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Instrument Tracking and Laser Marking News

The main risk of being misled about surgical instrument laser marking

History is something I love, because the more we learn from it, the more we understand the future.
In 1968 the Russians repeatedly told the American people “There is no way you will go to the moon, we have better technology and we haven’t even thought about it, there is no way you will achieve it”….The rest as we all know is history.
Laser technology (Fiber) has been around for many years now, evolving and improving daily while becoming more accessible at affordable prices.
To achieve a good result with the laser in any industry, the price you have to pay is high and I am not referring to money. I am talking about research-based knowledge and this is why many gave up quickly because they don’t know/want to conduct deep research.
Laser marking has been around for many years and been used by many manufacturers and industries (highly regulated fields). This is because of the incredible flexibility you have, as well the precision and speed it moves in production.
Let’s take a look at what you might be missing now, especially with the impending FDA- UDI (Unique Device Identification) rule.

Myth: There is a physical change to the instrument surface with a laser etch:
A physical change involves a change in physical properties. Examples of physical properties include; melting, a transition to a gas, change of strength, change of durability, changes to crystal form, textural change, shape, size, color, volume, and density.
If laser etches makes physical changes on the surgical instrument so does chemical etching, chemical cleaning, buffing, sharping, pitting, placing stickers, engraving Doctor’s name, instrument to instrument scratches and pretty much any/all daily manipulations, and damages instruments go under during daily processes.
A laser mark is as big as 2.3mm X 2.3mm and is only just a few microns deep.

Myth: The passivation layer has to be reapplied by a facility:
Passivation involves the creation of an outer layer of shield material that is applied as a micro-coating, created by chemical reaction with the base material, or allowed to build from spontaneous oxidation in the air. As a technique, passivation is the use of a light coat of a protective material, such as metal oxide, to create a shell against corrosion.
I could spend hours explaining this but, the answer will be short. No passive layer is possible to re-apply, Oxygen (O2) mixed with Chromium creates Chromium Oxide, a very thin layer (a few atoms thick) above the surface to keep elements away. This is a naturally occurring chemical reaction. It cannot be reapplied by the facility nor can be lifted to apply a mark under.

Myth: Laser marks will rust:
Stainless steels are corrosion-resistant by nature, which might suggest that passivating them would be unnecessary. However, stainless steels are not completely impervious to rust. One common mode of corrosion in corrosion-resistant steels is when small spots on the surface begin to rust because grain boundaries or embedded bits of foreign matter (such as grinding) allow water molecules to oxidize some of the iron in those spots despite the alloying chromium. This is called rouging. Some grades of stainless steel are especially resistant to rouging; parts made from them may, therefore, forgo any passivation step, depending on engineering decisions.
During the process of marking (Both Laser and Electrochemical etching), there is a need to clean these potential molecules of iron. See statement from the electrochemical manufacturer: https://www.monode.com/electrochemical-etching-stencils-pads-markers-electrolytes-neutralizer-paper.php
"A custom-blended, near-neutral solution that will encapsulate any residual oxides or electrolytes from the surface of the parts being marked, therefore preventing corrosion or staining. As electrochemical etching involves an aggressive chemical reaction, it can be an initiation site for future corrosion. Thus, all etched parts must be neutralized after the etching process takes place."
The fact is the laser mark does not rust the stainless steel. Stainless steel by its very nature will rust if not properly treated and cared for. This is why it is imperative to have an SPD which is closely inspecting ALL surfaces, grooves and parts of the surgical instruments during processing.

Myth: Mineral and Bio-Burden build up:
It is a fact, some minerals as well Bio-Burden can grow on the surface of the mark, any mark. Keep in mind; these bioburdens grow as well in other grooves, channels, textures, under plastic labels, stickers etc...all on the instruments. Add human secretion to the equation and you will have bacteria growing. It is imperative that a complete and perfect washing & cleaning process is implemented for each instrument to remove all these bio-burdens from the entire surface of the instrument. If you find Bio-Burden on a mark (using our R+ reader) it is time to review the cleaning/washing process which took place prior to reassembling that tray. We would also suggest tracking the other instruments in that tray to see if they were properly washed and cleaned.
 NuTrace R+

Myth: Patient safety risk:
I will leave this one to you to judge, but if you have a CJD case involving Neuro instruments or Eye instruments and you are unable to identify them in the first case because the inability of electrochemical etching to mark them, which instruments were compromised? And with which patients?
Laser technology will bring not only the incredible flexibility to make marks as small as 800 microns (.08mm X .08mm) with 33 characters but allows you to mark plastics, anodize material, titanium, stainless steel, and any other small and ultra-small instrument to be identified in the supply chain and these laser marks will stand for the lifespan of the instrument. Laser etching of surgical instruments has been implemented worldwide for many years and there has never been an incident of patient safety being compromised. If anything… the exact opposite with precise tracking of all instruments.

For more data/information about the science of laser marking or inquiries about our NUX-20 surgical instrument marking system please contact us at www.nutrace.net

 
 

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