Prevalence and nature of adverse medical device events in hospitalized children
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Patrick W Brady1, Kartik Varadarajan, Laura E Peterson
1Pediatric Center for Education and Research on Therapeutics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA. patrick.brady@cchmc.org
Insights
Adverse medical device events (AMDEs) are common in children's hospitals, affecting 3.3% of admissions. Vascular access and nervous system devices were most frequent, particularly in young children with complex chronic conditions.
Area of Science:
- Pediatric healthcare research
- Medical device safety
- Health informatics
Background:
- Tertiary care children's hospitals manage complex pediatric populations.
- Medical devices are integral to modern pediatric care.
- Understanding adverse medical device events (AMDEs) is crucial for patient safety.
Observation:
- A retrospective cohort study analyzed over 4 million inpatient admissions across 44 children's hospitals.
- Data spanned from January 1, 2004, to December 31, 2011, using the Pediatric Health Information System (PHIS).
- AMDEs were identified through specific diagnostic codes related to medical devices.
Findings:
- 3.3% of pediatric inpatient admissions (136,465 out of 4,115,755) experienced at least one AMDE.
- Vascular access and nervous system devices accounted for 44.4% of all pediatric AMDE admissions.
- The majority of AMDE admissions (75.5%) involved children with complex chronic conditions, with the highest incidence in those aged 2 years or younger.
Implications:
- AMDEs represent a significant burden in pediatric tertiary care settings.
- Further research is needed to identify specific predictors and risk factors for AMDEs in children.
- Improved understanding of AMDEs can inform strategies to enhance medical device safety and patient outcomes in pediatric populations.
Abstract:
Our objective was to describe the prevalence and nature of adverse medical device events (AMDEs) in tertiary care children's hospitals. In our retrospective cohort study of patients at 44 children's hospitals in the Pediatric Health Information System (PHIS), we included all inpatient stays with an AMDE-related diagnosis from January 1, 2004 to December 31, 2011. We identified AMDEs by diagnoses that specified a device in their definition. We included events present on admission as well as those complicating hospital stays. We described the characteristics of these admissions and patients, and stratified analysis by device category and presence of a complex chronic condition. Of 4,115,755 admissions in the PHIS database during the study period, 136,465 (3.3%) had at least 1 AMDE. Vascular access and nervous system devices together represented 44.4% of pediatric AMDE admissions. The majority (75.5%) of AMDE admissions were of children with complex chronic conditions. The most common age group was patients aged 2 years or less at the time of their first AMDE-related admission. AMDEs occur commonly in a population cared for in tertiary children's hospitals. Research to more specifically delineate AMDEs and their predictors are next steps to understand and improve device safety in children.
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