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New Requirements of ISO 17664/AAMI ST 81
How the instrument manufacturer
validate the cleaning process
Klaus Roth SMP GmbH
Tübingen Germany
21.09.2017 ©SMP GmbH 2017 1
Operation, which have been cancelled due to not sufficient
reprocessed instruments
Year 2002 2003 2004 2005
Data of 57
hospitals** 1252 1661 1926 1765
Estimated for England
and Wales 7500 9900 11500 10500
** 57/340 Datensätze
* mit freundl. Genehmigung G.Shapp MP
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21.09.2017 ©SMP GmbH 2017 3
•Preparation at the point of use
•Preparation, cleaning, disinfection
•Drying
•Inspection, maintenance and testing
•Packaging
•Sterilisation
•Storage
ISO 17664 (2004)
21.09.2017 ©SMP GmbH 2017 4
ISO 17664 (2004)
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©SMP GmbH 2017 6
Instrument circulation in a hospital
Storage/transport
Cleaning/disinfection
Service and maintenance
Functional testing
Sterilisation
Storage
Available for
use
Use
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©SMP GmbH 2017
3.5 Cleaning
A validated method of cleaning shall be specified. At least one validated
automated method using a washer-disinfector shall also be specified unless
the medical device cannot withstand any such process, in which case a
warning should be issued.
Where appropriate, at least the following information shall be included:
.accessories required for cleaning process;
.identification and concentration of chemicals required for cleaning;
.identification of water quality,
.limits and monitoring of chemical residues
.limits on temperature, concentration of solution(s), exposure time,
.process temperature(s);
.techniques to be used including rinsing;
ISO 17664 (2004)
21.09.2017 7
Chapter 5 allows the building of groups of instruments:
„Where the manufacturer supplies a number of different medical
devices which share common features and attributes, the validation
specified may be performed with respect to these medical devices
as a group of family, provided that the manufacturer can
demonstrate the commonality of the medical devices and that the
tests and assessments address the worst case feature or attribute
of the group of family“
________________________________________________________ Standard EN/ISO 17664:
21.09.2017 ©SMP GmbH 2017 8
ISO 17664 (new)
Scope
1.1 Inclusions This International Standard specifies requirements for the information to be
provided by the medical device manufacturer for the processing of a medical
device that requires cleaning followed by disinfection and/or sterilization to
ensure that the device is safe and effective for its intended use. This includes
information for processing prior to use or reuse of the medical device.
The provisions of this standard are applicable for medical devices that are
intended for invasive or other direct patient contact.
Processing instructions are not defined in this standard. Rather, this
International Standard specifies requirements to assist manufacturers of
medical devices in providing detailed instructions for processing that consists
of the following activities where applicable:
21.09.2017 ©SMP GmbH 2017 9
ISO 17664 (new)
1.1 Inclusions
a) Pre-treatment at the point of use before processing;
b) Preparation before cleaning,
c) Cleaning,
d) Disinfection;
e) Drying;
f) Inspection, maintenance and testing;
g) Packaging;
h) Sterilization;
i) Storage
j) Transportation.
1.2 This standard excludes:
• noncritical medical devices not intended for direct patient contact;
• Textile devices used in patient draping systems or surgical clothing;
• processing of medical devices specified by the manufacturer for
single-use only and supplied sterile.
21.09.2017 ©SMP GmbH 2017 10
.
ISO 17664 (new)
21.09.2017 ©SMP GmbH 2017 11
.
ISO 17664 (new)
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6.7.1.2 If the medical device is intended to be disinfected a validated method of manual disinfection
Shall be specified if automated disinfection is not possible
ISO 17664 (new)
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ISO 17664 (new)
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Categories of instruments and specific requirements for use:
Instruments, to be used
outside the body.
Instruments, to be used
inside the body without
penetration of the mucosa
or skin.
Instruments, penetrating
the skin or mucosa.
Clean / Disinfected
High Level Disinfected
Sterile
Spaulding Classification by the CDC
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21.09.2017 ©SMP GmbH 2017 17
Classification of the instruments groups
Group 1: Critical Instruments,
like hooks; no hidden surfaces and lumens
Group 2: Critical Instruments
Scissors, Clamps
Group 3: Shift shaft instruments
Rongeur etc.
Group 4: Shaft instruments for MIS
need validation, as the result of the cleaning can not be
inspected
Group 5: Micro surgical Instruments
need validation, as the result of the cleaning can not be
inspected
Group 6: Complex Devices
has to be tested, as no analogical conclusions can be
made
Group 7: Flexible Instruments
need validation, as the result of the cleaning can not be
inspected
21.09.2017 ©SMP GmbH 2017 18
1. Messung
nach
Kontaminati
on
2. Messung
nach
Vorreinigung
+ 10 min
40°C
Einweichen
4. Messung
nach
Reinigung
1. Messung
nach
Kontaminati
on
2. Messung
nach
Vorreinigung
+ Ultraschall
10 min 40°C
3. Messung
nach
Reinigung
Nr.87/26 Zr Zr Zr Zr Zr Zr
Crile clamp 1 98 4 4 122 3 3
Crile clamp 2 66 3 3 97 3 3
Crile clamp 3 121 2 2 145 3 3
Crile Clamp,
Comparison of Group 2 Instruments
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Group 2 (Instruments with hidden surfaces): Side cutter
1. Messung
nach
Kontaminati
on
2. Messung
nach
Vorreinigung
+ 10 min
40°C
Einweichen
3. Messung
nach
Reinigung
1. Messung
nach
Kontaminati
on
2. Messung
nach
Vorreinigung
+ Ultraschall
10 min 40°C
3. Messung
nach
Reinigung
Nr.87/26 Zr Zr Zr Zr Zr Zr
Wire cutter 1 69 10 10 95 4 4
Wire cutter 2 79 9 7 57 4 4
Wire cutter 3 59 9 8 65 3 421.09.2017 ©SMP GmbH 2017 20
Tischler-Morgan
(Not dismountable)Step 1
Yes 1 Yes 2 Yes 3
NoStep
2
Yes 1 Yes 2 Yes 3
No Step 3
Yes 1 Yes 2 Yes 3
NoValidation not
successfull
Group 3: Shift shaft instruments
21.09.2017 ©SMP GmbH 2017 21
Group 3 (Shift shaft instruments): Rongeur,Arthroskopiezangen etc.
1. Messung
nach
Kontaminati
on
2. Messung
nach
Vorreinigung
+ 10 min
40°C
Einweichen
4. Messung
nach
Reinigung
1. Messung
nach
Kontaminati
on
2. Messung
nach
Vorreinigung
+ Ultraschall
10 min 40°C
3. Messung
nach
Reinigung
Nr.87/26 Zr Zr Zr Zr Zr Zr
Rongeur 1 85 14 16 249 13 7
Rongeur 2 121 11 10 311 12 7
Rongeur 3 88 17 17 245 30 17
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©SMP GmbH 2017 21.09.2017 23
Bronchoscopy
Forceps
(Dismountable)
Step 1
Yes 1 Yes 2 Yes 3
NoStep
2
Yes 1 Yes 2 Yes 3
No Step 3
Yes 1 Yes 2 Yes 3
NoValidation not
successfull
Group 3: Shift shaft instruments (dismantable)
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Group 3: Shift shaft instruments (improved design)
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©SMP GmbH 2017
Instruments for Minimally invasive surgery
Dismountable
Not dismountable
with Luer adapter
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©SMP GmbH 2017
Mechanics: Amount of Water
Pressure
Ultrasound
Temperature
Interacting
Time
Chemical Agent
Water Quality
Parameters of the Cleaning Cycle
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©SMP GmbH 2017
Results: Remaining contamination in the shaft
MIS Instruments dismountable
100%
0%
100%
0%
73%
27%
27%
73%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Hunderte
Miele 7836 Oxivario Gesamt
Anteill der Ins. 11
Miele 7836 Tw/Tb Gesamt
Anzahl der Ins. 11
Miele 7735 Alkalisch
Gesamt Anteil der Ins.11
Miele 7735 Enzymatisch
Gesamt Anteil der Ins.11
Anzahl der Instrumrnte unter 5 Counts/sec
Anzahl der Instrumrnte über 5 Counts/secManual pre-cleaning required
21.09.2017 28
ISO 17664 (new)
Chemistry
21.09.2017 ©SMP GmbH 2017 29
©SMP GmbH 2017
100%
0%
95%
5%
84%
16%
48% 52%
42%
58%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Hunderte
Niagara Enzymatisch
Gesammt Anteil der
Ins.19
Miele 7836 Oxivario
Gesamt Anteill der Ins.
19
Miele 7836 Tw/Tb
Gesamt Anzahl der
Ins. 19
Miele 7735 Alkalisch
Gesamt Anteil der
Ins.19
Miele 7735
Enzymatisch Gesamt
Anteil der Ins.19
Anzahl der Instrumrnte unter 5 Counts/sec
Anzahl der Instrumrnte über 5 Counts/sec
MIS Instruments, not dismountable with Luer adapter Results: Remaining contamination in the shaft
Manual pre-cleaning required
21.09.2017 30
©SMP GmbH 2017
Tab. 58: Zusammengefasste Ergebnisse Gruppe 2 „Alkalisch maschinell und ggf. manuellen Vorreinigung“
Step 3
Step 2
Step 1
2 A Titan 2 A Ceramic 2 B 2 C 2 D 2 E 2 F
Group 2: Alkaline
Eff
ort
fo
r cle
an
ing
Instruments sorted by category
Tab. 59: Zusammengefasste Ergebnisse Gruppe 2 „Enzymatisch maschinell und ggf. manuelle Vorreinigung“
Step 3
Step 2
Step 1
2 A Titan 2 A Ceramic 2 B 2 C 2 D 2 E 2 F
Group 2: Enzymatic automated and manual if necessary
Eff
ort
fo
r cle
an
ing
Instruments sorted by category
Vali
dati
on
no
t
su
ccessfu
ll
Vali
dati
on
no
t
su
ccessfu
ll
Influence of the detergent
21.09.2017 31
©SMP GmbH 2017
Power of cleaning processes
Enzymatic process
Alcaline process
Multicomponent Enzymatic process
Multicomponent Process
Power Flush
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©SMP GmbH 2017
Mechanics: Amount of Water Pressure Ultrasound
Temperature
Interacting Time
Chemical Agent Water Quality
Parameters of the Cleaning Cycle
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©SMP GmbH 2017
Validation of the cleaning step …
Monitoring of
water pressure
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Foaming
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„Vario“
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Influence of Velocity of Flow
Laminar Flow
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R e Reynolds number
r Density v Velocity l Length m Viscosity
u kin. Viscosity
l r v
m Re=
Influence of Velocity of Flow
Turbulent Flow
21.09.2017 ©SMP GmbH 2017 39
Test procedure: OPA-Testing according to ISO 15883
Improved Cycle of the Medisafe PCF with High Pressure
Ultrasonic Irrigation
• Pre-Wash –internal & external @ 3 bar
• Detergent Dispense
• De-gas
• 15 minute Ultrasonic Main Wash – internal/external 3 bar
• Pre-Rinse – internal & external @ 3 bar
• Final Rinse
• Empty – each cycle
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Guidelines and legal
Requirements
21.09.2017 ©SMP GmbH 2017 41
Cleaning: Contamination of the artery clamps with 100µl coagulable sheep blood
Investigation of Cleaning Performance Following the Standard prEN/ISO 15883-1. Zentr Steril 2005; 13: 34-44
21.09.2017 ©SMP GmbH 2017 42
Validation of Washer/Disinfectors (Cleaning tests)
PCD: Vacuum package Real
contamination
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SDS-Elution for OPA-testing
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Results of the round robin test 2004
Charge I 1 x = 100
Charge I 1 x und Charge II 2 x = 100
Charge III 1 x = 100
Charge II 1 x = 100 21.09.2017 ©SMP GmbH 2017 45
First results of the year 2005 of automated reprocessing
In order to implement the up and coming EN ISO 15883 in practice, we
worked out the “Guidelines of the DGKH, DGSV and AKI for validating
and routinely monitoring automatic washing and disinfecting processes
for thermo-stable medical devices, and principles for selecting a
washer-disinfector (WD)”Part 1**.
In an inter-hospital trial conducted with 18 hospitals, the practicability
and meaningfulness of the test method was investigated.
5 of 18 WD involved in the trial were over threshold.
Although the sensitivity of the semi-quantitative Biuret / BCA method
used in the tests is fairly low, it can be presumed that the evaluation
framework is sufficient for the moment to identify WDs with poor
cleaning quality, and to monitor the quality of the measures carried out
here. Inter-hospital trials to determine minimal cleaning performance according to the Guidelines from DGKH, DGSV and AKI;
Zentr Steril 2005; 13
21.09.2017 ©SMP GmbH 2017 46
Summary of 10 years validation
73%
20%
4% 2%
Restprotein an Prüfinstrumenten, Anzahl: 4122
uNwg
≤50µg
50-75 µg
75-100µg
Remaining protein on test instruments (4122) in 2012
21.09.2017 ©SMP GmbH 2017 47
Summary of 10 years validation
64%
18%
6%
12%Restprotein an Realinstrumenten, Anzahl: 3780
uNwg
≤50µg
50-75 µg
75-100µg
Remaining protein on real used instruments (3780) in 2012
21.09.2017 ©SMP GmbH 2017 48
Summary of 10 years validation
Remaining protein on real used MIC instruments (786) in 2012
21.09.2017 ©SMP GmbH 2017 49
Protein detection methods
• Bradford-Method • Modified OPA-Method • Biuret-Reaction • BCA-Protein Assay Kit • Ninhydrin-Reaction • TOC (Total organic Carbon) • ATP • Combur 3Test • HemoCheck-S
21.09.2017 ©SMP GmbH 2017 50
Protein detection methods
21.09.2017 ©SMP GmbH 2017 51
0,1 -- 1000
160 µg/ml 16 µg/ml 1,6 mg/ml Protein: 160 mg/ml
0,1
HemoCheck-S
21.09.2017 ©SMP GmbH 2017 52
• Test Kit for a qualitative determination blood on surgical
instruments
100µg 1µg 0µg
21.09.2017 ©SMP GmbH 2017 53
Dilution of Blood
Full blood
Visual detection of blood is possible up to 1:1000
21.09.2017 ©SMP GmbH 2017 54
Combur 3 Test
21.09.2017 ©SMP GmbH 2017 55
Combur 3 Test
21.09.2017 ©SMP GmbH 2017 56
• Hemoglobin katalysed the Oxidation of the indicator by
organic H2O2
• Very sensitive
• Detection limit at 0,3 µg/ml
• Extraction of the protein from the instrument can be
performed with SDS
Method Sensitivity
Recovery Training Costs Results
Bradford + ++ 0 - 3
OPA + ++ - -- 0
Biuret + ++ - -- 0
BCA + ++ - - 1
Ninhydrin
+ - + + 2
TOC - + - -- -3
ATP - - + 0 -1
Hemo check
++ - + + 3
Combur test
++ ++ + ++ 7
Criteria for selection of the test method
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Recovery of protein: Group 1 instruments
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Recovery of protein Group 2 instruments
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Elution of protein:
Group 3
instruments
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Elution of protein Group 4 instruments
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Qualification of the recovery
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©SMP GmbH 2017
Products: Endoscopic Take-Apart Instrument / Company:…...
ADVICE:
Reprocessing procedures have only limited implications to a surgical instrument. The limitation of the numbers of reprocessing procedures is therefore determined by the function / wear of the device. In case of damage the device should be reprocessed before sending back to the manufacturer for repair.
Reprocessing Instructions
Preparation at the Point of Use:
Remove gross soiling by submerge the instrument into cold water (<40°C) immediately after use. Don’t use a fixating detergent or hot water (>40°C) as this can cause the fixation of residua which may influence the result of the reprocessing process.
Transportation: Safe storage and transportation to the reprocessing area to avoid any damage and contamination to the environment.
Preparation for Decontamination:
The devices must be reprocessed in a disassembled state.
Pre-Cleaning: Warning: Do not allow the instruments to rest on the bottom of an ultrasonic cleaner unit during cleaning, as damage or incomplete cleaning could result. 10 minutes at 40°C in an ultrasonic bath with 0,5% detergent. Brushing the instrument under running tap water until all visible residues are removed Flushing the inner lumens of all parts with a water jet pistol (pressure min. 3 bar) with cold tap water for at least 10 seconds.
Cleaning:
Manual Cleaning Process: 1. Rinsing under running tap water (<40°C) until all visible soil has been removed. If needed a soft bristle brush should be used to remove visible soil; 2. Submerge instruments in an detergent (if ultrasonic bath is used, ultrasonic process of 3 minutes and ultrasonic frequency of 35 kHz have been shown to be effective). Follow the instructions of the manufacturer of the detergent; 3. Rinse the instrument under running tap water to remove the detergent.
Automated Cleaning: Connect the instrument to a rack for MIS-instruments and start the program
4 min pre-washing with cold water (<40°C);
6 min washing with 0,5% detergent at 55°C;
3 min neutralising with warm water (>40°C);
2 min intermediate rinsing with warm water (>40°C). Special instructions of the manufacturer of the automated washing machine have to be followed.
21.09.2017 65
©SMP GmbH 2017
Disinfection:
Manual Disinfection: 1. Submerge instruments in an disinfection detergent according to the instructions of the manufacturer of the detergent; 2. Rinse the instrument with sterile water to remove the detergent.
Automated Disinfection: Automated Thermal Disinfection in washer/disinfector under consideration of national requirements in regards to A0-Value (see EN 15883)
Drying: Manual Drying: Dry the instrument with a lint free towel. The instrument may never be heated up >140°C. To avoid water residues we recommend using sterile compressed air to insufflate cavities.
Automated Drying: Drying of outside of instrument through drying cycle of washer/disinfector. If needed, additional manual drying can be performed through lint free towel. Insufflate cavities of instruments by using sterile compressed air.
Functional Testing, Maintenance:
Functional testing, if available according to instructions of use and visual inspection for cleanliness. If necessary perform reprocessing process again until instrument is visibly clean.
Packaging: Appropriate packaging for sterilization.
Sterilization: Sterilization of instruments by applying a fractionated pre-vacuum process (according DIN EN 554 / ISO 11134) under consideration of the respective country requirements. Parameters for the pre-vacuum cycle: 3 prevacuum phases with at least 60 milli bar Heat up to a minimum sterilization temperature of 132°-134°C Minimum Holding time: 3,5 min Drying time: minimum 10 min Flash sterilization is not allowed on lumen instruments!
Storage: Storage of sterilized instruments in a dry, clean and dust free environment at modest temperatures of 5°C to 40°C.
Reprocessing validation study information
The following testing test devices, materials & machines have been used in this valdition study; Detergent: deconnex 28 Alka One, (Borer, Zuchwil, Switzerland) deconnex 23 Neutrazym, (Borer, Zuchwil, Switzerland) Washer / Disinfector: Miele 7735 CD Instrument Rack: Miele E450-1 Details: See report SMP 05506011407-1
21.09.2017 66
Conclusion
• ISO 17664 is demanding more information from the manufacturer for the user
• ISO 17664 is requiring qualified equipment according to the standard and validated processes
• Methods for the evaluation and quality control of cleaning processes has already been developed and establish in some countries.
• They have led to an improvement of the outcome of the cleaning process
• Sensitive test methods have to be validated when applied in the daily routine
21.09.2017 ©SMP GmbH 2017 67
©SMP GmbH 2017
SMP GmbH
Hechingerstrasse 262
72072 Tübingen
Thank you
21.09.2017 68