Yan Yi

Analysis of Medical Device Recall Reports in FDA Database in 2005-2006

Objectives: To analysis of medical device recall reports and to address the safety issue of medical device. Method: Of overall reports, the recall class, product name, product class and recall reason were recorded to classify for analysis. Results: 3093 recall reports were translated to Chinese and identified; reason types of three recall classes were significant difference. It is indicated that main recall reason for medical equipments are design defect (45%) and system failure (39%), for medical material are package problem (39%) and design defect (19%), for medical tools are design defect (27%) and package problem (26%). Software-related recall is 109 cases. The main recall reason for high risk device is design defect. The ratio of Class I device with high risk is decline in 2006 compared to 2005. Conclusion: Supervising and utilizing of medical device recall information should be enhanced to understand the objective law of medical device safety issue and to provide reference for carrying out supervision of postmarket medical device.