PMID- 29463158
OWN - NLM
STAT- MEDLINE
DCOM- 20180321
LR  - 20220321
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 17
IP  - 4
DP  - 2018 Apr
TI  - 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.
PG  - 347-357
LID - 10.1080/14740338.2018.1442431 [doi]
AB  - 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.
FAU - Lawal, Oluwadolapo D
AU  - Lawal OD
AUID- ORCID: 0000-0003-4466-6675
AD  - a Consulting Unit , Analgesic Solutions, LLC , Wayland , MA , USA.
FAU - Mohanty, Maitreyee
AU  - Mohanty M
AD  - a Consulting Unit , Analgesic Solutions, LLC , Wayland , MA , USA.
FAU - Elder, Harrison
AU  - Elder H
AD  - a Consulting Unit , Analgesic Solutions, LLC , Wayland , MA , USA.
FAU - Skeer, Margie
AU  - Skeer M
AD  - b Department of Public Health and Community Medicine , Tufts University School of 
      Medicine , Boston , MA , USA.
FAU - Erpelding, Nathalie
AU  - Erpelding N
AD  - a Consulting Unit , Analgesic Solutions, LLC , Wayland , MA , USA.
FAU - Lanier, Ryan
AU  - Lanier R
AD  - a Consulting Unit , Analgesic Solutions, LLC , Wayland , MA , USA.
FAU - Katz, Nathaniel
AU  - Katz N
AD  - a Consulting Unit , Analgesic Solutions, LLC , Wayland , MA , USA.
AD  - c Department of Anesthesiology and Perioperative Medicine , Tufts University 
      School of Medicine , Boston , MA , USA.
LA  - eng
PT  - Journal Article
DEP - 20180220
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
SB  - IM
MH  - Analgesia, Patient-Controlled/*adverse effects/instrumentation
MH  - Databases, Factual
MH  - Equipment Safety/*statistics & numerical data
MH  - Equipment and Supplies/*adverse effects
MH  - Humans
MH  - Incidence
MH  - Medication Errors/statistics & numerical data
MH  - Product Surveillance, Postmarketing/*statistics & numerical data
MH  - United States
MH  - United States Food and Drug Administration
OTO - NOTNLM
OT  - Adverse events
OT  - intravenous patient-controlled analgesia
OT  - medication error
OT  - pharmacovigilance
OT  - post-marketing studies
OT  - postoperative pain
EDAT- 2018/02/22 06:00
MHDA- 2018/03/22 06:00
CRDT- 2018/02/22 06:00
PHST- 2018/02/22 06:00 [pubmed]
PHST- 2018/03/22 06:00 [medline]
PHST- 2018/02/22 06:00 [entrez]
AID - 10.1080/14740338.2018.1442431 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2018 Apr;17(4):347-357. doi: 10.1080/14740338.2018.1442431. 
      Epub 2018 Feb 20.