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DB 2006(04) Single-use Medical Devices: Implications and Consequences of Reuse

Document details:

Type: Publication
Series No: DB2006(04)
Audience: Healthcare professionals
Published: October 2006
Format: Electronic only
Size: A4
Pages: 14
Price: Free
ISBN/ISSN: 1-9-0073156-8
Author: MHRA
Copyright: Crown
   

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This publication replaces Device Bulletin 2000(04) ‘Single-use medical devices: implications and consequences of reuse’ published in 2000.

To reuse a single-use device without considering the consequences identified in this document could expose the patient and staff to risks which outweigh the perceived benefits of using the devices.

Key points:

  • A device designated for ‘single-use’ must not be reused. It should only be used on an individual patient during a single procedure and then discarded. It is not intended to be reprocessed and used again, even on the same patient.
  • The reuse of single-use devices can affect their safety, performance and effectiveness, exposing patients and staff to unnecessary risk.
  • The reuse of single-use devices has legal implications.

 

We have also published a leaflet to help clarify the term 'single-use' and the symbol that is used to represent it - see 'Related information' to the right.

 

Permission to reproduce section 4.2 from BS EN 980: 2003 (E) is granted by BSI.  British Standards can be obtained from BSI Customer Services, 389 Chiswick High Road, London W4 4AL.  Tel:  +44 (0)20 8996 9001.  email:  cservices@bsi-global.com.

Page last modified: 16 October 2006