Two Decades of Evolution
and Revolutions
Significant changes in materials usage, the rise of electron beam
sterilisation and a reminder of some unrecognised heroes are featured
in this 20-year perspective on industry developments.
L. Woo, Baxter Healthcare and L. Woo Associates LLC, Libertyville, Illinois, USA
Defining the lessons of history
In celebrating the 20 years of this publication, one reflects that there have certainly
been profound evolution and revolutions
taking place during that time. For anyone
who uses history as a guide for future
developments, there are plenty of lessons.
One profound evolution has been the
material selection debate over whether or
not the industry should switch from using
polyvinyl chloride (PVC). The debate
had just started and there was considerable skepticism over the likelihood that
a suitable alternative candidate could
be found. Skeptics pointed out that the
concern over PVC would be just like many
previous false alarms over di(2-ethylhexyl)
phthalate (DEHP), the most widely used
plasticiser for PVC. We can see now that
not only was it possible to find alternatives—in fact, chlorine- and plasticiser-free products are rapidly dominating the
marketplace. However, instead of a debate
over PVC and plasticisers, a new focus
over bisphenol A BPA has gained a lot of
regulatory and consumer attention. Here
the concerns are that the BPA could mimic
some natural hormones with harmful
effects on pregnant women and children
and the effect could be nonlinear.
Another global issue that has taken
centre stage is climate change and the
focus is on everyone’s “carbon footprint.”
As responsible global citizens, we in
the medical device industry should take
steps to ensure that our burden on future
generations is minimised. In this way, lead
for electronic instrument assembly and
chlorofluorocarbon (CFC) for much of the
cleaning of electronics and devices have
mostly disappeared as a result of environ-
mental regulations.
Dr Lee Woo
is Baxter Distinguished Scientist Emeritus,
Baxter Healthcare, and Founder of L. Woo
Associates LLC, Libertyville, Illinois, USA
tel. +1 847 367 6804
e-mail: leconwoo@gmail.com
lwooassociates.com