Cleaning procedures and testing Challenging the process

Peter Newson Abu Dhabi Patient Safety 15 October 2012

 How clean is clean ? Manual cleaning

Objectives

EN ISO 15883 and the need for soil removal efficacy and protein testing Ultrasonics Standard instrument cleaning systems Complex and lumen instruments Conclusion

Learning Objectives
decontamination reprocessing reusable instruments

Discuss how to manage and control the risks associated with

Identify best practices for evaluating the effective cleaning of

Present the difference between soil removal and protein residue tests
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 Instrument cleaning is the first and arguably the most important step in the decontamination process.

Cleaning Processes

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.

Cleaning Processes
regulated by the. Medical Device Directive

Cleaning and disinfection of medical devices is

Recommendations of national authorities National guidelines EN ISO 15883 1 to 4 and TS EN ISO 15883-5

EN ISO 15883
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 washerdisinfectors that have been subjected to a type test as per ISO 15883-1 may be purchased.

 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.

Manual Cleaning

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 available or appropriate. Two methods of manual cleaning Immersion Non immersion

Manual cleaning
Brushes: external and internal

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

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!

Examples

Manual cleaning
Spray gun

A spray gun is essential for rinsing/flushing of hollow instruments. Various nozzles 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 sure that the water pressure is not too high in order to limit splashing. Only use cold water for blood removal!

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

 To be performed by a person trained in cleaning techniques and fully conversant with the instrument they are cleaning

What leads to successful Manual cleaning

debris drying.

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

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.

Mechanical cleaning

- Part 1: General requirements, terms and definitions and tests - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for 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

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 before Level of soil Load configuration.

EN ISO 15883

6.10 Tests of cleaning efficacy 6.10.1 General During tests of cleaning efficacy, the cycle shall be run without a disinfection stage. The drying stage may also be omitted if this is necessary to facilitate the detection of residual contamination 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 the appropriate test method(s) and test soil(s) as described in ISO/TS 15883-5 by taking into consideration the corresponding category of load.

Routine Monitoring: In General

Every load Independent from type and age of the WD Documentation of the results The results must reflect the demands

Minimum for Routine Monitoring

Loading pattern as described in standards and dependent on the process and instruments being cleaned Cleaning efficacy daily optical control of cleaning daily optical view of drying cleaning indicator protein test

So is it clean ??

 Soil removal a visual test

Soil removal test and Protein test

Protein test protein is invisible so a swab plus chemical interpretation is required

Guidelines - Soil Testing

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)

Cleaning Efficacy / soil testing

a total of 19 different test soils are described.

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

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

Load type Surgical instruments ( including rigid endoscopes)

Test Soils - 15883 5

Country NL Constituents
Bovine serum albumin fraction 5, porcine gastric mucin type 3, bovine fibrinogen fraction 1, bovine trombin Citrated cattle blood coagulated with calcium chloride Defibrinated horse/sheep blood, egg yolk, dehydrated hog mucin

Annex

Annex K Annex M Annex N

SE UK

DE

Sheep blood, E. faeciumb Egg yolk, E. faeciumb Semolina, butter, sugar, milk powder, E. faeciumb

Annex G

US

Protein/organic soil (user preference), B. atrophaeus endospores

Annex S

Load type Flexible endoscopes

Test Soils - 15883 5

Country AT Constituents
Nigrosin, wheat flour, hens egg, E.Faecium Blood E Faecium

Annex

Annex E Annex I Annex L

DE NL

Bovine serum albumin, porcine mucin,bovin fibrinogen, bovin thrombin Glycerol, dehydrated hog mucin, horse serum, unbleached plain flour, aqueous safranine solution, water

UK

Annex R

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.

Protein testing - EN ISO 15883-1

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.

The test method for performance qualification of cleaning

EN ISO 15883 -1 Protein testing

EN ISO 15883-1:2004(E) 10 NOTE 4 The three test methods for protein residue testing in Annex C are not equally sensitive. The ninhydrin method (C.1) and Biuret method (C.3) have similar sensitivities but should be regarded as a limit test and a semi-quantitative test respectively. The OPA method (C.2) is more sensitive but requires the use of laboratory facilities.

 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.

So how do we protect the patient, the healthcare worker and the hospital?

Added to this is the routine need to test protein residues up to an accuracy of a minimum 2ug.

Surrogate devices standard

box joints , burr baskets hinged instruments etc. the cleaning process.

Representative of standard hospital instrumentation such as

Most made from stainless steel offering various challenges to

Universally applicable and in most cases usable in Ultrasonic machines.

Surrogate devices - standard

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.

Surrogate devices

Surrogate devices

TS ISO 15883 Annex R 6 Test pieces ( UK )

A surrogate device for investigation of cleaning and disinfection may 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.

Surrogate devices

Conclusion

In conclusion the challenge to those in the CSSD is

The more complex the instrument the more vital it is that we are 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.

Thanks for your time !

References
EN ISO standards
EN ISO 15883 1 TS EN ISO 15883 - 5 National and regional guidelines

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