| dc.description.abstract | Based on the statistics of the US FDA′s recall data from 2002 to 2019, the total recall events were 38,180, and the repeated events were 15,209 after deduction. Correspondence analysis can find the relative relationship between variables in a low-dimensional space. This study selects the top 30 companies with the most recall events, deducts N/A models, and discusses the top ten recall causes. The research sample is 2,021 recall events. Correspondence analysis is used to analyze the recall models and recall causes to achieve the following two goals : (1) The US FDA still has the possibility of the recall through the rigorous review system before the medical device is placed on the market. Whether there is a problem in which link to explore the possibility of recall; (2) Integrate correspondence analysis and cluster analysis to construct a recall map, find out the correlation between the recall cause and the category of medical device, and compare the recall events in different periods.
The research results are as follows: (1) According to the recalled models of 30 sample companies, more than 90% or even higher proportions are permission for listing through 510(k). Because the 510(k) review only determines whether it meets the specifications in writing, this study believes that there are still undetected potential risks; (2) Analysis of recall data from 2002 to 2019 can be divided into the following three clusters: ① The first group is the ＂Packaging Process Control＂ mistakes, and the frequency of small disposable medical devices is relatively high; ② The second group can be subdivided into ＂R&D and Design＂, ＂Manufacturing Process Design＂ and ＂Process Control＂ mistakes, ＂medical device of analysis system＂ and ＂surgical or implantable device＂ occur more frequently; ③The third group is the mistake of ＂software design＂, and the ＂medical device of discrimination system＂ has a higher frequency.
Taking 2011 as the watershed, comparing between the groups, each model in addition to ＂small disposable medical device＂, there is no obvious difference between other models in the two periods; Within the group comparison, each model has changed in two periods. Among them, the ＂Software Design Category＂ has changed from DIHD (Immunology and Hematology Devices) to DHT1A (Ophthalmic Devices). The easiest thing for us to understand is that 3C products have caused an increase in people′s eye diseases, and the demand for such equipment has also increased.
Therefore, the recall map is used to discuss the frequency and trend of the causes for the recall of each model, and to formulate related issues of risk management, which can reduce the possibility of recall events. | en_US |