This program reviews requirements of the Safe Medical Devices Act, which requires organizations to report adverse events caused by faulty or improperly labeled medical devices.
Outline reporting requirements when a patient is injured/dies due to medical device
Distinguish between device adverse events that are reported to the FDA vs those reported to the manufacturer.
Define the penalties for non-compliance with the Safe Medical Devices Act.
Course Length: .5 hour(s)
Audience: CNE, Nursing
CE Credit: .5 hour(s) awarded after successful completion of post-test with a score of 80% or better.
CNE Expiration: November 30, 2023
Accreditation Statement: Home Care Institute LLC is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center's Commission on Accreditation.
Disclosures: The authors, planners and reviewers of this educational activity declare no conflicts of interest with this activity. There are no commercial interests or sponsorships related to this educational activity.