Establishment of a Hydrocephalus Registry

Issue

The Australian Government's position on clinical registers.

Response

The anxiety and risks that patients experience when shunts need to be replaced in the course of managing hydrocephalus are well documented and highlight the potential role of clinical registers in improving patient outcomes.

The former Parliamentary Secretary for Health and Ageing, the Hon Catherine King MP, recently met with Associate Professor Brian Owler, a patron of the Hydrocephalus Support Association, to discuss shunt registers. Associate Professor Owler also met with the Department of Health and Ageing to provide more detail about his proposal.

The Australian Government is giving active consideration to clinical registers more broadly and their capacity to monitor the longer term performance of a range of high risk implantable medical devices.

Two recent Senate inquiries into regulatory standards governing medical devices in Australia have recommended that clinical registers for certain high risk implantable medical devices be established to improve post-market surveillance and to ensure that patients can be identified and contacted in the event of a recall. In responding, the Government supported further work around clinical registers and has been engaging with stakeholders around options for development.

As part of the next stage of work, a preliminary regulation impact statement was published on the Department of Finance and Deregulation’s website in September 2012 proposing a number of options and recommending that further work on the development of specific clinical quality registers and/or a national patient contact register be undertaken.

In October 2012 the Department of Health and Ageing engaged the Australian Commission on Safety and Quality in Health Care to consult with industry, clinicians, consumers, health care providers and other interested stakeholders to canvass views and options. This report was completed in December 2012 and is currently being considered by Government.