The nature, magnitude, and reporting compliance of device-related events for intravenous patient-controlled analgesia in the FDA Manufacturer and User Facility Device Experience (MAUDE) database.
Approach to Improving Safety
Setting of Care
This study reviewed mandatory reporting of patient-controlled analgesia device-related events to the Food and Drug Administration postmarketing surveillance database. Less that 10% of reported events were deemed adverse events, and the vast majority of these were preventable. The authors call for development and adoption of patient-controlled analgesia devices with improved safety features and better training.