1. Introduction
This manual provides instructions for the proper use of Medline Self-Seal Sterilization Pouches, Model MPP100535GS. These pouches are designed for effective steam and gas sterilization of medical instruments, featuring a self-sealing adhesive strip and a distinct color change process indicator to confirm sterilization conditions have been met. Each pouch measures 5.25 inches by 12 inches and is constructed from strong material suitable for holding heavy instruments.
2. Setup and Preparation
Proper preparation of instruments and pouches is crucial for successful sterilization.
- Inspect Pouch: Before use, visually inspect each pouch for any damage, tears, or compromised seals. Do not use damaged pouches.
- Clean Instruments: Ensure all instruments to be sterilized are thoroughly cleaned, rinsed, and dried according to standard protocols before placing them into the pouch.
- Load Instruments: Place instruments inside the pouch without overcrowding. Ensure instruments do not puncture the pouch material. Sharp instruments should be placed with tips facing the paper side to prevent damage to the film.
- Seal Pouch:
- Peel off the protective strip from the self-seal adhesive.
- Fold the prefolded adhesive flap along the perforation line and press firmly from the center outwards to create a secure, airtight seal. Ensure no air bubbles are trapped and the seal is uniform.
- Labeling: Label the sealed pouch with the date of sterilization, sterilizer identification, and contents, using a non-toxic marker that will not bleed through the pouch material.
3. Operating Instructions (Sterilization Process)
These pouches are compatible with both steam and gas (Ethylene Oxide - EO) sterilization methods.
3.1. Steam Sterilization
- Loading: Place sealed pouches into the steam sterilizer according to the sterilizer manufacturer's instructions, ensuring proper spacing for steam penetration.
- Indicator Check (Steam): The steam process indicator on the pouch will change color upon exposure to steam sterilization conditions.
- Before Sterilization: The indicator for steam is typically a shade of pink or rose.
- After Sterilization: The indicator should change to a distinct brown or dark color.
- Interpretation: A color change indicates that the pouch has been exposed to steam. This does not guarantee sterility of the contents. Always follow your facility's sterilization protocols and use biological indicators as required.
3.2. Gas (Ethylene Oxide) Sterilization
- Loading: Place sealed pouches into the gas sterilizer according to the sterilizer manufacturer's instructions, ensuring proper spacing for gas circulation.
- Indicator Check (Gas/EO): The gas process indicator on the pouch will change color upon exposure to Ethylene Oxide sterilization conditions.
- Before Sterilization: The indicator for gas is typically a shade of purple or blue.
- After Sterilization: The indicator should change to a distinct green or yellow.
- Interpretation: A color change indicates that the pouch has been exposed to Ethylene Oxide. This does not guarantee sterility of the contents. Always follow your facility's sterilization protocols and use biological indicators as required.
Important: Do not use if the pouch is damaged or if the process indicator has already changed color prior to sterilization.
4. Storage and Handling
- Store unused pouches in their original packaging in a cool, dry place, away from direct sunlight and extreme temperatures.
- Handle sterilized pouches carefully to avoid punctures or damage to the seal.
- Sterilized items should be stored in a clean, dry, and protected environment until ready for use.
- Observe the expiration date printed on the packaging. Do not use expired pouches.
5. Troubleshooting
| Issue | Possible Cause | Solution |
|---|---|---|
| Process indicator did not change color. |
|
|
| Pouch seal compromised after sterilization. |
|
|
| Pouch appears wet after steam sterilization. |
|
|
6. Specifications
- Model Number: MPP100535GS
- Dimensions: 5.25 Inches x 12 Inches (13.3 cm x 30.5 cm)
- Sterilization Method Compatibility: Steam and Ethylene Oxide (Gas)
- Indicator Type: Dual process indicators for Steam (pink to brown/dark) and Gas/EO (purple/blue to green/yellow)
- Material: Strong, durable material suitable for heavy instruments.
- Closure: Self-seal adhesive strip with prefolded design.
- Quantity: Case of 1000 pouches.
- Manufacturer: Medline Industries Healthcare
- Date First Available: August 6, 2015
7. Support and Warranty
For technical assistance, product inquiries, or to report any issues, please contact Medline Industries Healthcare directly.
- Manufacturer Contact: 800-633-5463
- Website: www.medline.com (Please note: This link is for general information and not specific to this product's support page unless otherwise specified by Medline.)
Warranty Information: Specific warranty details for Medline Self-Seal Sterilization Pouches are not provided in the product description. Please contact Medline Industries Healthcare directly for information regarding product warranties and return policies.
