surfaces have not suffered in the handling
process and there are no worries about the
actual sterilisation conditions in a mixed
autoclave load.
People’s expectations have changed. I
remember resistance to the introduction
of the clean-peel opening for single-use
disposables. There were complaints that
the new chevron pouches did not exhibit
fibre tear at their paper–film interface
when peeled open—nurses were wary of
undetected leaks if the seal was not strong
enough to tear paper. Now some quality inspectors fear complaints if a little
delamination occurs when removing an
otherwise clean-peel Tyvek lid from a
thermoformed tray. In the 1990s concern
was still being mooted that nonporous
materials would prevent the escape of
contaminates caused by product degradation on irradiation. The current usage
of nonporous peel pouches suggests that
those concerns have been forgotten.
In 1990 much of industry still followed
Eucomed labelling recommendation
83/10: “If product is subject to material
degradation within five years, the expiry
date (year and month) should be printed
on the unit and shelf container. For all
other practical purposes, products will
remain sterile indefinitely if handled correctly. Maintenance of sterility is event-related rather than time related.” US FDA
did not demand expiry dating.
Despite creation of the HIBC3 in 1984,
bar codes were little used for inventory
control. One senior orthopaedic sister
with responsibility for inventory in three
operating theatres remarked to me that
she had personal control of more than
£210 000 of implant stock and more
than £140 000 of disposable items and
yet used pencil-and-paper stock-control
methods. Clearly computers and bar codes
bring progress. Advances in computer and
printing technology have enabled device
manufacturers with appropriate software
to meet the ever-increasing demand for
more languages on product labels. I can
now report that our Editor in Chief uses a
colour monitor.
References
1. Council Directive 90/385/EEC.
2. European Directive on Electromagnetic
Compatibility 89/336/EEC.
3. Health Industry Bar Code, administered
in the US by the Health Industry Business
Communications Council (HIBCC) and in the
EU by EHIBCC and HIBCC France.
Rolande E Hall
Medical Pack Solutions, Pinewood Lodge, 16,
Tullyvarraga Hill, Shannon, Co. Clare, Ireland
tel. +353 61 364837
e-mail: rolande@m-p-s.ie
www.m-p-s.ie
Year Milestones
High-Performing Flow and Humidity Sensor Solutions
The Swiss sensor manufacturer Sensirion AG is a leading international
supplier of CMOS-based sensor components and systems for medical and
various other demanding applications. Its range of high-quality products
includes humidity and temperature sensors, mass flow meters and controllers, gas and liquid flow sensors, and differential pressure sensors.
The excellent sensor performance is based on the innovative
CMOSens® Technology. With itś dynamic flow measurement
principle, Sensirionś flow sensor solutions work with superb
long-term stability and achieve highest accuracy and sensitivity, particularly at very low flow rates. Thus, they help to
increase the safety and reliability of medical devices.
VISIT THE EMDT TIMELINE AT:
www.emdt.co.uk/emdt-timeline
emdt.co.uk European Medical Device Technology
June 2010 | 45
