Over 13,000 cases reported over 10 years, even deaths occurred, but no damage compensation was provided.
[서울경제TV 남원=최영 기자] Adverse events caused by medical devices have steadily increased over the past 10 years, with the highest number of cases reported last year. There were a number of cases requiring hospitalization or extension of the hospitalization period, but it was confirmed that little causality investigation was conducted and no compensation for damages was provided.
As a result of analysis of data submitted by the Ministry of Food and Drug Safety by National Assembly member Park Hee-seung (Democratic Party, Namwon, Jangsu, Imsil, Sunchang, National Assembly Health and Welfare Committee), a total of 13,758 adverse medical device cases were reported over the past 10 years from 2016 to June of this year. The number of reported cases, which was 739 in 2016, increased 2.9 times to 2,116 last year, and the increase continues with 1,136 cases already reported in the first half of this year (as of June).
By type, ‘others such as minor results’ were the most common at 10,423 (75.8%), and ‘cases requiring hospitalization or extension of the hospitalization period’ were also reported at 3,306 (24.0%). In addition, there were 15 cases (0.1%) of ‘irrecoverable or severe disability or functional decline’ and 14 cases (0.1%) of ‘death or life-threatening’ cases, and it was confirmed that 4 people actually died.
Meanwhile, looking at the status of recall actions under the Medical Device Act, 1,118 voluntary recalls and 243 recall orders were counted from 2020 to 2024. The most common reason for the recall order was quality nonconformity (54 cases) (22.2%), followed by GMP (manufacturing and quality control) violations 50 cases (20.6%), other 44 cases (18.1%), unauthorized changes 42 cases (17.3%), unauthorized 27 cases (11.1%), and contamination of foreign substances with 26 cases (10.7%).
However, the causal relationship investigation into such adverse cases is extremely insufficient. From 2018 to August of this year, only 34 cases were investigated, and only 7 of them (medical auxiliary circulatory devices, personal respirators, etc.) were recognized as causal, and measures such as changes to permits or provision of safety information were taken.
In addition, starting from July 2022, a system is being implemented that requires manufacturers and importers of human implantable medical devices to subscribe to liability insurance or mutual aid to compensate for damages in the event of death or serious side effects caused by the device. However, as of 3 years after implementation, there has not been a single case of compensation for damages.
Rep. Park Hee-seung emphasized, “As the medical device market is rapidly expanding due to the aging population and technological development, we need to more actively pursue causality investigations of adverse cases.” He added, “There is a need to strengthen the effectiveness of the liability insurance and mutual aid system that has been in place for three years, and consider introducing a damage relief system in the long term.”
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