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Clinical Registers for High Risk Implantable Medical Devices – Implementation Regulation Impact Statement – Department of Health and Ageing

In the 2013-14 Budget, released on 14 May 2013, the Australian Government announced its decision to establish a national patient contact register for implantable devices, and two clinical quality registers for breast implants and cardiac devices. The Government had previously prepared a Regulation Impact Statement (RIS) to support an in-principle decision to develop clinical registers for high risk implantable medical devices, and committed to examine options to track the use and performance of such devices and funding models. The purpose of this implementation RIS was to assist the Australian Government in deciding how to best implement the decision to support the registers. The development of clinical quality registers for specific implantable devices, over time, will allow better information to be developed about the performance of implantable devices. This can flow through to more proactive monitoring by regulatory agencies, and better clinical practice by medical practitioners. The benefits are difficult to quantify but a similar initiative, the National Joint Replacement Register, is estimated to have avoided around 4400 recalls for surgery revisions over a seven year period, at a cost saving of $110 million. The main benefits of a patient contact register accrue to the patients themselves, who will have more timely access to medical advice in the event of a recall or other warnings relating to their implanted medical devices; and hospitals which will be able to better fulfil their duties of care to patients. The expected cost of two clinical quality registers and building enhanced national capability to identify and contact patients with particular implanted high risk medical devices is about $4 million, which is expected to be cost-recovered from industry. Ongoing administrative costs for the medical device industry, clinicians and hospitals are likely to be relatively small, as this is largely information that is already collected. A RIS was prepared by the Department of Health and Ageing. The RIS was assessed as adequate by the Office of Best Practice Regulation.