User reporting of medical device related incidents.
In many countries, health-care professionals are required to notify relevant authorities about certain incidents that can be linked to properties, performance and usability issues of medical devices. This study examines whether the user-reporting scheme could add to the information that is already available from manufacturer incident reports.
Sievänen
Harri
H
Medical Devices Department, National Agency for Medicines, Helsinki, Finland. harri.sievanen@nam.fi
D004868:Equipment Failure / Q000706:statistics & numerical data*; D004869:Equipment Safety / Q000379:methods / Q000592:standards; D004864:Equipment and Supplies / Q000009:adverse effects / Q000592:standards* / Q000706:statistics & numerical data; D005062:European Union; D005387:Finland; D019983:Guideline Adherence / Q000331:legislation & jurisprudence; D019221:Mandatory Reporting; D019300:Medical Errors / Q000517:prevention & control; D013677:Medical Laboratory Science / Q000331:legislation & jurisprudence / Q000592:standards; D011358:Product Surveillance, Postmarketing / Q000379:methods* / Q000592:standards