FDA Takes Step Forward on Custom Devices

Richard Martin, JD; Julia Williams

The American Association of Orthopaedic Surgeons (AAOS) office of government relations (OGR) has been successful in getting language, which allows greater flexibility in the Food and Drug Administration’s (FDA) Custom Device Exemption, included in the Medical Device User Fee Act (MDUFA) bills in the House and Senate.

What Are Appropriate Use Criteria?

Mary Ann Porucznik

According to Kristy L. Weber, MD, past chair of the AAOS Council on Research and Quality, “Appropriate Use Criteria (AUC) specify when it’s appropriate to perform a procedure or service.” An “appropriate” procedure is one for which the expected health benefits exceed the expected health risks by a wide margin. AUC are a response to the dilemma faced by physicians every day.

Reinventing Chemonucleolysis: From Papayas to Polymers

Sally T. Halderman

Thirty years ago, chemonucleolysis—a minimally invasive procedure to relieve the excruciating pain of a herniated lumbar disk by injecting chymopapain, an enzyme derived from papayas—seemed like a good idea. The enzyme dissolved the soft, bulging disk nucleus, shrinking the disk and reducing its pressure on nerve roots. The procedure had been available in Canada—and had been drawing enthusiastic patients across the border—for years. So when the U.S.