2 Industrial Laser Solutions SEPTEMBER/OCTOBER 2017 www.industrial-lasers.com
Tests on surgical instruments demonstrate
UDI laser marking durability
TUTTLINGEN AND SELMSDORF,
GERMANY – Add’n Solutions, which
provides Unique Device Identifcation
(UDI) laser marking on medical devices,
worked in close cooperation with FOBA
Laser Marking + Engraving to conduct
a long-term study on reusable surgical instruments, with the aim of proving
that laser marks remain clearly readable
despite multiple reprocessing procedures. The UDI must resist increased
wear throughout the whole product life
cycle to ensure safe traceability, which
is also offcially required.
The comprehensively documented
study demonstrated that laser-marked,
high-contrast UDI codes can resist
at least 500 sterilization and cleaning
cycles. FOBA’s short-pulse fber marking lasers optimally adapt to the surface characteristics of different types
of stainless steel, with appropriate laser
parameters to prevent the inscription
from fading out or corroding. An additional passivation ensures that the complete device, including marked areas, is
protected against corrosion. The ASTM
967 standard for stainless steel passivation was used for passivation of the
In the study, Add’n Solutions used
a precisely matched laser marking process, followed by a cleaning and passivation cycle. The surgical instruments were then sterilized
and cleaned 500 times, simulating actual wear conditions
in a hospital. The steam sterilization was accompanied by
an instrument cleaning with high-alkaline cleaners (pH value
14), which is also equivalent to clinical cleaning procedures.
A direct mark on a medical product must be of high contrast and resistance and also not have a negative impact
on surface quality. Until recently, it was unknown how often
laser-marked surgical instruments can be reprocessed
without negatively impacting the quality of the mark.
Notwithstanding the type of laser used (short- or ultra-
short-pulse laser), the recent study provided evidence that
only an additional passivation developed to exactly
match the marking process creates appropriate
long-term protection against corrosion, ensuring
readability of the marks.
The present study suggests the assumption
that marking with an ultrashort-pulse laser does
not require passivation is incorrect—only accompanied by a passivation process can the complete product
be reliably protected.
The latest legal regulations of the U.S. Food and Drug
Administration (FDA) and the European Medical Device
Regulation require that all medical products must bear UDI
marks, with implementation deadlines that vary according
to the risk class of the device.
An application case study with a detailed description of
the durability test on reusable surgical instruments is available for free download at www.fobalaser.com.
For more information about Add’n Solutions, please visit
Marks on stainless
steel medical scissors,
reprocessed 500 times
with laser annealing, is
shown; the UDI marking
is still clearly readable.