New Requirements of ISO 17664/AAMI ST 81

How the instrument manufacturer

validate the cleaning process

Klaus Roth SMP GmbH

Tübingen Germany

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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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•Preparation at the point of use

•Preparation, cleaning, disinfection

•Drying

•Inspection, maintenance and testing

•Packaging

•Sterilisation

•Storage

ISO 17664 (2004)

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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)

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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:

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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:

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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.

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.

ISO 17664 (new)

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.

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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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

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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

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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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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

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ISO 17664 (new)

Chemistry

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©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

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©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

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©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

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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

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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

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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

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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

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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

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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

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Summary of 10 years validation

Remaining protein on real used MIC instruments (786) in 2012

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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

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Protein detection methods

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0,1 -- 1000

160 µg/ml 16 µg/ml 1,6 mg/ml Protein: 160 mg/ml

0,1

HemoCheck-S

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• Test Kit for a qualitative determination blood on surgical

instruments

100µg 1µg 0µg

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Dilution of Blood

Full blood

Visual detection of blood is possible up to 1:1000

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Combur 3 Test

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Combur 3 Test

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• 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.

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©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

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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

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©SMP GmbH 2017

SMP GmbH

Hechingerstrasse 262

72072 Tübingen

Thank you

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