THE AESCULAP
RIGID CONTAINER SYSTEM
Julia Cristobal, Territory Sales Manager O.R. Division
TRUDELL MEDICAL MARKETING LIMITED
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
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.
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.
1993
1970
The evolution of the sterile
container
1998
1900-1970
2003
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.
Current Situation & Challenges for some hospitals
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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
Advantages
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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
Materials
• The Aesculap STERILCONTAINER
System is manufactured of specially
formulated aluminum alloy.
• The surface 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.
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.
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.
Aseptic Preparation in the Operating Room
 opening
 getting the basket
 removing the lid
 removing the basket
Aseptic Preparation in the Operating Room
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.
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
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.
REUSABLE FILTERS
Validated for 1000 sterilization cycles
REUSABLE FILTERS II
Removable cover
Removable
retainer with PTFE
filter
Non Removable frame for
retainer
Non Removable top cover
CONSUMABLES STEAM
CONSUMABLES STERRAD
Changes to blue
Automatic destruction
of the seal when lock
is opened:
Quick and safe
Processindicator
Storage of Sterile Containers
Compatible with Instrument Tracking Program
Sealing
Labelling
Tracking with Barcode
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.
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.
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
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.
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
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
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?
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.
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