne R. Fantz. "Patient Misidentifications Caused by Errors in Standard Bar Code Technology." Clinical Chemistry 56, no. 10 (October 1, 2010): 1554–60. http://dx.doi.org/10.1373/clinchem.2010.150094.
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BACKGROUND Bar code technology has decreased transcription errors in many healthcare applications. However, we have found that linear bar code identification methods are not failsafe. In this study, we sought to identify the sources of bar code decoding errors that generated incorrect patient identifiers when bar codes were scanned for point-of-care glucose testing and to develop solutions to prevent their occurrence. METHODS We identified misread wristband bar codes, removed them from service, and rescanned them by using 5 different scanner models. Bar codes were reprinted in pristine condition for use as controls. We determined error rates for each bar code–scanner pair and manually calculated internal bar code data integrity checks. RESULTS As many as 3 incorrect patient identifiers were generated from a single bar code. Minor bar code imperfections, failure to control for bar code scanner resolution requirements, and less than optimal printed bar code orientation were confirmed as sources of these errors. Of the scanner models tested, the Roche ACCU-CHEK® glucometer had the highest error rate. The internal data integrity check system did not detect these errors. CONCLUSIONS Bar code–related patient misidentifications can occur. In the worst case, misidentified patient results could have been transmitted to the incorrect patient medical record. This report has profound implications not only for point-of-care testing but also for bar coded medication administration, transfusion recipient certification systems, and other areas where patient misidentifications can be life-threatening. Careful control of bar code scanning and printing equipment specifications will minimize this threat to patient safety. Ultimately, healthcare device manufacturers should adopt more robust and higher fidelity alternatives to linear bar code symbologies.
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Brijnath, Bianca, Nabita Singh, and Danielle Mazza. "Stakeholder perspectives on the new sickness certificate in Victoria: results from a mixed-methods qualitative study." Australian Health Review 40, no. 1 (2016): 27. http://dx.doi.org/10.1071/ah14136.
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Objective The aim of this study was to present the views of four stakeholder groups, namely general practitioners (GP), employers (EMP), injured workers (IW) and compensation agents (CA), about the content and usability of the draft of the new Victorian sickness certificate. Methods A cross-sectional mixed-methods qualitative study was conducted in GP clinics and community settings in Melbourne, Australia. Interviews were conducted with GPs, EMPs and IWs and one focus group discussion was completed with CAs (n = 29). Data were collected between October and December 2013. Thematic analysis was performed. Results All stakeholders viewed the new draft certificate as an improvement on the old one. GPs saw the certificate as a form of communication, whereas EMPs and CAs saw it as a therapeutic device. GPs continued to certify based on incapacity and provided little information about what IWs could do on return to work. All groups said that assessments for mental health needed more clarity and specificity. GPs, EMPs and CAs also said that the new certificates must be electronically available and integrated into existing medical software to streamline uptake. Conclusions To ensure appropriate use of the new certificate, stakeholders must share a common understanding about its purpose and the certificate must be incorporated into existing medical software. Content on mental health assessment, an area of continued difficulty, needs additional refinement. The new certificate replaced the old certificate in March 2015; after it has been established in clinical practice, an impact evaluation should be completed to determine whether GPs are certifying capacity and earlier return to work. What is known about the topic? When it comes to sickness certification, GPs tend to focus on what injured patients cannot do, rather than what they can do. The new sickness certificate aims to change GP behaviour by focusing the certificate more on capacity (i.e. what the injured patient can do). What does this paper add? Four stakeholder groups agreed that the content and usability of the new certificate has improved. However, they agreed that the assessment of mental health capacity needs further specificity. Dissonances also remain between the stakeholders on the purpose of the certificate. What are the implications for practitioners? Appropriate use of the new certificate requires a common understanding about the purpose of the certificate, training on its appropriate use, incorporation into existing medical software and clarity on mental health assessment.
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Nistor, Cristina, and Catherine Tucker. "Third Party Certification: The Case of Medical Devices." SSRN Electronic Journal, 2015. http://dx.doi.org/10.2139/ssrn.2554984.
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Fujikawa, Joji, Ryoma Morigaki, Nobuaki Yamamoto, Teruo Oda, Hiroshi Nakanishi, Yuishin Izumi, and Yasushi Takagi. "Therapeutic Devices for Motor Symptoms in Parkinson’s Disease: Current Progress and a Systematic Review of Recent Randomized Controlled Trials." Frontiers in Aging Neuroscience 14 (March 29, 2022). http://dx.doi.org/10.3389/fnagi.2022.807909.
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BackgroundPharmacotherapy is the first-line treatment option for Parkinson’s disease, and levodopa is considered the most effective drug for managing motor symptoms. However, side effects such as motor fluctuation and dyskinesia have been associated with levodopa treatment. For these conditions, alternative therapies, including invasive and non-invasive medical devices, may be helpful. This review sheds light on current progress in the development of devices to alleviate motor symptoms in Parkinson’s disease.MethodsWe first conducted a narrative literature review to obtain an overview of current invasive and non-invasive medical devices and thereafter performed a systematic review of recent randomized controlled trials (RCTs) of these devices.ResultsOur review revealed different characteristics of each device and their effectiveness for motor symptoms. Although invasive medical devices are usually highly effective, surgical procedures can be burdensome for patients and have serious side effects. In contrast, non-pharmacological/non-surgical devices have fewer complications. RCTs of non-invasive devices, especially non-invasive brain stimulation and mechanical peripheral stimulation devices, have proven effectiveness on motor symptoms. Nearly no non-invasive devices have yet received Food and Drug Administration certification or a CE mark.ConclusionInvasive and non-invasive medical devices have unique characteristics, and several RCTs have been conducted for each device. Invasive devices are more effective, while non-invasive devices are less effective and have lower hurdles and risks. It is important to understand the characteristics of each device and capitalize on these.
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"Knowledge, Attitude and Awareness towards the Usage of Halal Medical Devices in Shah Alam, Selangor." Social & Management Research Journal 18, no. 2 (February 28, 2022): 255–70. http://dx.doi.org/10.24191/smrj.v18i2.15397.
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The halal industry nowadays not only covers the food industry, but has expanded to logistics, consumer goods, cosmetics, and pharmaceutical industries. Halal medical device industry players started to request the certification for medical devices in 2013 to make the products accepted in Muslim countries, thus expanding the marketability of the product worldwide. With the addition of medical devices as one of the latest schemes that can be applied for the halal certificate, this study aims to investigate the knowledge, attitude and awareness among Muslim society towards the usage of halal medical devices in Shah Alam, Selangor. This study adopted a quantitative method to collect the data. The data collected were analysed for Descriptive Statistics and Correlation Analysis by using the SPSS. All the items in the questionnaire were analysed with Reliability Testing (Cronbach Alpha) to test for their reliability. The findings of this research showed that all the independent variables in this study, which were knowledge attitude and the awareness level have a significant relationship with the dependent variable, which was the usage of halal medical devices. Besides, the correlation analysis showed that knowledge, attitude, and awareness are positively correlated with the usage of halal medical devices. However, the awareness level has the lowest positive correlation relationship with the usage of halal medical devices, indicating that Muslim’s consumer awareness is still low. Therefore, this study recommended that both stakeholders, whether the government or the halal authority may increase the awareness level on a halal medical device for Muslim consumers by campaign promotion as the demands are increasing with the growth of the industry.
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Prayitno, Lukman, and Max Joseph Herman. "Perdagangan Bebas Produk Farmasi dan Alat Kesehatan serta Kesiapan Memenuhi Persyaratan Cetak Biru Masyarakat Ekonomi ASEAN." Jurnal Kefarmasian Indonesia, February 24, 2020, 67–78. http://dx.doi.org/10.22435/jki.v10i1.1966.
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The implementation of the ASEAN Economic Community (AEC) as an Indonesian Government’s strategic step has an impact on economic globalization. The study on pharmaceutical products and medical devices free trade was done using qualitative and quantitative methods. The data were collected from a round table discussion about "Free Trade in Health Goods and Services in ASEAN" which involved the Ministry of Health (MoH), Ministry of Trade (MoT), and National Agency for Drug and Food Control (NADFC). The discussion aimed to obtain information on the readiness to meet the AEC blueprint. Secondary data on export and import of pharmaceutical products and medical devices were obtained from the MoT. The results of the study show that between 2013 and 2017 there were 70-72 product items exported to 9 ASEAN countries with a value much greater than the import. The tariff measure (TM) requirements included the Most Favored Nation (MFN) assessment and regulation of the trade remedy procedure by MoH and MoT. The implementation of ASEAN Common Technical Dossier (ACTD) and Good Manufacturing Practice inspection agreements, Bioequivalence reporting agreements, agreements related to traditional medicines and health supplement have been done by NADFC and industry. The simplification of Certificate of Origin, operation certification procedures and realization of ASEAN self-certification have to be specified. MoH must coordinate with NADFC and MoT in deciding and implementing regulations
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Mastrandrea, G., F. Cangialosi, P. Notarangelo, G. Chetta, and E. A. Graps. "New organizational model to foster good practice. Central venous access management in cancer patients." European Journal of Public Health 30, Supplement_5 (September 1, 2020). http://dx.doi.org/10.1093/eurpub/ckaa166.045.
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Abstract Issue Central Venous Access positioning is a common practice in cancer patients, however improper devices' management lead to complications and multiple accesses to hospital services, increasing costs. Assessment and certification of Central Venous Access insertion site at hospital so as proper dressing at home, are required; patient empowerment in management of complex technologies is desirable to improve outcomes. Problem Description To tackle the abovementioned issues, PICC project was drawn up in joint action between the Strategic Health and Social care Agency and the Research Institute on Cancer in Puglia. The aim is to pilot an organisational model for central venous access positioning and remote monitoring barely technology driven and based on safe storage of outcomes pictures, patient/care-givers empowerment, integrated care approach. A sistematic review of good practices for Central Venous Access management was conducted in june 2019; besides an analysis of medical devices public procurement procedures was performed at national scale; a survey was edited to probe the existence of diverse organisational models to insert and manage Central Venous Access. Results Very preliminary data are avalaible. Procurement analysis showed: around 15 companies of Central Venous Access and related medical devices' producers; a spread of Central Venous Access location medical devices/supply of services based on few firms (including consumables). The analysis helps to identify the “least common multiple” in technologic equipment to support Central Venous Access management to develop a standard and applicable model, not driven by a conditioning “starting choice” (catheter selection, tip location, dressings). Lessons A standard Central Venous Access management certification procedure can be realized regardless of potential technology driven approach. A Central Venous Access remote monitoring model based on images and empowered patients can allow daily review fostering integrated care. Key messages Patients’ proper training, even in complex technologies usage, can increase self awareness and empowerment and promote compliance to innovative organizational models. Collaboration among patients – caregivers and professionals, set up of a dynamic pictures store to record Central Venous Access management procedures can improve oucomes avoiding added costs.
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Boudreau, Martha A. "Abstract 229: Cardiopulmonary Resuscitation Compliance of Clinical Nurses Using Feedback Technology from the Zoll R Series Defibrillator." Circulation 142, Suppl_4 (November 17, 2020). http://dx.doi.org/10.1161/circ.142.suppl_4.229.
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Use of technology driven devices aimed at providing audio-visual feedback during CPR have been developed, however research is limited to their usefulness effecting chest compression quality of clinical nurses who are often first to respond and begin chest compression on patients experiencing cardiac arrest. This study aimed to examine CPR chest compression compliance of nurses with and without feedback from the Zoll R Series® defibrillator on a manikin. Hypothesis: Audio-visual feedback technology use from the Zoll R Series defibrillator improves the percentage of appropriate chest compression depth and rate of nurses during a CPR manikin demonstration exercise. Methods: Thirty-four nurses participated using an AHA approved manikin. Each nurse performed two minutes of uninterrupted chest compressions without feedback, followed by a rest period and two minutes of uninterrupted chest compressions using feedback technology from the defibrillator. Compression data for rate and depth and total compressions in target within AHA 2015 ECC Guidelines were recorded by the defibrillator and entered into Zoll RescueNet® software. Demographics obtained for years of BLS and ACLS certification. Results: Of the 34 nurses, mean years of ACLS certification was 3.4 years and 11.7 certified years of BLS. Compressions performed with feedback showed a higher percentage of compressions in target (M = 87.37, SD= 15.95) including rate (M= 86.33, SD =15.13) and depth (M= 97.12, SD = 5.63) of compressions compared to percent compressions in target without feedback (M= 64.42, SD = 30.54) including rate (M= 65.73, SD = 32.44) and depth (M=93.34, SD = 19.99) of compressions. Twenty nine or 85% of the 34 nurses improved chest compression performance using feedback. No significant correlation found between years of BLS and ACLS certification and pre and post feedback compliance. Conclusions: Defibrillators offering verbal encouragement and a visual display allow for adjustments in rate and depth of compressions to maintain chest compressions compliance within ECC Guidelines. Further studies should investigate whether the incorporation of feedback technology use in mock code and CPR training sessions could improve CPR performance of healthcare providers including nurses.
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Goda, Ibrahim, Mourad Nachtane, Yumna Qureshi, Hamza Benyahia, and Mostapha Tarfaoui. "COVID-19: Current challenges regarding medical healthcare supplies and their implications on the global additive manufacturing industry." Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine, January 22, 2022, 095441192110703. http://dx.doi.org/10.1177/09544119211070373.
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The covid-19 outbreak has caused a shortage of masks and other healthcare products for the general public around the globe. In addition, it has also affected the supply of personal protective equipment (PPE) used by healthcare services because of a sudden increase in their demand. This significant disruption in the global supply chain of these products resulted in, leaving many staff and patients without protection. The additive manufacturing (AM) industry is going through extraordinary times and can provide emergency responses to help deal with the global crisis caused by the COVID-19 pandemic. The objective of the present work is therefore to perform an up-to-date review to determine the capacity of AM to provide exclusive benefits for the medical healthcare supplies sector to fight this current situation. In this review, it is found that AM technology has proved that it can be used as a volume manufacturing technology for the ongoing crisis. However, the standardization and certification are appeared to represent the main challenges for adopting the AM in healthcare against COVID-19. Furthermore, additively manufactured materials for medical applications must be developed for medical environments. Most printed medical products for COVID-19 require biocompatibility evaluation and shall prove their ability to sterilize. Finally, this review concluded that AM technology can fulfill the requirements of face masks and ventilator parts for healthcare systems for proper controlling and treating of COVID-19 patients when the safety and efficacy of these devices are ensured.
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Koenig, C., P. Hellebart, J. Koch, F. Egger, T. Puntus, R. Kriz, K. Huber, M. Nuernberg, and D. Zweiker. "Is diversity harmful? - Mixed-brand cardiac implantable electronic devices undergoing magnetic resonance imaging." EP Europace 23, Supplement_3 (May 1, 2021). http://dx.doi.org/10.1093/europace/euab116.480.
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Abstract Funding Acknowledgements Type of funding sources: None. Introduction Many patients with cardiac implantable electronic devices (CIED) need to undergo magnetic resonance imaging (MRI). However, a significant proportion has a CIED system in place that has not been classified "MRI-conditional" because of generators and leads from different brands ("mixed-brand" group), although the individual components per se are MRI-conditional. There is only limited data available concerning the outcome of these patients with "mixed-brand" CIED systems undergoing MRI. Purpose To analyse complications or adverse effects in "mixed-brand" CIED patients undergoing MRI, compared to patients with a fully "MRI-conditional" CIED system. Methods A retrospective single-centre study was performed, including patients undergoing MRI between January 2013 until May 2020. Short- and long-term outcomes were compared between both groups. We defined the primary endpoint as death or any adverse event necessitating hospitalization or CIED revision in association with the MRI examination. Secondary endpoints were the occurrence of any surrogate for beginning device or lead failure or patient discomfort during MRI. Results A total of 227 MRI examinations, including 10 thoracic MRIs, were carried out in 158 patients, with a range of 1-9 MRIs per patient. Mean age was 73 years and 52 (32.9%) patients were female. We identified 38 patients undergoing 54 procedures in the "mixed-brand" group and 89 patients undergoing 134 MRI procedures in the "MRI-conditional" group. In 31 patients undergoing 39 MRI examinations the MRI-conditionality could not be determined. "Mixed-brand" patients were older than MRI-conditional patients (mean 77 vs. 72 years, p = 0.003). The primary endpoint occurred in 0% in the "mixed-brand" group and in 2.2% in the "MRI conditional" group (p = 1.000). Complications were as follows: Two patients had first diagnosed atrial fibrillation directly associated with the procedure, of whom one additionally had a transient CIED dysfunction. No patient in the "mixed-brand" group and three patients (3.4%) in the "MRI conditional" group met the secondary endpoints (p = 0.554). In patients with undeterminable MRI conditionality the complication rate was similar (0% for both the primary and secondary endpoints). Conclusion The complication rate of CIED patients undergoing MRI was low. There was no signal for increased risk of adverse events in patients with a CIED without MRI certification due to mixed brands systems compared to patients with "MRI-conditional" CIED systems.