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
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
원인
Ecri member hospitals have reported that clinicians are not responding quickly to critical alarms that are more musical in the latest intensive care respirator model. they report that the reason for all this is the non-recognition of alarms in more musical tones as alarms of urgency by the clinicians themselves. ecri reports that a delayed response may compromise the patient's condition or result in death.
조치
ECRI recommends (1) Please advise the staff in charge of this ECRI report and the alarm recognition problem. (2) Establish and initiate a program of awareness and recognition of alarms on respirators. (3) Ensure that all respirator patient care personnel are familiar with the importance and urgency of alarms with a more musical sounding of these respirators. For more information, contact your local representative or directly with ANVISA's Technovigilance at 0xx61-448-1331.