AK- BWA Automated Decontamination

Transcription

Automated Decontamination
7th
7th revised
revised edition
edition
AKBWA
AKBWA
Working Group
for Bedframe and Cart
Decontamination Systems
Automated Decontamination of
Bedframes
Bedside tables
Transport carts
Distribution containers
Sterilization containers
Surgical tables and furnishings
Surgical clogs
7th Edition
2006
© All rights reserved for the AK-BWA1).
Reproduction in whole or in part prohibited.
1) Working Group for Bedframe and Cart Decontamination Systems
Members of the AK-BWA
MANUFACTURERS OF CLEANING
AND DISINFECTION AGENTS
Dr. Jürgen Staffeldt (Chairman)
Chemische Fabrik
Dr. Weigert GmbH & Co. KG
Mühlenhagen 85
20539 Hamburg
Telephone +49 (040) 78 96 01 65
Telefax +49 (040) 78 96 01 23
E-mail juergen.staffeldt@drweigert.de
Inke Magens
Chemische Fabrik
Dr. Weigert GmbH & Co. KG
Telephone +49 (040) 78 96 01 76
Telefax +49 (040) 78 96 01 24
E-mail inke.magens@drweigert.de
Rudolf Glasmacher
Ecolab GmbH & Co. OHG
Reisholzer Werftstraße 38–42
40589 Düsseldorf
Telephone +49 (0211) 9 89 36 68
Telefax +49 (0211) 9 89 36 24
E-mail rudolf.glasmacher@ecolab.com
MACHINERY AND SYSTEM MANUFACTURERS
Georg Josef Moller
formerly:
Belimed GmbH
Edisonstraße 7a
84453 Mühldorf
Telephone +49 (08631) 98 96-0
Telefax +49 (08631) 98 96-300
Uwe Rößler
MMM
Münchener Medizin Mechanik GmbH
Hauptstraße 2
92549 Stadlern
Telephone +49 (09674) 80–342
Telefax +49 (09674) 80–2342
E-mail uwe.roessler@mmmgroup.com
Michael Dieterle
Dirschl Maschinen- und
Apparatebau GmbH
Fürholzer Weg 21
85375 Neufahrn/Munich
Telephone +49 (08165) 95 87 60
Telefax +49 (08165) 95 87 61
E-mail mdieterle@dirschl.de
Michael Streb
MEIKO Maschinenbau GmbH & Co. KG
Englerstraße 3
77652 Offenburg
Telephone +49 (0781) 2 03 11 13
Telefax +49 (0781) 2 03 13 43
E-mail stm@meiko.de
HYGIENISTS
OPERATORS
Guest contributors:
Köhler+Cie GmbH
69181 Leimen
Prof. Dr. Peter Heeg
Department of Medical Microbiology
and Hospital Hygiene
Elfriede-Aulhorn-Straße 6
72076 Tübingen
Telephone +49 (07071) 2 98 20 26
Telefax +49 (07071) 29 54 05
E-mail
peter.heeg@med.uni-tuebingen.de
Peter Krieger
Klinikum Großhadern
Dep. Sterilisations- and Kühltechnik
Marchionistraße 15
81377 Munich
Telephone +49 (089) 70 95 41 73
Telefax +49 (089) 70 95 88 33
E-mail
Peter.Krieger@med.uni-muenchen.de
Prof. Dr. Ulrich Junghannß
Hochschule Anhalt (FH)
Fachbereich 7 – LFG Mikrobiologie
Bernburger Straße 55
06366 Köthen
Telephone +49 (03496) 67 25 34
Telefax +49 (03496) 21 20 81
E-mail ulrich.junghannss@lbv.hs-anhalt.de
Matthias Panther
Klinikum Stuttgart – Katharinenhospital
Kriegsbergstraße 60
70174 Stuttgart
Telephone +49 (0711) 2 78 25 00
Telefax +49 (0711) 2 78 25 09
E-mail
m.panther@katharinenhospital.de
BEDFRAME MANUFACTURERS
Jürgen Fiß
Joh. Stiegelmeyer GmbH & Co. KG
Ackerstraße 42
32051 Herford
Telephone +49 (05221) 18 52 31
Telefax +49 (05221) 18 52 72
E-mail fiss@stiegelmeyer.de
MANUFACTURERS
OF TRANSPORT CARTS
Winfried Winkler
Novidex Transportsysteme GmbH
Schwinningstraße 20
52076 Aachen
Telephone +49 (02408) 93 05 44
Telefax +49 (02408) 93 05 33
E-mail Novi@Novidex.de
Zarges Leichtbau GmbH
82362 Weilheim
Aesculap AG & Co. KG
78532 Tuttlingen
Maquet GmbH & Co. KG
76437 Rastatt
Table of Contents
Foreword to the 7th edition . . . . . . . . . . . . . . . . . . . . . . . . . .8
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
3.13.
3.14.
3.15.
3.16.
Safety technology
Control panel and installation of equipment
Accompanying documents
Information about operating utilities
Scope of application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
PART 1
Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
2.1.
2.2.
PART 2
Legal obligations and regulations
in regards to cleaning . . . . . . . . . . . . . . . . . . . . . . . . .13
The European Medical Device Directive MDD 93/42/EEC
and the ordinance regarding the setup, operation,
and use of medical devices (German Medical Devices
Operator Ordinance – MPBetreibV)
Industrial safety
PART 3
Requirements for decontamination
systems (BDS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
3.1. The decontamination process in a circulation system
Process step I: Optional cold water pre-rinse
Process step II: Decontamination
Process step III: Rinsing and drying
3.2. Equipment inside the chamber
3.3. Loading cart
3.4. Spray jet systems
3.5. Design and dimensions
3.6. Usable space dimensions
3.7. Chamber requirements
3.8. Front panel
3.9. Lock and entrance opening
3.10. Machine room
3.11. Automatic control
3.12. Display and monitoring
4.1.
4.2.
4.3.
4.4.
PART 4
Requirements for the items to be treated (TI)
and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Construction and design
Item dimensions
Materials and components
Bedframes
Bedside tables, Transport carts
Sterilization containers and distribution containers
Surgical clogs
Maintenance
Inspection work
Maintenance work
PART 5
Requirements for process chemicals (PCH) . . . . . . .25
5.1. Decontamination agent
5.2. Rinsing agent
5.3. Material strength
5.4. Composition
5.5. Determining the concentration
5.6. Temperature
5.7. Changing the decontamination solution
5.8. Electric motors
5.9. Documentation
5.10. Dosage
6.1.
PART 6
Structural requirements . . . . . . . . . . . . . . . . . . . . . .27
Performance limitations
6.2.
Requirements for operating materials and systems
Water
Steam
Condensate
Compressed air
Electricity supply
Waste water
Exhaust air processing technology
Chamber air supply
Heat dissipation
6.3. Structural dimensions
6.4. Pit
6.5. Installations in the machine room
6.6. PCH dosing system
Appendix A: Connection and consumption values
Appendix B: Operating utilities for decontamination systems
PART 7
Operation and management of the BDS . . . . . . . . . .34
7.1. Initial start-up
7.2. Handover
7.3. Operating staff
7.4. Log book
7.5. Operating manual
7.6. Operating instruction
7.7. Parameter settings
7.8. Checks and controls
7.9. Microbiological efficiacy testing
7.10. Maintenance measures
PART 8
Tests and reports – Requirements . . . . . . . . . . . . . .36
8.1. Procedure test
8.1.1 Test bacteria and intermediate cultures
8.1.2. Carriers
8.1.3. Applying the test soil onto the carrier
8.1.4. Test parameters and set-up
for bedframes and bedside tables
for transport carts
for distribution containers
for reusable sterilization containers
for surgical tables and furnishings
for surgical clogs
8.1.5. Evaluation
8.1.6. Testing the decontamination solution
8.2. Operational qualification
8.3. Periodic testing
8.4. Special testing
9.1.
9.2.
9.3.
9.4.
9.5.
9.6.
PART 9
Ecological requirements . . . . . . . . . . . . . . . . . . . . . .44
Water
Energy
Process chemicals
Waste water
Exhaust air
Heat dissipation
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46
DIN Regulations
Normative References
Guidelines/Regulations
Closing remarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47
Foreword to the 7th edition
The AK-BWA was founded at the conclusion of the Hygiene
Conference in Marburg in 1988. Fifteen years have passed
since those first discussions about bed disinfection took
place, in which bedframe manufacturers, manufacturers of
bedframe and cart decontamination systems, and of detergents and disinfectants, as well as operators and hospital
hygienists took part. The fact that in order to aid the operator,
bedframes and the materials related to their manufacture
and care need to be coordinated invites discussion of the
problems posed by automated bedframe cleaning and disinfection. A specialized working group, the AK-BWA, has taken
up the challenge. Of prime importance at the conference
were cleaning methods that are led to a gentle processing of
the items to be cleaned and then the question of preventative measures against infection.
During this time, not only were additional alternatives for automated cleaning established, but it was precisely in the area
of cleaning that quite a number of recommendations, as well
as national and international standards, were put into effect.
Determining which decontamination method to use depends
on what the possible dangers of infection are, that is, on the
Prof. Dr. Peter Heeg, Tübingen
8
results of risk analyses, on the company specialization, on
the structural design and the technical facilities available
including transport options, as well as on staff and economic
issues.
Experience with decontamination systems, which use a circulation system, demonstrate that decontamination systems,
originally meant for bed preparation, could also be used for
other items, such as transport carts, distribution containers,
sterilization boxes, surgical tables and furnishings, as well as
surgical clogs. Furthermore, only automated cleaning offers
the option of validation and, therefore, the monitoring and
documentation required by the German Medical Devices
Operator Ordinance in effect since June 29, 1998.
This booklet is meant to provide comprehensive information
on this topic to the reader and to give him practical assistance.
Thanks to years of continuous revision and updating, this
booklet has become a valuable reference for all those interested in this field.
Prof. Dr. Ulrich Junghannß, Köthen
Introduction
Experience with decontamination systems has shown that
they can be used very successfully to clean items hygienically.
This includes bedframes, bedside tables, transport carts,
distribution containers, reusable sterilization containers,
surgical tables and furnishings, as well as surgical clogs.
쐍 Requirements for process chemicals (PCH)
쐍 Installation requirements
쐍 Operation and management
쐍 Tests and reports
쐍 Ecology
The goal of the AK-BWA is to make a resource guide available
for the planning, application, operation, and assessment of
decontamination systems. In doing so, great effort has been
made to take into account the specific requirements of each
individual item to be treated.
In the scope of current best practice in the field of modern
decontamination, the reader will learn about what to be
aware of when implementing a decontamination process in a
circulation system.
This brochure informs the reader about:
쐍 Terms
쐍 Legal obligations and regulations, as well as aspects of
industrial safety
쐍 Requirements for decontamination systems (BDS)2)
쐍 Requirements for the items to be treated (TI)
In the 7th edition of this booklet, the AK-BWA has included
the topic of decontaminating surgical tables and furnishings,
as well as reusable sterilization containers.
Each chapter has also been revised and updated.
2) BDS = Bedframe and cart decontamination system
Scope of application
This booklet handles the automated decontamination of
various items, chiefly from the area of medicine: Bedframes
with bedside tables, transport carts, distribution containers,
reusable sterilization containers, surgical tables and furnishings, as well as surgical clogs.
Recommendations do not include disinfection according to
§§ 17 and 18 of the German Infection Protection Act.
9
Part 1
Terminology
In this chapter, terms are defined in
relation to decontamination, chiefly as
used in the area of medicine.
The working group has found it very useful to develop clear and unambiguous
definitions of the terms in question.
This chapter has been placed at the
beginning in order to provide a quick
overview of a complex topic.
The terms are arranged alphabetically.
Please do not become confused when
at first glance some of the terms seem
“over formulated” while others seem to
be “taken for granted”. Once you have
become more familiar with the material,
you will recognize the justification for
some of the more detailed definitions.
DIN 58 955 applies to decontamination
systems. The AK-BWA definitions have
been incorporated in it.
Circulation system
A circulation system is a decontamination process in which the spray water
containing the PCH is recirculated.
This can also be a combined fresh water
circulation system, in which, for example, only the decontamination solution
is recirculated.
Cycle time
The cycle time is the operation time
plus the time necessary for loading and
unloading the decontamination chamber.
Decontamination
Decontamination, as used in this booklet, is the cleaning and disinfection of
those areas on items in a TI with which
the patient, the personnel or the items
being transported would normally come
into contact.
Decontamination agent
Decontamination agents are combined
disinfectants and detergents.
Decontamination process
A decontamination process is a combination of thermo chemical process
steps and methods, which ensure that
the TI is decontaminated and dried.
10
Decontamination time
The decontamination time is the length
of time during which the TI is sprayed
Abbreviations:
AK-BWA
Working Group for Bedframe and Cart
Decontamination Systems
TI
Item(s) to be treated
PCH
Process chemicals
BDS
Decontamination systems for bedframes, bedside tables, transport
carts, distribution containers, reusable
sterilization containers, surgical
tables and furnishings, surgical clogs,
and other items to be treated.
with water containing the decontamination agent.
Disinfectants and detergents
See decontamination agent.
Disinfection
Disinfection is the reduction of infectious microorganisms on and in contaminated objects to the point where it
can be assumed that no more infection
is present. The required reduction factor is normally indicated as a ⬎ 5 log10
reduction.
Distribution container
A distribution container is a rigid reusable
vessel for storing and transporting items
of all types. It needs to be cleaned regularly. For the purposes of this booklet, a
distribution container is an item to be
treated (TI).
Drying
Drying the TI refers to the drying of the
visible surfaces of the TI inside and outside of the decontamination chamber
until a tolerable level of residual moisture is achieved.
ture (see tolerated residual moisture)
to dissipate, so that it can then be used
again.
Fresh water system
In a fresh water system, all the spray
water is drained into the sewage system after every cycle.
Machine room
The machine room is the room which
contains components and/or mechanisms required to operate the BDS.
Part 1
Operating utilities
Operating utilities are resources used to
maintain and run the decontamination
system, for example, steam, electricity,
compressed air, water.
Drying the TI is dependent on several
contribution factors, for example, the
final drying temperature, specific heat
capacity, design and geometric shape,
materials, support by mechanical devices and process chemicals.
Items to be treated (TI)
The items to be treated are the items to
be decontaminated. The acronym TI
may refer to individual items or to items
in a collective sense. TI may include
any of the following items which can be
treated in an automatic BDS: bedframes with accessories, bedside tables,
transport carts, distribution containers,
reusable sterilization containers, surgical tables and furnishings, surgical
clogs and similar items.
Drying time
The drying time is the length of time
necessary to pre-dry the TI in the decontamination chamber.
Lifting unit
A lifting unit is a device integrated into
the BDS to put a TI at a certain incline in
order to allow liquid to better drain away.
Entrance dimensions
The inner entrance dimensions are the
effective dimensions of the entrance
door to the decontamination chamber.
The dimensions are given in mm and in
the order of height x width.
Loading cart
A loading cart is a mobile load-bearing
structure, on which different types of TI
can be transported through the automated decontamination system. The type
of cart used depends on the type of TI.
Process chemical (PCH)
Process chemical is the collective term
for decontamination agents, detergents, disinfectants, rinsing agents,
anti-corrosive agents, and lubrication
agents, all of which can be mixed in
water.
Final drying time
Final drying time is the length of time
that the TI must remain in ambient air
after being removed from the BDS in
order for any residual heat and mois-
Machine parts
Machine parts is the collective term
used for BDS components and/or
mechanisms which are located outside
the decontamination chamber.
Rinsing agent
Rinsing agents are products containing
wetting agents that are added to rinse
water in small amounts. They ensure a
uniform and thorough wetting of the TI,
Operation time
The operation time is the sum of the
time needed for decontamination, rinsing, and drying, not including the time
necessary for loading and unloading
the system.
Piggyback system
A piggyback system is the decontamination of bedframes and bedside tables
in the same decontamination cycle.
The bedside tables are placed in the
storage spaces of the bedframes. The
BDS must be set up for this accordingly.
11
Part
X1
aid drying, and prevent drip and stain
build up. The rinsing agent can also
contain anti-corrosive agents and/or
preservatives.
Rinsing time
The rinsing time is the length of time
necessary to spray the TI with warm
water containing the rinsing agent.
Spray water
For the purposes of this booklet, spray
water is water that usually contains PCH
and is sprayed under pressure through
nozzles onto the TI.
Sterilization container (container)
A sterilization container is a closable
germ-proof container for sterilizing,
transporting, storing, and the sterile
supply of surgical instruments for re-use.
Sterilization containers can be used for
the dry disposal of used instruments.
Wet disposal in a sterilization container
is only feasible if the surface of the sterilization container is resistant to the
12
disinfectant used in wet disposal and
the container is also constructed to
allow wet disposal.
Storage tank
The storage tank is the part of the BDS
that keeps the process chemical solutions ready to use.
For the purposes of this booklet, surgical
tables and furnishings are surgical
table tops and transporters of surgical
table systems, surgical table accessories, and additional surgical furnishings, which can be treated in a BDS.
Tilting
Tilting is the lifting and inclination of
the TI. Items can be tilted either lengthwise or crosswise or in a combination
of both directions.
Tolerable residual moisture
Tolerable residual moisture is regarded
as individual drops of water (not pools),
which are still present on unfavorable
areas of the TI approximately five min-
utes after removal from the BDS. The
ambient temperature of the TI must be
23 (+/–2) °C and the relative humidity
50 (+/–10) %.
Transport cart
For the purposes of this booklet, transport carts are used to transport supplies and waste materials, for example,
laundry, dishes, rubbish.
Usable space
Usable space is the space within the
decontamination chamber that holds
the TI.
Usable space dimensions
Usable space dimensions represent the
maximum area which the TI can occupy
and still be guaranteed complete
decontamination. Usable space dimensions are given in mm and in the order
of height x width x depth (length).
Warm-up time
The warm-up time is the length of time
required to put the BDS into a state
where it can be operated.
Legal obligations and regulations with regard to cleaning
When selecting the possible cleaning
methods for bedframes, bedside tables, transport carts, distribution containers, sterilization containers, surgical tables and furnishings, as well as
surgical clogs, etc., the following are to
be adhered to: the universally valid
technical guidelines for hazardous substances, the regulations for the prevention of industrial accidents specified by
the employer’s liability insurance associations, as well as the European Medical Device Directive (MDD) along with
its regulations specifically referring to
those items to be treated that are medical devices.
2.1. The European Medical Device
Directive MDD 93/42/EEC and
the ordinance regarding the setup,
operation, and use of medical devices
(German Medical Devices Operator
Ordinance – MPBetreibV)
Class 1 medical devices include, for
example, hospital beds, surgical table
tops, surgical furnishings.
The German Medical Devices Operator
Ordinance of August 29, 2002 requires
that:
쐍 The user of a medical device must
be convinced that it is functioning
correctly and is in proper condition
before he uses it.
쐍 The operator may only commission
persons, companies, and organizations
with the maintenance of the BDS,
who have the expertise, meet the requirements, and have the necessary
resources to perform the maintenance.
쐍 Cleaning
and disinfection using
suitable, validated, and standardized
methods are to be performed in such
a way that the success of these
methods is guaranteed and documented, and that the security and
health of patients, operators or third
parties are not endangered.
Part
42
쐍 After maintenance has been performed, the most important features
regarding the security and proper
functioning of the BDS must be
checked and documented.
For beds, these requirements can actually only be fulfilled at a centralized
bed-preparation facility. The necessary
visual check with the following functional testing is best integrated into the
process before the bed is reassembled
again. A “naked” bed is the easiest
to inspect. The inspector can take a
thorough look at each bed before it is
prepared for use.
For the necessary maintenance and/or
repair work, a direct affiliation with the
bed preparation facility has proven
most effective.
The same applies for the cleaning of
surgical table tops and surgical furnishings.
The demand for validated methods cannot be sufficiently fulfilled by manual
wipe-cleaning or wipe-disinfection.
However, these demands are fulfilled
with the use of an automatic decontamination process.
13
Part 2
2.2. Industrial safety
Recommendations for industrial safety
are provided by the European directives upon hazardous substances and
preparations and technical guidelines
for hazardous substances (e.g. German
TRGS), as well as the regulations for
the prevention of industrial accidents
developed by professional trade associations (Berufsgenossenschaften).
When working in decentralized or centralized cleaning or the manual or automated cleaning of bedframes and other
TIs, the German TRGS 531 “Danger to
the skin when working in a moist environment (moist work)” is to be observed
in particular. These technical guidelines
for hazardous substances are made
14
public by the German Federal Ministry
of Social Affairs in the official publication which is called in german “Bundesarbeitsblatt”.
The German TRGS 531 regulates duties
in which employees spend a substantial
number of working hours working with
their hands in a moist environment or
must spend a corresponding amount of
time wearing moisture-proof protective
gloves. For example, the German TRGS
531 specifies the following in detail:
쐍 Technical and organizational protective measures have precedence over
personal protective equipment and
all technical and organizational
options are to be used to avoid moist
work.
쐍 The employer must reduce moist work
as much as possible using technical
measures, for example, automation.
쐍 The employer must create a set of
operating instructions in which the
dangers to the skin related to moist
work as well as the necessary protective measures and rules of behavior
are defined.
Requirements for decontamination systems (BDS)
The function of the BDS is to uniformly
spray detergents and disinfectants onto
the surfaces to be decontaminated and
to prepare the TI for re-use according to
the guidelines defined for hygiene (see
part 8 Microbiological efficacy testing).
With these objectives in mind, this
booklet describes a proven decontamination process using a circulation system along with the basic technical details of the system.
Part 3
3.1. The decontamination process
in a circulation system
Process step I:
Optional cold water pre-rinse
When removing bloody residue, for
example, from surgical clogs or from
sterilization containers, a cold water
pre-rinse can improve the cleaning
results.
Process step II:
Decontamination
Warm water containing decontamination agents (decontamination solution)
kept in a storage tank is sprayed directly onto the TI. The detergent and disinfectant solution collects in a reservoir
positioned underneath the TI. They are
pumped back into the storage tank.
This is how the decontamination solution is recirculated. The recirculation of
this solution makes it possible to spray
a large volume flow onto the TI.
The decontamination time depends on
the process parameters chosen.
Process step III:
Rinsing and drying
After the TI has been successfully treated
with the decontamination solution, the
rest of the decontamination agent still
clinging to the TI is rinsed off by being
sprayed with a hot rinse aid solution
(max. 85 °C).
Complete decontamination program
Functions
Program sequence time definitions
Times
Open door 1
Load
Close door
Outside
of the machine:
Process steps
Decontamination
Rinsing
Drying
Open door 2
Unload
(Close door
Final drying
Cycle time
Loading/unloading time
Operation time
Rinsing time
Drying time
Final drying time
Time lapse
Figure 1: Example of a program sequence:
The decontamination process in a circulation system with drying process using specific heat, and additional sources, if necessary
15
Part 3
Temperature T (°C)
Temperature
Detergent and
disinfectant solution
Temperature
Rinsing solution
Temperature sequence
on the TI
100
90
80
70
60
50
40
30
20
10
Time lapse t
0
Load
Rinsing time
Drying time
Unload
Process steps
Outside the machine
Final drying time
Figure 2: Example of temperature sequence for a bedframe during a decontamination procedure in a circulation system with drying
After rinsing has been completed, the
chamber is ventilated and the steam
and moist air is evacuated. The heat
stored in the TI evaporates the film of
moisture clinging to the TI (drying using
the specific heat of the TI). This process
is aided by the rinsing agent and the
tilting of the TI. TI that does not possess
sufficient specific heat to dry itself due
to its construction may need additional
aid in drying.
Attention must be given to the following special details in order to reliably
run a decontamination process using a
circulation system, to achieve the degree
of drying defined in this booklet, and to
protect the TI:
16
쐍 A consistent concentration of decontamination agent must be ensured
during the time required for the
decontamination process. This is to
be guaranteed by adding additional
decontamination agent in conjunction
with the partial renewal of the decontamination solution using fresh water
or rinsing solution.
쐍 The decontamination solution must be
sprayed on the surfaces being treated
uniformly. The supply of decontamination agent during operation must
be guaranteed.
쐍 The temperature of all spray-water
systems used may only be set to a
point that a maximum temperature of
70 °C on the TI is not exceeded.
쐍 The warming up of the TI must be
done in such a way that drying using
the specific heat of the TI is possible.
The tolerable residual moisture must
lie within the values set in Part 1.
쐍 The decontamination process must
satisfy the efficacy tests according to
the requirements described in Part 8.
쐍 The level of dryness of the TI can be
increased by using warm or hot air.
3.2. Equipment inside the chamber
When loading the chamber, care must
be taken to place the TI in a predetermined position so that decontamination can be carried out according to the
requirements of the decontamination
process. Changing the predetermined
position can lead to parts of the TI
not being sprayed evenly which can
compromise the efficacy of decontamination.
ing cart designed especially for the
respective TI.
With respect to the design, dimensions,
and materials, the requirements described in Part 4 for TIs also apply to
loading carts. This normally includes
the use of stainless steel, process
chemical-proof fixed and swivel castors
as well as guide rollers, that will withstand the process chemicals.
warmed to the point of being able to
dry using their own specific heat, the
spray jet system, spray pressure, and
the flow rate of the pumps must be adjusted to suit the nominal capacity and
size of the heat exchanger, the storage
tank, and the dosing equipment. A
safe and reproducible decontamination
process is only guaranteed if the
system is set up with great care.
Part X
3
3.5. Design and dimensions
In addition, the unit must be equipped
with a device for tilting the TI into
an optimal incline. This enables the
sprayed-on decontamination agent and
rinsing solutions to drain away more
easily. The lifting unit must be automatically integrated into the program
sequence. It should have a guide rail
and clamping mechanism for the TI.
The guide rails and the lifting unit must
be adapted to the needs of the TI.
3.3. Loading cart
Loading carts are used to transport TI
(for example, surgical clogs, distribution
containers). The loaded cart is pushed
into the chamber for the decontamination of the TI (similar to the procedure
for bedframes). The TI must be fastened
into a suitable position on the loading
cart to ensure that the TI is properly and
uniformly sprayed with the application
solution of the process chemicals.
This normally requires a specific load-
3.4. Spray jet systems
The spray jet system used is decisive
for the success of the decontamination
process. It must be ensured that the
decontamination solution is sprayed
uniformly and completely onto the
surfaces to be decontaminated. This is
influenced by the following:
쐍 Spray pressure
쐍 Flow rate of the decontamination
solution
쐍 Number of spray jets
쐍 Spray angle and the angle of inclination of the jets
쐍 Spray jet characteristics
쐍 Impact pressure and angle of the
spray water jet onto the TI
쐍 Distance of the spray jets from the TI
쐍 Position of the TI
It is therefore very important to coordinate the individual details exactly.
In order to achieve an optimal decontamination process in which the TI are
A BDS is designed for two-door operation. This results in a separation of the
loading and unloading sides as defined
in hygienic requirements.
Normally, the BDS is designed for
ground level loading on wheels. If it is
not possible to guarantee the required
installation depth for ground level
loading on wheels, a different solution
must be found (for example, by installing loading and unloading ramps
adapted to the ground clearance of the
TI). It is important that sufficient freedom of movement is provided both in
front of and behind the unit to allow
smooth operation. The dimensions of
the TI determine the size of the entrance opening and the working space
in the BDS.
The following reference values guarantee the effective utilization of space
in the chamber which is required for
perfect decontamination.
17
Part 3
Chamber height
with floor pan
Usable space depth
A = 2300
B = 2600
Required entrance dimensions
3.6. Usable space dimensions
Transverse cross-section
The usable space dimensions must be
adapted to the TI.
Entrance opening
Height = 2000
Chamber cross-section – lateral
Upper edge
of entrance
(e.g. upper
edge of floor)
A = without piggyback
system
B = with piggyback system
Usable space
Width = 1100
Entrance opening
Width = 1200
Area for arranging
the spray jet system
(manufacturer specific)
Chamber lock/door
B: For beds with lifting pole and bedside tables using the piggyback system
Height . . . . . . . . . . . . . . . . . . . .2000 mm
Width . . . . . . . . . . . . . . . . . . .1100 mm
Depth . . . . . . . . . . . . . . . . . . . .2600 mm
Usable space
width
Chamber width
Chamber layout
Usable space depth
C: For surgical tables
Height . . . . . . . . . . . . . . .min. 1450 mm
Width . . . . . . . . . . . . . . .min. 800 mm
Depth . . . . . . . . . . . . . . . . . . . .1900 mm
Figure 3: Usable space and inside entrance opening dimensions for bedframes
Transverse cross-section
Chamber height
with floor pan
Entrance opening
Height > 1450
Chamber cross-section – lateral
Upper edge
of entrance
(e.g. upper
edge of floor)
Usable space depth
Depth > 1600
Usable space
Width > 800
Required entrance
dimensions
Entrance opening
Width > 900
Area for arranging
the spray jet system
(manufacturer specific)
Chamber lock/door
Usable space
width
Chamber width
Chamber layout
Usable space depth
18
Examples
A: For beds with lifting pole
Height . . . . . . . . . . . . . . . . . . . .2000 mm
Width . . . . . . . . . . . . . . . . . . .1100 mm
Depth . . . . . . . . . . . . . . . . . . . .2300 mm
Figure 4: Usable space and inside entrance dimensions for transport carts, distribution
containers, sterilization containers, surgical tables and furnishings, as well as surgical clogs
Depending on the structural conditions,
the external dimensions of certain unit
components must be adapted to the required conditions for installation and
loading, see Part 6.
3.7. Chamber requirements
The chamber, including the doors, must
be water proof. All joints, seals, etc.,
must be checked for chemical resistance to the decontamination and rinsing agent used. In addition, the materials and components used must also be
able to withstand the temperatures and
mechanical stresses involved.
The chamber and doors should be made
of stainless steel, preferably material
1.4301 AISI 304 or better. Alternative
materials may also be used if they have
the same properties and resistance. It
is absolutely essential that the floor
area of the chamber be made in the
shape of a (water) splash-proof basin.
The interior of the chamber must be
adequately illuminated. The outer walls
of the chamber must fulfill the requirements of DIN 4140 (German industrial
standard for heat insulation).
3.8. Front panel
Ideally the units should be constructed
as two-door models with a loading
and an unloading side. The front and, if
necessary, the rear sides should be
covered with paneling. The paneling
should ideally be made out of stainless
steel with the usual surface treatment
(polish, graining) for such equipment.
The entrance to the machine room
should be large enough for maintenance purposes.
3.9. Lock and entrance opening
Entrance aids are to be provided for
safe and easy loading of the TI. Doors
which open and close automatically
should be provided. Sliding doors, folding doors, and similar constructions may
be used. Sliding doors should be poweroperated and open from the side.
If an automatic door operating system
is used, the German “Guidelines for
power-operated windows, doors and
gates” (ZH 1/494) must be adhered to.
Each door should be fitted with an observation window for checking function
and safety.
recommended for this. The storage
tank should be fitted with a sampling
valve. The storage tank overflow should
be placed so that floating contaminants are drawn off. Access to the machine room should be laid out in agreement with the person responsible for
hygiene and in accordance with structural conditions.
Part
X3
3.10. Machine room
The minimum dimensions of the machine room are based on the space
needed for the machines, storage tanks,
pumps, heat exchangers, pipelines,
valves, etc., which are required for the
process.
In order to guarantee smooth maintenance, the basic installation dimensions may not be narrowed (see Part 6).
In particular, the space above the machines should be kept accessible for
maintenance work (third-party channels and pipes may not be laid there).
Special care should be taken that all
the components required, for example,
storage tanks, heat exchangers, pumps,
dosing devices, as well as measuring,
control, and regulation equipment (I&C
equipment) are arranged in a clear and
easy-to-maintain order, as many components require daily checks and maintenance to ensure smooth operation.
For example, it should be possible to
change the detergent and disinfectant
solution quickly and easily as required.
An automatically controlled program is
If the machine room is accessible from
an operating room, the climatic requirements specified in DIN 1946-4 must be
taken into account.
3.11. Automatic control
The entire program sequence, including door closing and opening movements, should take place automatically. From the front of the loading side, it
should be possible to select the required programs (if there is more than
one choice) and have the individual
program steps displayed as they take
place. The installation of programmable logic controllers (PLC) is recommended.
3.12. Display and monitoring
Decontamination systems should be
equipped with the necessary control
and display instruments. The following
information should be displayed:
쐍 The currently selected program when
multiple programs are available
19
Part 3
쐍 The current process step during operation
쐍 The temperature of the decontamination solution and the rinse water
쐍 When the program ends
쐍 Messages when the PCH containers
(canisters, tanks) are empty
쐍 Control and measurement of the decontamination solution
It must be possible to read all the displays from a distance of 1 meter.
3.13. Safety technology
The units must be equipped with the
safety devices required by the German
employer’s liability association responsible for industrial safety and insurance
(Berufsgenossenschaft) and the German
Association for Electrical, Electronic
and Information Technologies (VDE).
This includes monitoring the door closing and opening movements, an emergency system for unlocking the door
from inside the chamber, a chamber
door-locking system preventing opening
during operation so that no contami-
20
nants can escape into unprotected
normal working areas, etc.
3.14. Control panel and installation
of equipment
The electrical equipment of the BDS
must comply with the German standard
DIN VDE 0100. All the electrical equipment and connections in the machine
room must be installed in compliance
with the level of protection specified in
the German standard DIN VDE 0470-1
IP 33. Push buttons, warning lights,
and control panels are to be installed
on the working area side according to
protection class IP 30. The power for
this equipment is to be supplied by a
control transformer built into each device. PELV (protective extra low voltage)
(24 V) current must be provided for control and safety circuits.
3.15. Accompanying documents
At least two sets of documents must
accompany the BDS during the acceptance process.
a) Operating instructions with a
description of the process
b) Abbreviated operating instructions
with – if necessary – loading information
C) All necessary circuit diagrams,
pipeline diagrams and process
diagrams
d) Spare parts lists as well as maintenance instructions
3.16. Information about operating
utilities
The supply, return and drain pipes,
operating utilities, and other structural
necessities required by the machines
are described in Part 6 “Structural requirements”.
Appendix A in Part 6 contains a form to
help you determine consumption values.
In addition, you will find helpful information about operating utilities in
Appendix B in Part 6.
Requirements for the items to be treated (TI) and maintenance
For the treatment of bedframes, bedside tables, transport carts, distribution
containers, reusable sterilization containers, surgical tables and furnishings,
as well as surgical clogs in decontamination systems, there are some basic
requirements.
4.1. Construction and design
The most important requirement is that
any items to be treated are constructed
in a suitable way for decontamination, in
particular at those areas where the patient,
the personnel or the items being transported would normally come into contact.
The TI must be qualitatively designed
for automated decontamination and the
manufacturer must attest its suitability
for decontamination.
Components such as, for example, castors, hydraulics, pneumatics, cranks,
drive mechanisms must be constructed
in such a manner that they can withstand the effects of the decontamination and rinsing solutions without
damaging.
The TI should be constructed in such a
way that it has no gaps or parts susceptible to corrosion. Hollow areas and
cavities, where liquid can collect, are to
Part 4
be avoided or constructed in such a
way that the liquid can drain off. This
is especially important for achieving
thorough drying using the specific heat
of the TI.
Tolerable residual moisture is regarded
as being individual drops of water (not
pools ), which are still clinging to unfavorable areas on the TI approximately five
minutes being removed from the BDS.
4.2. Item dimensions
TI dimensions must not exceed the
following maximum dimensions:
Figure 5a: Bedframes
Height incl. lifting pole . . . . . . .1980 mm
Width . . . . . . . . . . . . . . . . . . . . .1080 mm
Length . . . . . . . . . . . . . . . . . . . . .2300 mm
When cleaning a bedframe and bedside
table together (piggyback system), the
following maximum dimensions must not
be exceeded:
Height incl. lifting pole . . . . . . .1980 mm
Width . . . . . . . . . . . . . . . . . . . . .1080 mm
Length . . . . . . . . . . . . . . . . . . . . .2600 mm
For cleaning bedside tables and other
types of TI separately, the loading and
transport carts used must also not exceed
these dimensions.
21
Part 4
22
Figure 5b: Transport carts
Height . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1980 mm
Width . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1080 mm
Length . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2300 mm
Figure 5d: Surgical table tops with transporter
Height . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1450 mm
Width . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .800 mm
Length . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1900 mm
Figure 5c: Loading carts for sterilization containers
Height . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1980 mm
Width . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1080 mm
Length . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2300 mm
Figure 5e: Loading carts for surgical clogs
Height . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1980 mm
Width . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1080 mm
Length . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2300 mm
Hydraulic and pneumatic components,
cranks, pneumatic springs, and electric
motors can all be used to power adjusting devices. All drive mechanisms must
be designed to withstand the decontamination process. Electric motors must
have an additional certificate of suitability for use in the BDS issued by a
recognized testing office. All materials
and drive mechanisms used in the item
to be treated and decontaminated must
be resistant to the following influences:
쐍 Temperatures of up to 70°C
쐍 pH-values varying between 5–8 (9)1
쐍 PCH solutions and water (for water
Figure 5f:
Loading carts for distribution containers
Height . . . . . . . . . . . . . . . . . . .1980 mm
Width . . . . . . . . . . . . . . . . . . .1080 mm
Length . . . . . . . . . . . . . . . . . . .2300 mm
quality requirements, see Part 6)
쐍 Spray pressure of 5–8 bar
쐍 Under certain circumstances, surgical
tables require lower spray pressures,
for example, 1.5 bar
4.3. Materials and components
The materials used must be corrosion
resistant or have a corrosion-resistant
coating and should be able to store
heat. Suitable materials include:
쐍 Steel and aluminum with protective
coating
쐍 Stainless steel
쐍 Plastic coating (paint finish). The
plastic coating should be tight and at
least 90 µm thick. Polyester coating
has proven effective.
쐍 Non-metallic materials, for example,
polyamide, Formica-covered HPL sheeting, and polypropylene.
Bedframes
Residual moisture is not to be tolerated
on the flat horizontal surfaces of the bedframes so that the bed can be prepared
for use immediately after a secondary
drying time of approximately five minutes.
Bedside tables,
Transport carts
Due to their construction, bedside tables
and transport carts have a lower heat
storage capacity than other types of TI
and therefore, under certain circumstances, do not have enough specific heat
to dry their horizontal surfaces to a tolerable level of residual moisture.
For this reason, this type of item should
be constructed in such a way that the
process chemical solutions can drain
off when the TI is tilted.
Part
X4
Sterilization containers
and distribution containers
In order to be able to decontaminate
sterilization containers and distribution
containers in a BDS, the following requirements must be met:
쐍 Sterilization containers and distribution containers must be constructed
in such a way that there are no surfaces that the spray water cannot
reach and that there are no hollow
areas where spray water can collect
and not be able to drain off. Unavoidable hollow areas or undercuts due to
construction constraints must be provided with adequately-sized drainage
outlets.
쐍 A loading cart adapted to the shape of
the respective sterilization container
or distribution container must be
available. The sterilization containers
or distribution containers must be secured to this cart in such a way that
the spray water can reach all the interior and exterior surfaces and, especially, that it can drain off completely
from all the concave areas of the TI. In
addition, securing the TI ensures that
the pressure of the spray water does
not move the containers out of their
1
After consulting with the manufacturer of the TI
23
Part 4
set position. The size of the loading
cart must be adapted to make use the
best possible use of the available interior area of the BDS.
Surgical tables and
furnishings
The manufacturer of the PCH, in coordination with the manufacturer of the TI,
must ensure and certify the material
compatibility of surgical table tops suitable for decontamination with the PCH.
The moisture indicators on the surgical
table tops must be monitored according to the manufacturer’s instructions.
During automated decontamination,
lubricants may be discharged from
surgical table tops and surgical table
transporters. The re-lubrication cycles
recommended by the manufacturers
must be ensured.
Surgical clogs
Surgical clogs are made completely out
of polyurethane because this material
functions well and can be reliably disinfected. However, this material can only
be used in chemo-thermal disinfection
processes with a maximum temperature
of 60 °C. Clogs that contain other materials are not suitable for automated
decontamination.
24
Loading carts for surgical clogs must be
constructed in such a way that the PCH
can be applied to the entire interior
and exterior of each clog.
4.4. Maintenance
In order to guarantee and extend the
life of the TI, maintenance should be
performed at regular intervals according to the instructions provided by the
manufacturer. The following maintenance work should be performed at
least every 6 months: Medical devices
must be checked at regular intervals
according to the regulations specified
in the German Medical Devices Operator
Ordinance (MPBetreibV). Other types of
TI must be inspected according to the
German Equipment Safety Act (GPSG).
A: Inspection work
쐍 All functions and, if necessary, the
readjustment of Bowden cables and
adjustment devices must be inspected.
쐍 The surface of all plastic coating must
be inspected and, if necessary, repaired.
쐍 All accessories, for example, lifting
poles and side panels must be inspected.
쐍 The leakage current and insulation
resistance on electrical beds must be
measured.
쐍 The moisture indicators on surgical
table tops must be visually inspected.
B: Maintenance work
Maintenance should be performed on
the following parts according to the
manufacturer’s instructions:
쐍 Pivots
쐍 Guidance parts
쐍 Frame ends and pipe sleeves at head
and foot of bed
쐍 Brake rods
쐍 Adjustment devices
쐍 Journal pins and bearing bolts
쐍 Caster-locking mechanisms
쐍 Spindles and spindle guides
쐍 Telescopic tubes
쐍 Locks and bolts
During automated decontamination,
lubricants may be discharged. The relubrication cycles recommended by the
manufacturers must be ensured.
Refer to the maintenance instructions
for information about the various types
of grease and oil.
A suitable control system should be set
up to make it possible to check whether
maintenance has been carried out, for
example, using a colored number plate
or bar code. A card or computer system
is recommended for documenting any
inspection, service, and repair work
performed. A prerequisite for this is
that the bedframes are numbered.
CAUTION!
Consult the manufacturer for special
information about cleaning old bedframes, carts, surgical tables, and
accessories.
Requirements for process chemicals (PCH)
The specific properties of the process
chemicals (PCH) used in decontamination systems (BDS) must be adapted to
the purpose for which it is to be used.
In order to avoid damaging either the TI
listed in this booklet or the BDS, only
PCH which have been especially developed for use in a BDS and whose suitability has been proven may be used.
Liquid PCH, which can be automatically
dosed, is used. Dosing the PCH directly
from the container it was delivered in
(canister or barrel) is recommended.
The PCH must be sprayed on uniformly
so that it completely covers the entire
surface of the TI to be decontaminated
according to the hygienic guidelines
described in Part 8, Testing for efficacy.
PCH for medical devices such as bedframes, surgical tables or sterilization
containers must show the CE symbol
according to the European Medical
Device Directive.
Part 5
The requirements for PCH are described
in detail in the following:
5.1. Decontamination agent
The specified concentration of the decontamination agents should not exceed or fall below the pH ranges indicated in Table 1.
A tolerance test using the specified
water quality and the PCH used in
the decontamination system is recommended for sterilization containers,
transport carts, and distribution containers made out of aluminum.
If acidic or neutral PCH is used, the
chloride level in the solutions should
not exceed 100 mg/l and should be
checked regularly.
time ratio applied in the BDS. Evidence
of efficacy against Hepatitis B viruses
should not be determined in a procedural report but rather should be determined by performing suspension
tests. In this context, the test method
for “active against enveloped viruses”
disinfectants with BVDV (Bovine Viral
Diarrhea Virus) and vaccinia viruses
according to the RKI recommendation
“Test and declaration of the efficacy of
disinfectants against viruses” (Bundesgesundheitsblatt 47, 2004, p. 62–66)
is to be used. This test includes efficacy
against Hepatitis B viruses/HIV. Note
that it is the temperatures of the TI
during cleaning and not those in the
decontamination solution storage tank
that are taken into consideration during
the test.
5.2. Rinsing agent
Decontamination agents for sterilization
containers must be effective against
Hepatitis B viruses at the temperature-
The rinsing agents to be used should
achieve a uniform and thorough wetting
Table 1
pH range
of the solution
1
Surgical tables,
Bedframes,
Bedside tables
and accessories
Stainless
steel
Aluminium
Plastic
Stainless
steel
Aluminium
5–8(9)1
2–12
5–8(9)1
5–12
2–12
5–8(9)1
Transport carts
Sterilization containers and
distribution containers
Surgical
clogs
5–12
25
Part 5
of the various TI materials. Through
this, drying should be aided and the
build up of drips and stains avoided.
5.3. Material strength
During the life time of the TI indicated
by the manufacturer, the PCH used
should not cause any corrosion of the TI
materials and components described
in Part 4.
5.4. Composition
The PCH should not degrade the lubricants that ensure the movable parts of
the TI function properly (see also Part 4).
The PCH must conform to the technical
requirements of the BDS described in
Part 3. For example, they should not produce interference with foam or cause
deposits.
26
5.5. Determining the concentration
A method for determining the concentration (±10 % of the nominal value
for the decontamination agent) must
be indicated. A uniformly efficacy of
the decontamination solution must be
ensured throughout the entire operating period.
5.6. Temperature
The PCH must be usable in the temperature ranges recommended by the
manufacturers of the system and the TI,
as well as in the specified decontamination process.
5.7. Changing the decontamination
solution
The decontamination solution must be
regenerated or changed when necessary.
In any case, in order to ensure complete decontamination storage tanks
and filters, as well as jets, must be
cleaned regularly if not daily, depending on the type of items being cleaned.
5.8. Electric motors
The manufacturer's instructions must
be followed when decontaminating bedframes with electric motors.
5.9. Documentation
A safety data sheet must be provided
for every PCH.
5.10. Dosage
The dosage of the PCH can be done
either decentrally or from a central point
(see Part 6).
Structural requirements
The prerequisite for a properly functioning system is competent planning
and structural preparation, as well as
the proper coordination of the supply
and disposal systems for the operating facilities.
Part 6
6.1. Performance limitations
The acquisition of a BDS and the settlement of the warranties, i.e., the delivery
and the installation should be done according to the “Supplemental contract
conditions for VOB and VOL for trade
sterilization and disinfection systems”
(EVB STER/DES, last edition). The connection of the BDS to the building utilities (intake air/exhaust air/hot steam/
cold water/compressed air/power supply)
is the responsibility of the respective
construction trades. Shut-off devices
are third-party services.
Either the client or the operator must
provide the manufacturer with the necessary documents for creating the designs for construction preparation.
NOTE
For third-party installations
above the chamber:
The space above the system, especially above the chamber, must not
be restricted by third-party installations such as ventilation ducts,
pipelines, cable runs, or similar,
since the electric motors, drive
mechanisms, valves, and other
components located in this area
must remain accessible for maintenance work.
6.2. Requirements for operating
utilities and systems
The manufacturer must notify the client
or operator in good time about which
operating utilities in which qualities
and in which quantities must be provided and which third-party measures
are necessary for assembling, connecting, and operating the BDS.
The operator must meet the manufacturer’s requirements for the quality and
quantity of the operating utilities, in-
cluding supply and disposal systems.
Otherwise, the following can be expected: unsatisfactory function and insufficient efficacy of the decontamination, long cycle times, damage to the TI,
and damage to the system.
Water
pH value . . . . . . . . . . . . . . . . . .5–8 (9)1
Total hardness . . . . . .up to 0.5 mmol/l
(up to 3° d – German hardness)
Evaporation residue . . . . . .⬍ 500 mg/l
Chloride . . . . . . . . . . . . . . . . .⬍ 80 mg/l
Silicate as SiO2 . . . . . . . . . . .⬍ 15 mg/l
Iron . . . . . . . . . . . . . . . . . . .⬍ 0.05 mg/l
Manganese . . . . . . . . . . . .⬍ 0.05 mg/l
Copper . . . . . . . . . . . . . . . .⬍ 0.05 mg/l
Fully demineralized water may only be
used after consultation with the manufacturers of the PCH, TI, and BDS. Due
to reasons of material strength, fully
demineralized water is recommended
for sterilization containers, transport
carts, and distribution containers made
from anodized aluminum.
The cold feed water is heated in the BDS.
Warm water can be used.
Cold water pipes should be insulated
against condensation, where necessary.
The water connections should be made
in accordance with the regulations
specified by the DVGW (the German
Technical and Scientific Association for
1
27
Part 6
Gas and Water). Attention should be
paid to the compatibility of the piping
materials.
The manufacturer must notify the operator of the following:
쐍 Minimum overpressure or flow pressure at the connection point to the
system
쐍 Connection dimensions
쐍 Design performance (peak)
쐍 Consumption per hour (maximum consumption)
Steam
Steam conduits are to be drained on
site immediately before the BDS.
Horizontal pipelines should be installed
with the fall of not less than 1:50 in the
direction of the steam flow.
The steam conduits must be insulated
against heat loss according to the German Heat Conservation Provision.
쐍 Minimum overpressure at the connection point to the system
쐍 Connection dimension
28
The manufacturer of the decontamination system must be notified if any special materials have been used in the
pipework of the building.
Condensate
When operating a BDS with steam, condensation builds up. The operator must
be notified about the expected amount
of condensate and the dimensions of
the pipeline.
Compressed air
Compressed air (industrial quality) is
used for pneumatic operation and control processes.
Compressed air with a minimum overpressure of 6 bar must be available at
the connection point.
쐍 Minimum overpressure
Electricity supply
The connection requirements as specified
in the German standard DIN VDE 0100
must be observed. A mains connection
must be provided on site as follows.
Nominal voltage . . . . . . . . . . .3 x 400 V
Nominal frequency . . . . . . . . . . . .50 Hz
The manufacturer must be notified of
any discrepancies from these values.
쐍 Connection values (power consumption)
쐍 Fuse protection
Waste water
The German standard DIN 1986 (Drainage
systems on private ground) and local
waste water regulations are to be observed. The manufacturer must notify the
operator about the dimensions of the connection and the amount of waste water.
Exhaust air processing technology
The ventilation of the chamber using an
internal fan must be done via a separate pipe leading to the outside. The exhausted chamber air is saturated with
water vapor. Therefore, it is imperative
that the pipes are constructed so as to
be absolutely waterproof.
쐍 Flow volume (m3/h at Pa)
쐍 Exhaust air temperature
In pipes with high pressure loss, the
operator must have an additional fan
including drainage device installed at
the end of the pipe.
Chamber air supply
A sufficient supply of fresh air must be
provided for airing the chamber (drying) either from the working space on
the clean side or via the machine room.
If the BDS is located within the surgical
department, the machine room is considered a Class I surgical side room according to DIN 1946, Part 4.
The incoming air is to be channeled accordingly through filters, in as much as
its degree of purity does not meet the
guidelines for OP rooms set in DIN 1946,
Part 4.
Front view
Observation window
6.3. Structural dimensions
The minimum dimensions for the loading path must be supplied by the
manufacturer.
The load-bearing capacity of the foundations as well as the traffic load
capacity at the installation site must be
designed to take the weight of the system as indicated by the manufacturer.
Height of installation
Display and
operation
Items being
treated (TI)
Upper edge
of the flooring
Width of installation
Reservoir
for recirculated liquid
(Take drainage facilities and
floor depression into account)
Floor depression
(Follow manufacturer’s
specifications!)
Layout
TI
Machine room
Depth of installation
Width of
usable space
Depth of usable space
Unloading side
Maximum values for installation
dimensions:
Height . . . . . . . . . . . . . . . . . . . . 3000 mm
Width . . . . . . . . . . . . . . . . . . . . . 3000 mm
Depth . . . . . . . . . . . . . . . . . . . . 3600 mm
Loading side
The manufacturer must supply the following information:
쐍 Heat load on the front of the unit
쐍 Heat load in the machine room
쐍 Heat load on the TI at the “unloading
side”
Height of
usable space
Upper machine room
for supply and
waste disposal pipes
and for accessing
the components
Heat dissipation
The heat produced by the BDS must be
dissipated. Additional thermal loads
produced by auxiliary equipment and
third-party pipelines must be taken
into account.
The heat must be dissipated from the
machine room and fresh air supplied in
such a way that the temperature in the
machine room does not exceed 40 °C at
a height of 2 m.
Heat can be dissipated from the machine room via supply and exhaust air
or via exhaust air vents in the machine
room and air intakes in the front paneling on the clean side.
Part 6
Cross section of the BDS
Basic installation dimensions
for BDS
Installation
heights (mm)
Installation
widths (mm)
Installation depths
“Lengths” (mm)
A – BDS – for bedframes
WITHOUT piggyback system
3000
3000
3400
B – BDS – for bedframes
WITH piggyback system
3000
3000
3600
C – BDS – for transport carts,
distribution containers, surgical clogs,
sterilization containers, surgical tables
2700
3000
2750
Figure 6: Basic installation dimensions for a BDS
6.4. Pit
The operator must provide a waterproof
pit for the installation of the BDS. The
edges of the pit must be lined with noncorroding reinforcements constructed
according to the manufacturer's specifications. The operator must provide a
drainage facility with a siphon for the pit.
Maximum installation depth
below ground level . . . . . . . . . .250 mm
below the upper edge of the flooring
29
Part 6
6.5. Installations in the machine room
6.6. PCH dosing system
The operator must install lighting and
SCHUKO sockets in the machine room
which correspond to a protection class of
at least IP 34 according to DIN 40050.
The lighting must be laid out in such a
way that the machine room is well lit.
The dosing of the PCH can be done
either decentrally or from a central
point. For decentralized dosing, the
PCH container is usually located in the
BDS machine room. The machine room
entrance must be large enough for
deliveries of the PCH in vats (take vat
diameter into account).
Water and compressed air connections
(including hose connections) for maintenance and cleaning work must be
provided in the machine room.
vats) (Fig. 7). Normally, dosing centers
are located in a separate room. This
room should be easily accessible for
the delivery of large containers. The decision of which dosing method to use
must be taken into account during the
initial planning phases since this has
an influence on the structural requirements. For this reason, the PCH manufacturer must be involved in the early
planning stages.
Centralized dosing systems offer the
advantage of being able to supply different BDS and washer disinfectors with
PCH from large containers (for example,
Tunnel washer
for surgical instruments
Washer-disinfector
for surgical
instruments
When storing the PCH, the corresponding legal conditions according to the
Federal Water Act must be adhered to.
BDS I
BDS II
Centralized
dosing system
Detergents
30
Figure 7: Example of a dosing center
Neutralizing agent
Rinsing agent
Decontamination agent
Part 6
Centralized sterilization
Hygiene center
for sterilization
“Clean side”
“Clean side”
Unloading side
Unloading
side
Dosing
system/PCH
BDS
Washer-disinfectors
Machine
room
Tunnel washer
Loading side
Loading side
“Dirty side”
“Dirty side”
Figure 8: An example of the layout of a hygiene center and a centralized sterilization area with centralized PCH dosing system
31
Part 6
Appendix A: Connection and consumption values
Form for determining the connection and consumption values
for the supply and disposal services for a decontamination system.
Project: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Manufacture: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Model/type: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
32
Code letters
Name
Nominal
diameter
Pressure
Temperature Connection
ST
External steam
from building utilities
DN
bar
CO
Condensate
DN
bar
CW
Cold water, softened,
max. 0.5mmol/l (3°d)
DN
bar
m3/h
m3/h
CA
Compressed air, oil-free
DN
bar
Nm3/h
Nm3/h
DR
Discharge water
DN
GU
Gully
(floor drain)
DN
EA
Exhaust air from chamber
DN
TL
Thermal load/
exhaust air
TL1
TL2
TL3
TL4
IA
Intake air
Intake from the unloading side
EL
Electricity supply
3/ N / PE AC
400 V 50 Hz
Pa
Machine room
Unit front, loading side
Unit front, unloading side
Items to be treated
kg/h
°C
kg/h
kg/h
°C
l/min
°C
m3/h
kW
kW
kW
kW
kW
Fuse protection
Consumption
A
kWh
Appendix B: Operating utilities for decontamination systems
Part 6
SUPPLY (guideline values)
DISPOSAL (guideline values)
ST External steam
Dimensions
DN 25–40
Pressure
0.5–10 bar 2.5 bar recommended
Design performance 250–300 kg/h
CO Condensate (recirculated)
Dimensions
Pressure + temperature
Design performance
DN 20–25
each depending on FD
250–300 kg/h
CW Cold water, softened, max. 0.5 mmol/l (3°d)
Dimensions
DN 20–25
Pressure
3–5 bar
3 bar recommended
Design performance 30–40 l/min
DR Discharge water
Temperature
Design performance
up to 80° C
35–50 l/min
GU Gully (floor drain)
DN 65–80
CA Compressed air
Dimensions
DN 15–20
Pressure
6–10 bar
Design performance 10–15 Nm3/h
8 bar recommended
IA Intake air in machine room
the air from the room on the unloading side used for
machine room ventilation and for airing the chamber (EA)
EL Electricity supply (DIN/VDE 0100 is to be observed)
Power supply/
frequency
3 x 400 V 50 Hz
Backup fuse
35 A
Connection value
approx. 10–12 kW
TL Exhaust air
thermal load approx. 2–4 kW
TL1machine room
temperature ⬍ 40° C
TL2 unit front/loading side
thermal load approx. 0,5 kW
TL3 unit front/unloading side thermal load approx. 0,5 kW
TL4 addition thermal load for TI approx. 4–5 kW
EA Exhaust air from chamber (interior)
Flow volume
1000–1600 m3/h
Fan pressure
approx. 50–200 Pa
Exhaust air temperature
up to 80° C
humidity
100 % short-term
Make sure that the exhaust air pipeline and
its drainage facilities are large enough.
IMPORTANT NOTE:
The precise values needed for preparing the installation must be obtained from the manufacturer of the BDS.
The data depends on individual requirements. Appendix A in Part 6 can be used as an aid.
33
Part 7
Operation and management of the BDS
In order to guarantee the safe and reproducible operation of the BDS, the
maintenance measures specified by
the manufacturer must be performed
regularly (servicing, as well as inspection and maintenance work, as defined
by DIN 31 051).
sponsible for operating the system in
using and servicing the system.
The operator is responsible for making
sure his staff is sufficiently trained in
operating the system (operator manual).
the system competently. This instruction
is normally prepared by the operator
based on information provided by the
manufacturer.
7.7. Parameter settings
7.4. Log book
7.1. Initial start-up
Initial start-up must be performed by the
manufacturer or by a technically competent person assigned by the manufacturer. During start-up, the functions and
correct settings for all regulation, control,
and safety equipment must be checked.
In addition, the fuse protection for the
electrical circuitry and the measures for
shock-hazard protection must be checked.
7.2. Handover
The manufacturer must provide the operator of the system with the accompanying documentation and maintenance
instructions as well as the procedure
test report for the various applications
(see Part 8).
It is recommended that a log book be
kept in which running reports are entered daily (for example, number and
type of cycles, faults, concentrations
and pH values of the cleaning und disinfectant solution, tests performed, etc.)
7.5. Operating manual
The operating manual is an integral
part of the system and must be kept in
the room where the system is installed
so that each member of the operating
staff can refer to them at any time. It
is recommended that a short version
of the operating manual be kept in the
direct vicinity of the operating panel in
a clearly visible area.
34
During the handover of the system, the
manufacturer must train the staff re-
7.8. Checks and controls
The measures specified in the operator
manual and in the operating instructions must be carried out, for example:
쐍 Checking the concentration, tempera-
7.6. Operating instruction
7.3. Operating staff
When operating the BDS, the decontamination process parameter settings
determined by procedure testing and
specified in the operating instructions
must be adhered to. These are, for
example, temperature, reaction time,
PCH concentration, and drying time.
Any adaptation of the parameters due
to local conditions, such as temperature,
reaction time, PCH concentration, and
drying time, must be confirmed by procedure testing.
The BDS operating instruction contains
all the important information an operator needs to know in a form that is easy
to understand so that he can operate
ture, and if necessary, the pH-value of
the detergent and disinfectant solution.
쐍 Replacing the detergent and disinfection solution by emptying the storage
tank (see Part 5 also).
쐍 Regularly cleaning the filters and containers.
쐍 Checking the nozzles for free throughput and correct spraying position.
7.9. Microbiological efficacy testing
These tests must be carried out according to Part 8.
Testing with other types of TI is to be
specified in the operating instruction
by the operator.
7.10. Maintenance measures
Maintenance measures are to be carried
out according to the manufacturer’s
instructions.
1. It is recommended that a maintenance contract be signed with the
manufacturer.
2. The servicing and maintenance work
specified in Part 4 must be carried
out on the TI.
3. Process chemicals must be used
according to the manufacturer's
instructions. The recommended consumption must be checked (see
Part 5).
Safety regulations are to be observed,
in particular, parameters determined by
procedure testing and which influence
the decontamination process may not
be altered.
Part 7
When replacing components which
could change the process parameters
of the decontamination process, a special test must be performed as specified in Part 8.
Only experts and staff who have been
properly trained may carry out servicing
and inspection work.
When performing servicing work, the
manufacturer's instructions must be
observed when replacing parts.
35
Part
X8
Tests and reports
Requirements
In processes for cleaning and disinfecting bedframes and bedside tables
(with and without a piggyback system),
transport carts, distribution containers,
reusable sterilization containers, surgical tables and furnishings, as well as
surgical clogs, the process must guarantee a 5-log10 reduction of the level
of microorganisms detectable on any
area with which patients, personnel or
items being transported may come into
contact.
The minimum recommended reduction
of microorganisms of 5 to the power of
10 applies only to the decontamination
process described. It is not a statement
regarding the number of microorganisms
generally tolerated. The model, type
number, and manufacturer of the TI
tested are to be listed in the test report,
in as much as it is feasible.
NOTE
For sterilization containers, it is
assumed that they will be sterilized
with steam as a final processing step.
36
8.1. Evaluation of the antimicrobial
efficacy (Procedure test)
This deals with a test method for assessing chemo-thermal decontamination
processes for the TI mentioned above.
The number of TI and biological indicators to be used for the test as well as
the number of successive cycles are indicated according to the respective TI
in 8.1.4.
Procedure testing consists of a test of
the carriers and of the decontamination
solution.
8.1.1. Test bacteria and intermediate
cultures
The test bacteria used: Enterococcus
faecium ATCC 6057.
The intermediate E. faecium culture
must be plated onto tryptic soy agar
(TSA) three times at 48 h intervals. The
incubation temperature is 36°C ± 1°C.
To obtain the test suspensions, each
plate is flooded with 10 ml tryptic soy
broth (TSB). The suspensions are
washed by centrifugation, resuspended
in a 0.8 % NaCI solution, and then
renewed centrifugation. A sample of test
bacteria corresponding to the original
volume is then absorbed into a test
suspension of blood (sterile, heparinized sheep blood with protamine1) or of
a sterile solution containing BSA and
mucine (RAM2). The test suspension to
be used for each TI is indicated in 8.1.4.
The number of bacteria in the test
soil must total at least 1 x 108 CFU/ml
(CFU = colony forming units).
8.1.2. Carriers
Thin plates made from stainless steel
(X5 CrNi 18-10 according to the German
standard DIN EN 10088-1) with a surface
graining of 80 and a size of 10 mm x
130 mm are used as carrier material.
The area to be contaminated is 10 mm
x 100 mm.
When applying the test soil to the plate,
make sure that it does not come in contact with the sides of the plate. In order
to ensure uniform distribution on the
1
Heparinized sheep blood
Manufacturer: for example, Froscheck Labordiagnostik-Tierblutspezialisten GmbH, Arndtstr. 51–55,
45473 Mülheim, Germany or ACILA AG, Opelstr. 14,
64546 Mörfelden-Walldorf, Germany.
2
RAM test suspension
0.6 g BSA (Serva 11930) and 1.0 g mucine (Sigma
No. 2378) dissolved in a 100 ml NaCl-peptone
solution. The RAM test suspension therefore contains 1% mucine and 0.6 % bovine serum albumin.
The sedimented test bacteria are suspended in
this solution.
surface, the carrier must be thoroughly
degreased (alcohol is not sufficient!
Recommended are grease solvents, laboratory detergents or cleaning in an
industrial washer at approx. 60°C).
Multiple reuse is only possible if the
carrier is perfectly cleaned. After decontamination, the carriers must be
stored in a dry condition.
8.1.3. Applying the test soil onto
the carrier
A sample of 0.1 ml of the test soil is
uniformly applied to each contamination
area and dried for 24 h at 22°C ±1°C
and with a humidity of 50 % ±10 % (humidity and temperature must be indicated in the test report). The testing must
be performed within the first 24 hours
after the drying phase.
Three transport controls are to be carried
out at the same time as the test itself.
The number of bacteria per contaminated biological indicator must be high
enough that a 5-log10 reduction can be
demonstrated (at least 1 x 107 CFU/test
sample) even after taking the detectable
level into account.
8.1.4. Test parameters and set-up
Part 8
햴
햻
햸
햷 햵 햶
8.1.4.1. Test parameters
and set-up for bedframes
and bedside tables
Number of biological indicators
per cycle
10 biological indicators per bedframe
or 14 biological indicators per bedframe
with side rails (with and without piggyback system), 9 biological indicators
per child's bedframe, 5 biological indicators per bed-side table
Number of cycles to be tested
10 sequential cycles
Test suspension
Enterococcus faecium ATCC 6057 suspended in blood (sterile, heparinized
sheep blood with reactivated protamine
sulphate) according to 8.1.1.
Preparing the biological indicators
On the contamination area of each stainless steel plate, 0.1 ml of test soil is to be
applied and let dry according to 8.1.2.
and 8.1.3. In addition, three biological
indicators are to be prepared for the
transport control.
Test arrangement
The biological indicators are to be
arranged according to the illustrations
9a, 9b, 9c, and 9d:
Visible biological indicator
Biological indicator not in the line of sight
햲
햳
햺
햹
Figure 9a: Positioning the biological
indicators on a bedframe
햲 Head end panel, outer surface
햳 Head end panel, inner surface
햴 Head end rail
햵 Foot end panel, outer surface
햶 Foot end panel, inner surface
햷 Foot end rail
햸 Left sidebar
햹 Right sidebar
햺 Middle of lying area
햻 Lifting pole (if present/not removed)
햿 헀
햽
햾
Figure 9b: Positioning the biological
indicators on a bedframe with side rails
In addition to the biological indicators
shown in Fig. 9a, there are four additional
biological indicators to be put into position:
Side rail…
햽 at head, right panel on outer surface
햾 at head end, right panel on inner surface
햿 at foot end, left panel on outer surface
헀 at foot end, left panel on inner surface
37
Part 8
햶
햳 햲 햴 햵
The biological indicators must be fastened in special clamps so that they
cannot move and so that no distortion
of the results can be expected. The
contaminated areas of the biological
indicators must face outwards.
Soiling of the decontamination solution
After each test cycle, 5 ml of the test soil
are to be added to the decontamination solution in the storage tank.
Figure 9c: Positioning the biological
indicators on a bed-side table
햲 Surface top
햳 Bottom shelf space, middle of inner
surface
햴 Drawer, inner surface
햵 Drawer handle
햶 Folding table
햲 햴햳
햺 햹 햸
햶 햷햵
햺 햳
햵 햲 햻 햴
햶
햸
햹
햷
indicators on a transport cart
8.1.4.2. Test parameters and
set-up for transport carts
per cycle
10 biological indicators per transport cart
10 sequential cycles per type of transport cart
햲 Top plate, inner surface
햳 Side wall, left inner surface
햴 Side wall, right inner surface
햵 Back wall, middle inner surface
햶 Base plate, left inner surface
햷 Base plate, right inner surface
햸 Door, left handle area
햹 Door, right handle area
햺 Side wall, left outer surface
햻 Side wall, right outer surface
햳햺
햵
햲햴 햻 햹
Test suspension
Enterococcus faecium ATCC 6057 suspended in a RAM solution according to
8.1.1.
Figure 9d: Positioning the biological
indicators on a child's bedframe
햲 Head end bars, outer surface
햳 Head end bars, inner surface
햴 Head end, upper rail
햵 Foot end bars, outer surface
햶 Foot end bars, inner surface
햷 Foot end, upper rail
햸 Left side rail, top
햹 Right side rail, top
햺 Middle of lying area
38
Biological indicator not in line of sight
On the contamination area of each stainless steel plate, 0.1 ml of test soil is to
be applied and let dry according to
8.1.2. and 8.1.3. In addition, three biological indicators are to be prepared for
the transport control.
Test arrangement
10a and 10b:
햶
햸
햷
Figure 10b: Positioning the biological
indicators on a transport cart for dishes
햲 – 햻 as in Fig. 10a
햲햷
After each test cycle, 5 ml of the test soil
are to be added to the decontamination solution in the storage tank.
Test arrangement
11a and 11b.
햶햻
햳 햸 햴 햹 햵햺
indicators on the distribution container
and set-up for
distribution containers:
햲 Left inner side
햳 Front
inner side
outer side
햴 Floor side,
햹 Floor side,
inner surface
Number of TI and biological indicators
per cycle
5 distribution containers each with 10
biological indicators per cycle on a fully
loaded cart.
햷 Left outer side
햸 Front
outer surface
햵 Right
햺 Right
inner side
outer side
햶 Rear inner side
햻 Rear outer side
햲
햴
햳
2 sequential cycles per type of distribution container
Test suspension
Enterococcus faecium ATCC 6057 suspended in a RAM solution according to
8.1.1.
On the contamination area of each
stainless steel plate, 0.1 ml of test soil
is to be applied and let dry according to
햶
햵
Figure 11b: Positioning the distribution
containers with the biological indicators
on the loading cart
햲 Container, top left
햳 Container, top right
햴 Container in the middle area
햵 Container, bottom right
햶 Container, bottom left
Part 8
At least 4 distribution containers are to
be tested in the positions at the top and
at the bottom (front and rear) as well as
one in the middle. When the procedure
is done, make sure that not only the
biological indicator on the left outer side
but also the biological indicators on
the right outer side are collected.
Before the first test cycle, 5 ml of test
soil is to be added to the decontamination solution in the storage tank. In
addition after each test cycle, 5 ml of
the test soil is added to the decontamination solution.
and set-up for reusable
sterilization containers:
per cycle
5 sterilization containers incl. lid each
with 8 biological indicators on a fully
loaded cart
39
Part 8
2 sequential cycles per type of container
and set-up for surgical tables
and furnishings:
햸
Test suspension
sheep blood with reactivated protamine sulphate) according to 8.1.1.
Test arrangement
The distribution and positioning of the
biological indicators is to be done
according to the illustrations 12a and
12b (model).
per cycle
10 biological indicators per surgical table
and transporter.
햹
햷
햵햳
햶 햲 햴
indicators on the sterilization containers
햲 Bottom panel, right inner surface
햳 Bottom panel, left outer surface
햴 Side panel (short), right inner surface
햵 Side panel (short), left inner surface
햶 Side panel (long), right inner surface
햷 Side panel (long), left inner surface
햸 Lid, right inner surface
햹 Lid, left outer surface
햵
햲
햳
of the results can be expected. The contaminated areas of the biological indicators must face outwards.
After each test cycle, 5 ml of the test
soil are to be added to the decontamination solution in the storage tank.
40
Test suspension
sulphate) or into a RAM solution according to 8.1.1.
Test arrangement
arranged according to illustration 13.
햶
햴
Figure 12b: Positioning the sterilization
containers with the biological indicators
on a loading cart
햲 Container, top left
햳 Container, top right
햴 Container, bottom right
햵 Container, top right rear
햶 Container, bottom right rear
8.1.4.6. Test parameters and
set-up for surgical clogs:
햲
햵
햳
햶
Part 8
햴햷
per cycle
9 surgical clogs each with 2 biological
indicators on a fully loaded cart.
햸
햳 햲
햻햹
햺
Fig. 13: Positioning the biological indicators on the surgical table and transporter
햲 Head end plate, top
햳 Middle plate, on the side edge
햴 Underframe
햵 Plate, underside
햶 Foot end plate, underside
햷 Underframe
햸 Bar in the middle area
햹 Middle piece, underneath
햺 Underframe
햻 Middle piece, underneath
Test suspension
sulphate) according to 8.1.1.
Test arrangement
14a and 14b.
The biological indicators must be fastened in such a way that they cannot
move and that no distortion of the results can be expected. The contaminated areas of the biological indicators
must face outwards.
indicators on a surgical clog
햲 Sole, inner surface
햳 Sole, outer surface
햳
햲
햵
햶
햴
햷
햸
햹
햺
Figure 14b: Positioning the surgical
clogs with the biological indicators on
a loading cart
햲 Top left
햳 Top middle
햴 Top right
햵 Middle left
햶 Middle
햷 Middle right
햸 Bottom left
햹 Bottom middle
햺 Bottom right
41
Part 8
8.1.5. Evaluation
After the biological indicators are run
through the BDS program, they must be
removed under aseptic conditions (for
example, one sterilized pair of tweezers
per test sample), submitted to a visual
check for residue from the test soil, and
each transferred into 10 ml of phosphate-buffer solution (PBS), if necessary, containing inactivation agents.
Composition of the phosphate-buffer
solution (PBS)
The shaking is done in test tube racks
on shaking devices at a frequency of
approx. 500 min–1 for at least 20 min.
The bacterial count in the shaken liquid
is then determined. The method used
must be indicated.
The transport controls, which were not
treated in the decontamination system,
are transferred into 10 ml of PBS and
evaluated at the same time and in the
same manner.
Solution A: 16 g NaCl;
0.4 g KCI;
0.4 g KH2PO4
dissolved in 1600 ml
distilled water.
The following methods for assessing
the bacterial count are allowed:
쐍 Series dilution and surface culture
쐍 Spiral plater
Solution B: 0.2 g CaCl2
dissolved in 200 ml
distilled water.
A suitable culture medium (for example,
Kanamycin-Aesculin-Azide-Agar) is to be
used.
Solution C: 0.2 g MgSO4
dissolved in 200 ml
distilled water.
The method for determining the bacterial count as well as the nutrient broths
and culture media used are to be indicated in the report.
Solutions A to C are to be sterilized
separately and, after being fully cooled
under sterile conditions, mixed together,
if necessary, with the addition of inactivation agents, see above.
42
The test bacteria are recovered by shaking the treated biological indicators in
test tubes.
The determination of suitable inactivation agents is to be indicated in the
report.
The inoculated culture media are to be
incubated at 36 ± 1°C for 48 hours.
The reduction of microorganisms is determined by taking the difference between the number of test bacteria on
the CFU detected on the treated biological indicators and the mean value of
the three untreated biological indicators (transport controls). The reduction
factor must be at least 5 log10 steps.
8.1.6. Testing the decontamination
solution
In order to perform a microbiological review of the decontamination solution,
samples of 100 ml are taken from the
storage tank. This is done once before
the start of the test, and then after each
test cycle has been treated but before
the test soil is added.
At the end of the test (that is, after the
last test cycle), 1000 ml are taken from
the storage tank.
After being removed, the samples are
immediately mixed into the same
volume of a 2-fold concentration of TSB
with suitable inactivation agents and
then immediately cooled down.
The cultures are incubated at 36 ±1°C
for 72 h.
Cloudy cultures are streaked onto suitable culture media. This is to be indicated in the report.
The test bacteria must not be detectable
in the volumes tested (100 and 1000 ml,
respectively). Information about any
accompanying flora should be noted in
the report.
8.2. Operational qualification
After the system has been installed, the
operator must ensure operational qualification (OQ). This is used to demonstrate that, when operated properly,
the BDS provides the required decontamination performance according to current testing procedures.
These tests are carried out after the
technical acceptance and a trial run.
The same test method is used as for
the procedure test. Normally, two test
runs (test cycles), each with one TI resp.
with one loading cart with distribution
containers, surgical clogs, and sterilization containers are sufficient. If bedframes using the piggyback system are
tested, an additional test of bedframes
not using the piggyback system is not
required.
If the system is to be used to clean special bedframes (intensive care or children's beds), transport carts, surgical
tables and transporters or sterilization
containers, these types must be included in the testing series.
The biological indicators are to be prepared and positioned on the TI to be
tested as described in 8.1.1– 8.1.4.
8.3. Periodic testing
Periodic testing is to be performed at
least every 6 months in order to demon-
strate that the BDS fulfills hygienic
requirements when operated properly.
The same test method is used as for
OQ. The testing is to be performed on
the last cycle of the day.
At least two cycles with each type of TI
are to be run. If it is determined that
one type of TI is more difficult to decontaminate than others, then this TI is to
be used.
The biological indicators are to be prepared and positioned on the TI to be
tested as described in 8.1.1– 8.1.4.
In the order to perform a microbiological
test of the decontamination solution,
1000 ml is taken from the storage tank
at the end of operation time. The sample
is treated as described in 8.1.6. The
number of colonies may not exceed
100 CFU/ml. Test bacteria must not be
detectable.
8.4. Special testing
Special testing must be performed whenever repairs affecting the procedure,
program changes or alterations to the TI
are made. The testing is done according
to the guidelines for periodic testing.
If necessary, a microbiological test of
the decontamination solution is to be
performed as described in 8.3. (subsection 5).
REMARKS FOR 8.1. TO 8.4.
Part 8
The statement about the procedure
test in the report applies only to the
test conditions in regards to temperature, type, and concentration of the
decontamination agent, contact times,
specific system parameters, as well
as the type of TI used in each case.
In addition, statements about the
initial tests after installation and the
periodical testing refer only to local
on-site conditions. BDSs with fresh
water systems are subject to the same
testing methods except for specific
tests for circulation systems, for
example, decontamination solution
tests.
The RAM test suspension can also
be used for periodic and special
testing of bedframes.
For periodic testing, a regular technical review of the jets and filters can
be made together with a microbiological test of the decontamination
solution in the storage tank, instead
of a semi-annual microbiological test
with biological indicators. Technical
checks should be made 1–3 times
per week depending on how heavily
the BDS is used.
43
Part 9
Ecological requirements
A BDS must guarantee completely accurate decontamination results over
the course of the entire operating period while using the least amount of
power, water, and PCH possible.
From an ecological point of view, the
following requirements must be fulfilled:
9.1. Water
With regard to water consumption, a
circulation system is preferred. In order
to achieve the lowest possible consumption, it is necessary to return the
warm water containing the rinsing
agent back into the system. Experience
has shown that with a volume of 250 to
350 l of decontamination solution in
the storage tank and depending on the
TI and the degree of contamination, it is
necessary to add between 10 and 20 l
of water (approx. 4–7 %) per cycle.
9.2. Energy
44
A certain expenditure of energy is necessary to guarantee perfect operation
of the system. In order to keep energy
expenditures as low as possible, all
state-of-the-art technology and any
feasible alternatives are to be exhausted
(for more information, see Part 6).
9.3. Process chemicals
The goal, when assessing the procedure test, is to achieve totally accurate
hygienic results with the lowest possible
concentration of decontamination agent.
Note that decontamination times shorter
than 120 seconds require higher concentrations of decontamination agent.
The manufacturers of BDS and PCH provide dosing devices to ensure an exact
dosage. Overdosing means unnecessary
environmental pollution, while underdosing means inadequate decontamination or rinsing results.
Process chemicals must be developed
using raw materials which cause the
lowest possible amount of ecological
damage.
The PCH application solutions should
preferably be pH neutral. When treating
transport carts, which are normally
more heavily contaminated, alkaline or
acidic PCHs may be necessary.
The most important PCH components
are:
Surfactants decrease the surface tension of the decontamination solution or
of the rinse water. This promotes the
cleaning effect and ensures a uniform
wetting of the TI, thereby encouraging
independent drying. The biological
degradability of surfactants is stipulated in Regulation (EC) No. 648/2004 of
the European Parliament and of the
Council on detergents.
The disinfectants in the decontamination
agents must not pose a health hazard
to the bed center staff when the chamber
ventilation is functioning properly and
the usual drying times inside the BDS
are maintained. The disinfectants in
the decontamination agents must be
formulated in such a way that, when
used properly and diluted normally in
waste water, the concentration as well
as the antimicrobial properties of the
diluted decontamination agent cause
no acute danger to sewage sludge organisms and can be degraded or eliminated by them.
Other components such as softening
agents (chelating agents), dispersing
agents, anti-corrosive agents as well as
other cleaning agents are subject to
the same provisions with regard to
degradation or elimination as those for
disinfectants.
If the process chemicals contain or can
form absorbable organic halogen compounds by mixing with other types of
waste water or if they contain certain
heavy metals, then the limits set down in
the regulations for indirect dischargers
issued by the governments of the indi-
vidual federal states must be observed
or an application for a discharge permit
must be made.
Process chemicals for transport carts may
also contain alkalis or acids. Keeping
the pH of the waste water in the range
of 6 to 10 as specified in the waste
water regulations can be done by diluting
it with domestic waste water or, if necessary, by using neutralizing agents.
The containers used to deliver the PCH
should be, if at all possible, made of
environmentally friendly plastics (for
example, PE or PP). In order to dispose
of these containers properly, they need
to be emptied completely. In general,
the number of empty plastic containers
to be disposed of can be reduced by
increasing the use of large reusable
containers. This allows the PCH to be
delivered in refillable containers instead
of canisters.
9.4. Waste water
eration of the sewage treatment plant,
and waste-water monitoring. In order to
motivate indirect dischargers to reduce
the amount of pollutants they release,
many cities and communities have
introduced what are called “discharge
coefficients”. These values are based
on analytical data and used to evaluate
how much waste water individual indirect dischargers actually release into
the sewage system. This data is used to
calculate a fee based on the amount of
pollution produced (“pay as you pollute”
principle).
Independent of the question of fees, indirect dischargers are also subject to
the obligatory discharge limits specified in the indirect discharger regulations passed by the individual federal
states. These limits must not be exceeded. Due to the high degree of
dilution, the biocidal agents and PCH
solution components contained in the
waste water have no influence on the
biological treatment stage at sewage
treatment plants.
The operators of BDSs are normally
also indirect waste water dischargers.
The indirect discharge of waste water
into the sewage system is regulated by
state and local authorities. This means
that local regulations may vary from
place to place.
The decontamination agents used in a
BDS must be dosed using suitable dosing devices at the concentration determined in the procedure test.
Indirect dischargers pay an effluent
charge, which covers the cost of the
sewage tax, the sewage system, the op-
Exhaust air is ecologically safe. Normally, chamber air saturated with water
vapor is ventilated safely outdoors.
9.6. Heat dissipation
Part 9
Due to chemo-thermal chemical or
thermal decontamination processes,
heat dissipates from the front areas of
the BDS, the TI, and the machine room.
BDS manufacturers are urged to reduce
the heat dissipation to the lowest level
possible in as much as this is justified
by technical and economic considerations.
Steam conduits provided by the operator are to be insulated to reduce heat
loss according to the German Heat
Conservation Provision.
9.5. Exhaust air
45
Appendix
DIN REGULATIONS
DIN 58 955 – Decontamination
equipment for medical use
Part 1 – Terminology
Part 2 – Requirements
Part 3 – Efficiency testing
Part 4 – Biological Indicators –
Requirements
Part 6 – Operation
Part 7 – Structural Requirements and
Requirements services supply
When acquiring a BDS, the basis of
agreement between the client and supplier are the provisions in the “supplementary contractual conditions for VOB
(Verdingungsordnung für Bauleistungen
= Standard Conditions of Building Contract Terms) and VOL (Verdingungsordnung für Leistungen = Standard Conditions of Contract Terms for Works and
Services) for trade sterilization and
disinfection systems” – EVB STER/DES
07.00.
DIN 1946-4: 1999-03
Ventilation and air-conditioning
Part 4: Ventilation and air-conditioning
systems in hospitals (VDI ventilation rules)
DIN 1988: 1988-12
Drinking water supply systems (TRW)
Drainage systems on private ground
DIN 1986: 1988-06
Technical conditions for construction
DIN 50014: 1985-07
Climates and their technical
application – standard atmospheres
DIN VDE 0100: 1973-05
Erection of power installations with
nominal voltages up to 1000 V
DIN EN 50110-1: 1997-10
Operation of electrical installations;
German version EN 50110-1: 1996
(VDE 0105 Part 1)
DIN EN 50178 VDE 060: 1998-04
Electronic equipment for use in power
installations;
German version EN 50178: 1997
NORMATIVE REFERENCES
46
DIN EN 13190: 2002-03
Dial thermometer
DIN EN 60529 VDE 0470-1: 1991
Degrees of protection provided by
enclosures (IP code)
DIN 18202: 1997-04
Dimensional tolerances in building
construction – Buildings
DIN EN 10088-1: 1995-08
Stainless steels
Part 1: List of stainless steels
DIN EN 60073 VDE 0199: 1997-09
Basic and safety principles for manmachine interface, marking and identification - Coding principles for indicators and actuators
EN 60204-1 VDE 0113 Teil 1: 1998-11
Safety of machinery - Electrical equipment of machines
Part 1: General requirements,
DIN 10510: 2001-04
Food hygiene – Commercial dishwashing with multi-tank conveyor dishwashers – Hygiene requirements, procedure
testing
DIN 4140: 1996-11
Insulation work on industrial installations and building equipment –
Execution of thermal and cold insulation
DIN EN 61010 VDE 0411
Safety requirements for electrical
equipment for measurement, control
and laboratory use
Part 1: General requirements
(German version EN 61010-1:2001),
Part 2-045: Particular requirements for
washer disinfectors used in medical,
pharmaceutical, veterinary and
laboratory fields
(German version EN 61010-2-045: 2000)
GUIDELINES/REGULATIONS
a. European Medical Device Directive
(MDD)
b. German Medical Devices Operator
Ordinance (MPBetreibV)
h. Recommendation made by the
Robert Koch Institute: Testing and
declaration of the efficacy of disinfectants against viruses
i. German “Guidelines for poweroperated windows, doors and
gates” ZH 1/494
c. VDE regulations
d. DVGW Guidelines (German Technical
and Scientific Association for Gas
and Water)
e. Safety regulations
f. Workplaces Ordinance (ArbStättv)
incl. Workplace Regulations
g. Guidelines on hospital hygiene and
infectious disease prevention developed by the Robert Koch Institute
j. When connecting decontamination
systems to the power supply system,
the “Technical Connection Requirements” (TCR) published by the
respective power supply company
(PSC) are to be observed. According
to these requirements, the client
normally hands over the mains
connection for the decontamination
system to a licensed electrician
associated with the responsible PSC.
k. Regulation (EC) No. 648/2004 of
the European Parliament and of the
Council on detergents
l. German Chemical Act (Chemikaliengesetz) and German Chemical Regulation (Gefahrstoffverordnung) as well
as European Directives upon dangerous substances and preparations (e.g.
67/548/EEC, 1999/45/EC, 2001/58/EC)
m. German technical guideline for
hazardous substances 531 (German
TRGS 531): Danger to the skin when
working in a moist environment
(moist work)
n. German technical guideline for
hazardous substances 525 (German
TRGS 525, May 1998): Dealing with
hazardous substances in facilities
for human medical care
Closing remarks
This booklet describes how the various
aspects of the automated decontamination of different types of TI are interrelated.
The goal of all measures must be to
achieve reliable decontamination while
at the same time taking the following
points into account:
쐍 Legal requirements
쐍 Economic viability and cost effectiveness
쐍 Gentle treatment of the TI
쐍 Safety of the operating staff
쐍 Minimal ecological damage
During operation, be sure to observe all
the recommendations described in this
booklet, in particular those relating to
measures such as testing, checking
operating materials, and maintenance.
47
the Working
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Submitted by:
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AK- BWA Automated Decontamination

Transcription

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