The role of central sterile processing in the re-processing of ophthalmic organs

Read about the process of sterilizing eye instruments and devices.

If cataracts, glaucoma, eye trauma, or corrective eye surgeries are performed at an organization, it is important to ensure that eye instruments or devices used during these procedures are sterilized according to the manufacturer’s instructions for use (MIFUs) and sterilization guide-based guidelines (EBGs). ). Although most non-disposable ophthalmic instruments and devices only require sterilization, the B-scan probe requires manual high-level disinfection (HLD) for each manufacturer.1 This article will focus on the process of sterilizing eye instruments and devices.

The eyes are organs of the visual system and are considered high-risk tissues. Reprocessing guidelines indicate that all ophthalmic instruments and devices that are classified as critical based on their intended use must be sterilized. Therefore, ophthalmic instruments and ophthalmic devices require the same reprocessing steps (pre-cleaning at the point of use, cleaning or rinsing, HLD, or sterilization) based on intended use, MIFUs, and EBG sterilization. High-volume eye procedures such as cataract surgeries place additional stress on response times and delicate sterilization processes. Highly reliable aseptic practices that are part of standard work for a sterilization central processing team is essential to prevent patient harm.2

Pre-clean at the point of use Bioenergetic removal is a component of every procedure, not just ophthalmic procedures. Following pre-cleaning MIFUs and EBGs will ensure that soil does not dry out on the instruments or inside the lumen. Keep the device moist to prevent the soil on the device or equipment from drying out. Tools and devices must be eye Transfer in a confined manner (eg, leak-proof, puncture-proof, and biohazard-labeled, based on contents being transported) to protect personnel from contamination and to prevent injury during transport to a decontamination area.2,3

If the instrument is not clean, this directly affects the ability to perform high-quality sterilization. Many ophthalmic instruments are small, fragile, and easy to damage, so they require special handling during cleaning.

2. General guidelines for decontamination, which includes thorough rinsing and cleaning, should be done separately from non-ocular surgical instruments. Sterile central processing may choose to have a specific location within the precisely decontaminated area of ​​the ocular organs and organs. The mechanical wash should meet the MIFU standards for ophthalmic instruments; Follow the manual processing instructions if the recommended cycle parameters cannot be met. Ultrasonic cleaning systems are important for successful cleaning of ophthalmic instruments. Ocular MIFUs often require the use of an ultrasound system intended for ophthalmic instruments. Some MIFUs may require two ultrasonic cleaners – one unit for ultrasonic soaking and cleaning and a second unit for delivering ultrasonic water rinsing. Disinfection makes tools safe to handle. Because residual disinfectant chemicals can harm the eye, many MIFUs of ophthalmic devices warn against chemical disinfectants. Thermal disinfection is an alternative that uses heat instead of chemicals to kill microorganisms. Washing machines and ultrasonic units are capable of thermal disinfection.2,3

water quality Especially important when reprocessing ophthalmic instruments. Benefit/tap water quality varies across the country, with some areas experiencing heavy mineral deposits and pH levels that are not conducive to re-treatment of devices. It may be recommended to use the necessary water for the final rinse. Refer to Association for the Advancement of Medical Devices (AAMI) Technical Bulletin TIR 34:2014/(R)20211 and manufacturers of washers and ultrasounds to preserve eye instrument, device and equipment and prevent contamination.

cleaning chemistry particularly important for effective reprocessing. Inadequate cleaning chemistry selection and practices can lead to toxic anterior segment syndrome (TASS), damaged tools, incomplete soil removal, and interference with mechanical cleaning equipment. TASS is a severe, preventable ocular inflammation that can occur from any eye surgery that exposes the anterior segment. TAS is not an infection. It is a reaction to a foreign substance in the eye. Incomplete cleanings that leave cleaning chemical traces or mineral deposits from steam sterilizers or powder sterilized gloves have contributed to cases of TASS. The cleaning chemistry chosen must be compatible with each tool. If a tool’s MIFU calls for a pH-neutral cleaner, that means higher pH solutions will damage the surface of the tool. Ultrasonic cleaners have different requirements than automatic washing machines. Many ophthalmic instrument MIFUs have limited or discontinued the use of enzymatic chemistry for this reason. Incompatibility with MIFU may represent off-label use of cleaning chemistries, which has patient risks and legal implications.3

3. Well lit and magnified Ocular examination It is now a standard step in the sterilization process. Lumens, fissures, and fine details within instruments and instruments of the eye require enhanced magnification. Notches or crevices in eye instruments trap foreign material, residual soil, and chemicals that could be transferred into the eye during a procedure. If at any time any of these defects are identified, follow your facility’s protocols and manufacturer’s instructions to return the device or equipment to the manufacturer for further evaluation.3

Instrument staining has many causes. Of most concern are splashes from residual chemicals, hard water, or other foreign substances if they get into the eyes that can cause TASS. If instrument staining is observed, perform a full assessment of the entire reprocessing workflow from decontamination through sterilization to determine the exact cause of staining and how to resolve it. Protein-based residue screening will reliably identify tools that are not clean and need to be returned to the decontamination area to restart the process. The American National Standards Institute (ANSI)/AAMI ST79:2017 Appendix D lists 8 soil markers suitable for use for residual soil detection.2,3

4. The most popular way to sterilization Steam sterilization used in ophthalmic devices. Special courses may be required to sterilize some ophthalmic instruments. Always consult the relevant tool or device manufacturer’s instructions before deciding whether to standardize a course, and consider all possible outcomes before making a change. The method for sterilizing instruments should be based on guidelines from the medical device, packaging system, and manufacturer of the sterilizer. Perform routine monitoring and verification of sterilizer function with biomarkers at least weekly, preferably daily, according to the MIFU sterilizer, and document this in the facility log or automated log. Measures should be taken to ensure that preventive maintenance, cleaning and inspection of autoclaves are performed and documented on a scheduled basis, in accordance with autoclaving MIFUs.2

5. After sterilization processing, the packaged instruments may be Store In a sterile storage environment free from temperature and humidity extremes and supported by the organization’s policies and procedures. Sterile items should be stored under environmentally controlled conditions in a manner that minimizes the potential for contamination. Closed or covered cabinets are recommended for aseptic 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 infection risks due to reprocessing violations, reusable ophthalmic instruments should be handled according to each instrument’s MIFU. The increasing complexity of ophthalmic instruments and the reprocessing requirements of the instruments necessitate continued education, training and competence on the part of all involved in their handling, processing and monitoring.

As eye devices and equipment continue to advance, keeping up to date is critical to complying with the requirements of the manufacturer’s instructions. Any workflow improvements must consider the MIFUs as well as incorporate the needs of automated equipment, use appropriate cleaning chemistries, enforce single use requirements, and properly inspect all equipment. Intentional standard work supported by following MIFUs and evidence-based best practices minimizes the risk of TASS and patient infection and promotes a highly reliable process to enhance patient safety.

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