Medical device active surveillance of spontaneous reports: A literature review of signal detection methods

摘要

Abstract Purpose: The collection and analysis of real-world data for the active monitoring of medical device performance and safety has become increasingly important. Spontaneous reports, such as those in the Food & Drug Administration's (FDA's) Manufacturer and User Facility Device Experience (MAUDE), provide early warning of potential issues with marketed devices. This review synthesizes the current literature on medical device surveillance signal detection and provides a framework for application of methods to active surveillance of spontaneous reports. Methods: Ovid MEDLINE, Ovid Embase, Scopus, and PubMed databases were systematically searched up to January 2019. Additionally, five methods articles from pharmacovigilance were added that had potential applications to medical devices. Results: Among 105 articles included, the most common source of data (84%) was registries; median time between data collection and publication was 8 years. Surgical procedure outcome signal detection articles comprised 83% while 14% were on device outcome signal detection. The most common family of methods cited (70%) was Sequential Probability Ratio. Conclusion: Application of any signal detection algorithm requires careful consideration of influential factors, data limitations, and algorithmic assumptions. We recommend approaches using disproportionality, statistical process control, and sequential probability tests and provide R packages to further development efforts. The small number of published examples suggest that further development of statistical methods and technological solutions to analyze large amounts of data for device safety and performance is needed. Fundamental differences in products, data infrastructure, and the regulatory landscape suggest that medical device vigilance requires its own body of research distinct from pharmacovigilance.