List of Recommendations made in the Senate Community Affairs References
Committee report into The Regulatory Standards for the Approval of Medical
Devices in Australia
5.16 The committee recommends that the Therapeutic
Goods Administration make a list of the devices on the Australian Register of
Therapeutic Goods publicly available.
5.17 The committee recommends that the Department of
Health and Ageing fully implement Recommendation 8c of the Health Technology
Assessment Review regarding the need for increased rigour of regulatory
assessment of higher-risk medical devices.
5.18 The committee recommends that the level of
assessment of Class III medical devices be increased.
5.19 The committee recommends that the Therapeutic
Goods Administration 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.
5.23 The committee recommends that the Therapeutic
Goods Administration 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.
5.28 The committee recommends that the Therapeutic
Goods Administration 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.
5.39 The committee recommends that the Department of
Health and Ageing implements Recommendations 13, 14, and 15 of the Health
Technology Assessment Review in a timely manner. These recommendations 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.
5.40 The committee recommends that the Therapeutic
Goods Administration put in place mechanisms to educate and encourage doctors
to report adverse incidents associated with the use of medical devices. The
committee further recommends that the Department of Health and Ageing introduce
mandatory reporting for health practitioners to the Therapeutic Goods
Administration on relevant issues, in certain circumstances including problems
with medical devices.
5.41 The committee recommends that the Government
implements the Recommendations of the Therapeutic Goods Administration
Transparency Review in a timely manner.
5.42 The committee recommends that the Therapeutic
Goods Administration 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
5.43 The committee recommends that the Department of
Health and Ageing 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.
5.46 The committee recommends that the Therapeutic
Goods Administration consider whether custom made dental devices are adequately
regulated; and whether the approach used in the United Kingdom of requiring a
statement of manufacture to be provided to patients, and retained by the dental
practitioner, has merit.
5.47 The committee recommends that the Therapeutic
Good Administration carry out an investigation to ascertain whether importation
of medical devices via the internet is adequately regulated.
5.52 The committee recommends that the Therapeutic
Goods Administration, 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.
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.
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