Reusable transoesophageal echocardiography, transvaginal and transrectal ultrasound probes (transducers) – failure to appropriately decontaminate
(Invacare) Should be appropriately decontaminated between each patient use. (MDA/2012/038)
CAS deadlines
Action underway: 11 July 2012, action complete: 19 July 2012
Note: These deadlines are for systems to be in place to ensure the actions are undertaken.
Device
Reusable transoesophageal echocardiography, transvaginal and transrectal ultrasound probes (transducers).
All models.
All manufacturers.
Problem
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.
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 Devices
Be 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 manual
Also be aware of similar advice as/when published by the devolved administrations.
Action by
Trust decontamination leads.
Healthcare professionals using these devices and staff responsible for reprocessing medical devices.
Distribution
This MDA has been sent to
- NHS trusts in England (chief executives)
- Care Quality Commission (CQC) (headquarters) for information
- HSC trusts in Northern Ireland (chief executives)
- NHS boards in Scotland (equipment coordinators)
- Local authorities in Scotland (equipment coordinators)
- NHS boards and trusts in Wales (chief executives)
- Primary care trusts in England (chief executives)
Onward distribution
Please bring this notice to the attention of relevant employees in your establishment. Below is a suggested list of recipients.
Trusts
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
- Adult intensive care units
- All wards
- Anaesthetists
- Coronary care departments
- A&E departments
- A&E departments
- Cardiologists
- Clinical governance leads
- Colposcopy departments
- Day surgery units
- Decontamination leads
- Directors of infection prevention and control
- Endoscope reprocessing units
- Endoscopy units
- Gastroenterology departments
- General surgery
- Gynaecology departments
- Gynaecology nurses
- Health and safety managers
- Infection control departments
- Infection control nurses
- Infection prevention and control directors
- Intensive care nursing staff (adult)
- Intensive care units
- Microbiologists
- Outpatients
- Radiographers
- Radiologists
- Radiology departments
- Risk managers
- Sonographers
- Sterile services departments
- Theatres
- Ultrasound departments
- Urologists
Primary care trusts
CAS liaison officers for onward distribution to all relevant staff including:
- Community hospitals
- Infection control nurses
Independent distribution
Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:
- Hospitals in the independent sector
- Independent treatment centres
Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.
Feedback
If you have any comments or feedback on this Medical Device Alert please email us at: dts@mhra.gsi.gov.uk
England
If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2012/037 or 2011/007/026/081/015.
Technical aspects
John McManus or Sharon Knight
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ
Tel: 020 3080 7226 or 020 3080 7202
Fax: 020 8754 3965
Email: john.mcmanus@mhra.gsi.gov.uk or sharon.knight@mhra.gsi.gov.uk
Clinical aspects
Dr Nicola Lennard
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ
Tel: 020 3080 7126
Fax: 020 8754 3965
Email: nicola.lennard@mhra.gsi.gov.uk
How to report adverse incidents
Please report via our website: Reporting adverse incidents involving medical devices
Further information about CAS can be found on the CAS website
Northern Ireland
Alerts in Northern Ireland will continue to be distributed via the NI SABS system.
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald BT4 3SQ
Tel: 02890 523 704
Fax: 02890 523 900
Email: NIAIC@dhsspsni.gov.uk
How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on the NIAIC website
Further information about SABS can be found on the SABS website
Scotland
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh EH12 9EB
Tel: 0131 275 7575
Fax: 0131 314 0722
Email: nss.iric@nhs.net
Wales
Enquiries in Wales should be addressed to:
Improving Patient Safety Team
Medical Directorate
Welsh Government
Cathays Park
Cardiff CF10 3NQ
Tel: 029 2082 3922
Email: Haz-Aic@wales.gsi.gov.uk
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