Rethinking high-level disinfection requirements for ophthalmic devices

ASCRS News: EyeSustain Update
Fall 2026

by Emily Schehlein, MD
EyeSustain Update Guest Editor

We previously interviewed Irene Kuo, MD, regarding her special report, “Disinfection of outpatient ophthalmic devices: a critique of ‘semicritical’ designation.”1,2 Dr. Kuo discussed that the regulatory framework for high-level disinfection (HLD) was developed with the outdated Spaulding classification system and designed for instruments used on heavily colonized mucosal surfaces. Applying these same standards to devices that briefly contact the low microbial burden ocular surface is not science or evidence based and poses significant financial, regulatory, and operational challenges for ophthalmologists.3

However, regulatory agencies such as the Joint Commission and Centers for Medicare & Medicaid Services (CMS) have penalized ophthalmology clinics and surgical facilities for not using HLD on ophthalmic devices, forcing organizations to adopt chemical HLD, autoclaving, or transitioning to single-use devices. 

To better understand current practice patterns and clinician perspectives, the EyeSustain High-Level Disinfection Task Force, co-led by Dr. Kuo and David F. Chang, MD, with representatives from ASCRS, AAO, AGS, ASRS, and OOSS, conducted a national survey of ophthalmologists and their cleaning practices for tonometry tips and diagnostic and laser lenses. The response rate included more than 1,000 ophthalmologists, making it one of the largest evaluations of ophthalmic device cleaning practices to date. The survey results, “Current practice patterns for cleaning tonometry tips and diagnostic/laser lenses,” were recently published in the Journal of Cataract & Refractive Surgery.4

The survey reveals a disconnect between regulatory expectations and everyday clinical practice. Use of HLD or disposable devices were uncommon and used by only a small minority of respondents. For tonometry tips, 73% of respondents reported cleaning devices with alcohol wipes. No other method of cleaning was used by more than 8% of respondents. Similar patterns were seen with alcohol wiping of diagnostic (63%) and laser contact lenses (50%). Rinsing lenses with water and/or soap was used by 21% and 27% of respondents, respectively. No other cleaning method was used by more than 5% of respondents for diagnostic or laser lenses. Perhaps most notable was why clinicians adopted HLD in the first place. Among those using chemical disinfection, disposable devices, or autoclaving, the overwhelming majority cited regulatory or facility requirements. Only 19% reported using HLD because they thought it was safer for patients, with the remainder using HLD due to regulatory requirements. More than half of respondents reported damage to each device class from using chemical disinfection.

With current cleaning practices, infection transmission associated with these devices appears to be exceedingly rare. Approximately 99% of respondents reported never encountering a convincing case of infection transmission from tonometry tips, diagnostic lenses, or laser lenses during their careers. The few reported events consisted primarily of isolated cases of viral conjunctivitis, with no long-term visual consequences. These findings are consistent with a growing body of literature suggesting that routine ophthalmic examinations and laser procedures have an excellent safety record using existing cleaning practices.5

Most respondents did not think HLD should be mandatory for these ophthalmic devices. Only 7% of respondents thought HLD should be required, while at least 88% thought HLD should not be mandatory for tonometry tips or diagnostic and laser lenses. When facilities are required to perform HLD or switch to disposable alternatives, the consequences extend beyond workflow disruption. HLD increases costs, generates waste, consumes resources, and contributes to healthcare-related carbon emissions without producing measurable clinical benefit.

In summary, this survey of more than 1,000 ophthalmologists found that more that 75% of respondents strongly oppose mandated HLD, and current cleaning practices demonstrate a clear safety record, with 99% of respondents never reporting a case of infection transmission. The task force thinks these findings should serve as a catalyst for meaningful dialogue among regulatory agencies and professional societies. Ophthalmology clinics and surgical facilities should not be required to use HLD for these devices that contact the cornea and limbal conjunctiva based on an outdated system. 


About the author

Emily Schehlein, MD
Glaucoma Specialist
Brighton Vision Center
Brighton, Michigan

References

  1. Schehlein E. Q&A with Irene Kuo, MD, on “Disinfection of outpatient ophthalmic devices: a critique of ‘semicritical’ designation.” EyeWorld. 2025;30:12–13.
  2. Kuo IC. Disinfection of outpatient ophthalmic devices: a critique of “semicritical” designation. J Cataract Refract Surg. 2025;51:355–358.
  3. Kowalski RP, et al. Normal Flora of the Human Conjunctiva and Eyelid. In: Duane’s Clinical Ophthalmology. 2016.
  4. Chang DF, et al. Current practice patterns for cleaning tonometry tips and diagnostic/laser lenses. J Cataract Refract Surg. 2026. Online ahead of print. 
  5. Wagner IV, et al. Incidence of conjunctivitis and keratitis with reusable ophthalmic laser lenses at an academic medical center. Clin Ophthalmol. 2025;19:4169–4176.

Contact 

Schehlein: emschehlein@gmail.com