Sterilization/Storage
 

Product Specific:

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STORAGE GUIDELINES

All products should be stored in cool, dark conditions in the containers in which they are supplied. Rubber and latex are particularly sensitive to sunlight and artificial light with ultraviolet content and to ozone which is generated by fluorescent lighting, electric motors and similar machinery. Products must not come into contact with metals, strong cleaning solutions, phenols, cresols, hydrocarbons, alcohol or oxidizing agents. Articles should be issued from storage in strict rotation to ensure only the latest remains. All products, particularly rubber and latex products deteriorate with age. Any products showing signs of deterioration should be destroyed and discarded. Any product with a "use by" date should be discarded if it is older than the date shown. Do not confuse this date with any date of sterilization which only shows the final processing and is not an indication of expiration.


STERILIZATION GUIDELINES

General Information


Re-use and re-sterilization will cause deterioration. To avoid failure in use, products should be checked and any product showing signs of deterioration must be discarded. As storage, use and exposure to many factors varies, a pre-set life (time) or number of re-sterilization cycles cannot be advised by RUSCH. All products indicated for re-sterilization should be thoroughly cleaned immediately after use.

Single Use Products

Products indicating that they are single use (disposable) should not be sterilized or re-sterilized as the product may be damaged functionally. Single use products are normally supplied sterile and are labeled on the pack "single use only" or similar.
ET0 Gas (Ethylene Oxide) Method
Black Rubber Products
Red Rubber Products
Silicone Products
Latex Products

Face Masks
On Face Masks, plugs must be removed and luer caps on red rubber E.T. Tubes left open: Even so if the vacuum cycle is too rapid, damage may result so care must be taken during the evacuation cycle. In other respects all reusable products are suitable for ET0 gas sterilization. Sterilization cycles with temperatures up to a maximum 52°C (125°F) are recommended. Equipment manufacturer's recommendations must be followed.

Laryngoscope Blades
Sterilization cycles with temperatures up to 65°C (150°F) are recommended. Follow accepted hospital protocol for aeration.
CAUTION: Use of inert gases in the sterilization process such as chlorinated hydrocarbons (e.g. Freon) may damage rubber and latex products. Check all products for signs of deterioration, particularly a sticky surface.

Aeration
Residual ethylene oxide must be eliminated so follow the sterilizer manufacturer's guidelines and accepted hospital protocol for aeration.

Steam (Autoclaving) Method

Black Rubber Products
(e.g., Anesthesia Masks, Tubes and Breathing Bags):
Remove plugs from inflatable face mask cushions to avoid damage.
Sterilization cycles with temperatures up to a maximum 121°C (250°F) are recommended. Avoid contact with instruments or any metal object. Conductivity will be affected by repeated sterilization and should be checked periodically. Allow to dry and recover for 48 hours.

Latex and Red Rubber Products
(E.g. Endotracheal Tubes, Urology Catheters):
Sterilization cycles with temperatures up to a maximum 121°C (250°F) are recommended. Avoid contact with instruments or any metal object. Allow to dry and recover for 48 hours.

Laryngoscope Blades
Sterilization cycles up to a maximum of 131°C (270°F) and pressure of 28 p.s.i. are recommended. Use standard autoclave wrap and avoid contact with other instruments. Securely tighten bulb in standard blades prior to use. CAUTION: Flash sterilization above 131°C (270°F) and hot air sterilization may damage the instrument. Repeated autoclaving may reduce the light transmission and life expectancy of the blade.

CAUTION: Sudden immersion of fiber optic blades in cold water may lead to cracking of the fiber optic bundles and potentially damage the light transmission.

Cold Method

All products: (except Laryngoscopes)
Cidex has been tested and has been found to be compatible with the materials we use. Sterilants based on phenol compounds, bleach or Betadine solutions are not suitable. Follow the sterilant manufacturer's guidelines carefully.
1 Immerse product fully in the solution ensuring displacement of trapped air.
2 Soak items according to manufacturer's instructions for disinfection or sterilization.
3 Remove products and allow to drain.
4 Rinse in sterile water for at least 5 minutes.
5 Blot dry on a sterile field.
6 Allow rubber and latex at least 48 hours to dry and recover elasticity.

Laryngoscope Blades
Soaking in Cidex solution for 10 to 15 minutes is acceptable; however, soaking for longer than 15 minutes may result in damage to the blade.

Dry Heat Method

Dry heat will cause rapid deterioration of materials and must not be used.

Washer Sterilizer Pasteurizer

Laryngoscope Blades
If a machine washer/sterilizer or pasteurization methods are used adhere strictly to manufacturer's instructions regarding concentration and duration.
Disinfect at temperatures up to 65°C (150°F).
CAUTION: Do not dry heat. Air cool for 5 minutes or blot dry.

Steris® Process

The Steris® Process as developed by Steris ® Corporation, Mentor, Ohio, consists of a peroxyacetic acid active compound for the sterilization of many medical devices. RUSCH laryngoscope blades have been successfully sterilized using this process. The process also proves to be anticorrosive.
Please note that Steris® processing should comply with a// directions and warnings which Steris® Corporation recommends with their units.

Product Resterilization

RUSCH Inc. and its associated product suppliers have manufactured sterile devices according to unique validated sterilization cycle parameters. The validated sterilization cycle is only effective with the sterilizer used in the products' initial manufacturing. RUSCH Inc. cannot make sterilization recommendations in instances where users want to resterilize product utilizing other sterilization equipment. Qualification of product sterility and integrity will remain the responsibility of the facility operating the sterilizing equipment. Note: Expiration dates on current packaging refer to concern for product integrity. Re-sterilizing expired product will not extend the shelf life.

WARNING: The above listed Sterilization Guidelines, provided by RUSCH Inc., are intended as suggestions only. They are based on procedures compatible with specific materials. Sterilization must be performed to approved hospital protocol. Because each sterilization chamber is unique, RUSCH Inc. cannot provide a guaranteed cycle for processing devices.