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One wonders how long before some of the 'diagnostic' tools that podiatrists use come under the radar...
From the Australian Doctor:
THE manufacturers of shonky devices used by alternative therapists to carry out what they claim are diagnostic tests will soon have to provide clinical evidence that they work under new Therapeutic Goods Administration regulations.
The changes, which will be introduced in July, are in response to growing concerns about the number of in-vitro diagnostic devices employed by alternative therapists.
Among the products advertised on the internet is the “Hemaview”, which, according to its manufacturer, uses one or two drops of blood projected onto a video screen to diagnose “nutritional deficiencies, organ dysfunction and certain biochemical imbalances”.
Director of the Alfred Hospital’s department of haematology Professor Hatem Salem said users of the device were “pulling the wool over people’s eyes”.
“The notion that one can diagnose all sorts of ailments by examining a drop of blood on a video screen is both ridiculous and plain stupid.”
Currently the TGA is only able to regulate diagnostic devices included on the Australian Register of Therapeutic Goods, including those that test for HIV and hepatitis C, as well as those used in the home.
However, many of the in-vitro diagnostic devices used by alternative therapists have been exempt from scrutiny because they are not considered medical devices.
From July the makers of all in-vitro diagnostic devices will then be required to show clinical evidence that their products work but will have four years to fulfil the new requirements. They will also have to make clear to the public the potential risks of the devices.
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