4/7/11

Cleaning  
Packaging    &    
Steriliza1on 
of Dental Instruments

Responsibility    Steriliza3on  
•  Sterile  is  an  absolute  term.  There  is  no  such  
•  One  of  the  most  important  responsibili3es  of   thing  as  “par3ally  sterile”  or  “almost  sterile.”  
the  office  is  to  process  contaminated  
•  Steriliza1on  destroys  all  microbial  forms,  
instruments  for  reuse.   including  bacterial  spores.  
•  Instrument  processing  involves  much  more   •  All  reusable  items  that  come  in  contact  with  
than  steriliza3on.   the  pa3ent’s  blood,  saliva,  or  mucous  
membranes  must  be  heat-­‐sterilized.  
•  Steriliza1on  is  a  process  intended  to  kill  all  
•  It  is  advisable  not  to  use  a  liquid  sterilant  for  
microorganisms  and  is  the  highest  level  of   any  item  that  can  withstand  heat  steriliza3on  
microbial  destruc3on.     or  is  disposable.  

Classifica3on  of  Instruments   SIX RECOMMENDED STEPS

•  Instruments  and  equipment  are  divided  into   1.  Cleaning  
three  classifica3ons:    
2.  Inspec3on  
–   Cri3cal  
–   Semicri3cal   3.  Packaging  
–   Noncri3cal    
4.  Steriliza3on  
•  The  classifica3ons  are  used  to  determine  the  
5.  Storage  &  Delivery  
minimal  type  of  post-­‐treatment  processing.  
6.  Quality  Assurance  Program  

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Personal  Protec3ve  Equipment  

STEP 1 - CLEANING  
•  Appropriate   You  must  always  use  personal  protec3ve  
aSre   equipment  ,  when  processing  instruments.  
–  PPE  
•  Transport      u3lity  gloves  
–  Rigid  leakproof      mask  
container  
   protec3ve  eyewear  
   clothing

Instrument  Processing  Area  

Basic  Principles  for  Work  Flow  PaZern  
•  The  instrument  processing  area,  or  steriliza3on  area,  
should  be  centrally  located  in  the  dental  office.     •  Processing  instruments  should  proceed  in  a  
single  loop,  from  dirty  through  clean  to  sterile,  
•  The  “ideal”  instrument  processing  area  should  be   without  ever  doubling  back.  
dedicated  only  to  instrument  processing.  
•  Good  air  circula3on  is  necessary  to  control  the  heat  
•  If  the  instrument  processing  area  is  small,  you  
generated  by  the  sterilizers.  The  size  of  the  area   can  use  signs  to  separate  the  contaminated  
should  accommodate  all  the  equipment  and  supplies   and  clean  areas.      
necessary  for  instrument  processing.  
•  This  method  works  well  to  prevent  mixing  of  
•  There  should  be  a  deep  sink  with  hands-­‐free  controls   contaminated  and  sterile  items  in  a  small  
for  instrument  rinsing.   steriliza3on  area.  

Contaminated  Area  
•  All  soiled  instruments  are  brought  into  the  
contaminated  area.  
•  Any  disposable  items  not  already  discarded  in  the  
treatment  room  are  disposed  of  as  contaminated  
waste.    
•  The  contaminated  area  contains  clean  protec3ve  
eyewear  and  u3lity  gloves,  counter  space,  a  sink,  
a  waste  disposal  container,  holding  solu3on,  
ultrasonic  cleaner,  eyewash  sta3on,  and  supplies  
for  wrapping  instruments  before  steriliza3on.      
•  Note:  Soiled  and  clean  instruments  are  never  
stored  in  the  same  cabinet.  

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Ultrasonic  Cleaning  
NEUTRAL pH DETERGENT   •  Used  to  loosen  and  remove  debris  from  instruments  
and  reduce  the  poten3al  of  hand  injuries  from  cuts  
and  punctures  during  the  cleaning  process.  
•  Puncture-­‐resistant  u3lity  gloves,  a  mask,  protec3ve  
•   Mechanically  clean   eyewear,  and  a  protec3ve  gown  should  always  be  
•  Ultrasonic   worn  when  using  the  ultrasonic  cleaner.  
•  Instrument   •  The  ultrasonic  cleaner  works  by  producing  sound  
disinfector   waves,  which  are  beyond  the  range  of  human  
hearing.    
•   Neutral  pH  detergent   •  The  3me  may  vary  from  5  to  15  minutes,  depending  
on  the  amount  and  type  of  material  on  the  
instruments,  and  the  efficiency  of  the  ultrasonic  unit.    

Ultrasonic  Cleaning  Solu3ons  

ULTRASONIC CLEANER   •  Use  ONLY  the  ultrasonic  solu3ons  that  are  specially  
formulated  for  use  in  the  ultrasonic  cleaner.      
•  DO  NOT  use  other  chemicals  such  as  plain  
Cavita1on   disinfectants  in  the  ultrasonic  cleaner.  
•  Specific  ultrasonic  solu3ons  are  available  that  
-­‐  Microscopic  
remove  difficult  materials,  such  as  cements,  tartar,  
bubbles  that  
stains,  plaster,  and  alginate.  
collapase  and  
remove  debris     •  The  ultrasonic  cleaning  unit  should  be  labeled  with  
both  a  chemical  label  and  a  biohazard  label  because  
it  contains  a  chemical  and  contaminated  
instruments.    

Automated  Instrument  Washers/  Disinfectors  

•  Automated  instrument  washers/disinfectors  look  and  
work  very  much  like  a  household  dishwasher.  
•  They  must  be  approved  by  the  U.S.  Food  and  Drug  
Administra3on  (FDA)  for  use  with  dental  instruments.  
•  These  units  use  a  combina3on  of  very  hot  water  
recircula3on  and  detergents  to  remove  organic  material,  
and  then  instruments  are  automa3cally  dried.  
•  They  have  a  disinfec3ng  cycle  that  subjects  the  
instruments  to  a  level  of  heat  that  kills  most  vegeta3ve  
microorganisms.  
•  Instruments  processed  in  the  automa3c  instrument  
washers/disinfectors  must  be  wrapped  and  sterilized  
before  use  on  a  pa3ent.  

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RINSE AND DRY   STEP 2 - INSPECTION  

Inspect  each  
Prior  to  packaging   instrument  for  
remaining  debris  
or  damage:  
•  Rinse  
•  Dry   As  needed  
• Reclean  
• Replace  

RECLEAN or REPLACE?
STEP 3 - PACKAGING  

• Clean  area  
• Low  contamina1on  
• FDA  approved  materials  only  
•    Pouches  or  Tubing  
•    CSR  wrap  

Internal  and  External  Indicators  

PACKAGING with Pouches    

Available  in  self  

seal  or  heat  seal    
design  for  use  with:  
Steam  
Dry  heat    
Chemical  vapor  

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REUSABLE or DISPOSABLE?  
PACKAGING with Pouches  
Select  appropriate    
size  and  be  sure  to  
Select  appropriate     use  2  sheets  to  meet    
size  and  be  sure     the  manufacturer’s    
w

to  not  over  load   performance  claims.  
instruments  as  
Add  mul1parameter    
to  hinder  sterilant     chemical  indicator    
contact.   inside  each  pack.  

PACKAGING with CSR Wrap     PACKAGING with CSR Wrap    

• Instrument  casseRes    
• Instrument  trays  

STEP 4 - STERILIZATION  
•  Place  pouched  items  
on  top  shelf,  using  a  
rack    

•  Wrapped  packs    (being  

heavier)  should  be  
placed  on  the  lower  
shelf.    

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STEAM UNDER PRESSURE   OTHER STERILIZERS. . .  

Example  of  exposure   Although  the  CDC    

1mes:     recommends  STEAM    
steriliza1on  where    
•  250°F/121°C  for     possible,  Chemical    
         15  -­‐  40  minutes   vapor  and  Dry  heat    
sterilizers  are  also    
•  270°F/132°C  for     used  in  dental    
         3.5  -­‐  12  minutes   offices.      

CHEMICAL VAPOR   CHEMICAL VAPOR  

           Limita1ons:  

Load  size:  maximum  weight  =  3.3  lbs  per  load.  

Packaging:    paper/plas1c  pouches  or  disposable  wrap  

     only  –  do  not  use  linen,  tex1les  or  fabrics.    
 Also,  no  sealed  containers,  nylon  tubing  
     or  nylon  bags.  

CI’s  &  BI’s:    use  only  FDA  approved  indicators.  

DRY HEAT - Convection

DRY HEAT - Convection              Limita1ons:  
Load  size:          
CDC  recommends     •  Larger  loads  will  need  long  exposure  1mes.  
•  320°F    
•  1  to  2  hours   Packaging:      
•  Paper  bags  at  lower  temperatures  
•  Use  nylon  tubing  or  bags  at  higher  temperatures  
Limita1ons:  
•  No  linen  or  disposable  CSR  wraps.  
•  Load  size  
•  Packaging   CI’s  &  BI’s:      
•  Special  CI’s  &  BI’s   •  Use  only  FDA  approved  indicators.  

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Correct  Loading  of  a  Steam  

Sterilizer  
Sta3m  

Dry  Heat  Sterilizer  

DRY HEAT - Rapid Heat Transfer  
375°F  for  as  liRle    
as  6  min.  total    
1me,  unwrapped.  

Limita1ons:  
•  Load  size  
•  Packaging  
•  Special  CI’s  &  BI’s  

DRY HEAT - Rapid Heat Transfer

STEAM: THE PREFERRED  
           Limita1ons:   CDC  as  the  sterilizing  
process  of  choice,  
where  possible.  
Load  size:  Very  small  sterilizer  chambers.  
Advantages:  
Packaging:    Nylon  tubing  or  bags  only.  
     No  paper  or  paper/plas1c  pouches,   •  Fast  &  reliable  
     No  linen  or  disposable  CSR  wraps.   •  Choice  of  packaging  
•  Choice  of  CI’s  &  BI’s  
CI’s  &  BI’s:    Use  only  FDA  approved  indicators.  

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STERILIZATION   STEP 5 - STORAGE & DELIVERY  

Try  to  ensure    
The  storage  area    
that  all  the  packs  
for  sterilized  packages:    
are  completely    
•  Clean  
dry  before    
•  Dry  
removal  from    
•  Away  from  
the  sterilizer.   contamina1on  

STERILITY MAINTENANCE  
OPEN AT POINT OF USE  
Remember:    
Sterility  is  event-­‐related  -­‐  NOT  1me-­‐related:     Opening  sterile  packages  
•  inspect  packs     at  the  point  of  use:  
•  do  not  use   •  ensures  pa1ents’  
•  if  opened   confidence  
•  damaged       •  Compliant  with  CDC  
asep1c  prac1ces.  

STEP 6 - QUALITY ASSURANCE   CHEMICAL INDICATORS  

Chemical  indicators   Indicators  will  turn  

with  heat  alone:  
printed  on:  
•  not  a  sterility  
•  pouches     indicator  
•  autoclave  tape   •  only  a  process  
indicator  

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MULTI-PARAMETER CI’s   INSIDE EVERY POUCH  

Chemical     •  Mul1parameter  indicator    
indicators  that  
turn  when  all   •  Remove  excess  air  before  sealing  
condi1ons  for  
steriliza1on  are  
met  are  called    
mul1parameter  
indicators.  

Embedded  Internal  Indicator  

SPORE TESTING  
Biological  indicators    
(spore  tests)    
prove  steriliza1on    
was  achieved  and    
should  be  run    
weekly  in  a  full  
load,  along  with    
the  other  packs.  

IN-OFFICE SYSTEM   IN-OFFICE SYSTEM  

STEAM  
Self-­‐contained  BI’s    
have  spores  and          Addi3onal  example  of  
media  in  a  plas1c  vial.   biological  indicators  
for  sterilizer  
The  vial  is  ac1vated    
monitoring  via  spore  
ader  processing,    
then  incubated  for  
ampules  
48  hrs.  at  56°C.  

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IN-OFFICE SYSTEM   MAIL-IN SYSTEM  

Steam,  Dry  heat,  EO   ALL  Processes  -­‐  
or  Chemical  vapor   Steam,  EO  gas,                    
Dry  heat  or  C-­‐vapor  
Process  strip,    
then  transfer  to     Some  users    
media.    Incubate   prefer  to  mail-­‐in    
at  56°C  for  Steam  &     their  test  to  an  
C-­‐vapor  or  37°C  for     independent  Lab  
for  3rd  party    
EO  Gas  &  Dry  heat.  
verifica1on.  

PassPort®Plus SYSTEM
STERILIZER FAILURE?  
An  Immediate     Human  error  is  the  
Read-­‐out  Mail-­‐In   most  common  
BI  System   cause:  
•  Cold  start  
…cer1fied  for  use  
•  Wrong  cycle  
with  all  Steam    
cycles  (gravity,     •  Overloading  
vacuum  or  flash).   •  Improper  packaging  

Remember and use these 6 steps

for proper sterilization...  
 1.  Cleaning  
 2.  Inspec1on    
 3.  Packaging  
 4.  Steriliza1on    
 5.  Storage  &  Delivery  
 6.  Quality  Assurance  Program  

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