Transcript 2004 Recommended Practices for Sterilization

Cleaning, Packaging
and Sterilization of
Instruments
Provided by:
McKesson Corporation
McKesson Medical-Surgical
Richmond, VA
Continuing Education Program
Following established protocols for
instrument processing is an important
aspect of modern health care as it helps
to minimize the patient’s risk for
infection of the surgical site.
This program reviews the most current
recommended practices for instrument
processing and is approved through
two national sterile processing
organizations.
IAHCSMM and CBSPD offer
certification programs for sterile
processing personnel
INSTRUMENT PROCESSING
There are six (6) recommended
steps for Instrument Processing:
1.
2.
3.
4.
5.
6.
Cleaning
Inspection
Packaging
Sterilization
Storage & Delivery
Quality Assurance
STEP 1 - CLEANING
Cleaning of instruments should
be performed in a designated
area, immediately after the
surgical procedure.
Quick cleaning removes blood
or debris much easier, and can
minimize corrosion, pitting or
instrument staining.
STEP 1 - CLEANING
Whenever possible, it is best to
mechanically clean instruments
with an ultrasonic or washer
using a neutral pH detergent.
Mechanical cleaning has been
proven to be up to 16 times
more effective over manual
cleaning.
STEP 1 - CLEANING
Ultrasonic cleaners use high
frequency sound waves to
create microscopic bubbles
that collapse.
This “cavitation” process is
very effective in getting into
the serrations, box locks and
crevices of instruments.
STEP 1 - CLEANING
After cleaning, thoroughly
rinse instruments with tap
water to ensure loosened
debris and detergents are
removed.
If the tap water is of poor
quality, consider using
treated water as a final rinse
to avoid instrument staining.
STEP 2 - INSPECTION
Each instrument must be
critically inspected after
each cleaning for residual
debris or damage.
Replace instruments as
needed and never sterilize
a “dirty” instrument.
STEP 2 - INSPECTION
In addition, check each
instrument for proper
function and lubricate
those that have “metal
to metal” action.
Instruments with stiff
joints could be a sign
of inadequate cleaning.
STEP 3 - PACKAGING
Instrument packaging should
be done in a clean, low
contamination area using only
FDA approved materials,
such as:
• Sterilization pouches
• Sterilization wrappers
• Sterilization containers
STEP 3 - PACKAGING
Sterilization pouches are for
packaging single instruments
and small, light weight items.
Paper/plastic pouches allow
the user to see the packaged
instruments and are available
in heat-seal & self-seal design
for use with all sterilization
processes.
STEP 3 - PACKAGING
When packaging instruments,
be sure to select an appropriate
size pouch and to place hinged
instruments in an open position
to allow sterilant contact.
For quality control, be sure to
include a chemical indicator
inside and a lot label outside.
STEP 3 - PACKAGING
To assist sterilization and aid
drying, always place pouches
facing each other and on edge
using a pouch divider.
Inexpensive pouch dividers
are available for small and
large sterilizers.
STEP 3 - PACKAGING
Sterilization wrap is used for
packaging instrument cassettes
and/or trays.
To allow sterilant to reach the
instruments and to not trap air
inside the package, cassettes
and trays should be perforated.
Wrap should be snug to prevent low spots that could collect
condensate, but not too tight to cause strike through.
STEP 3 - PACKAGING
Instrument trays should be
double wrapped to maintain
sterility per the wrap mfg’s
instructions for use.
Instrument trays should be
wrapped in a way that allows
for sterile presentation of the
processed items.
STEP 3 - PACKAGING
Wrapped packs should be sealed
with 1”, 3/4” or ½” sterilization
indicator tape.
For quality control, be sure to
include a chemical indicator
inside and a lot label outside.
Class 5
Class 4
STEP 3 - PACKAGING
Wrapped packs (being heavier)
should be placed on the lower
shelf of the sterilizer.
Loading heavier items on the
bottom shelf and lighter items
on the top, enables condensate
to drain out without wetting
other items in the load.
To maintain sterility, packages need to be
visibly dry before transporting to a
sterile storage area
STEP 3 - PACKAGING
Sterilization containers can be
used to process instruments or
sets. Containers offer excellent
protection during storage and
transport to the sterile field.
As with wrapped trays, loading
containers on the bottom shelf
and lighter items on the top,
enables condensate to drain
away from lighter packages.
Some rigid containers can be stacked during
sterilization; however, all can be stacked
during storage to save space
STEP 4 - STERILIZATION
Steam sterilization is CDC
recommended as the process
of choice whenever possible.
Steam under pressure is
considered safe, fast and the
most cost effective sterilization
method for health care
facilities.
Gravity displacement and pre-vacuum
are the two common types of
steam sterilizers
STEP 4 - STERILIZATION
Steam sterilizers are Class II
medical devices subject to FDA
approval per a 510(k) clearance
letter.
They are available in a wide
variety of shapes and sizes for
sterilization of heat-stable
instruments.
STEP 4 - STERILIZATION
Always process according
to the sterilizer or instrument
manufacturer’s validated
Instructions For Use.
Some common sterilizer cycle
recommendations are:
• 250°F/121°C for 30 minutes
• 270°F/132°C for 10 minutes
• 273°F/135°C for 4 minutes
STEP 4 - STERILIZATION
Not all instruments can be processed
at common or “normal” cycle times.
For example, SYNTHES General
graphic cases:
• Gravity sterilizer:
132-135°C for 22 minutes
• Pre-vacuum sterilizer:
132-135°C for 8 minutes
STEP 5 – Storage & Delivery
Sterile items should be stored in a
manner that reduces the potential
for contamination.
The shelf-life of sterile packages
is event related and depends on
the quality of the packaging
material, storage conditions and
amount of handling.
STEP 5 – Storage & Delivery
Sterile packages should always be
handled with care. Avoid dragging,
crushing, bending, compressing or
puncturing, as this will compromise
the sterility of the contents.
Be sure to inspect sterile packages
before distributing. Do not use any
package that is damaged, wet or
opened.
STEP 5 – Storage & Delivery
Sterility maintenance bags
(dust covers) may be used
to protect items that could
be subjected to
environmental challenges
or multiple handling
before use.
Should be 2-3 mils thick and applied
ASAP after sterilization and after
the item has cooled.
STEP 6 – Quality Assurance
Chemical indicators should be placed
on the outside/inside of each package
to visibly show they have been
processed.
Biological indicators should be run
at least weekly to verify sterilization
and recorded as part of your formal
Infection Control – QA program.
STEP 6 – Quality Assurance
Chemical Indicators are available
in tape, card and strip formats for
use with all processes.
These devices change color as
indicated, for the process they
are monitoring.
STEP 6 – Quality Assurance
Most large steam sterilizers
are pre-vacuum and require
an air removal check before
using. This daily test is done
with a Bowie-Dick test pack.
Most table top sterilizers are
gravity displacement and do
not require this special test.
STEP 6 – Quality Assurance
Test Procedure:
Place a Bowie-Dick test pack on
the lowest shelf, over the drain in
an empty chamber at 273°F for
3.5 or 4 minutes.
After processing, the indicator
sheet inside the test pack must
show a uniform color change to
pass.
A shortened cycle omitting dry time
should be run first to properly heat
up the sterilizer.
STEP 6 – Quality Assurance
Biological Indicators are processed along
with a load for sterilizer verification. For
steam sterilizers, users purchase a 55-60°C
incubator and biological indicator vials.
Sterilizer failure is noted if the BI grows
during incubation. Growth is observed by
a color change in the media from purple
to yellow.
STEP 6 – Quality Assurance
Biological Indicators can also be
sent to an outside Lab for 3rd party
documentation.
Mail-in systems use BI strips and
pre-paid mailer envelopes. Users
simply run the BI strip and then
mail. A Lab Report is returned and
placed on a “password protected”
website: www.checkyourtest.com
STEP 6 – Quality Assurance
While sterilizers can and do
mechanically fail, human error
is the leading cause of sterilizer
failure.
•
•
•
•
Cold start
Wrong cycle
Overloading
Improper packaging
After processing, the BI strip is mailed to an
outside Laboratory for incubation. After
24 hrs, a formal Lab Report is returned
to verify steam sterilization
McKesson thanks you for taking
the time to review…
The six (6) recommended steps
for Instrument processing:
1.
2.
3.
4.
5.
6.
Cleaning
Inspection
Packaging
Sterilization
Storage & Delivery
Quality Assurance
CE Certificate Available
This continuing education program
was developed and produced by
SPSmedical Supply Corp. for the
McKesson Corporation.
Customers who view this program
may request a complimentary CE
Certificate from SPSmedical.
SPSmedical Supply Corp.
The largest sterilizer testing Lab
in North America with over 48
sterilizers, SPSmedical serves on
10 AAMI sterilization standards
committees & provides seminar
Speakers to health care
organizations.
For technical questions and
CE Certificates, please call:
1-800-722-1529 or E-mail:
[email protected]
References
ANSI/AAMI ST35:2003
Safe handling and
biological decontamination
of reusable medical
devices in health care
facilities and in nonclinical
settings
ANSI/AAMI ST33: 1996
Guidelines for the
selection and use of
reusable rigid
container systems for
EO & Steam
sterilization in HC
facilities, 2ed
References
ANSI/AAMI ST46: 2002
Steam sterilization
and sterility assurance
in health care facilities
ANSI/AAMI ST37: 1996
Flash sterilization –
Steam sterilization
of patient care
items for immediate
care use
References
ANSI/AAMI ST 60: 1996
ANSI/AAMI ST 66: 1999
Sterilization of health
care products-Chemical
indicators- Part 1:
General requirements
Sterilization of health
care products-Chemical
indicators- Part 2: Class
2 indicators for air
removal test sheets and
packs
McKesson Brand
Sterility Assurance Products
McKesson Brand
Sterility Assurance Products
To assist users in meeting their sterility assurance needs, contact
your local McKesson Representative and ask for the following
McKesson brand quality products:
PACKAGING
• Self-Seal & Heat-Seal Pouches
• Disposable Sterilization Wrap
• Sterilization Indicator Tape
• Record Keeping System
MONITORING
• Chemical Indicators
• Biological Indicators
• B-D and BI Test Packs
• Incubators/Record Books
McKesson Brand
Sterile Packaging Products
Self-Seal Pouches
73-SSP381
73-SSP382
73-SSP383
73-SSP387
73-SSP391
3.5” x 9”
5.25” x 10”
7.5” x 13”
8” x 16”
12” x 18”
Heat-Seal Pouches
73-HSP250
73-HSP254
73-HSP255
73-HSP256
73-HSP257
4” x 8”
5.25” x 10”
5.25” x 15”
6” x 10”
7.5” x 13”
McKesson Brand
Sterile Packaging Products
Sterilization Wrap
73-HDW1515
73-HDW1818
73-HDW2020
73-HDW2424
73-HDW3030
Sterilization Tape
15” x 15”
18” x 18”
20” x 20”
24” x 24”
30” x 30”
Label Applicator
Load Record Label
Load Record Card
Records Envelope
73-ST048
73-ST036
73-BT048
73-BT036
73-GT036
73-MDG001
73-URL012
73-DLC250
73-LEB100
3/4” x 60 yds
1” x 60 yds
3/4” x 60 yds
1” x 60 yds
1” x 60 yds
McKesson Brand
Sterilization Monitoring Products
Chemical Indicators
Chemical Integrators
73-SIS250
4” Steam Strip
73-SIL250
8” Steam Strip
73-GIL250
8” EO Strip
73-DMS250 8” Dual Strip
73-SSI100
73-SSI1000
73-STP025
Daily Air Removal Test
73-SBD030
Bowie-Dick Test Pack
Steam (100 pk)
Steam (1,000 pk)
Steam Test Pack
McKesson Brand
Sterilization Monitoring Products
Biological Indicators
73-SCS025
73-SCS100
73-SBT025
73-SBT255
73-PCS025
73-NDB055
73-NDB060
Steam vial (25 bx)
Steam vial (100 bx)
Steam Test Pack w/25 controls
Steam Test Pack w/5 controls
Peracetic Acid Culture Set (for STERIS System 1)
60°C Dry Block Incubator, 16 mm
60°C Dry Block Incubator, 11 mm
73-PP012
73-PP052
Mail-In System (12 bx)
Mail-In System (52 bx)