Impact of Design on Medical Device Safety

The growing number of emerging medical technologies and sophistication of modern medical devices (MDs) that improve both survival and quality of life indexes are often challenged by alarming cases of vigilance data cover-up and lack of sufficient pre- and post-authorization controls. Combining Quali...

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Bibliographic Details
Published in:Therapeutic innovation & regulatory science 2020-07, Vol.54 (4), p.839-849
Main Authors: Miclăuş, Teodora, Valla, Vasiliki, Koukoura, Angeliki, Nielsen, Anne Ahlmann, Dahlerup, Benedicte, Tsianos, Georgios-Ioannis, Vassiliadis, Efstathios
Format: Article
Language:English
Subjects:
Design
Dipoles
Drug Safety and Pharmacovigilance
Equipment Safety
Ergonomics
Human engineering
Human factors
Humans
Life cycle engineering
Medical equipment
Medicine
Performance indices
Pharmacotherapy
Pharmacy
Quality of Life
Review
Review Article
Risk Management
Safety
Vigilance
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Summary:The growing number of emerging medical technologies and sophistication of modern medical devices (MDs) that improve both survival and quality of life indexes are often challenged by alarming cases of vigilance data cover-up and lack of sufficient pre- and post-authorization controls. Combining Quality with Risk Management processes and implementing them as early as possible in the design of MDs has proven to be an effective strategy to minimize residual risk. This article aims to discuss how the design of MDs interacts with their safety profile and how this dipole of intended performance and safety may be supported by Human Factors Engineering (HFE) throughout the Total Product Life-Cycle (TPLC) of an MD in order to capitalize on medical technologies without exposing users and patients to unnecessary risks.
ISSN:2168-4790
2168-4804
DOI:10.1007/s43441-019-00022-4