Micro-Cide 28 HLD

Company: Micro-Scientific

3% Glutaraldehyde

Reusable Sterilizing and High Level Disinfecting Solution

INTENDED USE: Micro-Scientific^® Micro-Cide™ 28 HLD is a liquid chemical sterilant and high level disinfectant intended to sterilize or disinfect reusable medical devices which contact normally sterile areas of the body and mucous membranes, respectively, when used according to the Directions for Use.

Micro-Scientific^® Micro-Cide™ 28 HLD can be reused for 28 days provided the required conditions for use (glutaraldehyde concentration, time and temperature) exist based on monitoring with a chemical indicator, timer and thermometer. DO NOT RELY SOLELY ON DAYS

IN USE. Use patterns may reduce the established reuse life of the liquid chemical sterilant.

Active Ingredients

KEEP OUT OF REACH OF CHILDREN

DANGER

WARNINGS

DANGER! KEEP OUT OF REACH OF CHILDREN.

Direct contact is corrosive to exposed tissue, causing eye damage and skin irritation/damage. Harmful if swallowed or inhaled. Do not get into eyes, on skin or on clothing. Avoid breathing vapor. Use with adequate ventilation. See the Package Insert and the Safety Data Sheet for additional information.

Warning

This product can expose you to b-Myrcene, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.

PRECAUTIONS

Wear goggles or face shield and chemical resistant gloves (butyl or nitrile) and liquid proof body clothing when handling or pouring. Use in well ventilated area in closed containers. Avoid contamination of food. See the Package Insert and the Safety Data Sheet for additional information.

STATEMENT OF PRACTICAL TREATMENT

In case of contact, immediately flush eyes or skin with plenty of water for at least 15 minutes. For eyes, get medical attention immediately. If swallowed, give large quantities of water and call a physician immediately. If inhaled, move to fresh air.

NOTE TO PHYSICIAN: Probable mucosal damage may contraindicate the use of gastric lavage. See the Package Insert and Safety Data Sheet for additional information.

STORAGE CONDITIONS AND EXPIRATION DATE

The expiration date for Micro-Scientific^® Micro-Cide™ 28 HLD is shown on the side of the container. Store the unused and reusable solution at controlled room temperature (15°-25°C) away from sunlight. See the Package Insert and Safety Data Sheet for additional information.

DISPOSAL

Triple rinse empty containers with water before disposal. Do not reuse empty containers. Ensure compliance with all applicable federal, state and local regulations regarding disposal of used and unused solution.

FOR EMERGENCY MEDICAL & SAFETY INFORMATION CALL (24 hrs) 1-800- 535-5053.

FOR INFORMATION REGARDING THE SAFETY AND EFFECTIVENESS OF Micro-Scientific^® Micro-Cide™ 28 HLD CALL 1-800-837-8140.

Directions For Use

Micro-Scientific^® Micro-Cide™ 28 HLD is effective as a sterilant and high level disinfectant only if the devices are thoroughly cleaned, the solution is at or above the minimum effective concentration of 1.8% glutaraldehyde and the solution is used according to the Directions for Use.

PREPARATION OF SOLUTION

Activation: Activate Micro-Scientific^® Micro-Cide™ 28 HLD by adding the entire contents of the activator vial which is attached to the Micro- Scientific^® Micro-Cide™ 28 HLD container. Shake well. When activated, solution changes color to green. Record the date of activation on the indicated space, in a log book or on a label affixed to any secondary container used for the activated solution. See the Package Insert for additional instructions and information regarding the activated solution. Micro-Scientific^® Micro-Cide™ 28 HLD is intended for use in manual bucket and tray systems made from polypropylene, ABS, polyethylene, glass filled polypropylene or specially molded polycarbonate plastics.

Micro-Scientific^® Micro-Cide™ 28 HLD SHOULD NOT BE DILUTED.

PREPARATION OF DEVICES

Thoroughly clean devices to be disinfected according to device manufacturer’s instructions. Blood and other body fluids must be thoroughly cleaned from surfaces, lumens and objects before application of Micro-Scientific^® Micro-Cide™ 28 HLD. See the Package Insert for additional instructions and information regarding preparation of devices.

STERILIZATION

Immerse device in Micro-Scientific^® Micro-Cide™ 28 HLD solution and fill any device channels with solution, being careful to remove all air from any device channel. The device should remain in contact with Micro-Scientific^® Micro-Cide™ 28 HLD solution at 25°C for at least 10 hours. Remove device from the solution using aseptic technique, drain the channels and rinse according to the following directions.

Sterile Water Rinsing: Following immersion in the Micro-Scientific^® Micro- Cide™ 28 HLD, thoroughly rinse the device by immersing in three separate copious volumes of sterile water for a minimum of one minute while flushing all channels. Use fresh portions of water for each rinse. See the device manufacturer’s instructions for additional information about rinsing the device.

See the Package Insert for additional instructions and information regarding sterilization with Micro-Scientific^® Micro-Cide™ 28 HLD.

HIGH LEVEL DISINFECTION

Immerse device in Micro-Scientific^® Micro-Cide™ 28 HLD solution and fill any device channels with solution, being careful to remove all air from any device channel. The device should remain in contact with Micro-Scientific^® Micro-Cide™ 28 HLD solution at 25°C for at least 25 minutes. Remove device from the solution, drain the channels and rinse according to the following directions.

Rinsing: Following immersion in Micro-Scientific^® Micro-Cide™ 28 HLD, thoroughly rinse the device by immersing in three separate copious volumes of water for a minimum of one minute while flushing all channels. Use fresh portions of water for each rinse. See the device manufacturer’s instructions for additional information about rinsing the device.

See the Package Insert for additional instructions and information regarding High Level Disinfection with Micro-Scientific^® Micro-Cide™ 28 HLD.

REUSE

Micro-Scientific^® Micro-Cide™ 28 HLD may be reused for a maximum of 28 days provided the minimum effective concentration of 1.8% glutaraldehyde, time and temperature are maintained. Micro-MEC™ 1.8% Glutaraldehyde Monitor Strip* should be used before each use of Micro- Scientific^® Micro-Cide™ 28 HLD solution to determine the glutaraldehyde concentration is above the minimum effective concentration of 1.8%.

DO NOT USE BEYOND 28 DAYS EVEN IF THE CONCENTRATION OF GLUTARALDEHYDE IS ABOVE THE MINIMUM EFFECTIVE CONCENTRATION (1.8%) AS INDICATED BY THE MICRO-MEC™ 1.8% GLUTARALDEHYDE MONITOR STRIP*.

See the Package Insert for additional instructions and information regarding the reuse of Micro-Scientific^® Micro-Cide™ 28 HLD. * Micro-MEC™ is a trademark of Micro-Scientific, LLC. The Micro-MEC™ 1.8% Glutaraldehyde Monitor Strip has been verified for use with Micro-Cide™ 28 HLD.

Technical Information / Packaging Insert

REUSABLE STERILIZING AND HIGH LEVEL DISINFECTING SOLUTION

INDICATIONS FOR USE

This 3% GLUTARALDEHYDE solution is a liquid chemical sterilant and high level disinfectant intended to sterilize or disinfect reusable medical devices which contact normally sterile areas of the body and mucous membranes, respectively, when used according to the 3% GLUTARALDEHYDE package Directions for Use.

1) Germicide Level of Activity

This 3% GLUTARALDEHYDE solution is a sterilant and high level disinfectant when used according to the 3% GLUTARALDEHYDE package Directions for Use.

Sterilant: This 3% GLUTARALDEHYDE solution is a liquid chemical sterilant when used or reused according to 3% GLUTARALDEHYDE package Directions for Use, above the Minimum Effective Concentration (MEC) of 1.8% and for the maximum number of days as stated on the 3% GLUTARALDEHYDE package label at 25°C with an immersion time of at least 10 hours.

High Level Disinfectant: This 3% GLUTARALDEHYDE solution is a high-level disinfectant when used or reused, according to the 3% GLUTARALDEHYDE package Directions for Use at or above the Minimum Effective Concentration (MEC) of 1.8% and for the maximum number of days as stated on the 3% GLUTARALDEHYDE package label at 25°C with an immersion time of 25 minutes.

2) Reuse Period

This 3% GLUTARALDEHYDE solution has demonstrated efficacy in the presence of organic soil and a known amount of microbiological burden during reuse. This 3% GLUTARALDEHYDE solution can be reused for a period not to exceed the number of days as stated on the 3% GLUTARALDEHYDE package label provided the Minimum Effective Concentration (MEC) of 1.8% glutaraldehyde, time and temperature are maintained. The Micro-MEC™ 1.8% Glutaraldehyde Monitor Strip1 should be used before each use of this 3% GLUTARALDEHYDE solution to determine whether the glutaraldehyde is above the minimum effective concentration of 1.8%. DO NOT rely solely on the days in use.

Do not use beyond the number of days as stated on the 3% GLUTARALDEHYDE package label even if the concentration of glutaraldehyde is above the minimum effective concentration (1.8%) as indicated by the Micro-MEC™ 1.8% Glutaraldehyde Monitor Strip¹.

3) General Information on Selection and Use of Germicides for Medical Device Reprocessing

Choose a germicide with a 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 process:

First: determine whether the reusable device to be processed is a critical or semi-critical device as defined by the Spaulding Classification².

● 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 tissues 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 whenever practical, otherwise high level disinfection 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 the directions for the germicide.

4) Microbial Activity

The following table indicates the spectrum of activity as demonstrated by testing** of this 3% GLUTARALDEHYDE solution.

**Testing was performed after the number of days as stated on the 3% GLUTARALDEHYDE package label days of simulated reuse using the prescribed testing methods.

5) Material Compatibility

This 3% GLUTARALDEHYDE solution is compatible with the following devices and materials: respiratory therapy equipment, anesthesia equipment, rubber, most stainless steel instruments, plastic, most dental instruments (not including dental hand-pieces), many types of metals, such as stainless steel, carbon steel, and aluminum, and plated metals such as nickel plating or chrome plating.

Refer to the device labeling and consult with the device manufacturer for additional information regarding compatibility with specific reusable devices. This 3% GLUTARALDEHYDE solution is NOT recommended for the disinfection of one piece molded, solvent bonded or sonic welded polycarbonate equipment. Stress cracking has been observed after repeated treatments.

6) Pre-cleaning Agent Compatibility

This 3% GLUTARALDEHYDE solution is compatible with enzymatic detergents which are mild in pH, low foaming and easily rinsed from equipment. Detergents that are either highly acid or alkaline are contraindicated as pre-cleaning agents since improper rinsing could affect the efficacy of this 3% GLUTARALDEHYDE solution by altering its pH.

Contraindications

1) Sterilant Use

Routine biological monitoring is not feasible with this 3% GLUTARALDEHYDE solution and therefore this 3% GLUTARALDEHYDE 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. This 3% GLUTARALDEHYDE solution should NOT be used for sterilization of critical devices intended for single use (e.g.: catheters).

2) High Level Disinfectant Use

This 3% GLUTARALDEHYDE solution should NOT be used to high level disinfect a semi-critical device when sterilization is practical.

3) Endoscope Use

This 3% GLUTARALDEHYDE solution is NOT the method of choice for sterilization of rigid endoscopes which the device manufacturer indicates are compatible with steam sterilization.

WARNINGS

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 clothing. Harmful if inhaled or swallowed.

2) Avoid contamination of food.

3) Avoid inhalation of vapors.

4) Use with adequate ventilation.

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

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.

If inhaled, move to fresh air.

Refer to the Safety Data Sheet (SDS) and/or 3% GLUTARALDEHYDE package label for additional information.

PRECAUTIONS

1) Chemical resistant gloves (e.g., butyl or nitrile - do not use PVC or neoprene), eye protection, face masks, and liquid-proof gowns should be worn when cleaning and sterilizing/disinfecting soiled devices and equipment.

2) Contaminated, reusable devices must be WASHED THOROUGHLY prior to disinfection or sterilization, since residual contamination will decrease effectiveness of the germicide.

3) The user must adhere to the 3% GLUTARALDEHYDE package Directions for Use since 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 this 3% GLUTARALDEHYDE solution.

5) The use of this 3% GLUTARALDEHYDE solution in automated endoscope washers must be part of a validated reprocessing procedure. Contact the manufacturer of the endoscope washer for instructions on the maximum number of reprocessing cycles which may be used before refilling with fresh 3% GLUTARALDEHYDE solution. Use the Micro-MEC™ 1.8% Glutaraldehyde Monitor Strip1 to monitor this 3% GLUTARALDEHYDE solution concentration before each cycle to detect unexpected dilution and follow the endoscope washer instructions.

Directions For Use

This 3% GLUTARALDEHYDE solution is effective as a sterilant and high level disinfectant only if the devices are thoroughly cleaned, the 3% GLUTARALDEHYDE solution is at or above the minimum effective concentration of 1.8% glutaraldehyde and the 3% GLUTARALDEHYDE solution is used according to the 3% GLUTARALDEHYDE package Directions for Use.

1) Preparation of 3% GLUTARALDEHYDE Solution

Activate this 3% GLUTARALDEHYDE solution by adding the entire contents of the activator vial which is attached to the 3% GLUTARALDEHYDE solution container. Re-cap container and shake well. Activated 3% GLUTARALDEHYDE solution immediately changes color to green, thereby indicating the 3% GLUTARALDEHYDE solution is ready for use. This 3% GLUTARALDEHYDE solution is intended for use in manual bucket and tray systems made from polypropylene, ABS, polyethylene, glass filled polypropylene or specially molded polycarbonate plastics. Record date of activation (mixing date) and expiration date on the 3% GLUTARALDEHYDE solution container label in the space provided, in a log book or on a label affixed to any secondary container used for activated 3% GLUTARALDEHYDE solution. Once activated this 3% GLUTARALDEHYDE solution requires no further dilution before use.

2) Preparation of Devices

Blood and other body fluids must be thoroughly cleaned from surfaces, lumens, and objects before application of the disinfectant or sterilant. Blood and other bodily fluids should be autoclaved and disposed of in accordance with all 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 this 3% GLUTARALDEHYDE solution. Cleanse and rinse the lumens of hollow instruments before filling with this 3% GLUTARALDEHYDE solution.

Refer to the reusable device manufacturer’s labeling for additional instructions regarding disassembly, decontamination, cleaning and leak-testing of their equipment.

3) Use

a) Sterilization (Bucket/Tray Manual System)

Immerse medical equipment/device completely in this 3% GLUTARALDEHYDE solution and fill any device channels with 3% GLUTARALDEHYDE solution being careful to remove all air from any device channel. The device should remain in contact with this 3% GLUTARALDEHYDE solution for a minimum of 10 hours at 25° C to eliminate all microorganisms including clostridium sporogenes and bacillus subtillus spores. Remove equipment from the 3% GLUTARALDEHYDE solution using sterile techniques and rinse thoroughly with sterile water following the rinsing instructions below.

b) High Level Disinfection (Bucket/Tray Manual System)

Immerse medical equipment/device completely in this 3% GLUTARALDEHYDE solution and fill any device channels with 3% GLUTARALDEHYDE solution being careful to remove all air from any device channel. The device should remain in contact with this 3% GLUTARALDEHYDE solution for a minimum of 25 minutes at 25° C to destroy all pathogenic microorganisms except large numbers of bacterial endospores, but including mycobacterium tuberculosis (Quantitative TB Method). Remove devices and equipment from the 3% GLUTARALDEHYDE solution and rinse thoroughly following rinsing instructions below.

c) Rinsing Instructions

Following immersion in this 3% GLUTARALDEHYDE 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 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 for any other purpose. A final rinse using a 70% isopropyl alcohol solution is useful to speed the drying process.

Refer to 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 immuno-compromised patients, or potentially immuno-compromised patients based on institutional procedures (e.g.: high risk population served) and;

3) When practical, bronchoscopes, due to the risk of atypical mycobacteria from potable water supply.

POTABLE WATER RINSE

A high quality potable tap water rinse is acceptable for devices not requiring a sterile water rinse. 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.: endoscope) that is not completely dried provides an ideal situation for growth of bacteria. These bacteria are not normally pathogenic in patients with healthy immune systems, AIDS patients or other immuno-compromised 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.

d) Reuse

This 3% GLUTARALDEHYDE solution has also demonstrated efficacy in the presence of organic soil and a known amount of microbiological burden during reuse. This 3% GLUTARALDEHYDE solution may be used and reused within limitations indicated above for up to the number of days as stated on the 3% GLUTARALDEHYDE package label after activation provided the minimum effective concentration (MEC) of 1.8% glutaraldehyde, time and temperature are maintained. Micro-MEC™ 1.8% Glutaraldehyde Monitor Strip¹ should be used before each use of this 3% GLUTARALDEHYDE solution to determine whether the glutaraldehyde is above the Minimum Effective Concentration of 1.8%.

Do not rely solely on the days in use. Do not use beyond the number of days as stated on the 3% GLUTARALDEHYDE package label even if the concentration of glutaraldehyde is above the minimum effective concentration (1.8%) as indicated by the Micro-MEC™ 1.8% Glutaraldehyde Monitor Strip¹.

4) Monitoring of Use/Reuse Conditions

During the use of this 3% GLUTARALDEHYDE solution as a high level disinfectant or sterilant, it is recommended that a thermometer and a timer be utilized to ensure that the optimum use conditions are met. In addition it is recommended that the 3% GLUTARALDEHYDE solution be tested with glutaraldehyde test strips (Micro-MEC™ 1.8% Glutaraldehyde Monitor Strip1) prior to each use. 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 3% GLUTARALDEHYDE solution below its MEC.

5) Post-processing, Handling and Storage of Reusable Devices

Disinfected and/or sterilized reusable devices are to be immediately used or stored in a manner to minimize re-contamination. Refer to the reusable device-equipment manufacturer’s labeling for additional storage and/or handling instructions.

STORAGE CONDITIONS AND EXPIRATION DATE

1) Prior to activation this 3% GLUTARALDEHYDE solution should be stored in its original sealed container at controlled room temperature 15°-25° C. Once this 3% GLUTARALDEHYDE solution has been activated it should be stored in the original container until transferred to the closed containers in which immersion for disinfection or sterilization is to take place. Containers should be stored in a well ventilated, low traffic area at controlled room temperature.

2) The expiration date of the inactivated 3% GLUTARALDEHYDE solution will be found on the bottom or side of the container. The use period for activated 3% GLUTARALDEHYDE solution is for no longer than the number of days as stated on the 3% GLUTARALDEHYDE package label following activation or as indicated by the glutaraldehyde test strip. Once activated, the 3% GLUTARALDEHYDE solution requires no further dilution prior to its use.

EMERGENCY AND MEDICAL & SAFETY INFORMATION

Refer to the Safety Data Sheet (SDS) and/or 3% GLUTARALDEHYDE package label for additional information.

USER PROFICIENCY

The user should be adequately trained in the decontamination and disinfection or sterilization of medical devices, the handling of toxic substances such as liquid chemical germicides and the application of the Emergency and Medical & Safety Information.

DISPOSAL

Do not reuse empty 3% GLUTARALDEHYDE container. Triple rinse empty 3% GLUTARALDEHYDE container with water before disposal. Wrap 3% GLUTARALDEHYDE container and put in trash. Ensure compliance with federal, state and local regulations regarding waste disposal.

¹ Micro-MEC™ is a trademark of Micro-Scientific, LLC. The Micro-MEC™ 1.8% Glutaraldehyde Monitor Strip has been verified for use with this 3% GLUTARALDEHYDE solution.

² E. H. Spaulding, “The Role of Chemical Disinfection in the Prevention of Nosocomial Infections,” in Proceedings of International Conference on Nosocomia Infections, 1970,ed. P.S. Brachman and T. C. Eickof (Chicago: American Hospital Association, 1971), pp.254 -274.

Contraindications

Sterilization: Routine biological monitoring is not feasible with Micro- Scientific^® Micro-Cide™ 28 HLD and therefore, Micro-Scientific^® Micro-Cide™ 28 HLD 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. Micro-Scientific^® Micro-Cide™ 28 HLD should not be used for sterilization of critical devices intended for single use (e.g.: catheters).

High Level Disinfection: Micro-Scientific^® Micro-Cide™ 28 HLD should not be used to high level disinfect a semi-critical device when sterilization is practical. Endoscope Use: Micro-Scientific^® Micro-Cide™ 28 HLD is not the method of choice for sterilization of rigid endoscopes which the device manufacturer indicates are compatible with steam sterilization.

See SDS for additional information.

Store in a cool, dry area.

Emergency Phone Number

24-Hour Number: 1-800-535-5053

International: 1-352-323-3500

Manufactured under license by the authority of Micro-Scientific, LLC, 755 Tri-State Parkway, Gurnee, IL USA

Telephone: (Toll free in USA): 1-888-253-2536

Outside Continental USA: 1-847-454-0835

www.micro-scientific.com

71005F-1017

CPN: 1524013.0