Risk management for medical devices in research projects

The promises of Industry 4.0 in the medical device industry needs to be built on sound cybersecurity infrastructures, polices, and practices. During 2011-2017, the authors interviewed many manufacturers of medical devices in China, Germany, Israel, Japan, Taiwan, and U.S. about their attitude towards cybersecurity. Many manufacturers are not committed to cybersecurity risk management because they pursue lower cost and shorter product life cycles; do not have sufficient knowledge of operating environments of hospitals; have defensive attitude toward vulnerability disclosure; and reap quick benefits from the low-trust level among stakeholders and unequal power between manufacturers and distributors. Only a few large U.S. manufacturers of medical devices have set up robust secure platforms and interoperable optimal standards which benefit the users. As cybersecurity is a shared responsibility, many small and medium-sized enterprises need to be empowered through the support of international organizations and local government policies.

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

International Journal of Drug Regulatory Affairs ◽

10.22270/ijdra.v9i4.497 ◽

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.

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Embracing Cybersecurity Risk Management in the Industry of Medical Devices

Research Anthology on Privatizing and Securing Data ◽

10.4018/978-1-7998-8954-0.ch100 ◽

2021 ◽

pp. 2044-2064

Author(s):

Maria Lai-Ling Lam ◽

Kei Wing Wong

Keyword(s):

Risk Management ◽

Local Government ◽

Medical Device ◽

Medical Devices ◽

Industry 4.0 ◽

Life Cycles ◽

Shared Responsibility ◽

Operating Environments ◽

Set Up ◽

Industry Needs

The promises of Industry 4.0 in the medical device industry needs to be built on sound cybersecurity infrastructures, polices, and practices. During 2011-2017, the authors interviewed many manufacturers of medical devices in China, Germany, Israel, Japan, Taiwan, and U.S. about their attitude towards cybersecurity. Many manufacturers are not committed to cybersecurity risk management because they pursue lower cost and shorter product life cycles; do not have sufficient knowledge of operating environments of hospitals; have defensive attitude toward vulnerability disclosure; and reap quick benefits from the low-trust level among stakeholders and unequal power between manufacturers and distributors. Only a few large U.S. manufacturers of medical devices have set up robust secure platforms and interoperable optimal standards which benefit the users. As cybersecurity is a shared responsibility, many small and medium-sized enterprises need to be empowered through the support of international organizations and local government policies.

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Medical device risk management and its economic impact

Macedonian Pharmaceutical Bulletin ◽

10.33320/maced.pharm.bull.2013.59.006 ◽

2013 ◽

Vol 59 ◽

pp. 49-60 ◽

Cited By ~ 1

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

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Equipment in anaesthesia

10.1093/med/9780199642045.003.0024 ◽

2017 ◽

Author(s):

Antony R. Wilkes

Keyword(s):

Risk Management ◽

Medical Device ◽

Medical Devices ◽

Healthcare Workers ◽

Small Children ◽

Management Procedures ◽

Different Types ◽

First Time ◽

Work First ◽

Subsequent Patient

The anaesthetist will routinely use many different types of medical devices during normal working practice, and will have access to many other devices for more challenging use in emergency and other difficult scenarios. The anaesthetist will expect and rely on each medical device to work first time and not to compromise the safety of the user, the patient, their relatives, or other healthcare workers in the vicinity. The equipment will also be expected to be effective, that is, that it will perform as expected when used in a defined population of patients (e.g. small children). Manufacturers and users of equipment use risk management procedures to reduce the risk to patients and others of using the equipment. Following use, the equipment will need to be reprocessed to make it safe for use for a subsequent patient, or disposed of safely.

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Medical Device Regulation and current challenges for the implementation of new technologies

Current Directions in Biomedical Engineering ◽

10.1515/cdbme-2020-3086 ◽

2020 ◽

Vol 6 (3) ◽

pp. 334-337

Author(s):

Sebastian Kaule ◽

Andrea Bock ◽

Ariane Dierke ◽

Stefan Siewert ◽

Klaus-Peter Schmitz ◽

...

Keyword(s):

Medical Device ◽

Medical Devices ◽

New Technologies ◽

Transition Period ◽

Transitional Period ◽

Technical Documentation ◽

Transcatheter Aortic Valve ◽

Innovative Products ◽

One Year ◽

Medical Device Regulation

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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