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Decontamination of Equipment

1. Introduction

The aim of decontaminating equipment is to prevent potentially pathogenic organisms reaching a susceptible host in sufficient numbers to cause infection.
Certain items are classified as single-use only. These items must never be re-used. If in doubt, refer to the manufacturer’s recommendations.
Re-usable equipment should be appropriately decontaminated between each patient using a risk assessment model. Use only the method advised by the manufacturer - using any other process may invalidate warranties and transfer liability from the manufacturer to the person using or authorising the process. If you have any doubts about the manufacturer’s recommendations, seek further advice.
Definitions

  • Cleaning is a process ‘which physically removes contamination but does not necessarily destroy micro-organisms.’ The reduction of microbial contamination cannot be defined and will depend upon many factors including the efficiency of the cleaning process and the initial bio-burden (amount of contamination). Cleaning is an essential prerequisite of equipment decontamination to ensure effective disinfection or sterilisation can subsequently be carried out
  • Disinfection ‘is a process used to reduce the number of viable micro-organisms, which may not necessarily inactivate some viruses and bacterial spores.’ Disinfection will not achieve the same reduction in microbial contamination levels as sterilisation

 

  • Sterilisation (e.g. autoclaving) is a process used to render the object free from viable micro-organisms, including spores and viruses. It is essential that all instruments in contact with non-intact skin be sterile.

 

2. Risk Assessment

Equipment is categorised according to the risk that particular procedures pose to clients - by assessing the microbial status of the body area being manipulated during the procedure. For example, items that come into contact with intact mucous membranes are classified as intermediate risk and require disinfection between each use as a minimum standard. Items that enter normally sterile body areas, or come into contact with broken mucous membranes, are classified as high risk and must be sterile before use.
Risk Assessment for Decontamination of Equipment


Risk

Application of Item

Minimum Standard

Low & Medium

 

  • In contact with normal or intact skin   
  •  Not in contact with patient

e.g. furniture, surfaces

Clean & Dry

Intermediate

 

  • In contact with intact mucous membranes  or
  • Contaminated with virulent or readily transmissible organisms (body fluids) or
  • Prior to use on immuno-compromised clients

Disinfect or single-use

High

 

  • In contact with a break in the skin or mucous                 membrane    or
  • For introduction into sterile body areas

Sterilise, or single-use

 

3. Cleaning Methods

Cleaning is the first step in the decontamination process. Pre soaking is not necessary. It must be carried out before disinfection and sterilisation to make these processes effective. Thorough cleaning is extremely important in reducing the possible transmission of all micro-organisms, including the abnormal prion protein that causes vCJD.
Thorough cleaning with detergent and warm water - maximum temperature 350C - will remove many micro-organisms. Hot water should not be used as it may coagulate protein making it more difficult to remove from the equipment.
Mechanical cleaning using a washer/disinfector or ultrasonic bath is recommended.

Manual cleaning must be undertaken in a designated sink which is deep enough to completely immerse the items to be cleaned. Scrubbing can generate aerosols, which may convey infective agents. Therefore if scrubbing is necessary, it must be carried out with a brush beneath the surface of the water.
Personal protective equipment, including aprons, gloves and goggles or visors, must be readily available for staff.
Cleaning equipment - such as brushes, cloths and ultrasonic washers - must be stored clean and dry between uses. Use single-use, non-shedding cloths. Do not store brushes in disinfectant solutions. Brushes should be disposable or changed at least weekly.
After cleaning and thorough rinsing, the items should be dried using a disposable non-shedding absorbent cloth.

Mechanical Cleaning - Ultrasonic cleaning baths:
These machines are probably the most practical automated method of removing material from instruments prior to sterilisation. They are especially good for inaccessible areas on utensils. Ultrasonic cleaners do not necessarily kill all micro-organisms but they are very useful in preparing equipment for sterilisation in the autoclave as any dirt or debris such as coagulated blood and other body tissues left on equipment can seriously inhibit the sterilisation process.

  • Ultrasonic cleaners must be used in accordance with manufacturer’s instructions.
  • The lid must be on when operated to avoid dispersal of aerosols
  • Ultrasonic cleaners are not suitable for plastic or similar materials
  • Check with the manufacturer that the washer is suitable for the items to be cleaned. Hinged items should be opened before loading in the washer
  • Remove gross contamination and soiling from instruments before loading by cleaning manually (see Manual Cleaning above)
  • A low foaming surfactant or detergent should be used in the washer
  • Fill with clean water and the volume of detergent prior to use
  • Bring up to the operating temperature and operate for at least 5 minutes to de-gas the solution
  • After de-gassing, load the washer and replace the lid
  • Empty the tank after 4 hours, or when visibly soiled, or at the end of the session, whichever is soonest. Clean and dry
  • Service regularly and document, including repairs

 

4. Disinfection Methods

Disinfection methods apply to handwashing, skin preparation and equipment. Disinfection of equipment should be limited and, where possible, disposable or autoclaved equipment used instead. If disinfection is required, use the method recommended by the manufacturer. The table below outlines the advantages, disadvantages and uses of some of the more popular disinfectants.


Chemical

Advantages

Disadvantages

Uses

Chlorine-based:
Hypochlorites
(e.g. Domestos, household bleach, Milton)
NB Undiluted commercial hypochlorite usually contains approx. 100,000ppm available chlorine

 

  • wide range of bactericidal, virucidal, sporicidal and fungicidal activity
  • rapid action
  • non-toxic in low concentrations
  • cheap

 

  • inactivated by organic matter
  • corrosive to metals
  • diluted solutions can be unstable
  • need to be freshly prepared
  • does not penetrate organic matter
  • bleaches fabrics
  • needs ventilation

can be used on hard surfaces and for body fluid spills

Sodium Dichloroisocyanu-rates (NaDCC)
e.g. Presept, Haz-Tab, Sanichlor

 

  • slightly more resistant to inactivation by organic matter
  • slightly less corrosive
  • more convenient
  • long shelf-life
  • as above

as above

Alcohol 70%
e.g. isopropanol

 

  • good bactericidal, fungicidal and virucidal activity
  • rapid action
  • leaves surfaces dry
  • non-corrosive

 

  • non-sporicidal
  • flammable
  • does not penetrate organic matter  requires evaporation time

can be used on hard surfaces, or for skin and hand decontamination

Chlorhexidine
e.g. Hibiscrub, Chlorhexidine wound cleaning sachets

 

  • most useful as disinfectants for skin
  • good fungicidal activity
  • low toxicity and irritancy

 

  • limited activity against viruses
  • no activity against bacterial spores
  • inactivated by organic matter

for skin and hand decontamination

 

5. Sterilisation Methods

The suitability of a particular steriliser for a particular load needs to be evaluated as vacuum steam sterilisers are expensive to purchase, run and maintain in line with the current guidelines from the Medical Devices Agency. The use of sterile single use tubes, grips and individual client kits may be a more suitable option and although may appear more expensive may in fact be a far safer method.

You can obtain sterile instruments by:

  • Purchasing pre-sterilised single-use items (refer above)

These avoid the need for re-sterilisation and are a practical and safe method. You must store items using a stock rotation system according to manufacturer’s instructions. Do not use after the expiry date

  • Sterilising your own equipment using a benchtop steam steriliser/vacuum steam steriliser

Increasingly, owners are required to comply with a number of quality assurance standards, outlined in the following pages of this document.

Single-use Equipment

Single-use means that the manufacturer:
• Intends the item to be used once, then thrown away
• Considers the item unsuitable for use on more than one occasion
• Has insufficient evidence to confirm that re-use would be safe.

Single client use means that the item can be reused if re-processed using an appropriate method and is used on the same client only. The duration of use is dependent upon undertaking a risk assessment of individual risk factors.
The MDA (1995) guidance suggests that reprocessing and re-using such items may pose hazards for clients and staff, if the reprocessing method has not been validated. Therefore re-use of single-use products is not advisable unless the outcomes have been taken into account.

 

Sterilisation of Instruments – Responsibilities

If sterilisation is to be carried out, then the owner and other personnel are required to ensure that the sterilisers are operated safely and effectively and in compliance with legislation and standards. This is dependent on training and a sound general knowledge of the principles of sterilisation.

The key responsibilities can be summarised as follows:

  • To ensure that sterilisation is carried out in compliance with the law
  • To ensure all personnel connected with sterilisation, including any contractors, are suitably qualified and trained for their responsibilities
  • To ensure that purchased sterilisers conform to legal requirements, the minimum specifications set out in European standards and any additional requirements of the health departments
  • To ensure that sterilisers are installed correctly and safely with regard to proper functioning, safety of personnel and environmental protection
  • To ensure that newly installed sterilisers are subject to a documented scheme of validation comprising installation checks and tests, commissioning and performance qualification tests before they are put into service
  • To ensure that sterilisers are subject to a documented scheme of prevention maintenance
  • To ensure that sterilisers are subject to a documented scheme of periodic tests at yearly, quarterly, weekly and daily intervals
  • To ensure that procedures for production, quality control and safe working are documented and adhered to in the light of statutory requirements and accepted best practice
  • To ensure that procedures for dealing with malfunctions, accidents and dangerous occurrences are documented and adhered to

Bench Steam Steriliser (Autoclave)
The most reliable method of sterilising equipment is moist heat using steam under pressure i.e. autoclave. It is important that the correct type of autoclave is purchased for the type of sterilisation required by the equipment placed in it. The UK Medical Devices Agency guidance on bench top sterilisers applies to all operators including body modifications artists.
All persons operating benchtop sterilisers should have received training on the safe use of portable autoclaves and must follow manufacturer’s instructions. Training is often provided by the manufacturer but needs to be requested. All training should be documented. Sterilisation is a process whose efficiency cannot be verified retrospectively by inspection or testing of the product. Routine monitoring of the process, combined with periodic testing of the steriliser’s performance, is therefore needed to give assurance that sterilising conditions are consistently being achieved.

A European standard for benchtop steam sterilisers is currently being prepared.* It classifies benchtop steam sterilisers according to the types of load they are intended to process, which are summarised in Table 2

  


Choice of Autoclave
Classification of benchtop steam sterilisers

Table 2 Types of sterilization cycle

Cycle type

Air removal

Load type

Advantages

Disadvantages

N

Passive (gravity
displacement).

Non-wrapped solid
items.

Simplest type. Least
expensive to
purchase, operate
and maintain.

Not to be used for:

  • hollow devices or

those with lumens;

  • wrapped loads (e.g.

items in pouches).

B

Active (forced)
air removal.

Wrapped or nonwrapped
solid items
(e.g. forceps, dental
probes).
Wrapped or nonwrapped
hollow items
(e.g. cannulae within
dimensions specified
by sterilizer
manufacturer).
Porous loads (e.g.
fabrics, swabs,
dressings).

Widest range of
applications.

Expensive to purchase
and maintain.
Additional periodic
testing required.
Post-sterilization drying
stage essential for
wrapped items increases
total cycle times.

S

Active (forced)
air removal.

Only suitable for types
of loads specified by
the sterilizer
manufacturer.

Wider range of
applications than
Type N.

Expensive to purchase
and maintain.
Additional periodic
testing required.
Post-sterilization drying
stage essential for
wrapped items increases
total cycle times.

 

*Small steam sterilisers’ prEN13060 : 2002 (E)

Whichever type of autoclave is used the most important element is that all items are thoroughly cleaned both manually and ultrasonic bath to remove visible contamination BEFORE they are autoclaved.

  • Instruments must be dry before they are placed in the autoclave pouches
  • Wrap instruments separately or in a set required for a single client.
  • Open forceps and similar tools as wide as possible to ensure proper sterilisation.
  • Place pouches separately on the tray, paper side up and away from the inner walls of the autoclave.
  • Ensure autoclave tape is attached to each pouch and is dated.
  • Remove pouches carefully and store separately in a closed cabinet or drawer.
  • Store in a first in first out method as packs should be used within one month

 

Daily Testing
The owner/user is responsible for daily testing. These tests are designed to show that the operating cycle functions are correctly shown by the values of the cycle variables indicated and recorded by the instruments fitted to the steriliser.

Procedures for Daily Testing

  •  A normal cycle is operated with the chamber empty except for the usual chamber “furniture” (e.g. trays, shelves, etc.)
  •  A record should be made in the log book of the elapsed time and indicated temperature and pressure (the values shown on the dials or other visual displays fitted to the steriliser) at all significant points of the operating cycle – the beginning and end of each stage or sub-stage, and the maximum temperature and pressure values attained during the holding time
  •  If the steriliser is fitted with a temperature and pressure recorder, the printout should be compared with the records in the steriliser log book and retained for future inspection.

Table 1 – Steam sterilisation temperature ranges and holding times for sterilisers with high temperature steam  

Sterilisation
Temperature (°C)

Maximum Allowable Temperature (°C)

Minimum Hold
(min)

134

137

3

126

129

10

121

124

15

The preferred sterilisation temperature is 134ºC. However, any of the lower sterilisation temperature bands in Table 1 may be used where load items would be damaged at 134ºC

Weekly Testing
• Examine the door seal, check security and performance of door safety devices
• Check that safety valves, or other pressure limiting devices, are free to operate.

Quarterly and Annual Checks
A suitably qualified person should conduct these tests as they require the use of specialised equipment and will probably be conducted by the person who undertakes the maintenance.

 

6. Maintenance of Sterilisers

AUTOCLAVE RECORD
Please keep these records in date order for inspection

Autoclave Type: ..........................      Serial No: ..........................
Week Commencing: .....................      Location: ..........................
Type of Water used: ..........................

PLEASE KEEP THESE RECORDS IN A RING BINDER FOR INSPECTION

Daily Test

Saturday

Sunday

Monday

Tuesday

Wednesday

Thursday

Friday

Cycle Counter Number

 

 

 

 

 

 

 

Time to reach holding temp.

 

 

 

 

 

 

 

Temp during holding period

 

 

 

 

 

 

 

Pressure during holding period

 

 

 

 

 

 

 

Total time at holding temp/pressure

 

 

 

 

 

 

 

Water drained at end of day

 

 

 

 

 

 

 

Process check

 

 

 

 

 

 

 

Printout attached

 

 

 

 

 

 

 

Initials of authorised user

 

 

 

 

 

 

 

 

Weekly Safety Test

Yes/No

Comments

Door seals secure

 

 

Door safety devices functioning correctly

 

 

Safety Valves operating correctly

 

 

Note: in the event of a malfunction notify the engineer at once.
Comments:

Name

 

Date

Signature

 

 

7.  Decontamination Of Special Equipment

Equipment

Recommendations

Tattooists:
Holders for stainless steel bars i.e. tube, tip and grip

Needles and Needle bars

 

Pigment caps/trays

 

 

 

Motors & clipcords

 

Elastic bands

 

Dismantle after use and before cleaning/autoclaving

 

Single use only. Disengage from tube and dispose immediately into sharps box

Single use caps/trays recommended. Discard after each client. Always ensure caps are clean before use

If reusable cap trays should be stainless steel. Discard ink and caps after each client. Trays should be cleaned between clients and small enough to fit into ultrasonic and autoclave after each session.

Wash with warm detergent water between clients. Wipe with Alcohol (70% isopropyl)

Remove from machine and discard after each client

Body piercing:
Needles, cannulae

Clamps used for skin folds, looped forceps, pliers and receiving tubes

Jewellery

 

Pre sterilised single use only.

Wash thoroughly with detergent and hot water
Autoclave

Ultrasonic and autoclave before use

 

General
Stainless steel forceps

 

Plastic container for instruments

 

Stainless steel container for instruments

 

Towels

Cups

Razors

 

Wash, ultrasonic clean and autoclave after use

 

Wash with warm detergent water, rinse and dry thoroughly. Store inverted

Wash with warm detergent water, rinse and dry thoroughly. Wrap and autoclave.

Disposable paper towels are recommended

Disposable paper cups are recommended.

Single use only. Disposable razor should be used and discarded directly into sharps bin. Do not resheath prior to disposal.

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