Take a chance: Attend off-label symposium

It works in the knee…but will it work in the shoulder? Or the hip? Or the spine? It’s been tested on adults, but you’re a pediatric specialist. Can you risk the treatment on your patients?

If you’ve ever faced similar conundrums, don’t miss the symposium on “Off-label device use: When clinical need outpaces regulatory approval.” Beginning at 8:00 a.m. on Friday in the Venetian Ballroom G, a panel of experts will address the nuances of the use of orthopaedic medical devices “off-label” through a series of contemporary clinical and surgical situations.

Physicians should be aware that the prerogative to employ medical devices for uses other than those cleared or approved by the U.S. Food and Drug Administration (FDA) may, in certain instances, put both the physician and the institution at risk for liability. In most instances, a physician’s “off-label” use of a medical device is considered appropriate if, in the physician’s opinion, the device is used in the best interest of the patient.

The 1976 Safe Medical Devices Act brought medical device oversight under the auspices of the FDA. It does not, however, regulate physician-directed treatment that is medically determined to be in the best interest of the patient. As a result, standards of care have evolved often before regulatory approval is granted—a medical and ethical dilemma.

For example, clinicians frequently treat pediatric patients by using or modifying adult devices, or by adapting implants designed for other purposes. Although acting in the best interest of the patient, this leaves the clinician open to legal action if an adverse event results.

If you’ve ever used a drug or device “off-label,” you don’t want to miss this symposium. Be in the audience tomorrow, Venetian Ballroom G, at 8:00 a.m.