1. Cleaning, Packaging & Sterilization of Instruments

2. Presented by SPSmedical
Largest sterilizer testing Lab in North America with over 50 sterilizers
Develop and market sterility assurance products that offer advanced technologies
Provide full day sterilization Seminars and Facility audits for compliance with standards and recommended practices
Corporate member: CSA and AAMI, serving on numerous sterilization committees
Woman owned business, certified by the state of NY

3. Continuing Education Program
Following established protocols for
instrument processing is an important
aspect of modern dental care as it helps
to minimize the patient’s risk for
infection.
This program is intended to provide an
“overview” of current recommended
CDC guidelines and is approved for
1.0 CDE credit by DANB.
Approved for 1 hour by the Dental Assisting National Board, Inc. Category 4.

4. INSTRUMENT PROCESSING
There are six (6) recommended
steps for Instrument Processing:
Cleaning
Inspection
Packaging
Sterilization
Storage & Delivery
6. Quality Assurance

5. STEP 1 - CLEANING Cleaning of instruments (manual
or mechanical) should be
performed in a designated area,
immediately after the procedure.
Quick cleaning removes blood
or debris much easier and can
minimize instrument staining,
corrosion and/or pitting.

6. STEP 1 - CLEANING Mechanical cleaning is a safer
practice for staff and has been
proven to be up to 16 times more
effective over manual cleaning.
Therefore, whenever possible,
mechanically clean instruments,
using warm water and a neutral
pH detergent.

7. 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.

8. STEP 2 - INSPECTION Each instrument should be
critically inspected after
each cleaning for residual
debris or damage.
Replace instruments as
needed and never sterilize
a “dirty” instrument.

9. STEP 2 - INSPECTION In addition, check each instrument for proper
function and lubricate
those that have “metal
to metal” action.
Instruments with stiff
joints may be a sign of
inadequate cleaning..

10. STEP 3 - PACKAGING Instrument packaging should
be done in a clean and low
contamination area, using
FDA approved products:
Sterilization pouches
Sterilization wrappers
Sterilization containers

11. STEP 3 - PACKAGING Sterilization pouches are for
packaging single instruments
and small, light weight items.
Paper/plastic pouches allow
you to see the contents and are
available in heat seal and self
seal design and a wide selection
of sizes.

12. STEP 3 - PACKAGING When pouching instruments,
be sure to select an appropriate
size pouch and to remove any
excess air before sealing.
For quality assurance, include
a chemical indicator/integrator,
inside to verify the sterilization
parameters were met.
Indicators
Integrators

13. STEP 3 - PACKAGING
To assist sterilization and aid drying, place pouches facing each other and on edge using a pouch divider.
SPSmedical has inexpensive pouch dividers available for small and large sterilizers.

14. STEP 3 - PACKAGING Sterilization wrap may be used
for packaging dental trays or
cassettes.
For an effective barrier and to
maintain sterility until point of
use, be sure to double wrap per
the wrap mfg’s instructions for
use and FDA clearance.

15. STEP 3 - PACKAGING Wrap in a way that allows
sterile presentation of the
dental tray or cassette.
Select the appropriate size
wrap and be careful not to
wrap too tight or too loose as
this can compromise sterility
by creating air pockets or
allowing strike through..

16. STEP 3 - PACKAGING Wrapped instruments should be
sealed with a color change
indicator tape.
For quality assurance, include a
chemical indicator or integrator
inside, to verify sterilization
parameters were met.
Indicator Integrator

17. STEP 3 - PACKAGING Wrapped trays (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 should be visibly dry before transporting to a sterile storage area

18. STEP 4 - STERILIZATION Sterilizers are Class II medical
devices subject to FDA approval
per a 510(k) clearance letter.
They are available in a variety of
sizes with the following processes
most common to dental:
Steam
Chemical vapor
Dry heat / Rapid heat transfer

19. Chamberland autoclave built in 1880
STEP 4 - STERILIZATION
Saturated steam under pressure
is one of the oldest methods
used to sterilize dental
instruments.
The CDC recommends steam
sterilization as the process of
choice, because it is efficient,
fast, and inexpensive.
Chamberland autoclave built in 1880

20. STEP 4 - STERILIZATION By heating distilled water under
pressure, moist heat is created
and rapidly kills microorganisms.
Some common steam sterilizer
cycle parameters are:
250°F/121°C for 30 minutes
270°F/132°C for 10 minutes
273°F/135°C for 4 minutes

21. STEP 4 - STERILIZATION Chemical vapor sterilizers
are available with a pre-set
cycle of 270°F/132°C for
20 minutes exposure.
This proprietary process uses
a chemical solution, instead
of water, that rapidly kills
microorganisms.
OSHA requires a Material Safety Data Sheet on the chemical solution used for this proprietary sterilization process

22. STEP 4 - STERILIZATION Dry heat sterilizers are also used
in dentistry for instruments and
materials that can withstand very
high temperatures.
Static air dry heat sterilizers are
similar to an oven, as they utilize
heating coils to transfer heat to
the instruments over long
exposure times.
Static air dry heat sterilizers typically operate at 320°F/160°C for 1 to hours exposure time

23. STEP 4 - STERILIZATION Forced air dry heat sterilizers are
also called “rapid heat transfer”
sterilizers and they circulate hot
air during the cycle reducing the
time needed for sterilization.
This type of dry heat sterilizer is
capable of sterilizing unwrapped
instruments in as little as 6 mins.
Forced air dry heat sterilizers operate at a range of 375°F to 420°F depending on the manufacturer

24. 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.

25. STEP 5 – Storage & Delivery
Sterile packages should always be
handled with care. Avoid dragging,
crushing, bending, compressing or
puncturing, as this can compromise
sterility.
Be sure to inspect sterile packages
before distributing. Do not use any
package that is damaged, wet or
opened.

26. STEP 5 – Storage & Delivery
Special Note:
Opening sterile packages
at point of use, increases
patients’ confidence.

27. STEP 6 – Quality Assurance
Sterility assurance of processed instruments should be routinely
verified using three (3) types of indicators:
1) Physical
2) Chemical
3) Biological

28. STEP 6 – Quality Assurance
1) Physical indicators are the time,
temperature and pressure gauges
built into sterilizers.
These readings should be recorded
for every cycle and verified prior to
unloading the sterilizer.
Hospital sterilizers are required to
have a chart or printout, whereas this is optional for sterilizers
located in private offices or clinics.

29. STEP 6 – Quality Assurance
2) Chemical indicators should be on the outside and inside of all packages to visibly show they have been
processed.
Some internal chemical indicators are
FDA cleared as Class 5 “integrators”
which can measure all parameters of
sterilization inside the package.

30. STEP 6 – Quality Assurance
3) Biological indicators provide users
the highest level of sterility assurance
and contain bacterial spores available
in plastic vial or paper strip format.
The CDC says sterilizers should be
spore tested at least weekly, and
every load that contains an implant.

31. STEP 6 – Quality Assurance
Biological Indicators are processed along
with a normal load. After processing, self-
contained BI vials are activated by
crushing the side of the plastic vial and
then incubated.
Sterilizer failure is noted if the spores in
the vial grow during incubation. Growth
is observed by a color change in the media
from purple to yellow.

32. STEP 6 – Quality Assurance
Biological Indicators can also be
sent to an outside Lab for 3rd party
verification.
After processing the BI strip along
with a normal load, the BI is sent
to a lab for incubation. Test results
are returned via mail or fax, with
some services offering internet
record keeping via password.
If a failure is recorded, the Laboratory calls the user with recommendations and instructions to retest

33. STEP 6 – Quality Assurance
Mail-in spore testing of sterilizers is
very popular with medical device
mfg’s and private offices.
SPSmedical provides this 3rd party
service to thousands of customers
each day. For user convenience,
test reports are also posted online* at
* Password protected

34. STEP 6 – Quality Assurance
While sterilizers can and do
mechanically fail, operator
error is the leading cause of
sterilizer failure.
Cold start
Wrong cycle
Overloading
Improper packaging
Sterilizers that fail the spore test, should not be used until a passed test is recorded

35. SPSmedical 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

36. Cleaning, Packaging and Sterilization of Instruments
THANK YOU!
SPSmedical Supply Corp.
Sterilization Products & Services
6789 W. Henrietta Road
Rush, NY USA
Fax: (585)
Ph: (800)
Website:
© SPSmedical Supply Corp.
Cleaning, Packaging and Sterilization of Instruments
Certificate is available after viewing by calling SPSmedical or ing

37. Reference
Center for Disease Control and Prevention. Guidelines for infection control in dental health-care settings, MMWR Recomm Rep, 52 (RR-17): 1-76.

38. Monthly Audio Seminars
Continuing Education
Additional Self-Study CD-ROMS available
Hazard Communication
Decontamination, You & Biofilms
Personal Protective Equipment
Cleaning Surgical Instruments
Selection & Use of Packaging Systems
Steam Sterilization: Process of Choice
Flash Sterilization in the OR
Safe & Effective Use of ETO
Sterilization Quality Assurance
Eliminating Sterile Outdates
CJD: A Sentinel Event
Monthly Audio Seminars
Audio Seminars are presented each month for 1.0 CE credit to sterile processing personnel certified through CBSPD and IAHCSMM