Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는
Brazil
에서 N/A 에 의해 제조된 제품과 관련되어 있습니다.
이것은 무엇인가요?
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.
Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
데이터 추가 비고
LAW No. 6.437 OF AUGUST 20, 1977 - (Published in the Official Gazette of 24 August 1977, page 11145) - Configures infractions to federal sanitary legislation, establishes the respective sanctions, and makes other provisions. Art. 10. Sanitary infractions: XVI - Change the manufacturing process of products subject to sanitary control, modify its basic components, name, and other elements subject to registration, without the necessary authorization from the competent sanitary body.
원인
Existence of companies in the market that automate autoclaves of any manufacturing, replacing the existing electromechanical controls, making the autoclave fully automatic without the necessary consent of the manufacturer and authorization of the competent sanitary body.
조치
Do not accept that companies automate the autoclaves, with controllers, without the necessary consent of the manufacturer and authorization of the competent sanitary organ. ANVISA is supervising these companies.