July 9, 2010 — Clinicians administering hemostatic drugs or biological products such as fibrin sealants with sprayers pressurized by air or gas should adhere to recommendations for using these agents and sprayers to avoid life-threatening air or gas embolisms, the US Food and Drug Administration (FDA) announced today.
The agency has received reports of air or gas embolisms — and 1 fatality — that occurred during or immediately after the application of hemostatic agents using pressurized sprayers, according to MedWatch, the FDA's safety information and adverse event reporting program.
The FDA is not attributing the problem to the sprayers or agents in themselves. Rather, the agency stated 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, which come with dual syringes, simultaneously blend and apply 2 nonhomogenous liquids within a single spray head. They are connected to a pressure regulator and a source of compressed air or gas. The FDA listed a number of sprayers potentially subject to misuse in its announcement:
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)
In addition to following recommendations on pressure settings and the distance between spray head and tissue surface, clinicians should monitor blood pressure, pulse, oxygen saturation, and end-tidal CO2 for signs of an air or gas embolism. They also should ensure that regulators are properly maintained and regularly checked for safe performance, according to the FDA.
In October 2009, the agency issued a warning about the risk of improperly using fibrin sprayers in regards to Tisseel and Artiss — fibrin sealants made by Baxter Healthcare. At that time, Baxter Healthcare updated the labels of these fibrin sealants to emphasize the need to adhere to pressure and spraying-distance recommendations in light of the embolism problem. Omrix Pharmaceuticals also updated the label for its fibrin sealant, Evicel, along these lines.
Baxter Healthcare and Omrix Pharmaceuticals manufacture all of the fibrin sealants licensed in this country.
More information on today's FDA announcement is available on the MedWatch Web site.
To report adverse events related to fibrin sealants and sprayers pressurized by air or gas, contact MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.fda.gov/medwatch, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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Cite this: Use Fibrin Sprayers Correctly to Avoid Embolisms, Warns FDA - Medscape - Jul 09, 2010.