MetriCide Plus 30

This page contains information on MetriCide Plus 30 for veterinary use.
The information provided typically includes the following:
  • MetriCide Plus 30 Indications
  • Warnings and cautions for MetriCide Plus 30
  • Direction and dosage information for MetriCide Plus 30

MetriCide Plus 30

This treatment applies to the following species:
Manufacturer: Metrex

(GLUTARALDEHYDE 3.4%)

28-DAY STERILIZING & DISINFECTING SOLUTION

NOTE-Contents of attached vial must be added to solution before this product is effective.

See Directions for Use - Activation.

Contains Sodium Nitrite as a corrosion inhibitor.

Active Ingredient

Glutaraldehyde

3.4%

Inert ingredients:

96.6%

Total

100.0%

KEEP OUT OF REACH OF CHILDREN

DANGER: See additional precautionary statements.

A) INDICATIONS FOR USE

1) Germicide Level of Activity - MetriCide Plus 30 Long-Life Activated Dialdehyde Solutions are liquid chemical sterilants and high-level disinfectants, when used according to the Directions for Use.

Sterilant: MetriCide Plus 30 solutions are sterilants when used or reused, according to Directions for Use, at full strength for a maximum of 28 days at 25 °C with an immersion time of at least 10 hours.

High-Level Disinfectant: MetriCide Plus 30 solutions are high-level disinfectant when used or reused, according to Directions for Use, at full strength for a maximum of 28 days at 25 °C with an immersion time of at least 90 minutes.

2) Reuse Period - MetriCide Plus 30 solutions have also demonstrated efficacy in the presence of 2% organic soil contamination and a simulated amount of microbiological burden during reuse. MetriCide Plus 30 solutions can be reused for a period not to exceed 28 days provided the required conditions of glutaraldehyde concentration, pH, and temperature exist based upon monitoring described in Directions for Use. DO NOT rely solely on days in use. Efficacy of these products during their use-life must be verified by a 1.8% glutaraldehyde concentration indicator to determine that at least the minimum effective concentration (MEC) of 1.8% glutaraldehyde is present.

3) General Information on Selection and Use of Germicides for Medical Device Reprocessing - Choose a germicide with the level of microbicidal 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 process:

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

- A critical device presents a high risk of infection if not sterile. Critical devices routinely penetrate the skin or mucous membranes during use, or are otherwise used in normally sterile tissue of the body.

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

Second, determine the level of germicidal activity that is needed for the reusable device.

Critical Device - Sterilization required (e.g., products that enter sterile tissue or the vascular system, such as laparoscopes and microsurgical instruments).

Semi-critical Device - Sterilization recommended when practical, otherwise, High-Level Disinfection is acceptable (e.g., GI endoscopes, anesthesia equipment for the airway, diaphragm-fitting rings, etc.).

Third, select a germicide that is labeled for the appropriate germicidal level and is compatible with the reusable device. Follow directions for the germicide.

4) Microbicidal Activity - The following table indicates the spectrum of activity as demonstrated by testing of MetriCide Plus 30** solutions:

BACTERIA

FUNGI

VIRUSES

SPORES

VEGETATIVE ORGANISMS

NON-ENVELOPED

ENVELOPED

Bacillus subtilis

Clostridium sporogenes

Staphylococcus aureus

Salmonella choleraesuis

Pseudomonas aeruginosa

Mycobacterium tuberculosis

Trichophyton mentagrophytes

Poliovirus Types 1 & 2

Rhinovirus Type 14

Adenovirus Type 2

Vaccinia

Coxsackievirus B5a***

Cytomegalovirus

Influenza virus Type A2HK

HIV-1 (AIDS Virus)

Herpes simplex Types 1 & 2

**Testing was done after 28 days of simulated reuse using prescribed testing methods.

***MetriCide 28 and MetriCide Plus 30 only.

5) Material Compatibility - MetriCide Plus 30 is compatible with the following reusable devices and materials: Respiratory therapy equipment, anesthesia equipment, rubber, most stainless steel instruments, plastic, most dental instruments (not including dental handpieces), many types of metals, such as stainless steel, carbon steel, and aluminum, and plated metals such as nickel plating or chrome plating.

For a listing of specific device manufacturers that have reported device compatibility with MetriCide Plus 30, see Table 2 below.

Table 2. Manufacturers Reporting Device Compatibility with MetriCide Plus 30

Company

Instrumentation

Acoustic Imaging

Transducers

Advanced Technology Lab

Ultrasound Scanheads

Hewlett Packard

Omniplane TEE Probe

Instrumentation Industries

Respiratory Therapy Equipment

Please refer to labeling of the reusable device for additional instructions, or call the reusable device manufacturer directly.

PLEASE NOTE: MetriCide Plus 30 is incompatible with the following specific reusable devices: Acuson V510B transesophageal transducers, high-frequency cables, coagulating forceps, resectoscope instruments, and devices that have the potential for electrosurgical malfunctioning.

6) Precleaning Agent Compatibility - MetriCide Plus 30 solutions are compatible with enzymatic detergents which are mild in pH, low foaming, and easily rinsed from equipment. Detergents that are either highly acidic or alkaline are contraindicated as precleaning agents since improper rinsing could affect the efficacy of the MetriCide Plus 30 solutions by altering their pH.

B) CONTRAINDICATIONS

1) Sterilant Usage - Routine biological monitoring is not feasible with MetriCide Plus 30 solutions, and therefore, this solution should NOT be used to sterilize reusable medical devices that are compatible with other available methods of sterilization that can be biologically monitored, e.g., heat, ethylene oxide, or peroxide gas plasma. MetriCide Plus 30 solutions should not be used for sterilization of critical devices intended for single use (e.g., catheters).

2) High-Level Disinfectant Usage - MetriCide Plus 30 solutions should NOT be used to high-level disinfect a semi-critical device when sterilization is practical.

3) Endoscope Usage - MetriCide Plus 30 solutions are not the method of choice for sterilization of rigid endoscopes which the device manufacturer indicates is compatible with steam sterilization. In general, glutaraldehyde solutions that do not contain surfactants (e.g., MetriCide solution) are more appropriate for flexible endoscopes, because glutaraldehyde solutions containing surfactants (e.g., MetriCide 28 and MetriCide Plus 30 solutions) are more difficult to rinse from the devices. However, these surfactant-containing disinfectants may be used for reprocessing of flexible endoscopes if a validated protocol for rinsing and leak testing is employed.

C) WARNINGS - METRICIDE PLUS 30 ACTIVATED DIALDEHYDE SOLUTIONS ARE HAZARDOUS TO HUMANS AND DOMESTIC ANIMALS

DANGER: Keep Out of Reach of Children

Contains Glutaraldehyde

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 plenty 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. Probable mucosal damage from oral exposure may contraindicate the use of gastric lavage.

Emergency, safety, or technical information about MetriCide Plus 30 solutions can be obtained from Metrex Research Customer Care Department at 1-800-841-1428, or by contacting your local Metrex Research sales representative.

D) PRECAUTIONS

1) Protective gloves (butyl rubber, nitrile rubber, polyethylene or double-gloved latex), eye protection, face masks, and liquid-proof gowns should be warn when cleaning and sterilizing/disinfecting soiled devices and equipment.

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

3) The user MUST adhere to the Directions for Use, because any modification will affect the safety and effectiveness of the germicide.

4) The reusable device manufacturer should provide the user with a validated reprocessing procedure for that device using MetriCide Plus 30 solution.

5) The use of MetriCide Plus 30 solutions in automated endoscope washers must be part of a validated reprocessing procedure provided by the washer manufacturer. Contact the manufacturer of the endoscope washer for instructions on the maximum number of reprocessing cycles which may be used before refilling with fresh MetriCide Plus 30 solution. Use a 1.8% glutaraldehyde concentration indicator to monitor glutaraldehyde concentration before each cycle to detect unexpected dilution.

E) DIRECTIONS FOR USE

1) Activation - Activate the MetriCide Plus 30 solution by adding the entire contents of the Activator Plus activator vial which is attached to the MetriCide Plus 30 solution container. Shake well. Activated solution immediately changes color to bluish-green, thereby indicating solution is ready to use. MetriCide Plus 30 solutions are intended for use in manual (bucket and tray) systems made from polypropylene, ABS, polyethylene, glass-filled polypropylene or specially molded polycarbonate plastics. Record the date of activation (mixing date) and expiration date on the solution container label in the space provided, in a log book, or on a label affixed to any secondary container used for the activated solution.

2) Cleaning/Decontamination - Blood and other body fluids must be thoroughly cleaned from 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 medical instruments and equipment, thoroughly clean, rinse and rough dry objects before immersing in MetriCide Plus 30 solution. Cleanse and rinse the lumens of hollow instruments before filling with MetriCide Plus 30 solution. Refer to the reusable device manufacturer’s labeling far additional instructions on disassembly, decontamination, cleaning and leak testing of their equipment.

3) Usage - It is a violation of Federal Law to use this product in a manner inconsistent with its labeling.

a) Sterilization (Bucket/Tray Manual System) - Immerse medical equipment/device completely in MetriCide Plus 30 solution for a minimum of 10 hours at 25 °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 below

b) High-Level Disinfection (Bucket/Tray Manual System) - MetriCide Plus 30 - Immerse medical equipment/device completely in MetriCide Plus 30 solution for a minimum of 90 minutes at 25 °C to destroy all pathogenic microorganisms, except for large numbers of bacterial endospores, but including Mycobacterium tuberculosis (Quantitative TB Method). Remove devices and equipment from the solution and rinse thoroughly following the rinsing instructions below.

c) Rinsing Instructions - Following immersion in MetriCide Plus 30 solution, thoroughly rinse the equipment or medical device by immersing it completely in three separate copious volumes of water. Each rinse should be a minimum of one minute in duration unless otherwise noted by the device or equipment manufacturer. Use fresh portions 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 be contaminated with glutaraldehyde.

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

STERILE WATER RINSE - The following devices should be rinsed with sterile water, using sterile technique when rinsing and handling.

1. Devices intended for use in normally sterile areas of the body;

2. Devices intended for use in known immunocompromised patients, or potentially immunocompromised patients based on institutional procedures (e.g., high risk population served) and;

3. When practicable, bronchoscopes, due to a risk of atypical Mycobacteria contamination from potable water supply.

POTABLE WATER RINSE - For all other devices a sterile water rinse is recommended when practicable, otherwise a high-quality potable tap water rinse is acceptable. A high-quality potable water is one that meets Federal Clean Water Standards at the point of use. When using potable water for rinsing, the user should be aware of the increased risk of recontaminating the device or medical equipment with Pseudomonas and atypical (fast growing) Mycobacteria often present in potable water supplies. A device (e.g., colonoscope) that is not completely dried 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. Although these bacteria are not normally pathogenic in patients with healthy immune systems. AIDS patients or other immunocompromised individuals may be placed at high risk of infection by these opportunistic microorganisms. A final rinse using a 70% isopropyl alcohol solution is useful to speed the drying process and reduce the numbers of any organism present as a result of rinsing with potable water.

d) Reusage - MetriCide Plus 30 solutions have also demonstrated efficacy in the presence of 2% organic soil contamination and a simulated amount of microbiological burden during reuse. These solutions may be used and reused within the limitations indicated above for up to 28 days after activation. Do not use activated solutions beyond 28 days. Efficacy of these products during their use-life must be verified by a 1.8% glutaraldehyde concentration indicator to determine that the minimum effective concentration (MEC) of 1.8% is present.

4) Monitoring of Germicide to Ensure Specifications are Met - During the usage of MetriCide Plus 30 solution, as a high-level disinfectant and/or sterilant, it is recommended that a thermometer and timer be utilized to ensure that the optimum usage conditions are met. In addition, it is recommended that the MetriCide Plus 30 solution be tested with a 1.8% glutaraldehyde concentration indicator prior to each usage. This is to ensure that the appropriate concentration of glutaraldehyde is present and to guard against a dilution which may lower the effectiveness of the solution below its MEC. The pH of the activated solution may also be periodically checked to verify that the pH of the solution is between 6.5 and 8.5.

5) Post-Processing Handling and Storage of Reusable Devices - Sterilized or disinfected reusable devices are either to be immediately used or stored in a manner to minimize recontamination. Note that only terminal sterilization (sterilization in a suitable wrap) provides maximum assurance against recontamination. Refer to the reusable device-equipment manufacturer’s labeling for additional storage and/or handling instructions.

F) STORAGE CONDITIONS AND EXPIRATION DATE

1) Prior to activation, MetriCide Plus 30 solution should be stored in its original sealed container at room temperature. Once the MetriCide Plus 30 solution has been activated, it should be stored in the original container until transferred to the containers in which the immersion for disinfection or sterilization is to take place. Containers should be stored in a well-ventilated, low traffic area at room temperature.

2) The expiration date of the unactivated MetriCide Plus 30 solution will be found on the immediate container.

3) The use period for activated MetriCide Plus 30 solution is for no longer than 28 days following activation or as indicated by a 1.8% glutaraldehyde concentration indicator. Once activated, the solution requires no further dilution prior to its usage.

G) EMERGENCY AND TECHNICAL PRODUCT INFORMATION - Emergency, safety, or technical information about MetriCide Plus 30 solution can be obtained from Metrex Research Customer Care Department at 1-800-841-1428, or by contacting your local Metrex Research sales representative.

H) USER PROFICIENCY - It is a violation of Federal Law to use this product in a manner inconsistent with its labeling. The user should be adequately trained in the decontamination and disinfection or sterilization of medical devices and the handling of toxic substances such as liquid chemical germicides. Additional information about MetriCide Plus 30 solution can be obtained from Metrex Research Customer Care Department at 1-800-841-1428, or by contacting your local Metrex Research sales representative.

I) DISPOSAL INFORMATION - Germicide Disposal - Discard residual solution in accordance with federal, state and local regulations.

Container Disposal - One Quart (946 mL) and One Gallon (3.8 L) Size Containers - Do not reuse empty container. Wrap container and put in trash.

J) HOW SUPPLIED - MetriCide Plus 30

REORDER

Description

CASE CONTAINERS

 

10-3205

One Quart (946 ml) Container

4 x Quarts (4 x 946 mL)/box; 4 boxes/case; 16 x Quarts (16 x 946 mL)/case

70-5125-12

10-3200

One Gallon (3.8 L) Container

4 x Gallons (4 x 3.8 L)/case

70-5130-15

References supplied upon request.

Manufactured By: METREX® RESEARCH, 28210 Wick Road, Romulus, Michigan 48174

1-800-841-1428

MADE IN USA

70-1001-12

NAC No.: 13400092

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 MetriCide Plus 30 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

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