Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는
Slovenia
에서 Maquet Cardiopulmonary GmbH 에 의해 제조된 제품과 관련되어 있습니다.
이것은 무엇인가요?
현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
데이터 추가 비고
원인
Our internal investigations have confirmed that the current
published disinfection procedure of the hu 35 system’s water
paths (in the instructions for use) does not adequately meet
contemporary hygienic requirements and effectiveness against
atypical mycobacteria.
although the water in the hu 35 circuit does not come into
direct contact with the patient, there is the unlikely, but
potential risk that bacterial contaminated water could cause
adverse health consequences to the patient, e.G. by
transmission (insufficient hygiene) via clinical staff members
while managing the extra corporeal life support. .