Medical Device Alert: All types of bed mattresses (MDA/2010/002)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/002 or 2009/011/017/301/001.

20 copies of the poster will be distributed to liaison officers in acute care trusts, PCTs and social services by the end of January 2010. Further copies are available from the Department of Health Orderline (external link) – product code MATTRESS-POSTER. Alternatively download the PDF for local printing.

Technical aspects
Andy Marsden
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3205
Fax: 020 7084 3209

Email: andy.marsden@mhra.gsi.gov.uk

Brian Mather
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: brian.mather@mhra.gsi.gov.uk

Clinical aspects
Jonathan Plumb
Medicines and 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 in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre (NIAIC)
Health Estates
Estate Policy Directorate
Stoney Road
Dundonald
Belfast
BT16 1US

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).

The MDA referred to under the problem tab, MDA/2007/065 - Hospital beds: Hill-Rom TotalCare Duo 2 has a Scottish equivalent Hazard Notice, issued on 5 Sept 2007: HAZ(SC)07/14 Hill-Rom TotalCare® Duo 2® pressure relieving hospital beds: risk of cross infection (external link).

Requests for copies of the poster should not be directed to MHRA. The poster should be downloaded from the MHRA website for local printing as described under the England tab.

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:

National Assembly for Wales
HIMTE 3 Division
NHS Directorate
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3373
Fax: 029 2082 5479

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

If mattress covers are damaged, body or other fluids can pass through and contaminate the inner core.

There is the potential for cross-infection if contaminated mattresses remain in use.

The MHRA has received numerous reports of damaged covers and associated interior mattress contamination.

Three Medical Device Alerts have already been issued on specific models:
MDA/2007/065 - Hospital beds: Hill-Rom TotalCare Duo 2
MDA/2008/026 - Birthright birthing bed mattresses manufactured by Huntleigh Healthcare
MDA/2009/051 - Thermo contour mattress for hospital beds manufactured by Barrington Healthcare International Ltd (withdrawn).

Investigations have revealed that there is a widespread lack of inspection regimes that incorporate frequent checks for external damage and internal contamination.

Mattress covers can become damaged at any time during use or storage, for example from: needle stick; strike-through; damage from sharp objects; abrasion during handling, transport or movement; inappropriate cleaning and decontamination procedures.

If mattresses with non-removable covers are in use it is impossible to check the level of contamination on the inside.

• Inspect the exterior surface of each mattress cover for signs of damage, such as holes or cuts.
• Remove the cover and inspect its inside surface and the mattress core for staining or contamination.
• Safely dispose of any covers showing signs of damage or staining.
• Arrange for contaminated mattress cores to be either: cleaned and decontaminated in accordance with the manufacturer’s instructions; or safely disposed of.
• Ensure that a frequent inspection regime is established for all mattresses before and during use.
• Distribute the attached poster within your organisation.

A poster to help raise awareness of this problem is attached below as a PDF file, which should be distributed within your organisation. If you print the poster yourself, please print it in colour to show the contamination.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• Care Quality Commission (CQC) (Headquarters)
• HSC trusts in Northern Ireland (Chief Executives) – for information only
• 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)

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:

• A&E departments
• All wards
• Day surgery units
• EBME departments
• Equipment store managers
• Infection control staff
• Infection prevention and control directors
• Intensive care units
• Maintenance staff and contractors
• Medical directors
• Nursing executive directors
• Purchasing managers
• Risk managers
• Tissue viability staff

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

• Care homes providing nursing care (adults)
• Further education colleges registered as care homes
• Hospices
• Hospitals in the independent sector
• Independent treatment centres
• Infection control staff

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

• Community hospitals
• Community nurses
• Equipment store managers
• Infection control staff
• Maintenance staff and contractors
• Palliative care teams
• Tissue viability staff

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

• Equipment store managers
• Equipment supplies managers
• In-house domiciliary care providers (personal care services in the home)
• In-house residential care homes
• Care staff
• Nursing staff
• Maintenance staff and contractors
• Infection control staff

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

• Residential special schools