Decontamination Policy 2

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Ref No: CICT v.1 December 2011

Clinical Policy

DECONTAMINATION OF DENTAL INSTRUMENTS ANDEQUIPMENT POLICY

Version: V1

Date approved: 5th December 2011


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Document Control

Document ReferenceTitle of document Decontamination of Dental Instruments

and Equipment PolicyAuthors name(s) Sally Webster

Leasa BensonBeverly Lamb

Authors job title(s) Head of Health Protection Service

Clinical Lead Health Protection ServiceSpecialist Dental Infection ControlNurse

Directorate(s) Public Health

Document status V1Supersedes N/A

Clinical approval Community Infection Control TeamClinical Governance Group

NHS Manchester (Committee)approved by

Community Infection Control TeamClinical Governance Group

Date of approval 5th December 2011

Publication/issue date

Review date December 2013

Distribution NHS Manchester Website


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Contents1 Introduction ..........................................................................................................42 Rationale..............................................................................................................53

Legal Framework .................................................................................................5

4 Audit.....................................................................................................................65 Management Options for Decontamination of Instruments ..................................66 SSD......................................................................................................................67 Single use items...................................................................................................68 Safety Issues........................................................................................................79 Prion diseases......................................................................................................8

10

Patients with Suspected CJD...............................................................................811 Local Decontamination.........................................................................................8

12 General Principles................................................................................................913 Definition of Terms...............................................................................................914 Levels of Decontamination.................................................................................1015 Risk Assessment................................................................................................1016 Training ..............................................................................................................1117 Purchasing .........................................................................................................12

18

Instrument Cleaning ...........................................................................................12

19 Methods .............................................................................................................1319.1 Manual Cleaning .............................................................................................. 1319.2 Equipment required.......................................................................................... 1419.3 Procedure ........................................................................................................ 14

20 Ultrasonic Cleaner/Bath .....................................................................................1420.1 Testing and Maintenance of the ultrasonic cleaner.......................................... 15

20.2

Daily tests / checks .......................................................................................... 15

20.3 Weekly testing.................................................................................................. 1520.4 Quarterly testing............................................................................................... 15

21 Washer Disinfector.............................................................................................1622 Operating Procedure..........................................................................................16

22.1 Testing and Maintenance of the Washer Disinfector........................................ 1622.2 Daily tests / checks .......................................................................................... 1722.3 Weekly testing.................................................................................................. 17

22.4

Quarterly testing............................................................................................... 17

22.5 Annual.............................................................................................................. 1722.6 Cycle Monitoring .............................................................................................. 17

23 Rinsing ...............................................................................................................1724 Inspection...........................................................................................................18 25 Sterilisation.........................................................................................................18


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31 Storage...............................................................................................................23 32 Transportation....................................................................................................2433 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 ............................................2837 Appendix 2 Protocol for the Manual Cleaning of Dental Instruments .................3038 Appendix 3 Protocol for using the Ultrasonic Bath .............................................3139 Appendix 4 Washer Disinfector protocol ............................................................3240 Appendix 5 Decontamination of Dental Handpieces ..........................................33

41

Appendix 6 Protocol for using the Autoclave......................................................35

42 Appendix 7 Declaration of contamination status ................................................3743 Appendix 8 Key Roles and Responsibilities for Decontamination ......................3844 Appendix 9 Ultrasonic activity testing.................................................................4045 Appendix 10 Summary details Autoclave Log Book...........................................4246 Appendix 11 Daily test sheet N type ...............................................................4347 Appendix 12 Daily test sheet - vaccum ..............................................................4448 Appendix 13 Weekly test sheet - vaccum...........................................................45

49

Appendix 14 Autoclave history record sheet ......................................................4650 Appendix 15 Production of log sheet-bench top autoclave.................................47

51 Appendix 16 Summary details Ultrasonic Cleaner Log Book .............................4452 Appendix 17 Daily/Weekly test sheet .................................................................4553 Appendix 18 Quarterly test sheet .......................................................................4654 Appendix 19Quarterly Foil Test Results Sheet..................................................4755 Appendix 20 Ultrasonic Cleaner History Record Sheet......................................4856 Appendix 21 Production log sheet-ultrasonic cleaner ........................................4957

Appendix 22 Summary details Washer Disinfector Log Book ............................50

58 Appendix 23 Daily/Weekly test sheet .................................................................5159 Appendix 24Washer Disinfector History Record Sheet .....................................5260 Appendix 25 Production log sheet-washer disinfector........................................5361 Appendix 26Hypochlorite Preparations for surfaces / equipment soiled with bodilyfluids..........................................................................................................................54

1 Introduction

All Healthcare organisations must keep patients, staff and visitors safe by having safesystems to ensure that all reusable medical devices are properly decontaminated prior touse. The term re-usable medical device applies to all such devices whether owned bythe Trust, rented, or on loan.


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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 thePCT 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 becomecontaminated with micro-organisms and thus can present a risk to patients, as well as tothose subsequently handling or using them. Safe and effective decontamination of all re-usable equipment between uses is therefore an essential part of routine infection controlpractice. 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, 1987There may be exposure to civil liability, with payments for damages, for any injuriescaused to another person by a defective product. This could include an inadequatelydecontaminated item that causes an infection.

Control of Substances Hazardous to Health (COSHH) Regulations, 2002Staff 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 becarried 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 employeesand visitors to their premises, for providing safe equipment, safe systems of work andtraining for staff, e.g. how to handle contaminated equipment. As well as the employeesresponsibilities 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 tomake a systematic assessment of all the risks to the health and safety of theiremployees and others, arising from work activities.

Medical Devices Regulations, 2002Medical devices placed on the market within the UK after June 1998 must carry a CE


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Equipment should only be used by people who have received adequate information,instruction and training.

Pressure Systems Safety Regulations 2000Bench top sterilizers must comply with these Regulations, which are intended to prevent risk ofinjury from stored energy as a result of a failure of a pressure system.

Equality and DiversityAll 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 arrangementsto assess and consult on how their policies and functions impact on race, gender anddisability equality. NHS Manchester is committed to providing services that meet theequality and diversity needs of staff and service users within the framework of currentlegislation. Current equality and diversity legislation includes disability, gender, age,race, sexual orientation and religion. It is the responsibility of managers and staff toensure that they act on this policy in a manner that meets the needs of people fromthese groups. It is always appropriate to establish with individual staff and patients whattheir specific needs are, but needs may include providing information in an accessible

format, considering mobility and communication issues and being aware of sensitive andcultural 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 manageron 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

6 SSD

These services have the equipment and expertise to sterilise re-usable medical deviceseffectively and consistently. They also have systems to track instruments through thedecontamination process and retrospectively trace them back to the individual patientson whom they have been used. In the unlikely event of a sterilisation cycle failure,


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occasion of use and not on a single patient. The following symbol indicates that amedical device is single use;

The single-use symbolisused on a wide variety of single-use items/equipment fromcommonly used disposable gloves and aprons to surgical instruments. Every itemlabelled with a single-use symbol should be treated in the same manner and mustalways be disposed of after use.

All single-use items are classified as clinical waste after use and must be disposed ofin 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, cleanand dry storage area

8 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 cross-infection through inadequate decontamination, mechanical failure due to exposure of theitem to chemical agents or heat, material alteration, and reactions in patients to residuesfrom chemical decontamination agents. All equipment must always therefore be usedaccording to the manufacturers instructions (Medical Devices Agency, 2000).

Anyone re-using or reprocessing a single-use device is fully responsible for itssafety and effectiveness, not the manufacturer who has produced and labelled theitem as single-use only.

Anyone who reprocesses a single-use item for another person to use may betransferring the same legal responsibilities for the device to themselves as theoriginal manufacturer.

Anyone who reprocesses or uses a reprocessed single-use item may be committing an

offence or contravening to national guidanceSingle-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 decontaminatethem satisfactorily


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Any re-use of a single use device is likely to be associated with significant risk, is inbreach of the law, and is not supported by the PCT.

9 Prion diseases

Prions are infectious agents, which contain no nuclear material. They replicate bytransforming normal cellular proteins into abnormal proteins, which then accumulate inthe central nervous system where they can trigger neurological symptoms. Priondiseases 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 ofcleaning, disinfection and sterilisation of medical devices are only partially effective atinactivating prion proteins. In order to reduce the risk of transmission of prion proteinsduring surgical procedures, single use devices should be used whenever practicable andthey 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 CommunityInfection Control Team for advice on 0161 946 8242.

11 Local Decontamination

Wherever possible, the decontamination process should take place in a dedicateddecontamination room. Gold standard would be to have separate clean and dirty roomswith physical segregation between activities.

Where a separate decontamination room is not in use there must be a detailed plan onhow the decontamination services will move towards best practice which will includeremoving decontamination from the treatment area.

If decontamination takes place in the dental surgery, this must be carried out as far fromthe 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. Withinthe decontamination area there must be a clear one-way flow of equipment from dirty to


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stored above floor level in clean, cool, dry cupboards and open shelving should not beused. (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 decontaminatedbefore and after use

The decontamination process used must be compatible with the equipment andadequately 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 beconsidered for replacement by more suitable instruments / equipment.

A list must be kept of instruments that cannot be decontaminated in line with localpolicy

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 bodysubstances), microorganisms, dust, chemical residues, etc.

Decontamination the combination of processes (including cleaning, disinfection andsterilisation) used to make a re-usable medical device safe for further use on patientsand handling by staff. This process removes or destroys contamination thus preventingmicro-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 pathogensusing detergents and friction. This is the first level of decontamination and may be allthat is required for certain items. Cleaning is an essential pre-requisite for disinfection orsterilization as the presence of any organic matter may render higher levels ofdecontamination ineffective.

Disinfection a process which reduces the number of viable micro-organisms but is notnecessarily effective against bacterial spores or some viruses. Disinfection can beachieved through the use of heat or chemicals.The aim is to reduce the contamination to safe levels. Chemicals that achieve this resultare 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, includingspores (with the exception or prions). Equipment and materials which come into contactwith broken skin or mucous membranes should be sterilised, e.g., instruments, dressingsand injections Sterilisation is best effected by moist heat, usually by autoclaving underpressure. Disinfecting and sterilising techniques are not designed to cleanequipment/surfaces and are generally ineffective on surfaces that have not already beenphysically cleaned. In certain circumstances disinfecting prior to cleaning can exacerbatethe 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


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Prior to the decontamination of medical equipment, the level of risk should be established, themodified Spaulding classification defines four categories:

Minimal Risk o Surfaces that will not come into directcontact with patients e.g. floors andfittings.

Adequatecleaning anddrying is usuallyrequired

Low Risk o Surfaces and equipment that come intocontact with intact skin e.g. washingbowls, blood pressure cuffs

Adequatecleaning anddrying is usuallyrequired

IntermediateRisk

o

Items in contact with intact mucousmembranes i.e. endoscopeso Items in contact with diseased /

damaged skino Items that are heavily contaminated

with virulent or readily transmittedpathogens or substance i.e. faeces,blood etc

o Any items to be used on highly

susceptible / immuno0compromisedpatients

Adequatecleaning followedby sterilisation(ideally) oralternatelydisinfection isusually required

High Risk o Equipment that enters sterile cavitiesor vascular systems,

o Equipment that is in contact with abreak in the skin or mucousmembrane.

AdequateCleaning followedby sterilisation isusually required

All reusable instruments that have become contaminated with saliva, blood or otherbiological fluids should be cleaned and sterilized after use. Hand pieces should also becleaned and sterilized after each patient treatment. In order to prolong the life of handpieces, they should be processed in accordance with the manufacturers instructions.See appendix 5 for guidance on decontamination of dental handpieces. See alsoappendix 1 for decontamination methods of dental equipment.

Decontamination will only be effective if the chosen method has been completedcorrectly.

16 Training

All staff involved in the use or management of any decontamination equipment or process musth f ll l t d t b d t i i hi h i d t d d d t d


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The appropriate level of training must be undertaken and recorded in their personal developmentplans

The manager will audit training records on an annual basis.

The Infection Control Team can advise on the availability of training sessions and on thesuitability of others available elsewhere.

It is a requirement of the Provision and Use of Work Equipment regulations 1998 and MDA DB2002 (06) that all staff who manage, supervise or operate decontamination equipment aretrained in their use and maintenance. The practice owner / registered manager is responsible forensuring that systems are in place for ongoing staff training. It is essential that all staff usingdecontamination equipment have a sound knowledge of the principles, functions and safetyissues involved in their use. All Operators must therefore attend training so that they arecompetent 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 logbook, 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 ispurchased. The following points should be considered and if necessary discussed with theInfection 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 thatare 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 ofan item the Infection Pre ention and Control Team (IPCT) ill recommend that it is taken o t of


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Effective cleaning of instruments is an essential prerequisite before sterilization and will reducethe risk of transmission of infectious agents.

Wherever possible, cleaning should be undertaken using an automated and validated washer-disinfector in preference to manual cleaning, as a washer/disinfector includes a disinfection stagethat renders instruments safe for handling and inspection

Manual washing and or ultrasonic bath may be used in cases were instruments are notcompatible with the washer disinfector (procurement of devices should give consideration tocompatibility to suitable decontamination) (see also Medical Devices Policy)

Instruments with more than one component i.e. amalgam carriers must be dismantled prior todecontamination

Instruments must be decontaminated as soon as possible after use to avoid air drying, wherethis 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 andsterilized 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 criticalparameters should be controlled as much as possible to reduce the variability in cleaningperformance;

A Detergent specifically designed for cleaning instruments is used according tomanufacturers instructions, low foaming neutral detergents are recommended.(hibiscrub, detergent or creams should not be used)

Water temperature should not be above 45 degrees


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Wire brushes including bur brushes should be avoided as they may cause surfaceabrasion.

A written protocol must followed and on display where cleaning is undertaken (seeappendix 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 thefollowing 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 detergentsolution 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 referralto manufacturers instructions; Plastics will not be cleaned by the process and glass items maybe damaged by the process. Dental Handpieces may become damaged by the process.

Ultrasonic cleaning in a well-maintained machine enhances removal of debris although awasher-disinfector is preferred.

The ultrasonic cleaner can be used as a cleaning method including being used as an extracleaning stage prior to an automated washer-disinfector process. This may be particularly helpfulfor instruments with hinges and/or intricate parts.


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20.1 Testing and Maintenance of the ultrasonic cleaner

The ultrasonic bath should be tested and maintained in accordance with manufacturersinstructions 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 preventativemaintenance.

Daily and weekly testing should be carried out by the user or by delegation to the operator iftrained.

Quarterly tests are carried out by a competent person (decontamination) serviceengineer. Alternatively the designated user may carry out the ultrasonic activity test iftrained to do so.

20.2 Daily tests / checks

If applicable filters and strainers should be removed and cleanedMachine 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 carriedout following rinsing

20.3 Weekly testing

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

20.4 Quarterly testing

Including weekly tests plus:Verification of calibrationAutomatic Control TestCleaning efficacy test using an artificial soilUltrasonic activity test (see appendix 9 for guidance)

AnnualAnnual 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 thebest option for the control and reproducibility of cleaning. Washer disinfectors use a combinationof physical cleaning and thermal microbiocidal action to achieve disinfection of contaminated re-usable items. However, the process will not be active against bacterial spores and someviruses. This can either be as a process prior to re-use or to make items safe to handle beforefurther reprocessing.The manufacturers recommended detergent should be used, for most applications; mild alkalinedetergents in the pH range 8.011.0 are preferred. Alkalinity improves the efficacy of detergentsboth by enhancing their inherent cleaning capabilities, neutralizing and helping to remove acidsoils, emulsifying oils and fats and peptidizing proteins, and by synergistic action with otherdetergent compounds. Cleaning agents should be liquid to facilitate accurate dispensing, non-abrasive, low foaming and free rinsing.

22 Operating Procedure

A typical cycle will comprise:

Flush removes difficult / gross contamination, including blood, tissue, debris, bone fragmentsand other fluids and solid debris. Water temperature of less than 45 degrees Celsius is used toprevent protein coagulation and fixing of soil to the instrument

Wash removes any remaining soil. Mechanical and chemical processes loosen and break upcontamination adhering to the instrument surface. Detergents used in this process must bespecified by the manufacturer as suitable for use in a washer-disinfector. They should also becompatible 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 severalsub-stages. For the final stage of rinsing, water remaining contaminants, including salts, may bedeposited on the surface of instruments, affecting both appearance and subsequent sterilization.In recognition of this, most washer-disinfector manufacturers provide a separate water-supplyinlet for the final rinse stage. It is recommended that RO or freshly distilled water be used for thisstage

Thermal disinfection the temperature of the load is raised and held at the pre-set disinfectiontemperature for the required disinfection holding time: for example, 80oC for 10 minutes; or 90oCfor 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 becleaned effectively Therefore follow an instrument loading procedure that has been shown to


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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 iftrained.

Quarterly tests are carried out by a competent person (decontamination) serviceengineer.

22.2 Daily tests / checks

The spray arms should be checked to ensure they are rotating and the spray nozzles arechecked for any blockagesIf applicable filters and strainers should be removed and cleanedA visual examination of load items should be carried and confirmed as effective.

22.3 Weekly testing

All daily tests plus;

Check condition of door sealA protein residue test should be carried out to confirm that the cleaning process retains thecapability of removing proteins

22.4 Quarterly testing

Including weekly tests plus:Safety checks for safe operation of doors and door interlocksAutomatic control test

Cleaning efficacy testChemical dosingThermometric 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 ofall 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 shouldbe kept in the equipment log book


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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 illuminatedmagnifier is recommended because it makes it much easier to see residual contamination, debrisor damage

Any instruments that are blunt, bent, rusted or damaged or show any signs of pitting or othercorrosion must be discarded.

Instruments should be inspected for any visible contamination. If contaminated the instrumentshould 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 orreplaced.

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 andinstruments 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 theproduct is the preferred method for the sterilization of most instruments used in the primary caredental practices.

Dry heat (heat without the moisture) is less efficient and much more time consuming, is therefore


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CycleType

Air Removal Load Type Advantages Disadvantages

N Passive (gravitydisplacement)

Non-wrappedsolid items

Simple to use, leastexpensive topurchase, operateand maintain, quickcycle time

Not to be used for;Hollow devices orthose with lumens (i.e.dental handpieces)Wrapped / porousloads

B Active forced airremoval

Wrapped orunwrapped solid

or hollow itemsi.e. handpiecesPorous loads i.e.swabs, dressings

Widest range ofapplications

Expensive to purchaseand maintain

Additional periodictesting requiredIncreased cycle times

S Active (forced airremoval)

Only to be usedfor types of loadsspecified by thesteriliser

manufacturer

Wider range ofapplications than Ntype

Expensive to purchaseand maintainAdditional periodictesting required

Increased cycle times

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

26 Loading the Steam Steriliser

All instruments must be free from visible contamination and in good condition prior tosterilization

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


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All steam sterilizers are subject to the Pressure Systems Safety Regulations 2000 and must beexamined annually by a Competent Person (Pressure Vessels).

Testing is an integral part of ensuring that a sterilizer consistently performs to operatingparameters set during the machines commissioning. Failure to carry out routine periodic testsand maintenance tasks could compromise safety and have legal and insurance-relatedimplications

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 toshow 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 Steriliser Type Period

a Automatic control test ALL Dailyb Steam Penetration test Vacuum only Dailyc Air Leakage Test Vacuum only Weekly

Sterilizers should not be used until the daily tests and housekeeping tasks have been carried outand the results found to be satisfactory. All tests must be performed at the start of each daywhilst the autoclave is empty Some sterilisers need to run a warm up cycle before tests arecarried 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. Ifno printer or data logger is available the cycle must be observed and the followinginformation recorded;

Maximum values of the chamber temperatures ( and pressures indicated ongauge and holding stage duration in minutes and seconds

o 121C for 15 minutes


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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 testprogramme 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 designateduser 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 ontopouches / bags should only be used to distinguish processed items from unprocesseditems 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 cyclevariables for each correctly functioning operating cycle it can be provided by theauthorised person or the manufacturer.

The master process record is used as a comparison to confirm if sterilising conditionshave been achieved.

Permanent records of each sterilisation cycle should be kept in a process log. If thesterilizer has an automatic printer, the printout should be retained or copied to apermanent record. If a data logger is used the information should be stored securely. Ifthe sterilizer does not have a printer or data logger, the user will have to manually recordthe 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 bereported immediately to the owner of the steriliser and not used until repaired, the userwill arrange for repair. All PCT staff to immediately inform the estates department. Allfaults must be recorded in the equipment log book

At th d f th d t t l i ti f t i t t ili th t t


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Designated staff hand wash facilities must be available and used after the removal of protectiveclothing.

28 Installation and Validation of equipment

All decontamination equipment should be installed and validated by a registeredcompetent person (an engineer proficient in testing) A Named person in the practiceshould be accountable for its validation and periodic testing, maintenance and use.Following validation a schedule for periodic testing and planned preventativemaintenance should be drawn up. All decontamination equipment used must bevalidated 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. Allpersonnel using the equipment must be appropriately trained and records must be keptin the log book. Any person using decontamination equipment has a legal andprofessional responsibility to ensure that the equipment they are using is not onlyworking correctly but also that it is correctly maintained and tested

A list of named designated responsible persons must be kept in the equipment log bookwith an outline of the individuals responsibilities, everyone must be aware of each othersresponsibilities. Each practice will establish its own system concerning staffresponsibilities, see appendix 8 for key roles and responsibilities

29 Records

All decontamination equipment should have a dedicated log book The log book shouldbe kept close to the equipment and should include the following information:-

Clear concise operational instructions operating manual and summary ofworking 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 donewith the unsatisfactory load)

Records of maintenance and repair or modifications

The written scheme of examination under the pressure systems safety regulationsand the records of inspection under the scheme (for autoclaves)


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Unwrapped Instruments should be kept on covered trays in enclosed cupboards orboxes. They cannot be stored and must be used in the current treatment session. Ifunused 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 freeof clutter and wiped clean at session intervals

Instruments must be dry prior to packaging and wrapping materials must comply with BSEN ISO 11607In dental practices self seal sterilisation pouches are typically used

Regardless of packaging used all instruments / sets must be labelled with the date bywhich they should be used

Instruments that are packaged prior to sterilisation in a vacuum autoclave can be storedfor up to 60 days

Instruments that are packaged following removal from the steriliser may be stored for upto 21 days

Each instrument may be wrapped separately or a set of instruments may be held in acassette / 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 andshould 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


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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 fromclinical 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 clearfrom 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 policyand be vaccinated against hepatitis B

Where necessary clean/ sterilised items must be transported using a separate dedicatedtransport container

33 Management of medical devices prior to repair / service

Any loaned items being returned to a manufacturer or supplier should alsobe decontaminatedAnyone who inspects, services, repairs or transports medical, dental and laboratoryequipment, either on hospital premises or elsewhere, has a right to expect that medicaldevices and other equipment have been appropriately treated so as to remove or

minimise the risk of infection or other hazards; appropriate documentation is required tobe provided to indicate the contamination status of the item.

If medical devices or equipment require repair or service recipients have a right to expectthat it has been appropriately treated to minimise the risk of infection.


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suppliers may refuse to handle such items until they have been decontaminated and adeclaration 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 ofcomplaint or investigation may be altered or influenced by a decontamination process,the investigator may wish the item not to be decontaminated. In such situations, theadvice of the investigating body and the Community Infection Control Team should besought.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 toopening 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 theouter one.

In addition, agreement of any carrier used to transport a contaminated item may berequired.

The above also applies to items, which are not subject to investigation but cannot bedecontaminated before inspection, service or repair

Note: it is illegal to send contaminated items through the post


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35 References

Department of HealthHealth and Social Care Act 2008: Code of Practice for the Prevention and Control ofHealthcare 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 MedicalDevices; Management and Environment

Health and Safety ExecutiveThe 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 WorkRegulations: 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 gascontainers regulations 1989.

Consumer Protect Act 1987 HMSO 1987

MHRA / MDA

DB2006(04) Oct. 2006 Device bulletin Single-use Medical Devices: Implications andConsequences of Reuse

The Medical Devices Regulations 2002. Statutory Instrument 2002 No.618 HMSO 2002ISBN 0110423178

R f N CICT 1 D b 2011


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Bench-top steam sterilisers: guidance on purchase, operation and maintenance. MDADB2002(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; published2001

Equipped to Care, MDA, 2000

Device Bulletin Managing Medical Devices. Guidance for healthcare and social servicesorganisations. DB2006(05) November 2006

Symbols used on medical devices & their packaging, MDA, 2000

Advisory Committee on Dangerous Pathogens / Spongiform EncephalopathyAdvisory Committee (ACDP / SEAC). Transmissible SpongiformEncephalopathy Agents: safe working and the prevention of infection; 2001

Department of Health. Variant Creutzfeldt-Jakob Disease: Minimising the risk oftransmission. 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 CommunityChurchill Livingstone

90/679/EEC Council Directive of 26 November 1990 on the protection of workers from

Ref No: CICT v 1 December 2011


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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 manufacturersinstructions must always be followed in regards to decontamination of a product. Wheremanufacturers decontamination instructions are unclear, or alternative disinfectants to thosedescribed are recommended, the Infection Control Team should be contacted for further adviceon 0161 946 8242

Item How often Method

Light Cure Unit After each

use

Optical rod clean; manual, ultrasonic bath or washer

disinfector, inspect and sterilise.The unit itself should be cleaned with detergent

Electric PulpTester

After eachuse

Probe - clean; manual, ultrasonic bath or washer disinfector,inspect and sterilise.The unit itself should be cleaned with detergent

Dental Chair After eachuse

Use disposable headrest covers and disposable barriers oncontrols if hand operated - change between patientsClean with detergent.

NB some disinfectants may damage upholstery over timeDental Cart Bracket table ,couplings andtubing

After eachuse

Clean with detergent

Spittoon After eachuse

Rinse and clean with detergent.Filter / trap to be cleaned end of session according tomanufacturers instructions

Safety Glasses /visors After eachuse or whenvisiblycontaminated

Single use or cleaned with detergent

Dental Light After eachuse

Use disposable barriers on handles and controls if handoperated, change between patientsClean with detergent

Amalgamator After eachuse

Ensure no traces of amalgam present and Clean withdetergent

Amalgam carrier After eachuse

Remove amalgam debris and dispose as hazardous waste.Dismantle prior to cleaning manual, ultrasonic bath orwasher disinfector, inspect and autoclave.

InstrumentTransportC t i

After eachuse

Clean with detergent

Ref No: CICT v 1 December 2011


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Item How often Method

Air receiver /compressors

End of session Drain daily and change filters according tomanufacturers instructions

Aspirator andspittoon filter traps

End of session Clean in warm water and detergent according tomanufacturers instructionsReplace once worn or according to manufacturersinstructions

Aspirator tip / salivaejector

After each use Single use for single treatment episode dispose ofin clinical waste

Endodontic files

and reamers

Single use for single treatment episode dispose of

in sharps containerAll reusable dentalInstruments

After each use Cleaned manual or washer disinfector, inspect andautoclave

Rotary instruments(burs)

After each use Use single use whenever possible. Steel burs shouldbe single useIf single use not appropriate:Cleaned manual, ultrasonic bath or washerdisinfector, inspect and autoclave

Matrix bands After each use Dispose of band in sharps container , clean (manual,ultrasonic bath or washer disinfector) Inspect andautoclave retainer

3 in 1 Tip: After each use Single use for single treatment episode dispose ofin clinical waste

3 in1 syringeHandle

After each use Replace plastic sleeve & clean with detergent

Handpieces after each use Clean, oil inspect and autoclave (see appendix 5)

Ultrasonic scaler After each use Tips to be removed then cleaned manual, ultrasonicbath or washer disinfector. Inspect and autoclaveIf applicable base unit to be cleaned with detergent

Dapens Pots After each use Single use for single treatment episode dispose ofin clinical waste

Instrument trays /cassettes

After each use Clean manual, ultrasonic bath or washer disinfector,inspect and autoclave.ORSingle use for single treatment episode dispose ofin clinical waste

Impression trays After each use Single use for single treatment episode dispose ofin clinical waste



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37 Appendix 2 Protocol for the Manual Cleaning of Dental Instruments

Protocol for the Manual Cleaning of Dental Instruments

Immersion methodAll personnel involved in the decontamination of dental instruments should be trained in thecontent and application of this protocol and associated guidance. To minimise the risk topersonnel 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 bythe 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, functionaland 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 householdgloves, visor / mask and goggles

Instruments must be fully immersed to avoid the dispersal of aerosols and to protect



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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 removesome of the blood and other visible soil before ultrasonic cleaning. Care should be taken tominimise aerosol production in this process and to safeguard against inoculation injury. The useof a purpose-designed container with sealing lid is recommended. To avoid injury instrumentsshould 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 ultrasoniccleaner 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 inaccordance with the manufacturers instructions.

Do not overload the basket or overlap instruments, because this results in poor cleaning andcan cause wear to the instruments.

Do not place instruments on the floor of the ultrasonic cleaner, because this results in poorcleaning and excessive instrument movement, which can damage the instruments.

To avoid damage to delicate instruments, a modified basket or tray system might also benecessary depending on operational requirements.

Set the timer to the correct setting as per the ultrasonic cleaner manufacturers instructions.Atypical 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 everyclinical session and rinse the tank, because the build-up of debris will reduce theeffectiveness 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.

.



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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


Heavily soiled Instruments should be briefly immersed in cold water (with detergent) to removesome of the blood and other visible soil before being placed in the washer disinfector (ultrasonicbath may also be used as a pre-clean). Care should be taken to minimise aerosol production inthis process and to safeguard against inoculation injury.

Follow the manufacturers recommendations for the safe operating procedure of the washerdisinfector.

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 becleaned 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 arein 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 andin good condition.

Lubricate any relevant items prior to sterilization with a non-oil-based lubricant.



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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 allclean 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 equipmentshould 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 carrythe washer-disinfector symbol can be processed in a thermal washer disinfector.

Follow manufacturers guidance on lubrication requirements when using a washer disinfector itmay 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 (followmanufacturers 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 willvary 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


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

Automatic Control TestThis 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 bechecked against the cycle parameters before the steriliser is confirmed fit for use. If no printer ordata logger is available the cycle must be observed and the following information recorded onthe 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 themanufacturer 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 programmeotherwise 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



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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 untilrepaired, 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

Type of equipment: Manufacturer: ..

Description of equipment: ..

Other identifying marks: ...

Model No.. Serial No.

Fault

..

From (consignor): To (consignee): .

Address: Address: .

Reference: . Reference:

Emergency Tel:

Is theitemcontaminated? 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



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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 decontaminationequipment, responsible for ensuring that all personnel have received appropriate training andthey can demonstrate competency in their duties and that individual training records for all staffare retained

Decontamination Lead = the individual with the responsibility for infection control anddecontamination. This person should have the experience and authority to perform this task andshould be accountable to the Registered Manager.

Designated Person = the person that acts as the interface between the practice andsupport services supplied externally, including service, maintenance and testing (theDecontamination Lead could also act as the Designated Person)

User = the person with day to day responsibility for the management of the decontaminationequipment and processes, they must ensure that everyone operating and testing the equipmentis suitably trained and competent. They may seek advice from the manufacturer or serviceengineer on testing of equipment and daily tasks. With regard to infection control they may seekadvice from a microbiologist or infection control nurse.

Operator (s) = the person(s) who operates the decontamination equipment, they may alsocarry 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 adviceon compliance issues with decontamination. A list of suitable persons is available from thevoluntary 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 andcarries out the examination s in accordance with the written scheme periodically

Competent person (decontamination) Responsible for the servicing, testing and maintaining ofthe decontamination equipment

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



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Microbiologist Advice may be sought from the microbiologist for certain procedures andpractices, 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 testingThe activity of an ultrasonic cleaner may be investigated by the erosion pattern which is createdon aluminium foil exposed in the bath for a short period. The activity will not be uniformthroughout the ultrasonic bath.Tests carried out during commissioning are intended to establish the variation in activity atdifferent 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.

Method1. 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 hasbeen added and that the water in the tank is at thespecified operating temperature.

6. Start the ultrasonic cycle and carry out the degas procedure to eliminate dissolved gasesfrom the liquid in the bath.

7. Using strips of autoclave indicator tape across the top ofthe bath suspend nine strips of the prepared foil in thebath 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 mmabove, 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 D i th b th d l t d b i f d d l i i f il



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The erosion pattern will depend on the thickness of the foil, the hardness of the foil, and thetemperature 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 ofsteriliserSerial number

Location of Steriliser

ContentsForm Purpose SectionDaily test sheet A record of daily testingWeekly test sheet A record of weekly testingQuarterly and annual testsheets

Engineer quarterly and annual test sheets

Autoclave History record Record of all faults and maintenanceProcess Log A record of every steriliser load

Personnel Name/Organisation Tel No

Registered Manager

UserOperator(s)Infection control nurseCompetent Person (pressure vessels)*Authorised person (Decontamination)*Competent Person (Decontamination)*Service Engineer

Microbiologist*These personnel should have qualifications/training/registration defined in HTM01-01 part APressure systems regulations 2000This section to be filled in by the Competent Person (pressure vessels)

Written scheme of inspection exists/is suitable



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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 Start date for this sheetLocation of autoclave Make and Model Serial. No

During sterilizinghold period

Sterilizinghold time

Cyclenumber

TempC

min/max

Pressurebar

Min : sec

Signatureof testperson

Automaticcontrol test

resultPass/Fail

Certified fit foruse by user

Mon / : P/F

Tue / : P/F

Wed / : P/F

Thur / : P/F

Fri / : P/F

Sat / : P/F

Sun / : P/F

Reservoir water changes (where applicable). Drain, rinse and refill with freshly distilled orreverse osmosis water.

Cycle number when water

changed

Comments Water changed

byMonday

Tuesday

Wednesday


47 Appendix 12 Daily test sheet vaccum


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47 Appendix 12 Daily test sheet - vaccum

Daily test sheet- VacuumTest 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 Start date for this sheetLocation of autoclave Make and Model Serial. No

During sterilizinghold period

Sterilizinghold time

Cyclenumber

Temp

Cmin/max

Pressurebar

Min : sec

AutomaticControl

test resultPass / Fail

SteamPenetrationtest resultPass/Fail

Signature oftest person

Mon / : P/F P/F

Tue / : P/F P/F

Wed / : P/F P/F

Thur / : P/F P/F

Fri / : P/F P/F

Sat / : P/F P/F

Sun / : P/F P/F

Certified fit for use by user

Monday Tuesday Wednesday Thursday Friday Saturday Sunday

Reservoir water changes (where applicable). Drain, rinse and refill with freshly distilled or

reverse osmosis water.Cycle number when waterchanged

Comments Water changedby

MondayTuesdayWednesday


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49 Appendix 14 Autoclave history record sheet


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Decontamination of Dental Instrumentsand Equipment Policy Page 46 of 58 Beverly Lamb

49 Appendix 14 Autoclave history record sheet

Autoclave history record sheet

Practice Name

Start date for this sheet

Location of autoclave Make and Model of autoclave Serial. No

FAULTS RECORD MAINTENANCE RECORDFault

number

Date Cycle

number

Details of fault Noted

andreportedby

Date Fault

number

Maintenance Record-include

servicing as well as fault findingdetails

Carried

out by



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Decontamination of Dental Instrumentsand Equipment Policy Page 47 of 58 Beverly Lamb

50 Appendix 15 Production of log sheet-bench top autoclave

Production log sheet-bench top autoclave

Practice Name Start date for this sheetLocation of autoclave Make and Model of autoclave Serial. No

Date Cyclenumber

Cyclestarttime

Cycleselected

Description of load Cyclepass

Printoutchecked

OK (ifapplicable)

Commentsand operator

initials

YES/NO YES/NOYES/NO YES/NOYES/NO YES/NO

YES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NO

YES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NO


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51 Appendix 16 Summary details Ultrasonic Cleaner Log Book

Summary details Ultrasonic Cleaner Log book

Dental Practice Address

Make & model ofUltrasonic Cleaner

Serial number

Location of UltrasonicCleaner

ContentsForm Purpose Section

Daily / weekly test sheet A record of daily & weeklytesting

Quarterly test sheet A record of quarterlytesting

Annual test sheet Engineer annual testsheets

Ultrasonic Cleaner

History record

Record of all faults and

maintenanceProcess Log A record of everyultrasonic cleaner load

Personnel Name/Organisation Tel No

Registered ManagerUser

Operator(s)Infection control nurseCompetent Person (pressurevessels)*Authorised person


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52 Appendix 17 Daily/Weekly test sheet

Daily / Weekly test sheet

Weekly Test

Protein Residue Test Pass Fail

Safety Checks condition ofdoor seal / lid

Pass Fail

signature of test person

Comments

Location of Ultrasonic Cleaner

Make and Model

Serial Number

Date of test (week beginning)

Detergent used & dilution

Daily Test MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY

Cleaningefficacy

(visual)

Pass Fail Pass Fail Pass Fail Pass Fail Pass Fail

Tank drained& cleaned

AM PM AM PM AM PM AM PM AM PM

Remove andclean filters (ifapplicable)Initial of testperson


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53 Appendix 18 Quarterly test sheet

Quarterly test sheet

Automatic Control Test

Cycle start time

Cycle start temperatureUltrasonic clean - time atend of cycleTemperature at end of cycleTotal Cycle time

Ultrasonic Activity Test

Foil test PASS FAILProbe test PASS FAILProbe / Foil Positions Duration of Exposure

The test is confirmed as being within / not within* specified limits

Operator (test person) signature .

Location of Ultrasonic Cleaner

Make and Model

Serial Number




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54 Appendix 19Quarterly Foil Test Results Sheet

Quarterly Foil Test Results Sheet

1

2

3

4

5

6

7


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48

55 Appendix 20 Ultrasonic Cleaner History Record Sheet

Ultrasonic Cleaner History Record Sheet

Practice Name Start date for this sheetLocation of ultrasonic cleaner Make and Model of ultrasonic cleaner Serial. No

FAULTS RECORD MAINTENANCE RECORD

Faultnumber

Date Cyclenumber

Details of fault Notedandreportedby

Date Faultnumber

Maintenance Record-includeservicing as well as fault findingdetails

Carriedout by


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49

56 Appendix 21 Production log sheet-ultrasonic cleaner

Production log sheet-ultrasonic cleaner

Practice Name Start date for this sheetLocation of ultrasonic cleaner Make and Model of ultrasonic cleaner Serial. No

Date Cyclenumber

Cyclestart

time

Cycleselected


Printoutchecked

OK (ifapplicable)


initials

YES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NO

YES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NO


54/58


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58 Appendix 23 Daily/Weekly test sheet

Daily / Weekly test sheet

Weekly Test

Protein Residue Test Pass Fail

Safety Checks condition ofdoor seal

Pass Fail

signature of test person

Comments

Location of washer disinfector

Make and Model

Serial Number



Daily Test MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY

Cleaning

efficacy(visual)

Pass Fail Pass Fail Pass Fail Pass Fail Pass Fail

Remove andclean filters (ifapplicable)Initial of testperson


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52

59 Appendix 24Washer Disinfector History Record Sheet

Washer Disinfector History Record Sheet

Practice Name Start date for this sheetLocation of washer disinfector Make and Model of washer disinfector Serial. No

FAULTS RECORD MAINTENANCE RECORDFaultnumber

Date Cyclenumber

Details of fault Notedandreportedby

Date Faultnumber

Maintenance Record-includeservicing as well as fault findingdetails

Carriedout by

60 A di 25 P d ti l h t h di i f t


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53

60 Appendix 25 Production log sheet-washer disinfector

Production log sheet-washer disinfector

Practice Name Start date for this sheetLocation of washer disinfector Make and Model of washer disinfector Serial. No

Date Cyclenumber

Cyclestart

time

Cycleselected


Printoutchecked

OK (ifapplicable)


initials

YES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NO

YES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NOYES/NO YES/NO

7/27/2019 Decont

Documents

Decontamination Policy 2