Delivery of Topical Hemostatic Agents Using Spray Devices - Association with Air/Gas Embolism - Notice to Hospitals

Starting date:

August 26, 2010

Posting date:

August 27, 2010

Type of communication:

Notice to Hospitals

Subcategory:

Biologic/vaccine

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170002288

Notice about Health Canada advisories

Notice to Hospitals - Health Canada Issued Important Safety Information on Mis-Use of Spray Devices for the Application of Topical Hemostatic Agents

To: Hospital Chief of Medical Staff

Please distribute to relevant Departments [Surgery, Anaesthesia, Internal Medicine and/or other Departments as required], and other involved professional staff and post this Notice in your institution.

Subject: Association of Air/Gas Embolism with the Delivery of Topical Hemostatic Agents using Spray Devices

Topical hemostatic agents, composed of a mixture of fibrinogen and thrombin (also known as fibrin sealants or fibrin glues) or of thrombin alone, are authorized for adjunct hemostatic support during surgical procedures, in addition to other means of achieving hemostasis. These products can be delivered drop-by-drop onto the wound field, or sprayed in a thin layer, as indicated by the relevant product labelling.

• Incidents involving air/gas embolism, including one fatality, have been reported internationally after the use of spray devices with pressurized gas to apply topical hemostatic agents.
• These events appear to be related to the use of the spray device at higher than recommended pressures and/or in close proximity to the surface of the tissue.
• Physicians are reminded to use the appropriate applicator, pressure regulator, and delivery devices that have been designed for the specific hemostatic agent and as recommended in the Instructions for Use.
• Patients should be monitored for signs of air/gas embolism during and following product administration (blood pressure, pulse, oxygen saturation, end tidal CO₂).

Health Canada has received reports of incidents that occurred outside Canada of life-threatening events of air/gas embolism following the spray application of topical hemostatic agents. One fatal event was associated with the use of spray pressures higher than recommended, and at a closer distance than recommended to apply a fibrin sealant. An additional fatality due to air/gas embolism has been reported as inappropriate use of a spray device meant for the application of a topical hemostatic agent to dry a surgical surface without application of any product. There have been no Canadian cases of air/gas embolism related to the use of these products reported to Health Canada.

Healthcare professionals should ensure that the conditions of use of devices used to apply topical hemostatic agents during surgical procedures are as recommended in the product and device labelling, and that maximum spray pressures and minimum distances recommended in both the product and device labelling are followed. The spray device should not be used for any other purpose than for applying the product as recommended in the product labelling. Patients should be monitored for any signs of air/gas embolism during and after the spray application of the products.

Canadian Product Monographs for topical hemostatic agents can be found on the Health Canada online Drug Product Database.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-market adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse reactions in patients receiving topical hemostatic agents should be reported to Health Canada.

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345
• Complete a Reporting Form and:
  • Fax toll-free to 1-866-678-6789, or
  • Mail to: Canada Vigilance Program
    Health Canada
    Postal Locator 0701E
    Ottawa, Ontario K1A 0K9

The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffect™ Canada Web site in the Adverse Reaction Reporting section. The Reporting Form is also in the Canadian Compendium of Pharmaceuticals and Specialties.

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