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

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