In hospital Central Sterile Services Departments (CSSDs), sterilizers remain in focus as principal means of achieving sterility of medical instruments, but the real “last line of defense” is packaging. Even a perfectly executed cycle can fail the patient if sterilization pouches or packages made with sterilization reels are incorrectly sized, sealed, or handled. For infection prevention teams, OR nurses, and CSSD managers, understanding the safe use of these packaging formats is essential to maintaining sterility from reprocessing to the point of use.
1. Understanding Sterilization Pouches vs. Sterilization Reels
Prefabricated bags (self-sealed or heat-sealed) with one porous side (medical paper or Tyvek®) and one side with transparent film. They are ideal for standard and repetitive sizes: scissors, forceps, dental instruments, minor sets.
Continuous “tube” supplied on rolls, again with a porous side and a film side. Staff cut the desired length and seal both ends to create a custom bag. Reels are perfect for long or irregular devices (endoscopes, long forceps, suction tubes) and for reducing SKU complexity.
Both formats must:
- Allow sterilant to penetrate (steam, EO or other validated method).
- Maintain a microbial barrier after the cycle.
- Open cleanly and predictably for aseptic presentation.
2. Step One: Start with Clean, Dry Instruments
No packaging system can compensate for poor decontamination:
- Thorough cleaning: Follow the instructions for use for detergents and ultrasonic/manual cleaning.
- Inspection: Check operation (hinges, tips) and physical condition. Confirm that all hinged instruments (e.g., scissors, forceps, clamps) move smoothly and freely. Open and close them completely. There should be no stiffness, catching, or excessive looseness.
- Drying: Residual moisture on instruments or inside pouches can cause wet packages, weak seals, corrosion, and microbial survival.
Only clean, dry, and inspected items should be packaged in sterilization bags or reels.
3. Choosing between pouch and reel
Ask three questions:
- Is the instrument long or oddly shaped?
Yes → reels are usually safer and cheaper.
No → a standard bag may be faster and less prone to errors.
- How often is this size used?
Large volume, standard size → Pre-made sterilization pouches.
Variable length, reduced volume → cut to size from reels.
- What sterilization method is used?
Steam/EO → paper/film is usually appropriate.
VHP/plasma → Tyvek®/film, not conventional medical paper.
Always make sure the bag or reel is clearly marked for the sterilization method being used.
4. Sizing and Loading: Clearance Equals Safety
Whether you use prefabricated pouches or pouches made from sterilization reels:
- Avoid overpacking. The instruments should not press hard against joints or corners. Excessive packaging restricts the flow of sterilant and increases the risk of tears or channels.
- Leave head space. Try to leave a margin of at least 2 to 5 cm beyond the longest dimension of the instrument on all sides.
- Protect sharp tips. Use tip protectors and backing cards so sharp ends do not pierce material during pressure changes or transportation.
- Do not trespass the seal. No instrument should be placed on a seal band; Seals should only bond the layers of packaging, not to the metal.
5. Correct sealing: self-sealing versus heat-sealing
Self-seal sterilization bags
- Fold exactly according to the manufacturer's line.
- Press from the center outward to avoid wrinkles and trapped air.
- After sealing a self-seal sterilization pouch, it is crucial to perform a visual check to ensure the adhesive strip is fully engaged and continuous. This seal is the primary barrier to maintaining the sterility of the contents until the pouch is opened for use.
Heat-sealed bags and reels
- Use calibrated sealers with validated temperature, pressure and dwell time.
- Maintain a uniform and continuous sealing track (often ≥6 mm) at both ends of the package.
- Keep sealing areas clean – no dust, gauze lint, indicator ink or label adhesive in the sealing line.
- Visually inspect each seal: no gaps, no wrinkles, no contamination. A compromised seal means a non-sterile package.
6. Labeling, Indicators and Traceability
Safe use also means traceable use:
- External indicators show that the package was exposed to a sterilization process. They do not demonstrate sterility but are essential for workflow.
- Internal indicators should be placed inside prefabricated pouches and in pouches made out of reels, especially for devices with lumens.
- Labels should be in designated areas, never trespassing seal tracks or covering the porous area. Record the item name, load number, sterilizer ID, and date.
- Barcodes and tracking systems reduce human error and support recovery or investigation if a problem arises.
7. Loading into the sterilizer
Correct loading is as important as correct packaging:
- Place prefabricated sterilization pouches and reel-made pouches on edge when possible, alternating paper and film sides to promote air removal and steam/gas penetration.
- Avoid compressing packets; Do not wedge them so tightly that the materials warp or the seals become stressed.
- Separate heavy instrument sets from lightweight packages to avoid crushing.
- Follow the validated guidance for your sterilizer and packaging materials (often paper side up or film side down with steam, but always check your protocols).
After the cycle, the bags should come out dry and intact. Any wet, torn, or visibly damaged packages should be considered non-sterile and reprocessed.
8. Storage, handling and event-related sterility
In hospitals, sterility is best managed if it is event-related, not just time-related. A package remains sterile until:
- The sterilization pouch is torn, punctured, wet, or open.
- The seals are compromised or very wrinkled.
- The package has been dropped or is visibly contaminated.
To prolong safe life:
- Store in clean, dry, low-traffic areas, away from the floor, ceiling, and external walls.
- Avoid stacking heavy trays directly on top of lightweight prefabricated pouches or pouches made from sterilization reels.
- Protect from sunlight, dust and HVAC drafts that can stress materials.
9. Aseptic Opening in the Operating Room
All work in CSSD is wasted if packages are opened incorrectly:
- When presenting a sterile pack to a scrubbed (sterile) team member in an operating room or sterile field setting, the objective is to maintain aseptic technique by ensuring that the non-sterile staff member handles only the exterior of the pack while the sterile contents are delivered without contamination.
- Peel slowly and steadily along the chevron or corner, without breaking the seal.
- Avoid "jerk-opening" the seal, which can generate lint or particles.
- Let the instruments fall gently onto a sterile tray or be grasped by sterile personnel without crossing the boundary.
- Training OR staff in aseptic presentation is as important as training CSSD staff in sealing.
10. Building a culture of packaging safety
Finally, maintaining sterile barrier system is a team sport:
- Establish clear SOPs for the use of sterilization pouches and reels.
- Conduct regular audits: check seal quality, loading practices, and storage areas.
- Encourage frontline staff to quarantine and report any suspicious packages, no questions asked.
- Partner with suppliers to ensure materials meet international standards and are appropriate for your sterilization methods.
Conclusion
When properly selected, sealed, loaded and opened, sterilization bags and packages made with sterilization reels form a robust and reliable sterile barrier right from coming out of the sterilizer till time of reaching the patient. By treating packaging steps as seriously as sterilization cycles, hospitals can significantly reduce the risk of packaging-related failures and keep safety at the heart of sterility.