Inquiry on medical devices delivers report

The Senate Standing Committees on Community Affairs report’s 18 recommendations on 'The Regulatory Standards for the Approval of Medical Devices' are provided below in the full Senate Inquiry report, which is available here.

The Senate Inquiry received 34 submissions, including a substantive submission from AusBiotech. AusBiotech consulted widely including with its medical device members and identified four key issues that it believed should be considered by the Senate in the context of this Inquiry:

In regard to regulation of high risk medical devices AusBiotech recommended to the Inquiry that it find that the Therapeutic Goods Administration (TGA) should:

• Implement third party conformity assessment (CA);
• Implement mandatory timelines for completing CA and applications;
• Provide a mechanism for Australian medical device manufacturers to determine their application status; and
• Generally work to improve efficiencies in processing applications to ensure the TGA operates in harmony with other regulating bodies.

To improve the reimbursement system for medical devices AusBiotech recommended the development of the procedures for assessing the cost effectiveness of subsidised medical devices, including reform to abolish the negotiation of benefits for individual listed products as well as the setting of maximum benefits to eliminate the potential gap payments for private health insurance patients.

With the Prostheses List focused solely on the cost of the prostheses, AusBiotech suggests that the Senate Committee oversees an inquiry to assess the feasibility of the reimbursement system supporting treatment costs for patients over multiple admissions.

AusBiotech submitted that the Senate Committee consider an inquiry to address the safety concerns associated with reuse of single use medical devices in Australia.

AusBiotech recommends that the Senate Committee monitor the recommendations of the Health Technology Assessment (HTA) Review and their implementation by the Government.

The report’s recommendations were:

1. The TGA make a list of the devices on the Australian Register of Therapeutic Goods publicly available.
2. The Department of Health and Ageing (DoHA) fully implement the HTA Review recommendation regarding the need for increased rigour of regulatory assessment of higher-risk medical devices.
3. The level of assessment of Class III medical devices be increased.
4. The TGA investigate whether allowing an increasing number of medical devices onto the Australian market actually improves clinical outcomes; and whether a more judicious approach could improve pre-market assessment and post-market surveillance of higher risk medical devices, for the ultimate benefit of patients.
5. The TGA continue to consult widely with stakeholders, including consumer health organisations, on the amended proposals related to third party conformity assessment; and weigh carefully considerations of the advantages of streamlined international regulatory frameworks and patient safety.
6. The TGA continue its prudent approach to the regulation of reprocessed single-use medical devices, with due consideration for issues of informed patient consent and the need for suitable mechanisms to enable tracing of remanufactured medical devices in the case of adverse events.
7. DoHA implements HTA Review recommendations to address the need for improved post-market surveillance by increasing the rate of reporting of adverse events, including by health service providers and consumers; facilitating the expansion and use of post-market surveillance data to inform safety, effectiveness and reimbursement decisions; and establishing further clinical registers for high risk implantable devices and procedures.
8. The TGA put in place mechanisms to educate and encourage doctors to report adverse incidents DoHA introduce mandatory reporting for health practitioners to the TGA on relevant issues.
9. The Government implements the recommendations of the TGA Transparency Review in a timely manner.
10. The TGA consider simultaneously allocating or aligning the great variety of codes used to identify medical devices, in order to facilitate more efficient regulation and more rapid identification of devices when problems occur.
11. DoHA consider a mechanism for flagging billing codes in order to identify devices subject to an alert or recall; as well as a consequent adjustment to benefits paid, based on industry feedback as to the performance of the device.
12. The TGA consider whether custom made dental devices are adequately regulated; and whether the approach used in the UK of requiring a statement of manufacture to be provided to patients, and retained by the dental practitioner, has merit.
13. The TGA carry out an investigation to ascertain whether importation of medical devices via the internet is adequately regulated.
14. The TGA, in consultation with the National Joint Replacement Registry, investigate ways in which information provided by the National Joint Replacement Registry can be used and responded to in a more timely way for the benefit of patients, and to inform future evidence based decision making on the listing of prostheses on the Australian Register of Therapeutic Goods.
15. DoHA 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, and this be implemented as a standard process for any future adverse event reporting.
16. DoHA, 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.
17. 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, and consideration be given to funding for that research.
18. The committee recommends that the DoHA undertake further work to address the issue of inducements paid by pharmaceutical companies and medical device manufacturers to doctors and teaching hospitals.