STANDARD TECHNIQUES FOR STERILIZATION OF LAPAROSCOPY INSTRUMENTS BY DR SHASHWAT JANI

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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4. ‘Critical’ equipments
require
Sterilization /
High level disinfection
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Dr Shashwat Jani.
99099 44160.
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5. Definition
No Type Vegetative TB
bacilli
Spore
1 Low level
disinfection
+ - -
2 Intermediate
level disinfection
+ + -
3 High level
disinfection
+ + (+)
4 Sterilization + + +
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99099 44160. 5

6. Sterilization Cycle
Surgery
Storage/Transport
Soaking Washing
Sterilization
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99099 44160.
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7. Essential to perform the steps in
correct order . . .
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99099 44160.
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1) Dismantling,
2) Decontamination,
3) Pre cleaning,
4) Cleaning and rinsing,
5) Drying
6) Sterilization and
7) Storage.

8. Washing
Need:
•Good Quality water
•Detergent
•Enzyme preparations
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Dr Shashwat Jani.
99099 44160.
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9. Washing / Cleaning
Disassemble
Visual Check
Manual, mechanical or ultrasonic cleaning
Rinse & Dry
LubricationAssemble
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99099 44160.
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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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21. 26-Feb-18
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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Dr Shashwat Jani.
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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Dr Shashwat Jani.
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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Dr Shashwat Jani.
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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Dr Shashwat Jani.
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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Dr Shashwat Jani.
99099 44160.
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31. CIDEX (contd.)
• STERILIZATION-12-14 hrs
• DISINFECTION-15-20MINS
Heat sensitive & disposable
materials
-corrugated drains
-suction tubes
-Catheters
-Laparoscopes etc.
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Dr Shashwat Jani.
99099 44160.
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32. Formalin Chambers
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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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Dr Shashwat Jani.
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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Dr Shashwat Jani.
99099 44160.
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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
26-Feb-18
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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42. 26-Feb-18
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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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99099 44160.
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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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Dr Shashwat Jani.
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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Dr Shashwat Jani.
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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Dr Shashwat Jani.
99099 44160.