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

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Contact: Marketed Health Products Directorate

The Health Products and Food Branch (HPFB) posts on the Health Canada Web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

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

August 26, 2010

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.

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.