Glutaraldehyde Usage Guidelines

Infection Control Subcommittee, Safety and Security Subcommittee and the Subcommittee Coordinating the Value Analysis Program.
November 2000 APPROVED DATE

POLICY
Areas that use a glutaraldehyde solution for high level disinfection must;

• adhere to the cleaning/storage guidelines,
• follow the Manufacturers directions for use of glutaraldehyde for high level disinfection,
• have PPE, Departmental Spill kit and a Material Safety Data Sheet (MSDS) available.

DEFINITIONS
High-level disinfection: the elimination of vegetative microorganisms and most fungal spores, tubercle bacilli, and small non-lipid viruses. High level disinfection destroys virtually all known pathogenic microorganisms including mycobacteria, and low numbers of highly resistant bacterial endospores.

Glutaraldehyde: a chemical sterilant that will eliminate virtually all known pathogenic microorganisms and low numbers of bacterial endospores when used as a high-level disinfectant.

ppm: parts per million

TLV: Threshold Limit Value

Semi-Critical Items: instruments or objects that come in contact with intact mucous membranes, that do not ordinarily penetrate sterile body surfaces or cavities. Examples include endoscopes, intra-cavital transducers, and laryngoscopes. Semi-critical items may be sterilized, however, at a minimum, a high-level disinfection is required. This procedure is expected to destroy vegetative microorganisms, most fungal spores, tubercle bacilli, and small non-lipid viruses.

General Considerations

1. Areas where glutaraldehyde is in use will not exceed the Recommended Ceiling Limit or TLV of 0.2 ppm. The ceiling exposure limit is the concentration that should not be exceeded during any part of the working day. TLV of 0.2 ppm is the level used by Occupational Safety and Health Administration (OSHA) and National Institute for Occupational Safety and Health (NIOSH).
2. Areas using glutaraldehyde will be evaluated annually or as directed by Safety and Security. Safety and Security will contact areas using glutaraldehyde to schedule testing. If a change in process or location occurs, contact the Safety and Security office.
3. When possible use glutaraldehyde under a fume hood or in a room that is under negative pressure.

PROCEDURES

A. PERSONAL PROTECTIVE EQUIPMENT

Engineering controls, ventilation, and work practices are the primary methods utilized to reduce personal exposure to glutaraldehyde. PPE is used to supplement the protection provided by these controls. Personal protective equipment must be worn at all times when handling any contaminated instruments or devices and when using glutaraldehyde. Personal protective equipment includes Nitrile gloves*, mask, protective eye wear, and impervious gowns (poly aprons that come from Processed Stores). If only one or two persons within a department are performing the cleaning/disinfecting, then utility gloves marked individually may be used.

*If working with glutaraldehyde for less than 15 minutes latex gloves may be worn.

Note: There should be an eyewash station within 100 feet of where glutaraldehyde is in use.

B. INSTRUMENT CLEANING

All instruments or devices must be cleaned properly prior to being placed in a high-level disinfectant. Staff must follow the cleaning instructions approved by the manufacturer of the instrument or device.

C. SOAKING AND CLEANING

1. Fill basin with water, add detergent, liquid cleaner or enzymatic cleaner, and soak. If you have questions about what cleaner to use for soaking, refer to the manufacturer’s recommendations for the item being soaked or call Central Sterilizing Services (6-2534 ask for incharge person).

NOTE: Do not use Betadine, Hibiclens, dry detergents, or hand soaps from dispensers. These are skin cleansers, not instrument cleansers. Do not soak or clean instruments with Envy or Virex.

2. Disassemble instruments and/or devices before cleaning/disinfection following manufacturer’s instructions.
3. Irrigate and brush all accessible channels to remove particulate matter.
4. Dispose of or clean and disinfect any brushes used on a daily basis. Discard cleaning solution following manufacturer’s recommendations.

D. ACTIVATE SOLUTION

Once the instrument or device has been properly cleaned, you can begin using the glutaraldehyde solution. Prepare solution for use by following the manufacturer’s instructions for activating the solution. First add the entire contents of the activator vial to the solution in the container. Shake well. Activated solution usually changes color, thereby indicating the solution is ready to use. Do not use activated solution beyond reuse life.

Note: The activator contains a rust inhibitor. Do not add any other agent.

Record the date of activation (mixing date) and expiration on the primary solution container label. Any secondary container used for high-level disinfecting must be identified as gluteralydehye but a date is not required if disposed of daily. In areas that will be utilizing glutaraldehyde for one time use (that is for a length of time of less than 24 hours and discarded) there is no need to keep a log but the primary container must be dated.

E. HIGH-LEVEL DISINFECTION

Immerse clean and dry instruments or devices completely in the solution. Fill all lumens of hollow instruments. Follow the manufacturer’s recommendations for disassembling, channel connection directions and/or immersion of instruments or devices.

To reduce exposure to glutaraldehyde vapors, cover the solution tray, or bucket or secondary container with a secure lid at all times.

Soak instruments or devices for 20 minutes at room temperature.

F. RINSING INSTRUMENTS OR DEVICES

Remove instruments from solution and rinse thoroughly with bacteria free filtered water before storage or use. Flush lumens with 70 percent alcohol and forced air before storage to eliminate opportunistic waterborne microorganis The quality of rinse water will depend upon the intended use of the instrument or device. For example, if the instrument is to be placed on sterile field, sterile water shall be used as the last rinse.

G. DRYING

Allow the instrument or device to dry. Equipment should be used immediately or stored in a manner to minimize recontamination. Refer to the equipment manufacturer’s labeling for additional storage and/or handling instructions.

H. TESTING

It is important to note that a glutaraldehyde solution may lose its potency prior to the reuse days stated on the label. Do not rely solely on days in use. To determine if the Minimum Effectiveness Concentration (MEC) of the glutaraldehyde solution is still effective, the glutaraldehyde being used must be tested daily (or before use) with the appropriate solution test strip. This information should be logged.

I. DISPOSAL

In compliance with the United States Environmental Protection Agency (EPA) requirements, glutaraldehyde solutions may be disposed of as an ordinary domestic waste rather than a hazardous waste. Iowa has the same requirements. It is important to flush the disposal area with running water.

Department staff that use glutaraldehyde should be trained in clean up procedures for small spills (those that can be cleaned up using paper towels etc. or less than one gallon). The following procedure is recommended for department staff.

1. Limit access to the spill area.
2. Utilize Material Safety Data Sheet (MSDS).
3. Obtain department spill kit.
   • Nitrile gloves
   • Splash apron or gown
   • Goggles
   • Glute-Out Glutaraldehyde neutralizer
   • Mop or sponge
4. Put on personal protective equipment (PPE).
5. Neutralize spill with Glute-out or follow manufacturer's directions.
6. Wipe the area with a mop or sponge using water.
7. Flush down the drain with large quantities of water.
8. Complete a UI Hospitals and Clinics Unusual Incident and Accident Report.

For larger spills or if there are no trained staff or if the spill cannot be managed by trained staff, evacuate area and then call Safety & Security using the emergency number 195.

REFERENCES:

1. Rutala, WA. PhD, MPH. (1999) APIC Guidelines for Selection and Use of Disinfectants.
2. Jordan, Susan L.P.,PhD, Stowers, Marlo F., BS, Trawick, Earl G., MS, and Theis, Alan B., PhD,(April 1996), American Journal of Infection Control, Glutaraldehyde permeation: Choosing the proper glove.
3. American National Standard, "Safe use and handling of glutaraldehyde-based products in health care settings", 1996 Association for the Advancement of Medical Instrumentation, ANSI/AAMI ST58-1996.
4. Rutala, WA. Selection and Use of Disinfectants in Healthcare. In: Mayhall, CG. Eds. Hospital Epidemiology and Infection Control, 2^nd ed. Sec. X, Chap. 77. 1999
5. Healthcare Hazard Control, Analysis, "Eyewash and Quick-Drench Showers", Laboratory Hazards 2. April 2000
6. Healthcare Hazard Control, Analysis, "Glutaraldehyde", Chemical Hazards 2. April 2000