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MDA/2007/011 - BOC Ltd, AZ size aluminium medical nitrous oxide cylinders fitted with a key operated pin index valve for use in MRI units

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/011
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 5
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 05 February 2007 at 14:00
Ref: MDA/2007/011

 

Tick mark
Immediate action
 
Action
Tick mark
Update
 
Information request


This alert extends the guidance issued on 24 January 2007 in MDA/2007/007.  
Device:
BOC Ltd, AZ size aluminium medical nitrous oxide cylinders fitted with a key operated pin index valve for use in MRI units.		  
Problem:
Following the issue of MDA/2007/007, regarding AZ aluminium medical oxygen cylinders, BOC have informed MHRA that a similar problem has been found in a small number of medical nitrous oxide AZ cylinders. These cylinders have also been fitted with an obsolete pin index valve containing a ferromagnetic component that makes the cylinder potentially hazardous when used in an MRI environment.

>Page 2

Action by:
Anaesthetists, operating department practitioners and anaesthetic nurses working in MRI units. Hospital pharmacists, MRI safety advisors and MRI superintendent radiographers.		  

Action:

  • Identify the affected cylinders (images of the affected valve and the two acceptable alternatives showing the relevant stamp markings are appended to this Alert)
  • Quarantine affected cylinders outside the MRI suite and clearly label ‘unsuitable for MRI use’
  • Arrange for return to BOC Ltd
  • MRI unit operators are advised to carry out magnetic testing of all cylinders prior to their use in an MRI environment.
 Appendix

Distributed to:

NHS trusts in England - Chief Executives*
Healthcare Commission (CHAI) - Headquarters

* via CE Bulletin

>Page 2

Contacts:
Details of supplier contact and MHRA Defective Medicines contact.
Change of address or removal from address list for Healthcare Commission.

>Page 2

Appendix:
Images of the affected valve and the two acceptable alternatives.

>Pages 4-5



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 07 February 2007
Deadline (action complete): 14 February 2007


 

Page last modified: 07 February 2008