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Cleaning / Disinfection / Sterilisation
Guidelines for Healthcare Products
International SalesMedela AG, Medical TechnologyLättichstrasse
4b, 6341 BaarSwitzerlandPhone +41 (0)41 769 51 51Fax +41 (0)41 769
51 [email protected], www.medela.com
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General information
Guidance notes on cleaning, disinfecting and sterilising Medela
Healthcare products.
This is only a summary of information available and does not
cover the entire range of Healthcare products; some may require
other specific cleaning procedures.
These notes are for healthcare professionals, such as nurses and
infection control practitioners, who work in a hospital
environment.
Products
Type Intended Use Specification
Reusable
e.g.silicone tubings
for more than one patient
multiple uses possible
Requires cleaning before use, unless provided in a sterile
condition
The accessories must be cleaned, disinfected and sterilised
after each use
Must be checked regularly for damage and appearance and replaced
if necessary
Disposable /Single use
e.g.filters
for one patientonly
use once only
Ready for use
Use immediately after opening the packaging
To be disposed of after using
Not to be used by more than one person in order to avoid
possible health risks.
Reprocessing could cause loss of mechanical, chemical and/ or
biological characteristics.
Reuse could cause cross contamination.
Cleaning measures
Method Description
Cleaning To remove dirt and other matter from healthcare
products by:– wiping, brushing– washing, rinsing, immersing,
soaking.
Disinfection This removes many or all pathogenic micro-organisms
on the various parts except for bacterial endospore and gives a
selective reduction of viable germs (< 99.9%).–
Cleaning/Disinfection machine– Physical (thermal) – Chemical
disinfectants– Combination thermal/chemical
Sterilisation Removes all viable micro-organisms (100%)–
Autoclave– Steam sterilisers– Gas– Radiation
Cleaning method
These instructions are for cleaning Medela products.
They are general recommendations only that may be adjusted
individually, based on the hospital’s specific directives and
cleaning practices and policies.
Disassembly Separate all individual parts before cleaning,
disinfecting and sterilising.
Cleaning Use detergents with a pH range between 6.0 and 8.0
only, in order to avoidDetergents damaging the instruments and
containment devices. Enzymatic detergents
help with the removal of organic matter, such as blood.
Detergents should be used according to their manufacturer’s
recommended concentration levels. Some alkaline detergents have
been formulated to be safe for reprocessing medical devices. The
manufacturers of these detergents should provide in-formation about
specific materials that may be damaged by their detergents.
Water Use only the purest quality of water for cleaning. Water
hardness is a serious consideration since deposits left on medical
products may not be properly decontaminated. Use deionised water in
order to reduce this problem. The final rinse water is bacterial
free and contains no endotoxins.
Disinfecting Refer to chart.
Sterilising Refer to chart.
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Storing After sterilising, store the components in sterile foil
until required for use.components
Device care Wipe over with a damp cloth or use a non-abrasive
detergent (refer to chart).Daily, or as necessary
Cleaning/ A hot water rinse (maximum temperature 100°C) may
provide a medium-to-disinfection high level of disinfection. Every
section of the constituent parts must be machines accessible in
order to ensure efficient cleaning. We recommend using a
cleaning/disinfecting machine that has been approved by the Robert
Koch- Institute and complies with ISO 15883. Recommended
temperature for non-
critical medical devices (i.e. those that only come into contact
with uninjured skin) is 90°C for 1 minute. The time is increased to
5 minutes for all medical devices that are considered to be
critical.
Disinfection For all potentially contaminated parts: Perform
disinfection according to your standard hygiene plan or the
instructions of the manufacturer of your disinfecting agent: 1.
Wipe the surfaces with a surface disinfectant. Observe the
reaction
time of the agent. 2. Wipe with disinfectant once more and wipe
parts dry with a disposable
towel or allow to air-dry. – Dispose of protective gloves after
the disinfection procedure. – Disinfect your hands.
Recommended practice for reusable productsRecommended cleaning
methods have been validated by Medela to current international
guide-lines for cleaning. Use the products chart in order to
determine the correct cleaning method.
Cleaning
Unplug before cleaning electrical devices.– Follow hospital
guidelines on hygiene.– Separate all parts before cleaning,
disinfecting and sterilising.
Recommendation Cleaning Agents
NOT for use
C1 To remove dirt and other matter, clean by:– wiping, brushing–
if applicable: washing, rinsing, immersing and
soaking
standard soap
C2 Place individual constituent parts in top rack of dishwasher
(standard programme > 58°C).
standard dish-washer detergent
Do not exceed the manufacturer’s recommended concentrations,
soaking times or temperatures.
C3 Soak all parts thoroughly with warm, soapy wa-ter or in
enzymatic detergent for 1–5 minutes.
1. Remove visible dirt with a cleaning tool – ge-neral purpose
cleaning brushes, such as pipe cleaners or non-abrasive lint
cloths. Brushes and pipe cleaners should fit snugly but still be
able to be moved around easily within the area to be cleaned.
Rinse thoroughly in clear water.
2. Check the instruments for visible dirt and repeat these steps
if necessary.
standard soap
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Disinfection
Unplug before cleaning electrical devices.– Follow hospital
guidelines on hygiene.– Separate all parts before cleaning,
disinfecting and sterilising.
Recommendation Cleaning Agents NOT for use
D1 Clean the surfaces with a cloth moistened with an
aldehyde-free non-abrasive cleansing and disinfecting solution.
No cleansing solution should penetrate into the equipment.
Meliseptol rapid (B.Braun Medical AG), Hexaquart Plus (B.Braun),
Perform (Schülke & Mayr), Incidin foam (Ecolab), QuickClean
Anti- bacterial wipes (Medela Inc)Dispatch® (Caltech
Industries)
Terralin (Schülke & Mayr)TB Quat (3M)
D2 Disinfect with the disinfecting agent group ‘alcohol’.
Meliseptol rapid (B.Braun Medical AG)
D3 Use a disposable cloth to wipe off any visible dirt.
Disinfect surfaces with special disinfec-tant wipes.
Ensure use of disinfectants based on aldehydes and quaternary
ammonium compounds because of their material compatibility.
Incidur (Ecolab), Gigasept FF (Schülke & Mayr), Bacillotox
(Bode Chemie Hamburg), Dismozon® pur (Bode Chemie Hamburg),
Gevisol(Schülke & Mayr)
– halogen-releasing compounds
– strong organic acids
– oxygenre-leasing
D4 Suitable for cleaning in a Disinfecting Machine.Maximum
temperature for disinfection: 100 °C.
Neodisher FA (cleaning) and Neodisher Z (neutralisation) (Dr.
Weigert)
Cleaning/disinfecting agents based on phenol.
D5 Soak at room temperature for 30 minutes in a
disinfection/cleaning solution (A).
After the reaction time, use water to rinse the solution residue
from the individual parts and rinse the tubing.
Disassemble parts.
Rinse for at least 2 minutes with the cleaning solution (B).
(A) fluid aldehyde-free disinfection solution with cleaning
effect for use as a soaking bath, bacteri-cide, fungicide, limited
virucide, with good material compatibility for stainless steel,
non-ferrous material and plastics including silicone, slightly
alkalic. e.g. 2% neodisher® Septo MEDsolution
(B) Fluid, pH-neutral, enzymatic cleaning solution for the
treatment of instruments by machine or manually with very good
material compatibility for stainless steel, non-ferrous material
and plastics including silicone.
Do not use any cleaning/disinfecting agents based on phenol.
Sterilisation
– Comply with in-house directives on hygiene.– Separate all
parts before cleaning, disinfecting and sterilising.
Recommendation Cleaning Agents NOTE
S1 Remove any chemical disinfec-tant residue before
autoclaving.Do not stack during autoclaving.In the autoclave at
134°C for 10 minutes.
Comply with the manufacturer’s recommended concentrations,
soaking times and temperatures when preparing chemical
disinfectants for use.
S2 Ethylene oxide Ethylene oxide
S3 The sterilisation device must comply to ISO 17665:2003. The
following procedures are acceptable: In the autoclave with
saturated steam at 132°C, with triple pre-evacuation, sterilisation
time of 6 minutes. or at 135 - 137°C in an porous load vacuum
autoclave for 3-3.5 minutes
Cleaning Agents
B.Braun / Meliseptol® rapid100g contains: 50g 1-Propanol 0,075g
Dideclydimethylammoniumchloride
B.Braun / Hexaquart® plusContains: 6%
Dideclydimethylammoniumchloride< 10% quaternary ammonium
compound< 10% nonionic tensides< 5% Propan-2-ol
Schülke & Mayr / Perform®100g contains:45 g
Pentapotassium-bis-(peroxymonosulphate) bis(sulphate)
Ecolab / Incidin® Foam100g contains:20g 2-Propanol, 10g Ethanol,
0,2g Benzalkoniumchloride, 0,01g Glucoprotamine
Ecolab / Incidur®100g contains:8,8g Glyoxal, 4,5g Glutaral.
Schülke & Mayr / gigasept® FF100g contains:11,9g succine
dialdehyde3,2g Dimethoxytetrahydrofuran
Bode Chemie / Bacillol® plus(instead of Bacillotox) –
Aldehyde-free, alcohol-basedContains:400 mg/g Propan-1-ol 200 mg/g;
Propan-2-ol 1,0 mg/g. Glutaral
Bode Chemie / Dismozon® pur Oxygen-active disinfectant
cleanerContains: 800 mg/g. Magnesium
monoperoxyphthalateHexahydrate
Schülke & Mayr / gevisol®100g contains:33,5g chlorcresol1,5g
Biphenyl-2-ol
Dr. Wiegert / Neodisher® FAContains:15-30% Phosphates
Dr. Wiegert / Neodisher® ZContains:Organic Acids
Dr. Wiegert / Neodisher® Septo Med100g contains:9.2g
Dodecylbisprophylentriamin13.0g Dideclydimethylammoniumchloride
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sAid
E
last
omer
e (S
ilico
ne)
xx
xx
xx
60
2
077.
002
9 -
077.
003
7S
uctio
n C
ups:
Mal
mst
röm
M
etal
(sta
inle
ss)
Ela
stom
ere
(Sili
cone
)x
xx
xx
x6
05
077.
003
8S
uctio
n C
ups:
Mal
mst
röm
tr
actio
n ha
ndle
with
sto
p cl
ipM
etal
(sta
inle
ss)
xx
xx
xx
60
5
077.
007
8,
077.
007
9S
uctio
n C
ups:
Silc
Cup
with
tr
ump
et v
alve
M
etal
(sta
inle
ss)
Ela
stom
ere
(Sili
cone
)x
xx
xx
x6
02
077.
0761
, 07
7.07
62S
uctio
n C
ups:
Silc
Cup
sE
last
omer
e (S
ilico
ne)
xx
xx
xx
60
2
077.
0792
Suc
tion
Cup
s: S
ingl
e U
se
Bird
Cup
Pla
stic
(PC
)x
077.
0791
Suc
tion
Cup
s: S
ingl
e U
se
Silc
Cup
Pla
stic
(var
ious
)x
077.
1044
Suc
tion
Cup
s: T
ract
ion
hand
le w
ith h
ook
to B
ird
Cup
s
Met
al (s
tain
less
)x
xx
xx
x6
05
077.
0211
, 07
7.02
12,
077.
0221
, 07
7.02
22,
077.
0231
, 07
7.02
32,
077.
008
2,
077.
008
5
Suc
tion
jar
PC
Pla
stic
(PC
)x
xx
x
22
-
Dis
po
-sa
ble
Cle
an
ing
Dis
infe
cti
on
Ste
rilis
ati
on
Pro
du
ct
life
Art
.Nr
De
scri
pti
on
Ma
teri
al
sin
gle
u
seC
1C
2C
3D
1D
2D
3D
4D
5S
1S
2S
3st
eri
ti
me
sye
ars
077.
0110
, 07
7.01
11,
077.
0120
, 07
7.01
25,
077.
0130
, 07
7.01
50,
077.
0155
Suc
tion
jar,
PS
UP
last
ic (P
SU
)x
xx
xx
250
2
60
0.0
680
Trol
ley
for
Bas
ic 3
0 an
d D
omin
ant
50M
etal
(sta
inle
ss)
Pla
stic
(PS
-coa
ted
)x
x
077.
0511
Trol
ley
smal
lM
etal
(sta
inle
ss-c
oate
d)
Pla
stic
(var
ious
)x
x
077.
146
0-
077.
1463
Trol
ley
with
infu
sion
hol
der
, E
uro
plu
gsM
etal
(sta
inle
ss)
Pla
stic
(var
ious
)x
x
077.
0751
, 07
7.07
52Tu
bin
g ho
lder
sM
etal
(sta
inle
ss)
xx
xx
x50
05
077.
00
93Tu
bin
g se
t: d
oub
le d
rain
age
Pla
stic
(PO
M +
Sili
cone
)Y-
pie
cex
xx
x25
02
077.
095
1,
077.
09
62,
077.
09
63,
074.
00
03
Tub
ing:
dis
pos
able
P
last
ic (P
VC
)x
077.
097
4Tu
bin
g: d
isp
osab
le d
rain
age
Pla
stic
(PV
C)
x
077.
09
61Tu
bin
g: S
ilico
ne, g
reen
P
last
ic (P
OM
+ S
ilico
ne)
xx
xx
x25
02
077.
091
2 -
077.
093
1Tu
bin
gs: S
ilico
ne w
ith c
oup
-lin
g p
iece
sP
last
ic (P
OM
+ S
ilico
ne)
xx
xx
x25
02
077.
09
00
- 07
7.0
905
, 07
7.0
970
Tub
ings
: Sili
cone
with
out
coup
ling
pie
ces
Ela
stom
ere
(Sili
cone
)x
xx
xx
250
2
077.
116
0Va
cuum
Eje
ctor
with
cla
mp
hold
erM
etal
(sta
inle
ss)
Pla
stic
(var
ious
)x
x
077.
004
7,
077.
008
1Va
cuum
ext
ract
or: p
ump
Met
al (s
tain
less
)P
last
ic (P
P +
var
ious
)x
xx
077.
0831
Vario
car
ryin
g b
agP
last
ic (P
olye
ster
+ P
VC
)x
077.
0834
Vario
Dis
pos
able
Filt
er S
et
with
Ove
rflo
w P
rote
ctio
n/B
acte
ria F
ilter
Pla
stic
(PP
+ P
OM
)Tu
bin
g: E
last
omer
e (S
ilico
ne)
x
077.
0821
, 07
7.08
25Va
rio r
ail h
old
er 1
0x25
mm
Met
al (s
tain
less
)x
xx
xx
500
5
-
Dis
po
-sa
ble
Cle
an
ing
Dis
infe
cti
on
Ste
rilis
ati
on
Pro
du
ct
life
Art
.Nr
De
scri
pti
on
Ma
teri
al
sin
gle
u
seC
1C
2C
3D
1D
2D
3D
4D
5S
1S
2S
3st
eri
ti
me
sye
ars
077.
0824
Vario
tro
lley
pla
teM
etal
(sta
inle
ss)
xx
xx
500
5
077.
0823
Vario
uni
vers
al h
old
erM
etal
(sta
inle
ss)
xx
xx
500
5
077.
0832
Vario
: Car
con
nect
ion
cab
le
12 V
DC
Met
al (s
tain
less
)P
last
ic (v
ario
us)
xx
077.
0523
, 07
7.05
24W
all b
rack
ets
Pla
stic
(AS
A)
xx
xx
x50
05
077.
1020
Y-p
iece
Pla
stic
(PP
)x
