The FDA has received reports of air or gas embolisms (including one fatality) that occurred during or immediately after the application of hemostatic agents using pressurized sprayers. The FDA is not attributing the problem to the sprayers or agents in themselves, stating that the adverse events apparently stem from clinicians using sprayers in a manner inconsistent with approved product labeling and instructions. Specifically, some clinicians have used the sprayer at higher-than-recommended pressures or at a distance too close to the surface of a bleeding site. The sprayers in question are those supplied in a dual syringe configuration, simultaneously blending and applying two non-homogenous liquids within a single spray head; they are connected to a pressure regulator and a source of compressed air or gas.

The FDA therefore recommends that clinicians using these devices should make sure the regulators are maintained properly and checked for safe performance regularly. Furthermore, when using the applicator, spray set, and pressure control device or regulator, clinicians should use the device as recommended in the labeling; use an air or gas pressure setting within the range recommended by the manufacturer of the sprayer; ensure that distance between the spray head and the tissue surface is not less than the minimum recommended by the manufacturer of the sprayer; and monitor blood pressure, pulse, oxygen saturation (SpO2), and end tidal carbon dioxide (CO2) for signs of an air or gas embolism.

In October 2009, the FDA issued a warning about the risk of improperly using fibrin sprayers in regards to Tisseel and Artiss, fibrin sealants made by Baxter Healthcare (Deerfield, IL, USA), and Evicel, a sealant made by Omrix Pharmaceuticals (Somerville, NJ, USA). Both companies updated the labels of the fibrin sealants to emphasize the need to adhere to pressure and spraying-distance recommendations in light of the embolism problem.

Related Links:
U.S. Food and Drug Administration
Baxter Healthcare
Omrix Pharmaceuticals