CHA News Article

FDA Seeks Comments on Repair of Medical Equipment in Hospitals
Comments due June 3

The U.S. Food and Drug Administration (FDA) is seeking comments on whether hospital employees, vendors and others should be allowed to perform service and repair activities on medical equipment or whether those activities should be limited to original equipment manufacturers. CHA, the California Society for Healthcare Engineering and the American Society for Healthcare Engineering believe that restricting this work could lead to significant safety and financial issues. Given the varying impact this may have on different types of hospitals, CHA recommends that hospital biomedical experts review and respond directly to the FDA, copying Cheri Hummel. The deadline for comments has been extended from May 3 to June 3.