1. Cleaning, Maintenance & Sterilization in Laparoscopic Surgery

2. What is minimum in sterilisation ??
Can we compromise in instrument sterility ???
If so to what an extent ???
What is the effect ???

3. Stresilisation/ Disinfection / Decontamination
Sterilisation - 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

4. Sterile Critical Semi-Critical Non-Critical
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

5. Laparoscopic Instruments sterilization – what is minimum?
CDC guideline 2008
Although sterilization is preferred, no reports have been published of outbreaks resulting from high-level disinfection, when they are properly cleaned and high-level disinfected.
High level disinfection for HBV, HCV, HIV or TB contaminated devices
Membership survey :
10,000 Laparoscopic Gynecological procedures with High level disinfection  Infection rate < 0.3%
Put the ref.
Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 , William A. Rutala et al and the Healthcare Infection Control Practices Advisory Committee (HICPAC)3

6. Decontamination
It’s a combination of procedures used to make a reusable item safe for further use by staffs on patient’s by reducing bio burden. It has to be performed before disinfection/sterilization
Use
Inspect
Transport
Disinfect
Clean
Storage
Sterilization
Pack

7. Laparoscopic instruments
Complex in design and delicate in construction
Blood & tissue enter into the channels
Problems
Lodging of bioburden in the crevices
Gentlest methods need to be used for cleaning and sterilization

8. Cleaning path On table – wipe / keep in water bowls
Running water – decrease the organic load
(+ve pressure due to CO2 drives blood & debris into channels)
Dismantle & clean the channels
Dip in detergent & enzymes solution
Clean the channel, joints & serrations
Brush (preferably Nylon) / water jet
Ultrasound cleaner
Drying

9. Substances harmful for Instruments
Saline
Bleaching powder
Iodine based preparations
Abrasive cleaners- Vim powder etc
Laundry detergents
Surgeon’s hand scrub
Soap

10. 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

11. 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.

12. 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

13. Chemical Disinfectants
Ortho-phthalaldehyde(OPA) % 1, 2-benzenedicarboxaldehyde
(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

14. 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.

15. 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

16. Factors affecting efficacy of disinfection & sterilisation
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
Chemical test strips should be used after every 10th cycle

17. 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

18. Don’t Do This

19. Sterilization ע - Irradiation (for industrial use)
Kills all forms of microbial life including bacteria / virus / fungi / spores
Techniques
Steam
121oC x 15 mins at 15 psi
Low temperature steam (73oC)+ formaldehyde
Heat sensitive instruments
Not very popular
Hot air
Inefficient – good only for grease / ointment, oil etc.
ETO
Heat sensitive instruments(Make sure no soiled instrument
Paracetic acid
Denatures protein
Destroy cell membrane
50-56oC x 12 mins
Kills spores
ע - Irradiation (for industrial use)

20. Moist Heat (Autoclave)
Moist heat under pressure
Routinely 121oC for 15 – 30 min
Flash autoclave 132oC
3 min nonporous items
10mins porous items
4 min for nonporous items
4 mins for porous items
Quick penetration in material
Unaffected by presence of organic matter
For linens, metallic instruments, glass, fluids, plastics
In Gravity dependent autoclaves
In Pre-vaccum autoclaves

21. Dry Sterilization Same advantages as that of wet
Temperature range 1210C to 1710C
Disadvantage
Cycle time is longer
16 hrs at 1210C, 1 hr at 1710C
Load capacity is smaller

22. Monitoring Bowie – Davies Tape Biological Indicators
Bacillus stearothermophilus spores  for steam autoclaves
Bacillus subtilis spores  for dry heat sterilizers

23. 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

24. Low Temperature Steam with Gaseous Formaldehyde
An alternative to ETO
But Formaldehyde itself is Toxic & Carcinogenic
Combination of gaseous Formaldehyde saturated steam at 650C
Suitable for heat-labile material eg (moss plastics, non flexible endoscopes & equipments)
B. Subtilis
Monitoring  By spores
B. stearothermophilies

25. Gas Plasma Sterilization (Sterrad)
For temperature & moisture sensitive materials
Mechanism
H2O2 vapours + strong electric field applied
H2O2 in plasma state
Hydroxyl & Hydro-peroxy free radicles
Disrupts cell membranes, enzymes & Nuclic acids
Cell Death
Electric field turned off
Activated compounds recombine to form H2O + O2

26. Gas Plasma Sterilization
Advantage
No toxic by-products
Cycle time 55 to 75 min
No aeration period  instruments immediately ready for use
Disadvantage
Not for linens, powders & liquids
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

27. Formalin Chamber - The Bane of Laparoscopy
Size used: 9” x 9” x 20”
Tablets: 4, 6, 8, 10, 12, 14….???
Minimum exposure time: 24 hour
Ganjawala D, Shah M, Zaveri D.
Efficacy of formalin chamber for disinfection of instruments
Presented to Western India Regional Orthopedic Conference, 2000

28. 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
Don’t shove instruments in a chamber and hop from one hospital to another

29. How Good Is Formalin Chamber ?
Number of Tablets 4 6 8 10 12 14
Vegetative forms - Streaked petridish Dried soiled instrument Spores (Clostridia)
No Effect
No Effect
Ganjawala D, Shah M, Zaveri D.
Efficacy of formalin chamber for disinfection of instruments
Presented to Western India Regional Orthopedic Conference, 2000

30. Right place for this

31. Autoclave / flash autoclave
Cidex
Parasafe
ETO
Gas plasma
Formalin chamber
Sterile sleeve
Camera x ++
+++ +
Light cable
Telescope
Tubings / diathermy
harmonic scalpel cable
Heat sensitive hand instruments
Heat resistant hand instruments
Trocars

32. J Hosp Infect Aug; 45(4):263-77
Decontamination of minimally invasive surgical endoscopes and accessories
Ayliffe G; Minimal Access Therapy Decontamination Working Group
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

33. Ideal disinfectant – Search is on

34. Reuse of disposable instruments
Issues for and against reuse
Does it affect procedural outcomes?
Can disposable instruments be ever cleaned / sterilized adequately?

35. What the literature says?
Reuse of Disposable Laparoscopic Instruments
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 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 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 Oct;10(5):340-1

39. Minimal Access Surgery
Aim is less morbidity & good cosmesis Not this

40. Nosocomial Tubercular infection – a totally avoidable situation
Infect Control Hosp. Epidemiol, 2001 Aug22(8):474-5
Nosocomial Mycobacterium chelonae infection in laparoscopic surgery.
Rodrigues C, Mehta A, Jha U, Bharucha M, Dastur FD, Udwadia TE
Indian J Gastroenterol Nov-Dec;20(6):247-8
Port-site infection with Mycobacterium chelonei following laparoscopic appendicectomy
Bhandarkar DS, Bhagwat S, Punjani R
Scand J Infect Dis. 2002;34(12):928-9
Port-site tuberculosis: a rare compliction following laparoscopic cholecystectomy
Jagdish N, Sameer R, Omprakash R.
Surg Endosc Jun;17(6):930-2 Epub 2003 Mar 07.
Port-site tuberculosis after laparoscopy: report of eight cases
Ramesh H, Prakash K, Lekha V, Jacob G, Venugopal A, Venugopal B
A whopping cost of Rs. 23,800 per nosocomial non-tubercular infection (Baroda 1999)

41. Sterilization of Lap Instruments
What is right?
Are we doing it right?
Consequences of not doing it right
How can we do it right?

42. > 350 surgeons from around the country
- Audience poll with electronic keypads
MAS – Status in India
October 2002, Mumbai

43. MAS – Status in India
October 2002, Mumbai

44. Conclusions Thorough cleaning is an important primary step
Essential to follow rigid protocols for instrument cleaning and sterilization
Only well-established methods of sterilization / high level disinfection should be used
Some current practices should be abolished - formalin chambers - reuse of disposable instruments
It is necessary to establish stringent regulations for the instrument manufacturers

45. Food for thought How many of us would allow either of these
instrument sets to be used if we were
undergoing an open cholecystectomy?

46. Thank you