Medical Device Alert: Sigmoidoscope and anoscope systems and accessories manufactured by Welch Allyn Limited (MDA/2010/060)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/060 or 2009/012/008/081/012.

Technical aspects
Ian Smith or Allan Hidderley
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3306 or 3172
Fax: 020 7084 3106

Email: ian.smith@mhra.gsi.gov.uk or allan.hidderley@mhra.gsi.gov.uk

Clinical aspects
Jonathan Plumb
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3128
Fax: 020 7084 3111

Email: jonathan.plumb@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 Central Alerting System website (external link).

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

Northern Ireland Adverse Incident Centre (NIAIC) (external link)

How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on the NIAIC website (external link).
Further information about SABS can be found on the SABS website (external link).

Important note: Users should ensure that reusable devices are reprocessed in line with The Glennie Technical Requirements. Check the device compatibility with your decontamination process and equipment prior to acquisition and use. Any compatibility issues should be discussed with the manufacturer.

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

Health Facilities Scotland - Incident Reporting and Investigation Centre (external link).

Enquiries in Wales should be addressed to:

Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3922

Email: Haz-Aic@wales.gsi.gov.uk

Potential cross-contamination from inadequate decontamination of reusable insufflation bulb and light head accessories.

The reusable insufflation bulb and light head portions of the disposable sigmoidoscope and anoscope can potentially come into contact with body fluids during clinical use. If they are not effectively decontaminated they may then cause cross-contamination between patients with a risk of infection.

To mitigate this risk the manufacturer has:

• provided new, validated reprocessing instructions (external link), which include cleaning and high level disinfection or cleaning and sterilization
• recommended the use of a single-use insufflation bulb filter to minimise the risk of contaminating the internal surfaces of the bulb assembly.

This has been notified to users in a Field Safety Notice.

This alert has been issued as the manufacturer is unable to confirm that all users of the sigmoidoscope and anoscope systems have received the Field Safety Notice and associated new reprocessing instructions.

• Ensure that the new reprocessing instructions and manufacturer’s Field Safety Notice, are circulated to the relevant personnel within your organisation.
• Ensure that these devices are reprocessed in accordance with the new reprocessing instructions.
• Ensure that a single-use insufflation bulb filter is used, as recommended by the manufacturer.

This MDA has been distributed to:

• NHS trusts in England (chief executives)
• HSC trusts in Northern Ireland (chief executives)
• NHS boards in Scotland (chief executives)
• 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 all who need to know or be aware of it. This may include distribution by:

Trusts to:
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

• Accident and emergency departments
• Endoscopy suite managers
• Gastroenterology departments
• Gastroenterology, directors of
• Gastro-intestinal surgeons
• General surgical wards
• General medical wards
• Infection control departments
• Infection control nurses
• Infection prevention and control directors
• Outpatient departments
• Sterile services departments
• Theatre managers
• Theatre nurses
• Theatres

Care Quality Commission (CQC) (England only) to:
The MHRA considers this information to be important to:

• Hospitals in the independent sector
• Private medical practitioners

Primary care trusts to:
CAS liaison officers for onward distribution to all relevant staff including:

• Endoscopy suites
• General practitioners undertaking endoscopy

Jennifer Judge
Welch Allyn Limited
Navan, Co.Meath
Republic of Ireland

Tel: 00353 46 90 67732
Fax: 00353 46 90 67756

Email: judgej@welchallyn.com