Events

Reusable transoesophageal echocardiography, transvaginal and transrectal ultrasound probes (transducers) 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Invacare 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.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert / Field Safety Notice
  • 사례 연번
    MDA/2012/038
  • 날짜
    2012-06-28
  • 사례 출판 날짜
    2014-12-17
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-reusable-transoesophageal-echocardiography-transvaginal-and-transrectal-ultrasound-probes-transducers-failure-to-appropriately-decontaminate
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • 데이터 추가 비고
    MHRA is aware of an incident where the death of a patient from hepatitis B infection may have been associated with a failure to appropriately decontaminate a transoesophageal echocardiography probe between each patient use.MHRA is issuing this alert to advise users to appropriately decontaminate all types of reusable ultrasound probes.
  • 원인
    (invacare) should be appropriately decontaminated between each patient use. (mda/2012/038).
  • 조치
    Review, and if necessary update, local procedures for all ultrasound probes that are used within body cavities to ensure that they are decontaminated appropriately between each patient use, in accordance with the manufacturer’s instructions.Ensure that staff who decontaminate medical devices are appropriately trained and fully aware of their responsibilities.Be aware of the MHRA’s guidance document Managing Medical DevicesBe aware of the Department of Health’s publications (England only): Choice Framework for local Policy and Procedures 01-06 – Decontamination of flexible endoscopes: Operational management manual 13536:1.0.Available from Space for Health, sign-in required: Choice Framework for local Policy and Procedures 01-06 – Decontamination of flexible endoscopes: Operational management manualAlso be aware of similar advice as/when published by the devolved administrations.

Device

Reusable transoesophageal echocardiography, transvaginal and transrectal ultrasound probes (trans...
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Reusable transoesophageal echocardiography, transvaginal and transrectal ultrasound probes (transducers).All models.All manufacturers.
  • Manufacturer
    Invacare

Manufacturer

Invacare