The regulatory standards for the approval of medical devices in Australia – Senate Inquiry
On 16 June 2011 the Senate referred the following matter to the Senate Community Affairs References Committee for inquiry and report by 12 October 2011:
The regulatory standards for the approval of medical devices in Australia, with particular attention to devices with high revision rates, and in undertaking the inquiry the committee consider:
(a) the role of the Therapeutic Goods Administration in regulating the quality of devices available in Australia;
(b) the cost effectiveness of subsidised devices;
(c) the effectiveness and accuracy of the billing code and prostheses list;
(d) the processes in place to ensure that approved products continue to meet Australian standards;
(e) the safety standards and approval processes for devices that are remanufactured for multiple use;
(f) the processes in place to notify the relevant authorities and the general public of high revision rates or possible faulty devices;
(g) the effectiveness of the current regimes in place to ensure prostheses with high revision rates are identified and the action taken once these devices are identified;
(h) the effectiveness of the implemented recommendations of the Health Technology Assessment; and
(i) any other related matter.
1.2 The reporting date was extended to 8 November 2011 and subsequently to 22 November 2011.
5.57 The committee recommends that the Department of Health and Ageing prepare, as a matter of priority, a comprehensive communications strategy to inform medical practitioners, patients and the general public about the issues associated with De Puy hip and hip resurfacing devices as well as options for treatment, obtaining further information, and reporting adverse outcomes. The committee further recommends that such a strategy be implemented as a standard process for any future adverse event reporting.
5.58 The committee recommends that the Department of Health and Ageing, as a matter of urgency, consider the best way of establishing a process for monitoring the levels of cobalt, chromium, and other toxic metals; and any possible health effects, in all patients who have received metal-on-metal hip replacements.
5.59 The committee recommends that the Government consider the best mechanism for initiating and advancing research on the health effects of cobalt, chromium, and other toxic metals, on the human body. The committee also recommends that consideration be given to ensuring adequate funding for that research is made available.
5.64 The committee recommends that the Department of Health and Ageing undertake further work to address the issue of inducements paid by pharmaceutical companies and medical device manufacturers to doctors and teaching hospitals, in line with the Physician Payment Sunshine provisions of the Patient Protection and Affordable Care Act of 2009 in the United States. The definition of inducements should include a commercial interest in a company or device; any cash payments or discounts offered to medical practitioners; and any other gifts provided to medical practitioners.
Download the full report here – AU Senate medical devices report
- FDA seeks to include more women in medical device trials (earlsview.com)
- Howard Sdwin: What isn’t being published is the truth regarding the medical device world (earlsview.com)
- Australia – Government Enquiry into Hip Replacements (earlsview.com)
- Medical Devices – Balancing Regulation and Innovation (earlsview.com)
- Rottenstein Law Group Commends Subcommittee Recommendation of Greater Investigation of Metal-on-Metal Hips to Curb Under-regulation at USFDA (earlsview.com)
- IOM chair discusses 510(k) report: origins, findings, response (earlsview.com)
- New Models of Hip and Knee Implants Not Better, Study Finds – NYTimes.com (earlsview.com)
- Austen BioInnovation Institute, FDA to partner on medical device regulation (medcitynews.com)
- FDA Proposes Guidelines That Clarify Benefit-Risk Determinations For Medical Devices (earlsview.com)
- The Australian – Medical devices in spotlight (earlsview.com)
- UK – Answers to commonly asked questions from patients with metal-on-metal hip replacements / resurfacings (earlsview.com)
- UK surgeon warns public about dangers of all-metal hip implants, especially for women | Depuy Hip Recall (earlsview.com)
- Birmingham Hip Resurfacing or Surface Replacement Arthroplasty (BHR) With Stem (earlsview.com)
- Hip Resurfacing – Hip Surgery Option Loses Key Backer (NY Times) (earlsview.com)
- Faulty hip implants: senate inquiry wants action on ‘ticking time bomb’ (smh.com.au)
- Faulty hip implants: senate inquiry wants action on ‘ticking time bomb’ (theage.com.au)
- JBJS | Prevalence of Pseudotumor in Asymptomatic Patients After Metal-on-Metal Hip Arthroplasty (earlsview.com)
- Further Patient Problems – in response to NY Times Article (earlsview.com)