Lancing devices used in nursing homes and care homes - correction to list of disposable single-use lancing devices

(All) MHRA continues to receive reports of hepatitis B outbreaks in nursing homes and care homes, which is linked with single-use lancing devices being used on multiple patients. (MDA/2006/066)

06 December 2006 at 11:00

MDA/2006/066

Action deadlines for the Safety Alert Broadcast System (SABS)

Deadline (action underway): 13 December 2006, Deadline (action complete): 02 January 2007

Device

Lancing devices used in nursing homes and care homes.

A lancing device consists of a lancet and a firing mechanism.

  • In disposable single-use lancing devices the lancet and the firing mechanism are one unit and the entire device is disposed of after a single use.
  • Non-disposable lancing devices consist of disposable and reusable components. A single-use lancet is used on each occasion but the firing mechanism (often pen-like in design) is reusable. Lancing devices of this type are available which are intended for use on multiple patients. Careworkers and healthcare professionals should be aware that similar devices are also available for single patient self-monitoring and are often provided with a blood glucose meter purchased over the counter. Such lancing devices are not suitable for use on multiple patients.

Problem

Transmission of hepatitis B between nursing home residents has been linked with the use of the wrong sort of lancing device. This has resulted in acute infections and deaths.

Two Medical Device Alerts have been issued about the transmission of hepatitis B linked to careworkers or healthcare professionals using the wrong type of lancing device to take blood samples in multi-patient environments (MDA/2004/044 and MDA/2005/063). These can be downloaded from the MHRA website http://www.mhra.gov.uk > publications > safety warnings > medical device alerts.

MHRA continues to receive reports of hepatitis B outbreaks where the use of the wrong type of lancing device has been implicated in the transmission of the virus. These further reports all relate to nursing homes and care homes.

MHRA is issuing this further Medical Device Alert to reinforce the earlier advice, particularly to users of lancing devices in nursing homes and care homes.

Action

For blood glucose monitoring nursing home and care home staff must only use: * disposable single-use lancing devices (these are used once and then the entire lancing device is discarded) or * a non-disposable lancing device which is intended for use on multiple patients and is used with disposable single-use lancets

Nursing home and care home owners and all staff involved in the management and provision of lancing devices should ensure that the right devices are provided for taking blood samples in multi-patient environments. Examples of disposable single-use lancing devices and non-disposable lancing devices have been evaluated by the NHS Purchasing and Supply Agency Evaluation Report 06002 Lancing Systems. The devices evaluated in the report, which are suitable for testing patients in nursing homes and care homes, are listed below:

Disposable single-use lancing devices

  • HaeMedic Haemolance Plus
  • SurgiLance Safety Lancet
  • BD Genie Safety Lancet
  • HemoCue Safety Lancet
  • Owen Mumford Unistik 3
  • Roche Accu-Chek Safe-T-Pro Plus
  • Greiner Bio-One Vacuette Safety Lancet
  • VitalCare Auto Safety Lancet (this product is available on prescription)
  • Vitrex Safe Safety Lancet
  • ITC Tenderlett

Multi-patient non-disposable lancing devices

  • Bayer Glucolet 2 which uses Bayer Minilet single-use lancets
  • Roche Accu-Chek Softclix Pro which uses Roche Softclix Pro lancets (Note Roche Accuchek Softclix, Softclix II, Softclix Plus and Multiclix lancing devices are intended for self-use by one patient only to take blood samples for self-monitoring. They are not intended for use by healthcare or care workers to obtain blood samples from multiple patients).

Pages 25-31 of the evaluation report are appended to this Medical Device Alert (in pdf only). A full copy of the report can be downloaded from the PASA website at http://www.pasa.nhs.uk/evaluation > publications > pathology > blood glucose monitoring systems and lancing devices. Please note that this list is not exhaustive and that other products may also be suitable.

Action by

Nursing home and care home staff.

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:

SABS liaison officers for onward distribution to all relevant staff including:

  • Diabetes nurse specialists
  • Microbiologists

Healthcare Commission (CHAI) to:Headquarters for onward distribution to:

  • Hospitals in the independent sector
  • Independent treatment centres

Primary care trusts to:

SABS liaison officers for onward distribution to all relevant staff including:

  • Community diabetes specialist nurses
  • Community nurses
  • Community pharmacists
  • Directors of public health
  • District nurses
  • General practitioners
  • Infection control nurses
  • Pharmaceutical advisors

Commission for Social Care Inspection (CSCI) to: Headquarters for onward distribution to:

  • Adult placements
  • Care homes (adults, older people and children)
  • Care homes providing nursing care
  • Inspectors
  • Residential special schools

Social services to:

Liaison officers for onward distribution to all relevant staff including:

  • In-house residential care homes

Health Protection Agency to:

Directors for onward distribution to:

  • Consultants in communicable disease control
  • Health protection nurses

Contacts

Enquiries to the MHRA should quote reference number 2006/009/012/291/010 and be addressed to:

Technical aspects

Ainsley Wickens or Catriona Blake
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ

Tel: 020 7084 3273/3219
Fax: 020 7084 3209

E-mail: ainsley.wickens@mhra.gsi.gov.uk & catriona.blake@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

E-mail: jonathan.plumb@mhra.gsi.gov.uk

Change of address or removal from address list for CSCI:

CSCI Customer Service Unit
St Nicholas Building
St Nicholas Street
Newcastle-upon-Tyne
NE1 1NB

Tel: 0845 015 0120

E-mail: enquiries@csci.gsi.gov.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; online 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 officer 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

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