안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.
Belarussian data is current through June 2016. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Belarus.
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The manufacturer, on its own initiative, decided to implement a voluntary global recall from the medical device market. the reason for the global recall from the market was the analysis of unpublished data, carried out at the request of the ethicon medical safety team by two independent registries in the field of hernia treatment (the german herniamed registry and the danish hernia database dhdb). the rate of relapses / reoperations after laparoscopic surgery to remove ventral hernias using medical devices was higher than the average recurrence rate among patients in these registers.