Medical Design Briefs - September 2021 - 11

lasers. If devices and instruments are too heavily cleaned during
the passivation process, any disappearance of the laser
mark could cause the device to be out of compliance. It is also
critical that a groove isn't created in which bacteria could cling
and potentially infect the patient.
Medical device designers may not know all that is involved
with UDI, especially in terms of passivation. For instance, many
stainless-steel alloys commonly used in medical devices have a
natural outer surface of chromium oxide that stops corrosion
during repeated sterilization. Natural passivation can be compromised
by machining, grinding, polishing, or other mechanical
processes during device fabrication. If there is a need for
repassivation using a citric or nitric acid, the acid could remove
the unoxidized iron particles from the surface.
Picosecond Laser System Advantages
With picosecond lasers, the pulse duration is shorter than
the time for heat to flow out of the laser interaction zone, even
in metals, so peripheral thermal effects are greatly reduced
compared to nanosecond lasers. This means that a much higher
portion of the total laser power is used to create the mark,
rather than producing unwanted heating. Second, the high
peak power of picosecond pulses enables unique interactions
between the laser and the substrate, including multiphoton
absorption, where material is directly atomized in a relatively
cold process, rather than heated to vaporization. Picosecond
lasers systems do not melt the material and leave no burrs after
engraving, resulting in a very smooth surface.
While picosecond lasers are considered quite an investment,
these lasers can more than pay for themselves for medical device
companies where devices failures can result in costly recalls and
more. The areas treated with the picosecond laser absorb light
to appear as unreflective dark marks on stainless-steel devices. As
opposed to oxide-made marks that differ in appearance depending
upon the angle at which they are viewed, a black subsurface
marking produced by a picosecond laser system appears the
same from all angles.
UDI on Devices
Marking UDIs on devices and instruments is needed to follow
devices on the market and provides a straightforward way to document
and track device use in electronic health records (EHR),
clinical information systems, claim data sources, and registries.
Additionally, UDIs support post-market surveillance systems and
support pre-market approval or clearance of new devices as well
as any new uses of existing devices already on the market.
More specifically, the marking of UDIs on devices enables
better reporting, reviewing, and analyzing of adverse events so
that problematic issues can be quickly uncovered and corrected.
It can reduce medical errors because it enables healthcare
professionals to act more quickly and accurately in identifying
a device and allows access to any and all vital information concerning
device requirements. Additionally, the use of a standardized
UDI enables manufacturers, distributors, and healthcare
facilities to more effectively manage medical device recalls
and to act more quickly in locating where the device is in use.
These advantages make the use of picosecond and femtosecond
ultrashort pulse lasers a significant benefit for medical
device makers.
This article was written by David Locke, Regional Manager, ACSYS
Lasertechnik, Lenexa, KS. For more information, visit http://info.
hotims.com/79417-342.
Medical Design Briefs, September 2021
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Medical Design Briefs - September 2021

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