By, Casey Branham, MBA/CMLSO
There is a wide range of practices in how hospitals receive healthcare laser system (HCLS) disposables and accessories at their facility. As someone who works for a third-party provider that does this over 90,000 times a year, I’ve seen them all.
In some hospitals, the surgeon may ask for the instructions for use (IFU), or biomed may ask for the UL mark. In others, supply chain may just ask about the cost. There are very few exchanges where we see a Medical Laser Safety Officer (LSO) or Surgical Director present to review HCLS accessories and disposables – which is now a requirement under the latest Z136 guidelines.
Updated American National Standards Tackle Third-Party Provider Risk
ANSI Z136.3 (Sections 126.96.36.199 & 4.3.2) requires that a Medical Laser Safety Officer approve each HCLS and equipment prior to use. This includes any disposables and accessories for use in laser cases. This is necessary to ensure the correct combinations of items are used for each case.
For example, there is difference between an FDA approved item and an FDA approved system. The difference is that a disposable and an accessory can each be FDA approved, yet that specific combination may not be FDA approved based on the OEM and the IFUs for each.
When a facility owns its lasers and purchases fibers directly from the OEM, there isn’t much risk of running into that issue. However, most hospitals do not have a process – or the appropriately certified laser safety professionals – in place to ensure items brought in by third-party providers are also approved (1.4.2).
The result? Hospital staff may be unknowingly introducing risk into their OR that could impact patient outcomes.
The LSO community has an opportunity to educate healthcare professionals on a thorough intake procedure needed to control what enters the OR and what combination of HCLS accessories and disposables can be used without limiting the surgeon’s access to cutting edge technology.
A Good Place to Start: OEM vs. Non-OEM Fibers
My co-worker Richard Gama, CMLSO, presented a dynamic risk assessment tool at the International Laser Safety Conference last year to help LSOs take a closer look at the risk around non-OEM disposables used on different OEM devices. The concept is that risk is not binary or static – it is dynamic. Adding items to a procedure or using different non-OEM combinations may increase the risk that an unsafe event occurs in a laser case.
For example, the risk profile is very different between flexible fiber CO2 versus Holmium laser disposables. In the case of Holmium laser disposables, the fiber optic transmits laser energy. In the case of flexible fiber CO2, the CO2 fibers are made of different materials entirely (Silica hollow core or OmniGuide Polymer). The differences in materials create more aspects that require risk evaluation.
Holmium lasers emit 2100 nm wavelength energy, and the Holmium fibers transmit this energy. This relationship limits risk to the integrity of the fiber and the dexterity of the cladding. The IFUs for the Holmium fibers are validated for use on many different manufacturers’ Holmium lasers. However, the LSO should review and approve and the laser settings prior to use.
There are several well-established third-party Holmium fiber manufacturers that exist today with proven track records. The established track record combined with the simple make up of Holmium fibers makes a good argument for this being a low risk pairing.
The CO2 flexible fiber is a comparatively recent invention. OmniGuide claims to have produced the first hollow core polymer CO2 laser fiber in 1998. The OmniGuide fiber (known as a flexible instrument) carries 10,600 nm laser energy as well as helium gas at a predefined PSI based on the inner lumen of the flexible instrument.
The addition of this pressurized gas dramatically changes the risk profile. Due to this, the challenges around third-party silica fibers on OmniGuide equipment are many. The challenges for CO2 flexible fiber systems manufactured for use with silica fibers are not as dynamic because the material of the fiber is the same as the one intended for use on the HCLS.
Approving silica fibers for use on the OmniGuide laser creates several potential issues. The correct PSI setting for the pressurized gas is first and foremost, as no one wants to see an unanticipated tissue interaction or an airway fire. Once that risk is properly evaluated, the next risk is the durability of the silica fiber.
The OmniGuide polymer fiber is ideal for CO2 energy for a few reasons. The OmniGuide selling point is that it fails safely. Compared to a hollow core silica fiber, this is true. OmniGuide claims 23,000 surgeries without a single instance of a fiber breaking. The Maude database shows that a few hollow core silica-based CO2 fibers have broken inside patients or on the surgical field. CO2 laser energy does not diffuse at the same rate as Holmium energy; therefore, the risk of burns is high if the silica fiber breaks. In 2019, OmniGuide posted a product safety alert around the use of third-party silica fibers on their HCLS.
Approving silica CO2 laser fibers for use with systems designed to transmit CO2 energy through a silica fiber are much simpler to evaluate. The major issue there is identifying whether the IFU has a conversion chart for the PSI setting based on the CO2 silica laser fiber inner lumen diameter. The type of gas recommended for use with the HCLS OEM fibers and the one on the IFU for the non-OEM fiber also needs evaluation.
Imagining a Better Process to Reduce Risk
In order to mitigate the risk described above, hospitals should implement a defined process that involves LSO review of the IFU for HCLS, accessories and disposables. There should also be a follow-up evaluation to determine whether the combined products suggested for use fits that of the IFU for the laser, accessory and the disposable.
After the LSO approves each item use and their combined use, the process moves to the value analysis committee in the same way a facility evaluates a new purchase. Facilities that follow the value analysis process may slow down how quickly an item is available for use, but they ensure the item has been properly reviewed. I often see this process used for new HCLS entering facilities, but I rarely see it when disposables or accessories are involved.
In summary, any process that allows a laser disposable into the facility OR without review from the LSO and a subsequent trip to value analysis increases facility risk. Third-party providers should be required to add any disposable to their contract, and any item should go through the value analysis committee prior to the disposable being placed on contract or entering the OR.
This reduces the risk that disposables enter a facility without proper review of the related IFUs. If your facility has not followed this process in the past, requesting all related IFUs for all contracted items from your third-party partner is a quick way to evaluate the risk you have today. Adopting a more rigorous disposable entry path policy is a proven way to limit risk in the future.
About the Author
Casey Branham is the Operations Director at Agiliti where he works with OEMs to select new technology offerings and partners with large Health Systems around their laser program needs, including the service and delivery of over 330 surgical cases per day. Casey has over 7 years of experience as a certified laser operator and has over 6 years of experience managing multiple ambulatory surgery centers across the Eastern United States that provided laser treatments. He has also been a Board-certified medical laser safety officer for over 2 years