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Important Safety Information on Non-Invasive Ventilation Devices

December 10, 2013

Non-invasive ventilation devices are used to provide non-invasive respiratory support to patients
who experience respiratory insufficiency caused, for instance, by obstructive sleep apnea,
chronic obstructive pulmonary disease and neuromuscular or chest wall disorders. The therapy
has been increasingly used in the emergency and critical care settings for acutely ill patients.
However, Health Canada is concerned about Canadian and international adverse events
associated with these devices being used as life-supporting ventilators. One reported Canadian
case resulted in the patient requiring resuscitation.

Non-invasive ventilation devices can be divided into two groups, continuous positive airway
pressure (CPAP) and variable positive airway pressure (VPAP), also known as Bi-level positive
airway pressure (BiPAP) ventilators. Unlike mechanical ventilators that provide life-sustaining
ventilation, non-invasive ventilators may generally lack a power backup system, alarms, patient
monitoring features and other safety mechanisms that are necessary to protect ventilatordependent
patients against device failure or warn healthcare providers in case of changes in
patients’ health condition.

In order to minimize the risk of patient injury associated with the use of non-invasive ventilation
devices, Health Canada recommends the following:

  1. Non-invasive ventilators are not designed for life-supporting ventilation and should not be used in patients with insufficient respirator drive to tolerate brief interruptions in non-invasive ventilation therapy.  Improper use of these devices may result in patient harm.
  2. Select a compatible mask system recommended by the manufacturers.  Patients who have limited ability to remove the mask should be attended at all times during the therapy to avoid the risk of suffocation caused by prolonged rebreathing of exhaled air due to unexpected device failure.
  3. Closely monitor the patients’ condition when treating with non-invasive ventilation devices by continuing assessing patients’ heart rate, respiratory rate, blood pressure, and oxygen saturation.
  4. Ensure that relevant clinical staff are well trained with knowledge to distinguish these devices from life-supporting ventilators with respect to their different capacities and limitations.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them.  Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments.  Any cases of serious or unexpected adverse incidents in patients using non-invasive ventilation devices should be reported to Health Canada at the following address:

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

For other inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate (MHPD)
Telephone:  613-954-6522
Fax:  613-952-7738