Design Realization/Detailed Design - Medical Device Design: Innovation from Concept to Market - page 192

environment engineers and designers were guilty of wastefulness. However we have become the
saviors in this respect as only we can design the solutions to the problems. One way in which
this manifests itself is in “carbon footprints” and “zero to landfill” policies. In the medical
devices environment (at the time of writing) this is difficult as there is little chance of recycling,
say, a used hip. But many of us will be designing medical devices for the mass consumer market
and have no such excuse. ISO 14044 is the standard associated with life cycle analysis (LCA). It
is a standard you should have at hand if you intend to go down the LCA path. A cursory glance
at how much energy is used to make and recycle common materials ( Table 8.11 ) is
“eye-opening.”
Most countries have an environmental policy in place, and in most this exhibits itself in a
statute of some form. To cover the statutes in detail is beyond the scope of this text but you
should realize that as a trading company you will have legislative duties to environmental
impact, and these duties, normally, depend on the size of your company.
The obvious item that we all have in common is packaging. It is very easy to say that all
packaging should be from recycled materials, but do not forget that all of your materials must
be bio-burden and animal product free at the point of packaging. If the material is recycled
how do you know its source? It is unlikely that any sterile packs will be made from recycled
materials, purely because of this fear.
However it is also a truism that it is difficult to source metals that have not been recycled in
some form; they have, after all, been recycled from rocks. One thing we can be sure of though
is they have not been recycled from medical use as hospitals, etc., dispose of contaminated
materials diligently.
So as medical devices designers what can we do? Certainly exterior packaging can be
recycled after transportation. Devices that are supplied nonsterile can also have their
packaging recycled after transportation. If our risk analysis says it is safe to use recycled
materials in certain conditions (and we have avoided contamination from animal by-products,
etc.) then there is no real reason why it cannot be done. But remember, if you are doing
something new you will need to do a thorough evaluation to show what you are doing is safe
(see risk analysis and evaluation chapters later).
Also those of you who deal with instrumentation (say, ultrasound imaging devices) are
required to recycle under the European WEEE (Waste Electrical and Electronic Equipment)
directive. However, even this is fraught with issues. In the USA the EPA (Environmental
Protection Agency) considers some electronic components as hazardous (cathode ray tubes
for example), so even this avenue is unclear for the designer.
Thus, I think you can see we are at a bit of an impasse. Those of us designing devices for
direct clinical use would love to be “greener” but, for obvious reasons, our hands are tied.
Hence we can only do “what is practicable .” Those of us designing medical devices for the