Medical Device Alert: All types of Oxford slings and standing harnesses, for use with hoists and stand aids, manufactured by Joerns Healthcare Ltd (MDA/2010/019)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/019 or 2008/011/006/401/013.

Jonathan Smith or Emma Rooke
Medicines and Healthcare products Regulatory Agency
Centre for Assistive Technology
241 Bristol Avenue
Bispham
Blackpool
FY2 0BR

Tel: 01253 596 000
Fax: 01253 596 177

Email: bav@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).

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: 028 9052 3704
Fax: 028 9052 3900

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).

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

Unclear instructions for use. The MHRA has received various incident reports where occupants have been injured as a result of incorrect use or inadequate inspections of slings before use.

The manufacturer has now changed the instructions for use (IFU) to include details of pre-use checks including sling choice, sling position, checks of critical stitching elements and occupant transfer method to reduce the risk of further incidents.

Joerns Healthcare Ltd issued a Field Safety Notice (FSN) in November 2009 and placed the updated IFU on the Joerns Healthcare website (external link). However, the manufacturer cannot be sure that all relevant people received their FSN, so the MHRA has issued this alert.

• Obtain copies of the revised instructions for use (IFU) from the manufacturer.
• Ensure users are aware of the revised IFU and that procedures are in place to ensure that they are followed in future.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• Care Quality Commission (CQC)
• HSC trusts in Northern Ireland (Chief Executives)
• NHS boards in Scotland (Chief Executives)
• NHS boards and trusts in Wales (Chief Executives)
• OFSTED
• Primary care trusts in England (Chief Executives)
• Social services in England (Directors)
• Social services in Scotland (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:

• All wards
• Equipment store managers
• Maintenance staff and contractors
• Moving and handling co-ordinators
• Nurses
• Nursing executive directors
• Occupational therapists
• Physiotherapists
• Risk managers

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

• Care homes providing nursing care (adults)
• Care homes providing personal care (adults)
• Domiciliary care providers
• Further education colleges registered as care homes
• Hospices
• Hospitals in the independent sector
• Nursing agencies

OFSTED to:
The MHRA considers this to be important to:

• Educational establishments with facilities for the disabled
• Residential special schools

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

• Community hospitals
• District nurses
• Equipment store managers
• Maintenance staff and contractors
• Moving and handling co-ordinators
• Nurses
• Occupational therapists
• Palliative care team
• Physiotherapists
• Risk managers

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

• Care at home staff
• Care management team managers
• Community care staff
• Equipment store managers
• In-house domiciliary care providers (personal care services in the home)
• In-house residential care homes
• Moving and handling co-ordinators
• Occupational therapists

Customer Services Department
Joerns Healthcare Ltd
High Street
Wollaston
West Midlands
DY8 4PS

Tel: 01384 446 622
Fax: 01384 446 601

Email: info@joerns.co.uk