Eyeworld

12 | EYEWORLD | FALL 2025 ASCRS NEWS EYESUSTAIN UPDATE Reference 1. Kuo IC. Disinfection of outpatient ophthalmic devices: a critique of "semicritical" des- ignation. J Cataract Refract Surg. 2025;51:355–358. Relevant disclosures Kuo: None Contact Kuo: ickuo@jhmi.edu is lumped as a "mucous membrane." By this classification, ophthalmic equipment—such as ultrasound probes, laser lenses, and applana- tion tips—must undergo high-level disinfection or sterilization the way colonoscopes and anal manometers must. By contrast, blood pressure cuffs and stethoscopes are classified as non-crit- ical, by contacting intact skin. Interestingly, the conjunctiva and cornea are cleaner than skin, yet devices that contact them must undergo a higher level of disinfection by the Spaulding classification. This is where institutions fault ophthalmology departments for not following manufacturer "instructions for use" (IFU) on disinfection. You also discuss the difficulties of performing high-level disinfection (HLD) on ophthalmic devices (and the frequency of HLD, which is low in academic centers and likely non-ex- istent in private practice). Can you expand upon the challenges to ophthalmology clinics posed by this push for HLD? Dr. Kuo: First, as a specialty (along with David F. Chang, MD, I am leading an HLD task force consisting of reps from various ophthalmic societies), we need to push back because HLD for our equipment is neither science- nor evidence-based. For example, HLD varies by geographic location. Already, that is a problem when our devices are made by multinational corporations. Does that mean HLD has to be different in each country they sell to? Companies with disinfectant products can conduct studies on bacteria they choose and claim that their product qualifies as HLD. For certain, companies do not have any obligation to show that HLD is better than any methods we ophthalmologists currently use in our clinics to disinfect our lenses, ultrasound probes, or ap- planation tips. Lastly, there is no obligation that manufacturers show that highly delicate (and expensive) ophthalmic devices can withstand multiple exposures to HLD. This issue gets at the cross purposes of business interests (manu- facturers of devices, companies that make dis- infectant products or devices) and clinical care, and business interests and sustainability. Do we Q&A with Irene Kuo, MD, on "Disinfection of outpatient ophthalmic devices: a critique of 'semicritical' designation" Have you ever wondered why your institution may insist on disposable gonioscopy lenses, B-scan ultrasound probes, or tonometry tips? The alternative is sterilization practices that are not evidence-based, may lead to device destruction, and create a massive amount of medical waste. In the name of patient safety, regulatory bodies impose classifications and cleaning specifications on devices in all specialties in medicine. In this EyeSustain Update column, we feature a conver- sation with Irene Kuo, MD, cornea specialist and associate professor of ophthalmology at Wilmer Eye Institute, in Baltimore, Maryland, regarding her special report, "Disinfection of outpatient ophthalmic devices: a critique of 'semicritical' designation." 1 —Emily Schehlein, MD, EyeSustain Update Guest Editor In your report, you discuss how the U.S. FDA and Centers for Disease Control and Preven- tion (CDC) follow the Spaulding classification for medical devices and instruments across specialties. Can you discuss the Spaulding classification and why this system may not be aligned with mitigating infection risk in modern ophthalmology? Irene Kuo, MD: The Spaulding classification dates to the 1930s, when microbiologist Spauld- ing came up with a system to categorize the disinfection or sterilization needed for reusable medical devices and surgical instruments to mitigate the potential risk of infection posed to the next patient. While the Spaulding classification may have worked for decades and was a good frame- work (such that regulatory agencies continue to adhere to it), it needs to be updated, and/ or ophthalmic devices must be separated into their own category. In the 1930s, the ophthal- mic landscape was relatively primitive—no microscopes, no phacoemulsification, no corneal transplants, no lasers, no ultrasounds. Spauld- ing and others at regulatory agencies classify the whole of the eye as a "mucous membrane," which it is not, nor is it as contaminated as, for example, the colon, with which the eye

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