The Incidence and Nature of Adverse Medical Device Events in Dutch Hospitals:A Retrospective Patient Record Review Study

Objectives Despite widespread use of medical devices and their increasing complexity, their contribution to unintended injury caused by healthcare (adverse events, AEs) remains relatively understudied. The aim of this study was to gain insight in the incidence and types of AEs involving medical devices (AMDEs). Methods Data from two patient record studies for the identification of AEs were used. Identification of AMDEs was part of these studies. Patient records of 6894 admissions of a random sample of 20 hospitals in 2011/2012 and 19 hospitals in 2015/2016 were reviewed for AMDEs by trained nu... Mehr ...