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Lap instrument.pdf
1. Standard Techniques for
Sterilization Of
Lap. Instruments
Dr. Shashwat Jani.
M. S. ( Obs – Gyn ) , F.I.A.O.G.
Diploma in Advance Laparoscopy.
Consultant Assistant Professor,
Smt. N.H.L. Municipal Medical College.
Sheth V. S. General Hospital , Ahmedabad.
Mobile : 99099 44160.
E-mail : drshashwatjani@gmail.com
2. Sterilization/ Disinfection /
Decontamination
• Sterilization - A process that destroys or eliminates all
forms of microbial life.
• Disinfection - A process that eliminates many or all
pathogenic microorganisms, except bacterial spores, on
inanimate objects
• Decontamination– Removal of all pathogenic micro-
organism from object to make them safe to handle / use
/ discard
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Dr Shashwat Jani.
99099 44160.
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3. CRITICAL - objects which enter normally sterile tissue or the
vascular system or through which blood flows should be sterile.
SEMI CRITICAL - objects that touch mucous membranes or skin
that is not intact require a disinfection process (high-level disinfection
[HLD]) that kills all microorganisms but high numbers of bacterial
spores.
NON CRITICAL - objects that touch only intact skin require low-
level disinfection (or non-germicidal detergent).
Sterile HLD ILD LLD Decontamination
Critical Semi-Critical Non-Critical
Spaulding Classification of Medical Devices
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99099 44160.
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7. Essential to perform the steps in
correct order . . .
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1) Dismantling,
2) Decontamination,
3) Pre cleaning,
4) Cleaning and rinsing,
5) Drying
6) Sterilization and
7) Storage.
10. Cleaning path
On table – wipe / keep in water bowls
Running water – decrease the organic load
Dismantle & clean the channels
Dip in detergent & enzymes solution
Clean the channel, joints & serrations
Brush (preferably Nylon) / water jet
Drying
Ultrasound cleaner
Dr Shashwat Jani.
99099 44160.
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11. Brush
&
Flush
•Junctions between insulating sheaths and
activating mechanisms of laparoscopic instruments
•Articulations and grooves of forceps
•Long narrow lumen of sheaths
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Dr Shashwat Jani.
99099 44160.
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12. Substances harmful for Instruments
Saline
Bleaching powder
Iodine based preparations
Abrasive cleaners- Vim powder etc
Laundry detergents
Surgeon’s hand scrub
Soap
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Dr Shashwat Jani.
99099 44160.
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13. DISINFECTION
Removes and / or Kills the pathogenic micro organisms (SPORES NOT KILLED)
Low
• Reduces overall number of
veg micro organism
• Does not destroy
•TB bacilli spores
• Application – OT table,
floor etc.
Intermediate
• Kills TB bacilli, most
virus, & fungi but only
some spores
• Application – OPD,
where breach of skin /
mucosa is not there
High
• Kills most forms of
microbial life including
TB bacilli & most of the
spores
• Application – scopes
delicate instruments etc.
in minor surgical
procedures
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Dr Shashwat Jani.
99099 44160.
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14. Methods of Disinfection
Low temperature steam – 73oC x 20 mins
Boiling water – 100oC x 5 mins
Formaldehyde – air tight chamber at 50oC x ?
Glutaraldehyde 2% - effective against most bacteria, virus
including hepatitis B & C / HIV.
Cidex solution ( 2.4% alkaline glutaraldehyde) provides high
level disinfection in 20 – 45 mins.
Ortho phthalaldehyde 0.55% (OPA) 12 mins soak time at room
temp.
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Dr Shashwat Jani.
99099 44160.
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15. Chemical Disinfectants
Gluteraldehyde Paracetic acid
- Destroys microorganisms by
alkylation of amino acids
- Efficient bactericidal, fungicidal &
virucidal activity but slow myco-
bactericital activity (> 40 min)
- Once activated shelf life -14 days
- Contact time
- High level disinfection 20 – 90min
- Sterilization 6 – 10 hrs
- Denatures protein & destroy cell
membrane
- 30 min cycle
- Byproducts – are non toxic (Acetic acid,
water, oxygen)
- Maximum reuse period is 14 days
- Effective in presence of organic matter
& at low temperatures
- Has an additional Tuberculocidal
activity
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Dr Shashwat Jani.
99099 44160.
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16. Chemical Disinfectants
Ortho – phthalaldehyde (OPA) –
• Mode of Action
– interact with amino acids, proteins & micro-organisms.
– Superior mycobactericidal activity as compared to that of gluteraldehyde
• Advantage
– More stable
– OPA was effective over a 14-day use cycle
– Less irritant to eyes
• Disadvantage - Stains proteins gray (including unprotected skin)
• Soak time - 12 mins
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Dr Shashwat Jani.
99099 44160.
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17. Chemical Disinfectants
Hydrogen Peroxide –
Bactericidal, Virucidal, Sporicidal & Fungicidal Properties
• Mode of Action –
– Hydroxyl free radicals that can attack membrane lipids, DNA,
and other essential cell components.
– Accelerated hydrogen peroxide(0.5%) --- kills viruses in 1
minute and Mycobacteria and fungi in 5 minutes.
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Dr Shashwat Jani.
99099 44160.
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18. Chemical Disinfectants
Perasafe
0.08% Peracetic acid plus 1.0% hydrogen peroxide
• Mode of action - De natures protein and destroys cell membrane
• Advantage - Effectively inactivates Mycobacteria resistant to
glutaraldehyde
• Soak time - 10 mins
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Dr Shashwat Jani.
99099 44160.
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19. Factors Affecting Efficacy Of
Disinfection & Sterilization
Number and Location of Microorganisms
Innate Resistance of Microorganisms
Concentration and Potency of Disinfectants
Physical and Chemical Factors
[temperature, pH, relative humidity, and water hardness ]
Organic and Inorganic Matter
Prior cleaning
Moisture
Direct contact with the items
Duration of Exposure
Temperature
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Dr Shashwat Jani.
99099 44160.
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20. Safe Use Of Chemical Disinfectant
Check efficacy before use
Use sterilized stainless steel tray for cidex
Avoid using plastic tray for cidex
Thoroughly clean & dry the instruments before putting in cidex
water on instrument changes the pH of cidex
Allow cidex to drip back into the tray
Use gloved hands to pick up the instruments
Lifter should not touch the tray wall (Un sterile!!)
Rinse instruments thoroughly in sterile water (at least 3 times)
Sterilize the sterile water tray!
Dry all the instruments before use
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Dr Shashwat Jani.
99099 44160.
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22. Sterilization Methods
of Laparoscopic Instruments
Steam sterilization
Ethylene Oxide
Chemical Disinfection
Formaldehyde Cabinets?
Newer methods…..
Marshburn PB, Rutala WA, Wannamaker NS, Hulka JF. Gas and steam sterilization of
assembled versus disassembled laparoscopic equipment. Microbiologic studies.
J Reprod Med. 1991 Jul;36(7):483-7
Ayliffe G; Minimal Access Therapy Decontamination Working Group. Decontamination
of minimally invasive surgical endoscopes and accessories.
J Hosp Infect. 2000 Aug;45(4):263-77.
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99099 44160.
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23. Steam Sterilization
• Porous load Vacuum
autoclaves
– Wrapped instruments
– With long narrow lumens
• Temp & Time;
– 121oC 15min
– 134oC 5min
• Useful for
– Mechanical instruments
– Telescopes
Voyles CR, Sanders DL, Simons JE, McVey EA, Wilson WB. Steam sterilization of laparoscopic
instruments. Surg Laparosc Endosc. 1995 Apr;5(2):139-41.
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99099 44160.
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24. Ethylene Oxide Sterilization
• Temp & duration
– 54oC 150min
– 37oC 5 hours
(Aeration cabinet >24hrs)
• Use for
– Heat sensitive items
• Monitor
– Indicator strips
• Dangers to Staffs
– Inhalation injury
– Contact injury
• Expensive
Alfa MJ, DeGagne P, Olson N, Hizon R.
Comparison of liquid chemical sterilization
with peracetic acid and ethylene oxide
sterilization for long narrow lumens. Am J
Infect Control. 1998 Oct;26(5):469-77.
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99099 44160.
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25. Ethylene Oxide
• Useful for wide diversity of medical devices, eg. Plastics, rubbers,
endoscopes, instruments, fluids etc.
• Alkylates N-positions of Guanine in DNA directly
• Disadvantages :
– Carcinogenic & Mutagenic
– Chronic & acute toxicity syndromes
– Standard ETO cycle 285 mins + aeration time – 8 to 24 hrs
– Occupational hazard to workers & environment
• Monitoring with B subtilis spores
So necessary aeration period of 8 to 24 hours
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Dr Shashwat Jani.
99099 44160.
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26. Newer Methods of Sterilization
Gas Plasma sterilization ( STERRAD ) Steris System
•Hydrogen peroxide
•30 min at 500C
•For heat sensitive items
•Small trays/Special packing
•Peracetic acid
•30 min at 500C
•For heat sensitive items
•Point of use system
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Dr Shashwat Jani.
99099 44160.
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27. Gas Plasma Sterilization ( STERRAD )
• Advantage
– No toxic by-products
– Cycle time 55 to 75 min
– No aeration period instruments immediately ready for use
• Disadvantage
– Approved for use on
• Stainless steel devices with lumen > 3mm diameter & length < 40 cm
• Metal & plastic instruments with lumen > 6mm diameter & length < 31 cm
– Cycle turns off, if slightest moisture
– Expensive – Both Equipment and running
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Dr Shashwat Jani.
99099 44160.
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28. High Level Disinfection
Germicides
• Prewash & rinse
• Dwelling time : 45min/20/12
• Shelf life : 2 weeks/4/ 4
• Indicator strips
• Rinsing protocol
• Health hazards to Staffs
•2.4% Glutaraldehyde
•3.4% Glutaraldehyde
•OPA(ortho-
phthalaldehyde)
•Peracetic acid
•Hydrogen peroxide
•Superoxidised water
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99099 44160.
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29. National Survey on sterilization methods
1%
7%
53%
39%
Formalin Chamber Ethylene Oxide
2%Cidex Autoclave
53%
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Dr Shashwat Jani.
99099 44160.
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30. CIDEX
A 2.4% alkaline glutaraldehyde solution
• Fast and effective way to disinfect and sterilize medical devices
and instruments.
• 14 day use
• destroys 99.8% of Mycobacterium tuberculosis in 45 minutes at
25 degrees Celsius
• Cidex Plus (a high-level disinfectant, 20 minutes at 25 degrees
Celsius) is a 3.4% glutaraldehyde solution.
• Cidex OPA (ortho-phthalaldehyde) is compatible with a wide
range of medical devices. Requiring no activation or mixing,
Cidex OPA destroys Mycobacteruim tuberculosis in 12 minutes
at 20 degrees Celsius.
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99099 44160.
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33. Formalin Chamber - The Bane of Laparoscopy
No Standardization
• How much leak
• Chamber- How many times opened in 24hrs
• How many tablets
• Exposure – How many minutes
• Temperature
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99099 44160.
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34. Vegetative forms –
Streaked petridish
Dried soiled instrument
Spores (Clostridia)
4 6 8 10 12 14
Number of Tablets
No Effect
No Effect
How Good Is Formalin Chamber ?
Ganjawala D, Shah M, Zaveri D.
Efficacy of formalin chamber for disinfection of instruments
Presented to Western India Regional Orthopedic Conference, 2000
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35. • 10-15 tabs of HCHO are kept rolled up in
a gauze piece in the lowermost part of
the chambers.
• Change the tablets after 7-10 days.
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Dr Shashwat Jani.
99099 44160.
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36. Autoclave
/ flash
autoclave
Cidex Parasafe ETO Gas
plasma
Formalin
chamber
Sterile
sleeve
Camera
x ++ ++ +++ + ++
Light cable
+ ++ ++ +++ + ++
Telescope
+++ ++ ++ +++ x x
Tubings /
diathermy
x + + +++ +++ + x
harmonic scalpel
cable
x ++ ++ +++ + ++
Heat sensitive hand
instruments
x ++ ++ +++ +++ x x
Heat resistant hand
instruments
+++ ++ ++ +++ +++ x x
Trocars
+++ ++ ++ x +++ x x
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Dr Shashwat Jani.
99099 44160.
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37. • Heat tolerant endoscopes and accessories
- Steam sterilization is the first choice
• Heat sensitive endoscopes and accessories
- ETO / gas plasma / low temp. steam + formaldehyde
• Insufficient instruments / time to sterilize
- Immersion in 2% glutaraldehyde
- At least 25 min
- > 25 min if mycobacterial infection suspected
- At least 4 hrs required to kill spores
J Hosp Infect. 2000 Aug; 45(4):263-77
Decontamination of minimally invasive surgical endoscopes and accessories
Ayliffe G; Minimal Access Therapy Decontamination Working Group
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Dr Shashwat Jani.
99099 44160.
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38. Issues for and against reuse
Does it affect procedural outcomes?
Can disposable instruments be ever cleaned /
sterilized adequately?
Reuse of disposable instruments
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Dr Shashwat Jani.
99099 44160.
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39. What the literature says?
• “Reusing Disposable Laparoscopic Instrument did not change the operative and
postoperative outcomes or the infection rate”
Efficacy and safety of reuse of disposable laparoscopic instruments in laparoscopic cholecystectomy: a
prospective randomized study, Colak T, Ersoz G, Akca T, Kanik A, Aydin S; Surg Endosc. 2004
Aug;18(8):1161-2
• “None of the patients had infection at the wound site or intra-abdominally”
High-level disinfection with 2% alkalinized glutaraldehyde solution for reuse of laparoscopic disposable
plastic trocars, Gundogdu H, Ocal K, Caglikulekci M, Karabiber N, Bayramoghu E, Karahan M, J
Laparoendosc Adv Surg Tech A. 1999 Feb; 9(1): 117-8
• “Disposable laparoscopic instruments with a relatively complex structure is not
effective and may result in nosocomial disease transmission”
Is it possible to resterilize disposable laparoscopy trocars in a hospital setting?, Ulualp KM, Hazaoglu I,
Ulgen SK, Sahin DA, Saribas S, Ozturk R, Cebeci H, Surg Laparosc Endosc Percutan Tech. 2000
Oct;10(5):340-1
Reuse of Disposable Laparoscopic Instruments
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99099 44160.
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43. To Summarize…
• Endoscope disinfection or sterilization with
a liquid chemical sterilant involves five
steps after leak testing:
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44. 2.Disinfect: Immerse endoscope in high-level disinfectant (or
chemical sterilant) and perfuse (eliminates air pockets and
ensures contact of the germicide with the internal channels)
disinfectant into all accessible channels, such as the
suction/biopsy channel and air/water channel and expose for a
time recommended for specific products.
3.Rinse:Rinse the endoscope and all channels with sterile
water, filtered water or tap water
1.Clean: Mechanically clean internal and external surfaces,
including brushing internal channels and flushing each internal
channel with water and a detergent or enzymatic cleaners (leak
testing is recommended for endoscopes before immersion).
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99099 44160.
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45. 4. Dry: Rinse the insertion tube and inner channels with alcohol,
and dry with air after disinfection and before storage.
5.Store: Store the endoscope in a way that prevents
recontamination and promotes drying.
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99099 44160.
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46. Practical Guidelines
Soak them early and wash them well
Cleaning is critical…
Choose the appropriate sterilization method
Choose the one that suits you…
Monitor the Sterilization Process
Ensure reliability & Safety….
Maintain Wound Infection Register.
Always be on the look out for any trouble….
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99099 44160.
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