AI as a Medical Device Adverse Event Reporting in Regulatory Databases: Protocol for a Systematic Review.

Journal: JMIR research protocols
PMID: 38990628

Abstract

BACKGROUND: The reporting of adverse events (AEs) relating to medical devices is a long-standing area of concern, with suboptimal reporting due to a range of factors including a failure to recognize the association of AEs with medical devices, lack of knowledge of how to report AEs, and a general culture of nonreporting. The introduction of artificial intelligence as a medical device (AIaMD) requires a robust safety monitoring environment that recognizes both generic risks of a medical device and some of the increasingly recognized risks of AIaMD (such as algorithmic bias). There is an urgent need to understand the limitations of current AE reporting systems and explore potential mechanisms for how AEs could be detected, attributed, and reported with a view to improving the early detection of safety signals.

Authors

  • Aditya U Kale
    Department of Ophthalmology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
  • Riya Dattani
    Springer Nature Group, London, United Kingdom.
  • Ashley Tabansi
    School of Chemistry, Food and Pharmacy, University of Reading, Reading, United Kingdom.
  • Henry David Jeffry Hogg
    Population Health Science Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.
  • Russell Pearson
    Medicines and Healthcare Products Regulatory Agency, London, UK.
  • Ben Glocker
    Kheiron Medical Technologies, London, UK.
  • Su Golder
    Department of Health Sciences, University of York, York, United Kingdom.
  • Justin Waring
    Health Services Management Centre, University of Birmingham, Birmingham, United Kingdom.
  • Xiaoxuan Liu
    Birmingham Health Partners Centre for Regulatory Science and Innovation University of Birmingham Birmingham Reino Unido Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, Reino Unido.
  • David J Moore
    Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom.
  • Alastair K Denniston
    Centre for Patient Reported Outcomes Research Institute of Applied Health Research University of Birmingham Birmingham Reino Unido Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham, Reino Unido.

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