What’s new in sharps development?

Obviously, the development and introduction of a vast array of safety engineered safety needles and blades is a huge advance, though perhaps the real advance was the impetus actually to bite the financial bullet and buy them.

But further nanotechnology developments make needles redundant, at least for vaccine delivery. Presently managed with a vast number of single use syringe and needle assemblies, vaccine delivery is responsible for huge quantities of plastics-risk sharps waste that creates problems of cost and in the practicality of disposal.

Now, nanotechnology offers an alternative which is likely to spread rapidly. The Nanopatch is showing promise as a needle-free way to deliver vaccines.  The technology was developed by biomedical engineer Mark Kendall, who presented it at TEDGlobal 2013 in Edinburgh, Scotland, the birthplace of the  needle and syringe in 1853.

Kendall, a professor in the University of Queensland’s Australian Institute for Bioengineering and Nanotechnology, says while the  needle and syringe has transformed human fate by preventing disease and extending lifespan, it is 170-year-old technology with a  number of limitations that the Nanopatch can overcome.

Unlike the Nanopatch which is coated with dry vaccine, the needle and syringe form of delivery uses liquid vaccine that has to be  refrigerated from point of creation, through transport and site storage, to delivery, something referred to as the “cold-chain”. This  is very difficult to achieve in poor, remote regions with little or no healthcare infrastructures.

For instance, according to the World Health Organization (WHO), half the vaccines used in Africa aren’t effective because of  broken cold chains.

Another disadvantage of needles is the poor immune response because they have to be inserted into muscle, where there aren’t  many immune cells. In contrast, the Nanopatch makes thousands of small projections into the skin where immune cells  abound.

The Nanopatch is smaller than a postage stamp.  It is a one-centimetre-square of silicon, the surface of which has around 20,000  microprojections, all invisible to the naked eye.

Another potential cost saving is that the patch requires less vaccine.  Kendall’s studies with animals show that a 450 ng dose of flu vaccine delivered by Nanopatch is more effective than a 600 ng dose delivered via needle.

If such cost reductions turn out to be achievable, the Nanopatch could make it more viable to distribute  vaccine, especially the  more expensive ones, to the developed world.

Nanopatches offer obvious advantages far beyond issues of disposal and disposal-related safety advantages. Once perfected, expect these to be used for vaccine delivery worldwide, to overcome delivery issues in developing countries and to prevent screaming babies in the GP clinical here at home.

Everyone wins. But what about disposal? There will be no sharps injury risk but those coming into contact with the used patch may inadvertently be exposed to the drug substance. And in disposal, there will be some drug substance, plus nano materials entering the waste stream.

Inevitably, much of this, if not all, will go to the black bag waste stream. Like it or not, waste regulation must acknowledge and deal with this new challenge, in a practical and pragmatic way. That may necessitate change in current thinking, and in so doing rationalise some of the sloppy regulation that is applied to the waste sector, founded on bullying but unscientific thinking.