OTTAWA, March 15, 2013 /CNW/ - Health Canada and manufacturers are
strengthening the labelling and instructions for the use of spray
fibrin sealants following three deaths outside of Canada.
Fibrin sealants, also known as topical hemostatic agents, are used
during surgery to help reduce local bleeding. The sealant solution is
either dripped or sprayed onto bleeding tissue.
Efforts are ongoing to inform the medical community of the need to
ensure that spray devices are always used at the manufacturer
recommended pressure and distance from the tissue. Exceeding the
maximum recommended pressure or spraying too close to the tissue
increases the risk of an air or gas embolism (an air or gas bubble that
blocks a vein or artery) in the patient.
Health Canada has received reports of incidents that occurred outside
Canada of life-threatening air/gas embolisms associated with spray
applications of fibrin sealants, including three deaths. The Department
previously communicated to healthcare professionals in 2010 regarding this risk. The most
recent death occurred in the United Kingdom in January 2012. There have
been no reports of life-threatening or fatal air/gas embolisms in
Canada associated with fibrin sealant spray products.
While the current Canadian labelling for fibrin sealants provides
instructions for their safe use, the international incidents have
prompted regulators to request that manufacturers strengthen the
instructions to further reduce the risk of misuse. Changes will include
new labels stating the recommended pressure and distance for spraying
on the device itself. The strengthened labelling is expected later this
Health Canada reminds healthcare professionals to always follow the
instructions for the correct use of fibrin sealant spray devices, and
to report any cases of air/gas embolism, or other serious adverse
reactions, to the manufacturer or Health Canada.
Report a health or safety concern
Call toll-free at 1-866-234-2345
Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax
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product recalls using social media tools.
SOURCE: Health Canada
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