Non-Invasive Ventilation Devices (CPAP, VPAP/BiPAP) - Risk of Being Used as Life-supporting Ventilators - Notice to Hospitals

Starting date:

February 7, 2012

Posting date:

February 8, 2012

Type of communication:

Notice to Hospitals

Subcategory:

Medical Device

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170002654

Notice about Health Canada advisories

Notice to Hospitals - Health Canada Issued Important Safety Information on Non-Invasive Ventilation Devices

February 7, 2012

To: Hospital Chief of Medical Staff

Please distribute to the relevant Departments of Emergency Medicine, Critical Care, Surgery, Pediatric Department, Nursing and other involved professional staff and post this NOTICE in your institution.

Subject: Risk of Non-Invasive Ventilation Devices Being Used as Life-supporting Ventilators

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 ventilator-dependent 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 respiratory 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 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:

Any suspected adverse incident can be reported to:
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.

For other medical device inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc.public@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738