Human factors risk assessment: An integrated method for improving safety in clinical use of medical devices

2020 ◽  
Vol 86 ◽  
pp. 105918 ◽  
Author(s):  
Wenyan Song ◽  
Jing Li ◽  
Hao Li ◽  
Xinguo Ming
Keyword(s):  
Risk Assessment ◽  
Human Factors ◽  
Medical Devices ◽  
Clinical Use ◽  
Integrated Method

Human Factors Considerations in the Migration of Medical Devices from Clinical to Homecare Settings

2004 ◽  
Vol 48 (15) ◽  
pp. 1685-1689 ◽  
Author(s):  
Melanie J. Turieo ◽  
Marlene A. Devine ◽  
Rodney Hasler ◽  
Ronald Kaye ◽  
Wendy A. Rogers
Keyword(s):  
Human Factors ◽  
Medical Devices

scholarly journals A protocol for a systematic review investigating the factors influencing the statistical planning, design, conduct, analysis and reporting of trials

2020 ◽  
Vol 3 ◽  
pp. 36
Author(s):  
Marina Zaki ◽  
Marie Galligan ◽  
Lydia O'Sullivan ◽  
Declan Devane ◽  
Eilish McAuliffe
Keyword(s):  
Systematic Review ◽  
Medical Devices ◽  
Methodological Approach ◽  
Clinical Use ◽  
Key Factors ◽  
Eligibility Criteria ◽  
Factors Influencing ◽  
Comprehensive Search ◽  
Statistical Planning

Trials can be defined as prospective human research studies to test the effectiveness and safety of interventions, such as medications, surgeries, medical devices and other interventions for the management of patient care. Statistics is an important and powerful tool in trials. Inappropriately designed trials and/or inappropriate statistical analysis produce unreliable results, with limited clinical use. The aim of this systematic literature review is to identify, describe and synthesise factors contributing to or influencing the statistical planning, design, conduct, analysis and reporting of trials. This protocol will describe the methodological approach taken for the following: conducting a systematic and comprehensive search for relevant articles, applying eligibility criteria for the inclusion of such articles, extracting data and information, appraising the quality of the articles, and thematically synthesizing the data to illuminate the key factors influencing statistical aspects of trials.

scholarly journals Workers with Cardiac AIMD Exposed to EMF: Methods and Case Studies for Risk Analysis in the Framework of the European Regulations

2021 ◽  
Vol 18 (18) ◽  
pp. 9709
Author(s):  
Eugenio Mattei ◽  
Federica Censi ◽  
Giovanni Calcagnini ◽  
Rosaria Falsaperla
Keyword(s):  
Risk Assessment ◽  
Case Studies ◽  
Medical Devices ◽  
Risk Group ◽  
Health And Safety ◽  
Implantable Defibrillator ◽  
Safety Regulation ◽  
Implantable Medical Devices ◽  
European Regulations ◽  
The Eu

Workers with cardiac active implantable medical devices (AIMD), such as a pacemaker (PM) or an implantable defibrillator (ICD), are considered by the occupational health and safety regulation framework as a particularly sensitive risk group that must be protected against the dangers caused by the interference of electromagnetic field (EMF). In this paper, we first describe the general methodology that shall be followed for the risk assessment of employees with a cardiac AIMD exposed to EMF, according to the EU regulation, and in particular to the EN 50527-2-1:2016 and 50527-2-2:2018 standards. Then, three case studies related to specific EMF sources are presented, to better describe how the initial analysis of the risk assessment can be performed in practice, and to understand if a further specific risk assessment analysis is required or not.

Human Factors Regulations for Medical Devices

2021 ◽  
pp. 201-225
Author(s):  
Russell J. Branaghan ◽  
Joseph S. O’Brian ◽  
Emily A. Hildebrand ◽  
L. Bryant Foster
Keyword(s):  
Human Factors ◽  
Medical Devices

Nanomaterials in Medical Devices: Regulations' Review and Future Perspectives

2021 ◽  
pp. 1910-1917
Author(s):  
Karolina Jagiello ◽  
Anita Sosnowska ◽  
Alicja Mikolajczyk ◽  
Tomasz Puzyn
Keyword(s):  
Risk Assessment ◽  
Risk Management ◽  
Risk Analysis ◽  
Medical Devices ◽  
Future Perspectives ◽  
Medicinal Products ◽  
Advanced Therapy Medicinal Products ◽  
Probability Of Occurrence ◽  
Advanced Therapy ◽  
Related Harm

This article gives a brief description of the existing regulations related to biomaterials safety that need to be considered before it is introduced into EU market. According to these regulations, the risk analysis should include two characteristics: probability of occurrence of harm, and severity. Identified user-related harm should be reduced by managing the risk. Additionally, the review presents an overview of engineered biomaterials (EBMs), which in combination with nanoscale components (NPs) have shown promises in Advanced Therapy Medicinal Products (ATMP) and Medical Devices (MD). In this article, recent challenges, objectives and perspectives in risk assessment and risk management of ATMP and MD composed of nanobiomaterials were also highlighted.

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