Standard Operating Procedure (SOP)

1. Process

q       Cidex OPA is an effective sterilant and disinfectant that is used primarily for medical devices that are heat-sensitive and cannot be steam-sterilized

q       Cidex OPA contains less than 1% ortho-Phthaladehyde

2. Physical Hazards

q       Clear, light blue liquid

q       Practically odorless

q       Soluble in water, volatile in steam

q       May discolor surfaces to grey/black on exposure to proteins. [In a practical way, this means that the quality of the pre cleaning is essential because contamination will show up]

q       Incompatibilities and reactivities: strong acids and oxidizers

3. Health Hazards

q       Can cause irritation to the skin and the eye.

q       Prolonged or repeated contact with the skin may lead to dermatitis.

q       Potential skin and respiratory sensitizer

q       Target Organs: Skin, eyes and respiratory tract.

4. Personal Protective Equipment

Personal protective equipment shall be worn by the worker when placing and or removing instruments/items in/ from the solution.

q       EYE PROTECTION

·          Safety glasses, goggles or face shields shall be worn during operations in which Cidex OPA 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

·          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. 

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

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

·          Respirator use is not required when working with this product.

q       SAFETY SHOWER/EYEWASH

·          Where the eyes or body of any person may be exposed to Cidex OPA, 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       Post a sign on the door stating, “CAUTION – CIDEX OPA IN USE.”

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

q       Rooms in which Cidex OPA disinfection/sterilization shall have a minimum air exchange rate of 10-12 air changes per hour.

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

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       Verify with device manufacturer that device is compatible with Cidex OPA.

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

·          Cidex OPA solutions shall be used according to the manufacturer’s instructions. 

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

·          Use only enough Cidex OPA to perform the required disinfecting procedure.

·          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 Cidex OPA liquid.

q       Solution is good for 28 days after opening. 

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 Cidex OPA solutions shall be stored in tightly closed containers in a cool, secure, and properly marked location. 

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. 

q       Test strips should be used weekly to test the efficiency of the Cidex OPA.  The test strips are available from McKesson $15.50 per bottle containing 15 test strips or $54.00 per bottle containing 60 test strips to test the

7. Waste Disposal

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

q       Spent Cidex OPA 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 – disposed of through the WFUHS EH&S Hazardous Waste Program.

·          Liquid – residual Cidex OPA liquid shall be disposed through the WFUHS EH&S Hazardous Waste Program.

·          Contaminated Solids – paper towels and other materials that are contaminated with Cidex OPA shall be disposed of through the WFUHS 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 Cidex OPA shall immediately remove contaminated clothing and shoes and thoroughly wash contaminated skin with flowing water. In the case of eye contact with liquid Cidex OPA, 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 Cidex OPA 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 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 Cidex OPA must be trained initially and annually by their respective department.

Training shall include:

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

·          Hazard Communication

·          Use of PPE required for process

·          The contents of this Standard Operating Procedure