Ophthalmic practice is unpredictable and dynamic. It ranges from lens prescription and standard medical treatment, to the most delicate and precise surgical manipulations. In a typical workweek, ophthalmologists can see more than 100 patients and perform three or more major surgical procedures.1 Infection prevention and control is a fundamental part of the broader infrastructure required for safe ophthalmic practice. Various types of devices are used in ophthalmology; each intended use is associated with a risk category. To ensure the safety of the next patient, ophthalmologists find guidance in the Spaulding Classification (Table 1), a framework that helps to choose the appropriate level of disinfection based on the risk category of the intended use.

Table 1. The Spaulding Classification (1968) developed by Dr. Earle H. Spaulding.
This classification scheme defines how an item (e.g. medical device) should be disinfected based on its intended use.

Based on the classification, which has been adopted by the Standard for Canadian Medical Device Reprocessing, ophthalmic medical devices that come into contact with the surface of the eye are classified in the semi-critical risk category and therefore routine high-level disinfection is recommended.

A national benchmarking study shows that despite there being consensus on the appropriate level of disinfection within ophthalmology, there is dissensus on the recommended solutions between different jurisdictions in Canada due to the absence of a suitable solution. ²

In addition to the appropriate reprocessing standard, the solution also needs to be functional for the workflow; within ophthalmology, functionality would include speed, consideration of device size, and compatibility with device materials. Commonly seen solutions do not meet all the criteria; chemical soaks imply slow device turnaround and the potential to damage devices, and many wiping solutions lack microbiological efficacy.

All this makes for a tough dilemma for healthcare providers when choosing an appropriate solution. The options available are limited and pose a significant challenge to ophthalmologists to maintain workflow and simultaneously to infection control teams to pursue best practice.

A solution that addresses both interests has not been available, until now. In 2021, Tristel received approval for its high-level disinfection solution by Health Canada with product classification in accordance with the Canadian Medical Devices Regulations SOR/98-282, Tristel Duo OPH.

References:

1. https://www.aao.org/medical-students/practice-of-ophthalmology
2. https://www.canadianjournalofophthalmology.ca/action/showPdf?pii=S0008-4182%2815%2930095-8

More Information

Healthcare-associated infections (HAIs) are a major concern in ophthalmology. Click here to find out more about the risks & consequences of inadequate device reprocessing.

The Standard for Canadian Medical Device Reprocessing (CAN/CSA-Z314-18) addresses the safe and effective reprocessing of medical devices and supplies.