Quality analysis of manufacturer's incident reports regarding medical devices

BACKGROUND: Medical devices provide a great number of medical treatments and have an important role in patients’ healthcare; however, there are certain risks, sometimes even serious incidents, associated with their usage. To ensure that benefits of medical device usage always outweigh associated risks, it is necessary to closely monitor known risks post-market and detect new ones as early as possible. Among others, valuable instrument of post-market surveillance is manufacturer incident report. Yet to accomplish its intended use, such report must be sufficiently populated and supplied with correct information. Aim of this paper is to assess the quality of manufacturer’s incident reports received in HALMED since 2012 to May 2021. METHODS: The study included 578 initial reports and 566 final reports that were scored according to the evaluating system we designed and categorized as Excellent, Good, Medium, Qualified and Unqualified. For each report medical device risk class was also extracted to calculate the frequency of report occurrence per risk class and time that passed between the initial and final report. Difference in quality of the reports between manufacturers based on EU countries and countries outside the EU was determined by Mann Whitney U test. RESULTS: Most of initial and final reports fall into two highest quality category level, which means that a sufficient amount of reports are of good/excellent quality and quality of reports prevails. However, the study’s results indicate the need for higher scores, especially in critical fields of the form. CONCLUSIONS: Data obtained from the manufacturer can be scarce and insufficient, causing negative influence on Competent Authority’s investigation procedure. Another issue we recognized is extensive underreporting in Croatia, which can seriously undermine the established system.