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12 Medical Device Packaging and Loading
12.1. Preparing Medical Devices for Sterilization
For reusable device sterilization, clean devices for sterilizing according to the device manufacturer’s instructions for use before processing in the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series
Thorough cleaning is essential to achieve sterilization efficacy
DANGER: To reduce risks associated with exposure to ethylene oxide:
For reusable device sterilization, always follow the device manufacturer’s instructions for use (IFU), including device cleaning, drying, packaging, sterilizing, and aerating
Only sterilize medical devices that are manufactured with materials compatible with ethylene oxide sterilization processes Do not sterilize leather, liquids, or materials that are reactive to
ethylene oxide
WARNING: To reduce risks associated with fire and explosion:
Do not sterilize devices with energy sources which could create a spark in the sterilization chamber during the sterilization cycle
For reusable device sterilization, always follow device manufacturer’s instructions for use (IFU), including device cleaning, drying, packaging, sterilization, and aeration
CAUTION: To reduce patient risks associated with exposure to potentially non‑sterile devices or inadequate sterilization procedures:
For reusable device sterilization, always follow device manufacturer’s instructions for use (IFU), including device cleaning, drying, packaging, sterilization, and aeration
Only sterilize medical devices that are manufactured with materials compatible with ethylene oxide sterilization processes Do not sterilize leather, liquids, or materials that are reactive to
ethylene oxide
12.2. Packaging Medical Devices
Non‑compatible packaging and/or incorrect loading of the 3M™ Steri‑Vac™ Sterilizer/Aerator GSX Series may compromise the sterility of the processed devices
For reusable device sterilization, before packaging, ensure that the medical devices are clean and dry per manufacturer’s instructions for use
1221 Recommended Packaging
The following packaging is recommended for use with ethylene oxide (EO) sterilization:
•
Polyethylene plastic bags (designed for use as a sterile package and are not more than 5 mils thick)
•
Peel pouches:
• Spun‑bonded olefin polyethylene‑polyester laminate
• Paper/polyethylene‑polyester laminate
• Paper/polypropylene‑polyester laminate
•
Wraps:
• Woven textile
• Nonwoven textile
• Nonwoven polypropylene
• Paper, coated and uncoated
•
Rigid sterilization container systems
•
Plastic trays with paper or spun‑bonded olefin lids
