In Safety warnings

Enter a keyword or phrase to search all pages in this section:


Advanced search

Archive:

Looking for a previously published document in this section?

MDA/2004/022 - Cidex® OPA ortho-phthalaldehyde high level disinfectant solution

Printer friendly version (new window)

Document details:

Type: Medical Device Alert
Series No: MDA/2004/022
Audience: Healthcare professionals
Published:
Format:
Size: A4
Pages: 4
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

Help viewing PDFs:

Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.

Page 1

Ref. MDA/2004/022
Issued: 26 May 2004

IMMEDIATE ACTION  
ACTION Tick mark
UPDATE  
INFORMATION REQUEST  


  Further Information
DEVICE:
Cidex® OPA ortho-phthalaldehyde high level disinfectant solution.		  
*
PROBLEM:
Repeated exposure to Cidex® OPA high level disinfectant solution, following manual re-processing of urological instruments, may have resulted in hypersensitivity in some patients with a history of bladder cancer undergoing repeated cystoscopy.		  
*

ACTION BY:

  • Healthcare personnel using the above disinfectant
  • Healthcare personnel managing the above patients
  

ACTION:
When re-processing urological instruments for use inpatients who have potential for repeated exposure:

  • Do not use Cidex® OPA if a validated alternative is available.
  • If no validated alternative to Cidex® OPA is available:
    • carry out a risk assessment on the continued use of this disinfectant solution;
    • ensure that measures are in place to minimise disinfectant solution residues (e.g. use of a validated endoscope washer-disinfector);
  • plan and implement the replacement of this disinfectant solution with an alternative.
  
*

DISTRIBUTED to:

NHS Trusts (England) - Chief Executives
Healthcare Commission (CHAI) - Headquarters
Primary Care Trusts (England) - Chief Executives

 

  
*
CONTACTS:
Details of manufacturer/supplier contacts, MHRA contacts for technical and clinical aspects.		  
*
FEEDBACK REQUIREMENTS:
Non required.		  


* Further information supplied in the following pages.

Page last modified: 07 February 2008