Assessment of the Necessity for High-Level Disinfection (HLD) of Reusable Ophthalmic Devices: A Multisociety Position Paper.

Regulatory agencies in the United States and abroad are increasingly citing clinics and surgical facilities for what they deem to be inadequate disinfection of Goldmann applanation tonometry (GAT) tips, gonioscopy lenses, laser lenses, and other reusable clinic devices that contact the ocular surface. These regulators require routine high-level disinfection (HLD) of these reusable devices to prevent infection transmission. A multisociety task force formed to assess the necessity of HLD found no published evidence that these devices transmit sight-threatening infections or that HLD reduces infection transmission compared with lower-level disinfection methods. Meanwhile, routine use of chemical HLD reduces clinic efficiency, increases healthcare costs and waste, and may damage device surfaces potentially affecting patient care. Underlying these mandates for HLD is the nearly century-old Spaulding classification system, which inappropriately groups the ocular surface with heavily contaminated mucous membranes. A task force survey with more than 1000 ophthalmologist respondents found that the most common reprocessing methods were alcohol wiping for GAT tips and either alcohol wiping or soap and water for diagnostic or laser lenses. Many respondents using chemical HLD reported adverse effects, including ocular surface chemical toxicity and device damage. Despite infrequent use of HLD, reported infection transmission was exceedingly rare and generally limited to self-limited adenoviral conjunctivitis. The task force agreed with the majority (88%) of ophthalmologists surveyed that HLD should not be required for these reusable devices in routine clinical care. Instead, HLD should be a discretionary consideration in higher-risk circumstances, such as following use of these devices in patients with suspected infection. This paper presents the summary recommendations of a policy statement approved by the American Academy of Ophthalmology Board of Trustees and endorsed by four subspecialty societies.