Nancy Jo Vinson, RN, BA, CASC, of Healthcare Consultants International (a subsidiary of the Accreditation Association for Ambulatory Health Care) and NJM Consulting, addresses four reader questions relating to sterile processing of eye instruments.
Q: What are the steps ambulatory surgery centers should take to ensure proper sterile processing of eye instruments?
Nancy Jo Vinson: The cleaning and sterilization of ophthalmology instruments has been a topic brought to the forefront by toxic anterior segment syndrome (TASS). There are several very good resources that can be utilized for reference. It is extremely important to understand that national guidelines should be adhered to when developing your facility's policies.
Some of the references, although not all inclusive, you may utilize are:
- An excellent article was written in the ASCRS Eye World News Magazine (Week No. 37) found at www.eyeworld.org/ewsupplementarticle.php?id=200. The article is "Recommended Practices for Cleaning and Sterilizing Intraocular Surgical Instruments."
- ASORN has published the "Care and Handling of Ophthalmic Microsurgical Instruments," which can be purchased and utilized as your foundation reference.
- Manufacturers such as Bausch + Lomb Storz Ophthalmic Instruments have published instructions for cleaning, decontaminating and sterilization of their instruments that also reference not routinely flashing.
- AORN Perioperative Standards and Recommended Practices (www.aorn.org/PracticeResources/AORNStandardsAndRecommendedPractices/) provides information for pre-cleaning, cleaning, washing/decontamination and sterilization of surgical instruments.
- ANSI/AAMI S79 Sections 7.5 (1), 7.5.3.1-7.5.3.3 (1),7.5.6 (1), 7.5.4 (1), and 7.5.5. (1) provides recommendations regarding appropriate cleaning, methods of cleaning, rinsing and verification of the cleaning process.
Q: What are surveyors going to look for relating to sterile processing of intraocular surgical instruments when they visit an ASC? Are there particular types of trays that are not acceptable to surveyors?
NJV: Surveyors will survey for compliance with current accreditation standards. Specifically, they will identify that there is an infection control program based on nationally recognized infection control guidelines, a process in place for high-level disinfection and sterilization of medical equipment, accessories, instruments, and implants. If the AORN Perioperative Standards and Recommended Practices are adopted by the governing body as the nationally recognized infection control guidelines, then the surveyor will be looking to see if the processes being utilized within the center are in compliance with their own infection control program, including sterilization of instruments.
Immediate-use sterilizers are frequently located in ASCs. Immediate-use sterilization is appropriate in emergency situations, as when a one-of-a-kind item is dropped on the floor during surgery or otherwise becomes contaminated and is needed immediately. However, AORN and CMS do not support the use of immediate-use sterilization as a substitute for a sufficient inventory of surgical instrumentation. Major issues associated with immediate-use sterilization are insufficient time to correctly clean the devices before sterilization and the potential for contamination of the device after sterilization (because there is no packaging or container to protect it). Furthermore, many manufacturers no longer provide immediate-use sterilization instructions for their devices; therefore, compliance with manufacturers' instructions cannot be determined.
Immediate-use sterilization should not be attempted without the device manufacturer's written instructions for cleaning and sterilization. The sterilization instructions must be replicated exactly, meaning that if only a gravity-displacement immediate-use cycle was validated for the device, then the device must be sterilized in a gravity-displacement immediate-use cycle (not a dynamic-air-removal immediate-use cycle).
Historically, immediate-use sterilization was usually performed with the device unwrapped and in a perforated, mesh-bottom, open tray. It is now performed with the device in a containment device such as a rigid sterilization container.
Surveyors will not be looking for a particular type of tray for short cycle or terminal sterilization. However, they will want to know you have investigated the compatibility of the trays you have purchased with the type and model of autoclaves you are utilizing as well as utilizing the trays correctly.
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Q: What have you seen as common mistakes ASCs make concerning sterile processing of these instruments? What are the ramifications of these mistakes?
NJV: During my career and not specifically as a surveyor, I have been exposed to ASCs that only wipe off and clean instruments on the back table and do not clean eye instruments according to the same processes that they do all other instruments.
Frequently, the processes utilized for cleaning eye instruments is based on what someone else is doing instead of independent research and verification of current data published from nationally recognized agencies. Information being utilized is not always correct and does not adhere to the principles of infection prevention.
Additionally, utilizing single-use products such as blades or phaco tubing for multiple cases is routine in many facilities based on history of practice of healthcare professionals (physicians, nursing, etc.) rather than adherence to current national guidelines and regulations.
Not following nationally recognized infection control guidelines including sterile processing frequently results in non-compliance with CMS Conditions for Coverage, accreditation standards and state licensure requirements.
Q: What can ASCs do to help reduce the likelihood of these errors?
NJV: Be prepared to be able to produce manufacturers' instructions for instrument and supply sterilization, and to describe and demonstrate how instruments are being cleaned and decontaminated according to those written instructions.
Be prepared to explain your process for cleaning instruments, remembering that rinsing is rarely enough to properly remove soil from instruments.
Be prepared to identify the nationally recognized guidelines that your governing body has adopted for your infection control program and how these correlate to your instrument cleaning and sterilization processes.
Be prepared to produce any scientific literature that supports processes that your ASC follows outside of the nationally recognized guidelines adopted by your governing body such as not utilizing any detergent for the cleaning of instruments.
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