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

Starting date:
August 11, 2005
Posting date:
August 12, 2005
Type of communication:
Notice to Hospitals
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Hospitals
Identification number:
RA-17000925

Notice about Health Canada advisories

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

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.

Subject: Importance of Proper Preventive Maintenance for Anaesthetic Vaporizers

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:

Health Products and Food Branch Inspectorate
Health Canada
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Tel: The Inspectorate Hotline 1-800-267-9675

For other inquiries, please refer to contact information:

Medical Device Bureau Enquiries
Email: mdb_enquiries@hc-sc.gc.ca
Tel: (613) 957-4786
Fax: (613) 957-7318

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada web site.

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