THE AESCULAP RIGID CONTAINER SYSTEM

1. THE AESCULAP RIGID CONTAINER SYSTEM Julia Cristobal, Territory Sales Manager O.R. Division TRUDELL MEDICAL MARKETING LIMITED

2. Definition Rigid Sterilization Container System “Specifically designed heat-resistant, metal, plastic or anodized aluminum receptacles used to package items, usually surgical instruments, for sterilization. The lids and/or bottom surfaces contain steam - or gas-permeable, high efficiency microbial filters” • Source: 2002 AORN Standards, Recommended Practices for Selection and Use of Packaging Systems

3. The Development of the Sterile Container System • Aesculap created the first rigid container system in the 1890’s. It was first used in Europe. • Between 1900 and 1970, chrome-plated drums and instrument boxes were manufactured for the transportation of instruments and dressings.

4. The Evolution of the Sterile Container System • 1980’s – user acceptance established in North America • Use was sporadic due to limitations associated with containers in gravity sterilizers • No stacking and and poor air removal biggest issues. • Vacuum sterilizers and improved container designs led to improved acceptance • Containers could now be stacked as air removal was improved with vacuum process • Solid bottoms also introduced to assist in instrument transport while minimizing contamination • T oday, containers are made to be used in all three of the most popular sterilization methods – steam, gas and more recently Sterrad.

5. 1993 1970 The evolution of the sterile container 1998 2003 1900-1970

6. Sterilization packaging systems should: • permit identification of the contents, • completely secure the devices, • protect the package contents from physical damage • (e.g. tears, puncture, compression), • prevent the transfer of microorganisms, • be free of holes, • be free of toxic ingredients, • be tamper-resistant, • permit adequate air removal, • allow sterilant penetration and removal, • be non-linting, • be large enough to distribute the contents evenly, • maintain sterility of package contents until opened, • allow aseptic presentation of the contents, • be cost effective, and • have manufacturer’s written recommendations for use.

7. Current Situation & Challenges for some hospitals • Large medical waste disposal • High expense on disposable & reusable packaging material • Prone to rips and tears during handling • No ability to stack sets (sterilization, transport & storage) • Poor space utilization • No easy lifting mechanism - Sets are dragged during handling • Dust collects in the folds • Subject to contamination through compression and handling • No absolute assurance of sterility • No place for sterile processing information • Instruments & Baskets do not stay together through washing cycle • Double Cleaning Work with the Baskets • No Standardization

9. Advantages • Patient Safety First • Better Clinical Efficacy • Healthcare Staff Safety • Materials, Handling & Lifespan • Labour Efficiency • Better Organization • Better Supply of Sterile Sets to the OR • Environmentally Friendly • Reduce Waste Disposal • Cost Savings

10. Materials • The Aesculap STERILCONTAINER System is manufactured of specially formulated aluminum alloy. • Thesurface is protected by a layer of anodized oxide to prevent corrosion. • The Aesculap baskets are all made of stainless steel. Do not use abrasive cleaners, metal brushes or abrasive cleaning pads. Use of abrasive products can cause permanent damage to sterilcontainer surfaces. Use of abrasive cleaners or pads will result in warranty exclusion.

14. How do Rigid Containers work? • Sterilization containers have a filter mechanism designed to permit the sterilant to enter and exit as well as to act as a microbial barrier. (bidirectional steam penetration) • Sealed container systems are designed for sterilization and extended storage, utilizing a filter secured by a gasketed filter retention plate.

15. Patient Safety First • Provide an adequate barrier to microorganisms, particulates and fluids. • Assure aseptic delivery of contents to the sterile field. • Assure adequate seal integrity. • Assure validated bacterial barrier system according to: • EN 868, part 1, 8: European Standard for Sterile Containers. • ISO 11607, part 1: Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems.

16. Aseptic Preparation in the Operating Room • opening • removing the lid • getting the basket • removing the basket

17. Aseptic Preparation in the Operating Room

18. FILTERS A filter is a component of the rigid sterilization container system that allows passage of air and the sterilant during the sterilization process. What is the function of the filter? • The filter provides a protective bacterial barrier which maintains the sterile integrity of the contents during storage and transport. Type of filters. • There are several types: • 1. Single-use paper filters, also called disposable filters. They need to be replaced after the container has been opened or used in the OR. • 2. Reusable filters made of a strong inert material. Reusable filters need to be changed according to the manufacturer’s recommendations.

19. Aesculap PTFE Filters Micro Porous 100% PTFE = PolyTetraFluorEthylene • Highly resistant to chemicals • Resistant to age • The properties of the material do not change with time and use • Hydrophobic – water & other liquids simply bead off and are not absorbed • Extremely low coefficient of friction – bioburden will not stick to it

20. How does Aesculap validate the reusable filters? • Numerous tests are carried out to investigate and validate the safety of reusable filters as sterilizing filters in rigid containers designed for use in steam sterilization procedures. Some of the conclusions after the tests are: 1. Hygienic and microbiological criteria with regard to imperviousness to germs during transport and storage in daily hospital use were fully satisfied. 2. 100% toxicological safety was empirically demonstrated. 3. The filters can be reliably marked, and the history of their use can be documented.

21. REUSABLE FILTERS • Validated for 1000 sterilization cycles

23. REUSABLE FILTERS II

24. Removable cover Removable retainer with PTFE filter Non Removable frame for retainer Non Removable top cover

25. CONSUMABLES STEAM

26. CONSUMABLES STERRAD Changes to blue

27. Automatic destruction of the seal when lock is opened: Quick and safe Processindicator

28. Storage of Sterile Containers

29. Compatible with Instrument Tracking Program Sealing Labelling Tracking with Barcode

30. MECHANICAL CLEANING • Place the STERILCONTAINER bottom in the washer with the inside surface facing down to avoid water collection. • Fold the handles towards the inside of the lid. Place the lid with the inside surface facing down to avoid water collection. • Retention plates should be placed away from the direct force of pressurized washer jets to avoid damage during the washing cycle. Reusable filters can be cleaned mechanically inside the retention plate. • Thoroughly dry the STERILCONTAINER and components before final assembly.

32. Inspection • Verification that latches are properly functioning. • Inspect the rim of the lid to ensure the gasket is in good condition and free from cracks. • A cracked gasket indicates age and/or deterioration and should not be used. Remove the lid from service and return for repair. • Inspect filters for rips, tears, pitting, cracks, dents, foreign material or other signs of damage. • If any signs of damage exist, or if the recorded removal date is near, discard filter. If not, place filters back inside retention plates.

33. Container Standards • “Guidelines for selection and use of reusable rigid sterilization container systems for ethylene oxide sterilization and steam sterilization” – ANSI/AAMI ST33 – 1996 • “Recommended practices for selection and use of packaging systems” – AORN, 2002 • “Selection and use of rigid sterilization containers” – Canadian Standards Association, CSA Z314.14

34. Canadian Standards • A committee of end-users, CSA staff and representatives of container manufacturers have been working to update the previous standard. • Intended to help health care facilities choose products that are appropriate for their intended use.

35. Canadian Standard • Canadian Standard addresses the: • Preparation • Handling • Loading of medical devices in containerized sets. • Appendix A – Pre purchase Evaluation Protocol • Appendix B – Pre purchase Testing of Containers • We will review the requirements as outlined in the CSA Standard, Z314.14

36. TRUE or FALSE The purpose of any packaging system is: 1) to allow sterilization of the package contents, 2) to maintain sterility of contents until the package is opened, and 3) to permit delivery of contents without contamination. TRUE

37. TRUE or FALSE Facilities should have a copy of the manufacturer’s documented test data that provide assurance the packaging system selected meets the criteria required. TRUE, where is it? who has it?

38. TRUE or FALSE According to standards the combined weight of the containment device and the container shall not exceed 25 pounds when the containment device load is configured according to the manufacturer’s recommendations. FALSE, new CSA Z314.3 states the total weight with container cannot be over 10 kg/22 pounds.

39. TRUE or FALSE Filter material used in rigid container systems can be easily tested by healthcare personnel by using the nationally recognized test for the microbial barrier performance. FALSE