Prof. Burhan Uddin Khan Professor Dept. Surgery Holly Family RCMCH Sterilization in Endo-Laparoscopy ETO Autoclave Hot air Oven
History of sterilization Few definitions require for understanding sterilization process Why sterilization is important for endo-laparoscopy? Process of sterilization
History Hippocrates (460-377 BC) Irrigated wounds with wine or boiled water Foreshadowing of Asepsis
History Marcus Varro (117-26BC): proposed germ theory, invisible creature causes infection
Antony Von Leeuenhoek (1683): invented the microscope, bacteria could be seen
Lord Joshep: identify surgical infection Lister: infection could be prevented from air borne microbes Robert Koch: introduced steam sterilization
Pasteur (1862) Developed Pasteurization process History:
Advanced Sterilizer Low temperature system for endoscopic devices (1989) Plasma sterilizing system (1993)
CLEANING It is a process which removes visible contamination but does not necessarily destroy micro organisms. It is a necessary prerequisite for effective disinfection or sterilization . ASEPSIS Term used to describe methods which prevent contamination of wounds and other sites, by ensuring that only sterile object and fluids come into contact with them. DEFINITIONS
ANTISEPSIS It is the procedure or application of an antiseptic solution to an agent which inhibits the growth of microorganisms, remaining in the contact with them. DISINFECTION it is a process which reduces the number of viable microorganisms to an acceptable level but may inactive for some viruses and bacterial spores. STERLIZATION it is the process of destruction or removal of all microorganism from article, surface or medium, including spores.
Sanitizing - process that reduces microbial population on object to a safe level. Decontamination - process that removes pathogenic microorganisms from an object to make it safe to handle.
Disinfection Process that eliminates defined pathogens, n ot all microbial forms Main difference with sterilization = the lack of sporocidal activity Categorized into 3 levels: – High, – Intermediate – Low
Why sterilization is important in Endo-laparoscopy ?
HBV, HCV Cirrhosis
HIV (RNA-Virus) AIDS patient AIDS
MDRT tuberculosis
Vertical : mother to child Horizontal : blood transfer : sexual intercourse : drug abuser : surgery Mode of transmission Now Endo-laparoscopy is burning issue of transmitting communicable diseases in third world country.
Legislation in sterilization Varies from country to country Germany: steam autoclaving at 134 0C for 5min. France: steam autoclaving at 134 0C for 18 min. USA: Manufacturer’s gauideline Bangladesh !!!!
Dismantling Decontamination Pre-cleaning Cleaning and rinsing Drying Sterilization Storage Process of sterilization For proper processing, it is essential to perform the steps in correct order
Cleaning Disassemble the instruments Immersed completely in distilled water Thorough cleaning [remove debris, mucous, blood & tissue-bioburden]. Instruments those have irrigation channel, irrigate under pressure with water. [The first step of sterilization process]
MANUAL CLEANING Simplest and the cheapest method, but time consuming and difficult to achieve. heavy duty gloves and glasses must be worn to protect needle stick injury and to protect eye. Material used for manual cleaning -Soaps -Detergents
Ultrasonic technology for cleaning
ULTRASONIC CLEANING Principle - conversion of electrical energy into vibratory sound waves which pass through a soap solution containing the instrument. Used mainly for burs, bone files, bone cutter, artery forceps, saw etc.
MECHANICAL WASHING Principle - High-pressure jets of water with or without a detergent which removes debris from instrument. Small instrument like burs, blade are not suitable for this type of cleaning.
High pressure : 15-20 lbf/in 2 High temperature: 121-126 ℃ Time depend on T & P: 30 min the most completely reliable sterilization Autoclaving (Steam under Pressure) Sterilization process Unfortunately endo-lap instruments are not suitable for autoclaving
Only if autoclaving, dry heat, gas sterilization is NOT available (for metal, glass or rubber stuff) Minimum period is 20 min Period can be decreased to 10 min safely in addition of alkali Not effective against spore unless period >1 hour Dip in completely Time Calculation Boiling Not suitable for endo-lap instruments
Heat and moist sensitive medical device : Eto (ethylene oxide gas, Eto-Co2, CFC, HCFC): 3-6 h is required. Low-temperature sterilization system: H2O2 gas plasma: < 1h Peracetic acid, OZONE Sterilization process
Mechanism of action of chemical disinfectants The mechanism of action of most of the chemicals are nonspecific and complex but most of them affect microorganisms by one of the following mechanisms. Cell membrane injury. Coagulation and Denaturation . Interactions with functional groups of proteins.
Glutaraldehyde 2% ( Cidex ) Non corrosive Minimal harmful effect on the instrument Completely immersed for 10h at 25 0C in especially designed tray. After immersion item must be rinsed with water thoroughly prior to use Can be used maximum 15 times/21 days after activation which is earlier. Keep at least 40 min for disinfection Sterilization process
Formaldehyde Specially designed airtight formalin chamber 8-10 formalin tablets wrapped with moist gauze piece should be placed in the chamber and door should be closed. 12-24 hrs required to effective Can carry from one hospital to another Irritant to eye and nasal passages Carcinogenic effect Sterilization process
Sterilization process Cidex-OPA (orthopthalaldehyde) Effective against glutaraldehyde resistant mycobacterium
2% Glutaraldehyde 30 min 10% F ormaldehyde 20-30min 70% Ethanol 30 min 1:1000 Bromo Geramine 30 min 1:1000 Chlorhexidinium 30 min For delicate instrument, endoscope or laparoscope Soak Cleaning in Antiseptics
Formaldehyde : A broad-spectrum antimicrobial agent, used for disinfection, has limited sporicidal activity. Hazardous substance, inflammable and irritant to the eye, skin and respiratory tract. Glutaraldehyde : It is a high level disinfectant A solution of 2% glutaraldehyde ( Cidex ), requires immersion of 40 minutes for disinfection; and 6 to 10 hours of immersion for sterilization.
Key consideration Packing of the items after sterilization Monitoring the sterilization process Shelf life of the sterilized items Cost implications
Aseptic storage The maintenance of sterility during transportation and storage is of utmost importance. Instruments are kept wrapped until ready for use . To reduce the risk of contamination, sterile packs must be handled as little as possible. Sterilized packs should be allowed to cool before storage; otherwise condensation will occur inside the packs. To prevent contamination from rodents, ants, and cockroaches, the store must be subjected to adequate pest control . Materials should be stored at least 8” off the floor and 18” from the ceiling Sterile packs must be stored and issued in correct date order. The packs, preferably, are stored in drums which can be locked. Preset trays and cassettes, are useful as, the instruments can be organized as per the procedure