Eyeworld

FALL 2025 | EYEWORLD | 13 really need to buy $1 million more ultrasound probes because performing HLD will take our instruments out of service for a certain number of hours or days? This cost estimate does not even get at labor or HLD storage costs. You discuss regulators and how their as- sumption of "worst case" scenarios, for ex- ample with tonometry tips and prion disease, can lead to significant waste production and emissions. Can you outline this for our readers? Dr. Kuo: It is somewhat understandable from a risk perspective for regulators to look at worst case scenarios. Despite questionable study de- sign, a few studies have been cited by regulators that applanation can spread prion disease, and these studies do not show that at all. We may be performing applanation on patients harbor- ing prion disease, but truly no HLD is effective against prions—whether on an applanation tip, in a colonoscope or a bronchoscope. At some point, the regulation becomes onerous and not based on common sense. There is no evidence HLD is better at reducing the rate of infection transmission between YAG laser patients. Is it possible HLD reduces bacterial counts more than an alcohol wipe in a lab experiment? Yes. But in a clinical environment, with the antimi- crobial factors in the tear film and the mechan- ical cleaning of laser lenses and ultrasound probes, does that translate to infection risk that rises to any threshold we clinicians should be concerned about? To date, there is no evidence in the literature of transmission of any infection attributed to reusable ultrasound probes, laser lenses, or applanation tips. Bowing to regulation leads to significant waste (the move to single-use laser lenses and applanation tips and/or HLD for these pieces of equipment). It also begets lower quality of clin- ical care if these devices are lower quality than reusable ones or the reusable lenses become damaged with repeated HLD. The article opens with a discussion of the 2014 policy from the Centers for Medicare & Medicaid Services (CMS) preventing short cycle sterilization, which prompted ophthal- mic studies showing this is a safe practice and the Ophthalmic Instrument Cleaning and Sterilization (OICS) Task Force to issue specialty-specific regulations. How can ophthalmologists use this as an example to shape evidence-based, sustainable disinfec- tion protocols for ophthalmic devices moving forward? Dr. Kuo: We must thank David F. Chang, MD, Nick Mamalis, MD, and the other members of the OICS Task Force for the tremendous work they did to present to regulators that the tissue burden is different for the eye—in their words, regulatory guidelines from outside ophthal- mology "often do not take into account the unique conditions of intraocular surgery and special requirements for cleaning and steriliz- ing ophthalmic instrumentation. As a result, all-inclusive, broad guidelines attempting to cover surgery from head to toe could sometimes include inappropriate, or even risky, practices for ophthalmic cases." The Task Force showed not only that short-cycle sterilization is appropriate for sequential, same-day instrument reuse but also that instructions for use that required enzymat- ic detergents for decontaminating intraocular surgical instruments could damage the eye. Note, the Task Force did not say one must stop using enzyme cleaners, but it made the point that manufacturer IFUs are not always safe and certainly not always based on the risk posed to patients in real-life practice. Regulators need to value the point of view of us end users who perform surgery and conduct clinical care. In the end, experiments performed on other body parts or attempts to simulate the potential for an applanation tip to spread adenovirus by culturing steel discs exposed to a solution of adenovirus are just not helpful. I think ophthalmology, being a small but highly important specialty, can help our patients by educating regulators, some of whom are MDs or PhDs with little exposure to or knowledge about ophthalmology.

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