Analysis of software-related recalls of medical devices / 中国医学装备

ABSTRACT

Objective:To discuss the regulation requirements of software based on the analysis of software-related recalls of medical devices. Methods:The data of software-related recalls of medical devices in America were collected and processed, and the type, situation, cause and trend of software-related recalls were analyzed, then the suggestions on the regulation requirements of software were proposed. Results:During the four periods from 1983 to 2011, the percentage of software-related recalls vs medical device recalls in America increased from 6%to 19%, and the year-on-year growth rate of software-related recalls rose by 47%to 164%, significantly higher than medical device recalls in the same period (from 13%to 54%). Especially, the problem of software-related recalls in radiology medical devices was the most serious. Conclusion: The regulatory situation of software is more complicated and severe, so the regulation requirements of software, including software validation, adverse event monitoring and usability design, need to be further strengthened according to the particularity of software.