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. Issue 4 (3rd April 2018)

• Record Type: Journal Article
• Authors: Lawal, Oluwadolapo D.; Mohanty, Maitreyee; Elder, Harrison; Skeer, Margie; Erpelding, Nathalie; Lanier, Ryan; Katz, Nathaniel
• Is Part Of: Expert opinion on drug safety. Volume 17:Issue 4(2018)
• Page Start: 347
• Page End: 357
• Publication Date: 2018-04-03
• Subjects: Adverse events -- medication error -- pharmacovigilance -- post-marketing studies -- intravenous patient-controlled analgesia -- postoperative pain; Drugs -- Side effects -- Periodicals; Drugs -- Toxicology -- Periodicals; Chemotherapy -- Periodicals; 615.704
• DOI: 10.1080/14740338.2018.1442431
• Languages: English
• ISSNs: 1474-0338

Abstract

ABSTRACT: Background : The aim of this study is to determine the characteristics, magnitude, and the quality of reporting of mandated events involving intravenous patient-controlled analgesia (IV-PCA) devices in the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database; a postmarket surveillance system. Methods : We utilized a mixed-methods approach to systematically characterize structured data and text narratives associated with IV-PCA events submitted to MAUDE between 1 January 2011 and 12 September 2016. Results : Of 1, 430 IV-PCA events reported during the study period, 6.4% were adverse events (AEs) as identified via structured data fields in the MEDWATCH forms. Upon qualitative review of the narrative texts, 11.0% of events were associated with an unfavorable clinical outcome, which was 71% higher than the incidence of the adverse outcomes reported using the structured data fields. Device-related issues, which were mostly preventable, accounted for 86.9% of events. Of 65 reportable events submitted by manufacturers, 18.5% did not comply with reporting requirements as mandated by law. Conclusion : Patients on IV-PCA continue to experience serious complications as a result of preventable errors. Multi-modal interventions including educational training and the development and adoption of PCA devices with improved safety features are needed to improve safety.