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MDA/2005/063 - Lancing devices - including Roche Accu-Chek Softclix, Softclix II, Softclix Plus and Multiclix lancing devices

Document details:

Type: Medical Device Alert
Series No: MDA/2005/063
Audience: Healthcare professionals
Published:
Format:
Size: A4
Pages: 4
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Ref. MDA/2005/063
Issued: 28 November 2005

IMMEDIATE ACTION Tick mark
ACTION  
UPDATE  
INFORMATION REQUEST  


  Further Information
DEVICE:
Lancing devices - including Roche Accu-Chek Softclix, Softclix II, Softclix Plus and Multiclix lancing devices.
 

PROBLEM:
These, and some other, lancing devices are intended for self-use by one patient only, to take blood samples for self-monitoring.
The use of Softclix and Softclix II lancing devices by healthcare and care workers to take blood samples from multiple patients has been implicated in the transmission of hepatitis B between patients.

 >

ACTION BY:
All healthcare and care workers involved in the purchase, supply, provision or use of lancing devices.
 
ACTION:
When testing multiple patients, healthcare and care workers should not use single patient lancing devices such as the Roche Accu-Chek Softclix, Softclix II, Softclix Plus or Multiclix lancing devices to obtain blood samples.
When obtaining blood samples from more than one patient healthcare and care workers must ensure that the lancing device that they use is intended for this purpose.

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DISTRIBUTED to:

NHS Trusts (England) - Chief Executives*
Commission for Social Care Inspection (CSCI) - Headquarters
Healthcare Commission (CHAI) - Headquarters
Primary Care Trusts (England) - Chief Executives*
Social Services (England) - Directors*
Health Protection Agency (HPA) - Directors

* via CE Bulletin

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CONTACTS:
Details of manufacturer contacts, MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for CSCI and Healthcare Commission.

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> Further information supplied in the following pages.

Page last modified: 28 November 2005