Medical Device Alert: Walking frames manufactured by Sunrise Medical (MDA/2012/082)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2012/082 or 2012/010/010/081/005

Technical aspects
Patrick Sweeney or Catriona Blake
Medicines & Healthcare products Regulatory Agency,
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ
Tel:  020 3080 6898 / 7219                                                 
Fax:  020 8754 3965
Email:  patrick.sweeney@mhra.gsi.gov.uk  or catriona.blake@mhra.gsi.gov.uk

Clinical aspects
Mark Grumbridge
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ
Tel: 020 3080 7128  
Fax:  020 8754 3965
Email:    mark.grumbridge@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 (external link)

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 (external link)
Further information about SABS can be found on the SABS website (external link)

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 (IRIC) (external link)

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

Risk of falls due to the walking frame becoming unstable.

The rear screws that fasten the C-shaped lower bar to the frame may fail because of a manufacturing fault.

The failure usually occurs a short time after assembly.

• Identify affected devices.
• Undertake a visual check of affected devices located in stores. All rear screws should be checked to ensure that they are present, not loose or broken.
• Affected devices passed on to end users should also be visually checked for these failures.
• Devices that are found to have missing, broken or damaged screws are to be quarantined and not used.
• Return damaged devices to the manufacturer for replacement or corrective action.

Action by

All those involved in the provision and maintenance of walking frames. In particular: nurses, physiotherapists, occupational therapists and managers of equipment stores.

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)
• Health and Safety Executive
• Primary care trusts in England (chief executives)
• Social services in England (directors)

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:

• All wards and clinical departments
• Clinical governance leads
• EBME departments
• Equipment stores
• Health and safety managers
• Hospital at home units
• In-house maintenance staff
• Maintenance staff
• Occupational therapists
• Physiotherapists
• Rehabilitation engineers
• Risk managers

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

• Community hospitals
• Community nurses
• District nurses
• Equipment libraries and stores
• Maintenance staff
• Occupational health departments
• Occupational therapists
• Physiotherapists

Social services
Liaison officers for onward distribution to all relevant staff including:

• Day centres (older people, learning disabilities, mental health, physical disabilities, respite care, autistic services)
• Disability equipment stores
• Equipment stores
• Equipment supplies managers
• Loan store managers
• Loaned equipment store managers
• Occupational therapists

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)

• Care homes providing nursing care (adults)
• Care homes providing personal care (adults)
• Hospitals in the independent sector

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.

Simon Collins
Sunrise Medical Limited
Thorns road
Brierly Hill
West Midlands
DY5 2LD                                
Tel: 0845 605 6688                                   
Email:  UKquality@sunmed.co.uk

If you have any comments or feedback on this Medical Device Alert please email us at: dts@mhra.gsi.gov.uk