コンビネーション医薬品の機械器具部分における不具合報告の分析調査

抄録

Objective: Analysis of data from reports of medical device faults in drug-device combinations (DDCs) can prevent adverse events caused by errors and lead to improvements. However, there is a paucity of published articles reporting the analysis of data on faults in DDCs. The aim of this study was to analyze data of faults in these medical devices in Japan.

Methods: The review summarized information from the Pharmaceuticals and Medical Devices Agency data on “case reports of suspected failures of the mechanical and instrumental parts of DDCs” reported between 25 November 2014 and 31 July 2022. Information was collected from public documents on “year reported”, “age”, “gender”, “trade name”, “generic name”, “mechanical device part name”, “mechanical device part failure status”, and “hazard” and “outcome”.

Results: There were approximately 1,300 reports of medical device faults in DDCs over the study period, with the number increasing year by year. Five device parts (insulin pen injectors, pre-filled syringes, drug and vaccine injectors, disposable hypodermic needles, and intrauterine contraceptive devices) accounted for 90% of the reports. We found that there was a considerable amount of missing data on reportable items such as age and gender of the patient. Our analysis also showed that 90% of the medical device fault reports involving DDCs were related to malfunction or breakage.

Conclusion: In order to use DDCs more safely and effectively it is important to review reports and analyse data of faults in these devices.