cleaning procedure

7/30/2019 cleaning procedure

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Cleaning procedures and testing

Challenging the process

Peter NewsonAbu Dhabi Patient Safety

15 October 2012


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Objectives

How clean is clean ?

Manual cleaning

EN ISO 15883 and the need for soil removal efficacy and protein

testing

Ultrasonics

Standard instrument cleaning systems

Complex and lumen instruments

Conclusion


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Learning Objectives

3

Discuss how to manage and control the risks associated with

decontamination reprocessing

Identify best practices for evaluating the effective cleaning of

reusable instruments

Present the difference between soil removal and protein

residue tests


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Cleaning Processes

Instrument cleaning is the first and arguably the most

important step in the decontamination process.

Microscopic quantities of blood, skin, mucous etc. left on

the instruments by an ineffective washing process can

seriously compromise the overall sterility of the

instruments.


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This norm regulates the validation of processing sequences in

washer-disinfectors for medical devices as well as revalidation and

routine monitoring of these processes.

Since the coming into force of EN ISO 15883-1, only washer-

disinfectors that have been subjected to a type test as per ISO

15883-1 may be purchased.

EN ISO 15883


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Manual Cleaning

The most important step in all instrument including Endoscope

reprocessing and is defined as

"Manual cleaning" refers to the physical task, performed

by hand, of removing secretions and contaminants from

the endoscope with appropriate brushes, cloths, detergents and

water.


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Manual Cleaning

There are two purposes of manual cleaning

As a pre-cleaning prior to using an automated Washer

Disinfector

As a cleaning method where other methods are not availableor appropriate.

Two methods of manual cleaning

Immersion

Non immersion


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Manual cleaning

Manual cleaning can be done using a range of cleaning aids:

Brushes: external and internal

A wide range of brushes are available for manual cleaning, suitable for

individual cleaning tasks.

External brushes: for cleaning the outside surfaces of objects. They may have

hard or soft hairs.

Internal brushes: for cleaning of hollow instruments. A range of diameters and

lengths are available for any type/size of hollow instruments and materials.

steel brushes are not recommended for cleaning , as they damage the

protective layer on stainless steel and aluminium instruments!


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Examples


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Manual cleaning

Spray gun

A spray gun is essential for rinsing/flushing of hollow instruments. Variousnozzles are available for a range of specific cleaning applications.

Hand shower

The hand shower can be used for an initial rinse of instruments.

Use a deep basin, which will help to prevent splashing sideways. Make surethat the water pressure is not too high in order to limit splashing. Only usecold water for blood removal!


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Manual Cleaning

Hand shower

Personal protection during manual cleaning - a range of

materials are available including - Gloves , plastic aprons,

mouth masks , goggles, visors and splash screens


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What leads to successful

Manual cleaning To be performed by a person trained in cleaning techniques and fully

conversant with the instrument they are cleaning

To be undertaken as soon as possible after the procedure to avoid soil and

debris drying.

To follow the stated unit protocols , which using the appropriate detergents

and cleaning equipment allows for all internal and external instrument

surfaces to be cleaned.

To be followed by thorough rinsing to ensure that all debris and detergent

residues are removed prior to the next step in the decontamination process.


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Mechanical cleaning


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- Part 1: General requirements, terms and definitions and tests

- Part 2: Requirements and tests for washer-disinfectors employing thermal disinfectionfor surgical instruments, anesthetic equipment, bowls, dishes, receivers, utensils,

glassware, etc.

- Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection

for human waste containers

- Part 4: Requirements and tests for washer-disinfectors employing chemical

disinfection for thermolabile endoscopes

- Part 5: Test soils and methods for demonstrating cleaning efficacy (Technical

Specification)

EN ISO 15883


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What are we validating ?

The washer

Soil removal including the removal of protein

The cycle - including all parameters incorporated within the washing

cycle.

Impingement / spray arms, complex channel pressure

The load and the impact this load has on the effectiveness of the cycle.

This includes :

Type of instruments more challenging than beforeLevel of soil

Load configuration.


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EN ISO 15883

6.10 Tests of cleaning efficacy

6.10.1 General

During tests of cleaning efficacy, the cycle shall be run withouta disinfection stage. The drying stage may also be omitted if

this is necessary to facilitate the detection of residualcontamination or test soil

6.10.2 Cleaning efficacy test 1

6.10.2.1 General

The tests for cleaning efficacy shall be carried out using theappropriate test method(s) and test soil(s) as described inISO/TS 15883-5 by taking into consideration the correspondingcategory of load.


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Routine Monitoring: In General

Every load

Independent from type and age of the WD

Documentation of the results

The results must reflect the demands


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Minimum for Routine Monitoring

Loading pattern

as described in standards

and dependent on the process andinstruments being cleaned

Cleaning efficacy

daily optical control of cleaning

daily optical view of drying

cleaning indicator

protein test


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So is it clean ??


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Soil removal test and

Protein test

Soil removal a visual test

Protein test protein is invisible so a swab plus chemicalinterpretation is required


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Preference must be given to the use of standardised,

quantitatively assessable test models as they yield

reproducible results.

( i.e. The tests need to be consistent)

Guidelines - Soil Testing


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Cleaning Efficacy / soil testing

National test soils are described in TS EN ISO 15883 5 where

a total of 19 different test soils are described.

The challenge is a combination of the test soil and the barrier


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Test Soils - 15883 5Load type Country Constituents

Annex

Surgical

instruments (

including rigid

endoscopes)

NL Bovine serum albumin fraction 5,porcine gastric mucin type 3,

bovine fibrinogen fraction 1,

bovine trombin Annex K

SE Citrated cattle blood coagulatedwith calcium chloride

Annex M

UK Defibrinated horse/sheep blood,egg yolk, dehydrated hog mucin

Annex N

DE Sheep blood, E. faeciumbEgg yolk, E. faeciumb

Semolina, butter, sugar, milkpowder, E. faeciumb

Annex G

US Protein/organic soil (userpreference), B. atrophaeus

endospores

Annex S


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Test Soils - 15883 5Load type Country Constituents Annex

Flexible

endoscopes

AT Nigrosin, wheat flour,hens egg, E.Faecium

Annex E

DE Blood E Faecium Annex I

NL Bovine serum albumin,porcine mucin,bovin

fibrinogen, bovin

thrombin

Annex L

UK Glycerol, dehydratedhog mucin,

horse serum,unbleached plain

flour, aqueous safranine

solution,

water

Annex R


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EN ISO 15883 Protein testing

EN ISO 15883-1:2004(E) 10

NOTE 2 Additional verification of attainment of the required

cleaning efficacy during operational testing may be

provided by the use of one of the methods for the detection and

assessment of residual protein given in 10.2.3 and

Annex C.


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Protein testing - EN ISO 15883-1

The test method for performance qualification of cleaning

efficacy is described in 6.10.3 and shall include the use of

one of the methods for the detection and assessment of

residual proteinaceous contamination given in Annex C.


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EN ISO 15883 -1 Protein testing

EN ISO 15883-1:2004(E) 10

NOTE 4 The three test methods for protein residue testingin Annex C are not equally sensitive. The ninhydrinmethod

(C.1) and Biuret method (C.3) have similar sensitivities but

should be regarded as a limit test and a semi-quantitativetest

respectively. The OPA method (C.2) is more sensitive butrequires the use of laboratory facilities.


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So how do we protect the

patient, the healthcare workerand the hospital?

EN ISO 15883, and numerous national and international

standards and recommendations all reflect the need to

routinely monitor the Soil removal efficacy of your

process. In general this is undertaken on a daily basis.

Added to this is the routine need to test protein residues

up to an accuracy of a minimum 2ug.


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Surrogate devices standard

Representative of standard hospital instrumentation such as

box joints , burr baskets hinged instruments etc.

Most made from stainless steel offering various challenges to

the cleaning process.

Universally applicable and in most cases usable in Ultrasonic

machines.


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Surrogate devices - standard


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Surrogate devices

TS ISO 15883 Annex E E.6.1 Tubes for use as test pieces ( Austria )

(PTFE) tubes having a length of 2 m and inner diameters of 1,0 mm and

2,0 mm respectively.

A.6.2 Instruments for minimal invasive surgery

As a surrogate for rigid endoscopes dummies made of stainless steel

tubing should be used with a wall

thickness of approximately 1 mm and:

length of 150 mm, inner diameter of 8 mm;

length of 300 mm, inner diameter of 4 mm and 6 mm

respectively.


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Surrogate devices

TS ISO 15883 Annex R 6 Test pieces ( UK )

A surrogate device for investigation of cleaning and disinfectionmay be constructed from two 1,5 m lengths of PTFE tube having

an inner diameter of 2mm and one 1,5 m length of PTFE tube

having an inner diameter of 1 mm. These should be bound

together with adhesive tape at intervals of approximately 150

mm.


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Surrogate devices


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Conclusion

In conclusion the challenge to those in the CSSD is

The more complex the instrument the more vital it is that weare assured that it has been effectively cleaned. Not every now

and again but consistently hour by hour , day by day whether

manually or through an automated process.

It is therefore critical that we are constantly challenging that

process using the tools provided in international standards in

whatever form is most suitable to your needs and practices.


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Thanks for your time !


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References

EN ISO standards

EN ISO 15883 1

TS EN ISO 15883 - 5

National and regional guidelines

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cleaning procedure

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