Characterization of Medical Laser Related Occupational Injuries in the US FDA MAUDE Database

The use of lasers in medicine began soon after the first ruby laser was invented in 1960, and the variety of clinical applications has increased over the years and continue to grow as technology advances. Numerous healthcare and support workers are exposed to laser beam injuries each year. The Manufacturer and User Facility Device Experience (MAUDE) database is housed and maintained by the United States Food and Drug Administration’s (US FDA) Center for Devices and Radiological Health. Of the 1084 incident reports that pertained specifically to laser devices, 54 cases were identified as occupational related injuries. Human factors models were applied to four cases with complete incident information to elucidate causal factors in order to develop preventative recommendations. Through this research we have found the causal factors in medical laser-related beam injuries and provided adequate control recommendations to prevent future injuries for the cases analyzed. Shown are the pros and cons of using the MAUDE database and a list of deficiencies was created for the US FDA that can be used to improve the database.