Patient Safety and Medical Devices
Authors:   , Baartmans Mees Casper 
Published: May 2024

Hospitals are high-technical environments where medical devices are essential for providing
patient care. Often the application of medical devices is safe, but occasionally devices are
involved in events resulting in unintended patient harm. In some cases this patient harm
could potentially have been prevented. However, much is unknown about how events
leading to potentially preventable patient harm emerge and what role the device plays.

This thesis aims to increase knowledge and provide deeper understanding on how medical
devices are involved in unintended patient harm in Dutch hospital care, and identify leads
to further improve patient safety.
To fulfill this aim various studies were conducted, namely I) a patient record review study on
the incidence and nature of patient harm where medical devices are involved, II) a systematic
literature review on one method currently applied to study the causes patient harm, III) the
stepwise development of a new sentinel event analysis method, and IV) a retrospective
aggregated cross-hospital analysis of sentinel event reports identifying contributing factors
including those factors that relate to devices.

Based on data from reviewing 2,998 patient records from 20 Dutch hospitals, we found a potentially preventable Adverse Eevent involving a Medical Device (AEMD) occurred in 1.9% (95CI 1.5%- 2.5%) of patients who died during their admission in Dutch hospitals in 2019. Perforations, bleedings, and infections after invasive (endo)scopic procedures, heart- and vascular
implants, and tubes for enteral feeding or drainage were recurring topics identified in
these AEMDs. The contribution of the device often laid in provoking a known complication,
which in most cases was considered non-preventable. Preventability often not necessarily
related directly to device application, but rather laid in the subsequent management of the
perforation, bleeding or infection.

Current methods for studying such events not always successfully clarify the role of medical devices. Therefore the novel GAM was developed, in which a human factors perspective and systems thinking approach are embedded.

Aggregate cross-hospital GAM-analysis of sentinel events from 28 Dutch general hospitals indicates that characteristics of the device itself
often interact with contributing factors related to other socio-technical domains such as the
organization, patient, and professional. Jointly these factors trigger patient harm.

Additional in-depth analysis on specific topics using specialized instruments can help to further increase
our understanding and assist in formulating more specific measures for improvement.

From the findings of this thesis follow some important recommendations for practice and policy,
including guidance on future sentinel event investigations and strategies to reduce adverse
events involving medical devices. Future research should I) include prospective methods
to study the safe application of medical devices, II) also focus on safety of devices in nonhospital
settings, and III) study potential patient safety risks related to medical software
and information technology in health care, including the emerging application artificial
intelligence.