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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

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cleaning packaging and sterilization of instruments
Cleaning, Packaging and Sterilization of Instruments

Provided by:

McKesson Corporation

McKesson Medical-Surgical

Richmond, VA

continuing education program
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
INSTRUMENT PROCESSING

There are six (6) recommended

steps for Instrument Processing:

Cleaning

Inspection

Packaging

Sterilization

Storage & Delivery

6. Quality Assurance

step 1 cleaning
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 cleaning5
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 cleaning6
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 cleaning7
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
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 inspection9
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
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 packaging11
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 packaging12
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 packaging13
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 packaging14
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 packaging15
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 packaging16
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 packaging17
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 packaging18
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
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 sterilization20
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 sterilization21
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 sterilization22
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
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 delivery24
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 delivery25
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
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 assurance27
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 assurance28
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

gravitydisplacement and do

not require this special test.

step 6 quality assurance29
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 assurance30
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 assurance31
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 assurance32
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
McKesson thanks you for taking the time to review…

The six (6) recommended steps

for Instrument processing:

Cleaning

Inspection

Packaging

Sterilization

Storage & Delivery

6. Quality Assurance

ce certificate available
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.

sps medical supply corp
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:

education@spsmedical.com

references
References

ANSI/AAMI ST35:2003

ANSI/AAMI ST33: 1996

Guidelines for the selection and use of reusable rigid container systems for EO & Steam sterilization in HC facilities, 2ed

Safe handling and biological decontamination of reusable medical devices in health care facilities and in nonclinical settings

slide37

References

ANSI/AAMI ST46: 2002

ANSI/AAMI ST37: 1996

Steam sterilization

and sterility assurance

in health care facilities

Flash sterilization – Steam sterilization of patient care items for immediate care use

slide38

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 products40
McKesson Brand Sterility Assurance Products

To assist users in meeting their sterility assurance needs, contact

your local McKesson Representative and ask for the following

McKessonbrand quality products:

PACKAGING MONITORING

  • Self-Seal & Heat-Seal Pouches • Chemical Indicators
  • Disposable Sterilization Wrap • Biological Indicators
  • Sterilization Indicator Tape • B-D and BI Test Packs
  • Record Keeping System • Incubators/Record Books
mckesson brand sterile packaging products
Self-Seal Pouches

73-SSP381 3.5” x 9”

73-SSP382 5.25” x 10”

73-SSP383 7.5” x 13”

73-SSP387 8” x 16”

73-SSP391 12” x 18”

Heat-Seal Pouches

73-HSP250 4” x 8”

73-HSP254 5.25” x 10”

73-HSP255 5.25” x 15”

73-HSP256 6” x 10”

73-HSP257 7.5” x 13”

McKesson Brand Sterile Packaging Products
mckesson brand sterile packaging products42
Sterilization Wrap

73-HDW1515 15” x 15”

73-HDW1818 18” x 18”

73-HDW2020 20” x 20”

73-HDW2424 24” x 24”

73-HDW3030 30” x 30”

Sterilization Tape

73-ST048 3/4” x 60 yds

73-ST036 1” x 60 yds

73-BT048 3/4” x 60 yds

73-BT036 1” x 60 yds

73-GT036 1” x 60 yds

McKesson Brand Sterile Packaging Products

Label Applicator 73-MDG001 Load Record Label 73-URL012 Load Record Card 73-DLC250 Records Envelope 73-LEB100

mckesson brand sterilization monitoring products
Chemical Indicators

73-SIS250 4” Steam Strip

73-SIL250 8” Steam Strip

73-GIL250 8” EO Strip

73-DMS250 8” Dual Strip

Chemical Integrators

73-SSI100 Steam (100 pk)

73-SSI1000 Steam (1,000 pk)

73-STP025 Steam Test Pack

McKesson Brand Sterilization Monitoring Products

Daily Air Removal Test

73-SBD030 Bowie-Dick Test Pack

mckesson brand sterilization monitoring products44
Biological Indicators

73-SCS025 Steam vial (25 bx)

73-SCS100 Steam vial (100 bx)

73-SBT025 Steam Test Pack w/25 controls

73-SBT255 Steam Test Pack w/5 controls

73-PCS025 Peracetic Acid Culture Set (for STERIS System 1)

73-NDB055 60°C Dry Block Incubator, 16 mm

73-NDB060 60°C Dry Block Incubator, 11 mm

73-PP012 Mail-In System (12 bx)

73-PP052 Mail-In System (52 bx)

McKesson Brand Sterilization Monitoring Products