BIOTECH-GERMANDE
EN STANDARD FOR ENDOSCOPE
STORAGE CABINET
Lionel PINEAU PhD, BIOTECH-GERMANDE, France
ENDOSCOPE REPROCESSING
PROCEDURE
Patient
Reprocessing
Cleaning/disinfection
BIOTECH-GERMANDE
>12h
Storage
Drying
WHAT ARE THE RISKS?
"Further potential vehicles of infection are
inadequately designed or improperly maintained
automatic endoscope reprocessors, the use of
substandard disinfectant, or inadequate drying
and/or storage of endoscopes" BSG 2014
BIOTECH-GERMANDE
"Bacterial colonization during overnight storage
of endoscopes has been linked to patient
infection and death."Spach DH 1993, Streulens MJ
1993, Allen JI
BIOTECH-GERMANDE
WHAT ARE THE RECOMMENDATIONS?
DRYING
International recommendations
"Drying with alcohol and compressed air should be
done between each patient use when tap water is
used to rinse the endoscope channels and before
storage whether tap water or sterile water is used.”
APIC guidelines.
"Flush the channels with 70% to 90% ethyl or isopropyl
alcohol and dry with forced air.” Multi-society guideline
for reprocessing flexible gastrointestinal endoscopes. 2003.
“ If the endoscope is not used immediately, it is
recommended to dry it with medical grade air.”
DHOS/E2/DGS/SD5C/2003/N°591 du 17/12/2003
“ Dry channels with compressed air… Prior to storage, irrigate all channels with 70%
alcohol and dry with compressed air.”
QUEENSLAND HEALTH GUIDELINES BIOTECH-GERMANDE
GENCA/GSA
“Filtered air should be used as part of the drying process at the end of the working day
prior to endoscope storage. An alternative is to dry and store endoscopes in cabinets
….. Because of its fixative properties the use of isopropyl alcohol is no longer
recommended” BSG 2014
STORAGE
International recommendations
"Endoscopes should be hung vertically to
facilitate drying. Endoscopes should be stored
without control valves, distal hoods, caps, etc,
in place” APIC guidelines.
"When storing the endoscope, hang it in a
vertical position to facilitate drying (with caps,
valves, and other detachable components
removed as per manufacturer instructions)”
Multi-society guideline for reprocessing flexible
gastrointestinal endoscopes. 2003.
BIOTECH-GERMANDE
“ Endoscopes should be stored in a clean, dry an dedicated area away from any
source of microbial contamination.” CIRCULAIRE
DHOS/E2/DGS/SD5C/2003/N°591 du 17/12/2003.
“ Store endoscope (disassembled) in a well-ventilated storage cupboard, which
permits full length hanging on appropriate support structures...” QUEENSLAND
HEALTH GUIDELINES - GENCA/GSA
AFTER STORAGE
International recommendations
“When the endoscope has been stored for 12
hours or more, a disinfection (intermediary
level or high level disinfection according to the
endoscope considered) have to be performed
before the first use of this endoscope.”
CIRCULAIRE DHOS/E2/DGS/SD5C/2003/N°591
BIOTECH-GERMANDE
“Where appropriate quality assurance data is
available, the use of Endoscope Storage
Cabinets may obviate the need for repeat
endoscope reprocessing at the start of each
list.” SFHH guidelines March 2011
“Traditionally it has been recommended that, before the start of each list, each
endoscope to be used should undergo a full reprocessing cycle unless last used and
decontaminated within the preceding 3 hours. Where appropriate quality assurance
data is available, the use of drying/storage cabinets may obviate the need for repeat
endoscope reprocessing at the start of each list.” BSG guidelines 2014
BIOTECH-GERMANDE
STORAGE/DRYING CABINETS FOR
ENDOSCOPES (ESC)
BIOTECH-GERMANDE
STORAGE/DRYING CABINETS FOR
ENDOSCOPES (ESC)
FRENCH STANDARD ON STORAGE CABINETS FOR
HEAT SENSITIVE ENDOSCOPES (ESC)
NF S 98-030
BIOTECH-GERMANDE
January 2008
Revised in 2012
EUROPEAN STANDARD
BIOTECH-GERMANDE
CENT TC 102
France has proposed a new work item based on
the existing French standard.
The new work item has been accepted on May
2011.
Working Group 8 of TC102 was in charge to
draw up the draft European standard,
The document was submitted to CEN members
for formal vote in September 2014
The European standard EN 16442 was published
in March 2015.
EN 16442
INTRODUCTION
ESC are designed to provide a controlled environment for
the storage of endoscope(s) (with or without channels)
and, if necessary, drying of the endoscope(s) including
the endoscope(s) channels.
BIOTECH-GERMANDE
The controlled environment provided by the ESC ensures
that during storage there is no deterioration of the
microbiological quality of the endoscope. The drying
function is intended to supplement, if necessary, any
drying conducted during automated or manual
processing of the endoscope.
NOTE 1: Drying of an endoscope in a washer-disinfector can require
a prolonged cycle time.
EN 16442
INTRODUCTION
The ESC is designed to allow for the safe use of
endoscopes at an extended period from the time of
processing improving availability for use.
NOTE 2: It is strongly recommended to check the microbiological
quality of the endoscopes intended to be stored in the cabinet before
installation of the ESC.
BIOTECH-GERMANDE
NOTE 3: The ESC is not designed to clean and/or disinfect endoscopes
and any contaminated endoscope stored in the cabinet can still be
contaminated after the storage period.
NOTE 4: ESCs for processed thermolabile endoscopes are not
considered as medical devices.
EN 16442
SCOPE
This European Standard specifies the performance
requirements applying to cabinets designed to store, or
store and dry, thermolabile endoscopes following
automated or manual processing.
BIOTECH-GERMANDE
This European Standard specifies ESCs which flush the
channels and the external surfaces of endoscopes with
air.
This European Standard does not include the use of
other chemicals for drying and maintaining the quality of
endoscopes during storage
EN 16442
PERFORMANCE REQUIREMENT
BIOTECH-GERMANDE
4.2.1 The ESC shall maintain the microbiological quality of the
endoscopes during storage. Tests shall be performed according to
Annex E.
Endoscope surrogate devices and/or endoscopes from each
relevant endoscope type test group are :
contaminated (15 ml of 103 CFU/ml bacterial suspension).
maintained at room temperature for X min,
Purged with air (if recommended),
stored in the drying/storage cabinet for 12h, 24h, 48h, max
and max – 24 h hours.
sampled using a validated test method.
Results are compared to similarly contaminated endoscopes
stored outside the drying/storage cabinet.
EN 16442
Demonstration of the ability to maintain the quality of
endoscopes
BIOTECH-GERMANDE
Evolution of endoscope contamination level [E (log.)]
3.0
2.0
1.0
0.0
-1.0
-2.0
-3.0
-4.0
-5.0
-6.0
12h
24h
36h
48h
72h
Time (hours)
Endoscopes stored outside the storage/drying cabinet
Endoscopes stored in the storage/drying cabinet
Endoscope drying/storage cabinet: interest and efficacy L. Pineau, E. Villard, D.L. Duc, B.
Marchetti. Journal of Hospital Infection (2008) 68, 59-65
EN 16442
PERFORMANCE REQUIREMENT
4.2.3 If the ESC does not have a drying phase, it has to be
specified that the device (outside surfaces and internal channels)
has to be dried before storage [see 8.2 j)].
BIOTECH-GERMANDE
4.2.4 Any instructions given by the manufacturer for drying the
inside and outside of the endoscope shall conform to the
endoscope manufacturer's instructions (on pressure issues,
temperature issues, etc.).
4.2.5 Any requirements regarding the quality of the air supplied
to the ESC (see 5.2) shall be specified [see 8.2 f) 1)].
EN 16442
PERFORMANCE REQUIREMENT - DRYING
4.3 For ESCs that provide a drying function [see 8.2 d) 1)] the
following requirements apply:
BIOTECH-GERMANDE
a) The time required to dry the endoscopes [see 8.2 d) 4)]
shall be specified when tested according to 6.4 and shall
not exceed 3 hours.
b) The efficacy of the drying function shall be deemed to be
satisfactory if, when tested according to 6.4, there are no
visible moisture droplets on the test paper (Copper
sulphate paper or crepe paper).
EN 16442
PERFORMANCE REQUIREMENT – ESC CONNECTORS
4.4.1 General
Two types of ESC connectors exist:
BIOTECH-GERMANDE
a) ESC connectors providing independent air flow to each
endoscope channel; and
b) ESC connectors providing air flow to a group of endoscope
channels via a manifold (between the ESC and the
endoscope).
4.4.2 ESC connector qualification
Each ESC connector type shall be qualified during type testing. A
test protocol shall be provided to enable the user to verify the
compliance of the ESC connectors during routine testing [see 8.2
i)].
EN 16442
MECHANICAL AND PROCEDURE REQUIREMENTS
AIR QUALITY
BIOTECH-GERMANDE
5.2.1.1.2 The quality of the air supplying the ESC shall be
specified [see 8.2 f)] and may include specifications for maximum
relative humidity, pressure, oil content, particulate count and
flow rate.
5.2.2.1 General
Air inside the ESC and flowing through the channels of the
endoscope shall be of a microbiological quality which will not
impair the quality of the load. Tests shall be done according to
Annex C .
Active sampling: < 100 CFU/m3 (Class 8 of ISO 14644-1)
Sedimentation: < 50 CFU/m3 (Class 8 of ISO 14644-1)
EN 16442
MECHANICAL AND PROCEDURE REQUIREMENTS
AIR QUALITY
5.2.2.2 Overpressure
When tested according to 6.3, the air pressure in the ESC
chamber shall be higher than the ambient pressure where the
ESC is located.
BIOTECH-GERMANDE
5.2.2.3 Air changes
The number of air changes per hour inside the ESC chamber
using the method described in 6.2 shall be specified (at least 10
times the volume of the ESC).
5.2.2.4 Particulate contamination
5.2.2.4.1 If a specific cleanliness level is claimed and when tested
according to 6.6.1 the particulate contamination within the ESC
shall be consistent with the claims.
EN 16442
MECHANICAL AND PROCEDURE REQUIREMENTS
AIR QUALITY
BIOTECH-GERMANDE
5.2.2.5 Temperature
If the ESC operates at temperatures different from ambient, the
temperature inside the ESC shall be specified and controlled
within the temperature limits [see 8.2 b) and 8.2 d) 3)]. The
temperature limits of the endoscopes have to be considered.
5.2.2.6 Pressure
Throughout the operating cycle the rate and extent of any
change in pressure in endoscope channels shall be within
specified limits, which will not cause damage to the endoscope(s)
stored in the ESC [see 8.2 e) 4)].
EN 16442
MECHANICAL AND PROCEDURE REQUIREMENTS
CONTAMINATION OF THE STORAGE
CABINET CHAMBER SURFACES
BIOTECH-GERMANDE
5.3.1 The internal surfaces of the ESC chamber shall be capable
of withstanding routine cleaning and disinfection [see 8.2 r)],
without deterioration.
NOTE Removable trays of a cabinet, designed to store
endoscopes, are considered chambers.
5.3.2 A cleaning-disinfection procedure shall be provided,
including any requirements regarding the frequency of the
use, to ensure that surface contamination levels inside the ESC
that may contact endoscopes remain below 25 Colony
Forming Units (CFU)/25 cm2 when tested as described in 6.5.
EN 16442
MECHANICAL AND PROCEDURE REQUIREMENTS
ENDOSCOPE CHANNEL AERATION SYSTEM
BIOTECH-GERMANDE
5.5.1 Throughout the storage, air has to flow through each of the
internal channels and/or cavities of the device. The air circulation
may be either continuous or intermittent. Instructions shall be
provided on the verification of air circulation and can include:
a)verifying that all channels allow the passage of air before the
device is loaded into the ESC [see 8.2 j)];
b)confirming that all necessary connections were made before,
and were still in place at the end of, the storage cycle [see 8.2 i)];
c)verifying the air circulation in each tubing of the ESC connector
using specified means [see 8.2 e) 1)];
EN 16442
MECHANICAL AND PROCEDURE REQUIREMENTS
ENDOSCOPE CHANNEL AERATION SYSTEM
NOTE 3 The attention of the user is drawn on the fact that means
provided to verify the free passage of air can be either
continuous or intermittent, automatic and under the control of
the automatic controller of the ESC
BIOTECH-GERMANDE
d) Confirming by reference to the ESC process record that the
supply of air to the device used to connect the endoscope was
maintained during each stage of the process.
EN 16442
MECHANICAL AND PROCEDURE REQUIREMENTS
BIOTECH-GERMANDE
5.6 Automatic temperature control
5.7 Fault indication/monitoring
5.8 Cycle indicators
The following cycle indicators shall be located in such a way that
they are clearly visible by the user:
a) "status" indicator;
b) "fault" indicator;
c) ”storage time” indicator for each endoscope;
d) hours run meter or cycle counter that cannot be re-set by the
user.
EN 16442
MECHANICAL AND PROCEDURE REQUIREMENTS
BIOTECH-GERMANDE
5.13 Traceability
The ESC shall be designed to allow the recording of all critical
cycle parameters and faults.
This shall include but is not limited to:
a) any fault indicated during storage and/or drying;
b) the time for which each endoscope is stored;
c) conformity of all defined critical parameters;
d) recording of the identity of each endoscope;
e) recording time and date when each endoscope was placed,
dried (when applicable) and when it was removed;
f) recording the identity of the operator(s) loading and unloading
the endoscope.
EN 16442
TESTING FOR CONFORMITY
BIOTECH-GERMANDE
6.1.1 Tests conditions shall take into account:
— environmental conditions where the ESC will be installed (e.g.
temperature, humidity) and
— the state of the endoscope (e.g. volume of water in endoscope
channels prior storage).
6.1.2 Endoscope surrogate devices and/or endoscopes from each
relevant endoscope type test group (see F3) shall be included
in type testing.
These test devices shall be selected using the method described
in Annex F, considering the specific characteristics and
limitations of the ESC.
EN 16442
ENDOSCOPE TYPE TEST GROUP
BIOTECH-GERMANDE
Based on a risk assessment, the ESC manufacturer is
responsible for selecting the most relevant endoscope type
test groups (see Table F.1) to be included in type testing,
taking into consideration the specific characteristics and
limitations of the ESC.
The risk assessment should consider, and where
necessary, include the measurement of parameters that
may influence the efficacy of the process (such as pressure,
flow, etc.) in combination with the ESC.
EN 16442
BIOTECH-GERMANDE
ANNEX F: ENDOSCOPE BLOCKS
EN 16442
BIOTECH-GERMANDE
ANNEX F: ENDOSCOPE BLOCKS
EN 16442
TESTING FOR CONFORMITY
Performance qualification tests shall be performed on at least
one model of each relevant endoscope type tests group as
defined in Annex F and the choice shall be made according to the
endoscopes available on site.
BIOTECH-GERMANDE
Alternatively performance tests may be performed with one
model of each endoscope product family (see Annex G) for which
the same ESC connector set is used, if it is demonstrated that the
endoscopes selected are the most challenging.
EN 16442
BIOTECH-GERMANDE
TESTING FOR CONFORMITY
EN 16442
ANNEXES
BIOTECH-GERMANDE
Annex A (informative) Summary of test programmes Annex B
(informative) Cross-contamination between endoscopes
Annex C (normative) Methods for evaluation of airborne
microbial contamination in the ESC
Annex D (informative) Procedure for parametric performance
qualification
Annex E (normative) Internal residual contamination of
endoscopes after storage .
Annex F (normative) Establishing endoscope type test groups
Annex G (normative) Establishing endoscope product families
CONCLUSION
BIOTECH-GERMANDE
The use of ESC consistent with the essential
requirements of prEn 16442 combine with a routine
sampling program to monitor the microbiological quality
of the endoscopes and the ESC should:
Permit to increase the maximum storage time
allowed before reprocessing partially or completely
endoscopes prior to use.
Increase the microbiological quality of endoscope
Reduce the staff time per exam
decrease endoscope reprocessing cost per
exam.
BIOTECH-GERMANDE
THANK YOU VERY MUCH…
WHAT ARE THE RISKS OF ENDOSCOPE
CONTAMINATION?
Nelson DB. Infectious disease complications of GI endoscopy:
part II, exogenous infections.
BIOTECH-GERMANDE
Gastrointest Endosc 2003;57:695-711.
Cause of endoscope contamination
%
Cases
•Contaminated AEWD
39 %
n=153
•Inadequate disinfectant
29 %
n=115
•Failure to dry (70% alcohol)
14,5 %
n=57
•Water bottle contaminated
4,3 %
n=17
•Failure to disinfect elevator channel
4,1 %
n=16
•Biopsy forceps
3,8 %
n=15
•No disinfection
1,5 %
n=6
•No treatment of air/water channels
1,3 %
n=5
•unknown
2%
n=8
BIOTECH-GERMANDE
WHAT ARE THE RISKS?
"Accurate endoscope drying is crucial, whereas a
humid environment facilitates microbial growth
during storage. The final drying steps greatly
reduce the risk of remaining pathogens as well as
the possibility of recontamination of the endoscope
by waterborne microorganisms such as
Pseudomonas spp." J. Kovaleva Clin Microbiol Rev.
Apr 2013; 26(2): 231–254
TO SUMMARIZE
BIOTECH-GERMANDE
Lawrence F. Muscarella, Am J Gastroenterol 2006;101:2147–2154)