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BACKGROUND/RATIONALE:
Background/rationale
This study addresses problems of patient safety in intensive care units (ICUs) in VA hospitals. Medical devices, including alarms, are in ubiquitous use in these settings. Errors and adverse events associated with medical devices are an understudied area in patient safety. The broad goals of this study are to define the incidence of problems associated with medical devices, to evaluate their causes, and to identify potential solutions. This study is designed to examine two major hypotheses. The first hypothesis is that adverse medical device events (AMDEs) and device-related hazards occur at a clinically significant frequency across a spectrum of ICUs and types of therapeutic and monitoring devices. The second hypothesis is that error-producing conditions are important causes of these problems. Error-producing conditions are factors that are recognized to affect reliability and human performance in non-healthcare industries. Five types of error-producing conditions will be specifically addressed: 1) task interruption; 2) task familiarity; 3) time pressure; 4) task feedback (signal-to-noise ratio); 5) task ambiguity. This hypothesis will be evaluated drawing from methods from the disciplines of cognitive psychology, human factors, and epidemiology.
OBJECTIVE(S):
Objectives:
The objectives of this study are to
1. Systematically characterize nursing tasks related to medical device use in six VA intensive care units (ICUs) and one non-VA ICU
2. Estimate the incidence of device-related hazards and adverse medical device events (AMDEs) in the participating ICUs
3. Ascertain the occurrence of error-producing conditions in the participating ICUs
4. Assess the causal effects of error-producing conditions on device-related hazards and AMDEs
5. Feedback results of the analyses to ICU and patient safety personnel at each institution
METHODS:
Methods
This study relies on the technique of direct observation to ascertain AMDEs. potential adverse events (device-related hazards), and error-producing conditions. The observational data is supplemented with nurse survey and patient record abstraction. Task analysis is used to subdivide device-related clinical care activities into clusters of sub-tasks, organized together with goals and plans. Planned analyses include estimation of rates of events as well as use of regression models to examine the association between error-producing events and device-related hazards.
FINDINGS/RESULTS:
Findings/results
Our effort to date has focused on four major activities: 1) recruitment of study personnel and completion of regulatory documents; 2) accomplishment of device task analysis; 3) development of the data collection instrument on the tablet computer; 4) collection of pilot data, focusing initially on the effect of interruptions on error. The data collection instrument is designed to sequentially track nursing tasks, to allow a quantitative assessment of the impact of an interruption on performance of the task, to ascertain omitted components of appropriate device management, to identify patient hazards, and to measure short-term patient outcomes.
IMPACT:
Impact
We have submitted an abstract to the VA HSR&D meeting based on our pilot observations. We believe that this study will yield information of high relevance to efforts to improve patient safety in VA intensive care units. It will be a significant contribution to the relatively sparse literature about patient safety problems associated with medical devices.
PUBLICATIONS:
None at this time.
DRA:
Health Services and Systems
DRE:
Communication and Decision Making, Technology Development and Assessment
Keywords:
Adverse events, Safety, Surgery
MeSH Terms:
none
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