Are you reprocessing your instrument containers correctly? – Part 3 Copy
Focus on details and big picture
The days of departments having only one or two instrument sets for a potential eye case may be over. As they become more aware of specific processing needs for each ophthalmic instrument, sterile processing managers are grouping instruments into sets identified for their special processing requirements. In addition, some departments are choosing to have a specific location within the decontamination area that’s devoted strictly to eye instrumentation.
Providing readily accessible key information, tools and supplies for technicians and not comingling with other specialties increases control of the ophthalmic reprocessing function. It is also helpful to review the quality system in place for ophthalmic reprocessing protocols and apply Lean principles to optimize these procedures in all settings, including the hospital central sterile department, the outpatient surgery department, and the reprocessing areas in freestanding surgery centers.
Sterile processing departments often focus on big changes and lose sight of specific processes and procedures they should already have implemented. It’s crucial to review all instruments’ IFU regularly, including but not limited to instructions for ophthalmic instruments, other procedural instruments, washers, ultrasonic units, brushes, cleaning chemistries, sterilizers, and supporting tools and accessories, to assure up-to-date compliance. In addition, watching the sterile processing department in action may help managers identify some common processing problems.
Don’t be shortsighted about mats
While silicone instrument mats are ideal for protecting delicate tools inside an automated system, mats can also inhibit cleaning. For example, mats can over-absorb the cavitation action of ultrasonic systems and decrease the cleaning ability of their cycles. Developing an ultrasonic process for ophthalmic instruments without mats will help ensure effective cleaning the first time and eliminate the need for rework.
Watch out for water contaminants
Water quality is vital in all phases of reprocessing and is especially important when reprocessing ophthalmic instruments. Utility/tap water is not of the same quality in all areas of the country, and some regions may have additional issues with heavy mineral deposits and pH levels that are not conducive to instrument reprocessing. The Ophthalmic Instrument Cleaning and Sterilization (OICS) Task Force noted in 2018 that utility/tap water may contain heat-stable endotoxins and gram-negative bacteria in municipal water supplies and recommended critical water for the final rinse.
Help is available to tackle any water quality questions that may arise, first from the AAMI Technical Bulletin TIR 34:2014 Water for the reprocessing of medical devices, and then from the washer and ultrasonic manufacturers. They can typically direct sterile processing departments to water testing resources. These professionals understand the needs specific to instrument reprocessing. Proper water quality will ensure a long life for the surgical instruments and for the mechanical washers and ultrasonic cleaners.
Avoid cleaning chemistry blind spots
The proper selection and use of cleaning chemistries is very important for effective reprocessing. Poor cleaning chemistry choices can lead to damaged instruments, incomplete soil removal, and interference with mechanical cleaning equipment. Inappropriate rinsing of chemistries may also leave residues that can lead to TASS.
The chosen cleaning chemistry must be compatible with each instrument. For example, if an instrument’s IFU calls for a neutral pH detergent, this is a strong indication that high pH solutions will damage the instrument finish. Therefore, alkaline cleaning chemistries would not be appropriate for this device. The cleaning chemistry must also be compatible with the equipment or process. Ultrasonic cleaners have different requirements from automated washers, for example.
It is critical to review all cleaning chemistry claims. If doubt or confusion exists, contact the product’s manufacturer to request a technical data monograph (TDM). TDMs provide detailed information about the product itself and frequently include results of product testing that illustrate how the manufacturer arrived at the claims for the cleaning chemistry.
Getting soap in your eye may sting but getting residual enzymes in your eye from a poorly processed instrument may blind you. Many ophthalmic instrument IFU have limited or discontinued the use of enzymatic chemistries for this reason.
One more caution: selecting a chemistry based on cost, convenience, or a shorter cycle or soak time, rather than choosing one that complies with your instrument’s IFU, is shortsighted. Not aligning with the IFU may represent an off-label use of the chemistry, which could put a facility in the difficult position of defending their practice to a reviewer during a survey.
Another change: single-use brushes
Ophthalmic instrument IFU revised in the last three years may now include a restriction to single-use brushes for cleaning. Departments must define what ‘single use’ means. Additionally, departments with mixed inventory (some instruments’ IFUs that allow brush reuse and some that don’t) must have a means to segregate instruments to ensure proper brush use. These requirements may impact brush inventories (and waste management procedures) to account for increased disposal of some reusable brushes.
While lighted and magnified visual inspection is now a standard, it may not be enough for today’s intricate instruments. Lumens, cracks, and fine details make enhanced magnification tools a necessity. Using a borescope or video enlarger allows a full assessment of the entire instrument, including the internal surfaces of lumens.
Burrs, cracks, or breaks trap foreign material and residual soils and chemistries that may be transferred to the eye during the procedure. If any of these flaws are identified at any time, follow facility protocols for repair or return to the manufacturer for further evaluation.
Instrument staining is more than cosmetic – it’s a serious concern. Staining has many causes. The most troublesome are stains from residual chemical, hard water or other foreign substances that can cause TASS if transferred to the eye. If instrument staining is noted, a full review of the entire reprocessing workflow from decontamination through sterilization should be done to determine the exact cause of the staining and how to resolve it.
Making the invisible visible
Eyes are sensitive organs, but they can’t see everything, even with magnification. Yet even a microscopic amount of powder from a glove or residual debris can induce catastrophic reactions in the eye. Using powderless gloves solves one problem, but how can reprocessing technicians see other contaminants that can’t be seen?
A quality procedure for soil testing needs to be in place before the instruments are prepared for sterilization, to verify that instruments are clean beyond what can be visualized. ANSI/AAMI ST79:2017, Annex D lists eight soil markers that are appropriate for use to identify residual soils. Protein is listed first because protein is present in all human soils. Checking for protein-based residuals will reliably identify instruments that are not clean and that need to be returned to the decontamination area to restart the process.
Reducing unnecessary complexity in reprocessing is valuable. It helps to reduce errors and makes work easier for staff members. However, some streamlining efforts may be detrimental. For example, special cycles may be required to sterilize some ophthalmic instruments, but not all. One set of instructions may call for a 10-minute 270°F prevacuum steam sterilization cycle, while other IFU call for a four-minute exposure. Standardizing on the 10-minute exposure cycle streamlines the process, but then the four-minute instruments are not being processed per their IFU. Moreover, the extra exposure may have a negative effect on these delicate instruments. Longer exposures could increase repair/sharpening frequency and shorten the useful life of the instruments. Always consult the relevant instrument manufacturers before determining whether or not to standardize a cycle and consider all potential consequences of a streamlining change before it is made.
Set your sights on the future
Because of documented patient injury risks, reusable ophthalmic instruments must be processed with great attention to detail and to each instrument’s IFU. The increasing complexity of ophthalmic instruments and their reprocessing requirements will require ongoing attention by everyone involved in their handling. As they continue to evolve, so will their IFU, so it’s important to check periodically for updated requirements. Any workflow improvements should also take the IFU into account, including automated equipment needs, the appropriate use of cleaning chemistries, single-use accessory requirements, and proper inspection tools. By keeping an eye on ophthalmic reprocessing in your facility, you will help prevent TASS and infections and thereby improve patient safety.
1. AAMI TIR34:2014 Water for the reprocessing of medical devices (2014th ed.). (2014). AAMI.
2. ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities. (2017). AAMI.
3. ASCRS, American Academy of Ophthalmology, & Outpatient Ophthalmic Surgery Society. (2018). Guidelines for the cleaning and sterilization of intraocular surgical instruments. https://www.aao.org/clinical-statement/guidelines-cleaning-sterilization-intraocular
4. Handling Guidelines for optimal performance. (2020). Katena. https://199752-598097-raikfcquaxqncofqfm.stackpathdns.com/pub/media/pdf/handling-guidelines-for-optimal-performance.pdf
5. Storz Ophthalmic Instruments. (2018, August). Bausch+Lomb Instruments Ear, Nose, Throat & Plastic Surgery. https://www.storzeye.com/PDF/STORZ%20Non-Powered_Instruments_Reprocessing_Ins_GBL_STL.pdf