AN ANALYSIS OF HOME AND HOSPITAL MEDICAL DEVICE INCIDENTS IN THE MAUDE DATABASE

摘要

A review of the U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience Database (MAUDE) was performed to identify medical device incident trends relating to the type of device involved, incident location, injury severity, the nature and/or cause of the event, and human factors issues involved. A total of 317,931 medical device incident reports submitted by manufacturers between the years 1997 and 2002 were reviewed. The analysis revealed that 203,021 (64%) of these reports did not contain useful event location information. Of the remaining reports, 102,303 (89%) incidents occurred in hospitals, 6,153 (5%) incidents occurred in outpatient treatment facilities, 2,511 (2%) incidents occurred in ambulatory surgical facilities, and 3,157 (3%) incidents occurred at home. The majority of the incidents that occurred at home involved blood glucose meters (42%), defibrillators (10%), ventilators (8%), and wheelchairs (5%). Home incidents resulted in 108 fatalities and 776 injuries. The majority of the fatalities were associated with defibrillators (32%), ventilators (19%), oximeters (8%), and hemodialysis devices (6%). Seven of the 21 fatal home ventilator-related incidents were attributed to low, delayed, or non-sounding alarms. Hospital incidents comprised 102,303 records, with 2,046 incidents resulting in fatalities. A large share of the fatal hospital incidents were related to defibrillators (11%), catheters (11%), heart valves (10%), pacemakers (5%), and ventilators (4%). Six fatal hospital ventilator-related incidents were attributed in part to delayed, silenced, or non-sounding alarms.