Compliance

This page contains information on Compliance for veterinary use.
The information provided typically includes the following:
  • Compliance Indications
  • Warnings and cautions for Compliance
  • Direction and dosage information for Compliance

Compliance

This treatment applies to the following species:
Manufacturer: Metrex

Sterilizing and Disinfecting Solution

NOT FOR USE ON FLEXIBLE ENDOSCOPES

Active Ingredients

Hydrogen Peroxide

7.35%

Peracetic Acid

0.23%

Inert Ingredients

92.42%

TOTAL

100%

Keep Out of Reach of Children

See Below for Additional Precautionary Statements

DO NOT ALLOW TO FREEZE

USAGE: Compliance is a liquid chemical sterilant and high-level disinfectant for medical instruments/devices when used according to the DIRECTIONS FOR USE.

14 Day Extended Reuse Solution at 68°F (20°C)

Directions For Use

IT IS VIOLATION OF FEDERAL LAW TO USE THIS PRODUCT IN A MANNER INCONSISTENT WITH ITS LABELING.

Compliance is a ready to use sterilant/disinfectant solution. Compliance can be used in manual (bucket and tray) systems made from polypropylene, ABS, polyethylene, glass-filled polypropylene or specially molded polycarbonate plastics and stainless steel. Record initial date of use and the expiration date (14 days hence) in a log book or a label affixed to any secondary container used to contain the solution. The used solution must be discarded after 14 days.

Directions For Cleaning/decontamination

Blood and other body fluids must be thoroughly cleaned from the surfaces, lumens, and objects before application of the disinfectant or sterilant. Blood and other body fluids should be autoclaved and disposed of according to all applicable federal, state and local regulations for infectious waste disposal.

For complete disinfection or sterilization of heat sensitive medical instruments and equipment, thoroughly clean, rinse and rough dry objects before immersing in Compliance. Cleanse and rinse the lumens of hollow instruments before filling with Compliance. Refer to the reusable device manufacturer’s labeling for instructions on disassembly, decontamination, cleaning and leak testing of their equipment.

Directions For Sterilization

(Bucket/Tray Manual System)

Sterilant: Compliance is a sterilant for medical instruments/devices when used or reused, according to the DIRECTIONS FOR USE, at 68°F (20°C) with an immersion time of 180 minutes (3 hours) for a use period not to exceed 14 days.

Immerse medical equipment/devices completely in Compliance for a minimum of 180 minutes (3 hours) at 68°F (20°C) to eliminate all microorganisms including Clostridium sporogenes and Bacillus subtilis spores. Remove equipment from the solution using sterile technique and rinse thoroughly with sterile water.

Directions For High-level Disinfection

(Bucket/Tray Manual System)

High-Level Disinfectant: Compliance is a high-level disinfectant for medical instruments/devices when used or reused, according to the DIRECTIONS FOR USE, at 68°F (20°C) with an immersion time of 15 minutes (see insert) for a use period not to exceed 14 days.

Immerse medical equipment/devices completely in Compliance for a minimum of 15 minutes at 68°F (20°C) to destroy all pathogenic microorganisms, except for large numbers of bacterial endospores, but including Mycobacterium strains as represented by M. bovis (Quantitative TB Method). Remove equipment/devices from the solution and rinse thoroughly with sterile or potable water, followed by an alcohol rinse.

Refer to package insert for more detailed usage/product data.

Intended Use

Sterilization: This solution should be used for the sterilization of heat sensitive medical equipment for which alternative methods of sterilization are not suitable. Medical equipment which should always be sterilized is that which is categorized as critical (e.g., used in procedures in which contact will be made with tissue that is normally considered

sterile).

High-Level Disinfection: This solution should be used for the high-level disinfection of heat sensitive medical equipment for which sterilization is not practical. Medical equipment which should always be subjected to high-level disinfection or sterilization is that which will be used in procedures categorized as semi-critical (e.g., used in procedures in which contact will be made with mucous membranes or other body surfaces which are not normally considered sterile).

Precautionary Statements

HAZARDS TO HUMANS AND DOMESTIC ANIMALS

DANGER: Keep Out of Reach of Children. Contains Hydrogen Peroxide and Peracetic Acid.

Direct contact is corrosive to exposed tissue, causing

irreversible eye damage and skin irritation/damage. Do not get into eyes, on skin or on clothing. Appropriate hand, eye and face protection (goggles, face shield, or safety glasses) as well as liquid proof gowns should be worn when cleaning and sterilizing/disinfecting soiled devices and equipment. Avoid contamination of food. Use in a well ventilated area in closed containers.

Wash thoroughly with soap and water after handling. Harmful if inhaled. Avoid breathing (vapor or spray mist). Remove contaminated clothing and wash clothing before reuse.

Storage And Disposal

DO NOT ALLOW COMPLIANCE TO FREEZE. Do not use Compliance that has been frozen and thawed. Do not use Compliance that has a cloudy appearance or has visible precipitants.

Compliance solution should be stored in its original sealed container at room temperature 15°-30°C (59-86°F).

Container Disposal: Container must be triple rinsed and disposed of in accordance with federal, state and/or local regulations.

Used Solution Disposal: Used solution should be disposed of in accordance with federal, state and/or local regulations.

Toxicological Information

Statement of Practical Treatment:

In case of contact, immediately flush eyes or skin with copious amounts of water for at least 15 minutes. For eyes, get medical attention. Harmful if swallowed. Drink large quantities of water and call a physician immediately.

NOTE TO PHYSICIAN: Probable mucosal damage from oral exposure may contraindicate the use of gastric lavage.

A. Intended Use/directions For Use

Compliance solution is a liquid chemical sterilant and a high-level disinfectant when used according to the Directions for Use.

NOT FOR USE ON FLEXIBLE ENDOSCOPES

1. Germicide Level of Activity - Compliance can be used at the following germicide levels of activity:

High Level Disinfection:
14 Day Reuse:
Compliance is a high-level disinfectant when used or reused, according to the Directions For Use, at 68°F (20°C) with an immersion time of 15 minutes for a use period not to exceed 14 days.

Sterilant:
14 Day Reuse:
Compliance is a sterilant when used or reused, according to the Directions For Use, at 68°F (20°C) with an immersion time of 180 minutes (3 hours) for a use period not to exceed 14 days.

2. Reuse Period - Compliance has demonstrated efficacy in the presence of five percent (5%) organic soil contamination and a simulated amount of microbiological burden under the following temperatures:
68°F (20°C) - with a contact time of 15 minutes and the product discarded after 14 days for high-level disinfection. For sterilization, a contact time of 180 minutes (3 hours) is required with the product discarded after 14 days.

3. General Sterilization/Disinfection Information - Choose a germicide with the level of microbial activity that is appropriate for the reusable medical device or equipment surface. Follow the reusable device labeling and standard institutional practices. In the absence of complete instructions, use the following guidance:

First, for patient contacting devices, determine whether the reusable device to be processed is a critical or semi-critical device.

- A critical device routinely penetrates the skin or mucous membranes during use or is otherwise used in normally sterile tissues of the body.

- A semi-critical device makes contact with mucous membranes but does not ordinarily penetrate sterile areas of the body.

Second, determine the level of sterilization/disinfection required:

- Critical Device - Sterilization is required.

- Semi-critical Device - Although sterilization is recommended whenever practical, high-level disinfection is acceptable (e.g. anesthesia equipment to be used in the airway, diaphragm-fitting rings, etc.)

Third, determine the time needed to achieve the level of disinfection or sterilization required for the specified medical device as indicated on the Compliance solution label.

4. The germicidal activity of Compliance was demonstrated using stressed solutions* in performance, clinical and simulated use testing using the following organisms:

 

20°C 14 Day Reuse*

Spores

- Bacillus subtilis

- Clostridium sporogenes

180 minutes

Vegetative Organisms

15 minutes

- Staphylococcus aureus

3 minutes

- Salmonella choleraesuis

3 minutes

- Pseudomonas aeruginosa

3 minutes

- Mycobacterium bovis

15 minutes

Fungi

- Trichophyton mentagrophytes


5 minutes

Non-lipid Small Virus

- Polio 2


5 minutes

Lipid Medium Virus

- Herpes simplex

- HIV-1 (Human Immunodeficiency Virus)

5 minutes

*Testing was performed using Compliance solution which had been stressed in accordance with EPA “Reuse Test Protocol Specifications” and aged 46 days. Due to a lack of a test strip for monitoring concentration of active ingredients the reuse period is limited to 14 days.

5. Device/Material Compatibility - Compliance solution is recommended for usage with medical devices made from the following materials: Black Anodized Aluminum**, 303 Stainless Steel, Teflon*, Polyethylene*, Polyethylene Tubing*, Polyurethane*, Black Rubber*, Cemedine (epoxy)/Liquid Silicone***, Adhesive***, Loctite Impruv-Loctite 330++, Masterbond.

*Represents 1500 cycles - 20 minute exposure plus rinsing and drying.

**Some loss of color observed after 48 cycles; complete color loss observed on some specimens from 394 cycle to 657 cycles. (No damage to base metal was observed).

***Cemedine epoxy adhesive remained flexible with good adhesion for 72 hours immersed in Compliance at 20°C. Cemedine epoxy adhesive became brittle and failed adhesively at 50°C immersion for 30 hours. Liquid silicone adhesive remained flexible with good adhesion for 72 hours at 20°C. Liquid silicone adhesive maintained shiny appearance with good flexibility, but failed adhesively at 50°C with 30 hours immersion.

Note: Similar tests were conducted at 50°C in tap water with failure of flexibility and adhesion observed between 20 and 44 hours of immersion. This suggests that adhesive damage and/or failure is likely due to elevated solution temperature rather than due to chemical action.

++Loctite Impruv and Loctite 330 adhesive remained optically clear with good adhesion at 63°C with a 24-hour immersion.

CAUTION: Compliance has not been demonstrated to be compatible with finished devices. Do not use with devices with labeling contraindicating use with hydrogen peroxide or peracetic acid solutions. Contact the reusable device manufacturer for information on compatibility.

Following sterilization or disinfection, the sterilized or disinfected medical device should be rinsed according to the Directions for Use, Rinsing (Section D.4), and dried according to manufacturer’s instructions.

6. Pre-cleaning Agent Compatibility - Compliance is compatible with enzymatic detergents which are neutral in pH, low foaming and easily rinsed from equipment. Detergents that are either highly alkaline or acidic are contraindicated as precleaning agents since improper rinsing could effect the efficacy of the Compliance solution by altering its pH.

B. Warnings

COMPLIANCE IS HAZARDOUS TO HUMANS AND DOMESTIC ANIMALS

DANGER: Keep Out of Reach of Children.

Contains Hydrogen Peroxide and Peracetic Acid

1. Direct contact is corrosive to exposed tissue, causing eye damage and skin irritation/damage. Do not get into eyes, on skin or on clothing.

2. Avoid contamination of food.

3. Use in well-ventilated area in closed containers.

In case of contact, immediately flush eyes or skin with copious amounts of water for at least 15 minutes. For eyes, seek medical attention.

Harmful if swallowed. Drink large quantities of water or milk and call a physician immediately.

Emergency, safety, or technical information about Compliance can be obtained from Metrex Research Corporation Customer Care Department at 1-800-841-1428, or by contacting your local Metrex Research Corporation sales representative.

C. PRECAUTIONS

1. Sterilant Usage - Routine biological monitoring is not possible with Compliance solution, and therefore Compliance solution should NOT be used to sterilize reusable medical devices that are compatible with automated sterilization processes that can be biologically monitored. Compliance solution should not be used for sterilization of critical devices intended for single use (e.g. catheters).

2. High-Level Disinfectant Usage - Compliance should not be used to high-level disinfect a semi-critical device when heat sterilization is practical.

3. Endoscope Usage - Compliance is not for use on flexible endoscopes. Additionally, Compliance is not the method of choice for sterilization of rigid endoscopes which the device manufacturer indicates are compatible with steam sterilization.

4. Appropriate hand, eye and face protection MUST be worn when cleaning and sterilizing/disinfecting soiled devices and equipment.

5. Contaminated reusable devices MUST BE THOROUGHLY CLEANED prior to disinfection or sterilization, since residual contamination will decrease effectiveness of the germicide.

6. The user MUST adhere to the DIRECTIONS FOR USE since any modification will affect the safety and effectiveness of the germicide.

7. The reusable device manufacturer should provide the user with a validated reprocessing procedure for that device using Compliance solution.

D. Directions For Use

Compliance is a ready to use disinfectant/sterilant solution. Compliance is for use in manual (bucket and tray) systems made from polypropylene, ABS, polyethylene, glass-filled polypropylene or specially molded polycarbonate plastics and stainless steel.

1. Record initial date of use and the expiration date (14 days hence) in a log book or a label affixed to any secondary container used to contain the solution. Compliance must be discarded after 14 days.

2. Cleaning/Decontamination - Blood and other body fluids must be thoroughly cleaned from the surfaces, lumens, and objects before application of the disinfectant/sterilant. Blood and other body fluids should be autoclaved and disposed of according to all applicable federal, state and local regulations for infectious waste disposal.

For Compliance to be an effective disinfectant or sterilant, thoroughly clean, rinse and rough dry medical instruments and equipment. Clean and rinse the lumens of hollow instruments before filling with Compliance solution. Refer to the reusable device manufacturers labeling for instructions on disassembly, decontamination, cleaning and leak testing of their equipment. Avoid dilution of the Compliance solution.

3. Usage - IT IS VIOLATION OF FEDERAL LAW TO USE THIS PRODUCT IN A MANNER INCONSISTENT WITH ITS LABELING.

a. DIRECTIONS FOR STERILIZATION (Bucket/Tray Manual System) - Compliance is a liquid chemical sterilant for medical instruments and devices when used according to the Directions for Use.

14 Day Reuse Solution - at 68°F (20°C)

Sterilant: Compliance is a sterilant for medical instruments/devices when used or reused, according to the DIRECTIONS FOR USE, at 68°F (20°C) with an immersion time of 180 minutes (3 hours) for a use period not to exceed 14 days.

Immerse medical equipment/devices completely in Compliance solution for a minimum of 180 minutes (3 hours) at 68°F (20°C) to eliminate all microorganisms including Clostridium sporogenes and Bacillus subtilis spores. Remove equipment from the solution using sterile technique and rinse thoroughly with sterile water following the rinsing instructions in Section D.4.

b. DIRECTIONS FOR HIGH-LEVEL DISINFECTION (Bucket/Tray Manual System) - Compliance is a liquid chemical high-level disinfectant for medical instruments and devices when used according to the Directions for Use. Medical instruments/devices when expected to come in contact without penetration of mucous membranes are semi-critical devices and therefore may be high-level disinfected.

14 Day Reuse Solution - at 68°F (20°C)

High-Level Disinfectant: Compliance is a high-level disinfectant for medical instruments/devices when used or reused, according to the DIRECTIONS FOR USE, at 68°F (20°C) with an immersion time of 15 minutes for a use period not to exceed 14 days.

Immerse medical equipment/devices completely in Compliance solution for a minimum of 15 minutes at 68°F (20°C) to destroy all pathogenic microorganisms, except for large numbers of bacterial endospores, but including Mycobacterium strains as represented by M. bovis (Quantitative TB Method). Remove equipment/devices from the solution and rinse thoroughly following the rinsing instructions below.

4. Rinsing Instructions - Following immersion in Compliance solution, thoroughly rinse the equipment or medical device by immersing in two gallons of water. Repeat this procedure a second time with a fresh two-gallon volume of water.

For instruments with lumens, a minimum of 500 ml of water should be flushed through lumens during each separate rinse unless otherwise noted by the device or equipment manufacturer. Use fresh volumes of water for each rinse. Discard the water following each rinse. Do not reuse the water for rinsing or any other purpose as it will become contaminated with hydrogen peroxide.

Refer to the reusable device/equipment manufacturer’s labeling for rinsing instructions.

a. Sterile Water Rinse: Critical devices which are sterilized with Compliance must be rinsed with sterile water.

b. Potable Water Rinse: A sterile water rinse is recommended when practical, for all devices. Alternatively, a high quality potable water (one that meets Federal Clean Water Standards at point of use) may be used.

The use of potable water for rinsing, increases the risk of contaminating the device or medical equipment with Pseudomonades and atypical (fast growing) Mycobacteria that are often present in potable water supplies. The devices (e.g. colonoscope) need to be completely dried, because any moisture remaining provides an ideal situation for rapid colonization of bacteria. Additionally, mycobacteria are highly resistant to drying, therefore, rapid drying will avoid possible colonization but may not result in a device free from atypical mycobacteria. A final rinse using a 70 percent isopropyl alcohol solution should be used to speed the drying process and reduce the numbers of any organism present as a result of rinsing with potable water.

E. Reuse

Compliance solution has demonstrated efficacy in the presence of 5 percent (5%) organic soil contamination and a simulated amount of microbiological burden during reuse. The hydrogen peroxide and peracetic acid concentration of this product will remain stable and effective during its use life (14 days). Compliance must be discarded after 14 days.

Due to lack of test strip for monitoring concentration of active ingredients the reuse period is limited to 14 days.

F. post-processing Handling And Storage Of Reusable Devices

Sterilized or disinfected reusable devices are either to be used immediately or stored in a manner to minimize contamination. Refer to reusable device equipment manufacturer’s labeling for additional storage and/or handling instructions.

G. STORAGE CONDITIONS AND EXPIRATION DATE

1. Compliance solution should be stored in its original sealed container at room temperature 15°-30°C (59°-86°F).

2. The expiration date of Compliance solution will be found on the bottle.

3. Do not allow Compliance solution to freeze. Compliance solution known to have been frozen, cloudy, or exhibit visible precipitants, (i.e. particles) should not be used, but discarded immediately.

H. Safety Information

Emergency, safety, or technical information about Compliance solution can be obtained from Metrex Research Corporation Customer Service Department at 1-800-841-1428, or by contacting your Metrex Research Corporation sales representative.

I. User Training

The user should be adequately trained in the decontamination and disinfection or sterilization of medical devices and the handling of liquid chemical germicides. Additional information about Compliance solution can be obtained from Metrex Research Corporation Customer Service Department at 1-800-841-1428, or by contacting your Metrex Research Corporation sales representative.

J. Disposal Information

Used solution should be disposed of in accordance with Federal, State and Local regulations. Thoroughly rinse container and discard in trash.

For product or technical information, contact Metrex at 800-841-1428 or visit our web site at www.metrex.com.

Manufactured For: Metrex Research Corporation, 1717 West Collins Ave., Orange, CA 92867

1-800-841-1428

75-2522-4, 2520-4

REORDER INFORMATION

Reorder #

Description

Case Contains

10-2500

1 gallon (3.785 liters)

4 gallons/case

NAC No.: 13400031

METREX® RESEARCH
1717 W. COLLINS AVENUE, ORANGE, CA, 92867
Telephone:   800-841-1428
Order Desk:   800-841-1428
Fax:   714-516-7904
Website:   www.metrex.com
Email:   info@metrex.com
Every effort has been made to ensure the accuracy of the Compliance information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the US product label or package insert.

Copyright © 2014 North American Compendiums. Updated: 2014-07-28

(web4)