Human Factors Engineering in the Design of Surgical Instruments

In July 2010, the FDA released a warning on a number of fibrin-based bleeding control products that were demonstrated to cause air embolisms in patients when used improperly during surgery. The article reported that the embolisms, though rare, could be caused by the clinician using pressure settings that were too high, or when the sprayer tip was held too close to the bleeding site. The FDA has emphasized that clinicians need to follow the manufacturer’s recommendations for use and those instructions have been rewritten to make the hazard more clear. The FDA also recommended that clinicians should monitor patients for signs of embolism.