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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.
Lawal OD, Mohanty M, Elder H, et al. 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. Expert Opin Drug Saf. 2018;17(4):347-357. doi:10.1080/14740338.2018.1442431.
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July 18, 2018
Lawal OD, Mohanty M, Elder H, et al. Expert Opin Drug Saf. 2018;17(4):347-357.
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.
