Events

Alerte Ou Avis De Sécurité sur Reusable transoesophageal echocardiography, transvaginal and transrectal ultrasound probes (transducers)

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Invacare.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • Numéro de l'événement
    MDA/2012/038
  • Date
    2012-06-28
  • Date de publication de l'événement
    2014-12-17
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://www.gov.uk//drug-device-alerts/medical-device-alert-reusable-transoesophageal-echocardiography-transvaginal-and-transrectal-ultrasound-probes-transducers-failure-to-appropriately-decontaminate
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    (invacare) should be appropriately decontaminated between each patient use. (mda/2012/038).
  • Action
    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...
  • Modèle / numéro de série
  • Description du dispositif
    Reusable transoesophageal echocardiography, transvaginal and transrectal ultrasound probes (transducers).All models.All manufacturers.
  • Manufacturer
    Invacare

Manufacturer

Invacare