See It Clearly: Central Sterile Processing’s Role in Reprocessing Eye Devices

Infection Control Today, Volume 27, Issue 1

Read about the sterilization process of eye instruments and devices.

If cataract, glaucoma, eye trauma, or corrective eye surgeries are performed at an organization, it is important to confirm that the eye instruments or devices used during these procedures are being sterilized according to the manufacturer’s instructions for use (MIFUs) and sterilization evidence-based guidelines (EBGs). Although most eye instruments and devices that are not single-use disposable require only sterilization, the B-scan probe requires manual high-level disinfection (HLD) per the manufacturer.1 This article will focus on the sterilization process of eye instruments and devices.

The eyes are organs of the visual system and are considered a high-risk tissue. Reprocessing guidelines advise that all ophthalmic instruments and devices classified as critical based on intended use must be sterilized. Therefore, ophthalmic instruments and eye devices require the same reprocessing steps (point-of-use precleaning, cleaning, rinsing, HLD, or sterilization) based on intended use, MIFUs, and sterilization EBGs. High-volume eye procedures such as cataract surgeries place an added stress on turnaround times and accurate sterilization processes. Highly reliable sterilization practices that are part of central sterile processing staff’s standard work are imperative to prevent patient harm.2

Precleaning at point of use to remove bioburden is a component of every procedure, not only ophthalmic procedures. Following MIFUs and EBGs for precleaning will ensure that soils do not dry on the instruments or within the lumens. Keep the instrument moist to prevent soil from drying on the instrument or device. Eye instruments and devices should be transported in a contained manner (ie, leakproof, puncture resistant, biohazard labeled, based on the contents being transported) to protect personnel from contamination and to prevent injury during transport to the decontamination area.2,3

If an instrument is not clean, this directly impacts the ability to perform a quality sterilization process. Many ophthalmic instruments are small, fragile, and easily damaged, so they require special handling during cleaning.

2. General decontamination guidelines, which include thorough rinsing and flushing, should occur separately from nonophthalmic surgical instruments. Central sterile processing may choose to have a specific location within the decontamination area strictly for eye instrumentation and devices. Mechanical washing must meet ocular instruments' MIFU parameters; follow manual processing instructions if the recommended cycle parameters are unable to be met. Ultrasonic cleaning systems are important to the successful cleaning of eye instruments. Ophthalmic MIFUs often require that a dedicated ultrasonic system be utilized for ophthalmic instruments. Some MIFUs may even require 2 ultrasonic cleaners—one unit to soak and ultrasonic clean and the second unit to deliver critical water ultrasonic rinsing. Disinfection makes instruments safe to handle. Because residual disinfectant chemicals can injure eyes, many ophthalmic instrument MIFUs caution against chemical disinfectants. Thermal disinfection is an alternative, which uses heat rather than chemicals, to kill microorganisms. Washers and ultrasonic units are capable of thermal disinfection.2,3

Water quality is especially important when reprocessing ophthalmic instruments. Utility/tap water varies in quality across the country, with some regions encountering heavy mineral deposits and pH levels that are not conducive to instrument reprocessing. Critical water for the final rinse may be recommended. Refer to the Association for the Advancement of Medical Instrumentation (AAMI) Technical Bulletin TIR 34:2014/(R) 20211 and washer and ultrasonic manufacturers to maintain the eye instrument, device, and equipment and to prevent contamination.

Cleaning chemistries are particularly important for effective reprocessing. Inadequate cleaning chemistry selection and practices can lead to toxic anterior segment syndrome (TASS), damaged instruments, incomplete soil removal, and interference with mechanical cleaning equipment. TASS is a preventable acute inflammation of the eye that can occur from any ocular surgery that exposes the anterior segment. TASS is not an infection; it is a reaction to foreign material carried into the eye. Incomplete cleaning processes that leave residual cleaning chemistries, mineral deposits from steam sterilizers, or powder from sterile gloves have contributed to cases of TASS. The chosen cleaning chemistry must be compatible with each instrument. If an instrument’s MIFU calls for a neutral pH detergent, this implies that high pH solutions will damage the instrument's finish. Ultrasonic cleaners have different requirements than automated washers. Many ophthalmic instrument MIFUs have limited or discontinued the use of enzymatic chemistries for this reason. Not aligning with the MIFU may represent an off-label use of the cleaning chemistry, which has patient risk and legal implications.3

3. Well-lit, magnified visual inspection is now a standard step in the sterilization process. Lumens, cracks, and fine details within eye instruments and devices require boosted magnification tools. Cracks or breaks in the eye instruments trap foreign material and residual soils and chemistries that during a procedure may be transferred to the eye. If any of these imperfections are identified at any time, follow your facility’s protocols and manufacturer instructions to return the instrument or device to the manufacturer for further evaluation.3

Instrument staining has many causes. The most concerning are stains from residual chemicals, hard water, or other foreign substances if transmitted to the eye could cause TASS. If instrument staining is noted, perform a full assessment of the entire reprocessing workflow from decontamination through sterilization to determine the exact cause of the staining and how to resolve it. Inspecting for protein-based residuals will reliably identify instruments that are not clean and need returned to the decontamination area to restart the process. The American National Standards Institute (ANSI)/AAMI ST79: 2017 Annex D lists 8 soil markers that are appropriate for use to detect residual soils.2,3

4. The most common method of sterilization used for ophthalmic devices is steam sterilization. Special cycles may be required to sterilize some ophthalmic instruments. Always consult the relevant instrument or device manufacturer’s instructions before determining whether to standardize a cycle, and consider all potential outcomes before a change is made. The method of instrument sterilization should be based on guidelines from the medical device, packaging system, and sterilizer manufacturer. Perform routine monitoring and verification of sterilizer function with biological indicators at least weekly, and preferably daily, in accordance with the sterilizer MIFU, and document this in the facility log or automated record. Measures should be taken to ensure that preventive maintenance, cleaning, and inspection of sterilizers are performed and documented on a scheduled basis, according to the sterilizer MIFUs.2

5. After sterilization processing, packaged instruments may be stored in a sterile storage environment area free of temperature and humidity extremes and supported by organization policies and procedures. Sterile items should be stored under environmentally controlled conditions in a manner that reduces the potential for contamination. Closed or covered cabinets are recommended for sterile storage. Open shelving may be used but requires special attention to traffic control, area ventilation, and environmental services.2

Because of documented patient infections or other injury risks due to reprocessing breaches, reusable ophthalmic instruments must be processed according to each instrument’s MIFU. The increasing complexity of ophthalmic instruments and the instruments’ reprocessing requirements necessitate ongoing education, training, and competency by everyone involved in their handling, processing, and auditing oversight.

As eye instrumentation and devices continue to advance, staying up to date is crucial to compliance with manufacturer instruction requirements. Any workflow improvements should consider the MIFUs as well as incorporating automated equipment needs, using appropriate cleaning chemistries, applying single-use requirements, and properly inspecting all devices. Intentional standard work that is supported by following MIFUs and evidence-based best practices minimizes the risk of TASS and patient infections and promotes a highly reliable process to strengthen patient safety.

References:

1. Association for the Advancement of Medical Instrumentation. AAMI TIR34:2014 Water for the Reprocessing of Medical Devices (2014/(R)2021). August 4, 2014. Updated March 29, 2021. Accessed November 21, 2022. https://www.aami.org/detail-pages/product/aami-tir342014-r-2021-pdf-a152e00000e0k4dqar


2. Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST79:2017 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care facilities. Arlington, VA: Association for the Advancement of Medical Instrumentation; 2017.

3. Guidelines for the cleaning and sterilization of intraocular surgical instruments - 2018. American Academy of Ophthalmology. April 2018. Accessed November 11, 2022. https://www.aao.org/clinical-statement/guidelines-cleaning-sterilization-intraocular