Events

Safety Alert Or Field Safety Notices for Reusable transoesophageal echocardiography, transvaginal and transrectal ultrasound probes (transducers)

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Invacare.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event Number
    MDA/2012/038
  • Date
    2012-06-28
  • Event Date Posted
    2014-12-17
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-reusable-transoesophageal-echocardiography-transvaginal-and-transrectal-ultrasound-probes-transducers-failure-to-appropriately-decontaminate
  • Notes / Alerts
    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.
  • Extra notes in the 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.
  • Reason
    (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...
  • Model / Serial
  • Product Description
    Reusable transoesophageal echocardiography, transvaginal and transrectal ultrasound probes (transducers).All models.All manufacturers.
  • Manufacturer
    Invacare

Manufacturer

Invacare