Healthcare partner Katie McDermott will speak on the panel for "Off-Label Device Use: Acting in the Best Interest of Your Patient" at the 2013 American Orthopaedic Association (AOA) Annual Leadership Meeting.
The 1976 Safe Medical Devices Act (SMDA) enacted by the US Congress brought medical device oversight under the auspices of the US Food and Drug Administration (FDA). What it does not do, however, is regulate physician-directed treatment which is medically determined to be in the best interest of the patient.
This enactment has led to the evolvement of standards of care often out in front of the indicated utilization for these particular devices. This symposium will provide an understanding of the terminology and legal implications of physician-directed off-label use of medical products while explaining the process for clinical application through a series of contemporary clinical/surgical experiences.
This symposium will seek to appreciate the clinical, legal, regulatory and
manufacturing nuances of off-label use through a series of contemporary surgeon experiences involving orthopaedic products. It will further provide orthopaedic surgeons with the rationale for choosing off-label medical device use in individualized patient treatment.
Thursday, June 13, 2013
Sheraton Denver Downtown Hotel