FDA increases training on alarm standards and safety
Patient Safety Monitor Insider
March 28, 2012
In an effort to reduce alarm fatigue in hospitals, the FDA is increasing the amount of training on alarm standards and safety for its reviewers of applications from medical device manufacturers. Equipment such as heart monitors, medication pumps, ventilators, and hospital beds continuously emit noise, which could cause nurses to become desensitized to the alarms and ultimately lead to patient deaths.
The FDA is focusing its efforts on new alarms and devices to prevent additional noise in the hospital setting. Manufacturers of medical devices have begun creating alarms that monitor several functions to ensure greater accuracy in predicting whether a patient is in trouble. Manufacturers of such devices must prove to the FDA reviewers that combining multiple functions into a single alarm will lead to positive outcomes, according to an FDA spokesperson.