Reflections on the Last 20 Years of
Medical Device Packaging
From robust validation protocols designed into packaging equipment to pristine orthopaedic implants that
go directly from a sterile barrier pack to the surgeons’ hands, progress has been constant.
R.E. Hall, Medical Pack Solutions, Shannon, Co. Clare, Ireland
The year of living monochromatically
1990 was an important year: Medical
Device Technology (MDT ) was founded,
the first of the medical device directives1
was published and on 3 October the
German Democratic Republic ceased to
exist, as the Federal Republic of Germany
was simultaneously expanded by five new
states. The word “validation” had yet to
become an important part of my vocabulary. Medical device customers were
expected to read English-language labels;
if they were lucky they might also have
French and German text. In 1990, the editor of MDT used a monochrome PC.
some metal detectors. However, compliance with the European Electromagnetic
Compatibility Directive 2, which came
into force in the 1990s, has helped to
minimise this issue.
Now cams are replaced by stepping
motors with their attendant adjustment
and control flexibility. Time controllers are extremely accurate because they
use quartz crystal controlled electronic
clocks. Electronic temperature controllers
have gained proportional control ability;
Evolution of the machine
In 1990, much packaging
machinery used cam shafts,
gears, chain, notched belts and
pulleys to maintain synchronisa-
tion. Timers were mainly electro
mechanical with clutches, some
temperature readouts were still
analogue, temperature control
was generally by power-on/
power-off at set points and
remote machine controls were
basic and hardwired. The devel-
opment of stepping motors,
microprocessors, networking and
the Internet has changed all this.
There have been problems with
electromagnetic compatibility—
mobile phones interfered with
machine electronics, especially
some even automatically tune themselves
to compensate for changing load condi-
tions. Worldwide, the influence of elec-
tronic miniaturisation and falling prices
of electronics has revolutionised machine
design. Validation requirements form part
of machine design criteria. Machines may
now be fitted with computerised systems
that make a record of the parameters used
for each successive machine cycle. Record-
ing systems and secondary control panels
can be linked by Ethernet cable to any
conveniently located PC for supervision.
Changing expectations
During the past 20 years many
devices previously sold nonsterile
for sterilisation by the user are
now terminally sterilised by the
manufacturer. Improved machine
control systems have, in many
cases, aided the validation process. For example, an orthopaedic surgeon will normally receive
a sterile knee or hip femoral
component in pristine condition
in a manufacturer’s sterile barrier pack. In earlier times the
implant may have reached the
surgeon after several visits to the
local central sterilisation unit
for autoclaving. Now there can
be confidence that the bearing
