Friday, February 10, 2017

Clearly bicycle helmets are medical devices

In Kyoto, Japan ... last Tuesday
Dear Therapeutic Goods Administration Staff,

From my reading of the Therapeutic Goods Act (1989) I am of the view that a bicycle helmet could be classified as a medical device under the provisions of section 41BD(1)(a)(iii) of the Therapeutic Goods Act (1989) - clearly a bicycle helmet is deemed for use by human beings and for the purpose of modification of the anatomy.

Upon further reading it becomes evident that a mini-caveat has been inserted into the act at section 41BD(3) where the provisions state that:
'the Secretary may, by order published in the Gazette or on the Department's website, declare that a particular instrument, apparatus, appliance, material or other article, or that a particular class of instruments, apparatus, appliances, materials or other articles, are not, for the purposes of this Act, medical devices'
From subsequent reading of the Therapeutic Goods (Excluded Goods) order No.1 of 2011 where particular instruments, apparatus', appliances, materials or other articles, or particular classes of instruments, apparatus', appliances, materials or other articles have been listed as per section 41BD(3), it becomes apparent that 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.

It has been suggested to me that bicycle helmets fall within this description and therefore may not be regulated by the Therapeutic Goods Administration under the Act.

However I think it would be pertinent to mention here that I do not think this could be the case as I do not use my bicycle in my home and nor do I use my bicycle for occupational purposes and nor do I use my bicycle for recreational purposes.

My house is not big enough to use a non-stationary bicycle inside, and my occupation has nothing to do with bicycles whatsoever, and I certainly would never use my bicycle as a means of recreation, in fact I cannot imagine anything worse than 'playing' or 'relaxing' on a bicycle if that is what recreation is. My bicycle is my mode of transport period - I use it for nothing else. I do not have a car, and where I live there is next to no public transport.

Therefore after reading the Therapeutic Goods Act and the Therapeutic Goods (Excluded Goods) order No.1 of 2011 I am of the opinion that a bicycle helmet in my particular case does indeed meet the definition of a medical device which therefore requires my informed consent before I wear one and requires regulation by you of this bicycle helmet medical device.

Currently the Australian Road Rules (reg 256) subsection (1) states that:
'The rider of a bicycle must wear an approved bicycle helmet securely fitted and fastened on the rider's head, unless the rider is exempt from wearing a bicycle helmet under another law of this jurisdiction.'
 Given that the Therapeutic Goods Act is a Commonwealth act I believe that as the rider of my bicycle when I am using it as a mode of transport I am exempt from wearing a bicycle helmet because a bicycle helmet could be defined as being a medical device for use by human beings and for the purpose of modification of the anatomy which obviously requires my informed consent before I wear one which I certainly do not give.

I am very interested in your thoughts on this subject and look forward to hearing from you very soon as I will be raising this issue in an Adelaide Court in the not too distant future.

Yours faithfully,
Sue Abbott

9 comments:

  1. "...for the purpose of modification of the anatomy." ?

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  2. Yes by wearing a bicycle helmet you modify your head (which Is part of your anatomy) !!!

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    2. Spellings, sorry.
      Do you 'modify your head' by wearing a beanie, or a wig etc etc?

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  3. Sounds, to my naïve ears, as just the kind of legalese gobbled-e-gook that may just work.

    Also ...

    Loved cycling in Kyoto. The riverside cycleway is like a cycling superhighway allowing you to travel quickly from one side of Kyoto to the other. I wish my city (Sydney) had something similar. After all, we have Parramatta river down the centre, but (unfortunately) no decent infrastructure beyond Homebush.

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  4. How does wearing a bicycle helmet modify your head?

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  5. Hi Sue

    I wish you very good luck with your campaign.

    On a slightly related topic, it's noticeable that cycling without a helmet appears to be one of the few activities that Australian state and national governments get hot under the collar about, while they appear to condone or ignore other activities that present much higher orders of risk and cost to society.

    I've dug around for information on some of these: I won't provide links but it should be easy enough to find the sources I tracked down and perhaps even find more recent data (and apologies if you've seen it before!).

    Skin cancer kills 2,000 or so Australians annually and care for those afflicted costs $700+ million a year. Where is the legislation mandating the use of sunscreen?

    Smoking related diseases kill about 15,000 Australians annually and the cost of treating these diseases is $31.5 billion a year. Where is the legislation mandating a ban on cigarettes?

    Obesity-related illness kills 5,600 Australians annually. Treating overweight and obesity cost Australia $56.6 billion - in 2005. Eleven years on obesity rates are such that Australia is now among the most obese nations on the planet. Where is the legislation mandating against overeating and neglecting personal health?

    The annual cost of treating sports injuries in Australia is about $2 billion. Where is the legislation mandating against partaking in sports activities? (and why is boxing not illegal in Australia?)

    Alcohol-related illness kills 5,500 Australians a year. The cost of treating excessive alcohol consumption in Australia is $36 billion a year. Where is the legislation mandating against alcohol consumption?

    Typically motor vehicle collisions account for 48% of head injuries (cycling collisions account for just 1%). Treating car occupants with head injuries in Australia costs about $3.7 billion a year. Where is the legislation mandating helmets for car occupants?

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  6. And while checking the links look for the research that finds physical exercise (bicycle riding qualifies) alleviates many of these dis-evolutions. Daniel Lieberman finds fit people have less cancer, hormonal balance from exercise decreases stress decreasing urge to smoke, etc.

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