Surveillance of Medical Device-Related Hazards and Adverse Events in Hospitalized Patients
2004
ContextAlthough adverse drug events have been extensively evaluated by computer-based
surveillance, medical device errors have no comparable surveillance techniques.ObjectivesTo determine whether computer-based surveillance can reliably identify
medical device–related hazards (no known harm to patient) and adverse
medical device events (AMDEs; patient experienced harm) and to compare alternative
methods of detection of device-related problems.Design, Setting, and ParticipantsThis descriptive study was conducted from January through September
2000 at a 520-bed tertiary teaching institution in the United States with
experience in using computer tools to detect and prevent adverse drug events.
All 20 441 regular and short-stay patients (excluding obstetric and newborn
patients) were included.Main Outcome MeasuresMedical device events as detected by computer-based flags, telemetry
problem checklists, International Classification of Diseases,
Ninth Revision (ICD-9) discharge code (which could include AMDEs present
at admission), clinical engineering work logs, and patient survey results
were compared with each other and with routine voluntary incident reports
to determine frequencies, proportions, positive predictive values, and incidence
rates by each technique.ResultsOf the 7059 flags triggered, 552 (7.8%) indicate a device-related hazard
or AMDE. The estimated 9-month incidence rates (number per 1000 admissions
[95% confidence intervals]) for AMDEs were 1.6 (0.9-2.5) for incident reports,
27.7 (24.9-30.7) for computer flags, and 64.6 (60.4-69.1) for ICD-9 discharge codes. Few of these events were detected by more than
1 surveillance method, giving an overall incidence of AMDE detected by at
least 1 of these methods of 83.7 per 1000 (95% confidence interval, 78.8-88.6)
admissions. The positive predictive value of computer flags for detecting
device-related hazards and AMDEs ranged from 0% to 38%.ConclusionsMore intensive surveillance methods yielded higher rates of medical
device problems than found with traditional voluntary reporting, with little
overlap between methods. Several detection methods had low efficiency in detecting
AMDEs. The high rate of AMDEs suggests that AMDEs are an important patient
safety issue, but additional research is necessary to identify optimal AMDE
detection strategies.
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