Human Error Medical Devices

Human Factors and Medical Devices | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/human-factors-and-medical-devices

Human factors/usability engineering is used to design the user-device interface. The user interface includes all components with which users interact while preparing the device for use (e.g.,...

Human Error and Quality Control in Medical Devices

https://www.mddionline.com/news/human-error-and-quality-control-medical-devices

Human Factors Implications of the New GMP Rule …

https://www.fda.gov/medical-devices/human-factors-and-medical-devices/human-factors-implications-new-gmp-rule-overall-requirements-new-quality-system-regulation

Human factors relevance: In addition to other hazards, risk analysis should include use error as well. A risk analysis is appropriate for any device where use error can lead to …

Human Error Prevention in Pharma | NSF

https://www.nsf.org/knowledge-library/reducing-human-error-health-care-pharma

Human error must be the investigation starting point, not its automatic conclusion. There is no such thing as one single root cause for any error or mistake. If …

An Informed Guide to Human Error in CAPA …

https://www.thefdagroup.com/blog/an-informed-guide-to-human-error-in-capa

Two Places to Look for Systemic “Human” Errors. When errors are revealed to be less “human” upon closer examination, start asking questions that cast light …

Medical Device Use Error: Focus on the …

https://www.medtechintelligence.com/feature_article/medical-device-use-error-focus-severity-harm/

Under his leadership of the cardiovascular regulatory teams, Boston Scientific obtained numerous regulatory approvals for cardiovascular medical devices …

Medical Devices, Medical Errors, and Medical Accidents …

https://www.taylorfrancis.com/chapters/edit/10.1201/9780203751725-9/medical-devices-medical-errors-medical-accidents-senders

Human error in medicine, and the adverse events that may follow, are problems of psychology and engineering, not of medicine. The Anesthetic and Life Support Drugs …

Normal accidents: human error and medical equipment …

https://pubmed.ncbi.nlm.nih.gov/12538141/

Abstract. High-risk systems, which are typical of our technologically complex era, include not just nuclear power plants but also hospitals, anesthesia systems, and the practice of …

Human Error in Medical Equipment - Ebrary

https://ebrary.net/180568/engineering/human_error_medical_equipment

These devices, in the order of least error-prone to most error-prone, are as follows [34]: [2] • Permanent pacemaker electrode • Administration kit for peritoneal dialysis • …

[Medical device use errors] - PubMed

https://pubmed.ncbi.nlm.nih.gov/19213452/

Medical devices define our everyday patient treatment processes. But despite the beneficial effect, every use can also lead to damages. Use errors are thus often explained by …