scholarly journals Integrating a Usability Engineering Process into a Consisting Risk Management

2018 ◽  
Vol 4 (1) ◽  
pp. 645-647
Author(s):  
Michael Scholtes ◽  
Stephanie Buedenbender ◽  
Annemarie Behrend ◽  
Keywan Sohrabi ◽  
Volker Gross
Keyword(s):  
Risk Management ◽  
Medical Device ◽  
Engineering Process ◽  
Usability Engineering ◽  
User Interactions ◽  
Management Processes ◽  
Medical Device Manufacturers ◽  
Incident Reports ◽  
Development Step ◽  
Medical Device Regulation

AbstractThe complexity of medical devices and its user interactions increases. A growing number of incident reports are assumed to be associated primarily with user errors. This development is tackled through current modifications in standards, such as ISO 13485:2016 and legislations, such as the Medical Device Regulation. Both intensify the focus on use errors significantly. The aim of this paper was the development of a process orientated approach integrating usability engineering into a consisting risk management based on a classic V-model. An appropriate procedure was worked out. For each development step, risk and usability activities were cumulated. Thus, the present paper might help medical device manufacturers to reflect their risk management and usability management processes to find synergies. Prospectively, a step-by-step guide for the integration of risk management and usability engineering based on this approach should be developed.

scholarly journals EU MDR 2017/745 will reduce the Risk of Medical Devices. Does MDCG got it Right?

2021 ◽  
Vol 9 (4) ◽  
pp. 33-36
Author(s):  
Vidya Sagar ◽  
Piyush Patel ◽  
Avni Rana ◽  
Bhavin Trivedi ◽  
Deepak Patel ◽  
...  
Keyword(s):  
Risk Management ◽  
Medical Device ◽  
Medical Devices ◽  
Management Plan ◽  
European Database ◽  
Periodic Safety ◽  
Post Market ◽  
Periodic Safety Update Report ◽  
Medical Device Regulation

Under the new European Union Medical Device Regulation (EU MDR), framed by Medical Device Coordination Group (MDCG), for each device manufacturers must have a documented risk management plan, identify and analyse the known and foreseeable hazards, estimate and evaluate the associated risks and eliminate or control those risks. In contrast with the MDD, the new EU MDR contains an explicit obligation in the new Article 10 (2), that manufacturers establish, document, implement and maintain a system for risk management. The detailed requirements of which are listed in the new Annex I Chapter I. Compared to MDD there is more emphasis on Post Market Surveillance (PMS) activities with the inclusion of European Databank or European Database for Medical Devices (EUDAMED) and mandatory submission of Periodic Safety Update Report (PSUR) to all the actors in the possession with the medical devices. A poll conducted by Aegis Lifesciences Pvt. Ltd, Ahmedabad, India concludes that the relevant annexures and sections in MDR 2017/745 have more emphasis on PMS, Vigilance, PSUR, EUDAMED, tracking, Implantation card etc. that are directed in regard to the safety of the Medical Device.

scholarly journals Medical Devices: Regulation, Risk Classification, and Open Innovation

2020 ◽  
Vol 6 (2) ◽  
pp. 42 ◽  
Author(s):  
Lukas Peter ◽  
Ladislav Hajek ◽  
Petra Maresova ◽  
Martin Augustynek ◽  
Marek Penhaker
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Social Structures ◽  
Added Value ◽  
Strategic Decisions ◽  
The Czech Republic ◽  
Risk Class ◽  
Medical Device Manufacturers ◽  
Legislative Changes ◽  
Medical Device Regulation

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.

scholarly journals Medical device risk management and its economic impact

2013 ◽  
Vol 59 ◽  
pp. 49-60 ◽  
Author(s):  
Katerina Krsteva Jakimovska ◽  
Marija Glavas-Dodov ◽  
Jasmina Tonic-Ribarska ◽  
Suzana Trajkovic-Jolevska
Keyword(s):  
Risk Management ◽  
Adverse Events ◽  
Medical Device ◽  
Medical Devices ◽  
Economic Losses ◽  
Serious Adverse Events ◽  
Safety Level ◽  
Management Standards ◽  
Medical Device Manufacturers ◽  
Potential Risks

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

Inevitable Influences: AI-Based Medical Devices at the Intersection of Medical Devices Regulation and the Proposal for AI Regulation

2021 ◽  
pp. 1-18
Author(s):  
Sofia Palmieri ◽  
Paulien Walraet ◽  
Tom Goffin
Keyword(s):  
Artificial Intelligence ◽  
European Commission ◽  
Medical Device ◽  
Medical Devices ◽  
Medical Field ◽  
Medical Device Manufacturers ◽  
Regulatory Landscape ◽  
Medical Device Regulation ◽  
Regulatory Intervention

Abstract In recent years, the use of Artificial Intelligence (AI) in the medical field has attracted increased attention. Due to their impressive advantages, AI systems offer excellent prospects for medical device manufacturers using these systems to upgrade their products. Such AI-based medical devices are already subject to partial regulation within the lines of Medical device regulation 745/2017. However, following the proposal for a regulation on artificial intelligence published by the European Commission, the regulatory landscape for these devices has partially changed. This article aims to clarify the influences that this regulatory intervention by the European Commission brings to the path towards the use and marketing of AI-based medical devices.

scholarly journals Distinguishability and identifiability of products with small bore connectors according to ISO DIS 80369 series: risk analysis and summative evaluation

2017 ◽  
Vol 3 (2) ◽  
pp. 505-507
Author(s):  
Elisabeth Ibenthal ◽  
Uvo M. Hölscher ◽  
Claus Backhaus
Keyword(s):  
Risk Management ◽  
Risk Analysis ◽  
Risk Control ◽  
Summative Evaluation ◽  
Engineering Process ◽  
Additional Consideration ◽  
Mechanical Problem ◽  
Usability Engineering

AbstractThe ISO 80369-series replace Luer-connectors in five application areas to fight misconnections. Although the standard avoids the mechanical problem of misconnections, the design of products and packages remains arbitrary. So, packages and products with same functions but different connectors could have similar designs and hence could be mixed-up.To ascertain whether standardization is needed for marking non-distinguishable products and packages, a risk management and usability engineering process were carried out, partly.The ensuing risk analysis created nine unacceptable risks relating to non-distinguishable packages and lookalike-products. Based on this, risk control (standardization) is needed for lookalikes with the following proposed measures: colour allocation and haptic textures for products, colour allocation and symbols for packages. Furthermore, three scenarios were planned for summative evaluation.An additional consideration of the efficiency of proposed combinations of measures and products relying on measures would be helpful.

Europäischer Medizinproduktemarkt: Wie sich Einkauf und Logistik auf die europäische MDR vorbereiten müssen

2019 ◽  
Vol 01 (04) ◽  
pp. 74-77
Author(s):  
Thomas Gallmann
Keyword(s):  
Medical Device ◽  
Medical Device Regulation

Nicht lieferbare Medizinprodukte sind für Kliniken ein Albtraum – mitunter müssen sogar geplante OPs abgesagt werden. Die Folge: Die mit den Kostenträgern vereinbarten Leistungszahlen sind schwieriger zu erfüllen und es könnte zu schwer kompensierbaren Erlöseinbußen für die Leistungserbringer kommen. Die Medical Device Regulation (MDR) wird die Liefersituation von Medizinprodukten ab 2020 wahrscheinlich noch weiter verschärfen.

Regulating Medical Devices in the United States

2020 ◽  
Author(s):  
Patricia J. Zettler ◽  
Erika Lietzan
Keyword(s):  
United States ◽  
Medical Device ◽  
Medical Devices ◽  
Complete Information ◽  
The United States ◽  
Risk Level ◽  
Management Tools ◽  
Medical Technologies ◽  
The Us ◽  
Medical Device Regulation

This chapter assesses the regulation of medical devices in the United States. The goal of the US regulatory framework governing medical devices is the same as the goal of the framework governing medicines. US law aims to ensure that medical devices are safe and effective for their intended uses; that they become available for patients promptly; and that manufacturers provide truthful, non-misleading, and complete information about the products. US medical device law is different from US medicines law in many ways, however, perhaps most notably because most marketed devices do not require pre-market approval. The chapter explores how the US Food and Drug Administration (FDA) seeks to accomplish its mission with respect to medical devicecough its implementation of its medical device authorities. It starts by explaining what constitutes a medical device and how the FDA classifies medical devices by risk level. The chapter then discusses how medical devices reach the market, the FDA's risk management tools, and the rules and incentives for innovation and competition. It concludes by exploring case studies of innovative medical technologies that challenge the traditional US regulatory scheme to consider the future of medical device regulation.

Medical Device Regulation: Requirements for Dental Professionals Who Prescribe and Manufacture Custom-Made Devices

2021 ◽  
Vol 10 (1) ◽  
pp. 64-88
Author(s):  
James I. J. Green
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Transition Period ◽  
Eu Directive ◽  
Custom Made ◽  
Dental Setting ◽  
The Uk ◽  
Dental Professionals ◽  
The Eu ◽  
Medical Device Regulation

A custom-made device (CMD) is a medical device intended for the sole use of a particular patient. In a dental setting, CMDs include prosthodontic devices, orthodontic appliances, bruxism splints, speech prostheses and devices for the treatment of obstructive sleep apnoea, trauma prevention and orthognathic surgery facilitation (arch bars and interocclusal wafers). Since 1993, the production and provision of CMDs have been subject to European Union (EU) Directive 93/42/EEC (Medical Device Directive, MDD) given effect in the UK by The Medical Devices Regulations 2002 (Statutory Instrument 2002/618), and its subsequent amendments. Regulation (EU) 2017/745 (Medical Device Regulation, EU MDR) replaces the MDD and the other EU Directive pertaining to Medical Devices, Council Directive 90/385/EEC (Active Implantable Medical Device Directive, AIMDD). The EU MDR was published on 5 April 2017, came into force on 25 May 2017 and, following a three-year transition period was due to be fully implemented and repeal the MDD on 26 May 2020, but was deferred until 26 May 2021 due to the coronavirus disease 2019 (COVID-19) pandemic. In the UK, in preparation for the country’s planned departure from the EU, the EU MDR, with necessary amendments, was transposed into UK law (Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, UK MDR). The UK left the Union on 31 January 2020 and entered a transition period that ended on 31 December 2020, meaning that, from 1 January 2021, dental professionals in Great Britain who prescribe and manufacture CMDs are mandated to do so in accordance with the new legislation while Northern Ireland remains in line with the EU legislation and implementation date. This paper sets out the requirements that relate to the production and provision of CMDs in a UK dental setting.

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