Can A Healthcare Facility Etch Their Surgical Instruments? (Part II) Over the past few years there has been a growing consensus among regulatory agencies that using colored tape or markers on surgical instruments is a bad idea. In their view, the use of tapes or markers should be discouraged or discontinued because of the infection risk caused by their use. So why is laser etching superior to tapes or markers? Laser markers produce a low local heat that changes the color of the surface layer of the instrument. The resulting laser etched mark is permanent and the surface of the material remains intact eliminating groves and channels, thus eliminating the potential for bacteria to colonize and grow in those spaces.¹ Medical device manufactures rely on the precision and accuracy of laser marking to help meet the FDA’s strict product identification and traceability guidelines (Unique Device Identification, or UDI). Laser marks done with the annealing process are corrosion resistant and can withstand many processes such as passivation, centrifuging, and autoclaving. ² The regulatory pressure to discontinue the use of tapes and/or markers has prompted many healthcare facilities to consider etching their surgical instruments. Facilities can either send their instruments out to a commercial laser etching company or, they can purchase a laser etching machine and do the job themselves in their facility. If you think you might want to etch your instruments in-house, there are several issues that you must address. The first issue is choosing which laser marker to purchase. A quality laser marker suitable for etching medial grade surgical instruments will cost your facility between $40,000 to well over $100,000. A laser etched mark on a medical device must be of high contrast and resistance.  Additionally, the mark can’t have a negative impact on surface quality. The second issue centers on the staffing requirements to etch your instruments once you’ve purchased a laser etching machine. You should expect to allocate one full-time staff person to focus on this task alone. Depending on the number of instruments in your inventory (an average size facility will have between 15,000 to over 20,000 instruments) it can easily take one person working 40 hours a week, a year or longer to complete the task. Third, after you’ve completed the labor intensive, time-consuming and expensive process of etching your instruments, you’ll need to purchase several scanners or readers at $3,000 - $4,000 each to scan the instruments. The number of locations as to where you scan your instruments will have a significant impact your total investment in scanners or readers. In addition to considering all of the benefits associated with laser etching your instruments, you need to consider the negative aspects of laser etching. The negative aspects and/or risks associated with laser etching surgical instruments in your facility include:

• Surgical instruments can and do get damaged in the process of putting them onto and then taking them off of the laser etching machine.
• Poor quality laser marks are subject to wear and tear over time and sometimes can't be read at all, or just read intermittently. When this happens, you may lose your tracking servicing history for the instrument that won’t scan.
• Instruments can rust if the etching is not done properly or the marks are not passivated properly after marking.
• Laser markers used for marking surgical instruments are typically Class 4 laser devices. These laser markers produce diffuse reflections that are hazardous to your eyes and skin (see below).
• Many laser markers have automatic doors which creates the potential for crush-type injuries.

If after considering all of the costs, risks and liability issues associated with doing laser etching in your facility and you decide against it, what are your other options? You can have a professional laser etching company do it for you, either in your facility or at their facility. A commercial laser etching company will make arrangements to bring a laser and technicians to your facility. They have the ability to etch a lot faster and more efficiently than your already overworked staff. More importantly, they are skilled in etching titanium, stainless steel, aluminum, anodized titanium, plastic, transparent plastic, eye instruments, needless, drill bits, retinal instruments, sensitive Neuro/Spine instruments and more. ³ The second option is to send your instruments out to a commercial laser etching company and have them do the etching in their facility. This is usually the most cost efficient and least disruptive option. The company will work with you and your staff to set up a schedule for them to do a certain number of your instruments every week. You simply send the pre-arranged number of instruments to them and over time all of your instruments and other devices will be etched. ⁴ Sending your instruments out to a commercial laser etching company eliminates the need for your facility to make the large investment in a laser marking machine. It also eliminates the big investment in staff time and effort to etch your instruments. Finally, the negative aspects, risks and potential liabilities associated with laser etching in your facility are all eliminated when they are assumed by a commercial laser company. Rest assured, Novo Surgical instruments are laser marked and passivated in house, per industry standards.

1. https://gtschmidt.com/marking-medical-devices
2. Op. Cite.
3. https://www.fobalaser.com/industry-solutions/medical-technology/
4. https://www.accumet.com/laser-marking-etching/