Thursday, August 25, 2011
On the face of it helmet promoters don't actually promise that helmets will completely protect their wearers but instead offer a feeling of protection, a veneer of safety...
...which is probably why a bicycle helmet, notwithstanding seemingly fulfilling the provisions of section 41BD(1)(iii) of the Therapeutic Goods Act 1989 (Cth), could never be classified as a 'medical device' because the Act insists that any claims made under its provisions must be proven through scientific tests.
It is patently clear that bicycle helmet testing, with its omission of an 'oblique impact test', does not meet such rigourous standards.
In fact it could even be suggested that perhaps it is not in the interest of helmet promoters to make such catergorical protection claims given that all too often cyclists killed or injured are wearing helmets (66% of pedal cycle fatalities & 82% of all pedal cycle injuries were wearing helmets - 'The Chair's Final Report', NSW Parliament Joint Standing Committee on Road Safety Vulnerable Road Users - Inquiry into Motorcycle and Bicycle Safety; p.22, at 3.55).
Essentially, such an absolute claim would require a higher standard of 'marketing rules'.
Interestingly & somewhat conveniently for helmet promoters, a touch of regulatory assistance absolves them from any likelihood that bicycle helmets could ever be deemed 'medical devices' automatically requiring the higher standard of proof...
Therapeutic Goods (Excluded Goods) Order No. 1 of 2011
5 'Goods that are not therapeutic goods when used, advertised, or presented for supply in a particular way' - Table 1, Column 1, Item no. 4
You've gotta hand it to those helmet promoters - seems all bases are covered! sigh...