Events

Alerta De Seguridad O Notificaciones De Seguridad para Reusable transoesophageal echocardiography, transvaginal and transrectal ultrasound probes (transducers)

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Invacare.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • Número del evento
    MDA/2012/038
  • Fecha
    2012-06-28
  • Fecha de publicación del evento
    2014-12-17
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/medical-device-alert-reusable-transoesophageal-echocardiography-transvaginal-and-transrectal-ultrasound-probes-transducers-failure-to-appropriately-decontaminate
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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.
  • Causa
    (invacare) should be appropriately decontaminated between each patient use. (mda/2012/038).
  • Acción
    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...
  • Modelo / Serial
  • Descripción del producto
    Reusable transoesophageal echocardiography, transvaginal and transrectal ultrasound probes (transducers).All models.All manufacturers.
  • Manufacturer
    Invacare

Manufacturer

Invacare