y y y g q

General Information on Selection and Use of Germicides ELASTOMERS5 least 15 minutes. Seek medical attention. In case of skin
Cidex OPA ® for Medical Device Reprocessing: Choose a germicide
with the level of antimicrobial activity that is appropriate for
Polychloroprene (Neoprene)
Kraton G
contact, immediately wash with water. Refer to the
MSDS for additional information. Do not form sprays,
ortho-Phthalaldehyde Solution the reusable device. Follow the reusable device labeling and Polyurethane mists or aerosols of this product.
high level disinfectant for semi-critical medical devices standard institutional practices. In the absence of complete Silicone rubber6
Active Ingredient instructions, use the following process: Natural Rubber Latex 3. Avoid contamination of food. Ingestion may cause irritation
ortho-Phthalaldehyde . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.55% or chemical burns of the mouth, throat, esophagus and
5
Inert Ingredients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99.45% First, for patient contacting devices, determine whether the ADHESIVES stomach. If swallowed, DO NOT INDUCE VOMITING.
Dipotassium hydrogen phosphate reusable device to be reprocessed is a critical or semi- Cyanoacrylate8 Drink large quantities of water and call a physician
Potassium dihydrogen phosphate critical device. EPO-TEK 301 Epoxy8 immediately. Probable mucosal damage from oral
Benzotriazole EPO-TEK 353 Epoxy exposure may contraindicate the use of gastric lavage.
Citric acid Critical device: Presents a high risk of infection if not sterile.
D&C Green Dye #5 Routinely penetrates the skin or mucous membranes during 1. Exposed to 31 days (744 hours) of continuous contact with 4. Avoid exposure to ortho-phthalaldehyde vapors, as they
N-(hydroxyethyl) -ethylenediaminetriacetic acid (HEDTA) use or are otherwise used in normally sterile tissue of the body. CIDEX OPA Solution with no effect unless otherwise noted. may be irritating to the respiratory tract and eyes. May
Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100.00% cause stinging sensation in the nose and throat,
Does not require activation before use. Semi-critical device: Makes contact with mucous 2. Shows signs of surface discoloration at 7 days or greater. discharge, coughing, chest discomfort and tightness,
membranes but does not ordinarily penetrate normally difficulty with breathing, wheezing, tightening of throat,
sterile areas of the body. 3. Most grades tested show no effect. Others may exhibit
INSTRUCTIONS FOR USE slight discoloration at 7 days or greater. Stainless steel 440 urticaria (hives), rash, loss of smell, tingling of mouth or
Second, determine if sterilization or high level disinfection is shows rust at 14 days immersion. lips, dry mouth or headache. May aggravate a pre-
Intended Use: CIDEX ® OPA Solution is a high level required. existing asthma or bronchitis condition. In case of
disinfectant for reprocessing heat sensitive reusable semi-critical 4. Treated with 500 cycles of CIDEX OPA Solution. Surface adverse reactions from inhalation of vapor, move to fresh
medical devices, for which sterilization is not feasible, and when Critical device (e.g., cardiac catheters, scalpels, surgical breakdown noted after 150 cycles (25 hour total contact). air. If breathing is difficult, oxygen may be given by
used according to the Directions for Use. CIDEX OPA Solution instruments): Sterilization is required. qualified personnel. If symptoms persist, seek medical
is intended for use in manual (bucket and tray) systems made 5. Exposed 7 days of continuous contact with CIDEX OPA attention.
from polypropylene, acrylonitrile-butadiene-styrene (ABS), Semi-critical reusable device (e.g., endoscopes): Solution with no effect unless otherwise noted.
polyethylene, glass-filled polypropylene and/or polycarbonate Sterilization is required whenever feasible; where not 5. The use of CIDEX OPA Solution with semi-critical
feasible, high level disinfection is the minimum acceptable 6. Some grades or applications exhibit discoloration. devices must be part of a validated rinsing procedure as
plastics. CIDEX OPA Solution may also be used in automated
endoscope reprocessors according to the manufacturer’s process. 7. Some sonic welded parts may exhibit crazing. provided by the device manufacturer. See DIRECTIONS
instructions and should be monitored with CIDEX OPA Solution FOR USE Rinsing Instructions – for important information
Third, select a germicide that is labeled for the appropriate 8. Some loss in shear strength but show no signs of severe on rinsing.
Test Strips. See DIRECTIONS FOR USE – Reusage for Disinfection. germicidal level and is compatible with the reusable device. degradation.
The semi-critical medical devices reprocessed in CIDEX OPA Follow directions for the germicide. 6. ALWAYS follow the Directions For Use Rinsing
Solution must first be cleaned according to a validated cleaning Olympus, Pentax, and Fujinon endoscopes are compatible Instructions (Part B) and the SPECIAL INSTRUCTIONS
Microbicidal Activity: The following table indicates the with CIDEX OPA Solution. for transesophageal echocardiography (TEE) probes in
protocol or standard, such as the ASTM F 1518 “US Standard spectrum of activity as demonstrated by testing of CIDEX
Practice for Cleaning and Disinfection of Flexible Fiberoptic and Part C EXACTLY or residues of CIDEX OPA Solution may
OPA Solution using prescribed test methods. If questions arise regarding the compatibility of a device remain on the device. Failure to follow rinsing
Video Endoscopes Used in the Examination of the Hollow Viscera.” with CIDEX OPA Solution, contact the device manufacturer.
MICROORGANISM instructions exactly has resulted in reports of chemical
Indications for Use: CIDEX OPA Solution is a high level VEGETATIVE ORGANISMS Cleaning Agent Compatibility: CIDEX OPA Solution is burns, irritation, and staining of the mouth, throat,
disinfectant for reprocessing heat sensitive semi-critical medical Staphylococcus aureus compatible with enzymatic detergents which are mild in pH, esophagus and stomach.
devices, for which sterilization is not suitable, and when used Salmonella choleraesuis low foaming, and easily rinsed from equipment (e.g., ENZOL ®
according to the Directions for Use. Pseudomonas aeruginosa Enzymatic Detergent). Detergents that are either highly acidic
Manual Processing: High Level Disinfectant at a minimum Mycobacterium bovis or alkaline are not recommended as cleaning agents. PRECAUTIONS
of 20ϒC (68ϒF). CIDEX OPA Solution is a high level FUNGI
disinfectant when used or reused, according to the Trichophyton mentagrophytes Follow OSHA Bloodborne Pathogens Universal Precautions
Directions for Use, at or above its Minimum Effective VIRUSES CONTRAINDICATIONS when handling and cleaning soiled devices.
Concentration (MEC) as determined by CIDEX OPA Solution NON-ENVELOPED
Poliovirus Type 1 1. CIDEX OPA Solution should not be utilized to process 1. When disinfecting devices, use gloves of appropriate
Test Strips, with an immersion time of at least 12 minutes for type and length, eye protection and fluid-resistant
a reuse period not to exceed 14 days. Rhinovirus Type 42 any urological instrumentation used to treat patients with
Adenovirus Type 2 a history of bladder cancer. In rare instances CIDEX OPA gowns. When using latex rubber gloves, the user should
Automatic Endoscope Reprocessors that can be set to Vaccinia (Wyeth) Solution has been associated with anaphylaxis-like double glove and/or change single gloves frequently,
a minimum of 25ϒC: High Level Disinfectant at a minimum Coxsackievirus Type B-3 reactions in bladder cancer patients undergoing e.g., after 12 minutes of exposure. For those individuals
of 25ϒC (77ϒF). CIDEX OPA Solution is a high level ENVELOPED repeated cystoscopies. who are sensitive to latex or other components in latex
disinfectant when used or reused in a legally marketed Coronavirus gloves, 100% synthetic copolymer gloves, nitrile rubber
automatic endoscope reprocessor (that can be set to a Cytomegalovirus 2. CIDEX OPA Solution should not be utilized to process gloves, or butyl rubber gloves may be used.
minimum of 25ϒC) according to the Directions for Use, at or Influenza Virus [Hong Kong] instrumentation for patients with known sensitivity to
CIDEX OPA Solution or any of its components. Note: Contact with CIDEX OPA Solution may stain
above its Minimum Effective Concentration (MEC) as HIV-1 exposed skin or clothing.
determined by CIDEX OPA Solution Test Strips, with an Herpes simplex Types 1,2 3. CIDEX OPA Solution should not be used to sterilize heat
immersion time of at least 5 minutes for a reuse period not sensitive medical devices. When sterilization by a 2. Use CIDEX OPA Solution in a well-ventilated area and in
to exceed 14 days. To qualify CIDEX OPA Solution as a high level disinfectant, closed containers with tight-fitting lids. If adequate
the reused solution passed the AOAC Sporicidal Activity biologically monitorable process is not feasible, high
level disinfection of rigid endoscopes is recommended ventilation is not provided by the existing air conditioning
Note: If your AER cannot be set to a minimum of 25ϒC Test in 32 hours at 20ϒC and in 32 hours at 25ϒC. system, use in local exhaust hoods, or in ductless fume
please follow the time and temperature stated in Indications by the Centers for Disease Control and Prevention (CDC)
Material Compatibility: CIDEX OPA Solution has been tested and the Association for Professionals in Infection Control hoods/portable ventilation devices which contain filter
for Use, Manual Processing. media which absorb ortho-phthalaldehyde from the air.
and found to be compatible with the materials shown below. and Epidemiology (APIC).
Minimum Effective Concentration (MEC): 0.3%. 3. Contaminated reusable devices MUST BE
METALS1 PLASTICS5
Reuse Period for Disinfection: CIDEX OPA Solution has Aluminum Polymethylmethacrylate (Acrylic) THOROUGHLY CLEANED prior to disinfection, since
demonstrated disinfection efficacy in the presence of 5% Anodized aluminum2 Nylon WARNINGS residual contamination with soil or lubricants will decrease
organic soil contamination and microbiological burden Brass Polyethylene terephthalate the effectiveness of the germicide.
during reuse. CIDEX OPA Solution may be reused for up to Carbon steel (Polyester) 1. May elicit an allergic reaction. Possible allergic reactions
have been reported in rare instances. In the majority of 4. The user MUST adhere to the Directions for Use, as
a maximum of 14 days provided the required conditions of Chrome plated brass2 Polystyrene modification to the Directions for Use may affect the
ortho-phthalaldehyde concentration and temperature exist Chrome plated steel2 Polyvinylchloride (PVC)6 these instances health care workers were not using the
product in a well-ventilated room or not wearing proper safety and effectiveness of the germicide.
based upon monitoring described in the Directions for Use. Copper Acrylonitrile/butadiene/styrene (ABS)
DO NOT rely solely on days in use. Concentration of this Nickel plated brass2 Polysulfone personal protective equipment. (See PRECAUTIONS). 5. Do not use CIDEX OPA Solution on critical medical devices
product during its reuse life must be verified by the CIDEX Nickel silver alloy2 Polycarbonate7 2. Avoid contact with eyes, skin, or clothing. (See that are intended for use in a sterile area of the body (e.g.
OPA Solution Test Strip prior to each use to determine that Stainless steel3 Polyethylene PRECAUTIONS – for important information on how to cataract surgical instruments).
the concentration of ortho-phthalaldehyde is above the Titanium Polypropylene protect eyes, skin and clothing.) Direct contact with eyes
MEC of 0.3%. The product must be discarded after 14 days, Tungsten carbide2 Acetal 6. The reusable device manufacturer should provide the
may cause irritation. Direct contact with skin may cause user with a validated reprocessing procedure for that
even if the CIDEX OPA Solution Test Strip indicates a Vanadium steel4 PTFE temporary staining. Repeated contact with skin may
concentration above the MEC. Polyamide device using CIDEX OPA Solution.
cause skin sensitization. In case of eye contact,
immediately flush eyes with large quantities of water for at
7. The use of CIDEX OPA Solution in automated • Manually flush all lumens with large volumes A device that is not completely dried provides an ideal 3. The expiration date of the CIDEX OPA Solution is found on
endoscope reprocessors must be part of a validated (not less than 100 mL) of rinse water unless situation for rapid colonization of bacteria. As these the immediate container.
reprocessing procedure. The contact conditions must be otherwise noted by the device manufacturer. waterborne bacteria are highly resistant to drying,
25ϒC for 5 minutes. (See note following the Indications for • Remove the device and discard the rinse rapid drying will avoid possible colonization but may
Use section). water. Always use fresh volumes of water for not result in a device free from these bacteria. A final
each rinse. Do not reuse the water for rinsing rinse using a 70% isopropyl alcohol solution can be
EMERGENCY AND TECHNICAL PRODUCT
8. Use CIDEX OPA Solution Test Strips to detect ortho- or any other purpose. used to speed the drying process and reduce the INFORMATION
phthalaldehyde concentration before each cycle to detect • Repeat the procedure TWO (2) additional numbers of any organism present as a result of
the MEC. Follow the Directions For Use provided with the times, for a total of THREE (3) RINSES, with rinsing with potable water. For further hazard information please refer to the Material
CIDEX OPA Solution Test Strips. large volumes of fresh water to remove CIDEX Safety Data Sheet. Emergency, safety, or technical
OPA Solution residues. Residues may cause C. Special Instructions for Transesophageal information about CIDEX OPA Solution can be obtained
serious side effects. SEE WARNINGS. THREE Echocardiography (TEE) probe reprocessing: As with from Advanced Sterilization Products at (888) 783-7723, or
(3) SEPARATE, LARGE VOLUME WATER all devices, carefully follow all probe manufacturer by contacting your local Advanced Sterilization Products
DIRECTIONS FOR USE IMMERSION RINSES ARE REQUIRED. recommendations such as use of a sterile protective sales representative.
• Refer to the reusable semi-critical medical device sheath when performing TEE. Soaking for a minimum of
Cleaning/Decontamination: Blood, other body fluids, and 12 minutes in CIDEX OPA Solution is required for high
lubricants must be thoroughly cleaned from the surfaces and manufacturer’s labeling for additional rinsing
instructions. level disinfection (HLD). Excessive soaking of the probes USER TRAINING
lumens of semi-critical medical devices before reprocessing in (e.g., longer than an hour) during HLD and/or not rinsing
the disinfectant. Blood and other body fluids should be disposed b) Automated Processing: three times with a fresh quantity of water each time as The user should be adequately trained in the
of according to all applicable regulations for infectious waste • Select a rinse cycle on an automatic described in Part B, may result in residual CIDEX OPA decontamination and disinfection of semi-critical medical devices
disposal. endoscope reprocessor that has been Solution remaining on the device, the use of which may and the handling of liquid chemical germicides. Additional
Refer to the reusable device manufacturer’s labeling for validated for use with this product. cause staining, irritation or chemical burns of the mouth, information about CIDEX OPA Solution can be obtained by
instructions on disassembly, decontamination, cleaning and • Ensure that the automated rinse cycle selected throat, esophagus and stomach. contacting your local Advanced Sterilization Products sales
leak testing of their equipment. will thoroughly rinse the semi-critical medical device representative.
including all lumens with large volumes of sterile D. Reusage for Disinfection: CIDEX OPA Solution has
Before immersion in CIDEX OPA Solution, thoroughly clean or potable water equivalent to the reusable demonstrated efficacy in the presence of organic soil
devices, including all lumens, using a cleaning protocol or device manufacturer’s recommendations. contamination and microbiological burden during reuse. DISINFECTANT/CONTAINER DISPOSAL
• Verify that each rinse is a minimum of 1 minute The ortho-phthalaldehyde concentration of CIDEX OPA
standard, such as the ASTM F 1518 “Standard Practice for
Solution during its use-life must be verified by the CIDEX INFORMATION
Cleaning and Disinfection of Flexible Fiberoptic and Video in duration unless the reusable device
Endoscopes Used in the Examination of the Hollow Viscera.” manufacturer specifies a longer time. Ensure OPA Solution Test Strips prior to each use, to determine
that the MEC of 0.3% is present. CIDEX OPA Solution Disinfectant Disposal: Check state and local disposal
that a fresh volume of water is used for each regulations. Glycine (free base) may be used as a neutralizer
Thoroughly rinse and rough dry all surfaces and lumens of rinse. Do not reuse the water for rinsing or any may be used and reused within the limitations indicated
cleaned devices. above for up to a maximum of 14 days. CIDEX OPA for CIDEX OPA Solution prior to disposal, if required. A
other purpose. minimum of 25 grams of glycine (free base) should be used to
• Refer to the reusable device manufacturer’s Solution must be discarded after 14 days, even if the
Usage: NO ACTIVATION IS REQUIRED. CIDEX OPA Solution Test Strip indicates a concentration neutralize one gallon of CIDEX OPA Solution. The minimum
labeling for additional rinsing instructions. recommended neutralization time is one hour. Discard
Record the date the container was opened on the container above the MEC.
2. STERILE WATER RINSE: The following devices residual solution into drain. Flush drain thoroughly with water.
label, or in a log book. After opening, the solution remaining 1. MONITORING OF GERMICIDE: During reuse, it is
in the container may be stored for up to 75 days (providing should be rinsed with sterile water, using sterile
technique when rinsing and handling: recommended that the CIDEX OPA Solution be Container Disposal: Do not reuse empty container. Rinse
the 75 days does not extend past the expiration date on the and dispose per hospital policy.
tested with CIDEX OPA Solution Test Strips prior to
container) until used. Devices intended for use in normally sterile areas of each use. This is to ensure that the Minimum Effective
Record the date the solution was poured out of the original the body. Concentration (MEC) of ortho-phthalaldehyde is
container into a secondary container in a log book (separate Devices intended for use in known immuno- present. HOW SUPPLIED
from the one mentioned above), or on a label affixed to the compromised patients, or potentially immuno-
secondary container. The solution in the secondary container During the usage of CIDEX OPA Solution as a high Reorder Description Case Contains
compromised patients based on institutional level disinfectant, it is recommended that a 20390 One Gallon (3.785L) 4 gals (4 x 3.785L)/case
can be used for a period up to 14 days. The product must be procedures (e.g., high risk population served).
discarded after 14 days even if the CIDEX OPA Solution Test thermometer and timer be utilized to ensure that the Container
Strip indicates a concentration above the MEC. When practical, bronchoscopes, due to a risk of optimum conditions are met.
contamination from potable water supply. Although Monitoring Temperature in Automatic Endoscope 20392 CIDEX OPA Solution 60 strips/btl; 2 btls/case
A. High Level Disinfection microorganisms in this type of water system are not Test Strips
Reprocessor that can be set to a minimum of
1. Manual Processing: Immerse device completely, filling normally pathogenic in patients with healthy immune 25ϒC: As with all high level disinfectants, temperature
all lumens and eliminating air pockets, in CIDEX OPA systems, AIDS patients or other immuno- monitoring is critical for use of CIDEX OPA Solution at 20393 CIDEX OPA Solution 15 strips/btl; 2 btls/case
Solution for a minimum of 12 minutes at 20ϒC (68ϒF) or compromised individuals may be placed at high risk of a minimum of 25ϒC for 5 minutes in an AER. If you Test Strips
higher to destroy all pathogenic microorganisms. infection by these opportunistic microorganisms. cannot monitor temperature appropriately in your
Remove device from the solution and rinse thoroughly machine, contact ASP at (888) 783-7723 for further
following the rinsing instructions below. 3. POTABLE WATER RINSE: For all other devices, a
sterile water rinse is recommended when practical. instructions.
2. Automatic Endoscope Reprocessor that can be Otherwise, potable tap water rinse is acceptable. Visually inspect the solution during the reuse life for
set to a minimum of 25ϒC (See note following the the presence of precipitates which may result from
Indications for Use section): High Level Disinfectant When using potable water for rinsing, the user should
be aware of the increased risk of recontaminating the the use of hard water. Discard solution if precipitation
at a minimum of 25ϒC (77ϒF). For use in a legally occurs. MARKETED BY:
marketed AER (that can be set to a minimum of 25ϒC) device or medical equipment with microorganisms
with a minimum immersion time of 5 minutes. As with which may be present in potable water supplies. POST-PROCESSING HANDLING AND STORAGE OF
all high level disinfectants, it is critical that REUSABLE DEVICES: Disinfected reusable devices are
temperature is monitored when using CIDEX OPA Water treatment systems, such as softeners or
deionizers, may add microorganisms to the treated either to be immediately used, or stored in a manner to
Solution in an AER at 25ϒC. See section D. 1 minimize recontamination. Refer to the reusable device
“Monitoring of Germicide.” water to the extent that microbial content of the water
at the point of use could exceed that of the manufacturer’s labeling for additional storage and/or 33 TECHNOLOGY DRIVE, IRVINE, CA 92618-9824
B. Rinsing Instructions pretreated drinking water. To ensure proper water handling instructions.
For technical information and/or information regarding
1. RINSING PROCEDURE quality, adherence to maintenance of the water
treatment system(s) is recommended. safety and effectiveness, call 1-888-783-7723
a) Manual Processing:
• Following removal from CIDEX OPA Solution, The use of a bacterial retentive (0.2 micron) filter STORAGE CONDITIONS AND EXPIRATION DATE
thoroughly rinse the semi-critical medical device system may eliminate or greatly reduce the amount of ©ASP, 2006 LC-20390-008 Rev. D (FAX)
by immersing it completely in a large volume (e.g. these waterborne bacteria from the potable water 1. CIDEX OPA Solution should be stored in its original sealed
2 gallons) of water. Use sterile water unless source. Contact the manufacturer of the filter or UV container at controlled room temperature 15 - 30ϒC (59 -
potable water is acceptable. See item 2 or 3 system for instructions on preventative maintenance 86ϒF) in a well-ventilated, low-traffic area.
below. and periodic replacement of the filter to avoid 2. Once opened, the unused portion of the solution may be
• Keep the device totally immersed for a colonization or formation of biofilms in the filter. stored in the original container for up to 75 days until used.
minimum of 1 minute in duration, unless a
longer time is specified by the reusable device
manufacturer.