Wednesday, February 15, 2017

Dear Minister, bicycle helmets are medical devices

Melinda Pavey, Minister for Roads, Maritime and Freight

Dear Minister,

First congratulations on your cabinet appointment. I look forward to your fresh approach to the Roads and Maritime Services Department as you embark upon your ministerial post.

Now to launch straight in to my communication.

Given that the Therapeutic Goods (Excluded Goods) Order No 1 of 2011 specifically excludes non-sterile protective or safety apparel or equipment used in the home or for occupational or recreational use from regulation by the Therapeutic Goods Act (1989) and that bicycle helmets are captured by this order, my reading of the exclusion order leads me to believe that a bicycle helmet is a medical device under the provisions of section 41BD(1)(a)(iii) of the Therapeutic Goods Act (1989).

I do not use a bicycle helmet in the home or for occupational use or recreational use, and should I choose to wear a bicycle helmet on a bicycle, it would be for the purposes of transport and traffic and not for the purposes for use in the home or for occupation or recreational use.

Prima facie I remain of the opinion that a bicycle helmet in my particular situation is a medical device and therefore requires my informed consent rather than mandatory compulsion.

When it is convenient, I would like to make an appointment with you to discuss Australia's unfortunate issue of bicycle helmet law which has cost and still costs the New South Wales community dearly.

Kind regards,
Sue Abbott

Bicycle helmets medical devices - I think so!

Dear Medical Devices Information Unit,

Thank you for your response to my email.

Given that the Therapeutic Goods (Excluded Goods) Order No 1 of 2011 specifically excludes non-sterile protective or safety apparel or equipment used in the home or for occupational or recreational use from regulation by the TGA and that bicycle helmets when presented in the way I presented them to you in my email are captured by this order, I can only conclude that a bicycle helmet is a medical device.

I do not use a bicycle helmet in the home or for occupational use or recreational use, and should I choose to wear a bicycle helmet on a bicycle, it would be for the purposes of transport and traffic and not for the purposes for use in the home or for occupation or recreational use.

Prima facie I remain of the opinion that a bicycle helmet in my particular situation is a medical device and therefore requires my informed consent rather than compulsory regulation by law.

Kind regards,

Sue Abbott

Bicycle helmets are medical devices - yes/no

(The TGA got back to me today!)

Good Afternoon Sue

Thankyou for your email to the Therapeutic Goods Administration
The Therapeutic Goods (Excluded Goods) Order No 1 of 2011 specifically excludes non-sterile protective or safety apparel or equipment used in the home or for occupational or recreational use from regulation by the TGA. Bicycle helmets when presented in such a way are captured by this order therefore these products are declared not to be therapeutic products under the Therapeutic Goods Act 1989.

Hence there are no entries for these products on the Australian Register of Therapeutic Goods.

I trust this is of some assistance

Kind regards

Medical Devices Information Unit
Medical Devices Branch
Therapeutic Goods Administration

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

Tuesday, November 1, 2016

My Adelaide day in court postponed four months

My Adelaide court date last week was vacated because the 'informant' (policeman) was otherwise engaged.

Hmmm, you know I've noticed a bit of a recurring theme with 'informants' over the last couple of years; they're pretty keen to book me but when it comes to turning up at court they'd rather just hand over their statements and leave me to it.

But I figure if they're eager-beaver enough to book me for riding a bicycle without wearing a helmet then they ought to give me the common courtesy of turning up to court to see this dastardly matter through ... or is it not criminally cool enough?

Anyhoo new Adelaide date is now Monday 27 February 2017, unless of course the policeman can't make it!!!! Then in which case don't you think it might be an idea for the prosecution to consider dropping the case!!!!!

I mean it's so incredibly inconvenient for all of us!

Saturday, October 29, 2016

MEDIA ALERT: 3rd Adelaide Helmet Optional Protest Ride

Helmets, a matter of choice … yours!

What: 3rd Helmet Optional Protest Ride, on Adelaide’s fabulous separate bike paths along the Torrens River

Where: meeting at Elder Park just behind the Adelaide Convention Centre nr Torrens River, and then cycling to Henley Beach (15km journey, approx 1 hour ride)

When: Sunday 30th October 2016, starting at 2:00pm

Why: Australia needs better cycling infrastructure nationwide coupled with the repeal of mandatory helmet laws.

A free event and everyone is welcome to join in. The pace is leisurely but the message is ardent:

“Australia’s mandatory bicycle helmet law is holding us back - REPEAL IT!”

A helmet exemption has been arranged with the police for all participants on this ride (could it be that wearing a helmet is not that serious an issue after all … who knew!) and as with the other two helmet optional rides, there is a likelihood that there will be a mounted-bike police escort for the cycle trip.

After the ride, it will be possible to catch a train from Grange station back to the city. In previous years it has also been possible to ride back to the city with the police officers along linear park. Anyone riding by themself after the ride concludes will no longer be exempt from wearing a helmet, so you will need to bring one with you if you plan to make your own way home.

There will be some volunteer speakers at the start to talk on the issue of helmet laws and other recent developments.

This will be a relaxed ride at a gentle pace, on off-road bike paths and shared pathways the whole way. The route has been chosen to be extremely safe, however all participants take part at their own risk, and will be expected to follow any instructions from the police on the day.

Media Contact - for more information, images or interviews please contact:

Sundance Bilson-Thompson, Helmet Optional Rider organiser, 0412 254 511

Kathy Francis, Secretary, Freestyle Cyclists, 0481 372 956

Nik Dow, Treasurer, Freestyle Cyclists, 0412 703 483, or nik@cbdweb.net

Media Images: contact Sundance Bilson-Thompson or Nik Dow

Further Info: Visit the Freestyle Cyclists’ facebook page

Media Alert sent by: Freedom Cyclist