Saturday, April 6, 2013

Non-sterile bicycle helmets are not medical devices; non-sterile tampons are




























I received correspondence at the end of January from the Hon Catherine King MP stating:

'Non-sterile protective or safety apparel or equipment, for use in the home or for occupational or recreational use, has been declared not to be therapeutic goods. This declaration has been made under the Therapeutic Goods (Excluded Goods) Order No.1 of 2011. As per your example, bicycle helmets fall within this decription and therefore are not regulated by the Therapeutic Goods Administration under the Act.'

But yes, yes...I knew this which is why I asked in my letter to have the actual reason explained to me why bicycle helmets were not deemed to be therapeutic goods.

Inconsistency is evident on the  Australian Register of Therapeutic Goods (ARTG) and appears to make a contrary case in that the Hon Catherine King's 'non-sterile protecitve or safety apparel or equipment, for use in the home or for occupational or recreational use' has been declared to be therapeutic goods...

...for example:

'Johnson & Johnson Pacific Tampons Non-Sterile; ARTG No: 67066; Type: Device; Sponsor: Johnson & Johnson'

Ok, ok, we all know that tampons are way more useful than bicycle helmets but still no-one or nothing to date has explained why bicycle helmets aren't listed on the ARTG.

When you read the provisions of section 41BD(1)(a)(iii) of the Therapeutic Goods Act (1989) a bicycle helmet ought to fit them because we know that bicycle helmets are deemed for use by human beings and for the purpose of modification of the anatomy.

But it seems to me that bicycle helmets have been disqualified as medical devices in order to cancel consent and refusal entitlements which would have automatically followed if bicycle helmets had been recognised as medical devices. Consequently a mini caveat has been slotted in at section 41BD(3) to provide a convenient little escape hatch for designated Secretary to be able to declare 'to be or not be' medical device proclamations even though designated Secretary may not even be a medical device expert.

It's all smoke & mirrors...as well as very flawed and very inconsistent and utterly contradictory.

2 comments:

  1. We might have trouble trying to get the TGA to act as an effective regulator.

    "The TGA is required by Government to fully recover its operating costs for all activities that fall within the scope of the Act, including the TGA's public health responsibilities."
    http://www.tga.gov.au/about/fees.htm

    It's fully funded by the industries it's supposed to regulate.
    If you use the therapeutic goods list search function on their website for "helmet" it returns several orthotic helmets which simply state their function as head protection.
    If the industries which pay for the TGA want some helmets to be listed and, presumably, qualify for government subsidy to the consumer and other helmets to be exempted from listing to allow mandating use by law then that's the way it will be.

    Episode 1 of "The checkout" has a relevant segment. It's on iview.
    http://www.abc.net.au/iview/#/view/31798

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    Replies
    1. Thanks for the link, Steve - I'm loving the series and I missed the first one.

      Thanks also for your comment. Sadly, I know everything you say is correct - it sucks (not your comment, the reality)

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