Benchtop Steam
Sterilizers –
Guidance on
Purchase,
Operation and
Maintenance

BULLETIN

MDA DB2002(06)
October 2002

The Medical Devices Agency helps safeguard public health by working with users, manufacturers and
lawmakers to ensure that medical devices meet appropriate standards of safety, quality and performance
and that they comply with the relevant Directives of the European Union.

Our primary responsibility is to ensure that medical devices achieve their fullest potential to help
healthcare professionals give patients and other users the high standard of care they have a right to
expect.

The Medical Devices Agency is an Executive Agency of the Department of Health

CONTENTS
1. EXECUTIVE SUMMARY ................................................................... 3

2. INTRODUCTION ................................................................................. 4
2.1 Classification of benchtop steam sterilizers ......................................... 6

3. PURCHASING...................................................................................... 8
3.1 Service and maintenance.................................................................... 10

4. OPERATION....................................................................................... 11
4.1 Installation, validation and periodic testing ....................................... 11
4.2 Use of sterilizers................................................................................. 11
4.3 Training.............................................................................................. 11
4.4 Records............................................................................................... 12
4.5 Storage of devices after sterilization .................................................. 13
4.6 Health and safety................................................................................ 14
4.6.1 Hazards...................................................................................... 15
4.6.2 The circumvention of sterilizer safety features ......................... 15
4.6.3 Legal and insurance considerations........................................... 15

5. MAINTENANCE, PERIODIC TESTING, ROUTINE

MONITORING AND DOCUMENTATION ..................................... 17
5.1 Introduction........................................................................................ 17
5.2 Maintenance ....................................................................................... 17
5.3 Periodic testing................................................................................... 17
5.3.1 User daily tests........................................................................... 18
5.3.2 Weekly safety checks ................................................................ 19
5.3.3 Weekly tests .............................................................................. 19
5.3.4 Quarterly and annual checks and tests ...................................... 20
5.4 Use of chemical and biological indicators ......................................... 20
5.4.1 Chemical indicators................................................................... 20
5.4.2 Biological indicators ................................................................. 20
5.5 Procedure on failure of a test ............................................................. 21
5.6 Monitoring and documentation .......................................................... 21

6. MAINTENANCE OF RESERVOIRS AND STERILIZER

CHAMBERS ....................................................................................... 23
6.1 Introduction........................................................................................ 23
6.2 Sources of contamination................................................................... 23
6.3 Cleaning ............................................................................................. 24
6.4 Water quality ...................................................................................... 24
6.5 Suggested maintenance ...................................................................... 24

7. GLOSSARY ........................................................................................ 26

8. REFERENCES .................................................................................... 28

1
Appendix 1 Factors to consider in choosing between benchtop
sterilizers, single-use devices or SSD ................................................. 31
Flow chart for decision making.................................................................... 32

Appendix 2 Ten good-practice points for the use of benchtop steam

sterilizers ............................................................................................. 33

Appendix 3 Examples of logbook pages ...................................................... 34

Appendix 3(i) Summary details.................................................................... 34

Appendix 3(ii) Daily test sheet..................................................................... 35

Appendix 3(iii) Weekly test sheet ................................................................ 36

Appendix 3(iv) Autoclave history record sheet............................................ 37

Appendix 3(v) Production log sheet- benchtop autoclave............................ 38

Appendix 4 User tests for benchtop steam sterilizers................................... 39

Appendix 5 Regulation of transportable steam sterilizers............................ 43

Appendix 6 Sources of further information.................................................. 45

List of tables

Table 1 Sterilization temperature bands, holding times and pressures

for steam sterilization. ....................................................................... 5

Table 2 Types of sterilization cycle................................................................ 6

Table 3 Summary of user daily tests ............................................................ 18

Table 4 Summary of weekly tests ................................................................ 19

2
 1. EXECUTIVE SUMMARY
This Bulletin provides guidance on the purchase, operation and maintenance of
all types of benchtop steam sterilizers. It is a revised compilation of the
guidance previously issued in DB9605 and DB2000(05).

Who this document This guidance is intended for potential purchasers, and all current owners
is for and users of benchtop steam sterilizers and should be of particular interest
to:

• chiropodists and podiatrists;

• community healthcare workers;
• consultants in communicable disease control;
• consultant microbiologists;
• day surgery unit staff;
• dental nurses;
• dental practice managers;
• dental practitioners;
• environmental health officers;
• general practice managers;
• general practice nurses;
• general practitioners;
• infection control teams;
• operating theatre staff;
• outpatients departments;
• primary care trusts (PCTs);
• risk managers.

3
2. INTRODUCTION
Minor surgical procedures are increasingly being performed in primary
healthcare facilities. There are a number of choices for obtaining the
sterilized devices for these procedures:

• use single-use equipment;

• have your reusable devices reprocessed by a SSD; or
• reprocess them yourself.

Never reuse medical devices designated for single-use

Note: The term ‘devices’ is used throughout this bulletin to encompass devices,
instruments and medical equipment.

If you choose to use reusable devices, whenever practicable you should obtain
them from a Sterile Services Department (SSD). These have the equipment and
expertise to clean and sterilize reusable medical devices effectively and
consistently, combined with economy of scale.

In the absence of a central sterilizing service, a benchtop steam sterilizer

may be used. However, it must be suitable for the intended loads, and it must
be validated, maintained and operated properly. Benchtop steam sterilizers
contribute to the prevention of cross infection, especially in primary
healthcare, but also in non-medical practices such as tattooing, body piercing
and beauty treatments. Benchtop steam sterilizers do not require permanent
connections to mains services.

Steam sterilization is the most practicable method for sterilizing reusable

medical devices in healthcare premises because it has high lethality, it is rapid
and it is non-toxic. The standard temperature/pressure/time relationships for
steam sterilization are shown in Table 1. We recommend that you use the
highest temperature compatible with the load items.

4
Table 1 Sterilization temperature bands, holding times and pressures for
steam sterilization.

Sterilizing temperature
range (oC) Approximate Minimum hold
pressure (bar) time (minutes)
Minimum Maximum

134 137 2.25 3

126 129 1.50 10

121 124 1.15 15

The effectiveness of the process depends upon direct contact between the
steam and all surfaces of the load. Therefore all items that you intend to
sterilize must be clean and dry before you place them in the sterilizer
chamber. Contamination with residual tissue, body fluids, oil or other
deposits:

• will prevent contact between the steam and the surfaces of the load;
• might become fixed to the load items and be difficult to subsequently
remove;
• might also contaminate the water and encourage bacterial growth.

Cleaning may be done manually or mechanically but we recommend

mechanical cleaning wherever possible, as it is more consistent than manual
cleaning and can be validated. Manual cleaning can also carry a risk of
generating infectious aerosols unless the process is carried out carefully.

The MDA's publication ‘Sterilization, disinfection and cleaning of medical

equipment: guidance on decontamination from the Microbiology Advisory
Committee to Department of Health Medical Devices Agency’ provides details
of decontamination methods and procedures.

Air retained within the chamber and load can also prevent steam contact.
Consequently it is important that the operator should load the sterilizer
according to the manufacturer’s instructions and take care not to overload it,
otherwise air removal might be impaired and sterilizing conditions might not
be attained.

‘…all parts of the load to be sterilized must be free of air, so that it may
be permeated by the steam.’
Sterilisation by steam under increased pressure.
The Lancet 28 February 1959.

5
2.1 Classification of A European standard for benchtop steam sterilizers is currently being
benchtop steam prepared*. It classifies benchtop steam sterilizer cycles according to the types
sterilizers of load they are intended to process, which are summarised in Table 2:

Table 2 Types of sterilization cycle

Cycle type Air removal Load type Advantages Disadvantages

Not to be used for:

Simplest type. Least
Passive (gravity Non-wrapped solid y hollow devices or
expensive to
N displacement). items. those with lumens;
purchase, operate
and maintain.
y wrapped loads (e.g.
items in pouches).
Wrapped or non-
wrapped solid items
Expensive to purchase
(e.g. forceps, dental
and maintain.
probes).
Additional periodic
Active (forced) Wrapped or non-
testing required.
air removal. wrapped hollow items
Widest range of
B (e.g. cannulae within
applications. Post-sterilization drying
dimensions specified
stage essential for
by sterilizer
wrapped items increases
manufacturer).
total cycle times.
Porous loads (e.g.
fabrics, swabs,
dressings).
Expensive to purchase
and maintain.

Only suitable for types Additional periodic

Active (forced) Wider range of
of loads specified by testing required.
S air removal. applications than
the sterilizer
Type N.
manufacturer. Post-sterilization drying
stage essential for
wrapped items increases
total cycle times.

Note: Ideally, only the highest specification cycle should be available to the
operator. Other cycles should be disabled, until specifically needed.

*
‘Small steam sterilizers’ prEN13060 : 2002 (E)

6
Traditional (gravity displacement) benchtop steam sterilizers displace air
passively from the chamber and load by steam generated within the sterilizer
chamber or in a separate boiler within the sterilizer’s casing. This is known as a
‘Type N’ cycle.

Vacuum benchtop sterilizers have a pump or some other active method to

remove air from the chamber and load. This type of air removal is found in
‘Type B’ cycles and some ‘Type S’ cycles.
They are described variously as vacuum benchtop sterilizers, benchtop
porous load sterilizers, Type B sterilizers, or sometimes Type S sterilizers.

Note: Type S sterilizers should be used to process only the types of loads
specified by the sterilizer manufacturer.

Vacuum benchtop steam sterilizers have:

• a forced air removal stage prior to the sterilizing stage;
• a post-sterilization drying stage.

Alternative air removal systems. Some sterilizers remove air by using a

succession of steam pulses, in which the chamber is alternately pressurised
and then depressurised to near atmospheric pressure (or to below
atmospheric pressure where this process is augmented by a vacuum pump).
Air can also be removed from tubular devices by injecting steam through the
lumens.

Type N cycles are intended to be used to sterilize solid devices that are not
wrapped. Devices that are wrapped (the term ‘wrapped’ includes sterilization
pouches) and devices that are hollow or have lumens cannot be sterilized in this
type of sterilizer. These types of loads should ideally be sterilized in a SSD but
alternatively may be sterilized in a properly functioning vacuum steam
sterilizer that has been validated for the intended load (see section 4.1).

Type B cycles are intended for wrapped solid items (e.g. forceps, dental
probes), hollow items (e.g. cannulae, tubing), whether or not they are
wrapped, and for porous loads e.g. fabrics, swabs and dressings. They are
necessary for items that cannot be processed using a Type N cycle (or a
Type S cycle, unless it is intended specifically for these load types). Type B
cycles must have a drying stage to ensure that the load is dry before the door
is opened, which can increase the total cycle time considerably.

Type S cycles are intended for types of loads specified by the manufacturer
of the sterilizer. They have a forced air removal system. (Forced air removal
can be achieved using a vacuum pump, or superatmospheric pulsing or
steam injection through the lumens of devices).

The effectiveness of the air removal stage determines the types of load they
are designed to process. Some models have a drying stage, which will
prolong the cycle time.

7
3. PURCHASING
Before purchasing a benchtop steam sterilizer, you should consider the
numerous factors involved in obtaining sterilized medical devices. These are
summarised in Appendix 1.

Benchtop sterilizers are regulated as medical devices and must comply with
the Medical Devices Regulations 2002, which require all medical devices to
carry the CE marking. Therefore, the CE marking does not help in choosing
between makes and models.

Buyer beware

y The manufacturer should state clearly the types of load for which the
sterilizer is suitable.

y You should only use the type of sterilizer that is suitable for the types of
loads that you intend to process.

y Some sterilizers have more than one type of cycle. Ensure you use the
correct cycle for the load.

y The presence of a vacuum stage does not guarantee that the sterilizer
is capable of processing every type of load.

When seeking quotations from prospective suppliers you should specify

clearly the type of load that you intend to reprocess. Important factors will
be:
• quantities of instruments you are likely to reprocess per load and per
day;
• whether the loads are solid (e.g. forceps, dental probes);
• if you want to process hollow items (e.g. cannulated devices, dental
handpieces), what the limitations are for their length and diameter;
• whether you intend to process porous loads;
• the types and numbers of layers of wrapping that you expect to use;
• whether you wish to store sterile devices in packs or wrapping for future
use.

This will form part of the purchasing contract and places the onus on the
supplier to provide equipment that is fit for the purpose that you have
specified. The supplier will also be under an obligation to draw your
attention to any limitations to the use of the sterilizer. The contract should
also specify who has the responsibility for installing the sterilizer and
performing installation checks and tests to ensure that the sterilizer will
perform to its design specification. These tests are likely to require
specialist knowledge and equipment.

8
 Many sterilizers are bought on verbal assurances of their suitability but
are later found to be unsuitable for the intended purpose. You should ask
for the assurances in writing to reduce the possibility of
misunderstandings.

The purchasing decision should be made in conjunction with a person with

the necessary purchasing authority (e.g. the purchasing manager). The
decision will also benefit from inputs from:

• your local infection control advisor;

• the estates and medical engineering departments (or anyone else who is
likely to maintain, service and test the equipment);
• an Authorised Person (sterilizers) (AP);
• any other users who can provide personal experience of the equipment.

It is also important to try to involve everyone who might use the sterilizer. If
possible obtain one for a trial period before committing yourself to purchase
as this will help you to assess other important aspects e.g.:

• whether the instructions for use are intelligible to the operator;

• the routine maintenance;
• the running costs;
• ease of use;
• cycle time.

Later difficulties will be minimised if you consult fully at the

purchasing stage.

You might be offered the option of a printer, installed on the machine. It is

not a requirement to have a recorder fitted, or attached, to the sterilizer but it
is desirable because it makes testing easier and provides permanent records
(see sections 4.4 and 5.6).

9
3.1 Service and Efficient and effective service support is vital and should be an important factor
maintenance in your purchasing decision.

Ask the supplier if:

• they can provide a service contract;
• they provide periodic testing;
• they can provide evidence that the test person is qualified;
• they have the necessary calibrated test equipment;
• spares are readily available;
• they place restrictions on the provision of spares;
• they give a guaranteed response time in the event of the sterilizer
malfunctioning and what the costs are;
• they will provide a loan machine if repairs cannot be made on site.

If the supplier is unable to provide any of the above, ask if they have a
servicing agent, or if there is an organisation they can recommend.

Vacuum benchtop steam sterilizers are much more complicated than their
traditional counterparts and, in general, complicated devices tend to break
down more frequently, and cost more to repair.

Ideally all repairs and servicing activities should be covered by a recognised

quality system. Section 5 provides more information on maintenance and
testing of benchtop steam sterilizers, and general information is provided in
MDA’s Device Bulletin DB9801. Guidance on the use of third party repair
and maintenance organisations has been published in another MDA Device
Bulletin, DB2000(02).

If considering purchasing a used steam sterilizer, please refer to MDA

DB9801 (Supplement 2) Guidance on the Sale, Transfer of Ownership and
Disposal of Used Medical Devices.

10
 4. OPERATION

4.1 Installation, After you have bought your sterilizer it has to be:
validation and
periodic testing (i) Installed and then validated.
A new sterilizer has to be installed, commissioned and validated before you
use it. You should retain all records of these activities in the sterilizer
logbook for future reference (see section 4.4). An AP will be able to provide
advice about the validation of a new sterilizer and a qualified Test Person
(sterilizers) (TP) should carry out the validation tests.

(ii) Used according to the manufacturer’s instructions.

You should use your sterilizer only to process the types of loads that the
manufacturer specifies and you should keep the weight of the load within the
limit specified by the sterilizer manufacturer. If you process other types of
loads, or exceed the weight limit, the devices might not be sterilized (see
section 2.1 for further information about the types of sterilizer and their correct
application).

(iii) Maintained and tested periodically.

See section 5.

Because sterilizers perform a crucial role in prevention of cross infection,

a new machine should never be used ‘straight from the box’. Although
the manufacturer should have tested it to ensure that it was working
before it left the factory, that does not guarantee that it will function
correctly when it is delivered. It must be tested before you use it to
ensure that it is working correctly.

4.2 Use of sterilizers Before any loads are processed you should ensure that all the relevant checks
and tests are performed to provide assurance that the sterilizer is safe to use,
that it is functioning correctly and that it will sterilize loads consistently. Check
that there is water in the reservoir before you attempt to operate the
sterilizer. (You will find information about the appropriate water quality in
section 6).

It is a requirement of the Provision and Use of Work Equipment Regulations

4.3 Training 1998 that everyone who operates, supervises or manages work equipment
must be trained adequately.

Effective cleaning of devices prior to disinfection or sterilization is of the

utmost importance in reducing the risk of transmission of infectious agents
(NHS Executive HSC 1999/179). If they are not clean they cannot be
sterilized. It is therefore essential to train operators in the correct techniques.

11
 Well-trained staff using well-maintained equipment minimises risks both to
themselves and to the patient; failure to sterilize a device has implications
for both. Litigation involving cross infection is particularly difficult to
defend and in the event of an adverse incident, discovery of failures in
training or maintenance may lead to a finding of liability by the courts, and
charges of professional misconduct.

Vacuum benchtop sterilizers are complicated pieces of equipment and

operators who are familiar with other types of steam sterilizer are not
necessarily trained to operate vacuum benchtop steam sterilizers unless
they have received specific training in the use of this equipment.

You should keep a permanent record for each sterilizer, to provide evidence
4.4 Records
that it was/is functioning correctly and achieving sterilizing conditions
consistently.

This permanent record can take any convenient form e.g. a book, a loose-leaf
folder, or an electronic device (provided that it will give a printout on
demand). Appendix 2 gives examples of logbooks.

It should be kept close to the sterilizer so that records can easily be kept up
to date. It should provide a complete history of the sterilizer and should
include:

• records of commissioning and validation tests and checks;

• routine monitoring of every sterilization cycle (see section 5.6);
• if the cycle failed, the actions taken to correct the problem – and what
you did with the unsatisfactory load;
• results of all periodic testing (daily and weekly tests performed by the
operator, and the quarterly and annual tests performed by the TP);
• records for every item of maintenance, repair, or any modifications;
• the written scheme of examination under the Pressure Systems Safety
Regulations 2000 (PSSR) (see section 4.6.3);
• records of the inspection under the scheme of examination;
• certificate of insurance for the pressure system;
• records of training of the operator.

The NHS Executive publication HSC 1999/053 provides guidance on the

time for which records should be retained.

The logbook is an important document that provides the maintenance and

performance history of the sterilizer and could provide useful evidence in
the event of an adverse incident.

12
4.5 Storage of devices After the end of the sterilizing stage, the steam condenses in the sterilizer
after sterilization chamber, so the load will be wet unless there is a subsequent effective drying
stage whilst in the sterilizer.

Non-wrapped wet devices

Devices that have been sterilized, non-wrapped, in either a traditional or a
vacuum sterilizer, may be used wet, directly from the sterilizer (the water will
be sterilized). These devices will not be sterile at the point of use unless they
are removed from the sterilizer, kept, and used, in a controlled atmosphere
such as in a hospital operating theatre.

Controlled atmospheres are seldom found in primary care. The sterilized load
items will be contaminated immediately the sterilizer door is opened. The
devices cannot therefore be regarded as being sterile but will be in the same
condition as the atmosphere in the treatment area.

Devices processed in a traditional benchtop steam sterilizer should be

processed non-wrapped and ideally used directly from the sterilizer.

Non-wrapped dried devices

If you wish to store sterilized devices for later non-sterile use:
• they must be dried thoroughly in the sterilizer, before opening the door;
• they can then be stored in a clean, disinfected, dry, airtight container.

The microbiological condition of these devices should differ little from those of
non-wrapped devices that are used direct from the sterilizer.

Micro-organisms are carried on dust particles and thrive in wet or damp

conditions. They cannot propagate in dry conditions.

Sterile use
If you wish to store sterilized devices for future use in sterile conditions you
must:
• process them in suitable wrapping material, in a suitable sterilizer that has
an effective post-sterilization drying cycle;
• ensure that the packaging material is thoroughly dried before the sterilizer
door is opened.

Micro-organisms can penetrate through packaging that is wet or has any

damp patches and may re-contaminate the load from the moment the
sterilizer door is opened. Subsequently drying the packages (e.g. on a
radiator) is inappropriate.

13
 Items within packaging can only be regarded as sterile if they have been
subjected to a validated sterilization process and they are dry when they
are removed from the sterilizer. Loads packaged after sterilization, for
later use, cannot be considered sterile.

Some users of traditional benchtop sterilizers process non-wrapped devices,

then wrap them (e.g. in a pouch) and repeat the process, presuming that the
wrapped devices will then be sterile. This procedure is time-consuming and
is unlikely to offer any improvement over sterilization of non-wrapped
devices, drying them in the sterilizer and then keeping them clean (as
described above).

Storage time
There is no specified shelf life for sterilized items. Products will remain
sterile indefinitely provided the packaging remains intact, clean and dry.
However, you should be aware that some devices and/or packaging might
deteriorate over time. You should therefore:
y set a shelf life by consultation with the manufacturers of the device and
wrapping;
y have an effective stock management system to ensure sterile items are
either used within that shelf life, or are re-sterilized.

Packages must be inspected for damage before they are opened. If there is
any sign of damage to the packaging, the contents must be re-sterilized
before they are used.

4.6 Health and safety Users will go some way towards meeting their obligations under the Consumer
Protection Act and Health and Safety at Work etc Act by ensuring that
equipment:

• complies with safety requirements;

• is installed and maintained appropriately;
• is validated and routinely tested;
• is operated by properly trained operators.
• is operated in accordance with the manufacturer's instructions.

Users should also ensure that there is a written scheme of examination for
the pressure system under the PSSR. The pressure system must be examined
periodically in accordance with this scheme.

14
4.6.1 Hazards
Some common hazards associated with benchtop steam sterilizers are:

• Burns from steam or hot instruments.

• Hot pressurised steam in the chamber.
• Contamination of the sterilizer load with endotoxin (see section 6).
• Infection resulting from inadequate processing.

4.6.2 The circumvention of sterilizer safety features

On no account should any safety feature be interfered with,

circumvented or overridden.

Benchtop steam sterilizers are equipped with a number of safety features

designed to protect the operator and anyone else in their vicinity from
hazards, should any part of the sterilizer fail. You should have these safety
devices inspected and tested in accordance with the manufacturer's
instructions, which should be incorporated into the sterilizer's planned
programme of maintenance to satisfy the PSSR.

To prevent serious injury to the operator and others, the sterilizer door must
prevent access to the chamber while it is under pressure.
y You should not be able to open the door until the ‘cycle complete’ signal
is indicated and there is no residual pressure in the chamber.
y If the chamber pressure is indicated electronically, there should also be a
mechanical indication in case the electronics or power fails.
y Opening the sterilizer door when a fault message has been cancelled
may result in hot water being spilt and possible injury to the operator.

Anyone who becomes aware of any malfunction or faulty equipment should

report it immediately and all necessary remedial action should be taken
before the sterilizer is operated.

Sterilizers that are not maintained correctly and are not tested periodically
can be dangerous. The force on a benchtop sterilizer door can be about ¾
tonne.

4.6.3 Legal and insurance considerations

Everyone who uses the sterilizer, or the equipment processed in it, should be
aware of the legal implications if infection occurs due to failure of the
sterilizing process (Gifford 1998, Leigh 1998). Users should have third party
liability insurance to cover the particular risks associated with pressurised
equipment and steam. General insurance almost certainly will not cover
these risks and medical practice insurance might not cover sterilizers unless
they are mentioned specifically.

15
 Pressurised steam is hazardous. Sterilizers should be insured to cover the
particular risks associated with steam sterilizers. Some insurers specialise
in this type of risk and might be the most economical choice.

The PSSR covers the installation and use of this type of equipment and
amongst other things require:

• a ‘written scheme of examination’ for the pressure system to be drawn

up by a Competent Person (pressure vessels) (CP) and
• periodic examination of the pressure system by a CP in accordance with
the written scheme.

The insurer, the sterilizer manufacturer or an independent inspection

organisation should be able to provide a suitable written scheme of
examination. They might also have a CP who can carry out the inspection.
Before the insurer will accept the insurance risk, they might insist that their
own CP inspect the pressure system. This inspection might also satisfy the
requirement for periodic examination under the PSSR.

An operator or owner acting negligently in circumventing safety features

might:
• put themselves and others at risk of injury (or even death);
• incur legal liability for injury or damage to people and property;
• be committing a criminal offence.

Their actions might also invalidate insurance cover taken out to indemnify
users and their employers against legal liability.

Relevant safety legislation imposes obligations for the safe operation of

pressure systems. Sterilizer door locks and their operating mechanism,
hinges and door seals all form part of the pressure containment system.
Failure to ensure the safety of a pressure system can be a criminal
offence.

16
 5. MAINTENANCE, PERIODIC TESTING, ROUTINE
MONITORING AND DOCUMENTATION
Maintenance, periodic testing, routine monitoring and documentation are an
5.1 Introduction
essential combination to ensure that a sterilizer is functioning correctly and
that it will produce sterilized loads consistently. This is because the
effectiveness of the sterilization process cannot be verified retrospectively by
inspection or testing of the product, and can only be guaranteed if sterilizing
conditions are created throughout the sterilizer chamber and the load during
every cycle. Guidance on these activities is provided in HTM2010 (NHS
Estates) and DB9804 (MDA 1998).

5.2 Maintenance A Test Person (TP) should draw up a schedule for periodic testing. It is the
responsibility of the TP and the owner or user to ensure that these tests are
performed.

You should carry out the manufacturer’s recommended routine maintenance

tasks at the intervals specified in the user instructions or manual. Appropriate
maintenance and safety checks are necessary to ensure that the sterilizer will
sterilize consistently and safely. The integrity of the pressure system must be
checked periodically to ensure it conforms to the PSSR.

Poor maintenance has been a major factor in incidents in which sterilizer

doors have opened while the chamber is under pressure, or where failure of
the door seal has caused rapid discharge of steam. You should pay particular
attention, therefore, to door locking mechanisms, which should be tested and
inspected for wear as part of the weekly testing procedure. Door seals should
be inspected weekly and replaced if they leak or show signs of deterioration.

The recommended safety features are described in HSE Guidance Note PM

73 ‘Safety at Autoclaves' (Health and Safety Executive 1998).

5.3 Periodic testing Periodic testing consists of a programme of tests that are intended to
demonstrate that the sterilizer’s performance is satisfactory. The tests are
carried out at daily, weekly, quarterly and yearly intervals, with the user and the
TP sharing the responsibility for performing them. These tests are preceded by
safety checks which are intended to ensure the sterilizer is both safe to use and
to test.

If the sterilizer fails any safety check you should not attempt to test it until
the faults have been corrected and the sterilizer passes all safety checks.

y The user does the daily tests. After suitable training and with the agreement
of the Authorised Person (AP) the user may also do the weekly tests.
y Some of the weekly tests for vacuum benchtop steam sterilizers normally
require the services of a TP and use of specialised equipment, and therefore
cannot be performed by the user. However, some manufacturers have
designed an automated test facility into the sterilizer so that the sterilizer
can perform some of the specialised tests itself.

17
 y The quarterly and annual tests require specialised equipment and skills, and
should be carried out only by a properly qualified TP. Each cycle available
to the user should be tested.

If the sterilizer is not tested periodically you will not know if it is working
correctly.

5.3.1 User daily tests

Table 3 Summary of user daily tests

Type N Type B & S Appendix 4 DB 9804

Daily test
(Traditional) (Vacuum) reference reference

(i) Steam penetration 9 1.2 A.1

(ii) Automatic control 9 9 1.1 A.2

(i) The steam penetration test is intended to show that steam will penetrate
rapidly and evenly into a test device that is at least as difficult to sterilize as
the intended load. The test device contains an indicator that responds
(usually it changes colour – and should do so completely) only when steam
penetration is adequate. It is essential to use both the steam penetration test
device and the indicator specified by the sterilizer manufacturer, otherwise
the test results may be dangerously misleading (see section 5.4). The test
piece and the indicator should be as specified in BS EN867, or an alternative
provided that it is equivalent.

If a cycle is provided specifically to test the effectiveness of steam

penetration, it must have the same air removal stage as used during
routine sterilization cycles.

If you do not use the test device and indicator combination specified by
the sterilizer manufacturer, the results might be dangerously misleading.

(ii) The automatic control test may be done at the same time as the steam
penetration test, but is not required if the sterilizer is equipped with a
recorder that provides a permanent record of the temperature, pressure and
elapsed time during all sterilizing cycles. However, it is essential to compare
the printed record of every cycle with one obtained when the sterilizer was
known to be functioning correctly (e.g. during the periodic testing performed
by the TP).

18
 You should check with the manufacturer whether you have to pre-heat the
sterilizer chamber before performing these tests, as this can extend the test
time.

5.3.2 Weekly safety checks

The user should perform the following safety checks before starting the
sequence of weekly tests:

y examine the door seal for signs of deterioration or leaks;

y check the security and performance of door safety devices.

WARNING do not attempt to open the door while the chamber is

pressurised.

Any defects must be corrected before attempting to perform the weekly

tests or before using the sterilizer.

5.3.3 Weekly tests

These tests should be performed after successful completion of the weekly
safety checks. They should be performed by the TP but the user may perform
them with the agreement of the AP.

Table 4 Summary of weekly tests

Appendix
Type N Type B & S DB9804
Weekly test 4
(Traditional) (Vacuum) reference
reference
a) Air leakage test (automatic) 9 2.2.1 A.3.1
b) Automatic air detection 9 2.3 
system function test
c)* Automatic control test 9 9 1.1 A.2
d)* Steam penetration test 9 1.2 A.1

 Test method specified by the manufacturer.

* These tests may be done at the same time.

The air leakage test is intended to check that air will not leak into the sterilizer
during periods of vacuum, at a rate that is greater than that specified by the
sterilizer manufacturer. Air leaking into the chamber can:

• impair steam penetration into the load and prevent sterilization;

• recontaminate the damp load during the drying phase.

19
 5.3.4 Quarterly and annual checks and tests
These require specialised test equipment and only a person (e.g. a TP) who has
the necessary training, experience, skills and equipment should perform them.
Guidance on quarterly and annual testing should be sought from an AP.

5.4 Use of chemical and If the sterilizer’s controller indicates a failed operating cycle, the cycle must be
biological indicators regarded as unsatisfactory, regardless of the results obtained from any chemical
or biological indicators. Chemical and biological indicators do not indicate
that the load is sterile.

5.4.1 Chemical indicators

If you use chemical indicators, they should meet the requirements of relevant
standards (e.g. BS EN 867, ISO 11140) and they should be used only for the
process specified by the manufacturer. If you wish to use an indicator you
should select the correct one and follow the indicator manufacturer's
recommended instructions precisely – both for use and storage. The use of an
inappropriate indicator may give dangerously misleading results;
indicator performance can be adversely affected by the storage conditions
before use, the methods of use, and storage conditions after use. Indicators
should not be used beyond the expiry date stated by the manufacturer.

Three types of chemical indicator are commonly used in steam sterilizers:

• process indicators e.g. autoclave tape and indicators printed onto bags and
pouches. These indicators serve only to distinguish processed items from
unprocessed items, and should not be used for any other purpose;
• performance indicators for specific tests e.g. the indicators used to check
the effectiveness of steam penetration into a test pack or a process
challenge device;
• integrating indicators (emulating integrators) are available for
monitoring steam sterilizers. They are designed to monitor the
attainment of two or more critical variables in the sterilization process,
either by a graduated response or a defined end point reaction.

Integrating indicators do not indicate sterility of the product.

5.4.2 Biological indicators

Biological indicators must meet the requirements of the standard BS EN 866
(BSI 1997). They are of limited value in steam sterilization and are restricted to
a few special applications in process validation. In those applications they
should always be regarded as additional to the measurement of temperature,
pressure and time.

Biological indicators should not be used for periodic testing of steam

sterilizers or for the routine monitoring of the process.

20
5.5 Procedure on failure A failure of a test implies that the sterilizer is not working to specification. The
of a test user should have a written procedure for handling test failures but, in all cases,
the sterilizer must be withdrawn from service, the failure investigated, the cause
rectified, and the sterilizer re-tested successfully before being used.

Note: The user has the ultimate responsibility for certifying that the
sterilizer is fit for use.

5.6 Monitoring and Records of maintenance, testing and operating cycles provide evidence that the
documentation process will deliver sterile product consistently. HTM2010: Part 4 (NHS
Estates 1997) provides guidance on the testing documentation that should be
kept. Records of checks, tests and maintenance performed on the sterilizer’s
chamber must be documented and kept securely as specified in the PSSR (see
section 4.6.3 and Appendix 5).

Routine monitoring
For each production cycle you should:

• note whether the sterilizer’s controller indicated a passed or failed cycle;

• examine printouts from the sterilizer’s recorder to ensure that they are
within the prescribed limits;
• note the actions you took if a failed cycle was indicated;
• note any fault or malfunction of the sterilizer;
• keep records of every cycle.

Routine monitoring of the process, in addition to periodic testing, is

essential to provide assurance that sterilized loads are consistently being
produced.

Cycle records
Every production cycle must be fully documented and the records kept securely
for the time specified by management. The information recorded should
include:
• the date and cycle number;
• the type of load (e.g. whether porous materials, solid instruments, hollow
instruments or a mixture etc.);
• the sterilization cycle selected;
• whether the cycle was a pass or a fail;
• the chart record for the cycle;
• the identity of the operator.

21
Recorders
It is not a requirement to have a recorder fitted, or attached, to the sterilizer
but it is desirable because it:

• provides a permanent record of daily tests;

• reduces time spent in performing daily tests;
• provides a permanent record of all production cycles;
• provides a unique cycle number that can be entered in the patients’ notes
to assist traceability;
• eliminates the possibility of typographical errors.

Records must be kept; the MDA recommends that benchtop steam

sterilizers should always be equipped with a printer.

The printout should be kept securely in the sterilizer logbook (see section
4.4). Electronic data storage can replace printed records.

Note: Some types of printouts fade quickly (e.g. from thermal printers) and
you might therefore need to take special action to preserve these records
(e.g. photocopying).

Master process record

A record of the values and permitted tolerances of the cycle variables for each
correctly functioning operating cycle, and for each load type that is to be
processed, should be provided by the AP, the TP or the manufacturer. This is
the master process record against which:

• the user should compare production cycle records to verify that sterilizing
conditions have been achieved for each load;
• the results of the weekly tests should be compared to establish whether the
sterilizer is functioning correctly and achieving sterilizing conditions;
• the results of periodic tests and performance re-qualification tests can be
compared.

Daily test records

The results of the daily tests should be recorded in the sterilizer logbook, dated
and signed by the user. Steam penetration indicator test sheets, marked with the
result of the test, dated and signed by the operator, should be retained for at
least six months and stored under the conditions recommended by the
manufacturer of the test sheet.

The NHS Executive’s Health Service Circular HSC 1999/053 provides

guidance on the time for which records should be retained.

22
 6. MAINTENANCE OF RESERVOIRS AND
STERILIZER CHAMBERS
It is important that the sterilizing process should not contaminate the load
6.1 Introduction
items. It is possible for benchtop sterilizer loads to be contaminated by
impurities in the water used to generate the steam. Contamination can be
minimised by appropriate maintenance of the sterilizer chamber and
reservoir, and by the use of suitable quality water.

Water supply
6.2 Sources of
Benchtop steam sterilizers generate their own steam either within the
contamination
chamber or in an adjacent boiler within the casing. Water droplets are
present in steam, therefore it will contain the same contaminants as the
water. These include minerals, toxic metals, and micro-organisms and their
toxic products. When the steam condenses on the load during sterilization,
contaminants will be transferred to the surfaces of the load items where they
will be concentrated when the load dries. The quality of the water in the
sterilizer reservoir, and chamber/boiler, is therefore crucial.

Reservoir water
Benchtop sterilizers usually have a reservoir for storing water to supply the
chamber/boiler. Many benchtop steam sterilizers discharge condensate and
residual water back into the reservoir at the end of each cycle Water left
standing in the reservoir, and residual water or moisture in the
chamber/boiler following a sterilization cycle, will quickly become
colonised with micro-organisms which can be harmful to the patient.

Endotoxins
Although the micro-organisms in the water will be killed during the
sterilization cycle, a heat-stable toxic substance (endotoxin) in the cell wall
of many of them will remain intact. Endotoxins are resistant to steam
sterilization and are only inactivated by heating for several hours at
temperatures above 180oC. Endotoxins will continually accumulate in the
water and increasingly contaminate the steam until the water is changed. There
are also benchtop steam sterilizers that discharge residual water and condensate
into a separate container or direct to a drain. This minimises the accumulation
of endotoxins in the water in the reservoir, but it does not remove the need to
drain and clean it frequently.

Debris
Microbial growth may be assisted by contamination of the water, for
example with debris from poorly cleaned instruments, or oil from dental
handpieces.

23
6.3 Cleaning The water reservoir should be cleaned regularly, however few sterilizer
reservoirs are designed to be easily cleaned. The MDA recommends that you
follow the manufacturer’s guidance on how to clean the reservoir. There are
anecdotal reports that some maintenance organisations have suggested the use
of disinfectants to clean reservoirs, the internal surfaces of pipework and
chambers/boilers. These disinfectants might cause corrosion of the chamber or
other components of the pressure containment system and cause failure, with
the associated high risk of injury to persons nearby (see section 4.6.1). If you
are considering using disinfectants for this purpose, you should follow the
advice of the sterilizer manufacturer.

6.4 Water quality The MDA recommends the use of sterile water for irrigation BP in benchtop
steam sterilizers as it has specification limits for mineral, toxic metal, and
endotoxin contaminants.

Tap water is not recommended as it contains dissolved minerals which can

cause scaling (furring) of the heating element (or boiler) and the chamber,
and lead to their early failure.

Sterilizer manufacturers usually recommend the use of distilled, de-ionised,

or reverse osmosis water. These generally have low (but unknown) levels of
mineral contaminants but they do not have a specification for either
endotoxins or micro-organisms and they are likely to be contaminated with
both. Although there is no official specification for reverse osmosis water,
when the process is carefully controlled it can produce water that has both
low mineral and low endotoxin contents.

Manufacturers’ recommendations to use purified water safeguards the

sterilizer but may not prevent contamination of the load with organic
substances that could be harmful to the patient.

Sterile water for irrigation safeguards both the sterilizer and the patient and is
the preferred quality if you perform surgically invasive procedures, in which
endotoxin might be introduced parenterally into the patient. Endotoxin
contamination of the sterilizer water might be of less concern if all the
procedures carried out in a practice present low risk of endotoxin
contamination to the patient (e.g. the instruments only make contact with
intact skin or mucous membrane).

6.5 Suggested The following guidance should help you to minimise contamination of your
maintenance sterilizer.

• Don’t leave water standing in the reservoir for more than a few hours. If
you are not sure how long the water has been there, change it.
• At the end of the working day, or whenever the sterilizer is to be left
unused for several hours, drain the chamber and water reservoir, rinse all
internal surfaces with sterile water for irrigation and leave them dry.

24
• Don’t top up the reservoir. First drain the contents and then rinse it
carefully with sterile water for irrigation before refilling to the level
recommended by the manufacturer.
• Ensure all load items are scrupulously clean and dry before placing them
in the sterilizer.

To minimise contamination of the sterilizer and its load, contents of part

used containers of sterile water for irrigation should be discarded, as its
microbiological purity will be compromised from the moment the
container is opened.

Further information on clean steam for sterilization, and more detailed

guidance, is available in HTM 2031 ‘Clean steam for sterilization’ (NHS
Estates 1997); paragraphs 4.50 to 4.66 provide information that is particularly
relevant to users of benchtop steam sterilizers.

25
7. GLOSSARY
AP – see Registered Authorised Person

BP – British Pharmacopoeia

Competent Person (pressure vessels) (CP) is a competent person or

organisation undertaking certain legal responsibilities under the Pressure
Systems Safety Regulations.

Controlled atmosphere – is one which has adequate controls to maintain a

comfortable working temperature (e.g. 18 to 26°C), the relative humidity
between 40% and 60%, and airborne microbiological contaminants below 35
colony forming units per cubic metre.

Forced air removal (active air removal) is the removal of air from the
chamber using mechanical means. (A vacuum pump, steam pulsing or steam
injection through the lumen of a device may be considered to be forced air
removal).

Hollow devices e.g. devices with lumens

If a device is open at one end, it is hollow if:
– the ratio of cavity length to diameter is greater than one,
If a device is open at both ends, it is hollow if:
– the ratio of cavity length to diameter is greater than two.

Lumen – a cavity or channel within a tube.

Manager – the person who is ultimately accountable for the operation of the
premises. Depending on the nature of the organisation, this may be the owner,
occupier, employer, general manager, chief executive, or other person of
similar authority. In small, autonomous installations the manager might also be
the user.

Manufacturer – a person or organisation responsible for the manufacture of a

sterilizer or other equipment.

Operator – any person with the authority to operate a sterilizer, including the
noting of sterilizer instrument readings and simple housekeeping duties and by
agreement daily/weekly testing.

Performance qualification (PQ) is the process of obtaining and documenting

evidence that the equipment as commissioned will produce acceptable product
when operated in accordance with the process specification.

Porous material – material, or load configuration, that can hold or trap air that
will interfere with steam penetration.

26
Registered Authorised Person (sterilizers) [AP(s), abbreviated to AP] is a
person designated by management to provide independent auditing and advice
on sterilizers and sterilization and to review and witness validation and periodic
test documentation. A list of suitably qualified APs is maintained by the
Institute of Healthcare Engineering and Estates Management (IHEEM) (see
Appendix 6).

Sterile – an object or area is sterile if it is free from viable micro-organisms,

including bacterial spores and viruses.

Sterilizing conditions – the ranges of the cycle variables that must prevail
throughout the chamber and load during the holding time.

Test Person (sterilizers) [TP(s), abbreviated to TP] is a person designated by

management to carry out validation and periodic testing of sterilizers.

Type B sterilization cycles are intended for the sterilization of wrapped and
non-wrapped solid, hollow and porous loads. They have a forced air removal
system.

Type N sterilization cycles are intended for the sterilization of non-wrapped

solid products. Air removal is achieved by passive displacement with steam.

Type S sterilization cycles are intended only for the sterilization of products
specified by the manufacturer of the sterilizer. They have a forced air
removal system.

User – the person designated by management to be responsible for the

management of the sterilizer. In a hospital the user could be a sterile services
manager or theatre manager or, in primary care, a general practitioner, dentist,
or other healthcare professional.

Validation – a documented procedure for gathering and interpreting data to

show that the sterilizer complies with the manufacturer’s specifications and
that it is capable of sterilizing product consistently, when used according to
the manufacturer’s instructions. It consists of commissioning checks and
tests to show that it is working correctly, and other (performance
qualification) checks and tests to make sure the load (as defined by the
manufacturer) will be sterilized.

27
8. REFERENCES
British Standards Institute. BS 3970-1:1990 Sterilizing and disinfecting
equipment for medical products. Specification for general requirements. BSI.

British Standards Institute. BS EN 554: 1994. Sterilization of medical devices-

validation and routine control of sterilization by moist heat. BSI.

British Standards Institute. BS EN 866: 1997 Biological systems for testing

sterilizers and sterilization processes. BSI

British Standards Institute. BS EN 867-3:1997 Non-biological systems for use

in sterilizers. Specification for Class B indicators for use in the Bowie and Dick
test. BSI.

British Standards Institute. BS EN 867-5:2001 Non-biological systems for

use in sterilizers. Specification for indicator systems and process challenge
devices for use in performance testing for small sterilizers Type B and Type
S. BSI.

British Standards Institute. Draft BS prEN13060:2002 Small steam sterilizers.

BSI.

Consumer Protection Act 1987. HMSO. ISBN 0105443875.

Council Directive 93/42/EEC 14 June 1993 concerning medical devices.

Official Journal of the European Communities, L169, vol.36, 12.7.93.

Gifford P. HSE’s Strategy for the healthcare sector. ISSM Journal Vol.3 No.1
8-10 July - September 1998.

Health and Safety at Work etc Act 1974, HMSO ISBN 01105437743.

Health and Safety Executive (1998) Guidance Note PM 73 Safety at

Autoclaves. ISBN 0717615340 .

Leigh B. The Law and Hospital Infection. Journal of Hospital Infection, vol
40, Supplement A, September 1998, ISSN 0195-6701.

Medical Devices Agency (1998) Medical device and equipment management

for hospital and community-based organisations. DB9801.

Medical Devices Agency (1998) The validation and periodic testing of vacuum
benchtop steam sterilizers. DB9804.

Medical Devices Agency (2000) Medical devices and equipment management:

repair and maintenance provision. DB2000(02).

28
Medical Devices Agency (2002) Sterilization, disinfection and cleaning of
medical equipment: guidance on decontamination from the Microbiology
Advisory Committee to Department of Health Medical Devices Agency. ISBN
1 85839 518 6.

NHS Estates (1994) Health Technical Memorandum HTM 2010 Part 3:

Validation and verification. The Stationary Office.

NHS Estates (1997) Health Technical Memorandum HTM 2010 Part 4:

Operational Management. The Stationary Office.

NHS Estates (1997) Health Technical Memorandum HTM 2031 Clean steam
for sterilization. The Stationery Office.

NHS Executive (1999) Health Service Circular HSC 1999/053 Preservation,

retention and destruction of records. Department of Health.

NHS Executive (1999) Health Service Circular HSC 1999/179 Controls

assurance in infection control: decontamination of medical devices. Department
of Health.

The Medical Devices Regulations 2002. SI 2002 No.618. The Stationary

Office.

The Pressure Equipment Regulations 1999. SI No 2001. The Stationary Office.

The Pressure Systems Safety Regulations 2000 SI 2000 No. 128, The
Stationery Office.

The Provision and Use of Work Equipment Regulations 1998, SI No 2306, The
Stationary Office.

Sterilization of health care products -- Chemical indicators 1995, ISO 11140,

The International Organisation for Standardisation.

Wilson A P R, Brent D and Beckett G. Benchtop sterilizers and CSSD The

Journal of the Hospital Infection Society, 1999, 43, p246-247.

Other MDA publications relevant to sterilizers

DB 2002(05) Decontamination of endoscopes. July 2002.

DB 9801 Supplement 2 Guidance on the sale, transfer of ownership and

disposal of used medical devices. October 2001

DB 2000(04) Single-use medical devices: implications and consequences of

reuse. August 2000.

29
DB 9804. The validation and periodic testing of benchtop vacuum steam
sterilizers. June 1998.

HN 9503 Handpieces used in phaco microsurgical procedures and their re-

usable accessories. May 1995

SN 2002(24) Steam penetration tests in vacuum benchtop sterilizers.

SN 2002(17) Management of loaned medical devices, equipment or

accessories from manufacturers or other hospitals. June 2002.

SN 2002(11) Benchtop vacuum steam sterilizers - the ‘prion cycle’. March

2002.

SN 2002(07) Little Sister 3 and SES2000 benchtop steam sterilizers (long

chamber versions). March 2002.

SN 2002(02) Dry heat (hot air) sterilizers. January 2002.

SN 2001(34) Matachana Miniclave Model 21Le vacuum benchtop steam

sterilizer. December 2001.

SN 2001(28) Compatibility of medical devices and reprocessing equipment

with decontamination agents. November 2001.

SN 2001(17) Steam sterilization indicators - alternative Bowie and Dick test

packs - changeover from BS 7720: 1995 to BS EN 867-4: 2001. June 2001.

SN 2000(18) Handling of surgical instruments on loan from another

organisation. October 2000.

SN 1999(32) Storage of sterile medical devices. September 1999.

August 2002.

SN 9619 Compatibility of medical devices and their accessories and

reprocessing units with cleaning, disinfecting and sterilizing agents. July 1996

30
Appendix 1 Factors to consider in choosing between benchtop
sterilizers, single-use devices or SSD
By using single-use devices or by having your devices reprocessed by a SSD, you reduce your legal
liability that might arise from reprocessing devices yourself.

The practicability of using a SSD will be determined by a number of factors, particularly the timely
availability of sterilized devices, which will depend on:

• the turn-round time* of using the SSD service;

• the number of instruments or instrument sets that you have. (You will need more instruments when
the turn-round time is long or if you use the instruments frequently.)

Safety (e.g. the assurance that the load has been sterilized) should be the prime consideration. The most
cost-effective solution should emerge from careful consideration of the respective costs of each option.

If you use a SSD these will include:

• cost of additional instruments to accommodate long turn-round times;
• logistics;
• cost of the SSD service.

These should be weighed against the costs for the benchtop sterilizer option, including:
• the purchase price of the sterilizer;
• time required for daily testing;
• cost of maintenance and periodic testing;
• operational costs (electricity, sterile water, insurance etc.);
• cost of additional instruments to accommodate prolonged cycle times;
• cost of training operators;
• reliability factor (where assessable);
• cost of meeting legal requirements (see section 4.7.2);
• cost and operation of automated instrument cleaning equipment.

The costs of using a SSD will be counterbalanced by benefits, including:

• increase in time available to treat patients;
• reduction in maintenance costs;
• effective cleaning of instruments using validated process;
• sterilization in wrapping, providing assurance that the instrument is sterile up to the point of use;
• sterilization of hollow devices and devices that have lumens;
• transfer of risk and liability associated with the decontamination process to SSD;
• improved traceability of the devices.

MDA’s advice is to use a SSD to reprocess all reusable devices, wherever possible. This has been
shown to be cost effective (Wilson et al 1999).

* Turn-round time is the time between the used instruments being despatched and their return from the SSD.

31
 Flow chart for decision making

Is SSD available and will

Y they supply me? N

Have I got sufficient Use a benchtop

instruments to cover steam sterilizer
longer turnround time?
Y
N
Must instruments be sterile at
Carry out cost assessment point of use?
32

N
N Y

Is the cost of SSD etc. equal I want to process solid, I want to process
to or less than the running unwrapped instruments wrapped loads, porous
costs of own sterilizer? for immediate use or for loads and tubular devices
clean storage

Y
Use traditional (non- Use suitable vacuum
Use vacuum) benchtop steam benchtop steam sterilizer
SSD sterilizer
Appendix 2 Ten good-practice points for the use of benchtop
steam sterilizers

• Where possible, use a sterile service facility rather than processing locally.

• Do not process wrapped, tubular or textile products in a conventional benchtop

steam sterilizer – process them only in a suitable vacuum benchtop steam sterilizer.

• All items must be clean and dry before loading into the sterilizer. Do not overload
the sterilizer – the load items might not be sterilized.

• Sterilization performance must be checked frequently (daily [this includes the steam
penetration test on vacuum benchtop sterilizers] and weekly by the user; quarterly
and annually by a competent test person). Keep written records. This is in addition to
routine maintenance and cleaning.

• Drain and clean chamber and reservoir at the end of each day and leave dry.
Replenish with sterile water for irrigation from an unopened container.

• Have the sterilizer's pressure system checked for safety. Keep records of all checks
and repairs to the pressure system. This is a legal requirement. Do not circumvent
safety features.

• Keep permanent records of every sterilization cycle.

• Keep written records all testing and maintenance carried out on every sterilizer. The
records should be kept in a logbook.

• Technical advice is available from Registered Authorised Persons (sterilizers)

(AP(s)). Infection Control Nurses can advise on prevention of cross infection.
Consult them if you are not sure how to sterilize a piece of equipment.

• Never re-process single-use devices.

33
Appendix 3 Examples of logbook pages
Appendix 3(iv) and Appendix 3(v) are reproduced with the kind permission of Scottish Healthcare Supplies.
See Appendix 6 for contact details.

Appendix 3(i) Summary details

Autoclave details
Hospital/location Department Serial No.
Ref. No.

Contents - the following forms:

Name of form Code No. Copy Purpose Appendix
Daily test sheet 1 No A record of all daily testing 3(ii)
Weekly test sheet plant history 10 No A record of faults/maintenance 3(iii)
record
Quarterly and yearly test 54 Yes Test person’s quarterly and yearly test
sheets sheets
Test history record Yes History of the weekly, quarterly and 3(iv)
yearly tests
Autoclave history record sheet Yes Record of all faults, maintenance and 3(v)
repairs to the autoclave
Production log sheet No Provides a record of every sterilizer
load processed

Personnel Name/organisation Tel. No.

Management
User
Operator(s)
Infection control nurse
Competent Person(pressure
vessels)*
Authorised Person (sterilizers)*
Test person(s)*
Maintenance person(s)*
Microbiologist (sterilizers)*
*These personnel should have qualifications/ training/ registration defined in HTM2010 Part 1.

Pressure systems safety regulations 2000

This section to be filled in by the Competent Person (pressure vessels)
Written scheme of inspection exists/is suitable
Inspection carried out on Date: Inspected by:
Result of examination / comments

Review of records by Authorised Person (sterilizers)

Date Comments on review Signature

34
Appendix 3(ii) Daily test sheet

Tests to be carried out in accordance with HTM2010.

Sterilizer location Serial No. Week beginning

Department Ref. No.

During sterilizing Sterilizing

Automatic
hold period hold time Steam
control test Certified fit for use
Temp penetration test
Cycle o Pressure result by user
C Min : sec Pass/Fail
number bar Pass/Fail
min/max
Mon / : P/F P/F
Tue / : P/F P/F
Wed / : P/F P/F
Thur / : P/F P/F
Frid / : P/F P/F
Sat / : P/F P/F
Sun / : P/F P/F

Reservoir water changes (where applicable). Drain, rinse and refill with sterilized water for irrigation. See
HTM 2031
Cycle number when water Water changed
Comments
changed by
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Sunday

Faults-new or existing (also enter in plant history record)

35
Appendix 3(iii) Weekly test sheet
Tests to be carried out in accordance with DB9804.

Sterilizer location Serial No. Department

Ref. No.

*Automatic
*Automatic Automatic Steam Weekly safety
air detector Certified fit
Week Cycle air leakage control test penetration checks
system for use
beginning number test result result test Satisfactory/
function test by user
Pass/Fail Pass/Fail Pass/Fail Unsatisfactory
Pass/Fail
P/F P/F P/F P/F S/U
P/F P/F P/F P/F S/U
P/F P/F P/F P/F S/U
P/F P/F P/F P/F S/U
P/F P/F P/F P/F S/U
P/F P/F P/F P/F S/U
P/F P/F P/F P/F S/U
P/F P/F P/F P/F S/U

* Only where the sterilizer has an in-built self-test programme. Otherwise the test should be carried out by a TP
and copies of the TP’s test sheets should be inserted.

Weekly safety checks (tick if satisfactory)

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

Faults- new or existing (also enter in plant history record)

36
 Appendix 3(iv) Autoclave history record sheet

Type of autoclave
Hospital/Location Start date for this sheet
Department Ref. No Ser. No

FAULTS RECORD MAINTENANCE RECORD

Fault Date Cycle Details of fault Noted and Date Fault Maintenance Record-include PPM as Carried out
number number reported by number well as fault finding details by
37

©Scottish Healthcare Supplies 0131 551 8905 PHR1 / ISSUE 2 / Jan 2000
 Appendix 3(v) Production log sheet- benchtop autoclave

Hospital/ Location Start date for this sheet

Department Ref. No Ser. No

Date Cycle Cycle start Cycle Description of load Cycle Printout Comments
number time selected pass checked OK and
(if operator
applicable) initials
Yes/No Yes/No
Yes/No Yes/No
Yes/No Yes/No
Yes/No Yes/No
Yes/No Yes/No
Yes/No Yes/No
Yes/No Yes/No
Yes/No Yes/No
Yes/No Yes/No
38

Yes/No Yes/No
Yes/No Yes/No
Yes/No Yes/No
Yes/No Yes/No
Yes/No Yes/No
Yes/No Yes/No
Yes/No Yes/No
Yes/No Yes/No
Yes/No Yes/No
Yes/No Yes/No
Yes/No Yes/No
Yes/No Yes/No
Yes/No Yes/No
Yes/No Yes/No
Yes/No Yes/No
Yes/No Yes/No
©Scottish Healthcare Supplies 0131 551 8905 UIUS0 / ISSUE 1 / Jan 2000
Appendix 4 User tests for benchtop steam sterilizers

1 Daily tests

You should perform the daily tests every day that the sterilizer is used, as they are your check that the
sterilizer is achieving sterilizing conditions. (The daily tests also form part of the quarterly and annual
tests carried out by the TP(s).)

1.1 Automatic control test

The test requires the temperature and pressure profiles, and the elapsed time of the cycle to be compared
with the values obtained when the sterilizer was known to be working correctly e.g. immediately after the
TP(s) tested it using calibrated instruments. You should perform the test using the sterilizing cycle with
the highest temperature compatible with the load. If your sterilizer does not have a printer fitted, observe
and note the following during the sterilizing (holding) stage of the cycle:

• the chamber temperatures and pressures indicated on the gauges;

• their maximum values;
• its duration in minutes and seconds.

A printer fitted to the sterilizers will perform this task for you, providing an accurate, permanent, record
and saving your time. Note it is the MDA's opinion that benchtop sterilizers should be equipped with
a printer. You should compare the values that you noted, or the values on the print out, with those on the
master process record (see section 5.7).

The test can be considered satisfactory if at the end of the cycle:

• the chamber temperature and pressure is within the limits of the appropriate band, for the duration
of the holding time, as specified in Table 1(see section 2);
• a visual display of ‘cycle complete’ is indicated;
• no mechanical or other anomaly is observed.

For traditional, gravity displacement sterilizers (Little Sister® types), the test should be performed with the
chamber empty (see HTM 2010 Part 3,) but to save time, it is often performed while sterilizing a load. If
you perform the test with a load, ideally the load composition should be the same each day). For sterilizers
with a type B or type S cycle, you can do this test at the same time as the steam penetration test (T1.2) but
the steam penetration test must be performed with the chamber empty except for the test device.

1.2 Steam penetration test (for type B and S sterilizers only)

You should perform this test at the start of every day the sterilizer is used, as it is important to be sure that
the air removal stage is effective, and that any residual air and other non-condensable gases (NCG) will
not interfere with the sterilization process. It is essential to perform this test with only the test device in
the chamber. Anything else in the chamber will disrupt the test and produce an erroneous result.

1.2.1 Sterilizers with Type B cycles

This test is analogous to the Bowie and Dick test performed on large porous load sterilizers in hospitals’
SSD departments. A specified test pack of material, containing a special chemical indicator, is processed
through a sterilization cycle. When the level of NCG is below predetermined limits, steam will penetrate
rapidly and completely into the pack and the indicator will show a uniform colour change. When NCG is
present, it will collect towards the centre of the pack as a bubble and will impair contact between the
steam and the indicator. The temperature or moisture level (or both) will be lower in the region of the
bubble and will result in a non-uniform colour change of the indicator. When the indicator is examined

39
after processing, a uniform colour change of the indicator over its entire surface shows that sufficient air
and other NCG had been removed to allow the steam to penetrate rapidly and evenly into the test pack.

The result of the test should be recorded in the sterilizer log book, and the indicator paper should be
marked with the result and kept for reference for six months. (The relevant standard, BSEN867: 2001
requires the colour of the processed indicator to remain stable for six months after processing, when stored
according to the manufacturer's instructions.)

If the test result is unsatisfactory, repeat the test. If it is still unsatisfactory, the sterilizer is faulty.
Call an engineer to investigate and repair the fault. The sterilizer must not be used until the fault
has been rectified.

There are two types of test pack, a standard test pack that you make up yourself, and a proprietary single-
use test pack that you purchase. The specification for the standard pack is provided in BS EN 867: 2001
Part 5. You have to incorporate into the pack an indicator sheet made to a stringent specification.
Proprietary packs normally incorporate an appropriate indicator sheet during manufacture.

Note: You must use the test pack specified by the sterilizer manufacturer because if you do not, the
results could be dangerously misleading.

If you use the standard test pack, you should use it according to the instructions of the sterilizer
manufacturer but if you use a proprietary test pack, follow the instructions of the manufacturer of the test
pack.

1.2.2 Sterilizers with Type S cycles

This type of cycle is for processing the loads specified by the sterilizer manufacturer. The sterilizer
manufacturer will therefore have to specify the test to demonstrate the effectiveness of the air removal
stage. You should use only that test unless there is an alternative available that has equivalent
performance. (NB Validation data must be available to demonstrate equivalence.)

1.2.3 Test procedure

Use only the test pack specified by the sterilizer manufacturer.

Place the test pack in the position specified by the manufacturer - which should be the position from
which it is most difficult to remove air from the load. Select a standard cycle or the cycle specified by
the sterilizer manufacturer.
Note: if there is a special cycle for the air removal test, it must have exactly the same air-removal
process as the standard processing cycles.

At the end of the test, examine the indicator sheet. The test is satisfactory if the indicator has changed
colour uniformly over its entire surface, as specified by the indicator manufacturer.

2 Weekly tests

2.1 Safety checks

You should perform these before starting the sequence of weekly tests.

Examine the door seal and replace it if necessary. You might need to call an engineer to do this.

Check the security and performance of door safety features

40
Note: It would not be prudent to attempt to open the door while the chamber is pressurised. The
door securing mechanism (which includes hinges as well as the door lock and interlocks) should
be checked before the chamber is pressurised, or at the start of a cycle. You should consult the
sterilizer manufacturer for details of the appropriate procedure.

2.2 Air leakage test

This test should be performed weekly. It is an important test because if air leaks into the chamber at a rate
greater than that specified by the sterilizer manufacturer:

• it might interfere with the penetration of steam into the load and prevent sterilization;

• during the drying stages, it will not have passed through the bacterial retentive filter and there is a risk
of recontaminating the load.

Air is first removed from the chamber until the pressure is the lowest achieved in all of the cycles
available on the sterilizer and then the vacuum source is isolated and all valves connected to the chamber
are closed. The absolute pressure is measured at the end of the vacuum stage. Any subsequent rise in the
chamber pressure will be caused by air leaking into it - and the rate of pressure rise in the chamber is
measured.

Ideally the sterilizer should be equipped with an automated test cycle so the user can do the test. If there is
not an automatic test facility, a TP(s) has to do the test using special, calibrated instruments.

The pass/fail criteria are:

• the absolute pressure at the end of the air removal stage is within the limits specified by the
manufacture and

• the rate of pressure rise must not be greater than 1.3 mbar per minute.

A machine that fails to meet the requirements of this test should not be used until the fault has been
rectified and the test satisfactorily completed.

2.2.1 Automatic test - user.

You should carry out this test weekly, following the instructions of the sterilizer manufacturer

The sterilizer must indicate clearly whether the test result is a pass or fail.

2.2.2 Manual test - Test Person.

This test method is described in HTM2010: Part 3 paragraphs 11.1 to 11.18.

The test should be considered satisfactory if the absolute pressure at the start of the 10 minute period is
within the limits specified by the manufacturer, and the rate of pressure rise during the test is not greater
than 1.3 mbar per minute.

The detailed method and pass / fail criteria are in DB 9804 Annex A.

41
2.3 Air detectors

Because effective removal of NCG is so important to the achievement of sterilizing conditions, porous
load sterilizers must be fitted with a means to detect, during every cycle, residual NCG that would prevent
the attainment of sterilizing conditions. These devices are commonly called air detectors. Vacuum
benchtop steam sterilizers must be equipped with either an air detector, or another system that is capable
of being validated, for detecting the presence of NCG.

2.3.1 Air detector testing

The air detection system must be tested weekly, quarterly and annually to demonstrate that it is
functioning correctly. This test is performed weekly.
There is such a wide variety of vacuum benchtop steam sterilizers that there is not a standard air detection
system, and each sterilizer manufacturer must therefore specify the test method to demonstrate that the
automatic air detection system is functioning correctly. Although the test methods may differ, in all cases
the test result shall meet the criteria specified in 5.1 of DB9804 when using a test pack representing the
maximum density of porous load material that the sterilizer is capable of processing.

Air detector system performance tests and function tests must also be performed quarterly and annually by
the TP(s) using independent, calibrated instruments. The results of these tests shall demonstrate the correct
functioning of any automatic air detection system fitted to the sterilizer.

42
Appendix 5 Regulation of transportable steam sterilizers
The medical devices directive and the medical devices regulations
Medical devices are regulated throughout Europe by the Medical Devices Directive, Council Directive 93/42
EEC – which has been transposed into UK law as the Medical Devices Regulations 2002 SI 2002 No 618.
These pieces of legislation regard sterilizers as medical devices if their manufacturer intends them to be used
for re-processing reusable medical devices.

Since the Directive and the Regulations came into force in June 1998, medical devices may be placed on the
market (i.e. supplied) only if the manufacturer claims the equipment meets the relevant ‘essential
requirements’ of the Directive. This means that the equipment is considered to be as safe as possible and is
fit for its intended purpose. Such devices must bear the CE marking to signify the claim of conformity and
this enables the product to be freely sold throughout the EC without further control.

To help manufacturers to meet the essential requirements, the European Commission has mandated
harmonised European standards to cover specific essential requirements. Products manufactured to comply
with such standards are automatically presumed to satisfy the relevant essential requirements. A European
standard for transportable steam sterilizers is in preparation (BS prEN 13060:2002) but it will be some time
before it is finished. Until then only the following standards are considered to be relevant to vacuum
benchtop steam sterilizers:

European Standard BS EN 554: 1994: Sterilization of medical devices - validation and routine control of
sterilization by moist heat.

British Standard 3970: Part 1: 1990: Sterilizing and disinfecting equipment for medical products;
specification for general requirements.

Further information on the Medical Devices Regulations is available from the MDA.

Pressure systems safety regulations

Steam is particularly hazardous, and steam sterilizers are a source of contained energy. To protect Users and
others from risk of injury if any part of the pressure system fails, there are regulations for the design and
construction (including safety features) of these sterilizers, and also for their use. Design and constructional
aspects are covered by the Pressure Equipment Regulations while use and maintenance are covered by the
Pressure Systems Safety Regulations 2000 (PSSR). The owner of the sterilizer is primarily responsible for
compliance with the PSSR.

Operation.
There is a duty on the employer to ensure that anyone using, managing or supervising work equipment has
received adequate training (PSSR). The employer must also provide:
• all procedures and information needed for the equipment to be operated safely;
• any special procedures to be followed in the event of an emergency (e.g. failure of the door gasket);
• information on the dangers of forcing doors (either open or closed);
• instructions for checking door locking mechanisms in both the open and closed positions;
• instructions for checking that the chamber is not pressurised before attempting to open the door.

Maintenance
The equipment must be properly maintained and kept in good repair to prevent danger. The type and
frequency of maintenance will depend upon a number of factors including:
• the age of the equipment;
• how much it is used;
• reports of previous maintenance or inspection;
• any repairs or modifications that have been made;
• manufacturers instructions;
• reports of examinations made under the written scheme of examination.

43
The written scheme of examination.
The PSSR require pressure equipment to be inspected periodically and the owner's responsibilities
(summarised) are:

• to define the scope of the written scheme of examination. A Competent Person (pressure vessels) (CP)
must provide the written scheme, CPs may be found via the manufacturer or insurer);
• to ensure that the parts of the sterilizer defined in the written scheme are examined by a CP;
• not to allow the sterilizer to be operated unless a written scheme has been drawn up and certified as
suitable by a CP;
• to ensure that the system is properly maintained in good repair, so as to prevent danger.

The Competent Person (Pressure Vessels) has two principal duties under the Regulations:

• drawing-up the written scheme of examination, or certifying that it is suitable;

• carrying out examinations in accordance with the written scheme, assessing the results and reviewing the
written scheme for its suitability.

Information on Competent Persons (Pressure Vessels) can be obtained from United Kingdom Accreditation
Service (see Appendix 6).

An Authorised Person (sterilizers) will be able to advise on the application of these Regulations to any
particular system.

44
Appendix 6 Sources of further information
Association of British Health-Care Industries (ABHI)
St Georges House
195-203 Waterloo Road http://www.abhi.org.uk
London Email: [email protected]
SE1 8WD Tel: 020 7787 3060 Fax: 020 7787 3061

NHS Estates
The Information Centre
1 Trevelyan Square Website: http://www.nhsestates.gov.uk/
Boar Lane Email: [email protected],
Leeds LS1 6AE Tel: 0113 254 7070 Fax: 0113 254 7167

NHS Purchasing and Supply Agency (PASA)

Premier House
60 Caversham Road Website: http://nww.pasa.nhs.uk/
Reading Email: [email protected]
RG1 7EB Tel: 0118 980 8600 Fax: 0118 980 8650

Scottish Healthcare Supplies

Trinity Park House
South Trinity Rd Website: http://www.show.scot.nhs.uk/shs/
Edinburgh Email: [email protected]
EH5 3SH Tel: 0131 552 6255 Fax: 0131 552 6535

The Health and Safety Executive

Website: http://www.hse.gov.uk/
Tel: 08701 545500
E-mail: [email protected]

The Institute of Healthcare Engineering and Estate Management (IHEEM),

2 Abingdon House
Cumberland Business Park
Northumberland Road Website: http://www.iheem.org.uk/
Portsmouth Email: [email protected]
P05 1DS Tel: 023 9282 3186 Fax: 023 9281 5927

United Kingdom Accreditation Service (UKAS)

21-47 High Street
Feltham Website: http://www.ukas.com/
Middlesex E-mail: [email protected]
TW13 4UN Tel: 020 8917 8400

45
 DISTRIBUTION

This Device Bulletin should be brought to the attention of general practitioners, community healthcare workers, dental
practitioners, chiropodists and podiatrists, practice nurses, dental nurses, operating theatre staff, infection control teams,
risk managers and environmental health officers.

TECHNICAL ENQUIRIES

Enquiries concerning the content of this Device Bulletin should be addressed to:

Dr Catriona McNie Ms Ainsley Wickens

Medical Devices Agency Medical Devices Agency
Hannibal House Hannibal House
Elephant & Castle Elephant & Castle
London London
SE1 6TQ SE1 6TQ

Tel: 020 7972 8219 Fax: 020 7972 8106 Tel: 020 7672 8273 Fax: 020 7972 8106
Email: [email protected] Email: [email protected]

HOW TO OBTAIN COPIES

This Device Bulletin is available on our website: http://www.medical-devices.gov.uk

Copies of this Device Bulletin are free to health and social care providers and may be obtained on written request from:

Department of Health
PO Box 777
London
SE1 6XH Fax: 01623 724 524 Email: [email protected]

Quoting reference MDA DB2002(06)

Otherwise, copies of the bulletin at a charge of £25 per copy may be obtained from:

Medical Devices Agency

Business Services
Hannibal House
Elephant & Castle
London
SE1 6TQ Fax: 020 7972 8124 Tel: 020 7972 8360

Our website lists all current Device Bulletins and safety warnings: http://www.medical-devices.gov.uk

© CROWN COPYRIGHT 2002

Medical Devices Agency
An Executive Agency of the Department of Health
ISBN 1 84182 615 4
OCT 02 20K