TY - JOUR
T1 - The incidence andnature of adverse medical device events in dutch hospitals
T2 - A retrospective patient record review study
AU - Porte, Petra J.
AU - Smits, Marleen
AU - Verweij, Lisanne M.
AU - de Bruijne, Martine C.
AU - van der Vleuten, Cees P. M.
AU - Wagner, Cordula
N1 - Funding Information: The study was supported by the Dutch Ministry of Health, Welfare and Sport. The funder had no role in the design and conduct of the study; collection, management, analysis, or interpretation of the data; preparation, review, or approval of the manuscript. Publisher Copyright: © 2021 Lippincott Williams and Wilkins. All rights reserved.
PY - 2021/12/1
Y1 - 2021/12/1
N2 - 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 2015/2016were reviewed for AMDEs by trained nurses and physicians. Results: In 98.7%of the admissions, a medical device was used. Adverse events involving medical devices were present in 2.8% of the admissions, with 24% of the AMDEs being potentially preventable. Of all AEs, in 40%, medical devices were involved. Of all potentially preventable AEs, in 44%, medical devices were involved. Implants were most often involved in potentially preventable AMDEs. Conclusions: Medical devices are substantially involved in potentially preventable AEs in hospitals. Research into AMDEs is of great importance because of the increasing use and complexity ofmedical devices. Based on patient records, most improvements could be made for placement of implants and prevention of infections related to medical devices. Safety and safe use of medical devices should be a subject of attention and further research.
AB - 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 2015/2016were reviewed for AMDEs by trained nurses and physicians. Results: In 98.7%of the admissions, a medical device was used. Adverse events involving medical devices were present in 2.8% of the admissions, with 24% of the AMDEs being potentially preventable. Of all AEs, in 40%, medical devices were involved. Of all potentially preventable AEs, in 44%, medical devices were involved. Implants were most often involved in potentially preventable AMDEs. Conclusions: Medical devices are substantially involved in potentially preventable AEs in hospitals. Research into AMDEs is of great importance because of the increasing use and complexity ofmedical devices. Based on patient records, most improvements could be made for placement of implants and prevention of infections related to medical devices. Safety and safe use of medical devices should be a subject of attention and further research.
KW - Adverse event
KW - Medical device
KW - Patient safety
UR - http://www.scopus.com/inward/record.url?scp=85120667521&partnerID=8YFLogxK
U2 - https://doi.org/10.1097/PTS.0000000000000620
DO - https://doi.org/10.1097/PTS.0000000000000620
M3 - Article
C2 - 32168269
SN - 1549-8417
VL - 17
SP - E1719-E1725
JO - Journal of Patient Safety
JF - Journal of Patient Safety
IS - 8
ER -