Lisa Waldowski, DNP, RN, CIC, is an expert in infection prevention and control with more than 30 years of experience in the health care industry. She recently joined Wellstar Health System in Atlanta, Georgia, as system executive director of infection prevention and control. Waldowski holds a doctor of nursing practice in systems leadership and a master of science in nursing. She is board certified in infection prevention and control.

Lisa Waldowski, DNP, RN, CIC 

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.

 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.

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 

 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.

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.

, 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.

 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.

 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.

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.

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.

 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.

After sterilization processing, packaged instruments may be 

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.

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.

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

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: 

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

Articles

Read about the sterilization process of eye instruments and devices. 

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

Eye devices are too often overlooked and not being correctly cleaned, disinfected, or sterilized. To discuss this topic, 

 spoke with Katharine J Hoffman, MPH, CIC, infection preventionist, JPS Health Network, Fort Worth, Texas; and Lisa Waldowski, DNP, RN, CIC, regional director of Infection Prevention & Control, Kaiser Permanente,

Association for Professionals in Infection Control and Epidemiology (APIC) 2022 Annual Conference

, held June 13-15, 2022, in Indianapolis, Indiana. Hoffman and Waldowski discussed their presentation titled “Don't Lose Sight: Intentionally Approaching Eye Device Reprocessing.” In addition, they wrote the following article exclusively for 

Multiple eye devices in health care settings that touch the eye are reused on patients without being appropriately cleaned, high-level disinfected, or sterilized according to the specific device manufacturer’s instructions for use (MIFUs). Outbreaks associated with eye devices have occurred due to lack of cleaning, incorrect cleaning, or failure to high-level disinfect (HLD) or sterilize the eye device between patient use in neonatal intensive care units (NICUs), eye care clinics, and operating rooms (ORs).

Urgent care clinics (UCCs), emergency departments (EDs), NICUs, eye care clinics, ORs, and ambulatory surgery centers (ASCs).

Optometrists, Ophthalmologists, ED/Trauma physicians, and Ophthalmic surgeons.

Tonopens, ocular gonioscopes, A/B scan probes, Yag laser lenses, and eye specula.

Eye Device Manufacturer’s Instructions for use (MIFUs).

Many eye device MIFUs are not readily available, are outdated, or are not read and followed when it pertains to cleaning, high-level disinfection, and sterilization instructions. Eye device MIFUs should be reviewed and supported by central sterile processing, infection prevention and control, the respective manager, and end user of the device. Ideally, eye device MIFUs should be a component of a device/products analysis team before purchasing the device to assure that cleaning, disinfection, and sterilization instructions can be adhered to.

Eye Device High-level Disinfection (HLD) or Sterilization Opportunities

Eye devices that touch the eye according to the Spaulding Classification System, would be considered a semi-critical or critical device based on intended use, therefore, requiring minimally HLD or sterilization.Eye device MIFUs state the recommended HLD or sterilization requirements. What is frequently noted is that eye devices are being cleaned with either soap and water or a low-level disinfecting wipe in the patient exam room and allowed to air dry on a paper towel before next use. Required next steps of transporting the eye device to central sterile processing for HLD or sterilization never occur. Precleaning steps if noted by the manufacturer, or based on selected HLD or sterilization guidelines, and appropriate means of transport to central sterile processing are typically not known or implemented. Additionally, re-usable eye devices have been noted to be stored in their original wooden box, which is not only uncleanable storage containment, but also likely to be contaminated over time.

Obtain an inventory of all eye devices in your organization

Obtain current MIFUs for all eye devices. Have central electronic access for all key stakeholders to use MIFUs (central sterile processing department, infection prevention department, managers, physicians, frontline staff)

Consider single-use disposable eye device options

Follow eye device manufacturer’s MIFUs for cleaning, HLD, or sterilization

Include eye devices in the Infection Prevention and Control Risk Assessment

Include eye devices in HLD and sterilization process rounding/audits

Assure key stakeholders are competent, trained, and educated based on their role in the reprocessing of eye devices (frontline staff, central sterile processing, infection prevention, and managerial oversight)

Audit this process across settings for standardization as appropriate

Infection prevention and control has yet another opportunity to lay eyes on and validate evidence-based, manufacturer supported eye device HLD and sterilization reprocessing. Like other re-usable medical equipment and devices, omissions of HLD and sterilization reprocessing pose a significant risk to patient safety.

Videos

Eye devices often are not cleaned nor sterilized as they should be according to manufacturer’s instructions for use, which leads to poorer patient outcomes. 


Seeing Eye to Eye: Reprocessing of Eye Devices

A patient returns to your hospital after a vaginal ultrasound procedure with an infection. A look-back of this potential health care-associated infection (HAI) includes a review of the vaginal ultrasound probe that was used to perform this patient’s procedure. Can the probe be traced to the patient? Was the probe high-level disinfected based on intended use?

To answer these questions, a health care facility must have standard policies and procedures (P&Ps) in place, procedures that outline the approach to the high-level disinfection process and traceability of a vaginal ultrasound probe (or a surface probe based on intended use). Additionally, knowledge of the 3 definitions outlined in Table 1 should be understood to navigate our scenario. Staff should be trained and retrained to ensure consistent implementation of P&Ps to help ensure patient and staff safety.

An understanding of law and regulation (i.e., the Food and Drug Administration (FDA), the ultrasound probe manufacturer’s instructions for use, and nationally recognized evidence-based guidelines for high-level disinfection. Guidelines from, for example, the Centers for Disease Control and Prevention (CDC), the Association for the Advancement of Medical Instrumentation (AAMI), and the Association of periOperative Registered Nurses (AORN) should be consulted when developing and implementing P&Ps.

The FDA regulates the labeling of medical devices such as ultrasound probes and liquid chemical sterilants/high-level disinfectants. The FDA uses the Spaulding Classification System, and here are some examples.

Marketing Clearance of Diagnostic Ultrasound Systems and Transducers. Guidance for Industry and Food and Drug Administration Staff

Cleaning, Disinfection, and Sterilization that

 “the probe used in a semi-critical application should be cleaned and undergo sterilization or at least receive high level disinfection after use even if a sheath was used. Sheaths can fail during use, and the level of resulting contamination may not be easily visible.” 

In the Code of Federal Regulations, Title 21, 

a liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semi-critical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semi-critical devices make contact during use with mucous membranes or nonintact skin.”

Having a complete organization-wide inventory and location of all ultrasound probes and their respective ultrasound units is an advised initial approach. This should then be followed by a comprehensive review of all ultrasound probe instructions for use (IFUs). When IFUs are not clear, or information is missing, contacting the manufacturer is recommended. It is important to consult IFUs for compatible disinfection products and other information. For example, one manufacturer IFU states: “

When choosing a disinfectant, determine the required level of disinfection based on device classification. If the possibility of cross-contamination or exposure to unhealthy or non-intact skin exists, then high-level disinfection should 

.” It is important to review the IFUs in their entirety for complete instruction.

Examples of recommended evidence-based guidelines on high-level disinfection and traceability include those from AAMI and AORN. These documents detail the importance of traceability and information that should be collected and linked to the 

. They recognize that maintaining high-level disinfection records helps ensure that parameters for correct high-level disinfection have been met, helping manage recalls in potential outbreak situations, and establishing traceability and accountability. For each high-level disinfection cycle, one of the elements that should be recorded and maintained, in addition to the high-level disinfection parameters and unique device, includes the patient’s name and medical record number, if available.

The documentation log displayed in Figure 1 is an example log for an automated high-level disinfection (HLD) process. This method incorporates sticking the printed label generated from the automated HLD process in the documentation log-book next to the patient label or sticker. The label generated from the automated HLD process can also include the serial number of the HLD automated unit, the date and time, the HLD cartridge lot number, and expiration date, along with the chemical indicator lot number and expiration date, the operators, and probe. Where this is not available, space in the log can be made available to record this information, as shown in Figure 1. Incorporating the use of automatically generated labels can help save time and reduce the risk of error from manually recording and checking information.

When an ultrasound probe is not compatible with an automated process, as determined by the manufacturer, a manual HLD process may be the recommended method by the manufacturer. To complete documentation, the following needs to be recorded by staff: the HLD product, date processed, lot number, expiration date, temperature, immersion time (time-in and time-out), operator initials, and minimal effective concentration of the test strip used to check the HLD. The test strip used corresponds to the HLD product. The quality monitoring of the test strip, lot number, and expiration date are recorded in the documentation log. Documentation logs for a manual process may be found from the manufacturer of the HLD product for consideration. These key elements are essential to documenting the HLD process of the ultrasound probe, in addition to providing the patient label or sticker to the uniquely identified ultrasound probe to link the probe to the patient. All HLD product and test strip instructions for use should be consulted and followed.

Having one standardized method to complete traceability that links the ultrasound probe that has been high-level disinfected to the patient is best practice in a department and across a facility. A routine review or audit of the documentation components to identify any gaps or omissions is essential to supporting a highly reliable HLD process.

Traceability in ultrasound probe infection prevention enables facilities to demonstrate at any time that they have met their standard of quality and safe care for their patients. Traceability demonstrates that the facility and its staff are following law and regulation, manufacturer IFUs, and nationally recognized evidence-based guidelines across any department utilizing ultrasound probes that require high-level disinfection based on the intended use.

Traceability information and documentation logs are essential tools for infection preventionists (IPs), department heads, and risk and quality management. From a legal, risk management standpoint, having records that demonstrate P&Ps are being followed by staff helps minimize the risk of an adverse patient safety event, and can help identify potential areas that require staff retraining or improvement. As HLD processes are heavily scrutinized during accreditation or regulatory surveys and remain a top non-compliant scored standard, attention to these elements is advised.

Standardizing ultrasound infection prevention and traceability in a facility helps ensure the safety of patients and fellow staff. It is important to develop and maintain an ultrasound probe inventory with clear identifiers for each device in use. A standard approach should be used to select evidence-based guidelines for P&Ps, and when implementing P&Ps, standardizing high-level disinfection processes across the organization to include documentation is advised.Consider incorporating digitization of documentation into the workflow, if and where available, to minimize manual record-keeping and any associated risk of error. Be knowledgeable and perform oversight, audits, and validation on a routine basis.

The IP reviewed the documentation log for traceability of the patient in the above scenario. The department that had performed the vaginal ultrasound procedure had complete traceability documentation based on following the guidance above. They were able to demonstrate the probe had undergone HLD successfully before it was used in the vaginal exam on the patient.

Lisa Waldowski, DNP, RN, CIC, is an expert in the field of infection prevention and control with over 30 years of experience in the health care industry. An expert in accreditation and regulatory standards, Waldowski knows how to develop and implement comprehensive infection prevention and control programs. 

She currently works as a Regional Director in Infection Prevention and Control at Kaiser Permanente. The views expressed in this article are Lisa Waldowski’s, and not Kaiser Permanente’s.

The high-level disinfection process of an ultrasound probe, when indicated, includes documentation that demonstrates high-level disinfection was performed, and patient identifiers were documented to link the ultrasound probe to the patient. This is often referred to as traceability.

Lisa Waldowski, DNP, RN, CIC

Articles

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

Seeing Eye to Eye: Reprocessing of Eye Devices

How to Document the High-Level Disinfection Patient Connection