A lack of scrutiny of diagnostic and screening devices continues to undermine public safety, experts say.
Writing in the Internal Medicine Journal this week, Adelaide researchers said the regulatory environment for pre-market approval and post-market direct-to-consumer advertising of medical devices remained “inadequately patrolled” by the TGA and the Australian Competition and Consumer Commission (ACCC).
“Under the present system, devices with a questionable evidence base may enter the Australian marketplace without an evaluation of their effectiveness, and regulators are reliant upon self-regulation and consumer complaints to draw attention to cases of advertising misconduct,” they wrote.
They cited advertisements that first appeared in 2008-2009 for ‘thermography’, ‘electrical impedance’ and ‘palpation’ imaging devices for breast cancer screening.
Among their claims, these ads said the devices had “wonderful...
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