Cleaning, Packaging & Sterilization of

Instruments

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

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.

INSTRUMENT PROCESSING

There are six (6) recommended

steps for Instrument Processing:

1. Cleaning

2. Inspection

3. Packaging

4. Sterilization

5. Storage & Delivery

6. Quality Assurance

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.

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.

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 should be

critically inspected after

each cleaning for residual

debris or damage.

Replace instruments as

needed and never sterilize

a “dirty” instrument.

In addition, check eachinstrument for proper function and lubricate those that have “metal to metal” action.

Instruments with stiff joints may be a sign ofinadequate cleaning..

STEP 2 - INSPECTION

STEP 3 - PACKAGING

Instrument packaging should be done in a clean and low contamination area, usingFDA approved products:

• Sterilization pouches• Sterilization wrappers• Sterilization containers

STEP 3 - PACKAGING

Sterilization pouches are for packaging single instruments and small, light weight items.

Paper/plastic pouches allowyou to see the contents and are available in heat seal and selfseal design and a wide selection of sizes.

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

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.

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.

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..

STEP 3 - PACKAGING

Wrapped instruments should be sealed with a color change indicator tape.

For quality assurance, include a chemical indicator or integratorinside, to verify sterilization parameters were met.

Indicator Integrator

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

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

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

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

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.

STEP 4 - STERILIZATION

OSHA requires a Material Safety Data Sheet on the chemical solution used for this proprietary

sterilization process

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 2

hours exposure time

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 iscapable 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

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 can compromise sterility.

Be sure to inspect sterile packages before distributing. Do not use any package that is damaged, wet or opened.

STEP 5 – Storage & Delivery

Special Note:

Opening sterile packages

at point of use, increases

patients’ confidence.

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

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.

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.

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.

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.

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

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 www.checkyourtest.com.

* Password protected

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

SPSmedical thanks you for taking the time to review…

The six (6) recommended steps

for Instrument Processing:

1. Cleaning

2. Inspection

3. Packaging

4. Sterilization

5. Storage & Delivery

6. Quality Assurance

THANK YOU!!

SPSmedical Supply Corp.

Sterilization Products & Services6789 W. Henrietta RoadRush, NY 14543 USAFax: (585) 359-0167Ph: (800) 722-1529

Website: www.spsmedical.com

© SPSmedical Supply Corp.

Certificate is available after viewing by calling SPSmedical

or e-mailing education@spsmedical.com

Cleaning, Packaging and Sterilization of Instruments

Reference

Center for Disease Control and Prevention. Guidelines for infection control in dental health-care settings, 2003. MMWR Recomm Rep, 52 (RR-17): 1-76.

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