Air/Gas Embolisms with Pressurized Spray Devices

FDA is advising operating room personnel about the importance of using gas or air-pressurized sprayers properly. These products are used to deliver hemostatic agents, including fibrin and non-fibrin sealants.

FDA has reports in which gas and air embolisms occurred during or immediately after using the sprayers to apply a hemostatic agent. The adverse events appear to be associated with not using the devices according to their labeling and instructions. In some reports, the device was used at higher than the recommended pressure, or too close to the bleeding site.

Given the life-threatening consequences of a gas or air embolism, FDA recommends that clinicians using these sprayers take certain precautions. Use the sprayer device that is recommended by the manufacturer of the hemostatic agent. Select an air or gas pressure setting that is within the range recommended by the manufacturer of the sprayer, and keep the distance between the spray head and the tissue surface above the minimum recommended by the manufacturer.

Clinicians should also monitor patients for signs of an air or gas embolism, and be sure that the regulators are maintained properly and checked regularly for safe performance.