B BRAUN
SHARING EXPERTISE
INSTRUCTIONS FOR
CLEANING AND STERILIZATION
OF ALL
B.BRAUN AESCULAP
HAND HELD SURGICAL INSTRUMENTS AND POWER PRODUCTS
(UNITED KINGDOM REQUIREMENTS)
1 INTRODUCTION
This paper is intended to give general guidance on how medical devices
supplied by B.Braun Aesculap may be processed to prepare them for use.
Equipment, operators, cleaning agents and procedures all have a contribution
to the efficacy of the processing and the healthcare facility should ensure that
the combination actually in use results in a medical device that is safe for use.
Alternative methods of processing may be equally suitable.
Devices labelled “for single use only" must not be reprocessed for re-use. When
single use devices are supplied non-sterile, and require sterilization before use,
then the appropriate sections of these insiructions may be applied unless other
specific instructions are provided in the package insert.
2 Cleaning
Two methods of cleaning B.Braun Aesculap medical devices are provided in this
paper, @ manual method and a method using an automated
washer/disinfector. Whenever possible the automated method should be used.
The automated cleaning process is more reproducible and therefore more
reliable, and staff are exposed less to the contaminated devices and the
cleaning agents used.B|/BRAUN
SHARING EXPERTISE
Whichever method is used, staff should use suitable protective clothing and
equipment (PPE) at all times. Take careful note of the instructions provided by
the cleaning agent manufacturer for correct handling and use of the product.B|BRAUN
SHARING EXPERTISE
For cleaning medical devices, only specifically formulated cleaning agents
(detergents) should be used. For manual cleaning, enzymatic agents with both
bactericidal and fungicidal properties are to be prefered. For cleaning
insiruments manufactured from aluminium alloys a pH neutral agent should be
used, Contact with strong alkaline detergents or solutions containing iodine or
chlorine should be avoided since the aluminium can be chemically attacked
and the instrument may be damaged.
tral to mild alkaline agents (up
ise only agents recommended for use in these
machines. in all cases respect the indications, instructions and wamings
provided by the supplier of the cleaning agent. Pay particular attention to the
concentration used and the total dispersion of the detergent.
A list of cleaning agents is included in Appendix 1 of this document. These have
been used to support these processing instructions. B.Braun Aesculap does not
recommend any one of these in preference to the others. Other cleaning
agents not included in the list may be equally suitable.
The quality of the water used for diluting cleaning agents and for rinsing medical
devices should be carefully considered. Mineral residues from hard water can
result in staining of the device or prevent effective cleaning and
decontamination. Descaling agents may be needed and will not harm the
devices.
2.1 Point Of Use
Remove gross soil using absorbent wipes.
2.2 Transport to Processing Area
Avoid mechanical damage. (e.g. don't mix heavy devices with delicate ones}.
Pay particular attention to cutting edges, both to avoid injury and damage to
the medical device. Get the medical devices to the point where cleaning is to
be performed as soon as practical (if transfer to the processing area is likely to
take time, consider covering the instruments with a damp cloth to avoid drying
out of the soil).
2.3 Preparation for CleaningB/ BRAUN
SHARING EXPERTISE
Disassemble the device where possible. See instructions provided in operation
technique or separate information available from your B.8raun Aesculap
representative. Most heavy-duty powered insirumentation cannot be further
disassembled beyond removing attachments. Please refer to the product
instructions for these procedures. Cases should be loaded immediately
following washin rior to steril
2.4 Manual Cleaning
2.4.1 Pre-Cleaning & Cleaning
Equipment required:
+ Brushes ~ soft and firm, bottle brushes for cannulations etc.
+ Personal Protective Equipment (PPE) as recommended by the cleaning
agent supplier (minimum overalls, gloves, face/eye shield)
+ Absorbent wipes
Procedure:
+ Remove gross soil using absorbent wipes moistened with cleaning agent
+ Ensure that all surfaces are thoroughly wetted
* Using suitable brushes clean the medical device thoroughly paying particular
attention to rough surfaces and features where soil may be shielded from the
brushing
+ Use a soft bristle brush of appropriate diameter for cannulations. Ensure that
the brush passes the whole length of the cannulation
+ Operate articulating devices and those with moving parts
+ Rinse in running water until all traces of cleaning solution are removed
+ Pay particular attention to cannulations, hinges, blind holes and joints
between mating parts. Activate any blade/bur/bit holding or clamping
apparatus to clear away any remaining cleaning solution
+ Visually inspect for any remaining soil and repeat the steps above if
necessary
+ Allow to drain on absorbent wipes or transfer immediately to inspection step
2.5 Automated Cleaning Using Washer-Disinfector (Recommended,
2.5.1 Pre-Cleaning
Equipment Required:SHARING EXPERTISE
PPE as recommended by the cleaning agent supplier (minimum overalls,
gloves, face/eye shield)
Absorbent wipes
Procedure:
Remove gross soil using absorbent wipes moistened with cleaning agent
Ensure that all surfaces are thoroughly wetted
Visually inspect for any remaining soll and repeat the steps above if
necessary
Allow to drain on absorbent wipes or transfer immediately to cleaning stepB|/BRAUN
SHARING EXPERTISE
2.5.2 Cleaning
Equipment Required:
+ Washer/disinfector (see note below)
+ Cleaning/rinsing agents as required by washer disinfector
Procedure:
* Load the medical devices into the washer disinfector:
* Avoid contact between ‘ement during washin« Id
damage, and washing action could be obstructed)
+ Amange medical s so that cannulas are not horizontal_and
openings are oriented downwards (to assist drainage)
+ DO NOT USE STERILIZATION TRAYS THAT ORIENT THE EQUIPMENT VERTICALLY IN
THE WA\ = Damage to the handpi rif this is done
+ Operate the washer disinfector cycle. (See note below)
* On completion unload the washer disinfector. Visually inspect each device
for remaining soil and dryness. If soil remains repeat the cleaning process.
Remaining wetness may be removed with medical grade compressed air or
by heating in an oven below 110°C
Note: Washer/disinfectors should comply with the requirements of HTM 2030 and
ISO 15883 (in preparation). They should be properly installed and be regularly
tested in accordance with ISO 15883.
+ The washing cycle should include:
+ Pre Rinse with neutral or mild alkaline pH enzymatic detergent (2-4 minutes at
15-16°C)
+ Detergent can be omitted at the pre-rinse stage if washer/disinfector
equipment does not have this ability
+ Wash with neutral or mild alkaline pH enzymatic detergent (24 minutes ata
minimum of 60°C)
Drain
Cold Water Rinse for at least 2 minutes
Final Rinse (at least 2 minutes at a minimum of 60°C)
Drain
+ Dry Phase for 15 minutes (with max. temperature of 137°C)SHARING EXPERTISE
2.6 Inspection
* Before preparing for sterilization all medical devices should be inspected
+ Generally un-magnified visual inspection under good light conditions is
sufficient. All parts of the devices should be checked for visible soil, damage
and/or corrosion. Particular attention should be paid to:
* Soil “traps” such as mating surfaces, hinges, shafts etc.
= Recessed features (holes, cannulations)
* Features where soil may be pressed into contact with the device
* For devices that may be impacted check that the device is not
damaged to the extent that it malfunctions or that burrs have been
produced that could damage fissues or surgical gloves
Functional checks should be performed where possible:
+ Mating devices should be checked for proper assembly
+ Medical devices with moving parts should be operated to check correct
‘operation (medical grade lubricating oil suitable for steam sterilization can
be applied gs required and only in accordance with instructions for use’
3 Sterilization
The three minute time is for exposure, it does not include ramp up times or dry
cycle fimes needed.
B.Braun Medical Limited confirm that all handheld Instruments and Power Tools
can be decontaminated in accordance with HTM 2030 and sterilised in
accordance with HTM 2010.
However, based on different process parameters, sterility has to be proven by
each sterilisation site. Healthcare facilities should validate the process that they
use, employing the actual equipment and operators that routinely process the
devices.
Steam autoclave [moist heat) sterilization using a pre-vacuum (forced air
removal) cycle is required
Autoclaves should comply with the requirements of, and be validated in
accordance with, ISO 13683.Sterlization cases can be used and should be loaded just prior to the sterilization
step.
Sterilization Parameters Listed_In This Report Must Follow A Washer/Disinfector
Process. If A washer/disinfector is not available, sterilization parameters listed in
the instructions for use of the involved product must be followed.
Note: The final responsibility for validation of sterilization techniques and
equipment lies directly with the hospital. To ensure optimal processing all cycles
and methods should be validated for different steriization chambers, wrapping
methods and/or various load configurations.
4 Storage Before Use
The shelf life is depending on sterile barrier employed, storage, environmental
and handling conditions. A maximum shelf life for sterilized medical devices
before use should be defined by each health care facility.
5 References
+ ISO 11134: Sterilization of health care products - Requirements for validation
and routine control - Industrial moist heat sterilization
+ ISO 13683: Sterilization of health care products - Requirements for validation
and routine control of moist heat sterilization in health care facilities.B|/BRAUN
SHARING EXPERTISE
y -
N
Cleaning Agents Used To Support These Processing Instru:
Appendix 1
ns.
A cleaning agent (detergent) specifically formulated for cleaning medical
devices should be used.
+ For manual cleaning enzymatic agents with both bactericidal and fungicidal
properties are to be preferred.
+ For cleaning instruments manufactured from aluminium alloys, a pH neutral
‘or an enzymatic cleaner known to be suitable for aluminium should be used.
Contact with sirong alkaline detergents or solutions containing iodine or
chlorine should be avoided.
+ For automatic (washer/disinfector) cleaning mild alkaline agents (up to pH
10.5) may be preferred, however use only agents recommended for use in
these machines. In all cases respect the indications, instructions and warnings
provided by the supplier of the cleaning agent.
Notes:
1. Below are listed the cleaning agents used by B.Braun Aesculap to support
the instructions for processing hand held surgical instruments and power
products provided in this document.
2, B.Braun Aesculap does not recommend these products in preference to
others that are available. Other products may perform equally or better in
conjunction with the equipment being used.
3. The instructions provided by the supplier of the cleaning agent should be
followed.
4, Cleaning agent use must not contain chemicals that are not suitable for
aluminium instruments.
5. Personal protection for operators should be provided in accordance with the
suppliers instructions and safety data sheets
6. Suitability of altemative agents should be checked by reference to the
supplier's information and/or physical testing.
Cleaning agents used for manual and automated (washer/disinfector cleaning)
B.Braun - Contact Joanne Clegg for details.
Helimatic Cleaner Enzymatic for aluminium automatic washers
Helizyme for manual or ultrasonic cleaning
Supplier
DesignationB|BRAUN
SHARING EXPERTISE
Comment
Alkapharm
Alkazym
Suitable for aluminium instruments
Johnson and Johnson
Enzol
Suitable for aluminium instruments
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