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Ref No: CICT

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December 2011

Clinical Policy

DECONTAMINATION OF DENTAL INSTRUMENTS AND EQUIPMENT POLICY Version: V1

Date approved: 5th December 2011

Decontamination of Dental Instruments and Equipment Policy

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Beverly Lamb

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Document Control
Document Reference Title of document Authors name(s)

Authors job title(s)

Directorate(s) Document status Supersedes Clinical approval NHS Manchester (Committee) approved by Date of approval Publication/issue date Review date Distribution

Decontamination of Dental Instruments and Equipment Policy Sally Webster Leasa Benson Beverly Lamb Head of Health Protection Service Clinical Lead Health Protection Service Specialist Dental Infection Control Nurse Public Health V1 N/A Community Infection Control Team Clinical Governance Group Community Infection Control Team Clinical Governance Group 5th December 2011

December 2013 NHS Manchester Website

Decontamination of Dental Instruments and Equipment Policy

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Beverly Lamb

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Contents
1 Introduction ..........................................................................................................4 2 Rationale ..............................................................................................................5 3 Legal Framework .................................................................................................5 4 Audit .....................................................................................................................6 5 Management Options for Decontamination of Instruments ..................................6 6 SSD......................................................................................................................6 7 Single use items...................................................................................................6 8 Safety Issues........................................................................................................7 9 Prion diseases......................................................................................................8 10 Patients with Suspected CJD ...............................................................................8 11 Local Decontamination.........................................................................................8 12 General Principles................................................................................................9 13 Definition of Terms ...............................................................................................9 14 Levels of Decontamination .................................................................................10 15 Risk Assessment................................................................................................10 16 Training ..............................................................................................................11 17 Purchasing .........................................................................................................12 18 Instrument Cleaning ...........................................................................................12 19 Methods .............................................................................................................13 19.1 Manual Cleaning .............................................................................................. 13 19.2 Equipment required.......................................................................................... 14 19.3 Procedure ........................................................................................................ 14 20 Ultrasonic Cleaner/Bath .....................................................................................14 20.1 Testing and Maintenance of the ultrasonic cleaner.......................................... 15 20.2 Daily tests / checks .......................................................................................... 15 20.3 Weekly testing.................................................................................................. 15 20.4 Quarterly testing............................................................................................... 15 21 Washer Disinfector.............................................................................................16 22 Operating Procedure ..........................................................................................16 22.1 Testing and Maintenance of the Washer Disinfector........................................ 16 22.2 Daily tests / checks .......................................................................................... 17 22.3 Weekly testing.................................................................................................. 17 22.4 Quarterly testing............................................................................................... 17 22.5 Annual.............................................................................................................. 17 22.6 Cycle Monitoring .............................................................................................. 17 23 Rinsing ...............................................................................................................17 24 Inspection...........................................................................................................18 25 Sterilisation.........................................................................................................18 26 Loading the Steam Steriliser ..............................................................................19 26.1 Testing and Maintenance of the Benchtop Steriliser ........................................ 19 26.2 Daily and Weekly Testing................................................................................. 20 26.3 Automatic Control Test..................................................................................... 20 26.4 Steam Penetration Test ................................................................................... 20 26.5 Air Leakage Test .............................................................................................. 21 26.6 Process Log ..................................................................................................... 21 26.7 Faults ............................................................................................................... 21 27 Safety .................................................................................................................21 28 Installation and Validation of equipment.............................................................22 29 Records..............................................................................................................22 30 Packaging ..........................................................................................................22
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31 Storage...............................................................................................................23 32 Transportation ....................................................................................................24 33 Management of medical devices prior to repair / service ...................................24 34 Items that are the subject of a complaint or investigation...................................25 35 References.........................................................................................................26 36 Appendix 1 Decontamination of Dental Equipment ............................................28 37 Appendix 2 Protocol for the Manual Cleaning of Dental Instruments .................30 38 Appendix 3 Protocol for using the Ultrasonic Bath .............................................31 39 Appendix 4 Washer Disinfector protocol ............................................................32 40 Appendix 5 Decontamination of Dental Handpieces ..........................................33 41 Appendix 6 Protocol for using the Autoclave......................................................35 42 Appendix 7 Declaration of contamination status ................................................37 43 Appendix 8 Key Roles and Responsibilities for Decontamination ......................38 44 Appendix 9 Ultrasonic activity testing.................................................................40 45 Appendix 10 Summary details Autoclave Log Book...........................................42 46 Appendix 11 Daily test sheet N type ...............................................................43 47 Appendix 12 Daily test sheet - vaccum ..............................................................44 48 Appendix 13 Weekly test sheet - vaccum...........................................................45 49 Appendix 14 Autoclave history record sheet ......................................................46 50 Appendix 15 Production of log sheet-bench top autoclave.................................47 51 Appendix 16 Summary details Ultrasonic Cleaner Log Book .............................44 52 Appendix 17 Daily/Weekly test sheet .................................................................45 53 Appendix 18 Quarterly test sheet .......................................................................46 54 Appendix 19 Quarterly Foil Test Results Sheet..................................................47 55 Appendix 20 Ultrasonic Cleaner History Record Sheet......................................48 56 Appendix 21 Production log sheet-ultrasonic cleaner ........................................49 57 Appendix 22 Summary details Washer Disinfector Log Book ............................50 58 Appendix 23 Daily/Weekly test sheet .................................................................51 59 Appendix 24 Washer Disinfector History Record Sheet .....................................52 60 Appendix 25 Production log sheet-washer disinfector........................................53 61 Appendix 26 Hypochlorite Preparations for surfaces / equipment soiled with bodily fluids..........................................................................................................................54

1 Introduction
All Healthcare organisations must keep patients, staff and visitors safe by having safe systems to ensure that all reusable medical devices are properly decontaminated prior to use. The term re-usable medical device applies to all such devices whether owned by the Trust, rented, or on loan.
A medical device is any instrument intended by the manufacturer for use on a patient during his/her care. The term medical device covers a vast range of equipment, from simple dental instruments to specialist equipment such as the light cure machine or dental cart. As with medicines and other health technologies, they are essential for patient care

The following guidance relating to decontamination outlines the processes and methods used to reduce the risk of cross-contamination via commonly used dental instruments within dentistry. It also provides an overview of the legislative requirements and national guidance that govern decontamination in primary care dental practices (Health Technical Memorandum 01-05).
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All staff need to be aware of this policy. It should be kept in a convenient and prominent position in case needed in an emergency. The most up to date version will be on the PCT website. The policy should form part of the induction for new staff. 2 Rationale

All medical devices and equipment used in the healthcare environment may become contaminated with micro-organisms and thus can present a risk to patients, as well as to those subsequently handling or using them. Safe and effective decontamination of all reusable equipment between uses is therefore an essential part of routine infection control practice. The effective decontamination of re-usable medical devices is essential in reducing the risk of transmission of vCJD and a range of other infectious agents, including blood borne viruses. 3 Legal Framework

Consumer Protection Act, 1987 There may be exposure to civil liability, with payments for damages, for any injuries caused to another person by a defective product. This could include an inadequately decontaminated item that causes an infection. Control of Substances Hazardous to Health (COSHH) Regulations, 2002 Staff must be aware of these regulations that relate to biological and chemical risks, including the risks from disinfectants. These regulations require a risk assessment to be carried out of all potentially hazardous substances. Health and Safety at Work etc Act, 1974 This Act establishes the employers responsibility for the health and safety of employees and visitors to their premises, for providing safe equipment, safe systems of work and training for staff, e.g. how to handle contaminated equipment. As well as the employees responsibilities to follow safe systems of work and cooperate fully with employers

Management of Health and Safety at Work Regulations, 1999 These regulations expand on the Health and Safety at Work Act, requiring employers to make a systematic assessment of all the risks to the health and safety of their employees and others, arising from work activities. Medical Devices Regulations, 2002 Medical devices placed on the market within the UK after June 1998 must carry a CE marking. This denotes compliance with a number of essential requirements covering the safety and performance of the medical device. Medical Devices regulations to supply information to the user on the appropriate processes to allow re-use, including cleaning, disinfection, packaging and where appropriate, the method of sterilisation of the device and any restriction on the number of re-uses. The MDD also applies to devices such as benchtop steam sterilizers and washer/disinfectors Provision and Use of Work Equipment Regulations 1998 The Regulations require that equipment provided for use at work such as decontamination equipment (autoclaves, ultrasonic baths, washer disinfectors) are suitable for the intended use, safe for use, maintained in a safe condition and, inspected.
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Equipment should only be used by people who have received adequate information, instruction and training. Pressure Systems Safety Regulations 2000
Bench top sterilizers must comply with these Regulations, which are intended to prevent risk of injury from stored energy as a result of a failure of a pressure system.

Equality and Diversity All public bodies have statutory duties under the Race Relations (Amendment) Act 2000, the Disability Discrimination Act 2005 and the Equality Act 2006 to set out arrangements to assess and consult on how their policies and functions impact on race, gender and disability equality. NHS Manchester is committed to providing services that meet the equality and diversity needs of staff and service users within the framework of current legislation. Current equality and diversity legislation includes disability, gender, age, race, sexual orientation and religion. It is the responsibility of managers and staff to ensure that they act on this policy in a manner that meets the needs of people from these groups. It is always appropriate to establish with individual staff and patients what their specific needs are, but needs may include providing information in an accessible format, considering mobility and communication issues and being aware of sensitive and cultural issues. 4 Audit

Suitable local audit arrangements must be in place to ensure the policy is being applied. A summary of the audit findings should be made and reported to the relevant manager on a regular basis (at least once a year). 5 Management Options for Decontamination of Instruments
Centralise all decontamination to accredited sterile services departments (SSDs) Use only single use devices Undertake decontamination locally to HTM01-05 standards

SSD

These services have the equipment and expertise to sterilise re-usable medical devices effectively and consistently. They also have systems to track instruments through the decontamination process and retrospectively trace them back to the individual patients on whom they have been used. In the unlikely event of a sterilisation cycle failure, products can then be recalled. By using the services of the SSD for the supply of sterile goods, It is the SSD manager who will take legal responsibility for meeting the requirements both in terms of quality and quantity. 7 Single use items

A medical device is intended to be used on an individual patient during a single procedure and then discarded. It is not intended to be reprocessed and used again EVEN ON THE SAME PATIENT. It must be remembered that single-use refers to single
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occasion of use and not on a single patient. The following symbol indicates that a medical device is single use; The single-use symbol is used on a wide variety of single-use items/equipment from commonly used disposable gloves and aprons to surgical instruments. Every item labelled with a single-use symbol should be treated in the same manner and must always be disposed of after use. All single-use items are classified as clinical waste after use and must be disposed of in a clinical waste bag or container Sharps should be disposed of at point of use in a sharps container Packaged Single-use items should be stock rotated and stored in a dust free, clean and dry storage area Safety Issues

Any re-use of a single use device is likely to be associated with significant risk, is in breach of the law, and is not supported by the PCT. Potential risks include that of crossinfection through inadequate decontamination, mechanical failure due to exposure of the item to chemical agents or heat, material alteration, and reactions in patients to residues from chemical decontamination agents. All equipment must always therefore be used according to the manufacturers instructions (Medical Devices Agency, 2000). Anyone re-using or reprocessing a single-use device is fully responsible for its safety and effectiveness, not the manufacturer who has produced and labelled the item as single-use only. Anyone who reprocesses a single-use item for another person to use may be transferring the same legal responsibilities for the device to themselves as the original manufacturer.

Anyone who reprocesses or uses a reprocessed single-use item may be committing an offence or contravening to national guidance Single-use devices: Will not have been safety tested for more than one use; May be damaged or made unsafe by reprocessing May not have been constructed in a way that makes it possible to decontaminate them satisfactorily. The Consumer Protection Act 1987 will hold a person liable if a single use item is reused against the manufacturers recommendations. (MHRA DB:2006(04) Oct 2006 Device bulletin Single-use Medical Devices: Implications and Consequences of Reuse) Items that are difficult to clean effectively should be rendered single use; such items in dentistry include; matrix bands, steel burs, aspirator tips, 3in1 tips, saliva ejectors, plastic impression trays The Chief Dental Officer for England has published requirements for all endodontic files and reamers to be single use instruments in all cases
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Any re-use of a single use device is likely to be associated with significant risk, is in breach of the law, and is not supported by the PCT. 9 Prion diseases

Prions are infectious agents, which contain no nuclear material. They replicate by transforming normal cellular proteins into abnormal proteins, which then accumulate in the central nervous system where they can trigger neurological symptoms. Prion diseases are neuro-degenerative, with no known treatment. The abnormal proteins associated with prion diseases are very resistant to all conventional methods of decontamination. Most chemical and physical means of cleaning, disinfection and sterilisation of medical devices are only partially effective at inactivating prion proteins. In order to reduce the risk of transmission of prion proteins during surgical procedures, single use devices should be used whenever practicable and they must not be reused under any circumstances (Medical Devices Agency, 2002; Health Service Circular 1999/178). 10 Patients with Suspected CJD Disposal or quarantine of instruments may be required. Please contact the Community Infection Control Team for advice on 0161 946 8242. 11 Local Decontamination Wherever possible, the decontamination process should take place in a dedicated decontamination room. Gold standard would be to have separate clean and dirty rooms with physical segregation between activities. Where a separate decontamination room is not in use there must be a detailed plan on how the decontamination services will move towards best practice which will include removing decontamination from the treatment area. If decontamination takes place in the dental surgery, this must be carried out as far from the dental chair as possible and must not take place whilst the patient is in the room. Contaminated and clean items must always be segregated and stored separately. Within the decontamination area, there must be a clear one-way flow of equipment, from dirty to clean Airflow in the decontamination room must be from clean to dirty and adequate quantities of fresh air should be maintained to avoid excess heat from decontamination equipment. Ventilation systems should exhaust to the outside of the building, without risk to the public or recirculation into any public building mechanical ventilation systems must be cleaned, tested & maintained according to the manufactures instructions. Recycling air conditioning systems are not recommended in clinical areas. The decontamination area / room should be uncluttered and cleaned after each decontamination cycle. Equipment stored in the decontamination area / room must be
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stored above floor level in clean, cool, dry cupboards and open shelving should not be used. (Refer to environmental cleaning and disinfection policy for guidance on cleaning). 12 General Principles Each item of equipment used on a patient must be appropriately decontaminated before and after use The decontamination process used must be compatible with the equipment and adequately deal with the risk of infection Manufacturers instructions should be made available to the operator and followed Equipment / instruments which have no manufacturers instructions or if the instructions provided are inadequate for managing the associated risk must be considered for replacement by more suitable instruments / equipment. A list must be kept of instruments that cannot be decontaminated in line with local policy 13 Definition of Terms Contamination the soiling or pollution of inanimate or living material with harmful, potentially infectious or other unwanted substances, eg, organic matter (blood and body substances), microorganisms, dust, chemical residues, etc. Decontamination the combination of processes (including cleaning, disinfection and sterilisation) used to make a re-usable medical device safe for further use on patients and handling by staff. This process removes or destroys contamination thus preventing micro-organisms or other contaminants reaching a susceptible site in sufficient quantities to cause infection or other harmful response. NB. The life-cycle of reusable medical devices includes the acquisition, cleaning, disinfection, inspection, packaging, sterilization, transport and storage.

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14 Levels of Decontamination It is important that a distinction between the three levels of decontamination are highlighted to ensure that the most appropriate method is chosen Cleaning Physically removing soil, e.g. filth and grime, along with most pathogens using detergents and friction. This is the first level of decontamination and may be all that is required for certain items. Cleaning is an essential pre-requisite for disinfection or sterilization as the presence of any organic matter may render higher levels of decontamination ineffective. Disinfection a process which reduces the number of viable micro-organisms but is not necessarily effective against bacterial spores or some viruses. Disinfection can be achieved through the use of heat or chemicals. The aim is to reduce the contamination to safe levels. Chemicals that achieve this result are known as disinfectants. Such procedures are used when sterilisation is impractical. When applied to the skin this is often referred to as antisepsis Sterilisation means that the complete destruction of all micro-organisms, including spores (with the exception or prions). Equipment and materials which come into contact with broken skin or mucous membranes should be sterilised, e.g., instruments, dressings and injections Sterilisation is best effected by moist heat, usually by autoclaving under pressure. Disinfecting and sterilising techniques are not designed to clean equipment/surfaces and are generally ineffective on surfaces that have not already been physically cleaned. In certain circumstances disinfecting prior to cleaning can exacerbate the situation.
The basic requirements for good decontamination in practice are as follows:o An effective management control system is in place covering all aspects of the decontamination cycle. o Appropriate facilities are provided. o Appropriate equipment is utilised which is: Fit for purpose, properly maintained and calibrated, properly monitored and validated. o Staff are properly trained and supervised. o Single use medical devices are not reused. o Records of decontamination are kept.

15 Risk Assessment To choose the appropriate method of decontamination, a risk assessment must be done to ensure that the decontamination method will render the medical device safe for subsequent handling or use. Every medical device can be categorised according to the potential infection risk to the patient and the following method of risk assessment and selection of appropriate decontamination method can be applied across all care settings and situations.
The choice of decontamination process for equipment depends on a number of factors: The type of equipment The organism involved The time required for processing The risk to patients and staff The manufacturers written instructions
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Prior to the decontamination of medical equipment, the level of risk should be established, the modified Spaulding classification defines four categories:

Minimal Risk

Surfaces that will not come into direct contact with patients e.g. floors and fittings. Surfaces and equipment that come into contact with intact skin e.g. washing bowls, blood pressure cuffs Items in contact with intact mucous membranes i.e. endoscopes Items in contact with diseased / damaged skin Items that are heavily contaminated with virulent or readily transmitted pathogens or substance i.e. faeces, blood etc Any items to be used on highly susceptible / immuno0compromised patients Equipment that enters sterile cavities or vascular systems, Equipment that is in contact with a break in the skin or mucous membrane.

Low Risk

Intermediate Risk

o o o

Adequate cleaning and drying is usually required Adequate cleaning and drying is usually required Adequate cleaning followed by sterilisation (ideally) or alternately disinfection is usually required

High Risk

o o

Adequate Cleaning followed by sterilisation is usually required

All reusable instruments that have become contaminated with saliva, blood or other biological fluids should be cleaned and sterilized after use. Hand pieces should also be cleaned and sterilized after each patient treatment. In order to prolong the life of hand pieces, they should be processed in accordance with the manufacturers instructions. See appendix 5 for guidance on decontamination of dental handpieces. See also appendix 1 for decontamination methods of dental equipment. Decontamination will only be effective if the chosen method has been completed correctly. 16 Training
All staff involved in the use or management of any decontamination equipment or process must have successfully completed competence based training, which is documented and updated appropriate. The following learning outcomes should be covered: An understanding of the whole decontamination process An understanding of their roles and those of others An understanding of the need for infection control and all relevant infection control policies and procedures An understanding of and the ability to perform periodic testing All new staff should be trained at induction update training should be carried out routinely (at least once a year or more frequently if there is a change in guidelines or new equipment is introduced. GDC registrants must complete at least 5 hours of decontamination training in a 5 year CPD cycle
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The appropriate level of training must be undertaken and recorded in their personal development plans The manager will audit training records on an annual basis. The Infection Control Team can advise on the availability of training sessions and on the suitability of others available elsewhere. It is a requirement of the Provision and Use of Work Equipment regulations 1998 and MDA DB 2002 (06) that all staff who manage, supervise or operate decontamination equipment are trained in their use and maintenance. The practice owner / registered manager is responsible for ensuring that systems are in place for ongoing staff training. It is essential that all staff using decontamination equipment have a sound knowledge of the principles, functions and safety issues involved in their use. All Operators must therefore attend training so that they are competent in the use of the equipment. This applies also to agency and locum staff. Training records relating to training in use of equipment should be stored in each equipment log book, with details of staff name, and details of their role, date of training and provider (See also Medical Devices Policy).

17 Purchasing
It is vital that decontamination methods are considered before any piece of equipment is purchased. The following points should be considered and if necessary discussed with the Infection Prevention and Control Team; What is the equipment going to be used for? For example; Single patient use, Same patient, multiple use How invasive is the piece of equipment? If skin, orifices or mucous membranes are breached, what level of disinfection or sterilisation is needed? Is there a single use alternative that may ultimately prove cost effective in terms of cleaning time and other resources? How can the equipment be safely decontaminated? Is detergent satisfactory or are other specific agents required? (Consider COSHH requirements) Is the equipment easy to clean? For example; smooth surfaces and edges, constructed of a non-porous material. Additionally, consider crevices, ridges present, or hollow parts that are inaccessible If a Hypochlorite or alcohol solution is required, will the integrity of the equipment be affected? Additionally, will the device or piece of equipment withstand regular cleaning? If adequate methods of decontamination cannot be identified due to the structure or material of an item, the Infection Prevention and Control Team (IPCT) will recommend that it is taken out of service if already in use, or not purchased in the first instance. Whilst considering items for purchase, ensure that the manufacturer or representative provide as much information as possible with regard to cleaning requirements or restrictions. (See also Medical Devices Policy).

18 Instrument Cleaning
Cleaning will physically remove organic material and most micro organisms from a surface. The principal methods of cleaning reusable dental instruments currently available are: Washer-disinfector; Ultrasonic Bath manual
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Effective cleaning of instruments is an essential prerequisite before sterilization and will reduce the risk of transmission of infectious agents. Wherever possible, cleaning should be undertaken using an automated and validated washerdisinfector in preference to manual cleaning, as a washer/disinfector includes a disinfection stage that renders instruments safe for handling and inspection Manual washing and or ultrasonic bath may be used in cases were instruments are not compatible with the washer disinfector (procurement of devices should give consideration to compatibility to suitable decontamination) (see also Medical Devices Policy) Instruments with more than one component i.e. amalgam carriers must be dismantled prior to decontamination Instruments must be decontaminated as soon as possible after use to avoid air drying, where this is not possible the use of commercial gels / foam sprays for wetting of instruments is useful. Long periods of wet storage should be avoided. New instruments should be cleaned and sterilized before using for the first time, unless supplied as sterile. Cleaning should always be performed before disinfection and sterilisation.

19 Methods 19.1 Manual Cleaning


The use of manual cleaning presents particular problems. Because the process is not automatic, it is not possible to fully validate the process. Manual cleaning is thus not the preferred method of cleaning. Where possible manual cleaning should be replaced with automated cleaning. Where manual cleaning is necessary (for example, as advised by the manufacturer) the critical parameters should be controlled as much as possible to reduce the variability in cleaning performance; A Detergent specifically designed for cleaning instruments is used according to manufacturers instructions, low foaming neutral detergents are recommended. (hibiscrub, detergent or creams should not be used) Water temperature should not be above 45 degrees When able to, items should be fully immersed in order to minimise splashing and the creation of aerosols. The sink should be flat bottomed and large enough to accommodate immersion of all items for cleaning. Domestic household gloves and disposable apron should be worn during washing. Glasses/visor and mask should be worn as there is likely to be splashing or the creation of aerosols. A long handled brush with soft nylon bristles is used; brushes may be single use or cleaned with hot water and detergent after each use and stored head up. Brushes should be replaced when showing signs of wear.

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Wire brushes including bur brushes should be avoided as they may cause surface abrasion. A written protocol must followed and on display where cleaning is undertaken (see appendix 2)

Some medical devices will become compromised by soaking in an aqueous solution e.g. electrical equipment, where manufacturers instructions state immersion is not recommended the following cleaning method is recommended;

19.2 Equipment required


A warm water/ neutral detergent solution at correct dilution* A clean, disposable, absorbent, non-shedding cloth for application of detergent solution*. A clean, disposable, absorbent, non-shedding cloth

19.3 Procedure
Ensure electrical devices are disconnected from the mains supply Wearing protective clothing, immerse the cleaning cloth in the detergent solution and wring thoroughly* Commencing with the upper surface of the item, wipe thoroughly ensuring that detergent solution does not enter electrical components. Periodically rinse the cloth in clean water and repeat the above steps. Surfaces should be carefully hand-dried using a cloth *Alternatively a single use disposable detergent wipe may be used Note: Non-immersion, manual cleaning is not a disinfection process.

20 Ultrasonic Cleaner/Bath
The ultrasonic bath works by subjecting the load to high intensity, high frequency sound waves. The compatibility of all materials and items to be reprocessed should be established by referral to manufacturers instructions; Plastics will not be cleaned by the process and glass items may be damaged by the process. Dental Handpieces may become damaged by the process. Ultrasonic cleaning in a well-maintained machine enhances removal of debris although a washer-disinfector is preferred. The ultrasonic cleaner can be used as a cleaning method including being used as an extra cleaning stage prior to an automated washer-disinfector process. This may be particularly helpful for instruments with hinges and/or intricate parts. A low foaming alkaline or enzymatic detergent must be used according to manufacturers guidance. The tank should be emptied and refilled with fresh solution whenever there is visible soiling, or at the end of each session whichever is the sooner. After emptying water from the tank, the tank should be rinsed to remove soiling before a fresh charge of water is admitted. Records should be kept of the detergent change in the equipment log book. The tank should be drained down when not in use i.e. overnight and weekends and where practicable should be dried. See appendix 3 for ultrasonic cleaner / bath protocol
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20.1 Testing and Maintenance of the ultrasonic cleaner


The ultrasonic bath should be tested and maintained in accordance with manufacturers instructions if these instructions are not available the schedules outlined in HTM01-05 are followed Annual testing and revalidation must be carried out by a competent person (decontamination) service engineer. There is also a requirement under BS EN ISO 15883:1 for preventative maintenance. Daily and weekly testing should be carried out by the user or by delegation to the operator if trained.

Quarterly tests are carried out by a competent person (decontamination) service engineer. Alternatively the designated user may carry out the ultrasonic activity test if trained to do so. 20.2 Daily tests / checks
If applicable filters and strainers should be removed and cleaned Machine should be drained and cleaned at end of day or sooner if visibly soiled. A visual examination of load items should be carried and confirmed as effective. This is carried out following rinsing

20.3 Weekly testing


Including daily tests plus; If applicable the door seal should be checked to ensure good condition and clean A protein residue test should be carried out to confirm that the cleaning process retains the capability of removing proteins; this is carried out following rinsing to avoid false positives

20.4 Quarterly testing


Including weekly tests plus: Verification of calibration Automatic Control Test Cleaning efficacy test using an artificial soil Ultrasonic activity test (see appendix 9 for guidance) Annual Annual revalidation will require completion of all tests See appendices 16 - 21 for sample log sheets

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21 Washer Disinfector
Washer disinfectors are the preferred method for cleaning dental instruments as they offer the best option for the control and reproducibility of cleaning. Washer disinfectors use a combination of physical cleaning and thermal microbiocidal action to achieve disinfection of contaminated reusable items. However, the process will not be active against bacterial spores and some viruses. This can either be as a process prior to re-use or to make items safe to handle before further reprocessing. The manufacturers recommended detergent should be used, for most applications; mild alkaline detergents in the pH range 8.011.0 are preferred. Alkalinity improves the efficacy of detergents both by enhancing their inherent cleaning capabilities, neutralizing and helping to remove acid soils, emulsifying oils and fats and peptidizing proteins, and by synergistic action with other detergent compounds. Cleaning agents should be liquid to facilitate accurate dispensing, nonabrasive, low foaming and free rinsing.

22 Operating Procedure A typical cycle will comprise: Flush removes difficult / gross contamination, including blood, tissue, debris, bone fragments and other fluids and solid debris. Water temperature of less than 45 degrees Celsius is used to prevent protein coagulation and fixing of soil to the instrument Wash removes any remaining soil. Mechanical and chemical processes loosen and break up contamination adhering to the instrument surface. Detergents used in this process must be specified by the manufacturer as suitable for use in a washer-disinfector. They should also be compatible with the instruments being processed and supplied so as to perform correctly and avoid instrument degradation including discoloration, staining, corrosion and pitting. Rinse removes detergent used during the cleaning process. This stage can contain several sub-stages. For the final stage of rinsing, water remaining contaminants, including salts, may be deposited on the surface of instruments, affecting both appearance and subsequent sterilization. In recognition of this, most washer-disinfector manufacturers provide a separate water-supply inlet for the final rinse stage. It is recommended that RO or freshly distilled water be used for this stage Thermal disinfection the temperature of the load is raised and held at the pre-set disinfection temperature for the required disinfection holding time: for example, 80oC for 10 minutes; or 90oC for 1 minute. Drying Purges the load and chamber with heated air to remove residual moisture. It is crucial to load a washer-disinfector correctly, as incorrectly loaded instruments will not be cleaned effectively. Therefore, follow an instrument-loading procedure that has been shown to achieve effective cleaning in the washer-disinfector used in the practice. To do this: Do not overload instrument carriers or overlap instruments; Open instrument hinges and joints fully; Attach instruments that require irrigation to the irrigation system correctly, ensuring filters are in place if required (for example for handpieces, if specified by the manufacturer). See appendix 4 for washer disinfector protocol

22.1 Testing and Maintenance of the Washer Disinfector


The washer disinfector should be tested and maintained in accordance with manufacturers instructions if these instructions are not available the schedules outlined in HTM01-05 are followed
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Annual testing and revalidation must be carried out by a competent person (decontamination) service engineer. There is also a requirement under BS EN ISO 15883:1 and BS EN ISO 15883:2 for preventative maintenance. Daily and weekly testing should be carried out by the user or by delegation to the operator if trained.

Quarterly tests are carried out by a competent person (decontamination) service engineer. 22.2 Daily tests / checks
The spray arms should be checked to ensure they are rotating and the spray nozzles are checked for any blockages If applicable filters and strainers should be removed and cleaned A visual examination of load items should be carried and confirmed as effective.

22.3 Weekly testing


All daily tests plus; Check condition of door seal A protein residue test should be carried out to confirm that the cleaning process retains the capability of removing proteins

22.4 Quarterly testing


Including weekly tests plus: Safety checks for safe operation of doors and door interlocks Automatic control test Cleaning efficacy test Chemical dosing Thermometric disinfection test See appendices 22 - 25 for sample log sheets

22.5 Annual
Annual revalidation will require completion of all tests

22.6 Cycle Monitoring


The washer disinfector should be equipped with the means to provide independent monitoring of all critical cycle variables (these can be provided by the authorised person or the manufacturer. A printer or data logger would be suitable means of keeping a process log. The records should be kept in the equipment log book

23 Rinsing
Regardless of method of cleaning used ALL Instruments should be rinsed thoroughly either in potable water of a suitable quality or distilled or reverse osmosis water to remove residual soil and detergents with minimum risk of salt deposition. A dedicated sink or bowl (separate from the one used for the original wash) should be used, wash-hand basins should not be used. Clean rinse water is used and the instrument must be fully immersed. This step may be omitted if a washer-disinfector is used
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24 Inspection
All instruments that have been through any cleaning procedure, including processing by a washer-disinfector, must be inspected to ensure they are clean, functional and in good condition. A dedicated clean area of benching with good task lighting should be provided. An illuminated magnifier is recommended because it makes it much easier to see residual contamination, debris or damage Any instruments that are blunt, bent, rusted or damaged or show any signs of pitting or other corrosion must be discarded. Instruments should be inspected for any visible contamination. If contaminated the instrument should be rejected and should undergo another cycle of the cleaning process. Dental staff should ensure that: there is free movement of all parts and that joints do not stick; the edges of clamping instruments meet with no overlap and that teeth mesh together; scissor edges meet to the tip and move freely across each other with no overlap or burrs (rough edges); all screws on jointed instruments are tight and have not become loose during use. Instruments that are damaged or faulty should be taken out of use and either repaired or replaced. All cleanliness failures should be recorded in the fault log and regularly reviewed

Instruments that are to be wrapped prior to sterilisation must be dried using a disposable non linting cloth. Instruments sterilised in a downward displacement autoclave (N Type) must not be pre-packed. This stage may be omitted if a washer disinfector is used and instruments are dry at end of the cycle. 25 Sterilisation
Sterilization means the complete destruction or removal of all forms of micro-organisms, including spores. Moist heat, gas or irradiation best achieves it. Saturated steam under pressure delivered at the highest temperature compatible with the product is the preferred method for the sterilization of most instruments used in the primary care dental practices. Dry heat (heat without the moisture) is less efficient and much more time consuming, is therefore a less practical and reliable method and is not recommended (i.e. hot air ovens) Benchtop Steam Sterilisers must be suitable for the intended loads. There are two main types of Benchtop sterilisers available; traditional downward displacement autoclaves (N Type) and Vacuum Autoclaves (B&S Types)

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Cycle Type N

Air Removal Passive (gravity displacement)

Load Type Non-wrapped solid items

Advantages Simple to use, least expensive to purchase, operate and maintain, quick cycle time Widest range of applications

Disadvantages Not to be used for; Hollow devices or those with lumens (i.e. dental handpieces) Wrapped / porous loads Expensive to purchase and maintain Additional periodic testing required Increased cycle times Expensive to purchase and maintain Additional periodic testing required Increased cycle times

Active forced air removal

Active (forced air removal)

Wrapped or unwrapped solid or hollow items i.e. handpieces Porous loads i.e. swabs, dressings Only to be used for types of loads specified by the steriliser manufacturer

Wider range of applications than N type

NB- Some sterilisers have more than one type of cycle. Ensure you use the correct cycle for the load

26 Loading the Steam Steriliser


All instruments must be free from visible contamination and in good condition prior to sterilization Do not overload the autoclave. Instruments should not be touching. Hinged instruments should be opened out. Use the trays provided (do not place items in receivers or bowls) Receivers, bowls should be placed on their side/inverted. Small instruments e.g. burs should be placed in suitable holder which allows steam penetration

NB: Incorrect loading may prevent sterilisation. 26.1 Testing and Maintenance of the Benchtop Steriliser
The steriliser should be tested and maintained in accordance with manufacturers instructions if these instructions are not available the schedules outlined in HTM01-05 are followed Quarterly and annual testing must be conducted by a Test Person (steriliser). and requires specialised test equipment. There is also a requirement under BS EN 554: 1994, for preventative maintenance.
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All steam sterilizers are subject to the Pressure Systems Safety Regulations 2000 and must be examined annually by a Competent Person (Pressure Vessels). Testing is an integral part of ensuring that a sterilizer consistently performs to operating parameters set during the machines commissioning. Failure to carry out routine periodic tests and maintenance tasks could compromise safety and have legal and insurance-related implications

See appendix 6 for Autoclave protocol 26.2 Daily and Weekly Testing
The designated user is responsible for daily and weekly testing. These tests are designed to show that the operating cycle functions correctly. The user may designate the tasks to an authorised operator if appropriately trained. Before carrying out the daily tests, the user should: Clean the rubber door seal with a clean, damp, non-linting cloth; Check the chamber and shelves for cleanliness and debris; Fill the reservoir with freshly distilled or RO water (from a previously unopened bottle Turn the power source on.
Test Type a b c Automatic control test Steam Penetration test Air Leakage Test Steriliser Type ALL Vacuum only Vacuum only Period Daily Daily Weekly

Sterilizers should not be used until the daily tests and housekeeping tasks have been carried out and the results found to be satisfactory. All tests must be performed at the start of each day whilst the autoclave is empty Some sterilisers need to run a warm up cycle before tests are carried out this should be confirmed with the manufacturer

26.3 Automatic Control Test This can be carried out at the same time as the steam penetration test. If the steriliser has a data logger or printer, the print out / record for the test cycle must be checked against the cycle parameters before the steriliser is confirmed fit for use. If no printer or data logger is available the cycle must be observed and the following information recorded; Maximum values of the chamber temperatures ( and pressures indicated on gauge and holding stage duration in minutes and seconds o 121C for 15 minutes o 126C for 10 minutes o 134C for 3 minutes 2.2 bar pressure Total cycle time is recorded

26.4 Steam Penetration Test It is essential to use the steam penetration test device and the indicator specified by the manufacturer otherwise the tests results may be misleading i.e. Bowie Dick / Helix

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26.5 Air Leakage Test This is only carried out by the user / operator is the steriliser has an inbuilt self test programme otherwise it is carried out by the competent person at the quarterly check. Refer to the manufactures instructions on how to carry out this automatic test The results of the tests are kept in the log book, and should be signed by the designated user before it is returned for use, this acts as a certification of fitness for use.
See appendices 10 15 for sample log sheets

Chemical / process indicators i.e. TST strips, autoclave tape, indicators printed onto pouches / bags should only be used to distinguish processed items from unprocessed items and should not be used for any other purpose 26.6 Process Log A master process record should be available of the permitted tolerances of the cycle variables for each correctly functioning operating cycle it can be provided by the authorised person or the manufacturer. The master process record is used as a comparison to confirm if sterilising conditions have been achieved. Permanent records of each sterilisation cycle should be kept in a process log. If the sterilizer has an automatic printer, the printout should be retained or copied to a permanent record. If a data logger is used the information should be stored securely. If the sterilizer does not have a printer or data logger, the user will have to manually record the following information in the process log: Date & cycle number Type of load Sterilisation cycle selected satisfactory completion of the cycle cycle pass or fail Signature of the operator 26.7 Faults Where a daily or weekly test fails, the steam steriliser must not be used; faults must be reported immediately to the owner of the steriliser and not used until repaired, the user will arrange for repair. All PCT staff to immediately inform the estates department. All faults must be recorded in the equipment log book At the end of the day to prevent colonisation of water in steam sterilisers, the water must be drained and the reservoir left empty. The device should then be cleaned, dried, and left empty with the door kept open. 27 Safety
COSHH assessments must be undertaken for the detergents used during cleaning, spillage notices, hazard notices and eye-washing facilities should be provided as appropriate Operators must be trained in the use of all decontamination equipment and updated regularly Protective clothing must be worn during the cleaning of instruments; single use apron, gloves, mask and safety glasses or visor
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Designated staff hand wash facilities must be available and used after the removal of protective clothing.

28 Installation and Validation of equipment All decontamination equipment should be installed and validated by a registered competent person (an engineer proficient in testing) A Named person in the practice should be accountable for its validation and periodic testing, maintenance and use. Following validation a schedule for periodic testing and planned preventative maintenance should be drawn up. All decontamination equipment used must be validated and tested in accordance with HTM 01-05 In PCT premises, these procedures are arranged via the estates department A log book should be kept of validation and testing, maintenance and faults. All personnel using the equipment must be appropriately trained and records must be kept in the log book. Any person using decontamination equipment has a legal and professional responsibility to ensure that the equipment they are using is not only working correctly but also that it is correctly maintained and tested A list of named designated responsible persons must be kept in the equipment log book with an outline of the individuals responsibilities, everyone must be aware of each others responsibilities. Each practice will establish its own system concerning staff responsibilities, see appendix 8 for key roles and responsibilities 29 Records All decontamination equipment should have a dedicated log book The log book should be kept close to the equipment and should include the following information: Clear concise operational instructions operating manual and summary of working instructions sheet Records of validation tests and checks Routine monitoring of every sterilization cycle - process log Results of all periodic testing and housekeeping Details of failed cycles and action taken to correct the problem (what was done with the unsatisfactory load) Records of maintenance and repair or modifications The written scheme of examination under the pressure systems safety regulations and the records of inspection under the scheme (for autoclaves) Certificate of insurance for the pressure systems (for autoclaves) Training records for staff using the equipment (operator and users) Records Management: code of practice parts 1 & 2 (April 2006) provide guidance on the length of time for which records should be retained. The code requires that that records of tests be kept for not less than 2 years 30 Packaging Instruments can only be wrapped prior to sterilisation in a vacuum steriliser if using an N type steriliser DO NOT wrap instruments prior to sterilisation
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Unwrapped Instruments should be kept on covered trays in enclosed cupboards or boxes. They cannot be stored and must be used in the current treatment session. If unused at the end of the treatment session they must be regarded as contaminated and sent for reprocessing Instruments should be packaged using a dedicated open bench area which is kept free of clutter and wiped clean at session intervals Instruments must be dry prior to packaging and wrapping materials must comply with BS EN ISO 11607 In dental practices self seal sterilisation pouches are typically used Regardless of packaging used all instruments / sets must be labelled with the date by which they should be used Instruments that are packaged prior to sterilisation in a vacuum autoclave can be stored for up to 60 days Instruments that are packaged following removal from the steriliser may be stored for up to 21 days Each instrument may be wrapped separately or a set of instruments may be held in a cassette / tray prior to packaging as this prevents instruments overlapping Instrument packs should be inspected prior to use to ensure that: The outer wrapping and seals are intact The pack is dry The process indicator has changed colour (if autoclaved wrapped) The pack is still within the expiry date If the above requirements are not met the contents of the pack should not be used and should be sent for further decontamination Instruments that have been sterilised unwrapped are designated as sterilised only 31 Storage All instruments must be completely dry when stored as dampness encourages growth of micro organisms and corrosion of instruments. If a drying cycle as not been used instruments must be manually dried using a single use non linting cloth Instruments must not be stored loose in drawers or on open trays DO NOT store instruments on open shelving or on work surfaces in clinical areas Storage of wrapped instruments should be in clean, orderly, enclosed cupboards, drawers or boxes in a manner that avoids damaging the wrapping and allows for effective stock rotation to ensure sterilised items are used within their shelf life or when they are passed their shelf life are unwrapped and returned to the start of the decontamination process
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Storage areas must be clean & dry and be away from sources of direct sunlight, heat, waste and water Best practice requires that instruments are stored in separate environment away from clinical areas (this may be the clean area of the decontamination room) 32 Transportation All used instruments pose a risk of infection, to minimise this risk they must be kept clear from clean / sterilised items. Instruments must be placed in a closed, secure transport container which should be: Leak proof Easy to clean Rigid Capable of being closed securely Labelled to identify the contents appropriately Containers must be cleaned and dried before reuse Staff handling contaminated equipment must wear PPE in accordance with local policy and be vaccinated against hepatitis B Where necessary clean/ sterilised items must be transported using a separate dedicated transport container 33 Management of medical devices prior to repair / service
Any loaned items being returned to a manufacturer or supplier should also be decontaminated

Anyone who inspects, services, repairs or transports medical, dental and laboratory equipment, either on hospital premises or elsewhere, has a right to expect that medical devices and other equipment have been appropriately treated so as to remove or minimise the risk of infection or other hazards; appropriate documentation is required to be provided to indicate the contamination status of the item. If medical devices or equipment require repair or service recipients have a right to expect that it has been appropriately treated to minimise the risk of infection. Items for repair, service or investigation should be decontaminated prior to these activities taking place. This also applies to any loaned items being returned to a manufacturer or supplier. In order to identify contamination status, a written declaration must accompany any item of medical equipment when being transported within the PCT or outside of the PCT for repair or service (see appendix 7) If items are dispatched to suppliers, or presented for service or inspection on Trust premises without a declaration of contamination status and without prior agreement,
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suppliers may refuse to handle such items until they have been decontaminated and a declaration provided. This may result in delays and/or additional costs 34 Items that are the subject of a complaint or investigation In particular situations, for example when the condition of an item which is the subject of complaint or investigation may be altered or influenced by a decontamination process, the investigator may wish the item not to be decontaminated. In such situations, the advice of the investigating body and the Community Infection Control Team should be sought. Prior warning should be given to the intended recipient. The condition of the item should be clearly labelled so that it can be determined prior to opening of the inner package. The packaging should be sufficiently robust to withstand transport. The packaging should ensure that the content of the inner pack cannot contaminate the outer one. In addition, agreement of any carrier used to transport a contaminated item may be required. The above also applies to items, which are not subject to investigation but cannot be decontaminated before inspection, service or repair Note: it is illegal to send contaminated items through the post

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35 References Department of Health Health and Social Care Act 2008: Code of Practice for the Prevention and Control of Healthcare Associated Infections Standards for better Health, July 2004 Health Technical Memorandum 01-05 Decontamination in primary care dental practices Health Technical memorandum 01-01 part A Decontamination of Reusable Medical Devices; Management and Environment Health and Safety Executive The Personal Protective Equipment Regulations 2002.ISBN 0 11 039830 0. The Control of Substances Hazardous to Health Regulations, 2002 (SI No. 1657). Health and Safety at work etc. Act 1974 London: HMSO 1974 Health and Safety Commission (1992) Management of Health and Safety at Work Regulations: Approved Code of Practice. HMSO The classification, Packaging and Labelling of Dangerous Substances Regulations. 1984 (SI No. 1244). HSE Health and Safety No.2169. The pressure systems and transportable gas containers regulations 1989. Consumer Protect Act 1987 HMSO 1987 MHRA / MDA DB2006(04) Oct. 2006 Device bulletin Single-use Medical Devices: Implications and Consequences of Reuse The Medical Devices Regulations 2002. Statutory Instrument 2002 No.618 HMSO 2002 ISBN 0110423178 Checks and tests for newly delivered medical devices. MDA DB9801, Supplement 1; 1999 MHRA DB2003 (03) management of Medical Devices Prior to Repair, service or Investigation. Compatibility of medical devices and reprocessing units with decontamination agents. MDA SN2001(28); 2001 Guidance on the sale, transfer of ownership and disposal of used medical devices. MDA DB9801, Supplement 2; 2001
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Bench-top steam sterilisers: guidance on purchase, operation and maintenance. MDA DB2002(06); 2002
Medical Devices Directive (MDD) - Directive 93/42/EEC. OJ 1993; 169:1-43.

MDA/2010/001 Issued: 04 January 2010 Medical Devices Agency, 2002; Health Service Circular 1999/178 MHRA Devices in Practice; A guide for professionals in health and social care; published 2001 Equipped to Care, MDA, 2000 Device Bulletin Managing Medical Devices. Guidance for healthcare and social services organisations. DB2006(05) November 2006 Symbols used on medical devices & their packaging, MDA, 2000 Advisory Committee on Dangerous Pathogens / Spongiform Encephalopathy Advisory Committee (ACDP / SEAC). Transmissible Spongiform Encephalopathy Agents: safe working and the prevention of infection; 2001 Department of Health. Variant Creutzfeldt-Jakob Disease: Minimising the risk of transmission. HSC 1999/178; 1999 NHS Estates. A guide to the decontamination of re-usable surgical instruments; 2003 Scottish Dental Clinical Effectiveness Programme. Cleaning of Dental Instruments; Dental Clinical Guidance March 2007 National Patient Safety Agency (2008)Patient Safety Alert Clean Hands save lives Infection Control Services. 2008 www.infectioncontrolservices.co.uk Lawerence, J and May, D (2003) Infection Control in the Community Churchill Livingstone

90/679/EEC Council Directive of 26 November 1990 on the protection of workers from risks related to exposure to biological agents at work, Official Journal L374; 31.12.90. Royal Mail guide: a comprehensive guide to mail services, October 1992. HSG (93)13 Reporting adverse incidents and reactions and defective products relating to medical and non-medical equipment and supplies, food, buildings and plant and medicinal products. Ultrawave. www.ultrawave.co.uk admin@ultrawave.co.uk

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36 Appendix 1 Decontamination of Dental Equipment


This is not intended to be an exhaustive list of all items of dental equipment. The manufacturers instructions must always be followed in regards to decontamination of a product. Where manufacturers decontamination instructions are unclear, or alternative disinfectants to those described are recommended, the Infection Control Team should be contacted for further advice on 0161 946 8242

Item
Light Cure Unit

How often
After each use After each use After each use

Method
Optical rod clean; manual, ultrasonic bath or washer disinfector, inspect and sterilise. The unit itself should be cleaned with detergent Probe - clean; manual, ultrasonic bath or washer disinfector, inspect and sterilise. The unit itself should be cleaned with detergent Use disposable headrest covers and disposable barriers on controls if hand operated - change between patients Clean with detergent. NB some disinfectants may damage upholstery over time Clean with detergent

Electric Pulp Tester Dental Chair

Dental Cart Bracket table , couplings and tubing Spittoon

After each use

After each use After each use or when visibly contaminated After each use After each use After each use After each use

Safety Glasses / visors

Rinse and clean with detergent. Filter / trap to be cleaned end of session according to manufacturers instructions Single use or cleaned with detergent

Dental Light

Amalgamator Amalgam carrier

Instrument Transport Containers Xray film / sensor

Use disposable barriers on handles and controls if hand operated, change between patients Clean with detergent Ensure no traces of amalgam present and Clean with detergent Remove amalgam debris and dispose as hazardous waste. Dismantle prior to cleaning manual, ultrasonic bath or washer disinfector, inspect and autoclave. Clean with detergent

X-ray film clean with detergent and disinfect before taking to processor. Sensor use protective covering before use and clean with detergent and disinfect After each use After each use End of session Barrier covers may be used and replaced after each use Clean with detergent Clean tubing with detergent after each use. Keep tubing straight at all times to prevent twisting and trapping of debris in the lumen. Flush at the end of each session with non-foaming disinfectant according to manufacturers instructions.
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X-ray tube Aspirator tubing and suction unit

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Item
Air receiver / compressors Aspirator and spittoon filter traps

How often
End of session

Method
Drain daily and change filters according to manufacturers instructions Clean in warm water and detergent according to manufacturers instructions Replace once worn or according to manufacturers instructions Single use for single treatment episode dispose of in clinical waste Single use for single treatment episode dispose of in sharps container Cleaned manual or washer disinfector, inspect and autoclave Use single use whenever possible. Steel burs should be single use If single use not appropriate: Cleaned manual, ultrasonic bath or washer disinfector, inspect and autoclave Dispose of band in sharps container , clean (manual, ultrasonic bath or washer disinfector) Inspect and autoclave retainer Single use for single treatment episode dispose of in clinical waste Replace plastic sleeve & clean with detergent Clean, oil inspect and autoclave (see appendix 5) Tips to be removed then cleaned manual, ultrasonic bath or washer disinfector. Inspect and autoclave If applicable base unit to be cleaned with detergent Single use for single treatment episode dispose of in clinical waste Clean manual, ultrasonic bath or washer disinfector, inspect and autoclave. OR Single use for single treatment episode dispose of in clinical waste Single use for single treatment episode dispose of in clinical waste

End of session

Aspirator tip / saliva ejector Endodontic files and reamers All reusable dental Instruments Rotary instruments (burs)

After each use

After each use After each use

Matrix bands

After each use

3 in 1 Tip: 3 in1 syringe Handle Handpieces Ultrasonic scaler

After each use After each use after each use After each use

Dapens Pots Instrument trays / cassettes

After each use After each use

Impression trays

After each use

NB: A warm water/ neutral detergent solution at correct dilution may be used with a single use absorbent non shedding cloth. Alternatively a single use disposable detergent wipe may be used This is not a disinfection process, but where an alcohol wipe is used to dry surfaces, this may have a disinfecting effect. Surfaces can be effectively cleaned using commercial bactericidal cleaning agents and wipes, alcohol should be avoided as it binds to blood protein and stainless steel. Water and suitable detergent is satisfactory provided the surface is dried after cleaning If known contamination with bodily fluids follow with 0.1% (1000ppm) hypochlorite solution see appendix 26 for hypochlorite preparations All surfaces that have potentially become contaminated should be cleaned after each patient including work surfaces, handles and cupboard / drawer fronts (see also environmental cleaning policy)
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37 Appendix 2 Protocol for the Manual Cleaning of Dental Instruments Protocol for the Manual Cleaning of Dental Instruments
Immersion method All personnel involved in the decontamination of dental instruments should be trained in the content and application of this protocol and associated guidance. To minimise the risk to personnel undertaking manual cleaning, the splashing and creation of aerosols should be avoided at all times. Remember: Maintaining a dirty-to-clean workflow procedure will assist in the cleaning process. Wash hands. Wear personal protective clothing (PPE). Prepare sinks, equipment and setting-down areas. Dismantle and open the instruments, as applicable, ready for immersion. Fill the clean sink (NOT wash-hand basin) with the appropriate amount of water and detergent (specified for the purpose). Note: ensure correct temperature as recommended by the detergent manufacturer is maintained (kept below 45 degrees) Fully immerse the instruments in the solution and keep under water during the cleaning process to prevent aerosols. Agitate/scrub the instruments using long-handled brushes with soft plastic bristles. Drain any excess cleaning solution prior to rinsing. Rinse in a second sink with potable water of a suitable quality, freshly distilled or RO water. After rinsing, drain and dry if instruments are to be wrapped. Visually inspect all items under an illuminated magnifier ensuring they are clean, functional and in good condition. Lubricate any relevant items prior to sterilization with a non-oil-based lubricant. Dispose of cleaning materials safely in accordance with local policy. Replace cleaning solution and the rinse-water after each use. Complete any relevant documentation.

Safety Precautions PPE must be worn when manually scrubbing instruments; gown / apron, domestic household gloves, visor / mask and goggles Instruments must be fully immersed to avoid the dispersal of aerosols and to protect operators. If instruments are washed in the surgery this must not take place whilst the patient is present A long handled brush with soft nylon bristles to be used to prevent sharps injury

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38 Appendix 3 Protocol for using the Ultrasonic Bath Protocol for using the Ultrasonic Bath
Heavily soiled Instruments should be briefly immersed in cold water (with detergent) to remove some of the blood and other visible soil before ultrasonic cleaning. Care should be taken to minimise aerosol production in this process and to safeguard against inoculation injury. The use of a purpose-designed container with sealing lid is recommended. To avoid injury instruments should not be scrubbed Use a low foaming detergent recommended by the manufacturer at the recommended dosage Follow the manufacturers recommendations for the safe operating procedure of the ultrasonic cleaner and follow the points outlined below regarding loading and unloading the cleaner. Ensure that joints or hinges are opened fully and instruments that need taking apart are fully disassembled before they are immersed in the solution. Place instruments in a suspended basket and fully immerse in the cleaning solution, ensuring that all surfaces are in contact with the solution. The solution should be made up in accordance with the manufacturers instructions. Do not overload the basket or overlap instruments, because this results in poor cleaning and can cause wear to the instruments. Do not place instruments on the floor of the ultrasonic cleaner, because this results in poor cleaning and excessive instrument movement, which can damage the instruments. To avoid damage to delicate instruments, a modified basket or tray system might also be necessary depending on operational requirements. Set the timer to the correct setting as per the ultrasonic cleaner manufacturers instructions. A typical setting would be 20 to 40 o C for 3 minute, which minimizes the rate of coagulation of proteinaceous material or use default temperature setting Close the lid and do not open until the cycle is complete. After the cycle is complete, drain the basket of instruments before rinsing. Change the solution when it becomes heavily contaminated or otherwise at the end of every clinical session and rinse the tank, because the build-up of debris will reduce the effectiveness of cleaning. Record the fluid change in the log book. Items must be rinsed thoroughly with water to remove residual soiling and detergents Visually inspect all items under an illuminated magnifier ensuring they are clean, functional and in good condition. Lubricate any relevant items prior to sterilization with a non-oil-based lubricant.

. Safety Precautions PPE must be worn when using the ultrasonic bath; gown / apron, gloves, visor / mask and goggles These machines must only be operated with the lid in place to avoid the dispersal of aerosols and to protect operators from the noise that may be generated. Ultrasonic cleaners must never be operated whilst the tank is empty. Operators must never put their hands or any other part of their body into the tank whilst the machine is in operation.

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39 Appendix 4 Washer Disinfector protocol Washer Disinfector protocol


At the start of the session, before carrying out the daily tests:
Check and clean the door seal with a clean, damp, non-linting cloth; Check the chamber and baskets for cleanliness and debris; Check the spray arms are freely rotating Check the spray nozzles are not blocked Ensure the correct dilution and quantity of detergent Turn the power source on.

Heavily soiled Instruments should be briefly immersed in cold water (with detergent) to remove some of the blood and other visible soil before being placed in the washer disinfector (ultrasonic bath may also be used as a pre-clean). Care should be taken to minimise aerosol production in this process and to safeguard against inoculation injury. Follow the manufacturers recommendations for the safe operating procedure of the washer disinfector. Use a detergent recommended by the at the recommended dosage It is crucial to load a washer-disinfector correctly, as incorrectly loaded instruments will not be cleaned effectively. Therefore, follow an instrument-loading procedure that has been shown to achieve effective cleaning in the washer-disinfector used in the practice. To do this: Do not overload instrument carriers or overlap instruments; Open instrument hinges and joints fully; Attach instruments that require irrigation to the irrigation system correctly, ensuring filters are in place if required (for example for handpieces, if specified by the manufacturer). After the cycle is complete allow instrument to cool and remove ready for inspection Visually inspect all items under an illuminated magnifier ensuring they are clean, functional and in good condition. Lubricate any relevant items prior to sterilization with a non-oil-based lubricant.

Safety Precautions PPE must be worn when using the ultrasonic bath; gown/ apron, gloves, visor / mask and goggles Operators must never put their hands, or any other part of their body into the MACHINE whilst the machine is in operation.

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40 Appendix 5 Decontamination of Dental Handpieces Decontamination of Dental Handpieces


Pre-sterilisation dental handpiece cleaning machines Pre-sterilisation dental handpiece cleaning machines vary in design and sophistication but all clean and lubricate the internal components of the handpiece. A typical machine cleans the air and water channels with the aid of a detergent spray solution, Stage 2- cleaning and lubricating the bearings and gears with oil, Stage 3 - excess oil is purged and the interior dried with compressed air. The process takes about 35-40 seconds. Manufacturer's advice on which type of detergent is compatible with their handpiece equipment should be sought prior to using the cleaning machine. Some models also include a handpiece vacuum sterilisation stage. Thermal washer/disinfector safe handpieces Many of the handpieces currently available are thermal washer/disinfector safe. Only instruments designated by the manufacturer as being suitable for cleaning in a washer disinfector and carry the washer-disinfector symbol can be processed in a thermal washer disinfector.

Follow manufacturers guidance on lubrication requirements when using a washer disinfector it may be necessary to lubricate with service oil after the thermal washer disinfector stage. Attach handpiece to connector for a pressure flush of dental handpieces if available

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MANUAL METHOD External Cleaning Wear protective clothing; disposable apron, heavy-duty gloves, goggles/visor, and a mask. Flush handpiece with water for 20 seconds prior to removal from the coupling Remove bur Wipe external body of Handpiece with alcohol wipe or a detergent with a neutral PH (follow manufacturers instructions for compatibility) DO NOT use chlorine based wipes DO NOT immerse in disinfectant DO NOT place in ultrasonic bath Internal Cleaning Use oil recommended by Handpiece manufacturer Check oil has correct nozzle and the o rings are present and intact Shake the oil can and place on a flat surface Hold the head of the Handpiece in an absorbent paper towel Connect securely to nozzle; keep can on flat surface and spray oil for approximately 1 second If the paper towel is visibly soiled repeat oiling Clean off excess oil with absorbent paper towel Sterilise according to manufacturers instructions NB: Handpieces run by an electric motor do not require oil lubrication. Manufacturers may offer different advice for their equipment, which should be followed, and will vary according to the age and design of the handpiece.

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41 Appendix 6 Protocol for using the Autoclave Protocol for using the Autoclave
At the start of the session, before carrying out the daily tests:
Clean the rubber door seal with a clean, damp, non-linting cloth; Check the chamber and shelves for cleanliness and debris; Fill the reservoir with freshly distilled or RO water (from a previously unopened bottle Turn the power source on.

Daily Testing
Sterilizers should not be used until the daily tests and housekeeping tasks have been carried out and the results found to be satisfactory. All tests must be performed at the start of each day whilst the autoclave is empty Some sterilisers need to run a warm up cycle before tests are carried out this should be confirmed with the manufacturer The results of the tests are kept in the log book, and should be signed by the designated user before it is declared fit for use.

Automatic Control Test


This can be carried out at the same time as the steam penetration test. If the steriliser has a data logger or printer, the print out / record for the test cycle must be checked against the cycle parameters before the steriliser is confirmed fit for use. If no printer or data logger is available the cycle must be observed and the following information recorded on the daily log sheet:
Maximum values of the chamber temperatures and pressures indicated on the gauges Holding stage duration in minutes and seconds Total cycle time is recorded

Steam Penetration Test (vacuum autoclaves only)


It is essential to use the steam penetration test device and the indicator specified by the manufacturer otherwise the tests results may be misleading i.e. Bowie Dick or Helix Results of the steam penetration test should be recorded on daily log sheets

Weekly Air Leakage Test (vacuum autoclaves only)


This is only carried out by the user / operator is the steriliser has an inbuilt self test programme otherwise it is carried out by the competent person at the quarterly check. Refer to the manufactures instructions on how to carry out this automatic test

Loading the Steam Steriliser


Do not overload the tray, Instruments should not be touching. Hinged instruments should be opened out. Use the trays provided (do not place items in receivers or bowls) Receivers, bowls should be placed on their side/inverted. Items must be clean and dry prior to loading into the steriliser Small instruments e.g. burs should be placed in suitable holder which allows steam penetration When selecting the cycle ensure the highest temperature compatible with the load is used normally 134 137 degrees for a holding time of 3 minutes at a pressure of 2.2 2.5 bar Ensure the load is appropriate for the steriliser wrapped instruments / cassettes and instruments with lumens (ie handpieces) to be placed in a vacuum steriliser

NB: Incorrect loading may prevent sterilisation.

End of session
Drain autoclave chamber and reservoir
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The device should then be cleaned, dried, and left empty with the door kept open

All faults must be reported immediately to the owner of the steriliser and not used until repaired, the user will arrange for repair. All faults must be recorded in the equipment log book

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42 Appendix 7 Declaration of contamination status Declaration of contamination status From (consignor): Address: To (consignee): . Address: .

Reference: . Emergency Tel:

Reference:

Type of equipment: Manufacturer: .. Description of equipment: .. Other identifying marks: ... Model No.. Serial No.

Fault .. Is the item contaminated? Yes/ No/ dont know * State type of contamination: blood, body fluids, respired gases, pathological samples, chemicals (including cytotoxic drugs), radioactive material or any other hazard Has the item been decontaminated? Yes/ No/ dont know What method of decontamination has been used? Please provide details Cleaning Disinfection Sterilization Please explain why the item has not been decontaminated?

Contaminated items should not be returned without prior agreement of the recipient
This item has been prepared to ensure safe handling and transportation: Name ..
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Position
Beverly Lamb

Signature . Date . Tel .

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43 Appendix 8 Key Roles and Responsibilities for Decontamination Key Roles and Responsibilities for Decontamination Registered Manager = the individual with ultimate responsibility for decontamination equipment, responsible for ensuring that all personnel have received appropriate training and they can demonstrate competency in their duties and that individual training records for all staff are retained Decontamination Lead = the individual with the responsibility for infection control and decontamination. This person should have the experience and authority to perform this task and should be accountable to the Registered Manager. Designated Person = the person that acts as the interface between the practice and support services supplied externally, including service, maintenance and testing (the Decontamination Lead could also act as the Designated Person) User = the person with day to day responsibility for the management of the decontamination equipment and processes, they must ensure that everyone operating and testing the equipment is suitably trained and competent. They may seek advice from the manufacturer or service engineer on testing of equipment and daily tasks. With regard to infection control they may seek advice from a microbiologist or infection control nurse. Operator (s) = the person(s) who operates the decontamination equipment, they may also carry out daily and weekly tests and housekeeping duties if suitably trained. (the records must be singed by the user to confirm equipment is fit for use) Authorised engineer (decontamination) = an external role to provide guidance and advice
on compliance issues with decontamination. A list of suitable persons is available from the voluntary register held by the Institute of Healthcare Engineering and Estate Management (IHEEM) (www.iheem.org.uk/ authorising/decontamination.php).

Competent Person (pressure vessels) = Provides the written scheme of examination and
carries out the examination s in accordance with the written scheme periodically Competent person (decontamination) Responsible for the servicing, testing and maintaining of the decontamination equipment

Competent person (decontamination) = The Competent Person is responsible for the


servicing, testing and maintaining of the decontamination equipment within the practice.

Service Engineer / test person = A person provided under a service level agreement or contract who is certified by the service agent or equipment manufacturer to be competent to both service and test specified decontamination equipment. This person may, among other duties, perform validation tests in accordance with the EN standards and may give an opinion on the outcomes of validation testing as well as providing data to an Authorising Engineer. Infection Control Nurse Available to give advice on infection prevention and control, will carry out audits and implement relevant advice

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Microbiologist Advice may be sought from the microbiologist for certain procedures and
practices, access to a microbiologist can be made via the PCT

It is possible that one individual may carry out two or possibly more roles

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44 Appendix 9 Ultrasonic activity testing Ultrasonic activity testing


The activity of an ultrasonic cleaner may be investigated by the erosion pattern which is created on aluminium foil exposed in the bath for a short period. The activity will not be uniform throughout the ultrasonic bath. Tests carried out during commissioning are intended to establish the variation in activity at different positions within the bath and the time required to obtain a characteristic erosion pattern. Alternatively a commercial ultrasonic activity meter could be used. Tests should be carried out quarterly to ensure the ultrasonic activity remains unchanged The following equipment and materials are required: Aluminium foil of nominal thickness 0.015 mm to 0.025 mm Waterproof adhesive tape - autoclave indicator tape is ideal A stopwatch A rule or tape measure graduated in mm. Method 1. Measure the depth of the bath from the level of the lid to the bottom of the bath. 2. Cut nine strips of aluminium foil 15mm to 20 mm wide and the depth of the bath+ 120mm in length. 3. Roll 120mm of prepared foil strip into a cylindrical shape and secure with a paper-clip. 4. Repeat for all nine strips. 5. Ensure that the water in the tank is at the required level, that the required amount of any chemical additive has been added and that the water in the tank is at the specified operating temperature. 6. Start the ultrasonic cycle and carry out the degas procedure to eliminate dissolved gases from the liquid in the bath. 7. Using strips of autoclave indicator tape across the top of the bath suspend nine strips of the prepared foil in the bath in a 3 x 3 grid. 8. The rolled end of each foil strip acts as a sinker weight to maintain the foil in an approximately vertical position. The sinker weight should be not more than 10 mm above, but not touching, the bottom of the bath 9. Run an ultrasonic cycle for a minimum of 30 seconds. 10. Remove the strips from the bath, blot dry and examine. 11. Drain the bath and clean to remove debris of eroded aluminium foil. Results The zones of maximum erosion should be at similar positions on all nine foils and each should be eroded to a similar extent (by visual inspection). On re-testing the extent of erosion and the erosion pattern should have remained consistent with those originally determined during commissioning. Tests results should be kept in the equipment

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The erosion pattern will depend on the thickness of the foil, the hardness of the foil, and the temperature of the liquid in the ultrasonic bath

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45 Appendix 10 Summary details Autoclave Log Book Summary details Autoclave Log book Dental Practice Address

Make & model of steriliser Serial number Location of Steriliser

Contents Form Daily test sheet Weekly test sheet Quarterly and annual test sheets Autoclave History record Process Log Personnel

Purpose A record of daily testing A record of weekly testing Engineer quarterly and annual test sheets Record of all faults and maintenance A record of every steriliser load Name/Organisation

Section

Tel No

Registered Manager User Operator(s) Infection control nurse Competent Person (pressure vessels)* Authorised person (Decontamination)* Competent Person (Decontamination)* Service Engineer Microbiologist
*These personnel should have qualifications/training/registration defined in HTM01-01 part A

Pressure systems regulations 2000


This section to be filled in by the Competent Person (pressure vessels)

Written scheme of inspection exists/is suitable Inspection carried out on Date: Result of examination/comments

Inspected by:

Review of records by Authorised Person (sterilizers) Date Comments on review Signature

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46 Appendix 11 Daily test sheet N type Daily test sheet- N Type


Test to be carried out in accordance with HTM 01-05
Before carrying out the daily tests, the user should: clean the rubber door seal with a clean, damp, non-linting cloth; check the chamber and shelves for cleanliness and debris & fill the reservoir with freshly distilled or RO water.

Practice Name Location of autoclave

Start date for this sheet Make and Model Serial. No

Cycle number Mon Tue Wed Thur Fri Sat Sun

During sterilizing hold period Temp Pressure C min/max bar / / / / / / /

Sterilizing hold time Min : sec : : : : : : :

Signature of test person

Automatic control test result Pass/Fail P/F P/F P/F P/F P/F P/F P/F

Certified fit for use by user

Reservoir water changes (where applicable). reverse osmosis water. Cycle number when water changed Monday Tuesday Wednesday Thursday Friday Saturday Sunday

Drain, rinse and refill with freshly distilled or Comments Water changed by

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47 Appendix 12 Daily test sheet - vaccum Daily test sheet- Vacuum


Test to be carried out in accordance with HTM 01-05
Before carrying out the daily tests, the user should: clean the rubber door seal with a clean, damp, non-linting cloth; check the chamber and shelves for cleanliness and debris & fill the reservoir with freshly distilled or RO water.

Practice Name Location of autoclave

Start date for this sheet Make and Model

Serial. No

Cycle number Mon Tue Wed Thur Fri Sat Sun

During sterilizing hold period Temp Pressure C min/max bar / / / / / / /

Sterilizing hold time Min : sec : : : : : : :

Automatic Control test result Pass / Fail P/F P/F P/F P/F P/F P/F P/F

Steam Penetration test result Pass/Fail P/F P/F P/F P/F P/F P/F P/F

Signature of test person

Certified fit for use by user Monday Tuesday Wednesday Thursday Friday Saturday Sunday

Reservoir water changes (where applicable). reverse osmosis water. Cycle number when water changed Monday Tuesday Wednesday Thursday Friday Saturday Sunday

Drain, rinse and refill with freshly distilled or Comments Water changed by

If the sterilizer fails to meet any of the test requirements, it should be withdrawn from service and advice should be sought from the manufacturer and/or maintenance contractor. All Faults, new or existing should be entered on the autoclave history record sheet

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48 Appendix 13 Weekly test sheet - vaccum Weekly test sheet- Vacuum


Test to be carried out in accordance with HTM 01-05

Practice Name Location of autoclave

Start date for this sheet Make and Model Serial. No

Week beginning

Cycle no

*Automatic air leakage test result Pass/Fail P/F P/F P/F P/F P/F P/F

Residual air test Pass/Fail P/F P/F P/F P/F P/F P/F

Weekly safety checks Satisfactory / unsatisfactory S/U S/U S/U S/U S/U S/U

Signature of test person

Certified fit for use by user

*Only where sterilizer has an in-built self-test programme. Otherwise the test should be carried out by a competent person (Decontamination) and copies of the test sheets should be inserted

Weekly safety checks (tick if satisfactory)


Week beginning Cycle number Door seal Door pressure interlock Door closed interlock Satisfactory/ Unsatisfactory S/U S/U S/U S/U S/U Tested by

If the sterilizer fails to meet any of the test requirements, it should be withdrawn from service and advice should be sought from the manufacturer and/or maintenance contractor. All Faults, new or existing should be entered on the autoclave history record sheet

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49 Appendix 14 Autoclave history record sheet Autoclave history record sheet Start date for this sheet Practice Name Location of autoclave Make and Model of autoclave Serial. No

FAULTS RECORD Fault Date Cycle number number

Details of fault

Noted and reported by

MAINTENANCE RECORD Date Fault Maintenance Record-include number servicing as well as fault finding details

Carried out by

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50 Appendix 15 Production of log sheet-bench top autoclave Production log sheet-bench top autoclave Practice Name Location of autoclave Start date for this sheet Make and Model of autoclave

Serial. No

Date

Cycle number

Cycle start time

Cycle selected

Description of load

Cycle pass

YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO
Decontamination of Dental Instruments and Equipment Policy Page 47 of 58 Beverly Lamb

Printout checked OK (if applicable) YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO

Comments and operator initials

51 Appendix 16 Summary details Ultrasonic Cleaner Log Book Summary details Ultrasonic Cleaner Log book Dental Practice Address

Make & model of Ultrasonic Cleaner Serial number Location of Ultrasonic Cleaner Contents Form Daily / weekly test sheet Quarterly test sheet Annual test sheet Ultrasonic Cleaner History record Process Log

Purpose A record of daily & weekly testing A record of quarterly testing Engineer annual test sheets Record of all faults and maintenance A record of every ultrasonic cleaner load

Section

Personnel Registered Manager User Operator(s) Infection control nurse Competent Person (pressure vessels)* Authorised person (Decontamination)* Competent Person (Decontamination)* Service Engineer Microbiologist

Name/Organisation

Tel No

*These personnel should have qualifications/training/registration defined in HTM01-01 part A

Review of records by Authorised Person (decontamination) Date Comments on review Signature

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52 Appendix 17 Daily/Weekly test sheet Daily / Weekly test sheet


Location of Ultrasonic Cleaner Make and Model Serial Number Date of test (week beginning) Detergent used & dilution

Daily Test Cleaning efficacy (visual) Tank drained & cleaned Remove and clean filters (if applicable) Initial of test person

MONDAY Pass Fail

TUESDAY WEDNESDAY Pass Fail Pass Fail

THURSDAY Pass Fail

FRIDAY Pass Fail

AM

PM

AM

PM

AM

PM

AM

PM

AM

PM

Weekly Test Protein Residue Test Safety Checks condition of door seal / lid signature of test person Comments Pass Pass Fail Fail

I have reviewed the records with the Test Person and declare the Ultrasonic Cleaner is / is not* fit for use User Signature Name (*delete as appropriate)

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53 Appendix 18 Quarterly test sheet Quarterly test sheet


Location of Ultrasonic Cleaner Make and Model Serial Number Date of test (week beginning)

Detergent used & dilution

Automatic Control Test Cycle start time Cycle start temperature Ultrasonic clean - time at end of cycle Temperature at end of cycle Total Cycle time

Ultrasonic Activity Test Foil test Probe test Probe / Foil Positions

PASS PASS

FAIL FAIL Duration of Exposure

The test is confirmed as being within / not within* specified limits Operator (test person) signature Name . ..

I have reviewed the records with the Test Person and declare the Ultrasonic Cleaner is / is not* fit for use User Signature Name (*delete as appropriate)

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54 Appendix 19 Quarterly Foil Test Results Sheet


Quarterly Foil Test Results Sheet

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55 Appendix 20 Ultrasonic Cleaner History Record Sheet Ultrasonic Cleaner History Record Sheet Practice Name Location of ultrasonic cleaner Start date for this sheet Make and Model of ultrasonic cleaner

Serial. No

FAULTS RECORD Fault Date Cycle number number

Details of fault

Noted and reported by

MAINTENANCE RECORD Date Fault Maintenance Record-include number servicing as well as fault finding details

Carried out by

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56 Appendix 21 Production log sheet-ultrasonic cleaner Production log sheet-ultrasonic cleaner Practice Name Location of ultrasonic cleaner Start date for this sheet Make and Model of ultrasonic cleaner

Serial. No

Date

Cycle number

Cycle start time

Cycle selected

Description of load

Cycle pass

YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO

Printout checked OK (if applicable) YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO

Comments and operator initials

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57 Appendix 22 Summary details Washer Disinfector Log Book Summary details Washer Disinfector Log book Dental Practice Address

Make & model of Washer Disinfector Serial number Location of Washer Disinfector Contents Form Daily / weekly test sheet Quarterly test sheet Annual test sheet Washer Disinfector History record Process Log Personnel Registered Manager User Operator(s) Infection control nurse Competent Person (pressure vessels)* Authorised person (Decontamination)* Competent Person (Decontamination)* Service Engineer Microbiologist
*These personnel should have qualifications/training/registration defined in HTM01-01 part A

Purpose A record of daily & weekly testing A record of quarterly testing Engineer annual test sheets Record of all faults and maintenance A record of every load

Section

Name/Organisation

Tel No

Review of records by Authorised Person (decontamination) Date Comments on review Signature

50

58 Appendix 23 Daily/Weekly test sheet Daily / Weekly test sheet


Location of washer disinfector Make and Model Serial Number Date of test (week beginning)

Detergent used & dilution

Daily Test Cleaning efficacy (visual) Remove and clean filters (if applicable) Initial of test person Weekly Test

MONDAY Pass Fail

TUESDAY WEDNESDAY Pass Fail Pass Fail

THURSDAY Pass Fail

FRIDAY Pass Fail

Protein Residue Test Safety Checks condition of door seal signature of test person Comments

Pass Pass

Fail Fail

I have reviewed the records with the Test Person and declare the Washer Disinfector is / is not* fit for use User Signature Name (*delete as appropriate)

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59 Appendix 24 Washer Disinfector History Record Sheet Washer Disinfector History Record Sheet Practice Name Location of washer disinfector Start date for this sheet Make and Model of washer disinfector

Serial. No

FAULTS RECORD Fault Date Cycle number number

Details of fault

Noted and reported by

MAINTENANCE RECORD Date Fault Maintenance Record-include number servicing as well as fault finding details

Carried out by

52

60 Appendix 25 Production log sheet-washer disinfector Production log sheet-washer disinfector Practice Name Location of washer disinfector Start date for this sheet Make and Model of washer disinfector

Serial. No

Date

Cycle number

Cycle start time

Cycle selected

Description of load

Cycle pass

YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO

Printout checked OK (if applicable) YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO YES/NO

Comments and operator initials

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61 Appendix 26 Hypochlorite Preparations for surfaces / equipment soiled with bodily fluids Hypochlorite Preparations for surfaces / equipment soiled with bodily fluids
Hypochlorite Preparations Presept, Actichlor, Haz Tab 2.5 g Strength To make dilute solution (1,000 PPM) To prepare 4 tablets in 5 litres of water Uses Decontamination of surfaces that may be lightly (i.e. not visibly) contaminated with pathogenic viruses

Haz-Tabs 4.5g

To make 1,000PPM dilution

Milton Tablet To make dilute solution (1,000 PPM)

1 tablet in 2.5 litres (use the diluter provided) Add 500 ml water

Decontamination of surfaces that may be lightly (i.e. not visibly) contaminated with pathogenic viruses

Milton Solution

To make dilute solution (1,000 PPM)

Dilute 1:10 in water

Decontamination of surfaces that may be lightly (i.e. not visibly) contaminated with pathogenic viruses.

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