5 OPA Cidex - Johns Hopkins Hospital

1 Cidex OPAortho-Phthalaldehyde Solutionhigh level disinfectant for semi-critical medical devicesActive Ingredientortho-Phthalaldehyde .. Ingredients .. hydrogen phosphatePotassium dihydrogen phosphateBenzotriazoleCitric acidD&C Green Dye #5N-(hydroxyethyl) - ethylenediaminetriacetic acid (HEDTA)Total .. not require activation before FOR USEI ntended Use: Cidex OPA Solution is a high leveldisinfectant for reprocessing heat sensitive reusable semi-criticalmedical devices, for which sterilization is not feasible, and whenused according to the Directions for Use.

2 Cidex OPA Solutionis intended for use in manual (bucket and tray) systems madefrom polypropylene, acrylonitrile-butadiene-styrene (ABS),polyethylene, glass-filled polypropylene and/or polycarbonateplastics. Cidex OPA Solution may also be used in automatedendoscope reprocessors according to the manufacturer sinstructions and should be monitored with Cidex OPA SolutionTest Strips. See DIRECTIONS FOR USE Reusage for semi-critical medical devices reprocessed in Cidex OPAS olution must first be cleaned according to a validated cleaningprotocol or standard, such as the ASTM F 1518 US StandardPractice for Cleaning and Disinfection of Flexible Fiberoptic andVideo Endoscopes Used in the Examination of the Hollow Viscera.

3 Indications for Use: Cidex OPA Solution is a high leveldisinfectant for reprocessing heat sensitive semi-critical medicaldevices, for which sterilization is not suitable, and when usedaccording to the Directions for Processing: High Level Disinfectant at a minimumof 20 C (68 F). Cidex OPA Solution is a high leveldisinfectant when used or reused, according to theDirections for Use, at or above its Minimum EffectiveConcentration (MEC) as determined by Cidex OPA SolutionTest Strips, with an immersion time of at least 12 minutes fora reuse period not to exceed 14 Endoscope Reprocessors that can be set toa minimum of 25 C: High Level Disinfectant at a minimumof 25 C (77 F).

4 Cidex OPA Solution is a high leveldisinfectant when used or reused in a legally marketedautomatic endoscope reprocessor (that can be set to aminimum of 25 C) according to the Directions for Use, at orabove its Minimum Effective Concentration (MEC) asdetermined by Cidex OPA Solution Test Strips, with animmersion time of at least 5 minutes for a reuse period notto exceed 14 : If your AER cannot be set to a minimum of 25 Cplease follow the time and temperature stated in Indicationsfor Use, Manual Effective Concentration (MEC): Period for Disinfection: Cidex OPA Solution hasdemonstrated disinfection efficacy in the presence of 5%organic soil contamination and microbiological burdenduring reuse.

5 Cidex OPA Solution may be reused for up toa maximum of 14 days provided the required conditions ofortho-phthalaldehyde concentration and temperature existbased upon monitoring described in the Directions for NOT rely solely on days in use. Concentration of thisproduct during its reuse life must be verified by the CIDEXOPA Solution Test Strip prior to each use to determine thatthe concentration of ortho-phthalaldehyde is above theMEC of The product must be discarded after 14 days,even if the Cidex OPA Solution Test Strip indicates aconcentration above the Information on Selection and Use of Germicidesfor Medical Device Reprocessing: Choose a germicidewith the level of antimicrobial activity that is appropriate forthe reusable device.

6 Follow the reusable device labeling andstandard institutional practices. In the absence of completeinstructions, use the following process:First, for patient contacting devices, determine whether thereusable device to be reprocessed is a critical or semi-critical device: Presents a high risk of infection if not penetrates the skin or mucous membranes duringuse or are otherwise used in normally sterile tissue of the device: Makes contact with mucousmembranes but does not ordinarily penetrate normallysterile areas of the , determine if sterilization or high level disinfection device ( , cardiac catheters, scalpels, surgicalinstruments): Sterilization is reusable device ( , endoscopes):Sterilization is required whenever feasible.

7 Where notfeasible, high level disinfection is the minimum , select a germicide that is labeled for the appropriategermicidal level and is compatible with the reusable directions for the Activity: The following table indicates thespectrum of activity as demonstrated by testing of CIDEXOPA Solution using prescribed test ORGANISMSS taphylococcus aureusSalmonella choleraesuisPseudomonas aeruginosaMycobacterium bovisFUNGIT richophyton mentagrophytesVIRUSESNON-ENVELOPEDP oliovirus Type 1 Rhinovirus Type 42 Adenovirus Type 2 Vaccinia (Wyeth)

8 Coxsackievirus Type B-3 ENVELOPEDC oronavirusCytomegalovirusInfluenza Virus [Hong Kong]HIV-1 Herpes simplex Types 1,2To qualify Cidex OPA Solution as a high level disinfectant,the reused solution passed the AOAC Sporicidal ActivityTest in 32 hours at 20 C and in 32 hours at 25 Compatibility: Cidex OPA Solution has been testedand found to be compatible with the materials shown (Acrylic)Anodized aluminum2 Nylon BrassPolyethylene terephthalateCarbon steel (Polyester)Chrome plated brass2 PolystyreneChrome plated steel2 Polyvinylchloride (PVC)6 CopperAcrylonitrile/butadiene/styrene (ABS)Nickel plated brass2 PolysulfoneNickel silver alloy2 Polycarbonate7 Stainless steel3 PolyethyleneTitaniumPolypropyleneTungste n carbide2 AcetalVanadium steel4 PTFEP olyamideyELASTOMERS5 Polychloroprene (Neoprene)

9 Kraton GPolyurethaneSilicone rubber6 Natural Rubber LatexADHESIVES5 Cyanoacrylate8 EPO-TEK 301 Epoxy8 EPO-TEK 353 Epoxy1. Exposed to 31 days (744 hours) of continuous contact withCIDEX OPA Solution with no effect unless otherwise Shows signs of surface discoloration at 7 days or Most grades tested show no effect. Others may exhibitslight discoloration at 7 days or greater. Stainless steel 440shows rust at 14 days Treated with 500 cycles of Cidex OPA Solution. Surfacebreakdown noted after 150 cycles (25 hour total contact).

10 5. Exposed 7 days of continuous contact with Cidex OPAS olution with no effect unless otherwise Some grades or applications exhibit Some sonic welded parts may exhibit Some loss in shear strength but show no signs of , Pentax, and Fujinon endoscopes are compatiblewith Cidex OPA questions arise regarding the compatibility of a devicewith Cidex OPA Solution, contact the device Agent Compatibility: Cidex OPA Solution iscompatible with enzymatic detergents which are mild in pH,low foaming, and easily rinsed from equipment ( , ENZOL Enzymatic Detergent).