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Important Safety Information on Proper Preventive Maintenance for Anaesthetic Vaporizers - Notice to Hospitals

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August 11, 2005

To: Hospital Chief of Medical Staff

Please distribute to the Anaesthesia, Intensive Care (ICU), and Biomedical Engineering Departments and other involved professional staff and post this Notice in your institution.

Health Canada has received reports of anaesthetic vaporizer malfunctions which appear to be due to neglect of proper preventive maintenance.

Anaesthetic vaporizers are sophisticated devices which incorporate mechanical, pneumatic, fluidic and electronic technologies in order to deliver precise concentrations of anaesthetic agents to the patient. To ensure safe and reliable operation of the vaporizer, it is important to follow a planned maintenance schedule which will prevent any contamination or deterioration in its performance.

Health Canada makes the following recommendations to health care facilities:

• Review your centre's policies and procedures for ensuring that preventive maintenance is carried out according to the schedule recommended by the manufacturer.
  
  
• If your centre utilizes a contractor or its own biomedical engineering department for preventive maintenance, ensure that they perform all inspections and tests recommended by the manufacturer. Some examples of these are:
  
  
  1. Complete disassembly of the vaporizer for detailed technical inspection of wear and damage
  2. Multi-phase refractometer calibration and testing at different temperatures and flow rates
  3. Careful examination and cleaning of all parts, and replacement with original manufacturer's parts where necessary
  4. Installation of modifications and retrofits provided by the manufacturer
     
     
• All service should be documented and records should be maintained
  
  
• Outside contractors providing maintenance should be authorized by the manufacturer, and their work should be fully warrantied

The identification, characterization, and management of medical device-related adverse incidents are dependent on the active participation of health care professionals in adverse incident reporting programmes. Problems should be reported to Health Canada at the following address: