Mortality of patients as a result of the use of medical devices is included in the indicators of state control
The Government of the Russian Federation has included in the list of key indicators of state control over the circulation of medical devices the number of patients who died as a result of adverse events when using such devices. Target values are set at the level of 0.7 patients per 1 million population in 2022, with a decrease in the indicator to 0.55 in 2025.
The target indicators were approved by Decree of the Government of the Russian Federation No. 2220 dated December 7, 2021. The amendments will enter into force on March 1, 2022.
The value will be calculated on the basis of messages sent during the reporting year to Roszdravnadzor by the subjects of medical devices circulation. The target was approved at 0.7 per million in 2022, 0.65 in 2023, 0.6 in 2024 and 0.55 in 2025.
The Ministry of Health of the Russian Federation has developed profile amendments to the Regulation on federal state control over the circulation of medical devices in October 2021.
According to Roszdravnadzor, in 2020, 634 reports of adverse events when using specialized products were received from subjects of medical products circulation, of which 253 contained information about harm and threat to life and health, 43 – about deaths of patients. As of December 1, 2021, 599 events were registered with the use of medical devices, of which 11 cases were death of patients.