The UK MHRA has issued a Medical Device Alert relating to an incident in which a reusable transoesophageal echocardiography probe may have been associated with the death of a patient due to a failure to appropriately decontaminate the device between uses. Rather than identifying one particular manufacturer, type or brand of probe the MHRA is using this case as a general warning that local procedures for all ultrasound probes that are used within body cavities should be reviewed and if necessary updated to ensure that they are decontaminated appropriately between each patient use, in accordance with the manufacturer’s instructions.
Furthermore the agency is directing hospital trust decontamination leads, users and processors of these devices to ensure that staff who decontaminate medical devices are appropriately trained and fully aware of their responsibilities.
The full alert can be found here and pertains to reusable transoesophageal echocardiography, transvaginal and transrectal ultrasound probes (transducers).
Source: MHRA
published: July 2, 2012 in: Alerts/Adverse Events