Reporter’s occupation and source of adverse device event reports contained in the FDA’s MAUDE database

Abstract

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

Acknowledgments

The conclusions in this review do not represent the policy of the FDA.

Disclosure

Dr Kevin Kavanagh has received partial conference attendance and meeting support from the US Department of Health and Human Services, National Quality Forum, National Patient Safety Foundation (NPSF), The Leapfrog Group, Consumer Union and the Anesthesia Patient Safety Foundation. He has served on the Centers for Medicare and Medicaid Services’ Technical Expert Panel for Hospital Acquired Conditions, and most recently on the Strategic Working Group for Agency for Healthcare Research and Quality (AHRQ) for quality indicators, and AHRQ Health Care Effectiveness and Outcomes Research (HEOR) Study Section. He is an Associate Editor for the Journal of Patient Safety for which he receives an honorarium. He has a first degree relative, who is employed by a state university, and is involved with the development of cancer chemotherapeutic and diagnostic agents. Dr Raeford E Brown Jr is past Chair of the FDA Anesthetic and Analgesic Drug Products Advisory Committee, and Chair of the American Academy of Pediatrics Section on Anesthesiology and Pain Medicine. The authors report no other conflicts of interest in this work.