Initial Guidelines developed in April 2003 by the OPA Working Group, Endorsed by the DHS Social Justice & Country Division, SA Country Clinical Sub Committee of the SA Safety & Quality Committee 2003 Reviewed and Revised by ICS September 2004 NB: The information provided within may be useful in the application of safe work practices for the use of OPA. It is strongly recommended that this document be adapted to better accommodate the specifics of your organisations’ environment. It should be remembered that the manufacturers’ instructions must always be adhered to when these guidelines are applied to your organisation’s work practices. This document is to be used in conjunction with OPA Solution Guidelines for Use
Appendix 1: CIDEX OPA Directions for Use rev 200404* Page 1
CIDEX ® OPA DIRECTIONS FOR USE
CIDEX® OPA INSTRUMENT GRADE DISINFECTANT SOLUTION Active Ingredient ortho-phthalaldehyde….. 0.55%w/w Inert Ingredients Potassium phosphate dibasic Potassium phosphate monobasic Benzotriazole Citric acid – anhydrous Alizarin cyanine green F IC61570 Trisodium HEDTA Does not require activation before use.
INDICATIONS FOR USE CIDEX® OPA SOLUTION is a high level disinfectant for reprocessing heat sensitive medical/dental devices for which alternative methods of sterilisation are not suitable, and when used according to the Directions for Use. CIDEX OPA Solution is intended for use in manual (bucket and tray) systems made from polypropylene, acrylonitrile-butadiene-styrene (ABS), polyethylene, glass-filled polypropylene or polycarbonate plastics. CIDEX OPA Solution may also be used in automated endoscope reprocessors according to the manufacturer’s instructions. Medical/dental devices reprocessed in CIDEX OPA Solution must first be cleaned according to a validated cleaning protocol or standard, such as the AS4187-1998 “Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities”. Level of Disinfectant Activity. CIDEX OPA Solution is a high level disinfectant of semicritical devices above its Minimum Effective Concentration (MEC) of 0.3% as determined by the CIDEX OPA Solution Test Strip, when used or reused according to the Directions for Use, at 20oC for an immersion time of at least 10 minutes and a reuse period up to a maximum of 14 days. Reuse Period for Disinfection. CIDEX OPA Solution has demonstrated disinfection efficacy in the presence of 5% organic soil contamination and microbiological burden during reuse. CIDEX OPA Solution may be reused for a period up to a maximum of 14 days provided the required conditions of ortho-phthalaldehyde concentration and temperature exist based upon monitoring described in the Directions for Use. DO NOT rely solely on days in use. Individual hospital results on reuse will vary. Reuse of CIDEX OPA Solution for up to 14 days was determined was determined using the US EPA Reuse Protocol and an analytical test procedure. Concentration of this product during its reuse life, must be verified by the CIDEX OPA Solution Test Strip to determine that the concentration of orthophthalaldehyde is above the MEC of 0.3%. The product must be discarded after 14 days, even if the CIDEX OPA Solution Test Strip indicates a concentration at or above the MEC.
*Used With Permission From Johnson & Johnson Medical Pty Ltd
Appendix 1: CIDEX OPA Directions for Use rev 200404* Page 2
General Information on Selection and Use of Disinfectants for Medical/Dental Device Reprocessing. Choose a disinfectant with the level of microbial activity that is appropriate for the reusable device. Follow the reusable device labelling and standard institutional practices. In the absence of complete instructions, use the following process: First, for patient contacting devices, determine whether the reusable device to be reprocessed is a critical or semi-critical device....