Reprocessing of instruments used for eye procedures

 

To: Colorado healthcare partners (e.g., hospitals, ambulatory surgical centers, freestanding emergency departments) providing services and responsible for the reprocessing of instruments used for eye procedures.  From: CDPHE HAI/AR Program   Key points:   Instruments used for eye procedures, including ocular laser lenses, should be reprocessed between patients according to the manufacturer’s instructions for use (IFU). Follow all steps outlined in the most up-to-date IFU (e.g., cleaning, disinfecting or sterilizing, drying, and storing, etc.), including the selection and use of EPA-approved detergents.   Failure to appropriately clean, disinfect, or sterilize reusable ocular instruments (per the IFU) can put patients at risk for infection.   If the ocular instrument cannot be reprocessed according to the IFU, or IFU are not available, the instrument should be considered single use and immediately disposed of after use.   Background   The Healthcare-Associated Infections and Antimicrobial Resistance (HAI/AR) program at the Colorado Department of Public Health and Environment recently learned of a reprocessing technique involving instruments used for eye procedures that could put patients at risk for infections.   The technique involves the use of baby shampoo to clean reusable ocular laser lenses and/or other instruments that have direct contact with the ocular surface of the eye and/or ocular mucosal membranes. Baby shampoo is not an FDA-approved high-level disinfectant, nor is it validated for use in the IFU. All steps outlined in the IFU must be followed for the device to be considered safe for multi-patient use. Failure to follow the IFU puts patients at risk for infection (bacterial, fungal, and blood-borne pathogens [human immunodeficiency virus disease, hepatitis B virus, hepatitis C virus]).   While rare, there have been documented cases of eye infection in patients following use of ocular instruments that have not been cleaned, disinfected, or sterilized appropriately. All ophthalmologic instruments that have direct contact with the surface of the eye and/or ocular mucosal membranes should be cleaned, disinfected, or sterilized according to the IFU.   Recommendations/guidance   Facilities should ensure that reusable medical devices, including ocular laser lenses, are always reprocessed according to the IFU after use on a patient. This includes the use of approved enzymatics and detergents as outlined in the IFU. If the manufacturer does not provide such instructions, or the facility is unable to follow the instructions, the device should not be considered suitable for reuse and/or multi-patient use. Devices designated as single-use should only be used on a single patient and immediately discarded after patient use.    For more information:   Refer to CDCs Guideline for Disinfection and Sterilization in Healthcare Facilities (2008) or contact CDPHE’s HAI/AR program at cdphe_hai_ar@state.co.us or 303-692-2700 during business hours (Monday - Friday from 8 a.m. - 5 p.m.) for further assistance.