Adverse events involving medical devices in Dutch hospitals: A patient record review study

Abstract

Objectives

To report the incidence of potentially preventable Adverse Events involving a Medical Device (AEMD) and provide an overview of specific topics on how devices were involved in causing patient harm.

Methods

A retrospective nationwide patient record review study using randomly selected records of 2998 patients deceased during their admission in 20 Dutch hospitals in 2019.

Results

63 potentially preventable AEMDs were identified, corresponding to a weighted incidence of 1.9 % (95CI 1.5 %-2.5 %). Medical devices were involved in about half of all potentially preventable adverse events. Consequences for patients were often severe. Themes in how medical devices were involved in causing patient harm were: Endoscopes causing perforations and hemorrhages, bleedings and infections after placement of heart- and vascular implants, and respiratory harm related to naso- and orogastric tube application. In most cases, the role of the device in causing adverse events was that of prompting a known complication. Preventability in these cases often lied in the subsequent management of the bleeding, perforation or infection.

Conclusions

AEMDs occur in a small percentage of patients admitted and deceased in Dutch hospitals, but do represent a substantial part of all potentially preventable adverse events identified amongst the old and severely comorbid patient group in this study. An additional analysis of the data, provided a more thorough understanding of how the use of medical devices contributes to patient harm. Other study designs are necessary to learn more about technical and organizational issues that might trigger AEMDs.

Public interest summary

Most medical device applications are safe and effective. Though in a small number of cases an Adverse Event involving a Medical Device (AEMD) occurs. This study found that in 1.9 % (95CI 1.5 %-2.5 %) of patients deceased during their admission in 20 Dutch hospitals in 2019 a potentially preventable AEMD occurred. Identified topics in these AEMDs were perforations, bleedings, and infections after application of endoscopes, heart- and vascular implants, and tubes for enteral feeding or drainage. The role of the devices in these AEMDs was often that of prompting a known complication and considered non-preventable. Preventability in most cases lied in the subsequent management of the perforation, bleeding or infection.