Professional Documents
Culture Documents
Instr Decontamguide
Instr Decontamguide
surgical instruments
2003
STATUS IN WALES
APPLIES
9.0 TRANSPORTATION OF
3.0 ACQUISITION page 13 DECONTAMINATED SURGICAL
Purchasing INSTRUMENTS AND
Loan of surgical instruments and ASSOCIATED EQUIPMENT
equipment page 33
5
APPENDIX 1 – Processing of flexible
endoscopes
page 39
APPENDIX 2 – References page 41
APPENDIX 3 – Glossary page 45
Acknowledgements page 48
6
1.0 Introduction
7
Figure 1 3. ensuring that equipment used is
validated, maintained and tested in
standards should be applied to accordance with manufacturer’s
decontamination practices throughout an guidelines and legislation;
organisation.
4. the existence of effective management
Figure 1 highlights each stage of the arrangements;
decontamination process through which
surgical instruments pass before every 5. the existence of policies and
use. Effective decontamination requires procedures for all aspects of
the attainment of acceptable standards decontamination work.
at all stages of the life cycle. Failure to
address issues in any of these stages will BASIC REQUIREMENTS FOR
result in inadequate decontamination. DECONTAMINATION
8
In maintaining and developing • organisations should have systems in
organisation-wide decontamination place to trace instrument sets and
standards and practices, the following endoscopes through decontamination
should be included: processes and to the patient (see
below; see also HSC 2000/032 and
• an effective management control HSC 1999/178);
system must be in place to cover all
aspects of the decontamination life- • a documented training scheme must
cycle; be in operation with individual training
records for all personnel, including
• every organisation should have a management involved in
nominated lead with responsibility for decontamination activities.
decontamination, either at director
level or someone who has line TRACKING AND TRACEABILITY OF
management responsibility to a senior SURGICAL INSTRUMENTS
responsible person at that level;
It is important to be able to trace
• documented robust and products through the decontamination
comprehensive policies and processes to which they have been
procedures to ensure that subjected and also to the patient on
decontamination processes are whom they have been used. The ability
undertaken in a controlled manner to to track and trace surgical instruments
protect the health and safety of and equipment through the
patients and staff; decontamination life-cycle enables
corrective action to be taken when
• a procurement policy which ensures necessary. For example, in the unlikely
that all purchased instruments are event of a sterilization cycle failure,
compatible with decontamination products can then be recalled.
processes available within the
organisation; HSC 2000/032 states:
9
instrument is in addition to the • risk assessments for procedures used
measures for identification and in the reprocessing of surgical
tracking of flexible endoscopes set out instruments;
in Health Service Circular 1999/178.”
• spillage procedures;
Records should be maintained for all the
sets cleaned, identifying: • management and treatment of needle-
stick/sharps injuries.
• the cleaning and sterilization method
used; This policy should be written in
collaboration with the infection control
• the name of the person undertaking team.
the decontamination; and
Controls Assurance standards exist for
• details of the actual item being the related issues of decontamination,
processed. the management of surgical instruments
and associated equipment, and infection
This information is required so that control. Organisations are legally required
instrument sets can be traced, if to undertake assessments and complete
required, in the event of a failure in the their returns as part of their risk
decontamination cycle or for infection management system.
control reasons.
DECONTAMINATION TRAINING
Records relating to decontamination
processes should be maintained by the Members of staff undertaking
organisation for a minimum of 11 years decontamination must be competent,
or in accordance with local data policies. properly trained and supervised. A
national training scheme is currently
INFECTION CONTROL POLICIES being devised and will describe basic
training for staff involved in all aspects of
All organisations must have an infection
the decontamination of surgical
control policy that contains:
instruments.
• advice on decontamination and
Individual training records, detailing an
storage of surgical instruments;
individual’s core competencies and any
• local policies on recommended training received, must be maintained
disinfectants, their application, use, and updated regularly. Line managers are
storage and disposal; responsible for maintaining these
records.
• protocols for the cleaning and
disinfection of surgical instruments In the primary care setting, whoever
where instruments have to be owns or manages the practice is
processed in a local setting; responsible for ensuring that systems are
in place for ongoing staff training.
• protocols for the use of personal
protective equipment (PPE);
10
2.0 Transportation of contaminated surgical
instruments and associated equipment
11
3.0 Acquisition
Lack of consultation has often resulted in • Does the instrument have lumens/can
devices being purchased which cannot the device be easily cleaned? If not, is
be adequately decontaminated, as there an alternative reusable device
they are subsequently found to be which is easier to clean, or is a single-
incompatible with the decontamination use device available as an alternative?
processes available within an
organisation. For example, devices • Does the instrument need dismantling
manufactured outside the UK may require before cleaning? Are instructions
processes that are not routinely available provided by the manufacturer
within the UK, such as those that require describing how this can be done?
sterilization temperatures other than the
• Does the instrument have electrical
standard 121°C and 134°C cycles (see
components? If yes, does the
MDA SN 2001 (28)).
organisation have the capability to
To help organisations in purchasing clean and sterilize them in the manner
decisions, the NHS Purchasing and described by the manufacturer?
Supply Agency (PASA) has established
• Does the instrument have a limited
framework agreements for purchasing a
life? Is this specified by the
number of medical products and devices,
manufacturer?
for example washer-disinfectors, surgical
instruments etc. Details are available from • What method of cleaning does the
the PASA catalogue and their website. manufacturer recommend and is this
process available within the
organisation?
13
• What cleaning agents are LOAN SURGICAL INSTRUMENTS
recommended and does this comply AND EQUIPMENT
with local infection control policies,
COSHH and health and safety It may sometimes be necessary to
requirements? borrow equipment from another
organisation or manufacturer: for
• If the instrument needs to be example, for a trial, to treat a patient
sterilized, is the preferred method of where equipment is not routinely available
steam sterilization (134°C for a or where workload dictates that
minimum of three minutes) additional equipment is required on a
recommended? If another method of temporary basis. All surgical instruments
sterilization is recommended, is this and equipment entering the organisation,
available within the organisation? regardless of the source, should be
cleaned and sterilized before and after
• If the product is heat- or pressure- use in accordance with manufacturers’
sensitive, what alternative means of instructions (see MDA SN 2000 (18)).
sterilization is recommended? Is this
process available within the If staff are unfamiliar with on-loan
organisation? equipment or newly purchased devices, it
is essential to arrange training from the
• Has a risk assessment been supplier/manufacturer to ensure
undertaken to determine whether a equipment is decontaminated properly
single-use or a reusable product is and to minimise the potential for damage.
more appropriate for the Items requiring disassembly during
circumstances? processing must be dismantled in
accordance with manufacturers’
Manufacturers of re-usable surgical
instructions.
instruments are required to supply
information on the appropriate Device loans should be so arranged to
decontamination process to allow reuse, give adequate time for learning about the
including cleaning, disinfection and where equipment and for decontamination of
appropriate the method of sterilization the device before it is required for use on
(Consumer Protection Act 1997; Medical a patient.
Devices Regulations 2002).
14
4.0 Cleaning
15
DISASSEMBLY OF INSTRUMENTS Each stage of the decontamination
process should contribute to the
Equipment consisting of more than one reduction of bio-burden on the device
component must be dismantled so that being reprocessed. The recognised
each part can be adequately cleaned. stages of the washing process may
Advice on the methods for disassembly include a cool pre-wash (below 35ºC to
of surgical instruments should be sought prevent protein coagulation), main wash,
from manufacturers. Training should be rinse, thermal disinfection and post-
updated to take into account any new disinfection rinse (where appropriate). The
instruments introduced into the use of ultrasonic cleaners may be
organisation to ensure that the considered to assist the process (see
equipment is dismantled and that next section).
adequate cleaning and sterilization takes
place. Personal training records should Ultrasonic cleaners
reflect the range of devices upon which
an individual has been trained and is Ultrasonic cleaners may be of the stand-
competent to decontaminate. alone ultrasonic bath type or may be
washer-disinfectors of Type 1 (single
AUTOMATED CLEANING chamber) or Type 2 (multi-chamber).
16
used only if recommended by the 5. When the specified temperature has
instrument/device manufacturer. been reached, place the
opened/dismantled instruments into
Ultrasonic action is generated by the basket.
transducers that agitate the water by
creating bubbles. The bubbles implode 6. Place the basket of instruments into
and dislodge dirt from the surface and the tank. Never put instruments
joints of surgical instruments. directly onto the base of an ultrasonic
washer.
Ultrasonic action helps to thoroughly
clean devices with joints or multiple 7. Set the timer control to the time
components that are difficult to clean specified by the machine
manually. manufacturer.
Ultrasonic cleaners are not 8. After the cycle has been completed,
recommended for cleaning certain items, remove the basket from the tank and
in particular rubber products which will rinse the items with clean, potable
absorb the ultrasonic waves and reduce water – unless the machine has an
the efficacy of the cleaning process. automatic rinse stage, or the load is to
be transferred directly into a washer-
Directions for use of ultrasonic disinfector for further processing.
cleaners
9. Drain and dry the items using a non-
Staff must wear PPE at all times while linting cloth or mechanical drying
handling contaminated instruments and system.
working with the ultrasonic cleaner.
10. Record the instrument(s) that has
1. Fill the tank with potable water been processed, including the
(drinking quality) to the manufacturer’s method and solutions used and
designated level. This ensures that the details of the staff member who
device being cleaned is not completed the procedure.
contaminated by water impurities.
11. After use, the ultrasonic washer
2. De-gas the water as recommended by should be drained, cleaned, dried,
the machine manufacturer. covered and left dry and empty until
required for further use, as per the
3. Add detergent, ensuring the
manufacturer’s instructions.
manufacturer’s recommendations are
followed. It is advisable to use a Testing of ultrasonic cleaners
suitable enzymatic detergent that is
effective at low temperatures. In accordance with guidance contained in
HTM 2030, a qualified “test person”
4. If the tank has a heater, set the should regularly maintain and test
temperature control to be comparable ultrasonic cleaners. The test
with the detergent manufacturer’s requirements and the role of the test
recommendations. person can be found in HTM 2030. It is
recommended that a soil test and a
17
residual protein test should be performed Points for consideration
as part of the weekly tests to establish
the efficacy of the washer’s cleaning Contamination of instruments can occur
process. when the water in the ultrasonic bath is
not changed regularly: if gross
The following simple test may be contamination is present on the surface
undertaken to establish that there is of the water, debris can be deposited
ultrasonic action in the tank. It should onto instruments when they are lifted out
not, however, replace the detailed tests of the bath. Therefore, it is recommended
specified in HTM 2030: that the tank be emptied regularly – as a
minimum, every four hours, or when the
1. Clamp the edge of a piece of water is visibly soiled.
aluminium foil (approximately 5 cm2) in
a pair of metal forceps. PROCEDURE FOR MANUAL
CLEANING
2. Hold in the centre of the bath for
approximately three minutes. Manual cleaning would normally be
carried out using either immersion or
3. Remove, dry and inspect the non-immersion methods depending on
aluminium foil for changes. the construction of the device.
4. File the strips of foil as a record of the Immersion method
test having been undertaken, together
with all relevant test details, that is To minimise the risk to personnel
machine number, date, test result undertaking manual cleaning, splashing
(pass/fail), name of operator etc. and the creation of spray must be
avoided at all times. Staff carrying out
(Note: Do not put hands into the tank of manual cleaning should wear PPE at all
an ultrasonic cleaner while the machine is times.
in use.)
1. Fill sink 1 (not a hand basin or other
Effective ultrasonic action will serrate the clean receptacle) with potable water to
edge and pit/perforate the centre of the a predetermined level at the specified
foil. However, if the aluminium foil is temperature and with the appropriate
withdrawn without any noticeable change detergent. Sink 1 must be solely
to its condition, this may indicate that the dedicated for the cleaning of
machine is not functioning properly and instruments, and not for any other
the manufacturer/supplier should be purpose.
consulted. It should be noted however
that the strength of the ultrasonic waves 2. Detergents used must be specifically
will vary throughout the tank. designed to clean surgical
instruments: washing-up liquid should
(Note: the appropriateness of this test not be used. Detergent dilution and
will depend on the frequency at which water temperature should be in
the ultrasonic cleaner operates. Consult accordance with the manufacturer’s
the equipment manufacturer for further instructions and local policy.
information.) Consideration should be given to the
18
use of an enzymatic detergent to example, by using a clean, non-linting
facilitate the cleaning of surgical cloth or by mechanical drying. An
instruments with channels or complex alcohol wipe can be used to facilitate
parts. the drying process.
6. Remove the device from sink 1 and 1. cleaned using a non-linting cloth,
drain any excess cleaning solution impregnated with the appropriate
before placing in sink 2 for rinsing. detergent solution, followed by a
clean, damp, non-linting cloth; and
7. Change the rinse-water after every
then
batch of instruments or when it
becomes visibly soiled or cloudy. 2. dried using another clean, non-linting
cloth.
8. Rinse the item thoroughly with clean
potable water using the water-jet gun Alcohol-impregnated wipes may be used
when necessary (see point 5). following a manual cleaning process.
19
5.0 Disinfection
Moist heat is the method of first choice In the case of devices with lumens, it
as it is easily controlled, leaves no toxic may be necessary to agitate the device in
residues and is relatively safe to those the disinfectant to dislodge any air
involved in the process. Disinfection can trapped inside. Disinfectants will be
be achieved by washing or rinsing effective only if the solution reaches all
devices in water at between 73°C and surfaces of the device to be disinfected
90°C. Most of the washers manufactured and appropriate exposure times
for the reprocessing of surgical recommended by the disinfectant
instruments incorporate a disinfection manufacturer are adhered to.
stage.
If the device is for immediate use after
Devices that cannot withstand relatively disinfection, staff must use an aseptic
high temperatures required for technique when removing it from the
disinfection by moist heat may be chemical solution. Then, the device must
disinfected using chemicals. Receptacles be thoroughly rinsed in sterile water and
used for chemical disinfectant solutions carefully dried using a sterile, non-linting
must be cleaned and steam-sterilized cloth. The manufacturer’s recommended
before being used. Care must be taken method(s) and the compatibility of the
to ensure that the device is scrupulously device with the chosen process will also
clean, that the correct chemical be important considerations.
concentration is used and that the device
is properly submerged to ensure contact If the device is to be stored before being
with all parts. used, it can be removed from the liquid,
rinsed in sterile water, dried with a non-
It is important to note that when linting cloth and stored in a secure area.
preparing chemical disinfectants, staff Where a sterile product is required, it
involved must wear the appropriate PPE. should be processed immediately before
The room used for chemical disinfection being used and not stored before use.
must be well-ventilated or contain an
21
6.0 Inspection and function testing
23
lubricant should be used to avoid it reasons, but typically through
interfering (that is, preventing the steam inappropriate use, poor handling or
coming into contact with the instrument contact with corrosive substances. The
surface) with the sterilization process. damage to instruments may take the
form of physical damage, for example
In preparing instruments for wrapping when an item is dropped or as a result of
and sterilization, it is essential that all a reaction to contact with corrosive
surfaces are presented to the sterilization agents during use, for example iodine or
media (that is, steam or chemical) and saline solutions used in operating
that, where devices can be taken apart, theatres. Typical damage includes
they are sterilized in this state wherever rusting, pitting or general surface
practicable. For instruments with corrosion.
ratchets, to ensure steam can penetrate
to all surfaces, they should be closed on If devices are found to be faulty or
the first ratchet only. damaged during inspection and function-
testing, or if users identify that they are
It is vital to have a procedure whereby faulty, they should be taken out of use
the users of surgical instruments will and either repaired or replaced.
inform those responsible for reprocessing Instruments for repair should be returned
about defects and the need to have to either the manufacturer or a reputable
items repaired and/or replaced. In the repair company. They should be
case of instrument sets, the contents decontaminated in accordance with
sheet may be used to indicate faulty MHRA DB 2003 (05) and be
instruments but the actual item must be accompanied by a Decontamination
identified in case there are a number of Certificate (a sample of which can be
similar devices on the same set. found in the MHRA device bulletin; see
the MHRA web-site). Where instruments
REPAIRS
are taken out of use, which are part of
Instruments may become damaged instrument “sets”, the set should be
during use or suffer from general wear removed from use until the repair can be
and tear over their life span. Instruments undertaken and the instrument returned
become damaged for a number of to the set.
24
7.0 Packaging
25
LABELLING OF STERILE SURGICAL 2. Name of the manufacturer, that is
INSTRUMENTS “reprocessor”.
26
8.0 Sterilization
27
machines and provides information on • Rigid endoscopes cannot be
how these sterilizers should be used, processed in benchtop sterilizers
tested and maintained. unless designated as autoclavable by
the manufacturer and the process has
BOWL AND INSTRUMENT been validated for the instrument (see
STERILIZERS the Medical Devices Directive, Annex
1, ER 13.6(h)).
These sterilizers are similar in design and
operate in a similar way to porous-load • Hollow or lumen instruments are not
sterilizers, but without an active drying suitable for sterilization in non-vacuum
cycle or air removal. They must not be sterilizers.
used for wrapped items or those which
are hollow or have lumens. Machines All steam sterilizers are subject to the
located in operating theatres are Pressure Systems Safety Regulations
gradually being phased out as the 2000 and must be examined periodically
decontamination of surgical instruments by a Competent Person (Pressure
is transferred to central processing units, Vessels).
that is SSDs.
Use and testing of benchtop
BENCHTOP STERILIZERS sterilizers
Benchtop sterilizers must be operated to To ensure the safety of this device, the
ensure that: following points must be adhered to:
• they are compliant with safety 1. Each sterilizer will have a reservoir
requirements; chamber from which the water is
delivered for steam generation; this
• they are installed, validated and must be filled daily using sterile water
maintained appropriately (HTM 2010; for irrigation BP. At the end of the day
MDA DB 9804 and MDA DB 2002 or following final use, the chamber
(06)); should be drained (only when the
water has cooled), cleaned, dried,
• they are operated in accordance with covered with a lid and left empty for
the equipment manufacturer’s future use (see HTM 2031).
instructions.
2. Testing is an integral part of ensuring a
Users should be aware of the cautionary benchtop sterilizer consistently
notes relating to the improper use of performs to operating parameters set
small benchtop sterilizers. These include: during the machine’s commissioning.
• Wrap instruments only where this is Failure to carry out routine periodic
recommended by the manufacturer tests and maintenance tasks could
and where the sterilizer is vacuum- compromise safety and have legal and
assisted. The sterilizer must be insurance-related implications for the
validated for the intended load. user or owner of the sterilizer.
28
3. A schedule for periodic testing should The tests may be carried out at the same
therefore be planned and performed in time.
accordance with documented
procedures (see HTMs 2010 and Sterilizers must not be used until the
2031; and MDA DB 2002 (06)). The daily tests and housekeeping tasks
schedule should provide details of have been carried out, and the
daily, quarterly and yearly testing. results found to be satisfactory.
Each sterilizer should have a logbook
Before carrying out the daily tests, the
(file) in which details of the following
user should:
are recorded:
• clean the rubber door seal with a
– maintenance;
clean, damp, non-linting cloth;
– validation;
• check the chamber and shelves for
– faults; cleanliness and debris;
The daily tests should be performed by • Place the Bowie–Dick type test pack
the operator or user and consist of: (conforming to BS EN 867:2001)
within the chamber in a position
• a steam penetration test (vacuum recommended by the manufacturer.
benchtop sterilizers only); This will ensure that the test presents
the machine with the greatest
• an automatic control test (all benchtop challenge from which to remove air
sterilizers). from the load.
29
• Select a standard cycle or the cycle Use of chemical process indicators
specified by the sterilizer manufacturer.
(The test should always be performed Chemical process indicators are a
using the same cycle). mechanism by which sterilizer loads can
be identified as having passed through a
• At the end of the test, remove the test process. The chemical indicator reacts
sheet from the middle of the pack and when exposed to steam and
compare the results with the demonstrates a change in character,
manufacturer’s test sheet. usually colour. These chemical indicators
can take the form of an autoclave tape,
• The test is satisfactory if the indicator test tubes containing chemical indicator
shows a uniform colour change. or sterilization packaging/bags. In all
these cases, the chemical indicators will
• The test results PASS/FAIL should be
change colour when subjected to heat.
recorded in the sterilizer logbook.
• Indicators must be stored in
• The test result indicator paper should
conditions that will not adversely affect
be marked with the result, date and
the performance of the chemicals.
cycle number and kept within the
logbook for reference. (It should be • Store in accordance with
stored according to the manufacturer’s manufacturer’s instructions.
recommendations).
• Do not use indicators beyond the
• If the sterilizer is fitted with a chart expiry date stated by the
recorder, the test cycle print-out manufacturer.
should also be retained within the
logbook. • Chemical process indicators should be
used and read in conjunction with
If the test result is unsatisfactory, the sterilizer-process print-outs or a
machine should be taken out of use and sterilization cycle’s parameters.
the fault investigated (this may require
testing by a designated Test Person). Microbiological testing of steam sterilizers
is not recommended.
Automatic control test
Processed devices for immediate use
Daily tests are referred to as automatic
control tests. Details of how to undertake Non-vacuum benchtop steam sterilizers
these tests can be found in the are designed to process items for
manufacturer’s user manual. For accurate immediate use within a clinical
monitoring of the cycle parameters, a environment.
stopwatch is recommended for accurate
timings. (An automatic control test is not Upon completion of the sterilization
required if the sterilizer is equipped with a cycle, if the machine does not have a
recorder that provides a permanent vacuum cycle, steam is condensed within
record (print-out) of the temperature, the sterilizer’s chamber, resulting in a wet
pressure and elapsed time during all load. Partial drying does occur by natural
stages of the sterilization cycle/s in use.) evaporation after the load is removed
from the chamber, but once the door to
30
the sterilizer chamber has been opened, conditions to be achieved, load items
the load is compromised and must, therefore, be cleaned thoroughly
subsequently exposed to and air removed effectively from the
recontamination. Benchtop sterilizers sterilizing chamber and the load. Effective
used to sterilize unwrapped items should air removal is essential to enable steam
therefore only be used to sterilize loads to penetrate wrapped devices and those
for immediate use. with lumens. This can be achieved only if
the sterilizer is equipped with an active
It is not recommended that loads are air-removal system, as are vacuum
packaged after sterilization. benchtop sterilizers. They can process
porous loads (Type B cycle) or types of
(Note: where sterilized items are not
devices specified by the sterilizer
required for immediate use, they should
manufacturer (Type S cycle).
be dried using a clean, non-linting cloth
before storage in clean, closed, secured The drying stage must reduce the
containers until required. Such containers moisture content of packages and
should be regularly cleaned and porous materials to a level that will not
sterilized. Should unwrapped items need permit bacterial recontamination.
to be sterile at the point of use, the items
should be resterilized immediately before Because vacuum benchtop steam
being used.) sterilizers are more complex than their
non-vacuum counterparts, they require
Vacuum benchtop steam sterilizers more rigorous testing to demonstrate
that they function correctly. Therefore,
Steam sterilization requires direct contact
owners/users of benchtop sterilizers
between dry saturated steam and all
should ensure that the sterilizer is subject
surfaces of the load at a specified
to a planned and documented schedule
temperature and pressure for a defined
of preventative maintenance.
period of time. To enable sterilizing
31
9.0 Transportation of decontaminated
surgical instruments and associated
equipment
33
10.0 Storage of sterile products
Sterile products are usually stored at the Before being used, the sterile product
point of use, for example wards, clinics, should be checked to ensure that:
departments and operating theatres.
• the packaging is intact;
However, regardless of the location, the
storage area should be dedicated for the • the sterilization indicator confirms the
purpose and not used for other activities, pack has been subjected to an
for example patient treatment areas. appropriate sterilization process; and
• The storage area should be • the product is still within the expiry
appropriately designed to prevent date.
damage to packs and to allow for the
strict rotation of stocks. As a “rule of thumb”, product which has
remained unused for more than six
• Shelving should be easily cleaned and months should be deemed to be a
allow the free movement of air around product of over-stocking and an
the stored product. assessment undertaken as to its future
need.
• Products must be stored above floor
level away from direct sunlight and There are occasions where devices must
water in a secure, dry and cool form part of emergency stocks and as a
environment. result may not be used within this time
frame. Procedures should be put in place
Inadequate control of these areas may
to ensure that these products are subject
have an adverse effect on the integrity of
to a reprocessing regime over time.
35
11.0 Use of surgical instruments and
associated equipment
37
Appendix 1 – Processing of flexible
endoscopes
Flexible endoscope accessories should Detailed guidelines for the cleaning and
be processed in accordance with high-level disinfection of endoscopy
manufacturer’s instructions and identified equipment can be found in MDA DB
so as to allow tracking/tracing through 2002 (05).
the decontamination process of the
It is vital that the outer covering of the
flexible endoscope and the patient on
endoscope be tested before use for the
whom it is used.
safety of patient and staff. This is known
An automated endoscope reprocessor as “leak testing” (see MDA DB 2002
with an integrated cleaning and drying (05)).
39
Appendix 2 – References
41
MDA DB 2002 (05): Decontamination of INFECTION CONTROL/RISK
endoscopes, Medical Devices Agency, MANAGEMENT
2002.
Advisory Committee on Dangerous
Protocol for the local decontamination of Pathogens Spongiform Encephalopathy
surgical instruments, NHS Estates, Advisory Committee (SEAC):
HMSO, 2001. Transmissible spongiform
encephalopathy agents: safe working
Sterilization, disinfection and cleaning of and the prevention of infection,
medical equipment: guidance on Department of Health, 2001.
decontamination from the Microbiology
Advisory Committee to the Department of Controls Assurance Standard: Infection
Health Medical Devices Agency (MDA) Control, Rev(03), Department of Health,
1996, 1999, 2000, 2002, ISBN1 85839 2002.
518 6 (MAC Manual), Medical Devices
Agency, 1993-2002. Controls Assurance Standard: Medical
Devices Management, Rev(03),
DECONTAMINATION PROCESSING Department of Health, 2002.
AND EQUIPMENT
Controls Assurance Standard:
C30 – Model Engineering Specification Decontamination of reusable medical
for Washer-disinfectors for surgical devices, Rev(02), Department of Health,
instruments, NHS Estates, The Stationery 2002.
Office, 2001.
HSC 1999/053: Preservation, retention
HTM 2010: Sterilization, NHS Estates, and destruction of records. Department
HMSO, 1994-1997. of Health, 1999.
42
NHS Estates –
http://www.decontamination.nhsestates.
gov.uk
43
Appendix 3 – Glossary
Aerosol Decontamination
Dispersion of solid or liquid particles in a A process which removes or destroys
gas. contamination and thereby prevents
infectious agents or other contaminants
Automatic control test reaching a susceptible site in sufficient
A test designed to show that the quantities to initiate infection or any other
operating cycle – as evidenced by the harmful response. Differing levels of
values of the cycle variables indicated decontamination are available. They are:
and recorded by the instruments fitted to cleaning followed by high level
the sterilizer – functions correctly. disinfection; or cleaning followed by
sterilization, depending on the procedure
Benchtop sterilizer
and chemicals used.
Apparatus designed to achieve
sterilization, which requires no permanent Disinfection
connections or installation. A process used to reduce the number of
viable micro-organisms in a load but
Bio-burden
which may not necessarily inactivate
The population of viable infectious agents
some viruses and bacterial spores.
contaminating a medical device.
Disinfector
Bowie–Dick test
An apparatus designed to achieve
Test designed to indicate that the
disinfection.
sterilizer is capable of removing air and
non-condensable gases from a load. Fault
The recognition by the automatic
Central decontamination
controller that the pre-set cycle variables
When reprocessing occurs in a central
for the operating cycle have not been
decontamination unit, for example a
attained, and that sterilization or
sterile services department (SSD).
disinfection has been jeopardised.
Chemical indicator
Holding time
A device designed to show, usually by a
The period during which the temperature
change of colour, whether specified
in all parts of the chamber, load and any
values of one or more cycle variables
coolant fluid is held within the sterilization
have been attained.
temperature band. It follows immediately
Clinical area/setting after the equilibration time.
Any medical and surgical ward,
department or patient treatment area.
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Load Periodic tests
Collectively, all the goods, equipment and A series of tests carried out at specified
materials that are put into a sterilizer or intervals, for example daily, weekly,
disinfector at any one time for the monthly, quarterly or annually.
purpose of processing it by an operating
cycle. Porous-load sterilizer
A clinical sterilizer designed to process,
Load items by exposure to high-temperature steam
One of several discrete containers, packs under pressure, porous items such as
or other items that together constitute a towels, gowns and dressings, and also
load. medical devices that are wrapped in
porous materials such as paper or
Local decontamination fabrics.
When instruments are reprocessed within
the department where they are used. Potable water
Water of suitable quality for drinking,
Medical device cooking or food production.
Any instrument, apparatus, appliance,
material or other article, whether used Reusable device
alone or in combination, including the A medical device which can be
software necessary for its proper reprocessed for repeated episodes of
application intended by the manufacturer, use.
to be used for human beings for the
purpose of: diagnosis, prevention, Single use
monitoring, treatment or alleviation of A medical device that is intended to be
disease; diagnosis, monitoring, used on an individual patient during a
treatment, alleviation of or compensation single procedure and then discarded. It is
for an injury or handicap; investigation, not intended to be reprocessed and used
replacement or modification of the on another patient.
anatomy or of a physiological process;
Sterile
and control of conception: and which
Condition of a load item that is free from
does not achieve its principal intended
viable micro-organisms. BS EN 556-
action in or on the human body by
1:2001 details the requirements for a
pharmacological, immunological or
medical device to be designated as
metabolic means, but which may be
sterile.
assisted in its function by such means
(source: EU Council Directive Sterilization cycle
93/42/EEC). Automatic sequence of operating stages
performed in a sterilizer for the purpose
Operating cycle
of sterilization.
The set of stages of the sterilization or
disinfection process carried out in Sterilization process
sequence and regulated by the automatic The complete set of procedures required
controller. It is synonymous with the for sterilization of a load, including the
terms sterilization cycle for sterilizers and operating cycle and any treatment of the
disinfection cycle for disinfectors. load before or after the operating cycle.
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Sterilization temperature Type S (sterilization cycle)
Minimum temperature of the sterilization Designed to process air-retentive loads
temperature band. e.g. tubular devices, as specified by the
sterilizer manufacturer.
Sterilization temperature bands
The range of temperatures that may Validation
prevail throughout the load during the A documented procedure for obtaining,
holding time. These temperatures are recording and interpreting data required
expressed as a minimum acceptable (the to show that a sterilization process would
sterilization temperature) and a maximum consistently comply with predetermined
allowable, and are stated to the nearest specifications.
degree Celsius.
Washer-disinfector
Sterilizer Automated machine intended to clean
An apparatus designed to achieve and disinfect medical devices. Also
sterilization. known as an automated endoscope
reprocessor when dedicated to
Type B (sterilization cycle) endoscope decontamination.
Intended to process porous loads e.g.
wrapped instruments and fabrics.
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Acknowledgements
Our thanks to the following people for their contribution to the writing of this guide:
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