Criterion 7: #75111

Finding
Compliance

The provider plans an intensive hands-on course to train physicians to perform vascular interventions using new FDA-approved medical devices and equipment. The course director asks device manufacturers to provide equipment and medical devices for use in the CME activity and also to provide technicians to operate the equipment during the CME activity. The accredited provider tracks the loaned equipment as in-kind commercial support. The course director plans the CME activity independent of the device manufacturers; she determines what procedures will be taught, instructs the technicians on their limited roles, and is present to oversee and participate in the instruction. The course director monitors the CME activity to ensure that demonstration and comments provided by the device technicians are technical only (i.e., about the safe and proper use of the equipment) and do not include clinical recommendations about the medical devices/equipment of the manufacturer(s).