Access to shoulder arthroplasty in Australia: A balance of regulation, surveillance, and monitored efficacy to maximize patient outcome and optimum care

Prosthetic arthroplasty has emerged as a major contributor to the management of shoulder disorders. This paper outlines the situation in Australia regarding the process by which shoulder replacement devices are made available. Although entry of joint replacement devices to the Australian market is relatively unrestricted, they must be first approved by the Therapeutic Goods Administration—based on safety and efficacy—to be legally used. In addition, to obtain a private insurance rebate (Prescribed List) and thus be commercially viable, the Federal Department of Health and Aged Care requires a more stringent benchmark of comparative clinical effectiveness and value for money. The AOANJRR (Australian Orthopaedic Associate National Joint Replacement Registry) records the implantation and possible revision of virtually all (>98%) major joint arthroplasties in Australia and plays an important role in informing surgeons about their implant selection, but also in identifying and highlighting devices with a higher than anticipated rate of revision. Although the increased cost of health care is placing pressure on health care systems around the world, in Australia, access to shoulder arthroplasty remains relatively unrestricted—but carefully controlled and monitored.