Tuesday, July 13, 2010

FDA Warns on Fibrin Sealant Problem

Air embolisms can occur with some gas- or air-pressurized spray devices used for applying fibrin-based bleeding control products when used improperly during surgery, the FDA warned.
At least seven types of fibrin sealant sprayers were associated with air or gas embolisms, which appear to have occurred when pressure settings were too high or the sprayer tip was too close to the bleeding site.
The FDA emphasized that clinicians should follow manufacturers’ recommendations for pressure control settings and the minimum distance for applying the sealants.
“Although rare, the reports describe air embolisms that are life threatening and include one fatality,” the FDA said.
The bureau listed seven product series that have been affected:
EasySpray and spray set used with Duploject system (Baxter Healthcare)Tissomat and spray set used with Duploject system (Baxter Healthcare)Evicel application device (Omrix Medical)FibriJet Aerosol Applicator (MicroMedics)HemaMyst Surgical Applicator System (Haemacure)MicroMyst Applicator and Air Pump Models 20-5000 and AP-A-6063 (Confluent Surgical)Vitagel Hemostat Spray Set (Orthovita)
Label instructions for all fibrin sealants have been rewritten to note the risk of air embolismsassociated with improper sprayer use.
In addition to following the listed recommendations for pressure settings and proper distances for application, clinicians should be sure to monitor patients’ blood pressure, pulse, oxygen saturation, and end-tidal CO2 levels for signs of embolism, the FDA noted.
The sprayers should also be maintained and tested regularly, the bureau said.

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