Mueller Hinton 2 Agar 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Biomerieux 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.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2014-04-11
  • 사례 출판 날짜
    2014-04-11
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: biomerieux mueller hinton 2 agar medical device manufacturer, biomerieux, has issued a field safety notice concerning mueller hinton 2 agar with reference number 43301, 43302, 43309, 43511, 41864 and 51075. the manufacturer’s internal studies have shown that some strains of staphylococcus aureus with a low level resistance to methicillin may be not detected when tested on mueller hinton 2 by using a cefoxitin disk and whatever the standards used. the two potential risks associated with this issue are as follows: susceptibility testing of a clinical isolate (diagnosis of infection): the non-detection of mrsa corresponds to a false sensitive result for the given antibiotic. then, the risk is to prescribe an antibiotic that will not be efficient (inappropriate treatment) and to delay the correct treatment. confirmation of methicillin resistance when mrsa has been isolated during a screening process: this is a confirmation of a positive screening test. so, a false negative test will alert the microbiologist and will lead to additional testing because the false negative result (obtained with the mueller hinton 2 medium) will be in discordant with the first screening positive result (usually obtained with a screening medium as chromid mrsa). in parallel, the manufacturer has developed a mueller hinton e (mhe) medium which is compliant with the european committee on antibiotic susceptibility testing (eucast) and the clinical and laboratory standards institute (clsi) standards. this new medium allows methicillin-resistant staphylococcus aureus (mrsa) detection even for the isolates expressing resistance at low level and whatever the genotype is (meca or mecc). therefore, based on the internal studies, the manufacturer strongly advises users to use mueller hinton e in replacement of mueller hinton 2 agar. in parallel, the manufacturer has developed a mueller hinton e (mhe) medium which is compliant with the european committee on antibiotic susceptibility testing (eucast) and the clinical and laboratory standards institute (clsi) standards. this new medium allows methicillin-resistant staphylococcus aureus (mrsa) detection even for the isolates expressing resistance at low level and whatever the genotype is (meca or mecc). therefore, based on the internal studies, the manufacturer strongly advises users to use mueller hinton e in replacement of mueller hinton 2 agar. in the case users would not being able to use the mueller hinton e and if they are using the ca‐sfm 2013 guidelines for mrsa detection, the manufacturer advises users to test by an alternative method all the isolates that have a cefoxitin inhibition zone falling between 25 and 29 mm. if the inhibition zone is ≥ 30 mm, users do not need to confirm with other tests. in the case users are using the eucast or the clsi standard, the manufacturers advises users not to use mueller hinton 2 agar anymore for mrsa detection purpose. in addition, the manufacturer recommends users to discuss with their laboratory directors to evaluate the impact and determine if any retrospective analysis of results is required. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 11 april 2014.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Biomerieux Mueller Hinton 2 Agar
  • Manufacturer

Manufacturer