Results on cleaning validation:

New Requirements of ISO 17664/AAMI

ST 81

Klaus Roth; SMP GmbH

•Preparation at the point of use•Preparation, cleaning, disinfection•Drying•Inspection, maintenance and testing•Packaging•Sterilisation•Storage

ISO 17664 (2004)

ISO 17664 (2004)

6

Instrument circulation in a hospital

Storage/transport

Cleaning/disinfection

Service and maintenance

Functional testing

Sterilisation

Storage

Available for use

Use

3.5 Cleaning

A validated method of cleaning shall be specified. At least one validated automated method using a washer-disinfector shall a lso be specified unless the medical device cannot withstand any such proces s, in which case a warning should be issued.

Where appropriate, at least the following informati on shall be included:

.accessories required for cleaning process;

.identification and concentration of chemicals requi red 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)

Chapter 5 allows the building of groups of instrume nts:

„Where the manufacturer supplies a number of differe nt medical devices which share common features and attributes, the validation specified may be performed with respect to these me dical devices as a group of family, provided that the manufacture r can demonstrate the commonality of the medical devices and that the tests and assessments address the worst case featur e or attribute of the group of family“

________________________________________________________Standard EN/ISO 17664:

ISO 17664 (new)

Scope

1.1 InclusionsThis 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:

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) Storagej) 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.

.

ISO 17664 (new)

.

ISO 17664 (new)

6.7.1.2 If the medical device is intended to be disinfected a validated method of manual disinfectionShall be specified if automated disinfection is not possible

ISO 17664 (new)

ISO 17664 (new)

Categories of instruments and specific requirements for use:

>Instruments, to be used outside the body.

>Instruments, to be usedinside the body withoutpenetration of the mucosaor skin.

>Instruments, penetratingthe skin or mucosa.

Clean / Disinfected

High Level Disinfected

Sterile

Spaulding Classification by the CDC

Classification of the instruments groups

Group 1: Critical Instruments,like hooks; no hidden surfaces and lumens

Group 2: Critical InstrumentsScissors, Clamps

Group 3: Shift shaft instrumentsRongeur etc.

Group 4: Shaft instruments for MISneed validation, as the result of the cleaning can not be inspected

Group 5: Micro surgical Instrumentsneed validation, as the result of the cleaning can not be inspected

Group 6: Complex Deviceshas to be tested, as no analogical conclusions can be made

Group 7: Flexible Instrumentsneed validation, as the result of the cleaning can not be inspected

1. Messungnach Kontamination

2. Messungnach Vorreinigung + 10 min 40°C Einweichen

4. Messungnach Reinigung

1. Messungnach Kontamination

2. Messungnach Vorreinigung + Ultraschall 10 min 40°C

3. Messungnach Reinigung

Nr.87/26 Zr Zr Zr Zr Zr Zr

Crile clamp 1 98 4 4 122 3 3Crile clamp 2 66 3 3 97 3 3Crile clamp 3 121 2 2 145 3 3

Crile Clamp,

Comparison of Group 2 Instruments

Group 2 (Instruments with hidden surfaces): Side cutter

1. Messungnach Kontamination

2. Messungnach Vorreinigung + 10 min 40°C Einweichen

3. Messungnach Reinigung

1. Messungnach Kontamination

2. Messungnach Vorreinigung + Ultraschall 10 min 40°C

3. Messungnach Reinigung

Nr.87/26 Zr Zr Zr Zr Zr Zr

Wire cutter 1 69 10 10 95 4 4Wire cutter 2 79 9 7 57 4 4Wire cutter 3 59 9 8 65 3 4

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 notsuccessfull

Group 3: Shift shaft instruments

Group 3 (Shift shaft instruments):Rongeur,Arthroskopiezangen etc.

1. Messungnach Kontamination

2. Messungnach Vorreinigung + 10 min 40°C Einweichen

4. Messungnach Reinigung

1. Messungnach Kontamination

2. Messungnach Vorreinigung + Ultraschall 10 min 40°C

3. Messungnach Reinigung

Nr.87/26 Zr Zr Zr Zr Zr Zr

Rongeur 1 85 14 16 249 13 7Rongeur 2 121 11 10 311 12 7Rongeur 3 88 17 17 245 30 17

BronchoscopyForceps

(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)

Group 3: Shift shaft instruments (improved design)

Instruments for Minimally invasive surgery

Dismountable

Not dismountablewith Luer adapter

Mechanics: Amount of WaterPressureUltrasound

Temperature

Interacting Time

Chemical AgentWater Quality

Parameters of the Cleaning Cycle

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 GesamtAnteill der Ins. 11

Miele 7836 Tw/Tb GesamtAnzahl der Ins. 11

Miele 7735 AlkalischGesamt Anteil der Ins.11

Miele 7735 EnzymatischGesamt Anteil der Ins.11

Anzahl der Instrumrnte unter 5 Counts/secAnzahl der Instrumrnte über 5 Counts/secManual pre-cleaning required

ISO 17664 (new)

Chemistry

100%

0%

95%

5%

84%

16%

48% 52%

42%

58%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Hunderte

Niagara EnzymatischGesammt Anteil der

Ins.19

Miele 7836 OxivarioGesamt Anteill der Ins.

19

Miele 7836 Tw /TbGesamt Anzahl der

Ins. 19

Miele 7735 AlkalischGesamt Anteil der

Ins.19

Miele 7735 Enzymatisch Gesamt

Anteil der Ins.19

Anzahl der Instrumrnte unter 5 Counts/secAnzahl der Instrumrnte über 5 Counts/sec

MIS Instruments, not dismountable with Luer adapterResults: Remaining contamination in the shaft

Manual pre-cleaning required

Tab. 58: Zusammengefasste Ergebnisse Gruppe 2 „Alkalisch maschinell und ggf. manuellen Vorreinigung“

Step 3

Step 2

Step 12 A Titan 2 A Ceramic 2 B 2 C 2 D 2 E 2 F

Group 2: AlkalineE

ffort

for

clea

ning

Instruments sorted by category

Tab. 59: Zusammengefasste Ergebnisse Gruppe 2 „Enzymatisch maschinell und ggf. manuelle Vorreinigung“

Step 3

Step 2

Step 12 A Titan 2 A Ceramic 2 B 2 C 2 D 2 E 2 F

Group 2: Enzymatic automated and manual if necessar y

Effo

rt fo

r cl

eani

ng

Instruments sorted by category

Val

idat

ion

not

suc

cess

full

Val

idat

ion

not

suc

cess

full

Influence of the detergent

Power of cleaning processes

Enzymatic process

Alcaline process

Multicomponent Enzymatic process

Oxivario Process

________________________________________________________Future?

+Chemistry W/D

= ?

RDC 15

First results of the year 2005

In order to implement the up and coming EN ISO 1588 3 in practice, we worked out the “Guidelines of the DGKH, DGSV and AKI for validating and routinely monitoring automatic washing and disi nfecting processes for thermo-stable medical devices, and principles f or selecting a washer-disinfector (WD)”Part 1**.

In an inter-hospital trial conducted with 18 hospit als, the practicability and meaningfulness of the test method was investiga ted.

5 of 18 WD involved in the trial were over threshol d.

Although the sensitivity of the semi-quantitative B iuret / 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

Validation of Washer/Disinfectors (Cleaning tests)

PCD: Vacuum package Real contamination

SDS-Elution for OPA-testing

Foaming in the cleaning process

Logger data in a washer/disinfector loaded with hea vily soiled instruments

Dosing of the cleaning agent:

Pressure decrease from 0.2 bar to 0.1 bar

FDA Conference8.-9- June 2011

Silver Springs

Foaming

Summary of 10 years validationRemaining protein on test instruments (4122) in 2012

Summary of 10 years validation

Summary of 10 years validation

RDC 15

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

44

Protein detection methods

45

0,1 -- 1000

160 µg/ml16 µg/ml 1,6 mg/mlProtein: 160 mg/ml

0,1

HemoCheck-S

46

• Test Kit for a qualitative determination blood on surgical

instruments

100µg 1µg 0µg

Dilution of Blood

Full blood

Visual detection of blood is possible up to 1:1000

Combur 3 Test

Combur 3 Test

50

• 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

Hemocheck

++ - + + 3

Comburtest

++ ++ + ++ 7

Criteria for selection of the test method

Classification of the instruments groups

Group 1: Critical Instruments,like hooks; no hidden surfaces and lumens

Group 2: Critical InstrumentsScissors, Clamps

Group 3: Shift shaft instrumentsRongeur etc.

Group 4: Shaft instruments for MISneed validation, as the result of the cleaning can not be inspected

Group 5: Micro surgical Instrumentsneed validation, as the result of the cleaning can not be inspected

Group 6: Complex Deviceshas to be tested, as no analogical conclusions can be made

Group 7: Flexible Instrumentsneed validation, as the result of the cleaning can not be inspected

Recovery of protein: Group 1 instruments

Recovery of proteinGroup 2 instruments

Elution of protein:Group 3 instruments

Elution of proteinGroup 4 instruments

Qualification of the recovery

Unique Device Identifier: UDI

Unique Device Identifier: UDI

Unique Device Identifier: UDI

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 th e bottom of an ultrasonic cleaner unit during cleaning, as damage or incomplete cleaning could re sult. 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.

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 instrum ents!

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

Conclusion

• ISO 17664 is demanding more information from the manufacturer for the user

• ISO 17664 is requiring qualified equipement accordin g to the standard and validated processes

• Methods for the evaluation and quality control of c leaning processes has already been developed and establish in some countries.

• They have led to an improvement of the outcome of t he cleaning process

• Sensitive test methods have to be validated when ap plied in the daily routine

SMP GmbHHechingerstrasse 26272072 Tübingen

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