382 cases of AI medical devices were released... There were ‘0’ reports of adverse events.

27 adverse cases of new technology medical devices over 3 years... AI-related reporting executive director

Heo Jong-sik “We need to inspect the reporting system to catch software errors”

(Seoul = Yonhap News) Reporter Shin Seon-mi = Adverse events (side effects) related to the use of new technology medical devices have been increasing every year for the past three years, but there have been no reports of adverse events from artificial intelligence (AI)-based medical devices.

Accordingly, the National Assembly is pointing out that there is a possibility that the AI ​​medical device adverse event reporting system may not be working, and that the system needs to be reexamined.

According to data received from the Ministry of Food and Drug Safety by Rep. Heo Jong-sik of the Democratic Party of Korea, a member of the National Assembly Health and Welfare Committee, on the 12th, approval, certification, and reporting of AI-based software medical devices are increasing every year.

By year, it increased 2.5 times in two years from 62 cases in 2023 to 108 cases in 2024 and 157 cases last year, and 55 cases were added in the first quarter of this year.

Starting in 2023, 382 new AI medical devices will be introduced to the market.

However, there were ‘0’ adverse cases related to domestic AI medical devices and digital medical devices reported from 2023 to June of this year.

This is in contrast to the fact that during the same period, a total of 27 adverse events from new technology medical devices, including in vitro diagnostic medical devices, were reported.

As approvals for new technology medical devices are increasing, adverse cases have increased every year from 1 in 2023 to 8 in 2024 to 16 last year, with 2 cases reported as of June this year.

Regarding this, Rep. Heo pointed out, “Even though reporting (adverse cases) is a legal obligation, the fact that there has not been a single case in the case of AI medical devices for over three years could be a sign that the reporting system to catch software errors is not working.”

AI medical devices are used to assist in reading images such as computed tomography (CT) and magnetic resonance imaging (MRI) or to assist in disease diagnosis.

If algorithm errors or missed readings occur, there is a possibility that patient safety may be affected, including delayed diagnosis.

Rep. Heo said, “We need to establish standards so that risks inherent in software can be reported as abnormal cases, and check whether medical institutions and companies actually report them.”