Reporter’s occupation and source of adverse device event reports contained in the FDA’s MAUDE database
Received 21 April 2019
Accepted for publication 10 June 2019
Published 2 July 2019 Volume 2019:10 Pages 205—208
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Amy Norman
Peer reviewer comments 2
Editor who approved publication: Professor Lynne Nemeth
Kevin T Kavanagh,1 Raeford E Brown Jr,2 Steve S Kraman,3 Lindsay E Calderon,4 Sean P Kavanagh5
1Health Watch USA, Somerset, KY, USA; 2Department of Anesthesiology, University of Kentucky Medical Center/Kentucky Children’s Hospital, Lexington, KY, USA; 3Department of Internal Medicine, University of Kentucky College of Medicine, Health Watch USA, Lexington, KY, USA; 4Department of Biological Sciences, Eastern Kentucky University, Health Watch USA, Lexingtion, KY, USA; 5Health Watch USA, Solon, OH, USA
Introduction: A review of the medical device adverse events submitted to the United States Food & Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was undertaken to determine the major sources of the information.
Methods: The reporter’s occupation and source of the medical device report were determined for acquisition dates Jan 1, 1997 to Dec 31, 2018. A total of 7,766,737 adverse event records were analyzed.
Results: 96.6% of reports originated with the manufacturer. Patients (patients/family/friend) were the most frequent submitter of reports directly to the FDA, almost five times as often as physicians. Nurses submitted reports directly to the FDA 2.77 times as often as physicians. Only 0.49% of physician reports were submitted directly to the FDA, representing 0.09% of total MAUDE reports.
Conclusion: Increasing physician reporting directly to the FDA and MAUDE through the MedWatch reporting system is an imperative. Incorporating information from the perspective of the physician has the potential of increasing the quality of the data and improving the reliability of post-market surveillance.
Keywords: FDA, MAUDE, reporter, occupation, medical device, adverse events
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