PROBLEMS OF STERILISATION

OBJECTIVES IDENTIFY STANDARD TECHNIQUES AND CURRENT GUIDELINES WHAT ARE THE PRACTICAL DIFFICULTIES FACED IN RURAL & SEMI URBAN SETUPS SUGGESTIONS TO IMPROVE THE EFFICIENCY

DEFINITIONS CLEANING Removal of soil & redn in no of microorganisms from surface by washing in detergents DISINFECTION Inactivation of non-sporing organisms using either heat & water (thermal ) or by chemical means

STERILISATION A validated physical or chemical process that is used to render a product free of all forms of viable micro organisms

CLEANING CLEANING SINK RINSE IN LUKEWARM WATER / REMOVE VISIBLE BLOOD & BODY SUBSTANCES DISMANTLE THE ITEMS IF ABLE FULLY IMMERSE IN WARM WATER & USE DETERGENT / SCRUB WITH BRUSH

CLEANING RINSE THE INSTRUMENT IN RUNNING HOT WATER DRY THE INSTRUMENTS Air dry / Sterile Disposable Paper towel / Clean nonlined cloth WEAR GLOVES / WASH HANDS BEFORE & AFTER CLEANING BETTER WIPE BLOOD & TISSUE WHEN WET, DURING SURGERY

ENZYMATIC CLEANERS HAZARDOUS NOT FOR ROUTINE USE CONCEALED DEBRIS – DIFFICULT TO CLEAN ULTRACISION SCISSORS ENDOSCOPES

ULTRASONIC CLEANERS HIGH FREQUENCY HIGH ENERGY WAVES JOINTED AND SERRATED STEEL INSTRUMENTS LOOSENS AND DISLODGES SOIL FOLLOW BY RINSING IN WATER DOES NOT STERILISE INSTRUMENTS

Cleaning- ultrasonic cleaners objects are cleaned by ultrasonic cavitations Microprocessor based ultrasonic cleaning system used in hospitals is a two chamber or three chamber cleaning machine consisting of Ultrasonic tank, Rinsing tank,  Drying tank.

DISINFECTION CRITICAL - OBJECTS WHICH ENTER NORMALLY STERILE TISSUE OR THE VASCULAR SYSTEM OR THROUGH WHICH BLOOD FLOWS SHOULD BE STERILE. SEMICRITICAL - 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. NONCRITICAL -OBJECTS THAT TOUCH ONLY INTACT SKIN REQUIRE LOW-LEVEL DISINFECTION.

CHEMICAL STERILISATION MANY CHEMICALS ARE AVAILABLE TO STERILIZE, DISINFECT OR SANITIZE NONE IS THE “IDEAL” AGENT CHEMICALS PENETRATE CELL WALLS AND REACT WITH CELL COMPONENTS IN VARIOUS WAYS TO DESTROY OR INHIBIT GROWTH MANY CHEMICALS ARE DISINFECTANTS WITH VARYING LEVELS OF EFFICACY SOME ARE STERILANTS

CHEMICAL STERILISATION GLUTARALDEHYDE (> 2.0%) HYDROGEN PEROXIDE-HP (7.5%) PERACETIC ACID-PA (0.2%) HP (1.0%) AND PA (0.08%) HP (7.5%) AND PA (0.23%) GLUT (1.12%) AND PHENOL/PHENATE (1.93%)

ETHYLENE OXIDE ALDEHYDES VAPOR PHASE H2O2 HALOGENS PHENOLS High-cidal Activity ETHYLENE OXIDE ALDEHYDES VAPOR PHASE H2O2 HALOGENS PHENOLS 7TH GENERATION QUATERNARY ALCOHOLS CHLORHEXIDINE OLD GENERATION QUATERNARY Low-cidal Activity

CIDEX GLUTARALDEHYDE - INEXPENSIVE ADVANTAGES DISDVANTAGES GOOD ACTIVITY AGAINST SPORES, VIRUSES, FUNGI DISDVANTAGES GLUTARALDEHYDE ONLY MODERATELY ACTIVE AGAINST TB NEED LONG EXPOSURE TIME FOR FULL EFFECT (>3 HOURS) FRESHNESS & PH CRITICAL TOXIC!

CIDEX NEEDS ACTIVATOR 14 DAY USE LIFE 2 YEAR SHELF LIFE ( sodium bicarbonate) 14 DAY USE LIFE 2 YEAR SHELF LIFE NONCORROSIVE GOOD FOR PLASTICS, RUBBER, LENSES IN “COLD STERILIZATION” NOT INACTIVATED BY ORGANIC MATERIAL OR HARD WATER IRRITATING TO RESPIRATORY TRACT AND SKIN

PERASAFE EXTREMELY RAPID ACTION A TOTAL BIOCIDAL SPECTRUM SAFE AND NON-TOXIC TO USERS NON-CORROSIVE DOES NOT 'FIX' PROTEINS ENVIRONMENTALLY FRIENDLY STERILISES IN 10 MINUTES DISINFECTS IN 5 MINUTES 100% BIO-DEGRADABLE, NO SPECIAL DISPOSAL PROCEDURES.

IS DISINFECTANT STERILE? MANY REPORTED CASES OF GRAM-NEGATIVE ORGANISMS LIVING IN DISINFECTANTS!

TIPS DO NOT TOP UP OLD SOLUTION DO NOT DILUTE THE SOLUTION INSTRUMENTS SHOULD SUBMERGE DO NOT OVERLOAD USE STERILE METALLIC TRAY DISCARD AFTER EXPIRY RINSE FOR STIPULATED TIME

FORMALIN CHAMBER CLEAN THE INSTRUMENT THOROUGHLY BEFORE ARRANGING THEM IN THE TRAY. 8 - 10 FORMALIN TABLETS SHOULD BE KEPT EXPOSED IN THE CABINET FOR OVERNIGHT VAPOR SATURATION. THEREAFTER ONLY TWENTY TO SIXTY MINUTES OF EXPOSURE WILL BE REQUIRED TO ENSURE SATISFACTORY STERILIZATION. TIME PERIOD DEPENDS ON THE CONCENTRATION OF FORMALIN AND INSTRUMENT SOILING

AUTOCLAVES

AUTOCLAVE ADVANTAGES CONSISTENTLY ACHIEVES COMPLETE STERILITY INEXPENSIVE AND EASY TO OPERATE SAFE FOR MOST SURGICAL INSTRUMENTS AND EQUIPMENT, DRAPES AND GOWNS, SUTURE MATERIALS, SPONGES AND SOME PLASTICS AND RUBBERS SAFE FOR PATIENTS AND PERSONNEL ESTABLISHED PROTOCOLS AND QUALITY CONTROL INDICATORS ARE EASY TO ACCESS

FUNCTION COMPLETE STERILIZATION OF MOST ITEMS IS ACHIEVED AFTER 9 TO 15 MINUTES EXPOSURE TO 121° C (250° F) STEAM AT SEA LEVEL IS 100° C (212° F) AS PRESSURE IS INCREASED THE TEMPERATURE OF THE STEAM INCREASES THE MINIMUM EFFECTIVE PRESSURE OF THE AUTOCLAVE IS 15 POUNDS PER SQUARE INCH WHICH PROVIDES STEAM AT 121° C (250° F) MANY AUTOCLAVES ATTAIN 35 PSI WHICH CREATES STEAM TEMPERATURE OF 135° C (275° F)

ACTION OF MOIST HEAT STEAM CONTACTS A COOLER SURFACE, CONDENSES, CAUSING A HUGE DECREASE IN VOLUME AND SETTING UP A NEGATIVE PRESSURE THAT DRAWS MORE STEAM. CONDENSATION OCCURS AS LONG AS THERE IS A TEMPERATURE DIFFERENTIAL . ACTION OF STEAM : SURFACE HEATING, PENETRATION, AND PROTEIN COAGULATION

AUTOCLAVE TYPES GRAVITY DISPLACEMENT AUTOCLAVE PREVACUUM AUTOCLAVE

AUTOCLAVE Types Gravity displacement Water is heated in a chamber Continued heating creates pressure Steam displaces air within the chamber forcing it out through a vent Cycle timing begins when the temperature reaches at least 121°C

Gravity displacement After sufficient exposure time, steam is exhausted through a vent back into a reservoir Air that has been sterilized within the jacket and then filtered is admitted back into the chamber to replace the exhausting steam If the chamber is loaded improperly or there is insufficient steam, there will be air pockets remaining in the chamber that will interfere with steam penetration and result in non-sterile areas THE LOAD MUST BE DRIED WITHIN THE AUTOCLAVE

AUTOCLAVE Types Prevacuum Usually a much larger and more costly machine Equipped with a boiler to generate steam and a vacuum system Air is taken out of the loaded chamber by means of the vacuum system Steam at 121°C or more is introduced into the chamber The steam immediately fills the chamber to eliminate the vacuum Exposure time begins immediately At completion of the cycle steam is vacuumed and replaced by hot, dry sterile air Air pockets are eliminated and processing times are reduced due to the vacuum

FLASH AUTOCLAVE 132OC FOR 3 MIN AT 27-28 LBS PRESSURE IN GRAVITY USED FOR UNWRAPPED ITEMS THAT MUST BE USED IMMEDIATELY ITEMS THAT CANNOT BE PACKAGED, STERILIZED AND STORED BEFORE USE IMPLANTED SURGICAL DEVICES SHOULD NOT BE FLASH STERILIZED

FLASH AUTOCLAVE ITEM DECONTAMINATED; STERILIZER FUNCTION MONITORED BY MECHANICAL, AND BIOLOGICAL MONITORS NOT FOR REASONS OF CONVENIENCE, AS AN ALTERNATIVE TO PURCHASING ADDITIONAL INSTRUMENT SETS, OR TO SAVE TIME

FLASH STERILISER

Et O STERILISER

Et O STERILISATION ADVANTAGES VERY EFFECTIVE AT KILLING MICROORGANISMS PENETRATES MEDICAL PACKAGING AND MANY PLASTICS COMPATIBLE WITH MOST MEDICAL MATERIALS CYCLE EASY TO CONTROL AND MONITOR DISADVANTAGES TOXIC, CARCINOGENIC, EXPLOSIVE POTENTIAL HAZARD TO PATIENTS AND STAFF LENGTHY CYCLE/AERATION TIME

GAS PLASMA STERILISER The Vacuum Phase The Injection Phase The Diffusion Phase The Plasma Phase

H2 O2 GAS PLASMA ADVANTAGES SAFE FOR THE ENVIRONMENT AND HEALTH CARE WORKER; IT LEAVES NO TOXIC RESIDUALS FAST - CYCLE TIME IS 45-73 MIN AND NO AERATION NECESSARY USED FOR HEAT AND MOISTURE SENSITIVE ITEMS SINCE PROCESS TEMPERATURE 50OC SIMPLE TO OPERATE, INSTALL, AND MONITOR COMPATIBLE WITH MOST MEDICAL DEVICES

DISADVANTAGES CELLULOSE (PAPER), LINENS AND LIQUIDS CANNOT BE PROCESSED STERILIZATION CHAMBER IS SMALL, ABOUT 3.5FT3 TO 7.3FT3 REQUIRES SYNTHETIC PACKAGING (POLYPROPYLENE) AND SPECIAL CONTAINER TRAY

NEWER H2 O2 GAS PLASMA

STERIS ADVANTAGES RAPID CYCLE TIME (30-45 MIN) LOW TEMPERATURE (50-55OC) LIQUID IMMERSION STERILIZATION ENVIRONMENTAL FRIENDLY BY-PRODUCTS (ACETIC ACID, O2, H2O) FULLY AUTOMATED NO ADVERSE HEALTH EFFECTS COMPATIBLE WITH WIDE VARIETY OF MATERIALS EXCELLENT MICROBIAL KILLING

DISADVANTAGES POTENTIAL MATERIAL INCOMPATIBILITY USED FOR IMMERSIBLE INSTRUMENTS ONLY BIOLOGICAL INDICATOR NOT SUITABLE SMALL NUMBER OF INSTRUMENTS CAN BE PROCESSED IN A CYCLE MORE EXPENSIVE POINT-OF-USE SYSTEM, NO LONG-TERM STORAGE

STERIS

REUSE OF DISPOSIBLES DANGEROUS FOR BOTH THE PATIENT AND THE RE-USER. PLASTIC MATERIALS MAY BECOME BRITTLE, LOSE FLEXIBILITY, CRACK OR DARKEN; INFECTION ARISING FROM INADEQUATE CLEANING, DISINFECTION OR STERILISATION REUSER BEGETS LEGAL LIABILITY OF MANUFACTURER

PROBLEMS FACILITIES DO NOT MEET STANDARDS EQUIPMENT NEEDS UPGRADING NO PROPER DOCUMENTATION NO SURVEILLANCE STAFF POOR PRACTICES OF CLEANING NONUSAGE OF BIOLOGICAL INDICATORS LACK OF TRAINING AND PROTECTION FOR STAFF

FACILITIES DO NOT MEET STANDARDS GOV’T SECTOR PRIVATE PROBLEMS FACILITIES DO NOT MEET STANDARDS GOV’T SECTOR PRIVATE LACK OF FUNDS ECON VIABILITY IMPROPER MAINTAINENCE APATHY IGNORANCE

EQUIPMENT NEEDS UPGRADING PROBLEMS EQUIPMENT NEEDS UPGRADING FINANCIAL REASONS NO ENFORCEMENT “WE DON’T HAVE ANY INFECTION IN OUR HOSPITAL”

NO PROPER DOCUMENTATION GOVT SECTOR PRIVATE NO STAFF IGNORANCE PROBLEMS NO PROPER DOCUMENTATION GOVT SECTOR PRIVATE NO STAFF IGNORANCE NO GUIDELINES

PROBLEMS NO SURVEILLANCE STAFF

POOR PRACTICES OF CLEANING NO GUIDELINES NO TRAINING PROBLEMS POOR PRACTICES OF CLEANING NO GUIDELINES NO TRAINING INSUFFICIENT INSTRUMENTS INCREASED WORKLOAD

NONUSAGE OF BIOLOGICAL INDICATORS IGNORANCE OVERCONFIDENCE PROBLEMS NONUSAGE OF BIOLOGICAL INDICATORS IGNORANCE OVERCONFIDENCE

LACK OF TRAINING AND PROTECTION FOR STAFF PROBLEMS LACK OF TRAINING AND PROTECTION FOR STAFF ASSOCIATIONS SHOULD TAKEUP PROGRAMS NEED FOR WORKSHOPS LITERATURE

Nitrogen dioxide  The unique physical properties of NO2 gas allow for sterilant dispersion in an enclosed environment at room temperature and ambient pressure. Mechanism : degradation of DNA in the spore core through nitration of the phosphate backbone, which kills the exposed organism as it absorbs NO2  NO2 is also less corrosive than other sterilant gases compatible with most medical materials and adhesives rapid lethality and easy removal of the gas allows for shorter overall cycle times during the sterilization lower level of sterilant residuals Patented : Not commercially available worldwide outside of the USA

Ozone cycler For processing reusable medical devices. The sterilizer creates its own sterilant internally from USP grade oxygen, steam-quality water and electricity; the sterilant is converted back to oxygen and water vapor at the end of the cycle  ozone process is compatible with a wide range of commonly used materials including stainless steel, titanium, anodized aluminum, ceramic, glass, silica, PVC, Teflon, silicone, polypropylene, polyethylene and acrylic. The process should be safe for use by the operator because there is no handling of the sterilant, no toxic emissions, no residue to aerate, and low operating temperature means there is no danger of an accidental burn. 

Ultraviolet Radiation (UV) The application of UV radiation in the health-care environment (i.e., operating rooms, isolation rooms, and biologic safety cabinets) is limited to destruction of airborne organisms or inactivation of microorganisms on surfaces UV radiation has been employed in the disinfection of drinking water, air , titanium implants, and contact lenses

Gamma rays Gamma rays pass readily through plastics and kill bacteria by breaking the covalent bonds of bacterial DNA Gamma radiation is ideal for: Sterilization of single-use medical supplies such as syringes, implants, catheters, IV sets, surgical gloves, gauze and more Elimination of organisms from pharmaceuticals such as ointments and solutions

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