Safeguarding public health

MEDICAL DEVICE ALERT

Issued: 17 April 2008 at 11:00 Ref: MDA/2008/026

9 Immediate action
Action
Update
Information request

Device:
Birthright birthing bed mattresses manufactured by Huntleigh
Healthcare.
Problem: ►Page 2
A risk of cross-infection from contaminated mattress cores.
Action by:
All those using, providing or maintaining birthing beds. In particular maternity unit managers,
midwifery staff, maintenance staff and contractors.
Action:
• Trace all Huntleigh Healthcare Birthright mattresses in use or in storage.
• Open the mattress covers and check for signs of contamination on the mattress core and
also for wear, damage or holes in the mattress covers.
• Dispose of contaminated mattress cores and damaged mattress covers and contact
Huntleigh Healthcare on 01582 413 104 for replacements.
• Arrange for undamaged mattress covers to be cleaned in accordance with the
manufacturer’s instructions.
• For the future, ensure that procedures are in place for the cleaning and regular removal
of covers to check for contamination of the mattress core and damage to the cover, in
accordance with the manufacturer’s revised instructions.
Distributed to:
NHS trusts in England – Chief Executives*
Healthcare Commission (CHAI) – Headquarters ►Page 2
Primary care trusts in England – Chief Executives*
NHS Boards in Scotland – Chief Executives
* via CE Bulletin
Contacts:
Details of manufacturer contacts and contacts for technical and clinical aspects. ►Pages 2-3
Change of address or removal from address list for Healthcare Commission.

Action deadlines for the Safety Alert Broadcast System (SABS)

Deadline (action underway): 24 April 2008 Deadline (action complete): 23 May 2008

This notice is also on our website: http://www.mhra.gov.uk

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Issued: 17 April 2008 at 11:00 Ref: MDA/2008/026

Problem:
Investigation has revealed a risk of cross-infection with these mattresses if regular inspection of the cover
and core is not carried out. Residues of blood and bodily fluids from previous occupants have been found
inside mattress covers and on the mattress core. This has been caused by a combination of wear, damage,
and small flaws in the welded seam of the mattress cover, which allowed blood and bodily fluids to seep
through and contaminate the mattress core.

The manufacturer’s original instructions for use did not require frequent checks of the mattress cover and
core. Huntleigh Healthcare is updating the instructions for use to cover this issue and they will be available
shortly. In addition, they have improved the quality assurance during the manufacture of new covers.

Huntleigh Healthcare will provide free replacements for any affected mattress covers or cores that are less
than 12 months old. They have some mattress cores and covers in stock and have placed an order for
additional supplies, which will be available within two weeks.

Gloves and protective clothing should be worn when checking for contamination. Other general guidance on
the management of medical devices can be found in MHRA Device Bulletin DB 2006(05) available from the
MHRA website at www.mhra.gov.uk.

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: Healthcare Commission (CHAI) to:
SABS liaison officers for onward distribution to Headquarters for onward distribution to:
all relevant staff including: • Hospitals in the independent sector
• Clinical governance leads • Private midwives
• Equipment stores
• Health and safety managers Primary care trusts to:
• Infection control teams SABS liaison officers for onward distribution to
• Maintenance staff and contractors all relevant staff including:
• Maternity units • Community maternity units
• Midwifery departments • Community midwives
• Midwifery staff • Infection control teams
• Nursing executive directors • Risk managers
• Obstetricians
• Obstetrics and gynaecology departments
• Obstetrics and gynaecology directors
• Obstetrics nurses
• Risk managers
• Supplies managers

Contacts:
Enquiries to the manufacturer should be addressed to:
Huntleigh Healthcare Ltd.
310-312 Dallow Road
Luton
Bedfordshire LU1 1TD

Tel: 01582 413 104

Fax: 01582 459 100

E-mail: sales.admin@huntleigh-healthcare.com

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Issued: 17 April 2008 at 11:00 Ref: MDA/2008/026

Contacts (continued):
Enquiries to the MHRA should quote reference number MDA/2008/026 or 2007/010/025/061/001 and be
addressed to:
Technical aspects: Clinical aspects:
Sharon Knight or Andy Marsden Jonathan Plumb
Medicines & Healthcare products Regulatory Agency Medicines & Healthcare products Regulatory Agency
Market Towers Market Towers
1 Nine Elms Lane 1 Nine Elms Lane
London SW8 5NQ London SW8 5NQ
Tel: 020 7084 3202 / 3205 Tel: 020 7084 3128
Fax: 020 7084 3209 Fax: 020 7084 3111
E-mail: sharon.knight@mhra.gsi.gov.uk E-mail: jonathan.plumb@mhra.gsi.gov.uk
andy.marsden@mhra.gsi.gov.uk
Enquiries for Scotland should be directed 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
E-mail: iric@shs.csa.scot.nhs.uk

Change of address or removal from address list for Healthcare Commission:

Healthcare Commission
Finsbury Tower
103-105 Bunhill Row
London EC1Y 8TG
Tel: 020 7448 0842
E-mail: contacts@healthcarecommission.org.uk

How to report adverse incidents

Incidents relating to medical devices must be reported to the Medicines and Healthcare products
Regulatory Agency (MHRA) as soon as possible.
Further information about reporting incidents; on-line incident reporting facilities; and
downloadable report forms are available from MHRA's website (http://www.mhra.gov.uk).

Alternatively, further information and printed incident report forms are available from:
MHRA Adverse Incident Centre
Medicines and Healthcare products Regulatory Agency
Market Towers, 1 Nine Elms Lane, London SW8 5NQ
Telephone 020 7084 3080 or Fax 020 7084 3109
or e-mail: aic@mhra.gsi.gov.uk
(An answerphone service operates outside normal office hours)

Medical Device Alerts are available in full text on the MHRA website: http://www.mhra.gov.uk
Further information about SABS can be found at www.info.doh.gov.uk/sar2/cmopatie.nsf

MHRA is an executive agency of the Department of Health

© Crown Copyright 2008
Addressees may take copies for distribution within their own organisations

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