Analysis of quinquennial medical device recalls in Japan

Abstract

It has been reported that approximately 400 kinds of medical devices are recalled every year in Japan. We analyzed Pharmaceuticals and Medical Devices Agency recall data from April 2008 to March 2013. In total, 2163 recalls were issued in five years. We investigated the recall cases and the length of recall time (the time between when the devices were sold and recalled), classifying by diagnosis device and clinical department. Radiology, cardiovascular, and clinical laboratory devices were heavily recalled. Thirty-one point six percent of recalls were class 3 and 4 specially controlled medical devices. Sixty-four percent of recalled devices were general devices (non-disposable), and 28% were disposable devices such as catheter and syringe barrel. The length of recall time was 37.7 months on average, but the time was shorter when the device risk level was high, and longer with a high risk recall. In particular, disposable device recalls occurred in a short period. In contrast, radiology and clinical laboratory device recalls occurred 55.1 months after delivery on average, and 10% of them were recalled after a decade or more. We investigated the length of recall time classifying by diagnosis device and clinical department, and found that there is a large difference between disposable devices and general devices.

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