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INFECTION CONTROL GUIDE

INFECTION CONTROL PRACTICAL GUIDE FOR PRIMARY HEALTH CARE

Topics included 1. Handwashing 2. Surface Cleaning 3. Body Fluid spill Management 4. Clinical Waste Management 5. Sharps Injuries prevention and management 6. Staff Immunization 7. Cleaning of single patient and personal items 8. Instrument Processing 9. Supplementary notes specific to dental surgeries 10. CJD and inactivation of prions

January 2007 Margaret Jennings Microbiologist and Infection Control Consultant to Office Based Practice MARJEN EDUCATION SERVICES Jan 2007 1

INFECTION CONTROL GUIDE

INDEX
1. HAND HYGIENE AND PATIENT SKIN PREPARATION Pages 4 - 7 1.1. Knowledge Objectives 1.2. Introduction 1.3. What Is On The Skin? 1.4. When Is Soap Sufficient And When Is A Skin Disinfectant Required? 1.5. Correct Handwashing Technique To Protect The Skin 1.6. Glove Use, 1.7. The Use Of Alcohol Based Handrubs 1.8. Limitations To Alcohol Use 1.9 Handcream, Jewellery, Acrylic Nails 1.10. Reducing Adverse Effects Of Handwashing And Handrubs. 1.11. Disinfection Of Patient Skin Prior To Surgery 1.12. Hand Hygiene Prior To Wound Care 2. SURFACE CLEANING Pages 8 - 10

2.1. Knowledge Objectives 2.2. Introduction 2.3. Aim Of Regular Surface Cleaning & Maintenance 2.4. Explanatory Information 2.5. Products 2.6. Surface Cleaning Technique 2.7. Changing And Laundering Linen In The Clinical Area Eg. Treatment Room 3. MANAGEMENT OF BODY FLUID SPILLS Pages 11 - 13

3.1. Knowledge Objectives 3.2. Standard Precautions And Additional Precautions 3.3. Principle Of Disinfection And Correct Use Ie Limitations To Disinfection 3.4. Hospital Grade Disinfectants 3.5. How To Safely And Effectively Manage Various Body Fluid Spills 3.6. What A Spill Kit May Contain 3.7. Special Requirements During A Gastro Outbreak 4. CLINICAL WASTE MANAGEMENT 4.1. Knowledge Objectives 4.2. Defining Clinical Waste 4.3. Improving Waste Segregation. 4.4. Improving Safety In Waste Management 4.5. Safe Storage And Disposal Of Clinical Waste 4.6 Clinical Waste Generated During Treatment At Home Pages 14 - 16

MARJEN EDUCATION SERVICES Jan 2007

INFECTION CONTROL GUIDE

5.SHARPS INJURIES PREVENTION AND MANAGEMENT

Pages 17 - 20

5.1. Knowledge Objectives 5.2. Defining Sharps 5.3. How Sharps Injuries And Splash May Occur 5.4. Reducing Sharps And Splash Injuries. 5.5. Immediate Response To An Exposure 5.6 Evaluation Of The Exposure 5.7. After Evaluation Pep, Testing, Counselling, Confidentiality, The Source 5.8. Risk Of Infection Post Exposure, Precautions And Follow Up

6. STAFF IMMUNIZATION 6.1. Knowledge Objectives 6.2 Introduction 6.3. Are Staff At Extra Risk Of Infection? 6.4 Immunizations For HCWs

Pages 21 - 22

7. INSTRUMENT PROCESSING (INCL PERSONAL ITEMS EG SPACERS)

Pages 23 - 39

1 The Standard. 2 Disposable instruments, off site or on site processing? 3 Cleaning, Sterilisation and Validation of instrument processing I. Cleaning of the instrument reprocessing environment. II. Precleaning or initial treatment of used items III. Cleaning by manually or ultrasonic methods and drying IV. Processing of non critical and semi-critical items. V. Packaging, sealing and labelling of instrument packs. VI. Transport of instruments for off site processing and documentation. VII. Loading and unloading of the steriliser. VIII. Settings, monitoring, record keeping and tracking. IX. Storage of sterilised items. X. Validation of the sterilisation process. XI. Steriliser maintenance, service and troubleshooting. 8. SUPPLEMENTARY NOTES APPLICABLE TO DENTAL SURGERIES Pages 40 - 43

9. CREUTZFELDT JAKOB DISEASE AND INACTIVATION OF PRIONS Page 44

10. REFERENCES Page 45

11. PRODUCT LIST AND CONTACTS ADD AREA CODE IF DIALLING OUT OF VIC Page 46

MARJEN EDUCATION SERVICES Jan 2007

INFECTION CONTROL GUIDE

1. HAND HYGIENE AND SKIN DISINFECTION


1.1. KNOWLEDGE OBJECTIVES Recognize which products are suitable for certain procedures Use of correct handwashing technique designed to protect skin and maximise effect Understanding the limit of the barrier provided by gloves use Discriminate between when a hand wash is required or an alcohol hand rub is adequate.

1.2. INTRODUCTION At home, a hand wash with soap and water after using the toilet and changing babies nappies will reduce the spread of infection via hands. In the care or clinical setting, an alcohol handrub is an effective method to control spread of infection where sinks may not be close. Handwashing and handrubbing reduce the risk of direct and indirect spread of infection to sterile or vulnerable tissue and also protect staff. For this section, reference to soap is liquid soap which is detergent based. 1.3. WHAT IS ON THE SKIN? Bacteria and even viruses are normally found on the skin and are referred to as normal flora. This is a combination of resident, transitional and transient microorganisms. Resident flora Resident bacteria multiply within the outer layers of the skin and around sweat glands. They are not removed by soap but they are temporarily suppressed by skin disinfectants such as chlorhexidine. Resident bacteria are a part of our natural defences and protect us from infection. Staff in hospitals may become colonised by an antibiotic resistant organism. Resident flora is not removed with soap for some procedures staff hands require disinfection to temporarily reduce it eg prior to surgery. Transitional flora Transitional flora is acquired by touching objects and surfaces during normal activities the bacteria may persist on the skin for a couple of washes and temporarily colonise the skin. Skin disinfectants are usually required to remove them and this is required when working with susceptible patients in hospital. Antibiotic resistant organisms can act as transitional flora on staff and patient skin eg MRSA. Transient flora Transient bacteria are often contaminants also acquired during daily activities and generally require one soap wash for most to be removed. They may be pathogenic to susceptible patients and removal of such bacteria with a skin disinfectant may be required this may be via a hand wash or a hand rub 1.4. WHEN IS SOAP SUFFICIENT AND WHEN IS A SKIN DISINFECTANT REQUIRED? Liquid soap is often detergent based and contains a skin conditioner to reduce skin damage. It is best purchased as a single use pack inserted into a wall dispenser place directly above the sink to avoid water dripping on the floor. Smaller 500ml pump packs at the sink are also popular. If a refillable container is used, it needs to be washed, rinsed and dried before refilling to reduce carry over contamination. Use formulations developed for health care facilities because these incorporate moisturizer. Bar soap is discouraged but should be kept dry on a drainer. MARJEN EDUCATION SERVICES Jan 2007 4

INFECTION CONTROL GUIDE

A 15-30 second wash with soap will remove most contaminating microorganisms and is adequate for procedures not involving contact with sterile tissue or non intact mucous membranes. However, prior to surgery and when working in areas with drug resistant microorganisms a skin disinfectant is used to temporarily reduce the level of resident bacteria and persistent transient bacteria. Combined with gloves it will provide an effective barrier. The contact time required for surgery is 3-5 minutes and is related to how long it is necessary to keep skin flora reduced whereas prior to caring for a patient a 15 30 second handwash or a 15 second alcohol handrub with or without chlorhexidine is used. Confine skin disinfection to avoid unnecessary use of chemical ie not required in patient or staff toilet. Skin disinfectants should have immediate as well as residual persistent activity. 4% chlorhexidene gluconate in a detergent base or 0.75-1% povidone iodine provides good residual activity against a wide range of bacteria and viruses and is required prior to surgery. 2% chlorhexidine or 1% triclosan is more appropriate for non surgical procedures or non intact mucous membrane contact. When soap is used, the hands in the gloves sweat and bacteria pool in this, making hands extremely contaminated. Therefore it is important to wash and dry hands after all glove use this also removes latex and powder. Skin disinfection combined with glove use reduces the opportunity for bacteria to migrate through glove defects. 1.5. CORRECT HANDWASHING TECHNIQUE TO PROTECT THE SKIN Cover any break in the skin with a water resistant dressing before duty and avoid combining soap with a disinfectant as this may inactivate the disinfectant and cause damage to skin. We spend more time washing the hand we use less ie a right hander will wash the lesser used left hand better - wash both hands equally. Whether soap or disinfectant is used, the following applies. 1. Wet the hands before applying any product in order to reduce skin damage. The volume required will be displayed on the bottle (generally 1 -2 mls). 2. Washing with product involves rubbing hands over each other followed by placing fingers from one hand over the webs of the other with a clenching action for 15-30 seconds (longer prior to surgery). Keep nails short for more effective handwashing. Use a single use soft brush/sponge prior to surgery. 3. Rinse hands well under running water to remove product. When handwashing prior to surgery hold hands higher than elbows while rinsing to prevent contamination by skin flora on forearms. 4. Dry hands thoroughly by patting - wiping may cause skin damage wet hands transfers more bacteria than dry hands. Use paper towel or clean cloth towel (use a sterile towel pre surgery). 1.6. GLOVE USE Hands are washed after glove use to reduce high numbers of bacteria accumulating in sweat and to remove latex and powder. Gloves are used when contact with sharps and non intact tissue and when anticipating contact with all body substances excluding sweat and when cleaning clinical surfaces. Sterile gloves are used for sterile procedures. Nitrile gloves are an alternative to latex. To a void gloves becoming a source of contamination, they are not worn when using a telephone or for more than one task. Over use of gloves and incorrect hand washing technique contribute to skin damage. MARJEN EDUCATION SERVICES Jan 2007 5

INFECTION CONTROL GUIDE

1.7. THE USE OF ALCOHOL BASED HANDRUBS Alcohol based ha ndrubs are used where sinks are not conveniently located or where staff are attending to patients in rapid succession. All alcohol handrubs must incorporate a moisturizer (emollient or skin conditioner) to reduce drying and damage to skin. Alcohol acts rapidly against most microorganisms but evaporates quickly without residual effect. This may be adequate after home visits or between patients if no adequate handwashing facilities are convenient. 60 - 65% ethyl alcohol or 60-70% isopropyl alcohol may be used plain in gel form and will affect bacteria and some viruses within a few seconds this is adequate on wards when moving quickly from patient to patient. However, no activity remains after evaporation. If persistent activity is desirable, this can be achieved by using a product that combines alcohol with 0.5-1% chlorhexidine. Health care facilities may have either alcohol only gels or alcoholic chlorhexidine at patient bedside for staff use. Alcohol is preferably not kept at the sink because it may encourage poor technique and because its use is especially for when there are inadequate handwashing facilities. It has been found that when alcohol is provided, staff hand hygiene compliance improves more than 30%. It has also been shown alcohol may be more effective for both standard handwashing and skin disinfection than water based hygiene. Although the national guideline does not appear to support alcohol based products as a replacement for handwashing, many facilities use it as such especially where multi drug resistant organisms present problems. Such organisms tend to not be removed by just soap.

1.8. LIMITATIONS TO ALCOHOL USE Alcohol has reduced effectiveness against two main causes of gastroenteritis in health care facilities - norovirus and Clostridium difficile. Handwashing is used. Alcohol is inactivated by organic matter so hands must be visibly clean before use. Use the correct volume ie hands should still be wet at 10 seconds but soft by 15 seconds Ensure hands are dry before recommencing duty to reduce defects in gloves and flammability Alcohol and powder from gloves can interact so avoid contact by ensuring hands are dry first

1.9. REDUCING ADVERSE EFFECTS OF HANDWASHING AND HANDRUBS. Use correct technique Use a formulation designed for staff washing hands frequently Reduce unnecessary use of skin disinfectants Avoid prolonged use of gloves Use hand cream twice per day during working hours

1.10 HANDCREAM, JEWELLERY ACRYLIC NAILS Moisture from skin is lost - frequent use of detergent or alcohol dehydrates skin. Handcream should be used 2 -4 times/day and should be compatible with gloves. Oil based products affect gloves. Rings with mountings may split gloves and are not worn in clinical settings. While it is ideal to remove plain bands if possible pre surgery, this is not always possible but ring area must be dried thoroughly. Acrylic nails can harbour organisms and dirt in broken edges etc. These should not be worn when doing work of a clinical nature. MARJEN EDUCATION SERVICES Jan 2007

INFECTION CONTROL GUIDE

1.11. DISINFECTION OF PATIENT SKIN PRIOR TO SURGERY There are various products listed for use as skin preparations eg alcohol or alcohol/chlorhexidine swabs and iodine (Betadine) swabs. Use 10ml. single use sachets of disinfectant rather than stock containers. Discard opened sachets after use and do not return disinfectant to a stock container. Whilst there is no evidence for or against the need for skin preparation for some injections or venepuncture, it is essential for intrathecal injections and prior to IV insertion. Immunocompromised patients and IV drug users need all available protection since lesser numbers of bacteria may be required to cause infection in such compromised hosts. Always ensure the skin is clean first before using an alcohol swab. For effective skin swabbing, rub a 70% isopropyl alcohol swab for 15 seconds onto the site prior to injection and allow to dry. For preparation prior to surgery, use 0.5%-1% aqueous chlorhexidene but do not introduce it into the ear canal. 1% aqueous solution of povidone-iodine (Betadine) is an option for surgery.

1.12 HAND HYGIENE PRIOR TO WOUND CARE Staff may select a skin disinfectant for hand hygiene prior to wound dressings depending on the wound and patient a soap hand wash alone is accepted practice in many office based practice situations Wound surfaces do not provide as good a defence against infection as intact skin and therefore are more susceptible to infection. Wounds surfaces will normally have microorganisms growing on their surfaces but sufficient host defences usually exist to prevent the bacteria causing infection. Therefore when dressing or handling wounds wash hands and wear gloves prior to contact and wash hands after removing gloves. Regardless of technique used for dressing, wound surfaces are often touched by gloved hands both directly and indirectly. Bacteria from the staff involved may contact the wound surface if gloves are not used or hands are not washed or the area touched after glove removal. The type of hand hygiene practiced may depend on the patient, their wound and the environment ie if a patient is colonised by or infected with multiresistant bacteria such as MRSA or VRE, then the handwash should contain an agent that provides persistent activity eg chlorhexidine or triclosan. These prevent such bacteria (which are not necessarily removed by soap) becoming carried by staff to the next patient. If the hand hygiene used for such a patient is performed in a home setting then an alcohol handrub that contains chlorhexidine may be appropriate. If a patient doe not have MRSA or VRE then a wash with liquid soap or a rub with an alcohol gel may be sufficient. However this may depend on the immunocompromised status of the patient or the type of wound and use of chlorhexidine may be indicated. Gloves used are not necessarily sterile and this reflects the status of the wound and this reflects the nature of wound surface ie colonised with bacteria. Again, some wound dressings and some patients may require sterile gloves but this is not the norm.

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INFECTION CONTROL GUIDE

2. SURFACE CLEANING
2.1. KNOWLEDGE OBJECTIVES Identify how correct technique removes most microorganisms. Understand why cleaning with detergent is more important than use of disinfectants Use of Material Safety Data sheets Know why certain products are no longer used (ie brooms, dusters, sprays, routine bleach etc) Management of linen

2.2. INTRODUCTION Cleaning is the removal of foreign matter and should reduce numbers of microorganisms and transmission of infection. While alkaline pH detergent is preferred for dirty applications, cleaning is effectively achieved with dilute neutral pH detergent applied with a clean cloth/paper towel and correct technique an impregnated disposable towel is an alternative. The surface is wiped in one direction to avoid redistributing soil. Dusters and brooms are not used because they disperse dust. Cleaning of smooth non porous surfaces is easier than porous surfaces such as grouting and carpet. Cleaning may remove 90% of dirt and trapped microorganisms and can be adequate for managing small drops of blood on non porous surfaces. Disposable towel or impregnated detergent wipes are preferred to reusable cloths. Disposable towel or wipes are always used for cleaning clinical areas eg treatment couches or trolleys etc. Disinfection kills pathogenic (infection causing) microorganisms but is not a substitute for cleaning. In fact, attempting disinfection without prior cleaning is generally ineffective. If bare skin contact is anticipated with bloodied porous surfaces eg grouted areas, then application of a disinfectant after cleaning any visible blood first is recommended. Environmental surfaces are usually only disinfected during gastroenteritis outbreaks because causative pathogens may remain infective for some time. 2.3. AIM OF REGULAR SURFACE CLEANING & MAINTENANCE Regular cleaning and maintenance promotes aesthetics, safety and hygiene and reduces the dirt that contains a microbial load. Smooth surfaces such as linoleum, vinyl, laminates, stainless steel and glass are easily cleaned but uneven surfaces such as carpet or those with grooves pose challenges. Properties of surfaces such as their permeability and susceptibility to chemical and water damage should be considered whe n choosing a new surface. Keep walls, ceilings and floors in good condition. First attend to any repairs that contribute to safety such as exposed electrical equipment, lifting carpet/tiles, lifting laminate edges and splintering wooden trims. Then attend to aesthetics such as peeling paint and wallpaper. Have carpets, upholstery and curtains regularly steam cleaned to reduce soil load. Clean windows, blinds, doors/wall and lights as needed. The cleaner should vacuum, mop floors, damp wipe surfaces and handles and clean staff eating area and toilets daily. The cleaner does not handle clinical waste, bloodied items or clean instrument processing area unless trained and given appropriate materials. Surfaces are kept dry to avoid biofilms developing - these are slimy films of organic material that bacteria can grow in. Daily emptying and drying of bottles and tanks prevent this occurring. MARJEN EDUCATION SERVICES Jan 2007

INFECTION CONTROL GUIDE

2.4. EXPLANTORY INFORMATION Sprays are not used because they may be inhaled or cause splash back use a pour bottle. Diluted detergent solutions are made up daily and bottles emptied, cleaned and drained dry overnight to prevent carryover contamination Preimpregnated neutral pH detergent wipes are easier to use than detergent solutions Some detergents are also disinfectants but require specified contact times for disinfection Wear disposable gloves when cleaning clinical areas wash and dry hands after removing If a detergent leaves a streak, wipe over with a damp paper towel or wipe Refrain from bringing in non standard cleaning agents, especially abrasives Alcohol wipes are not cleaning agents and should only be used on cleaned surfaces Neutral pH detergents do not damage vinyl or plastic use for treatment trolleys, couches. Brooms, dusters etc redistribute dust damp wiping is used instead

2.5. PRODUCTS Avoid multiple products or selecting products by their smell. Observe manufacturers instructions on correct use and obtain information from the Material Safety Data (MSD) sheet for treatment for accidental ingestion of cleaning products or reactions. Do not use reusable cloths for cleaning up body fluid spills or clinical areas they may be used in non clinical areas and are washed and dried between uses. Refer to MSDs for product safety on skin contact. Microfibre cloths may be used for cleaning non clinical areas ie not teatment areas. They remove dirt effectively when correct technique is used ie wipe in one direction, fold cloth before each wipe to prevent redistributing dirt. The fibres trap dirt and therefore have a greater ability to reduce bacteria than conventional cloths. No detergent is required and all surfaces including windows can be cleaned. Dry or damp cloths may be used. Rinse cloths and mops in hot water, wring and allow to dry.

2.6 SURFACE CLEANING TECHNIQUE FOR VARIOUS SURFACES AND ITEMS Correct technique involves applying neutral pH detergent to a surface (Use alkaline pH if heavy grease or soil present) using a pour bottle to avoid spraying ie no aerosols wiping in one direction, folding towel/wipe after each streak to prevent redistribution of soil using a disposable cloth or paper towel or detergent wipe for clinical surfaces and may be adapted for carpet and surfaces that may have had body fluid spills see spills section For treatment surfaces in contact with bare skin eg treatment couch, plinth, dental chair. Use paper towel and detergent or detergent wipe for these clinical surfaces. If there is visible blood, wipe that first, allow to dry. If disinfection is required, after cleaning apply either an alcohol wipe for a few seconds or a disinfectant for 10 minutes then wipe off. Clean whole surface with new wipe. For washable surfaces in clinical area not in contact with bare skin eg benches, trolley, sink etc Use a paper towel/tissue with detergent or detergent wipe for cleaning such surfaces that may include contaminated handles. If there is visible blood, wipe off, allow to dry and clean using a new wipe. Food preparation area Use clean paper towel with detergent. Avoid reusable towels unless washed and dried each day. MARJEN EDUCATION SERVICES Jan 2007 9

INFECTION CONTROL GUIDE

Patient toilet Clean daily but should a patient have a fluid spill eg vomit or faeces, then wearing gloves, eye protection and a plastic apron, safely remove spill before cleaning further. See body fluid spills. Office area surfaces Avoid use of unsealed timber. Using a detergent wipe and wiping in one direction, clean computer keypads, telephones, benches and desks daily to reduce grease and grime in which microorganisms accumulate. This maintains clean surfaces but does not necessarily reduce transmission of infection. Cleaning of reusable liquid medicine cups Wash cup thoroughly in warm water and detergent. Rinse under hot running water and dry. Store in a covered area. Dispose of single use pill cups after use. Cleaning of equipment If a particular product has been recommended for cleaning your equipment, read the instructions for the equipment to see if there are any chemicals that should not be used for that surface and refer to the product to see if a specified dilution and contact time is required eg ultrasound heads. Toys Decide if toys are necessary. Supply washable toys and remove for cleaning after obvious mouthing to reduce transmission of infection. Weekly cleaning removes accumulated grime but is not primarily an infection control measure. Wash toys in diluted detergent and warm water, rinse well and air dry. Non removable and removable fabric Apply detergent wipe and pat and dab mark until it is removed. Dry with fresh towel/wipe. If blood/vomit has contacted this surface, refer to the section on body fluid spills but generally detergent is adequate. Contaminated removable fabric may be pretreated by first rinsing then place in Napisan for 20 minutes. Launder as for other linen. Carpet, curtains etc Carpet should be steam cleaned regularly. Upholstery, non removable fabrics and curtains may be professionally cleaned as needed. Spot clean with shampoo. If blood or vomit have contaminated this surface, refer to the section on body fluid spills but generally clean then steam clean large spills . 2.7. CHANGING AND LAUNDERING LINEN IN THE CLINICAL AREA EG. TREATMENT ROOM. Linen is rarely implicated in the spread of infection but scabies, lice, Community Acquired Multi resistant Staph aureus and Hepatitis B from blood spots are a consideration. Linen in the treatment room is changed to avoid accumulated odour daily as a suggestion only - and always after soiling. It is best laundered between 70-75 degrees Celsius for 10 minutes but a dedicated domestic washing machine on site may be adequate. Soiled wet linen should be placed in soluble alginate bags to contain fluid. Leak proof bags should be used for linen transport. The laundry may supply these. Linen is aesthetically pleasing so reject linen that is marked, torn or patched. Place a disposable towel on the pillowcase and a waterproof disposable towel eg bluey under anticipated spill areas. If staff are seeking alternatives to linen, vinyl pillow covers can replace pillowcases and a length of disposable sheeting can be used. Many patients sit on the couch so there would be no need to attend to couch after use. Ensure treatment couches are in good condition. Modesty blankets may accumulate odour and become stained so dry clean or wash frequently or use a length of disposable sheeting. If a spill occurs on the couch, then remove the linen and clean the couch with detergent. MARJEN EDUCATION SERVICES Jan 2007 10

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3. MANAGEMENT OF BODY FLUID SPILLS


3.1. KNOWLEDGE OBJECTIVES The requirements for Standard Precautions and Additional Precautions Identify where cleaning may not be sufficient for decontaminating a body fluid spill Understand the limitations of chemical disinfectants and the terminology for their use Check Material Safety Data sheets Restricting use of disinfectants Why bleach is restricted to certain circumstances Putting an appropriate spill kit together 3.2. STANDARD PRECAUTIONS AND ADDITIONAL PRECAUTIONS Standard Precautions protect from infection transmitted from blood regardless of perceived risk and includes all body fluids except sweat. All blood is considered to have potential to transmit blood borne viruses such as HBV, HCV and HIV. Contact with blood and bloodied material requires handwashing and gloves, also aprons and eye protection when splash may occur. Safe disposal of waste is required eg to sharps bins. Hepatitis B immunization is recommended if in contact with body fluids. The term Additional Precautions refers to extra precautions to prevent epidemiologically important or highly transmissible infections where Standard Precautions are insufficient eg those spread via vomit or by respiratory droplets eg a special mask when caring for TB patients or extra protective gear when caring for those with gastroenteritis or infected with MRSA or VRE. 3.3. PRINCIPLE OF DISINFECTION AND CORRECT USE IE LIMITATIONS TO DISINFECTION Disinfectants destroy different components of the bacteria or virus. Methods include heat, chemical and mechanical. The definition includes rendering a surface non infectious but not necessarily free of live spores. Chemical disinfectants are inactivated by organic matter, therefore cleaning of the surface is essential prior to disinfection - this alone may be sufficient in reducing infectious particles to a number unlikely to transmit infection. Wiping a surface with a disinfectant such as bleach or Viraclean is not effective and against directions the surface requires cleaning with detergent first to remove organic soil that interferes with disinfectant action then the bleach or Viraclean is applied and left for 10 minutes. Similarly, wiping with an alcohol wipe should only be done after first cleaning the surface then applying the alcohol which should remain in contact for 15 seconds ie rub for 15 seconds for disinfection to occur. Compare these correct uses to how we actually use them! Disinfection of a body fluid spill is considered if the spill occurred on a porous surface eg tiled areas with grout and rough edges the spill surface is in contact with bare non intact skin eg treatment couch the potential pathogen and amount posing a risk that requires disinfection eg TB Cleaning may remove 90% of the microbial load and disinfection following this may kill 99.99% of the remainder but it does not kill spores. When using a disinfectant, attention to the following is essential correct concentration and contact time suitability of surface material for a particular disinfectant eg alcohol affects plastic/vinyl removal of organic matter by first cleaning - timber, carpet & fabric inactivate disinfectants

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Do not leave surfaces in prolonged contact with disinfectants because no further action will occur and continued exposure to chemicals may damage surfaces bacteria may contaminate disinfectants the potential for contact with skin may occur and this should be avoided 3.4. HOSPITAL GRADE DISINFECTANTS The term means that the product has been tested to show it kills a standard number of certain bacteria or viruses over a specified time and under laboratory conditions. It does not mean that all microorganisms are killed by that product but it allows selection of one product over another based on required action. Some chemical groups act as both detergent and disinfectant eg quaternary ammonium compounds eg 3 minutes - alcohols only require seconds. If there are no instructions for decontaminating equipment or the surface cannot be left for 10 minutes, clean surface first, dry then apply an alcohol wipe for 15 seconds. This is not as effective as other products but rapidly kills most bacteria and some viruses but not spores. Products labelled Tuberculocidal means they can kill this bacteria as long as the guide is followed.

3.5. HOW TO SAFELY AND EFFECTIVELY MANAGE VARIOUS BODY FLUID SPILLS Small volume of blood Wearing gloves, wipe up a drop or spot of blood with a wet tissue or detergent wipe and allow to dry. For a spill less than 10 cm, wearing gloves, safely absorb the spill onto paper towel and remove then apply a detergent wipe until the site is visibly clean then dry with fresh paper towel. If the spill is on carpet, pat and dab with a detergent wipe do not rub because this may disperse aerosols of blood. Disinfection is optional after this eg Viraclean for 10 minutes but is recommended if the site is in contact with bare and non intact skin and especially if the surface is porous eg grouted areas. Do not disinfect carpets or fabrics but spot shampoo or steam clean these to reduce microbial load. Large volume of blood Wear gloves, apron and face shield and bring sharps bin to spill. With forceps, remove any broken glass to the sharps bin. If the volume is large or glass is still present, apply a commercial absorbent product from the spill kit to confine the spill area to solidify the spill so that splash is avoided. It can then be safely scooped into a bag (or wide necked sharps bin if glass is present) at the site. Clean spill with detergent and paper towel, using fresh towel until spill is removed. Pour detergent gently to avoid splash and dab carpet rather than rub to avoid aerosols. Vomit Keep the following on hand at reception or other likely area - vomit bags (Embags), wads of paper towel, gloves and a supermarket bag for safe and immediate application. Ask the patient or carer to seal vomit bag and place into the plastic bag. Offer another vomit bag while removing the used bag. Bring spill kit to site for spill. Apply absorbent material or wads of paper towel to prevent spread and reduce odour then place chair over spill with sign. After a few minutes, wearing gloves, mask and apron, use cardboard scoops to remove solidified spill and place in bag at hand for disposal. Clean the spill area by gently pouring detergent to side of spill then work in but avoid generation of aerosols on carpet by patting and dabbing not rubbing. Absorb to dryness. Steam clean any spills on carpet. Alcohol has reduced effectiveness against two main causes of gastroenteritis in health care facilities - norovirus and Clostridium difficile. Bleach is used MARJEN EDUCATION SERVICES Jan 2007 12

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3.6. WHAT A SPILL KIT MAY CONTAIN This is not exhaustive Safety gear such as gloves, apron and face shields Plastic forceps for retrieving glass and small sharps bin (optional) Small clinical waste bag and plain bag for vomit Small bag of absorbent material eg kitty litter and EM vomit bags Wads of paper towel (not a roll) and small bottle of dilute detergent 4 pieces of cardboard for scooping up glass and vomit Alcohol wipes and detergent wipes 3.7. SPECIAL REQUIREMENTS DURING A GASTROENTERITIS OUTBREAK Norovirus is a common cause of viral gastroenteritis in the young and very old and is only effectively removed from carpet by steam cleaning or use of chlorine on non porous surfaces. Hospital grade hypochlorite is an effective disinfectant but is a strong oxidising agent and reacts with many substances it contacts to form potentially harmful compounds. If using chlorine releasing compound such as hypochlorite or SDIC, pitting of metal can occur if traces remain. Fabric and carpet may be damaged by it. Care is required to avoid contact with skin and inhalation should be minimised. It is not used for routine cleaning nor is routine disinfection recommended. Specific guidelines are issued during outbreaks and these involve surface disinfection using specified concentrations. Similarly treat spills from gastroenteritis patients caused by Clostrdium difficile which is a spore forming bacteria. Alcohol has reduced effectiveness against these two microorganisms.

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4. CLINICAL WASTE MANAGEMENT


4.1. KNOWLEDGE OBJECTIVES More accurately identify Clinical Waste and Sharps within the national and state context Knowing whether both a clinical waste and sharps collection are required Be aware of what waste is actually found in most clinical waste audits Develop a method to improve segregation Knowing correct placement of sharps and clinical waste bins Know how to correctly handle full sharps bins and clinical waste bags/bins to reduce injury Understand the requirements for safe storage of sharps and clinical waste for collection Know the requirements for correct transport by licensed collectors Indicate various methods for clinical waste disposal

4.2. DEFINING CLINICAL WASTE Clinical and Related Waste includes clinical, infectious, cytotoxic, pharmaceutical, radioactive and body parts. It is disposed in accordance with state guidelines. Clinical Waste includes sharps, bloodied waste, body fluids but not urine or faeces normally and waste from patients with certain infections from Health Care Facilities (HCFs). Clinical Waste is not necessarily more infectious than home generated waste, however at home there is usually only one person involved in handling the waste from collection to disposal whereas in a HCF there may be many. Staff should not be handling body fluids and sharps unknowingly and therefore clinical waste needs to be identified for safe segregation and transport within and outside the facility. Related Wastes include Pharmaceutical, Cytotoxic and Radioactive waste these require segregation for separate handling and disposal. Clinical Waste would also include waste that would offend the public sensitivity if it was disposed to open landfill. The national guide in infection control includes expressible blood as requiring disposal to clinical waste. However some states including Victoria require that all bloodstained waste from HCFs be disposed as clinical waste. Given that a definition of expressible may vary among staff and may create potential for exposure to blood eg staff wringing out blood or emptying blood into a sink, it is probably safer to place any bloodied waste into a labelled yellow bag or pail. In Victoria this is an EPA requirement. To reduce costs both financial and environmental, be aware that approximately 30% of what is disposed to clinical waste is packaging. Sharps are defined as items that can pierce or penetrate the skin. This includes needles and lancets etc but also glass such as ampoules. Consider sharp points from swab sticks etc that can pierce bags they may scratch and cause nuisance. Sharps bins must be of standard quality and be sealable. 20 litre pails are not sharps bins. Sanitary napkins from patient treatment areas of a HCF eg maternity unit are classified as clinical waste. Staff may have their own sanitary bin and this is not clinical waste. While occasional bloodied tissues and bloodied paper towel may be disposed to this bin, sharps must never be disposed to it. Some sites generate a large volume of incontinence pads and as long as these are not bloodstained or from a patient with gastro, they are disposed either to a special bin, similar to a sanitary bin except larger or into a plastic bag and into the general waste. MARJEN EDUCATION SERVICES Jan 2007 14

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4.3. IMPROVING WASTE SEGREGATION. Clinical waste treatment and disposal is expensive and more environmentally damaging than landfill. Auditing shows that clinical waste contains misplaced waste such as handtowel, packaging, small boxes and office paper. Tips to improving waste segregation place both the clinical waste bin and general waste bin near each other never place the clinical waste bin next to the sink because it will fill with handtowel. If no clinical waste is generated, provide only a general waste bin for handtowel/tissues and provide a recycling bin for packaging and non confidential paper etc. If you generate clinical waste daily, use the bin size that best reflects your daily requirement to help reduce incorrect segregation (a bench top tidy size may be sufficient for some). large non contaminated non pyrex glass jars may be recycled. 4.4. WASTE MANAGEMENT AND IMPROVING SAFETY Non sharp clinical waste is placed in labelled bins lined preferably with leak proof yellow bags. Each treatment area requires such a bin generally this can be a small 8 or 10 litre plastic wall or bench mounted bin without a lid (these become contaminated) that is inaccessible to children. Into this is placed contaminated gloves, dressings, pap smear material and bloodied items. Any liquid blood is best absorbed with paper towel before placing in bin. Blood tubes are best placed in sharps bins. This waste is removed daily to reduce odour and for aesthetics and safety. Contents are never poured from one bag to another. To remove safely, bring the disposal bin from the storage area to the clinical area to avoid carrying leaking bags. Wearing gloves, tie off bag at neck, preferably with a tie rather than a knot (sharps may be present in bag) and place into the disposal bin. Each treatment area needs a wa ll or bench mounted sealable sharps bin the bench may be fitted with mount to prevent movement of the bin during use. If using wall mounted bins, ensure the opening is not above eye height so that protruding needles are visible. Seal when full which is never beyond the line - do not shake or compress contents or pour form one bin to another. The full bins are stored for collection. Ask your collector if you may place small full sharps bins in your clinical waste bags. Both disposable and reusable sharps bins are available. If clinical waste is only generated rarely such as in some community health disciplines, store in a locked area either both a 20 litre yellow labelled, sealable pail and sharps bin or a wide necked large sharps bin for both wastes. Bring this bin to the area when needed ie do not carry lose waste to storage area. If preferred, place waste in small plastic bag first then tie off this will reduce odour Tips on safety include never placing sharps bins on the floor or where they are accessible to children and do not provide a clinical waste bin next to a patient bed because children may access it. Any fluid spills in areas where there is a risk of transmission of infection are to be decontaminated by trained staff or reported by cleaners. Should needles be disconnected from the syringe? This is not recommended at all Pharmaceuticals? Bulk pharmaceuticals are packaged in a labelled box for separate treatment. Fluids? Catheter bags can be drained while bloodied bags are double bagged before disposal MARJEN EDUCATION SERVICES Jan 2007

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4.5. SAFE STORAGE AND DISPOSAL OF CLINICAL WASTE The storage area needs to be locked and with no public access a locked bin placed in a publicly accessible area is not suitable. The unused shower recess is ideal for storing a bin internally. A small locked shed or locked cupboard or room is required and for which the collector has his/her own key. Ensure clinical waste is always identifiable for safety use a biohazard sign. Facilities are responsible for waste until it is rendered safe by treatment and staff should be aware of what treatment is used. If sharps are disposed incorrectly and later traced, there may be a heavy penalty and liability should an injury occur. Facilities need a certificate from their waste company showing compliance with the law regarding disposal and a copy of the collection and disposal process. Transport from a facility must be to a licensed facility and not to another HCF unless a licence has been obtained specifically for storage of that waste. A licensed collector trained to decontaminate spills transports waste from its origin to a point of disposal in a vehicle properly fitted to secure its load. Treatment processes may include steam sterilisation, incineration, treatment with chlorine or deep landfill. 4.6 CLINICAL WASTE GENERATED DURING TREATMENT AT HOME Bloodied waste generated in the home as part of treatment by staff eg visiting nurses from a HCF requires a sensible approach. Staff should not transport waste in their cars - large volumes and offensive waste should be arranged for collection by a licensed transporter. Small volumes eg a small dressing may be removed by the carer to the external domestic bin. Any waste that must be transported from a home by staff requires safe transport in a labelled, rigid, upright, sealable container and should be removed for disposal each day to the collection point at the HCF where it is collected by a licensed collector. It is safest to transport in the boot. Sharps bins may need to be transported from home to home. Use a sealable standard small bin eg with a screw cap this must be transported upright and with a secure lid so that needles cannot fall out should an accident occur carry in the boot. Remove from the vehicle when duty is completed ie do not drive around unnecessarily with sharps in the boot. When full this is taken to the HCF storage area for collection by a licensed collector.

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5. SHARPS INJURIES PREVENTION AND MANAGEMENT


5.1. KNOWLEDGE OBJECTIVES More broadly define sharps Have a greater understanding of how most injuries occur and how to avoid them Know how to manage and report an injury or splash by body substances (exposure) Know the outline of the time frame for testing and why this is so Have an appreciation of the risk of transmission of Blood Borne Viral infection (BBV) Know about protecting privacy and who might best counsel them

5.2. DEFINING SHARPS A sharp is an item that can pierce skin. It includes needles, lancets, glass (incl. unbroken). Consider any item that can pierce a waste bag as a sharp for disposal purposes to avoid bags leaking contents but adopt a practical approach large non contaminated non pyrex glass jars may be recycled. 5.3. HOW SHARPS INJURIES AND SPLASH MAY OCCUR Blood borne viruses (BBV) are Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV). Hepatitis D is associated with HBV infection. The following is not an exhaustive list but all these actions have transmitted BBV infection. 1. Compressing overflowing sharps into a bin resulting in needles piercing bin. 2. Cleaners tipping sharps from containers into bags or other sharps bins. 3. Needles left around entrances to clinics, in meter boxes, patients toilets etc. 4. Staff placing a sharp within gauze which is left for unknowing staff to handle. 5. Staff not aware that metal pull caps from vaccines etc are sharps. 6. Staff not able to see opening of sharps bin (sharp may be protruding). 7. Staff tipping waste with hidden sharps from one bag to another. 8. Sharps bin on the floor or low bench and accessible to children. 9. Staff not wearing face shields when splash was anticipated. 5.4. REDUCING SHARPS AND SPLASH INJURIES. Injuries may result from lack of information. Consider these preventatives correct identification by all staff of what is a sharp and correct disposal avoid recapping needles ensure the sharps bin is next to the procedure site to avoid carrying sharps avoid emptying clinical waste bin contents or sharps bin contents into another bag or bin handle waste bags at neck and tie off full clinical waste bags with cable ties, not knots avoid compacting contents of sharps containers needles can pierce sides avoid compacting clinical waste bags - fluids may escape from burst bag and cause splash transport sharps containers by holding the secured lid and not hugging the sides wear visors/safety glasses when splash is a possibility wear gloves during venipuncture (this reduces exposure volume by 50%) do no t remove a bag from a bin and carry it it may be leaking MARJEN EDUCATION SERVICES Jan 2007

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5.5. IMMEDIATE RESPONSE TO AN EXPOSURE. Exposure is defined as an injury that involves direct skin contact with a body fluid or substance where the skin integrity is compromised eg open wound, abrasion or dermatitis. The fluids or substances that pose a relevant risk here are: blood/serum/plasma and items visibly contaminated with blood, pleural/synovial/amniotic/pericardial/peritoneal/CSF fluids and uterine/vaginal secretions or semen. Urine, faeces, vomit and sweat are not implicated in transmission of BBVs after an injury/splash unless visible blood is present. Immediately after exposure, any contaminated clothing is removed, eyes & mucous membranes are flushed gently with lots of water. For a sharps injury, wash the area thoroughly with soap and water. If the injured person requires suturing, this is attended to at the same time as reporting the exposure immediately and seeking relief from duty - the immediate management is considered a medical emergency in that prompt reporting and assessment of the exposure means that potentially life saving treatment can be offered ie Post Exposure Prophylaxis (PEP). Staff are supported in following correct procedure even if they think it was a minor incident. They require an accurate assessment by a qualified professional to determine if their risk from the exposure is significant or not. Staff should not use excuses for not reporting immediately eg own fault, clumsiness, new to job, reluctant to interrup t work or not enough staff. 5.6 EVALUATION OF THE EXPOSURE Sometimes, due to remoteness or time of day/night, the initial assessment may be conducted by phone but needs to be done immediately after the exposure. Questions are asked about the type of exposure the type of body substance involved volume of blood or fluid involved length of time in contact with blood or fluid time elapsed since exposure Then depending on this assessment, the exposed person may need to travel for further face to face risk assessment & possible PEP by a qualified professional. After an injury, information is sought on presence of visible blood etc on device causing injury type of device involved whether it was hollow bore needle or solid sharp object what procedure the device was used for gauge of needle or device time elapsed since device was used whether the injury was through a glove or any clothing The following factors are identified with HIV transmission deep injury device visibly contaminated with blood procedures involving a needle placed directly into a vein or artery terminal illness in the source

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Cases of infection transmitted through occupational exposure were shown to occur after percutaneous injury from a hollow bore needle often after venipuncture. Only with many further details can the assessment of risk be properly made and eventually this involves face to face contact with a professional. Some assessments may result in immunization for tetanus and possibly PEP within hours of the exposure if the exposure is significant. A medical evaluation is done to record information about current medications and underlying medical conditions. PEP and counselling should be available and offered. Treatment should be available 24 hours through an Infectious Diseases physician. Starter kits of HIV PEP should be available for significant exposure and especially where access to large HCFs is remote. The exposed person is counselled about the possibility of transmission of BBV disease. 5.7. AFTER EVALUATION PEP, TESTING, COUNSELLING, CONFIDENTIALITY, THE SOURCE PEP PEP for HIV is offered but only recommended when warranted. It is a 4 week course of usually two antiretrovirals and sometimes also a protease inhibitor. 40% of those taking it do not complete the course it is not always well tolerated but it does reduce the risk of HIV infection. For maximum effect it should be taken within 72 hours of exposure and if possible within a few hours of a significant exposure it should not be withheld while waiting for results. Medical facilities should have a starter kit for such exposures. The exposed is then referred on to an Infectious Diseases physician for care. If the exposed person is not protected for HBV then immune globulin is given. PRETEST COUNSELLING If the exposed is to be tested for HIV, then pretest counselling is essential and provided by a qualified person. This testing is related to events before the exposure. Even though staff have a right to keep antibody status confidential from their employer, this information is useful to the pretest counsellor. Counselling needs to be face to face and seeks details of existing lifestyle and risk factors and should not be carried out by a colleague or employer. It may even be necessary to delay testing until such a person is available but this should not delay PEP if the exposure is significant CONFIDENTIALITY It is not appropriate for other staff to be able to access the exposed staff members results. In a remote or small population setting, this requires careful thought. Name codes may be used etc and the HCF may need to make a link with another facility to offer exposed staff options about off site testing to protect privacy. Confidentiality and counselling also apply to the source. The names of injured and source should not appear together on histories etc. TESTING A specialist with knowledge of BBV infections should undertake follow up. The exposed staff will be asked to have blood tested for antibody status to HIV, HBV and HCV soon after the injury but preferably not before counselling. If the exposed refuses testing then this is documented and he/she is encouraged to have blood taken and stored. The results of the baseline testing are given in person. Under optimum conditions these tests can be done within hours of injury but a confirmatory test for HIV is required if screening detects antibody. MARJEN EDUCATION SERVICES Jan 2007 19

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At 6 weeks, 12 weeks and at 6 months these tests are repeated. Originally the first schedule for all three BBVs was at 3 months then was reduced to 6 weeks when it was found that some patients showed antibodies earlier and would have benefited from earlier treatment and found a 6 week interval more reassuring. More recently, it has been found that at 4 weeks, HCV RNA by PCR method can detect early infection so that earlier treatment can be commenced with Ribavirin and Interferon. Further counselling is provided prior to results. Even if PEP is given, HIV testing is done at 6 months. THE SOURCE If the source is unknown ie discarded needle, then other known factors about the local prevalence of BBVs etc is taken into account when considering PEP. Even if the source is known to be positive for HIV, PEP is only indicated if the exposure is significant. If the source refuses or is reluctant to be tested, this is documented but if the exposure is not significant, not knowing source details does not affect the immediate management of the exposed. The source may unknowingly be positive and requires counselling pre and post test as well. There needs to be an understanding that even if the source is negative he/she may be asked if they are in a risk behaviour group that could indicate they may be in the window phase of infection and possibly a risk to the exposed person. 5.8. RISK OF INFECTION POST EXPOSURE, PRECAUTIONS AND FOLLOW UP Probability of contracting HBV, HCV or HIV after a sharps injury From a source with HBV varies from 3-30% depending on status of source From a source with HCV approx 2% but up to 10% if the source has HCV RNA by PCR From a source with HIV approx 0.3% For many injuries the source will not be known and the risk will be much lower. For a body fluid splash the risk of transmission is less and for HIV is estimated to be 0.09% Post Exposure Precautions If it has been demonstrated that if the staff has been exposed to a blood borne pathogen, they should not donate blood, semen, organs or tissue for 6 months and should not share implements that may be contaminated with even small amounts of blood eg toothbrushes or razors. If the source person is found to be negative for all 3 BBVs then no further follow up of the exposed is necessary unless there is reason to suspect the source is seroconverting to one of these or was at high risk of BBV infection at the time. For demonstrated exposure to HIV and/or HBV, the exposed should be informed of the risk of transmission to sexual and injecting partners for a six month period and be counselled about issues of safe sex and safe injecting. However, should any results indicate the injured person is being infected, then he/she is to be advised by their treating doctor. If the exposed person is at risk for HIV then precautions are advised in the follow up period.

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6. STAFF IMMUNIZATION
6.1. KNOWLEDGE OBJECTIVES Have an appreciation of the principle of immunization Outline a staff immunization program appropriate to their facility Determine whether Hepatitis B and/or influenza immunization is advised Contact the appropriate person to arrange immunization if necessary

6.2 INTRODUCTION Babies receive protection to some previous maternal infections/immunization before birth from antibodies across the placenta and after birth via breast milk. This is passive immunity and it can be conferred by an injection of immune globulin eg for tetanus, following exposure to HAV or HBV in non immune staff. This type of protection is short term ie some months. In contrast, active immunization occurs when the body produces antibodies after exposure to the infection itself or through immunization this provides long term protection or immunity. Not all protection from infection requires antibodies. For some infections eg TB, the body programs white cells which are able to recognise previous exposure and produce cell mediated immunity. Infections such as Shingles (caused by reactivation of chicken pox virus) and TB are more common amongst the older population because infection that has remained in check by a functioning immune system diminishes with age and reactivation may occur. 6.3. ARE STAFF AT EXTRA RISK OF INFECTION? Staff working in HCFs have close contact with many clients and patients and may be in increased contact with various infectious diseases eg gastroenteritis. Staff who work with sharps may be at more risk for BBVs. Therefore, staff may need immunization at commencement of work. The consequences of an infection will depend on various factors eg pregnancy and rubella. This risk can be reduced by ensuring that staff are up to date with their regular immunization schedule. Staff should be familiar with the community immunization schedule because changes to that may also affect them eg under 25s have meningococcal vaccine. Staff should keep their own immunization records and HCFs should maintain a record for immunization and testing done while staff work there. For staff returning to work after a transplant or chemotherapy, exposure to viral infections such as measles or live vaccination may present a serious risk. Their immune response is altered and they risk developing fatal forms of these infections. They should seek advice first from their treating doctor. Not all infections are immunizable and procedures for reducing infection by the various modes of spread eg respiratory, gastrointestinal etc should be known. Staff with colds, cold sores or upset stomachs should not be at work. Protocols should be in place if staff acquire a serious work related infection. While the focus for immunisation may be on HCWs at risk, consider administrative staff who handle blood samples and pathology slips contract cleaners who may be exposed to blood spills These staff have contracted BBV infection and they should be included for protection against HBV. MARJEN EDUCATION SERVICES Jan 2007 21

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6.4 IMMUNIZATIONS FOR HCWs PASSIVE IMMUNIZATION There are passive and active immunizations for Tetanus, HAV & HBV after exposure by non immune staff. Should staff sustain a needlestick injury during a course, HBIG may be advised in addition. HEPATITIS B IMMUNIZATION The Hepatitis B immunization course is given as 3 doses at 0, 1 and 5 months after dose 2. 4 weeks after dose 3, the staff is tested for antibodies. 8-10% of those immunized with this course will not produce protective antibodies over the necessary protective level of 10mIU/ml. They are given either 2 doses, one in each arm or a further three doses one month apart (more cumbersome) A third to half will respond. Those who fail to respond could be tested for previous exposure to HBV. If found to be still unprotected they must be given HBIG within 72 hours of a needlestick injury. An alternative route of administration of Hepatitis B immunization for non responders is by the intradermal route. A smaller volume of Engerix is used and this is a four dose course given at 2 week intervals into the forearm. This appears to be extremely successful but must be delivered accurately. Hep B Boosters There is evidence that the Hepatitis B vaccine confers long tern immunity and there is no need for boosters normally. It is considered that once adequate antibodies have been produced, even if they wane over time, staff are still considered protected. Protecting new staff against HBV at commencement of duty If previous HepB has been given but staff are unsure if course is complete, then an injection is given on day one with a test in one month. If the antibody level is below 10IU/ml, then a further two doses are given with a retest in one month. Non immunized staff commence a course on day one of work HEPATITIS A IMMUNIZATION Hepatitis A immunization is a 2 dose course and is for staff working with children and incontinent clients and those exposed to clients/patients faecal waste. Doses are 6 months apart. TB Nursing and medical staff are considered low risk - they may choose to have a Mantoux at start and exit from the workplace other staff are very low risk and no mantoux testing is required. BCG vaccine is only recommended for HCWs working in high risk occupational exposure eg TB ward. MENINGOCOCCAL DISEASE Staff are not at more risk from meningococcal disease because of their work. If born since 1984 then they can receive the free immunization against Type C there is no vaccine against Type B which is now as common. HCWs between 20 25 are in a risk age group but not because of their work. INFLUENZA The Influenza vaccine is recommended for staff in contact with the elderly for whom it may be fatal. DIPHTHERIA, TETANUS, PERTUSSIS (WHOOPING COUGH) HCWs should check they have been immunised against all 3 before an adult Diphtheria Tetanus course is given. There is now no required gap between the two courses (originally 5 years) POLIO This is now given as an injectable vaccine, rather than orally and HCWs should maintain immunity. MARJEN EDUCATION SERVICES Jan 2007 22

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7. Instrument Processing and Validation


Topics 1 The Standard. 2 Disposable instruments, off site or on site processing a choice 3 Cleaning, Sterilisation and Validation of instrument processing XII. Cleaning of the instrument reprocessing environment. XIII. Precleaning or initial treatment of used items XIV. Cleaning by manually or ultrasonic methods and drying XV. Processing of non critical and semi-critical items. XVI. Packaging, sealing and labelling of instrument packs. XVII. Transport of instruments for off site processing and documentation. XVIII. Loading and unloading of the steriliser. XIX. Settings, monitoring, record keeping and tracking. XX. Storage of sterilised items. XXI. Validation of the sterilisation process. XXII. Steriliser maintenance, service and troubleshooting. 4. Creutzfeldt Jakob Disease and inactivation of prions.

Refer to supplementary notes for dental facilities

References 1. Joan F. Gardner and Margaret M. Peel. Introduction to Sterilization, Disinfection and Infection Control. 2 nd Edition, Churchill Livingstone 1991. 2. AS/NZS 4815:2006. Office Based Health Care Facilities Reprocessing of reusable medical and surgical instruments and equipment and maintenance of the associated environment. 3. RACGP Infection Control Standards for office based practices 4th edition 2006 4. Systematic Operating Procedures ADAVB - 2005 5. Victorian Infectious Diseases, Mar 2004 (CJDreview of current knowledge) 6. Infection Control in the Health Care Setting (ICG) Department of Health and Ageing, Feb 2004

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1. The Standard. Professionals in microbiology and instrument sterilization acknowledge the need for a high standard for processing using a universal method based on science and practical application. Both the professional and the patient should rely on a method that minimizes transmission of infection. Should a medico-legal case arise which may involve possible infection via instruments then AS/NZS 4815:2006 would be the most likely reference along with the standards required by that profession. It is the intention to demonstrate how the required standard may be achieved simply and inexpensively with explanations of the requirements and how they can be met. If a Health Care Facility (HCF) fails to demonstrate that it is taking steps to adopt the required standard, then it may be difficult to obtain accreditation and possibly registration. The appropriate standard for non complex sterilizer loads is AS/NZS 4815:2006 with guidelines supplied by RACGP and ADAVB to assist with practical interpretation. The following notes include monitoring for a prevacuum steriliser in the dental setting and transport requirements for practices sterilizing off site. They do not address sterilisation issues where cCJD or vCJD decontamination may be required. For those performing complex procedures, AS/NZS 4187:2003 is the standard required. 2. Disposable instruments, off site or on site processing a choice. There are three options although combinations of all may be convenient process the instruments on-site using a suitable sterilizer clean on site and transport to an accredited off site sterilizing facility purchase disposable instruments ideal for low turnover HCFs Combinations of these are worth considering ie. perform sterilization off-site and have disposable supplies on hand for backup or process simple packs and sterilize large, complex packs off site. If sterilizing off-site, the HCF needs to ensure the off-site facility is accredited and even when this is so, the HCF is responsible for ensuring adequate documentation is received to ensure all off site procedures are to the standard. If the off site facility is not accredited then the responsibility for the HCF is more onerous and involves storing results etc. Transport and monitoring protocols and a system to track patients and instruments for future recall are required if sterilizing off site. HCFs, especially those in more remote areas who are faced with purchasing a new steriliser and use very few instruments may find it more convenient to use disposable instruments. These packs of disposable instruments need to be stored correctly and a brief policy is required to demonstrate this.

3. Cleaning, Sterilization and Validation of Instrument processing HCFs need to annually review documented protocols for the total process. This includes having 1. Written procedures for all stages of the process. 2. Evidence of staff training 3. Sterilizer maintenance and service records 4. A record of monitoring for every cycle. 5. Results of annual validation of the sterilizer cycle. MARJEN EDUCATION SERVICES Jan 2007 24

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I. Cleaning of the instrument reprocessing environment. Hygiene The instrument processing area is ideally a dedicated room. Difficulties arise with shared use of sinks when instrument processing is colocated in the treatment room or a consulting room. HCFs should not share handwashing sinks with instrument processing sinks because issues of hygiene and possible cross contamination from splash arise. The instrument processing area must not be located where food is stored, served or eaten for the same reasons. Surfaces. The detergent used for instrument cleaning is suitable for bench cleaning - use a dilute neutral or slightly alkaline detergent: each morning make up a small volume (eg 200 ml) in a pour bottle. Avoid spray bottles because spray may be inhaled or if sprayed onto a contaminated surface will psread blood etc. At the end of the day, clean bottle and dry upside down to reduce carryover contamination. Use disposable gloves/towel and detergent or impregnated detergent wipe for cleaning contaminated areas eg benches, sinks, taps, plastic washing bowls, containers and external area of the sterilizer. Wipe surface in one direction then fold over towel to repeat with next stroke. Dry with fresh paper towel - if using impregnated detergent wipes, surface dries rapidly. Do not use a lcohol wipes to clean. Wearing gloves, apron and face protection, wash, rinse and wipe dry all used containers, washing bowls and sinks after each use. Use gently running water to avoid splash. Taps should be wiped clean after use. If the clean sink must be shared with handwashing (not desirable), place a small glad bag placed over the tap during washing instruments to make cleaning easier & reduce contamination. Detergents are considered sufficient if a spot of blood is found. However, refer to notes on managing body fluid spills for further information. Cleaning of aprons, gloves, face protection used in instrument processing. Change uniforms and gowns after a spill/splash. Wipe reusable plastic apron with detergent after each use and hang to dry. The apron is not worn outside the instrument area. Wash external surface of utility gloves with detergent while they are being worn then dry with paper towel remove and hang to dry many staff have their own set of dirty and clean gloves hanging inside the cupboard door under the sink. Remove safety glasses or face shield, apply detergent then rinse under running water and dry with paper towel dispose of masks. Store glasses/shield so they do not touch gloves or apron to avoid cross contamination.

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II. Precleaning or initial treatment of used items Initial treatment of the used item takes place immediately after use and involves removal of visible soil. There are two methods rinsing and wiping. If rinsing, this should not be performed over a handwashing sink in the consulting room. All surfaces are opened and safely rinsed with warm water while wearing full protective wear. If wiping, this can be safely done while wearing gloves and wiping the soiled item onto a piece of paper towel placed on a bench ie do not hold item to wipe since sharp ends could cause injury - dry or damp paper towel or tissue are used. Both methods prevent drying of matter onto instruments. This in turn hardens and compromises sterilization because steam cannot be guaranteed to penetrate the remaining dirt and sterilize microorganisms contained within it. Avoid hot or cold water on dirty instruments hot water causes organic matter to stick due to coagulation of protein - cold will cause solidification of body fats. The person who uses the instrument is responsible for ensuring initial treatment occurs straight after use either by performing it him/herself or by asking trained staff person to perform it immediately. If the instrument processing is taking place in a different room (ideal) to the treatment area then the used item(s) needs to be taken safely to that area. Sharp points on an open tray must be avoided so use a dry, sealable plastic container to take the rinsed or wiped item to the cleaning a rea. Sometimes there is a delay in this transport but at least the item is wiped or rinsed and soil removed. It is not desirable to transport containers with detergent and used items from room to room via corridors around the practice since spillage of contaminated waste should be avoided contamination will be high if items that have visible soil on them have been placed without removal of this soil. When the wiped/rinsed item(s) arrives in the instrument cleaning area, it is either brushed in detergent immediately or placed in a labelled detergent container while cleaning is delayed this should not be overnight because contamination may increase. Most staff either put the wiped items into a container of detergent with a lid until they can complete cleaning a couple of hours later or leave them for a few minutes in a dry container until the next lot of items arrive and clean them together. The standards are silent on what to do if there is a time delay between initial treatment and cleaning so the use of a labelled sealable plastic holding container next to the dirty sink is not unreasonable. The main purpose of placing items in a detergent is to prevent inadvertent use and to facilitate cleaning placing them in water alone will cause rusting. Most instrument detergents have an antirust incorporated. There is no minimum time for placing items in detergents in this setting but items should not be left more than a few hours to avoid increasing contamination. Most office based practices perform manual cleaning and do not have washer disinfectors. The preferred detergent is a slightly alkaline, free rinsing, non sudsing surfactant detergent Clinidet (slight alkaline) is more in line with the standard but Sonidet (neutral) is acceptable. For washer disinfectors, a two stage wash with alkaline then enzyme detergents is proposed for the future. Detergent loosens soil and is not a disinfectant although it can affect the bacterial membrane. There are differing views on use of enzyme detergents with respect to safety but they are superior cleaning agents when items are grossly soiled or have been left to dry. They are the detergent of choice for endoscopes. Clean the sink with detergent and paper towel after instrument processing and then dry it with paper towel to prevent accumulation of microorganisms.

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III. Cleaning by manual or ultrasonic methods and drying see order of tasks over page Manual Manual cleaning means brushing all surfaces under warm water and detergent. Use utility gloves, plastic apron and safety glasses/mask or face shield normal glasses may become contaminated. If there are two adjacent sinks, one is best used for handwashing if there is no other sink available while the other combined with an adjacent plastic bowl can provide a set up for instrument cleaning. Label sinks. Use sterilizable brushes and a disposable cytobrush. Do not use abrasive cleaning agents because scratches trap matter/microorganisms. If you sterilize off site then clean the brushes thoroughly, rinse under hot water, dry as thoroughly as you can and store them in a dry area. Wearing protective gear, if instruments have been placed temporarily in a holding container, gently tip off the detergent to avoid splash. Now rinse the sink gently with dilute detergent and dry with paper towel. Fill either the dirty sink (if you have two sinks for instruments) or washing bowl (if you have only one sink) with warm water and detergent to the required diluted volume. Instruments are not brushed under runni ng water but each instrument is removed from its container, opened and all surfaces brushed under water/detergent to avoid splashng all surfaces in the dirty sink or washing bowl. It is then rinsed under gently running warm/hot water in the adjacent sink and placed it on a plastic draining rack or on a clean plastic backed surface with a low lint towel over it. Workflow is from dirty to clean to avoid recontamination avoid moving dirty items over clean items. Ultrasonic Cleaning Ultrasonic cleaning is superior to manual cleaning especially for serrated surfaces because it can dislodge matter from these hard to reach surfaces. As a comparison, ultrasonic cleaning removes 99% of soil compared with 92% for brushing. It functions by generating tiny vacuum bubbles which crash against instruments and shatter or dislodge any matter. The detergent used will aid cleaning at the point of contact. Some HCFs follow ultrasonic cleaning as an adjunct to manual cleaning and perform it before brushing. Test daily to check that the frequency of the ultrasonic waves is high enough and spread evenly through the tank. Two tests are available - the foil test and the pencil load test. To perform the former: hang a piece of alfoil over a wire across the tank so that it dips into the tank (like toast in a toaster) without touching the bottom and ensuring no part of your body is in contact with the tank. You could use water without detergent for this test to pose a greater challenge. Turn the machine on using a 1015 second degassing cycle then remove foil to check for even pitting up to the water line. Rinse tank to remove aluminium and fill with detergent and water and degas ready for use. Change the solution daily and more often if solution appears visibly contaminated this reduces material deposited on instruments. Rinsing items under running warm water is critical after this because matter will settle back onto the items. Ultrasound is not disinfection. Drying A disposable low lint towel or a reusable lint free towel is used to avoid fibres being transferred to sterile tissue. Avoid paper towel or air drying because contamination may occur. A towel requires washing after each use. Prevent latex and powder attaching to item by using reusable vinyl utility gloves when drying washed instruments. Gloves protect user and instrument from contamination. Avoid touching instruments with bare hands because steam cannot penetrate any body oil that adheres. Pat instrument dry to remove moisture. Store clean if not sterilizing . MARJEN EDUCATION SERVICES Jan 2007 27

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Instrument Cleaning & Sterilisation Protocol


1. Wearing protective gear, open all contaminated surfaces and remove visible soil from the instrument by rinsing with warm water or safely wiping onto paper towel/tissue. Place in dry container if item requires transporting through facility then into labelled container of dilute detergent if cleaning is not to occur immediately. 2. Perform cleaning by immersing instrument in a sink or bowl of warm water with detergent. Brush all surfaces clean under the water. 3. Rinse instrument in warm to hot gently running water. 4. Dry instrument with low linting towel and check for cleanliness. 5. Place instrument in pouch and seal correctly. 6. Label pouch for date and batch. 7. Load pouches in the upright position in the sterilizer using a rack for separation. 8. Place rack on a tray so that pouches do not touch chamber walls. 9. Check cycle monitor is present (Printer, datalogger or Class 4, 5 or 6 indicator) 10. Ensure water level is adequate, close door and switch sterilizer on, using only the cycle for which it has been validated. 11. After completion of the drying cycle, open the door, remove tray and place on cake rack to allow load to cool. 12. When cool check all packs are dry and that the cycle has passed. 13. Record the results of each cycle after completion. 14. Place instruments in a dry, sealable or cupboard for storage. If sterilising off site insert after 4 1. Transport washed/dried items in a sealed labelled dirty container. 2. Receive sterilised items in a sealed labelled clean container. 3. Ensure that on arrival, pouches are dry with no tears, that the pouch indicator has changed colour and that they are labelled for date and batch -record this. 4. If the off site facility is not accredited then seek records of cycle results. 5. Keep a record book of incoming pouches and place patient name against each.

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IV. Processing of non critical and semi-critical items. Categories of procedures/instruments The Spaulding classification divides procedures into non critical, semi critical and critical. Non critical procedures are low risk and involve contact with intact skin. Examples are blood pressure cuffs. Items should be visibly clean before use. Semi critical procedures and instruments are those that do come in contact (even indirectly) with intact mucous membranes eg. Spacers for deep inhalation, vaginal specula for pap smears. Sterilization is the most practical option for their processing - if they are not sterilizable then they should not be reused on another patient. They do not need to be wrapped but this is often done to reduce environmental contamination and prevent mix ups. Items that are used to penetrate into sterile tissue or for use on non intact mucous membranes must be sterile at point of use ie from a pouch or wrap. Labelling of instruments If an item is labelled for single patient use then it should not be shared for use with others. If an item is labelled disposable then it is only used once. Single patient use items are only reprocessed for multi patient use when stringent criteria are satisfied and polices are in place. The processor effectively/legally becomes the manufacturer). Check the directions for use first and keep copies of all product information. Avoid products promoting chemical sterilisation. Plastic ear pieces for otoscopes Many brands are disposable so check first. If they are reusable, brush them in detergent and rinse them - use a separate small washing bowl. After drying, place in a covered container or sterilize them if they are sterilisable as best practice. Ear syringes The Spaulding classification indicates the level of processing required based on the type of risk of infection the procedure presents to the patient. Ear syringing is a non critical procedure when applied to an intact ear canal/drum. After use, the reusable syringe is disassembled and all parts cleaned. A cytobrush is useful for cleaning inside the ear piece. After drying, it may be sterilized between uses as best practice but this is not essential. Regrease if necessary. If the syringe is continuous flow then drying is difficult. Many practitioners now use 20 or 30 ml sterile disposable syringes. Spacers These are categorised as semi critical and in the same category as respiratory circuitry due to deep inhalation such that microorganisms are deeply inhaled and contact mucosal surfaces of the lung. If they are labelled single patient use then avoid multiple patient use this type is not manufactured to enable adequate access to all surfaces for cleaning and such surfaces may transmit infection from one patient to another. If the spacer is labelled for multi patient use then it must be cleaned first then steam sterilized. Refer to instructions because a coating of fresh clean detergent may be required to reduce static electricity prior to use. The legislation indicates it is not appropriate to share items intended for single patient use unless an emergency arises. Keep a supply of new spacers as per the guidelines or purchase those labelled for multi patient use and which are able to be sterilised according to directions. MARJEN EDUCATION SERVICES Jan 2007 29

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Nebulisers These appear to be less popular due to increased use of spacers. They are usually single patient use but if not the n follow directions for cleaning and ensure that any part that is deemed semi critical is either disposable or sterilizable. Tubing is deemed single patient use because it is difficult to process although on some other respiratory equipment, the presence o f a filter on incoming air permits multiple patient use see below. Other respiratory devices eg for spirometry The same semi critical classification applies to parts of this equipment. Refer to the ICG 2004 guide for specific equipment references. Do not clean the inside of tubing replace it if necessary. Consider direction of airflow and presence of filters if no information is available and a decision is required as to whether equipment reuse presents a risk of infection. Use single use spirometry mouthpieces. Vacutainer barrels These are either disposable or cleaned after use with a cytobrush and detergent. The manufacturer indicates that these are not for critical use but need to be clean before use. In the absence of directions, they could be washed and rinsed. For disinfection, place in undiluted Milton for 10 minutes then drained. The yellow type may be steam sterilised on its side cheap, easy but not essential. Diathermy, cautery and cryotherapy equipment Use disposable tips where the procedure is semi critical ie intact mucosa or non intact skin. Avoid any product where sterilisation is indicated by chemical means as this involves hazardous chemicals. Use single use cryotherapy and electrotherapy tips where labelled as such. Brushes Wash and sterilize in the last load of the day. If there is no sterilizer, wash with hot water, rinse and dry. Use disposable cytobrushes for accessing hard to reach areas. Ultrasound heads etc Remove gel as per manufacturers instructions. Clean as per same instructions. Access the guide that applies to the brand you have bought. If no guide is available, then clean by wiping with a detergent then follow with an alcohol wipe if disinfection is required. Reduce unnecessary work to save time and cost. The following may assist Use disposable covers for thermometers - thermometers still require cleaning Washing in detergent is sufficient processing for non-critical items Washing then sterilisation is required for semi critical items Only wrap dishes a nd bowls if they are required to be sterile at point of use

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V. Packaging, sealing and labelling of instrument packs. Packaging An item in contact with sterile tissue is for critical use and must be sterile at point of use. ie. it is wrapped prior to sterilization. If an item is for use on intact mucosa eg a speculum for a pap smear, then it is for semi critical use and is sterilized between patients and it is not essential to wrap it. If it is used in the insertion of an IUD, then it is for critical use and is required to be sterile at point of use ie wrapped. Many practices wrap all specula and handpieces for aesthetics, to avoid mix ups and reduce contamination. Packaging may be laminated pouches, paper bags, continuous roll, kimguard etc and must be of standard quality. Pouches must have a heat sensitive Class 1 process indicator often in the shape of an arrow impregnated onto their surface. This changes colour on exposure to heat, as does sterilizer tape. This is not a control but identifies processed loads and is placed on each shelf of unwrapped items in a sterilizer with a printer. For kimguard and continuous roll packaging, heat sensitive tape impregnated with chemical indicator is used for sealing. It may be easier to pouch the item as it is dried to save double handling but if there is a delay then place dried items in a labelled clean, sealable container until sufficient pouches are available to make up a load. Do not leave unsterilized pouches within view as they may be used inadvertently. Pack contents and placement In a pouch there may be sufficient room for 4 or 5 instruments. Steam must be able to reach all surfaces. Items should be unlocked and opened slightly but not necessarily wide open. Place handles in pack so that they are against the non sealable end. Prepare various combinations of instruments and sufficient single items. Avoid dense material and if processing gauze, place only 4 or 5 pieces per pouch dense material is more difficult to dry. Sealing When using self seal pouches, seal along perforated line so that surfaces align. It will be easier to leave the sealing until all items have been placed in pouches and gloves removed and hands washed and dried thoroughly wet hands facilitate transmission of bacteria through paper. If using continuous roll, double fold edges and ensure tape extends 2.5 cm to paper side use small lengths of tape so that removal does not result in pouch tearing such as may occur with one length of tape. Labelling Label for date (including year) just prior to sterilization (not in advance and not after), cycle or load number (use the cycle number generated by the printer). Use a laundry marker or peel off sticker to enable transfer of information when tracking critical instruments. Hollow ware If a bowl or dish requires wrapping, place the hollow side against the paper rather than the plastic side this facilitates drying.

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VI. Transport of instruments for off site processing/documentation. Transport of instruments for off site processing 1 Transport washed and dried items in a sealed labelled dirty container. 2. Receive sterilised items from the off site facility in a sealed labelled clean container. 3. On arrival, check the condition and labelling of pouches and any results sent. 4. A record of incoming pouches is kept to place the patients name against each in the event of a recall. Advised Requirements 1. There are separate containers for unprocessed and processed items. 2. Provide the off site processing facility with a copy of your cleaning protocol. 3. Obtain a copy of the accreditation certificate from the off site facility. 4. Request a copy of the off site facilitys protocols for further cleaning, packaging, sterilisation, monitoring and a sample copy of a page from its record book some provide the cycle monitor results with each returned load. 5. Transport all items safely to avoid the containers moving around in the vehicle. Transport the container either on the floor of the vehicle or the boot preferably. 6. Allow the off site facility to package items - some require recleaning as part of specific insurance criteria. 7. Suggest use bubblewrap in box to prevent pouches moving freely and tearing during transport. 8. Check and record that the pouch indicator (Class 1) has changed on return. 9. Check and record each pouch for dryness and any tears on return. 10. Place results of the cycle if supplied into a record book. 11. Check and record that all pouches have a date and batch 12. A record book is required to place patients name against each pack used. 13. If your off site facility is not accredited then seek records of each cycle result. You are responsible for the provision of sterile supplies from that facility.

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VII. Loading and unloading of the steriliser. Sterilization. Steam sterilization occurs when steam under pressure contacts a surface and releases sufficient heat to that surface over sufficient time to sterilize it. Sterilizer settings and water level always use the drying cycle regardless of the load type - this preserves instruments do not alter the settings of time and temp after it has been shown they are the validated conditions a printout is strongly advised - a Class 4 or 5 or 6 indicator is used every time in the interim check the printout after every cycle to ensure it is between 134-136 Celsius for the time set (if it is set for 134 C) and that it reads regularly according to sterilizer standards ie every 60 seconds Ensure that manual fill sterilisers receive the specific volume of water in the chamber. Too much water may result in the sterilizer not drying the load while not enough causes overheating, damaging delicate items. Loading Loading of the sterilizer should allow adequate penetration of the contents by steam and allow it to escape from pouches during the drying cycle. A rack is used to separate pouches and keep them upright some racks allow for up to 14 small pouches but most allow for 6-8 medium sized pouches. Pouches must not touch the wall of the chamber and are best placed plastic to paper in the rack. Pouches may be placed flat but not on top of each other. The standards specify that flat pouches should be placed with the paper side to the tray even though some manufacturers suggest the plastic side is placed on the tray. Drying occurs through the paper side. New models are superior for drying. Avoid combining porous (textile) and non porous (instrument) materials in a load if practical. If using multiple trays, do not place unwrapped items above wrapped items place below or on same tray to avoid condensate dripping on pouches. Wrapped perforated instrument trays may be placed flat. Hollow ware (bowls etc) can pose a challenge to steam sterilization because air may be trapped in the bowl if it is placed face down. Place pots, bowls and dishes on edge to allow air to be displaced. If you wish to stack dishes or bowls, use a metal spacer to allow air removal and steam penetration. Hollow items eg trocars require a sterilizer that can remove air from lumens Class B sterilizer cycles can usually achieve this but so also can some Class S types refer to the manufacturers claims. Unloading The door is opened immediately after the drying cycle has finished to prevent small amounts of steam vapour condensing if the load cools while the door is closed ie do not leave sterilizer operating overnight. The tray with its contents is then removed and can be placed on a cake rack for cooling the load do not place the tray on a flat, cool surface as condensation will occur, resulting in wet packs. Do not handle warm packs because the paper is more porous and contents are susceptible to hand contamination. Check for dryness when cool but handle edges only and with dry hands - bacteria from moist hands may pass through the pouch. Record that pouches and contents are dry and intact. Wet packs If moisture is seen on pouches at any stage after opening the door then those packs cannot be used. Reprocess using new pouches and record this. First review loading, load volume, pack density, pouch separation, volume of water and that the drying setting is as per manufacturers directions.

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VIII Settings, monitoring, record keeping and tracking Settings The most common temperature setting used is 134 degrees Celsius although some are set at 132 C. Many models have a lower setting for 121 C that is used for fluids and some plastics. The time setting accounts for heating (referred to as come up time), sterilization and drying - on many models the last two may be adjustable. The holding time is the time required for 134C to be held and is determined at annual validation. Sterilization itself always takes 3 minutes - this is the holding time and includes a safety factor - at 134 C. This does not take into account the extra time it takes for the centre of a pack to reach sterilizing conditions this is called the penetration time - after the chamber (which is where the temperature sensor is located) has reached 134 C. Therefore at validation, the penetration time is calculated this time plus 3 minutes holding time is referred to as the total processing time. If the total processing time is within that recommended by the manufacturer, the cycle length is not altered. Obviously it needs to be increased if the manufacturers guide is too low. If it is altered to a lesser but validated time, this may be seen as contrary to the manufacturer guide. You may validate for more than one load type. Ensure drying time is the recommended time and lengthen it if insufficient and record that this is checked at validation. The printer should be set to measure temperature every 60 seconds during the sterilization part of the cycle or at certain critical points in the cycle if it has pressure pulses or vacuum. If not, have the setting readjusted - this is the standard required. If it cannot be adjusted then use a Class 4/5/6 indicator in each load to confirm each cycle is achieving its correct parameters. Essential features of Monitoring 1. Every load must have a process (Class 1) indicator. All pouches have this on their surface as an arrow or other shape that changes colour on exposure to heat but does not show that a loa dhas been sterilized. Other types are steritape or steristrips an internal indicator may be used but is not essential. These indicators are used to distinguish processed from unprocessed loads. For unwrapped loads, if using a printer, place a Class 1 indicator on each tray of unwrapped items. 2. Every cycle must have a cycle monitor. A printer or datalogger is required but Class 4 or 5 or 6 indicators are still acceptable. Pressure recordings should be shown on printouts but not all printers do this. A data logger without a printer needs to be downloaded and checked after each cycle. The printout must be checked to see that the temperature does not go below 134 C or rise above 136 C and that it is maintained for the number of minutes set faded printouts mean ink must be replaced these cannot be read. Results are entered into a log book against details for tha t load. Keep record books for 7 years from last entry. Printouts and monitoring indicators may be stored but ensure they do not fade roll the printout on to create a new roll for storing and save space. If you have a loan unit or a new unvalidated unit, then in addition to a printer, use a Class 4/5/6 indicator for each cycle until your unit is returned or validation is complete do not delay. 3. Class S cycles ie vacuum assisted (more common in GP and podiatry than dental) that are not fitted with a leak detector require a weekly leak test if they are capable of being tested. Ask agent. 4. Biological testing is not required between validations except in certain situations eg an unvalidated load is processed (load needs to be kept until results available) or a thermostat has been replaced and revalidation has not yet been reperformed. If the staff are of the view that despite the printout being acceptable, some other unusual occurrence has been noted, then biological testing is reintroduced. Biological testing may also be performed as part of quality assurance. MARJEN EDUCATION SERVICES Jan 2007 34

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5. Annual service of the sterilizer is required and filters need to be checked each six months. Validation is done at the time of the annual service. 6. If a manufacturer makes a claim that their sterilizer can process hollowware type A items eg trocars and handpieces, then testing of both vacuum and steam penetration is required each day that these items are sterilized. If there is no air detector then a daily leak rate test is required. In addition, a daily test such as a Bowie Dick test or Helix test (Process challenge devices) is required to detect air entrapment. Ask your supplier where these are placed and to provide documentation that your sterilizer can process these devices if you are sterilizing them. Originally only Class B cycles or prevacuum models could be used for these items but some Class S cycle manufacturers may claim their Class S can process such items these cycles require testing to validate this claim. I tis suggested that those with a Class S need to perform leak tests weekly if an air detector is present. Record keeping for each cycle A log book is kept which provides the following details about each cycle Date and batch of load Contents of load eg number of pouches and basic content description such as removal set Class 1 (process) indicator result and result of printer or suitable indicator Load checked after processing for integrity ie. dryness and no tearing Signatures authorising processing steps and items able to be released for sterile use Example of setting out of log book Date Cycle Load Cleaning # description stage sig.

Pouch Indicator Class 1

Pack Cycle Integrity monitor Dry/intact 134C x min

Authorised For use

Tracking for recall It is necessary but not yet mandatory to be able to track the instruments used on a patient back to a cycle. This is for critical instruments only. This is not the same as tracing which identifies the instrument used. Tracking may be required if items from a failed cycle have mistakenly been used a patient who had certain procedures is later found to have CJD a patient subsequently develops an infection which requires documentation There are two main method types 1. Place the peel off label from the pouch or transfer pouch details to history if using hard copy or enter the data to the computer history. 2. Use a procedure book to record patient against cycle details on pouch. If a record is placed in a history only, recall will involve searching through histories to track the patient who used a pouch from a particular cycle unless the computer can do this. If not then a procedure book with details is easier than searching histories. MARJEN EDUCATION SERVICES Jan 2007 35

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IX Storage of sterilised items Storage Protocol 1. Transfer pouches to a drawer, cupboard, closed shelf with see through doors or sellable storage container to protect from moisture and dust. Allow for even rotation of stock by placing the most recently sterilized pouches to the rear. 2. Before removing an instrument for use, check that there is no break in the pouch and that the instrument looks clean and that the process indicator indicates processing has occurred. 3. Do not use use by dates but ensure the above criteria have been satisfied. Information notes on storage. If pouches of sterile instruments are stored unprotected on benches near sinks, moisture that contacts the paper is absorbed through to pouch contents, taking microorganisms with it and resulting in contamination - the paper acts as a wick through which bacteria migrate. Dust and microorganisms settling on pouches that are incorrectly stored will settle back onto the instruments when they are opened and contaminate them. Avoid ha ndling packs with wet hands or gloves as this will contaminate not just the pack required but other touched pouches when accessing a pack. It is not acceptable to store pouches on a bench. Do not break open a pouch by piercing the instrument through the pouch because this redistributes fibres and allows contamination from the external surface to the sterile instrument. Instead, peel back the plastic from the paper as intended. Use by dates Use-by dates on sterile supplies are no longer used as long because sterility is event related not date related. However, there must be a protocol to ensure stock is stored correctly. If a pouch from a successful cycle is being stored, then as long as there are no tears in the pouch and that it does not come into contact with moisture or dust or has not been dropped, it will remain sterile indefinitely. However, the plastic side of pouches may become brittle over a few months and may split. Always check a sterile pack before opening it. Hospitals often use use by dates if pouches or trays are not stored in an outer plastic cover. However, a smaller HCF does not transport or store wrapped packs on trolleys such as occurs in a large facility.

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X. Validation of the sterilization process Overview. VALIDATION MEANS TO CONFIRM OR PROVE. This process requires an annual review of current cleaning and sterilizing procedures. Testing is also performed at this time to check the sterilizer is delivering sterilizing conditions to the most challenging part of the most challenging load. Testing that it kills a number of standard microorganisms in parts of this load is done. Prior to performing testing, the following requires review and action Updating of any protocols for the process from initial treatment to storage Documentation of ongoing staff education in the procedures they perform Steriliser service and maintenance records available and current Log book is available that is correctly recording results of every cycle Requirements for validation Validation (Performance Qualification) of the sterilizer function is performed at the same time as the annual service (Operational Qualification) with assistance from service technician ie do not do later unless the unit is being serviced unavoidable off site. Results for the following four tests on your sterilizer are performed by the service agent 1. The Heat Distribution Study - required to identify the cold spot this normally does not change so does not need to be repeated annually ie use previous years results. However, do repeat if new thermostat is fitted. New sterilizers have this test performed at the factory at time of manufacture so check the manual. The test is done by placing temperature sensors from the thermocouple over the drain (at rear) and front in average size empty chamber. 2. The Penetration time test you need to prepare and document your densest load with a challenge pack so the technician can measure how much extra time the centre of your pack takes to reach the same temperature once the rest of the chamber reaches 134 C. For pouches of 4 or less instruments it is considered to be zero. For dense loads it may be so high that the time setting needs adjusting. It may not register if it is only a few seconds. There are at least two temperature sensors used, one placed inside the challenge pack which itself is placed in the coolest part of the chamber and the other placed next to the temperature sensor controller (usually located in the chamber drain). The door is closed on the wires or a port is used and cycle started. 3. The time at temperature test this test checks that the inside of your densest pack is receiving at least 3 continuous minutes at 134 136 C at 207kPa pressure (up to 220) which are the minimum sterilizing conditions and confirms what your steriliser is delivering think of it as a check on the printer too. This test and penetration time test may be done in the same cycle and you should ask if the current settings are adequate for you to now continue with your 3 biological test cycles or whether they require adjusting. 4. Drying time this needs to be done to ensure your challenge load dries and adjusted if not. Both test 2 and 3 form part of the Heat Penetration Study which involve testing your most challenging conditions to show your sterilizer is performing adequately. Note that there is usually a calibration factor assigned to the thermocouple that the service agent uses to measure temperature. This calibration factor should be shown on the report to you. MARJEN EDUCATION SERVICES Jan 2007 37

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You perform the Microbiological Qualification at the same time as Physical Qualification The final part of the Heat Penetration studies test is the Microbiological Qualification (preferably done by staff) to check that the sterilizer is killing a number of standard microorganisms. 7 Biological Indicators (BIs) with Geobacillus stearothermophilus and an annually calibrated 56 degree C incubator are used to prove that a standard number of this bacterium is killed. Method a. Use the manufacturers sterilization time and drying settings that have been confirmed to be adequate by the service technicians testing. Maintain copy of test results. b. Ensure you or the technician has 7 BIs to do the 3 microbiological testing cycles at this time. Label them to indicate cycle number and position and control = c. Use the same load type and configuration etc used for technician testing record or photograph it. c. Place two BIs next to the end of the technicians two probes to start cycle number 1 or wait until his/her testing is completed AS48145 assumes the former but RACGP suggests the latter. RACGP suggests place one BI on tray in the cold spot and the other inside a challenge pack while AS4815 suggests one BI inside a challenge pack which itself is placed over the cold spot and the second placed over drain where temperature sensor controller is located. Whichever, BIs must be adjacent to probes were placed. d. Run cycle 1 to end of drying if combining BIs with time at temperature test and obtain results from technician. Remove BIs and place in bag holes are porous while warm. e. If reprocessing same items, cool load then make up load 2 which must be the same type of load and run it as for load 1 although thermocouples may not be necessary. f. Remove BIs from load 2 and run load 3. g. Place the positive control in the bag with the other 6 to be sent for incubation unless you are doing this on site the temperature in the incubator needs to be checked annually Notes 1. A risk analysis may support only running one cycle with thermocouples - a poor history of consistent results may be an indication for running thermocouples on all 3 cycles. 2. Using more than two thermocouples may be required for large chambers 3. Only one drying cycle is required but all cycles may run through to drying note on printout. 4. You may have sufficient instruments to make up 3 identical loads this is a good opportunity to build up a store of sterilized packs for use except for the 3 pack that contains the BIs. 5. If incubating own tests, wait until BIs cool (hot tests may shatter) before crushing inner vial when placing in 56 C incubator with unprocessed control. All 7 are incubated in 56 C incubator for 48 hours. Acceptable result is 6 purple processed tests and a yellow unprocessed control. Validation establishes that as long as the densest load is not exceeded and all other aspects of the process are correct then the load is considered sterile. This is repeated annually, if steriliser has major repairs and if the density of the load is increased. Some validate for different load types to save time on longer cycles for gauze etc where longer cycles take up precious time eg dental surgeries MARJEN EDUCATION SERVICES Jan 2007 38

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XI Steriliser maintenance, service and trouble shooting Steriliser maintenance Annual service is a minimum requirement - filters require 6 monthly attention. There needs to be a maintenance policy and this is best kept in the steriliser service and maintenance folder. Steriliser cleaning Refer to the manufacturers recommendation first. Wipe the outside surface of the steriliser daily with a damp cloth to reduce dust. To keep equipment free of soil build up, check wipe chamber, trays and racks weekly daily and wipe with a damp cloth or wipe weekly if no build up or soil is noted at the end of each day. Wiping reduces build up of mineral deposit and is repeated until no residue appears on the cloth. The door is left open overnight. Some manufacturers recommend use of a specific product for cleaning the chamber - follow directions. If mineral deposit occurs, a weak acid such as vinegar or citric acid may be used soaked onto a cloth. Drain tank weekly, flush and refill with deionised water. There needs to be instructions for emptying, flushing, cleaning and type of water used. It should be in the steriliser service and maintenance folder or above the steriliser. The steriliser folder Keep the following information together. 1. The annual service records. 2. The date of the next service and validation. 3. The contact details of the service agent. 4. Instructions for cleaning, checking filters and maintenance. 5. Dealing with a failed cycle. See below before calling a service agent. Troubleshooting for failed cycles Always repeat cycle after rewrapping instruments before proceeding further When the class 1 (pouch) indicator fails ask 1. Was the steriliser turned on? Reprocess to find out. 2. Is this a new pouch batch? Process one from the old batch if available. 3. Was this pouch actually processed or confused with one awaiting processing? 4. Did overloading occur or was the setting faulty such that the pouch did not get warm? 5. If the printout passes, then suspect pouch indicator is faulty and return. If the printout or class 4,5 or 6 indicator shows a fail 1. Reprocess load with new pouches run a class 4/5/6 indicator with the printer. 2. Call your service agent if still required after first repeating 3. Do not use instruments from a failed cycle If the pouches are wet, those pouches have failed and must be noted on the record. Try 1. Reducing load and amount of dense material in each pouch 2. Ensuring pouches are in a rack and unwrapped items are not above them 3. Ensuring the correct amount of water is being used 4. Ensuring pouches are cool before checking 5. Ensuring the warm rack is not placed on a solid surface (use a cake rack) 6. Ensuring the drying time is set as per manufacturers directions or from validation.

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8. SUPPLEMENTARY NOTES APPLICABLE TO DENTAL SURGERIES 8.1. Initial treatment of the used item Wipe used items at chairside to remove blood and amalgam etc. They are then taken to the cleaning area in a dry container with a lid to avoid sharp items from falling out. Sharp items transported loose in open trays pose a risk if items fall of the tray or staff or others collide during transport. Avoid material drying on the item as trapped microorganisms may compromise the sterilization process. 8.2. Cleaning the handpiece After wiping the external surface, run dilute detergent over the external surface and brush, taking care not to allow moisture to enter the internal surface. Dry with a low lint towel and apply a lubricant under pressure for 1 second or use a purpose designed machine as directed. Remove excess oil to avoid leaking through the bag, facilitating heavy contamination. Some suggest placing gauze around the head of the handpiece to prevent oil leaking but suppliers appear not to support this. Handpieces are required to be placed in pouches according to SOPs even when not for use in critical procedures pouches do protect from environmental contamination. 8.3. Processing the bur stand Remove all burs and scrub or ultrasonically clean as for instruments. 8.4. The following are best regarded as single use unless otherwise labelled Metal matrix bands are single use and are detached from retainers Endodontic files - most are single use but some may be single patient use Dappendishes use single use or sterilize reusable types Reamers and most files are single use and not used for other patients. 8.5. Check the following for instructions on multiple use. Metal/acrylic impression trays - clean, dry and wrap for sterilisation. Sterilizable saliva ejectors - treat as above but do not need to be wrapped Brushes sterilize in the last cycle of the day but do not need wrapping. Retainers clean well before sterilizing wrapping will protect. Some saliva ejectors and all plastic impression trays are single use. There are verifiable methods for reusing rotary nickel titanium files. 8.6. The following cleaning tips will improve safety, standard and save time Do not rinse items in the surgery sink - splash increases contamination in this area. File cleaners are used to place sharp files into to prevent injury. Avoid hot or cold water on dirty instruments. Hot water causes coagulation of protein and cold solidifies body fats. Both cause matter to adhere. Place high speed burs, specified slow speed burs and small reusable endodontic files inside a tea infuser to keep them together in the ultrasonic cleaner. Clean sink with dilute detergent and paper towel after use then dry with fresh paper towel to prevent accumulation of microorganisms. Avoid abrasive brushes/agents - scratches will trap matter/microorganisms Brushing dirty items under running water is unsafe and not correct. Placing cleaned items in a sink of warm water to rinse is not correct use running water

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8.7. Packaging bur stands Dry the bur stand. Replace the clean burs and files after cleaning separately in the tea diffuser. Place the stand with burs/files in a bag and seal/label. Place the bag on its side on the sterilizer tray so that the burs are parallel with the tray this will assist steam penetration and drying regardless of the sterilizer class. 8.8. Other monitoring 1. If a manufacturer makes a claim that a particular sterilizer, usually a Class B cycle (prevacuum) type, can sterilize hollow loads type A eg handpieces, then an automatic leakage rate/vacuum test cycle must be available where a vacuum stage is present. This test must be performed weekly or daily where there is no leak rate detector fitted. 2. Air removal and steam penetration testing must be performed each day that such items are processed. Originally Bowie Dick tests were done but now a Process Challenge Device (PCD) called a Helix test is done at the start of the day to detect air entrapment. Ask the supplier to demonstrate the test. Place the PCD in the rear of the empty chamber and start the test cycle. 8.9. Tracking Invasive/critical/ sterile procedures include extractions and surgery. Cycle details used to process instrument packs required for these procedures ought be placed in the patient history. Scalers, curettes and ultrasonic instruments do not automatically require tracking it is the procedure that determines tracking it is suggested that root planing and removal of subgingival deposits should be tracked because this involves penetrating the mucosa. However, it would need to be demonstrated that sterile tissue must be penetrated as part of the procedure. Procedures that are high risk for a patient are those that bring sterile tissue into contact with instruments because the body defences of skin and membrane have been breached. In addition, it takes fewer microorganisms to cause infection. This means that if a cycle was shown to fail after instruments were used, with tracking, the patient can be tracked and unused items recalled. 8.10. Use of safety wear Aprons A plastic apron should be worn over a uniform or street clothes when cleaning instruments and decontaminating impressions - a plastic apron can be wiped down without being removed. However a gown is adequate as long as it is removed after a splash. Gowns A gown is worn over street clothes or a uniform while working in the surgery and moving between the surgery and instrument cleaning area. It is removed as soon as a splash occurs and treated as above and also removed when leaving the surgery or cleaning area. It is not worn while doing accounts or answering the reception telephone or going to the toilet or eating or drinking. Change the gown daily if there is no spill. This may seem unnecessary but avoids build up of body odour and marks etc. If a white gown is not accepted by children, choose coloured gowns with patterns etc. Uniforms Uniforms provide a corporate look but are not protective wear. If staff are required to wear a uniform then a gown would be required when attending patients to avoid contaminating the uniform the uniform is worn without a gown for accounts, eating, shopping etc. Change uniform and gown after a spill and place in waterproof bag for washing.

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Masks Masks are changed during a procedure if there is more than 20 minutes continuous exposure to aerosols or if they become moist or visibly soiled. They are not pulled down to the chin because this aids contamination by your hands and face of the mask. Masks are changed between patients because we touch them masks frequently, causing contamination. The most effective and preferred masks are the N95 type but are expensive they would be required if working with TB or Influenza. Safety glasses Both staff and patients must have protective eyewear (patients or staff own prescription glasses are not suitable). These are washed between uses. Face shields are preferred to safety glasses when cleaning instruments but they need to fit well so that material cannot enter from the side. They can be worn while tending patients but can look daunting. No personal protective equipment is worn outside the surgery or cleaning area. 8.11. Zones The patients mouth, dental light, triple syringe and holder, headrest, bracket table, handpieces and couplings and suction apparatus make up the operating field/zone. Regard all items from this zone as contaminated. The area outside this but within the clinical area is the peripheral zone. It may become contaminated. Avoid contaminating the peripheral zone by using sterilized tweezers or overgloves for retrieval of items from drawers etc. 8.12. Barriers Reducing cross contamination reduces indirect contact spread of infection. Barriers are advised on non sterilizable surfaces likely to be contaminated because they save cleaning time and if used correctly are effective. Cleaning some surfaces between patients is not always effective because of niches and gaps caused by articulating surfaces which may be difficult to clean well and in a short time eg light handles. The covered surface may still require cleaning between patients either at the edge that may have been touched or when covers have been incorrectly removed and leave contamination. Even so, there will be less contamination than if it was not covered so it will be easier and quicker to clean. Remove covers slowly ie do not tear them off quickly because it may generate aerosols. Broad, flat surfaces such as trays are easier to clean than light handles and may not require covering but exercise commonsense to develop a system that minimises cleaning time and waste accumulation. Reusable sterilisable covers are available as an environmental consideration. What should be barrier wrapped Adhesive clear tape, plastic sheaths and plastic covers are used to protect surfaces in the operating zone but not necessarily all surfaces in this zone require covering eg light supports that are not touched. Exposed barriers are changed between patients and if bloodied they are disposed to clinical waste. Specifically, it is suggested for each patient use plastic sheaths on handpieces etc to prevent contamination of fixed section attached to tubing disposable tape to cover relevant handles, switches/controls cover for bracket/cradle if it saves time and surface is complex sterilised transfer tweezers on bench cover (or overglove) for retrieval. barriers for top of bracket table may not be necessary but cleaning must be done correctly to avoid spreading the contamination. On broad flat surfaces, if not using a barrier, use detergent/paper towel with unilateral cleaning action to prevent redistributing contamination. Disposable detergent wipes (not alcohol) are advised. MARJEN EDUCATION SERVICES Jan 2007 42

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8.13. Retrieval of clean items during a procedure When an item that is not anticipated is required for a procedure, it needs to be retrieved from a drawer or a cupboard in the surgery without contaminating handles and other items. For each patient place a clean bib on the bench and using aseptic technique, shake a pair of sterilized forceps from a bag onto it. When such an item is requested then the staff place an overglove or bag over their hand to open the drawer and then retrieve the item with the forceps in the other hand. This does not require glove removal or handwashing. 8.14. X Rays To protect clean areas from contamination, one person remains contaminated while the other dons clean gloves and processes the film. After exposure, remove the film from its barrier envelope by shaking into a clean cup. Take it to the developing area as a clean uncontaminated item. Digital sensors should preferably be barriered eg gladwrap. Disinfectants may damage. 8.15. Cleaning and flushing of lines and suction units, antiretraction valves Flush the air and water lines for 2 minutes at the start of the day and for 30 seconds after use on patient. Triple syringe and ultrasonic scaler are flushed. For suction units, at the end of the day dilute a litre of non foaming detergent and suck half through the high volume aspirator and half through the low volume aspirator. Flush spittoon through suction. Dental equipment that supplies water to the mouth must be fitted with non-return valves and water should be at least the same standard as drinking water. Be aware that water supply companies do place alerts when the bacterial count requires boiling because this has implications in dentistry. It is suggested weekly tests be performed and recorded on antiretraction valves. The test is simple and easy to use. However ensure that the test on one valve type indicates the other types are working therefore test all valves weekly with correct equipment. If the test fails then seek advice from the service agent 8.16 Decontaminating the surgery chair Should a small blood spill contact the chair then clean this area with a detergent wipe without spreading the contamination then clean the chair as normal. 8.17. Impressions Wipe/rinse to remove visible soil. Clean with detergent if impression material can tolerate this without being affected. As a duty of care to the transporter and the receiving laboratory, use a ready to use solution such as Milton to decontaminate by wiping over and leaving wet for 10 minutes. Indicate on transport label if item is not able to be further If unable to decontaminate, place wiped impression in sealable bag and send off with label indicating contaminated item.

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9. CREUTZFELDT JAKOB DISEASE AND INACTIVATION OF PRIONS.


Prion disease Prions are p rotein particles capable of replicating in some tissues to cause terminal brain damage, referred to as the Transmissible Spongiform Encephalopathies (TSE). Both cCJD and vCJD are now notifiable in Australia cCJD is rare with an incidence of one case per million per year in Australia. vCJD is not yet documented in Australia. Resistant properties of prions and processing of instruments The prion is very resistant to sterilisation and is difficult to remove from a surface. There are three stages in cleaning for prion removal detachment, destabilisation and degradation. Drying of prions onto instruments may stabilise them so high risk items are placed after use into an alkaline detergent to prevent attachment and stabilisation. This should now be followed by washing in an enzyme detergent to degrade the prion. All instruments used for neurosurgery are be kept separate to general instruments. A known infected patients instruments are single use and are incinerated. Should a neurosurgical patient later be diagnosed with cCJD they are considered infectious some two years prior to development of symptoms and prior surgery requires notification of patients who may have had surgery performed with the same instruments. After cleaning, sterilisation classically requires 18 minutes at 134 degrees Celsius in a prevacuum steam steriliser but this has not been able to be reproduced since it was reported and further work is being done to ascertain whether it does completely inactivate the prion. For surface decontamination of infected CNS tissue, application of 20,000 ppm chlorine or 1N NaOH for an hour is recommended. Classical CJD Patients are placed on the CJD register when investigations determine likely cCJD. They present with particular neurologic symptoms and procedures involving CNS tissue are performed in a specialist facility. cCJD patients present in middle to late age and do not usually survive more than a few months after diagnosis. It appears that the odds of acquiring CJD increase where previous multiple surgery occurred, indicating that this prion could be present on instruments from previous unknown cases. Predisposition to CJD appears to involve those with a particular genotype. Variant CJD (referred to in cattle as mad cow disease) Both blood and CNS tissue appear capable of transmitting vCJD which poses a problem for general surgery. It is thought to be transmitted to humans via the blood from abrasions in the throat on ingestion of infected beef. Although vCJD is not yet reported in Australia, it is inevitable that a young person incubating it will migrate here the period of infectivity may be very long ie 10 years. Survival time is longer ie a couple of years and the age of onset is much younger ie young adult or adolescent. Most cases in cattle were initially in the UK but there have now been cases in cattle in other parts of Europe and more recently in Japan, Canada and USA. Cattle fed prion infected sheep meal may develop Mad Cow Disease. Humans consuming such beef may become infected. There is no evidence of blood borne transmission in humans ie person to person but it has been shown that ingestion of less than 0.1g of infected meat via the oral route could transmit the infection to a human. There is no proposal to use a disposable instrument strategy for all surgery due to cost. Tonsils and appendices are known to contain prion (lymphoreticular tissue) in vCJD patients. The UK has a strong policy of not reusing single use devices for this reason but appears to be acting alone.

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10. REFERENCES
1. Systematic Operating Procedures 2005. A manual for Infection Control and Occupational Health and Safety for the Dental Practice ADA Victoria 2. Guideline for Infection Control in Dental Health Care Settings CDC MMWR Recommendations and Reports December 19, 2003 3. Guidelines for Environmental Infection Control in Health-Care Facilities. Recommendations of CDC and HICPAC. CDC 2003 4. Standard Guidelines and Policy for NSW Public Hospital Cleaning Services B68 5. Infection Control in the Health Care Setting (ICG) Department of Health and Ageing, January 2004 6. Controlling an Outbreak of Gastroenteritis Interim Guidance for Institutions CDNA 2003 (Draft Infection Control Guidelines) 7. Ch 5 Linen. Canada Communicable Diseases Report. Disinfection and Sterilization in Health Care Supplement, Ottawa 1998 8. Best Practice in UK treatment rooms is linenless. Personal Communication with Helen Almond, Southern Tasmanian Division of General Practice, Feb 2006 9. Section on Linen and Laundry Services. Infection Control booklet by Kevin Kendall 10. Drug administration. Melbourne Health Policy and Procedure. Drugs. September 2005 11. The Re-manufacture of single use medical devices for reuse. TGA June 2005 12. Disinfection, Sterilization and Preservation. Seymour Block. 5 th Ed 13. Guideline for Hand Hygiene in Health Care Settings CDC MMWR Recommendations and Reports October 25, 2002 14. Improving Hand Hygiene. A guide for Improving Practices among Health Care Workers. 15. Efficacy of an alcohol/chlorhexidine hand hygiene program in a hospital with high rates of nosocomial methicillin-resistant Staphylococcus aureus infection. Paul Johnson, Rhea Martin etc MJA 2005 16. Using a non sterile technique in wound care. Journal of wound care management. Helen Hollingsworth, Joanne Kingston January 1998 17. Infection Control Policy (current). Supplied by a Private Pathology. 18. Skin preparation before injection. Nursing times. M.J Lewis. May 1975 19. Introduction to Sterilization, Disinfection and Infection Control. Joan F. Gardner and Margaret M. Peel. Introduction to Sterilisation, Disinfection and Infection Control. 2 nd Edition, Churchill Livingstone 1998. 20. The Blue book. Guidelines for the control of infectious diseases. DHS Victoria May 2005 21. Code of Practice for the Management of Clinical and Related Wastes. Australia and NZ Clinical Waste Management Industry Group. September 2004. 22. Manual for the Management and Disposal of Biomedical Waste in Victoria. 2 nd Edition. November 1993. Publication 268 EPA. (current) and EPA refer to ANZCWMIG. 23. RACGP Infection Control Standards for office based practice. 4 th ed 2006. Dr N Demediuk 24. Management of exposure to blood/body fluids in a health care setting The ANCHARD bulletin September 2002 25. 8th Edition. The Australian Immunization handbook. 2004. 26. Notes from seminar by Turning Point Drug and Alcohol Centre. Melbourne May 2006 27. AS/NZ 4815 2006 Office based health care facilities Reprocessing of reusable medical and surgical instruments and equipment and maintenance of the associated environment.

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APPENDIX 1
PRODUCT LIST Victorian contact numbers insert area code if dialling from interstate 1. Items already in practice or available from supermarket, hardware or stationer. 1. Two pair kitchen gloves (latex for washing, vinyl for drying eg Silk Touch) 2. Toothbrush for brushing instruments (Tek can be steam sterilised) and cytobrushes 3. Exercise book or folder for recording cycle results 4. Solvent based felt tip marker for writing on pouches eg laundry marker pen (non-toxic) 5. Large plastic containers with lids for storing instrument packs 6. Small plastic containers with lids for holding used instruments etc eg Decor 7. Washing bowl if only one sink for instruments 8. Kitty litter for body fluid spill kit 9. Cardboard scoops for spill kit 10. Kitchen tidy bins without lids to place on benches or in wall brackets for clinical waste 11. Safety glasses (available from hardware stores approx $5) 12. Plastic apron - reusable pinafore style provides adequate cover at front 13. Paper towel for drying hands and spill kit 14. A cake rack for placing trays to cool 2. Other required items the Practice may have or may obtain from medical suppliers listed in 3. 1. Blueys plus low linting towel to dry and place cleaned, wet items on 2. Low linting towel for drying instrument - reusable Aquasorb or disposable Senset 3. Commercial labels eg Meditrak instead of marker pens for pouches 4. Detergent such as Clinidet or Sonidet. Endozyme for endoscopes etc 5. Laminate pouches for wrapping instruments. 6. A purpose designed rack for placing pouches upright in chamber 7. Class 4,5 or 6 indicators if there is no printer 8. 7 x BIs for annual validation and access to a 56 degree Celsius incubator. 9. Liquid soap and moisturizer do not use supermarket brands 10. Suitable antimicrobial handwash - 4% chlorhexidine required for surgical procedures 11. Alcohol handrub with inbuilt moisturizer - do not purchase from supermarket 12. Hospital Grade disinfectant for some spills and alcohol swabs for spills kit (optional) 13. Vomit bags (do not use icecream containers for hygiene reasons) 14. Body fluid spill kit (you can make up your own) 15. Collection bins and sharps containers for clinical waste 16. Staff (HCW) immunisation cards from DHS - 1300 882 008 3. Contacts details if not available from your supplier 1. Sonidet detergent and Viraclean Disinfectant by Whiteley. 1 800 257 352. 2. Clinidet detergent and Aquasorb towel by Majac Medical. 07 3889 8008 3. Blueys and low lint towel eg versatowel Kimberley Clark. 03 9550 8088 4. Tuffie detergent wipes, Pouches, low linting senset towel - EBOS group 1800 269 534 5. Avagard liquid soap/handrub, chlorhexidine, Comply Indicators and BIs 3M 1300 363 878 6. Embags by Frontline Innovations. 1800 66 77 22 7. Microshield liquid soap/handrub, chlorhexidine - Johnson and Johnson 1800 029 979 8. SteriCorp for wall mounted sharps bins, clinical waste bins and collection 03 9797 5655

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