Standard Operating Procedure (SOP)

1.      Process

q       Glutaraldehyde-based products are effective sterilants and disinfectants that are used primarily for medical devices that are heat-sensitive and cannot be steam-sterilized.

q       Some synonyms and trade names for glutaraldehyde and glutaraldehyde products are:

2. Physical Hazards

q       Clear, colorless liquid that turns green when activated.

q       Soluble in water, volatile in steam.

q       Incompatible with strong oxidizing agents.

q       Incompatibilities and Reactivities: strong bases (Note: Alkaline solutions of glutaraldehyde (i.e., activated glutaraldehyde) react with alcohol, ketones, amines, hydrazines & proteins.)

q       May discolor on exposure to air.

q       Corrosive to metals.

3. Health Hazards

q       Glutaraldehyde is an irritant to the skin, eyes and respiratory system; dermatitis, sensitization skin; cough, asthma; nausea, vomiting

q       Skin contact can cause minor irritation with itching and slight local redness.

·          Prolonged contact causes mild to moderate local redness and swelling. 

q       Glutaraldehyde in concentration less than 5% is considered to be irritating to the eyes. 

·          Eye contact causes moderate to severe irritation, experienced as discomfort or pain, excessive blinking and tear production.

q       If swallowed, glutaraldehyde in concentrations less than 5% can be mildly to moderate irritating to the mouth, throat, and stomach.

q       In animal studies, glutaraldehyde caused teratogenic and fetotoxic effects and produced maternal toxicity.

q       There is a confirmed potential for worker sensitization as a result of dermal contact and/or inhalation exposure.

q       The current workplace standard for glutaraldehyde is 0.05 parts per million (ppm) ceiling threshold limit value (TLV-C) recommended by the ACGIH.

4. Personal Protective Equipment

Personal protective equipment shall be worn by the worker placing instruments/items into the activated solution. Personal protective equipment shall be worn by the worker removing items from the activated solution.

q       EYE PROTECTION

·         Safety glasses, goggles or face shields shall be worn during operations in which glutaraldehyde might contact the eyes (e.g., through vapors or splashes of solution).

·         Fisherbrand Chemical Splash Goggles, catalog # 19-041-739 (Fisher Scientific) or Fisherbrand Faceshield, catalog # 18-999-4542 (Fisher Scientific).

q       HAND PROTECTION

·         Nitrile gloves impervious to glutaraldehyde shall always be worn – Safeskin Purple Nitrile Xtra Exam Gloves, 12 inches long, catalog # 19-149-864 (Fisher Scientific).

·         Gloved hands shall be rinsed thoroughly with water before the cover is replaced on the solution container to avoid contaminating the surface of the container with solution. 

q       LAB COATS, ETC.

·         Protective apron shall always be worn - a polyethylene-coated, spun-bond polypropylene apron, Kimberly Clark – PE – Coated Polypropylene Apron, catalog # 19-057-434 (Fisher Scientific).

q       RESPIRATOR

·         Do not use N95 filtering face piece respirators. 

q       SAFETY SHOWER/EYEWASH

·          Where the eyes or body of any person may be exposed to glutaraldehyde, suitable facilities for quick drench or flushing of the eyes and body shall be provided within the work area for immediate emergency use. 

·          Bottle type eyewash stations are not acceptable.

5. Designated Area for Use and Containment Devices

q       Laboratory or other use area shall be marked as follows:

CAUTION

GLUTARALDEHYDE IN USE

q       Glutaraldehyde shall be used in an area that is properly ventilated area. 

q       Rooms in which glutaraldehyde disinfection/sterilization is performed shall be large enough to ensure adequate dilution of vapor and shall have a minimum air exchange rate of 10 air changes per hour.

q       The room shall be under negative pressure with respect to surrounding areas.

q       Local exhaust is required if the minimum air exchange rate of 10 air changes per hour is not met.

q       Keep glutaraldehyde bath under a fume hood where possible.

q       Traffic in the processing area shall be limited to trained personnel. 

q       Trained personnel must be aware of safe handling techniques and potential hazards and must wear appropriate protective attire.

6. Special Handling Procedures and Storage Requirements

q       Each operation where glutaraldehyde is used, shall have written, specific standard operating procedures for use of glutaraldehyde.

q       Glutaraldehyde solutions shall be prepared and activated according to the manufacturer’s instructions. 

q       Procedures must be developed that will prevent contact with glutaraldehyde and reduce exposure to glutaraldehyde vapor to the lowest reasonably obtainable level.  

q       Use only enough glutaraldehyde to perform the required disinfecting procedure.

q       Every effort shall be made to minimize splashing, spilling, and personnel exposure. 

q       The solution shall be poured from the container to the disinfection/sterilization basin by a method that will prevent employee contact with the chemical solution and reduce exposure to glutaraldehyde vapor.

q       The date of activation (mixing date) and the expiration date shall be recorded on the activated solution container.

q       Gently place clean, dry instruments/items in the activated solution, taking care to not disturb and agitate the surface of the solution.

q       When solution must be manually irrigated or flushed through internal channels or lumens of an instrument, care shall be taken to ensure that the employee is not splashed with the solution.  If a syringe used, it shall be carefully filled with the solution and securely attached to the channel opening or all-channel irrigator.  The solution in the syringe shall be slowly pushed into the channel; too much force can cause the syringe to disconnect from the channel opening or all-channel irrigator. 

q       Unused glutaraldehyde solutions shall be stored in tightly closed containers in a cool, secure, and properly marked location. 

q       Glutaraldehyde shall be stored in a closed container.

q       Soaking containers shall always be covered and clearly labeled.  The lid shall be kept on the soaking container at all times except when items are placed into or taken out of the solution. 

EXPOSURE MONITORING

 To ensure a safe work environmental and to establish compliance with recommended limits and voluntary guidelines on occupational exposure to glutaraldehyde, glutaraldehyde vapor monitoring will be performed annually by WFUHS EH&S in the various clinics/departments that uses glutaraldehyde solutions are used.

7. Waste Disposal

q       Excess glutaraldehyde and all waste material containing glutaraldehyde must be placed in an unbreakable secondary container labeled with the following "HAZARDOUS WASTE GLUTARALDEHYDE ". Full containers of glutaraldehyde waste must be disposed of according to WFUHS EH&S Hazardous Waste Program.

q       Spent glutaraldehyde may be discharged via sanitary sewer per agreement with the City of Winston-Salem.

8. Decontamination of Equipment and Area

Contact WFUHS EH&S at 716-1221 for decontamination information.

9. Spill and Accident Procedures

SMALL LIQUID SPILLS (LESS THAN 300 CC)

q       For drips and splashes use Spill X-FP Treatment Agent (Fisher Scientific, catalog # 1A-9894).

q       Drips and splashes can be wiped up quickly with a sponge, towel, or mop.

·          Spill X-FP solids – dispose of in ordinary waste container.

·          Liquid – residual glutaraldehyde liquid shall be disposed through the WFUBMC EH&S Hazardous Waste Program.

·          Contaminated Solids – paper towels and other materials that are contaminated with glutaraldehyde shall be disposed of through the WFUBMC EH&S Hazardous Waste Program.

LARGE LIQUID SPILLS (GREATER THAN 300 CC)

In the event of a liquid spill, immediately vacate and secure the area.  Contact WFUBMC Security at 716-9111.

First Aid

q       If any contact shall inadvertently occur, the eyes shall be flushed immediately with water; and washing shall be continued for at least 15 minutes. 

q       Protective clothing shall be removed quickly if it becomes saturated, and it shall be laundered before reuse.

q       Personnel who have come into contact with liquid glutaraldehyde shall immediately remove contaminated clothing and shoes and thoroughly wash contaminated skin with flowing water. In the case of eye contact with liquid glutaraldehyde, the eyes shall be flushed with copious amounts of water for at least 15 minutes. Contact lenses, if worn, shall not be removed.

q       If any skin contact with glutaraldehyde shall inadvertently occur, the skin shall be washed thoroughly with soap and water and shall be flushed with water for at least 15 minutes.

q       The employee shall be seen immediately by Employee Health Services.

q       Contaminated reusable clothing shall be laundered before it is worn again, and rubber goods shall be rinsed thoroughly before use. Any heavily contaminated clothing, shoes, or equipment that cannot be thoroughly washed and decontaminated shall be discarded.

10. Training

Faculty and staff engaged in the use of glutaraldehyde must be trained initially and annually.  The training shall include:

·          Specific procedures or techniques requiring the use and handling of glutaraldehyde products for sterilants/disinfectants.

·          Hazard Communication

·          Use of PPE required for process

·          The contents of this Standard Operating Procedure

Reference

Standard for Safe Use and Handling of Glutaraldehyde-Based Products in Health Care Facilities, American National Standard/Association for the Advancement of Medical Instrumentation, ST58 – 1996.