Time to improve transparency and communication to the public
Quality regulation of medical devices is essential to ensure that safe and effective devices and procedures are available for use in the health care system. This not only helps protect patients, but also the companies that manufacture and sell these devices. For a variety of reasons, medical device regulation in Australia and internationally has been under increased scrutiny in recent years. In Australia, a number of reviews have been undertaken, including a review of health technology assessment,1 the Therapeutic Goods Administration (TGA) transparency review,2 and the recent Senate enquiry into the regulatory standards for the approval of medical devices in Australia.3 Each has made valuable recommendations that have the potential to enhance our current regulatory practice.
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- 1. Australian Government Department of Health and Ageing. Review of health technology assessment in Australia, December 2009. Canberra: DoHA, 2009. http://www.health.gov.au/internet/main/publishing.nsf/Content/00E847C9D69395B9CA25768F007F589A/$File/hta-review-report.pdf (accessed Feb 2012).
- 2. Australian Government Department of Health and Ageing. Transparency review of the TGA. Report of the review to improve the transparency of the Therapeutic Goods Administration. 20 Jul 2011. Canberra: DoHA, 2009. http://www.tga.gov.au/newsroom/review-tga-transparency-1101.htm (accessed Feb 2012).
- 3. Australian Senate Community Affairs References Committee. The regulatory standards for the approval of medical devices in Australia 2011. Canberra: Parliament of Australia, 2011. http://www.aph.gov.au/Senate/committee/clac_ctte/medical_devices/report/report.pdf (accessed Feb 2012).
- 4. Australian Government Department of Health and Ageing Therapeutic Goods Administration. Australian regulatory guidelines for medical devices, Version 1.1, May 2011. Canberra: TGA, 2011. http://www.tga.gov.au/industry/devices-argmd.htm (accessed Feb 2012).
- 5. Dulhunty JM, Suhrbier A, Macaulay GA, et al. Guide wire fragment embolisation in paediatric peripherally inserted central catheters. Med J Aust 2012; 196: 250-255. <MJA full text>
- 6. Australian Government Department of Health and Ageing Therapeutic Goods Administration. Poly Implant Prothese (PIP) breast implants — the Australian perspective (4 January 2012 version). Canberra: TGA, 2012. http://www.tga.gov.au/safety/alerts-device-breast-implants-120104.htm (accessed Feb 2012).
- 7. Jeeves AE, Cooter RD. Transforming Australia’s Breast Implant Registry. Med J Aust 2012; 196: 232-234. <MJA full text>
- 8. Keogh B. Poly implant prosthesis (PIP) breast implants: interim report of the expert group. London: National Health Service, Department of Health, 2012. http://www.nhs.uk/news/2012/01January/Documents/pip-report.pdf (accessed Feb 2012).
- 9. European Commission. Scientific Committee on Emerging and Newly Identified Health Risks: The safety of PIP silicone breast implants. Version of 1st Feb 2012. Brussels: European Commission, 2012. http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_034.pdf (accessed Feb 2012).
- 10. de Steiger RN, Hang JR, Miller LN, et al. Five-year results of the ASR XL acetabular system and the ASR hip resurfacing system: an analysis from the Australian Orthopaedic Association National Joint Replacement Registry. J Bone Joint Surg Am 2011; 93: 2287-2293.
- 11. McGee RG, Webster AC, Rogerson TE, Craig JC. Medical device regulation in Australia: safe and effective? Med J Aust 2012; 196: 256-260. <MJA full text>
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