Health Canada Issues Warning For Non-Invasive Ventilation Devices

Health Canada just issued a warning for noninvasive ventilation devices. The devices are used to provide noninvasive respiratory support to patients who experience respiratory insufficiency that is caused, for example, by obstructive sleep apnea, chronic obstructive pulmonary disease, and neuromuscular or chest wall disorders.

The therapy has been used, more and more, in the emergency and critical care settings for acutely ill patients. Because of this, Health Canada has expressed its concern about Canadian and international adverse events associated with these devices when they are used as life-supporting ventilators. One reported Canadian case resulted in the patient requiring resuscitation.

Noninvasive 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, noninvasive ventilators typically lack a power backup system, alarms, patient monitoring features, and other safety mechanisms that are critical in protecting ventilator-dependent patients against device failure; these are also needed to warn healthcare providers in the event of changes in patients’ health conditions.

To minimize the risk of patient injury associated with noninvasive ventilation devices, Health Canada recommends that:

• • Because noninvasive ventilators are not designed for life-supporting ventilation, they should not be used in patients with insufficient respiratory drive to tolerate brief interruptions in noninvasive ventilation therapy. Improper use of these devices may result in patient harm.
• • A compatible mask system recommended by the manufacturers should be used and that patients who have limited ability to remove the mask should be attended to at all times during therapy to avoid suffocation risks as a result of prolonged re-breathing of exhaled air over unexpected device failure.
• • Patient’s condition should be closely monitored when treating with noninvasive ventilation devices by continuing assessing patients’ heart rate, respiratory rate, blood pressure, and oxygen saturation.
• • Relevant clinical staff must be well trained with the knowledge to distinguish these devices from life-supporting ventilators concerning the devices’ different capacities and limitations.

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 Inspectorate
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9.
Telephone: The Inspectorate Hotline: 1-800-267-9675. The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada Web site. Health Canada’s Marketed Health Products Directorate can be reached by
email at mhpd_dpsc.public@hc-sc.gc.ca, by telephone at 613-954-6522, and by fax at 613-952-7738.