Decontamination Puzzle in

CSSD/HSSU/CDU/LDU
Validation of Sterilsation
processes !

Hugh O'Connor AP

Tracability system

Fire Exit

Ergonomic Enginering

Extra Long Chamber

BBS Sterilizer

Plant centralised

Managers office
Enginers Workshop

Humidity controller

Data logger

The Documentation and Process Testing in

the Hospital Setting
Hugh O'Connor AP

CSSD IAP(Clean)Room

Hugh O'Connor AP

Decontamination

Decontamination is a process which removes or destroys

contamination and thereby
prevents micro-organisms or other contaminants reaching a susceptible
site in sufficient quantities to initiate infection or any other harmful
response.
A multitude of different processes are available for decontamination.
Choice of the
appropriate procedure for a given situation demands an understanding
of the processes available, the level of decontamination required and
the manufacturers instructions for decontamination.
Having determined the level of decontamination required, this should
be achieved by a method that combines reliability, cost effectiveness
and the minimum of hazard to the user.

Hugh O'Connor AP

Decontamination Testing

Sterilization/Disinfection is a process whose

efficacy cannot be verified retrospectively by
inspection or testing of the product.
For this reason Sterilization/Disinfection have
to be validated before use.
The performance of the process must be
routinely monitored and the equipment
maintained.
Hugh O'Connor AP

The Philosophy of Testing

Three main principles

All sterilizers/washers are monitored to a

planned programme of tests

All sterilizers/washers are subject to a planned

program of PM

Expertise on all aspects of the testing should be

available at three levels
1.
Competent Management
2.
Competent Users
3.
Competent Test People
Hugh O'Connor AP

Situtation Prior to standards

Myriad of small benchtops

No automated Washers
No standardised testing or auditing
No documentation process
No auditing/Validation process
No dedicated facilities for decontam
No ongoing education process

Hugh O'Connor AP

Introduction of HSE/EN standards

Look at how best to reduce risk of infections from

the reprocessing of medical devices especially
Surgical instruments/endoscopes.
Look at what is best practice for procedures on
cleaning, disinfection, sterilisation of such devices.
A healthcare institution should do everthing to
prevent spreading of infections within the
institution reason for manged CSSD.
Hugh O'Connor AP

Pilot review example

Introduction.
The pilot review was part of the process for
implementing the HSE Code of Practice for
Decontamination of Reusable Invasive
Medical Devices Part 5b. The code is based
on EU standards, directives and other
international standards for decontamination
of RIMD and health and safety legislation and
covers recommended practices for
decontamination in a local decontamination
unit (LDU).
Hugh O'Connor AP

The Structure of the Pilot Review

Time taken to review each location.

Problems with questionnaire.
Information on water quality in each location.
Status and type of autoclave present.
Design and dimensions of relevant rooms.
Record keeping.
Tracing systems.
Presence of clean and dirty areas.
Evidence of no validation, servicing of
equipment
Hugh O'Connor AP

10

Some anomalies found in study

Hugh O'Connor AP

11

Findings of the Pilot Review

Hugh O'Connor AP

12

Findings of the Pilot Review

Hugh O'Connor AP

13

Positive Findings Pilot Review

Hugh O'Connor AP

14

Positive Findings Pilot Review

Hugh O'Connor AP

15

Positive Findings Pilot Review

Hugh O'Connor AP

16

Recommendations Pilot Review

Sign off on final version of Part 5b of code of

practice.
Upgrade or centralisation.
Full national review of dental surgeries.
Estimate of cost of upgrading HSE dental
surgeries up to the HSE Code of Practice.
Develop timetable for upgrading.
Funding issue.
Hugh O'Connor AP

17

Cost of implementing HSE COP

Labour Costs for in house testing

Labour Costs for in house user testing
Labour costs for water sampling
Labour costs for management of testing
Labour costs for auditing of testing
Labour costs for auditing of compliance
Labour cost to read and understand code of
practice and standards
Hugh O'Connor AP

18

Brief Look at Other Audits

Healthcare Commission Report 2008 UK.

90 % of acute hospitals failed to comply
FULLY with Commision Hygene Code.
One in five failed to satify requirements of
decontamination.
From April 2009 CQC will enforce requirement
of CHQ for infection control.
Care Quality Commission can impose
conditions and fines.
Hugh O'Connor AP

19

COP Recommends Centralisation

Centralise for patient safety

Provide a quality process that is consistent,
controlled and validated.

Dedicated trained staff.

Improve working environment.

Update equipment.

Cost efficiency.

Hugh O'Connor AP

20

Some Advantages for User of CLDU !

Reduce high cost of decontamination operations.

Checking of water quality and storage tanks.
Costly disposal of empty distilled water bottles.
Savings on multiple site validation.
Savings on multiple service costs.
Centralisation of tracability.
Release staff from low productivity tasks.
Free staff to attend prohylactic treatments.
Hugh O'Connor AP

21

The Plan for CLDU may start like this

Hugh O'Connor AP

22

The Future CDU Department

dirty corridor

Staff room
Treatment
room
Treatment
room

Returns and
wash
Clean
process

Treatment
room

Patient
ward/waiting
area

Office

Storage
Sterilizers
Hugh O'Connor AP

clean corridor
23

Best Practice - CSSD

Hugh O'Connor AP

24

Area of Focus

Wash Room

Steriliser Loading Area

Steriliser Plant Room

Machinery and Equipment

Hugh O'Connor AP

25

How A Wash Room Should Look

Hugh O'Connor AP

26

Wash Room Aseptics

314 stainless
inspection and disassembly tables
Negative AHU
ventilation
White-rocked or
similar environment
No access to IAP
Pass through hatch
Hugh O'Connor AP

27

Cart Wash (to solve MRSA ?)

Hugh O'Connor AP

28

Decontamination Services in LDU/CSSD

Dirty in/Clean out environment

Separation of Processes

Environmental testing and control

ACs WDs validated and tested to EN,COP 5

Reverse Osmosis water quality

Designated decontamination staff

Competency assessed training

Computerised barcode traceability

Documented ISO quality management system

Regular audit

Hugh O'Connor AP

29

The Team from COPS

Infection
Control &
Microbiologist

Manufacturer of
the ACs,WDs

Health Estates
Authorized
Person/similar

Test
Person
(Sterilizers)
Sterile Services

Contractors
Testing/building

The User

Hugh O'Connor AP

Estates
Management
Planning
Servicing/repair
Routine testing30

The Ideal Sterilization/Disnfection Process

Effective

against all infective agents

Sterilant/Disinfectant

and its residues

non-toxic,bio-degradable
Not

inactivating by soiling,protein,etc

Highly

penetrative

Rapid

in action

Cheap

to install and operate

Hugh O'Connor AP

31

The Ideal Sterilization/Disinfectant Process

Requires
No

no training, technical knowledge

environmental or bio hazard

Can

be continuously and independently

monitored
Causes

no damage to any of the products

Acceptable

to National/European, International

regulations
Hugh O'Connor AP

32

Critical Steps in the Reprocessing Process

Before any automated or manual disinfection or
sterilisation procedures the critical steps to
be followed are.
1.
Clean the instruments manually,
meticulously removing all organic material
in or on the surgical
instruments/endoscope.
2.
Rinse all parts and lumens throughly with
copious amounts of water and dry them
before placing the scope in the reprocessing
unit.
Hugh O'Connor AP

33

Critical Steps in the Reprocessing Process

4.

5.

6.

The drying process here avoids dilution of the

disinfectant concentration or interaction between
the water and the sterilant/disinfectant.
Follow the manufacturers direction for
reprocessing that specific brand and model of
instruments. (Ensure endoscope can be
reprocessed in automated manner not all can.)
If in doubt about capability of washer to reprocess
particular models or brands of surgical instruments
check with manufacturer to establish if these have
been tested on the particular machine.

Hugh O'Connor AP

34

Critical Steps in the Reprocessing Process

Hugh O'Connor AP

Regardless of whether
you manually reprocess
or use automated
processes, incorporate a
final drying step in your
reprocessing protocol,
flush all channels with
alcohol/Hot Air followed
by purging of channels
with air to remove
alcohol.
35

Critical Steps in the Reprocessing Process

8.

9.

Visual inspection of the reprocessing

procedure and reprocessed surgical
instruments can identify conditions that may
affect cleaning and disinfection processes.
Keep records of the use of each instrument
/endoscope, showing the patient upon
which it was last used, the type of
procedure and the reprocessing method
and unit used.
Hugh O'Connor AP

36

Critical Steps in the Reprocessing Process

10.

11.

Regular review of training given to

reprocessing staff, including additional staff
training and supervised practice each time a
new instrument model is introduced into the
facility.(PQ)
Independent audits by an Authorised
Person to verify compliance with procedures
and processes.
Hugh O'Connor AP

37

First StepValidate the Washer/Disinfector

Mop available
Detergent available
Temp of water
Method to change
water
Method to change
mop
Check efficacy
Hugh O'Connor AP

38

Post Design, Wash Room example

Hugh O'Connor AP

39

How the Washer Works

Drying
Hepa Filtered
Final Rinse
90 c for 1 min
RO < 35 C

standby
s
t
a
n

Initial wash
<35 c DI/Potable
< 120 msc
Hugh O'Connor AP

40

How the Washer works

Hugh O'Connor AP

Print to Cleanroom
Instruments Dry
If not clean not
washed
Test with Ninhyrdin
Check for water
spotting
Check all critical
Parameters
41

Ao Lethality with Thermal Washers

Standard EN DIN ISO15 883-1, Annex a

Moist predicatable lethal effect on micros
WD must guarantee moist effect on micro
All inner outer surfaces on RMD are wet
Furniture and wall of WD reach temp
Ao is the equivilent time in seconds@80c
D value is the time to reduce micro count to
10%.the Z value temp to reduce D 90%
Hugh O'Connor AP

42

Bio-burden reduction required for

cleaning

Water is the solvent and carrier in which soil is

going to disolved,suspended and transported, away
from the items to be washed. It provides the
environment in which all cleaning actions take place
Mechanical action such as wiping,brushing,spraying
water under pressure or ultrasonic waves
Chemical action,detergent+water used to soak and
suspend germs,dirt,also kill and protect
Heat improves the diluting power of the water and
detergent in order to prevent the coagulation of
tissues and blood
Hugh O'Connor AP

43

Bio-burden reduction required for

cleaning

MIs are used in wounds of patients,should

have no micros or foreign particles
Left on instruments can cause Sepsis or
septicimia
If such a dirt particle enters blood stream
recovery and morbidity can be effected
Leaving food(fungi)blood(Hep B) pus
(bacteria ,gangerine) allows micro to divide
and multiply
Hugh O'Connor AP

44

Bio-burden reduction required for

cleaning

In Summary
Remove all visable dust and dirt
Removal of breeding ground for
surviving micros
Protection against corrosion
Ensure safe free movement of
equipment and material
Thats why we do efficacy tests
Hugh O'Connor AP

45

Bio-burden reduction required for

cleaning

1.
2.
3.

Washing bioburden lesser challenge

Process is checked with 5,5,5 process
5 kinds of micros
In 5 minutes
With a factor of 10 to the 5(100,000)
In otherword after process 5 mins the no of
survivors of 5 kinds of micros is 1/100,000
of the original no 1 million then 10 (bacilus
subtillus)
Hugh O'Connor AP

46

Bio-burden reduction required for

cleaning

Hugh O'Connor AP

Fibrin layer leftover

Simulates blood film
Not clean not sterile
All instruments
suspect
Quarintine loads
Call HELP Engineer
required
47

Efficacy Study - Pre Wash

Hugh O'Connor AP

Before machine
washing.
Orthophedic
intruments pr soiled.
Tosi and Brownes
test soil.

48

Cleaning Eefficacy tests on WDs

Tosi 95% water

soluble proteins + 5%
water insoluble fibrin.
Marginal Fail blood+fibrin
remain.
Absolute fail with some
washers and detergent.
Pass, acceptable with at
67 mins of main wash.
Hugh O'Connor AP

49

Efficacy Study - Post Wash

Hugh O'Connor AP

Visual cleaned
Ninhydrin test
Washing must
remove all visible
evidence of soiling
All washer must be
subjected to
performance tests
50

Closer Visual Inspection after Manual

Process .

Hugh O'Connor AP

51

Closer Visual Inspection after

Automatic Washer Disinfection process
!

Hugh O'Connor AP

52

Conclusion from Study

Hugh O'Connor AP

Disinfection kills or
removes most
parhogenic
microorganisms
Washer with validated
performance will
achieve expected
efficacy
If washing fails then
Not clean Not sterile
53

Washer at 5th Gear

Hugh O'Connor AP

54

Ao Letahlity for WDS

Disinfection at bacteria,fungi,mycobateria,
heat sensitive viruses.
Ao value 600 is defined or 600 s=10@80
The Ao 600 can be achieved 90 c@1 min
Heat resistant viruses Hep B need Ao 3000
Need hold time of 90 c for 10 min
Does not eliminate impeccable cleaning of MD
which is precondition for Disinfection
Hugh O'Connor AP

55

Reduction in number of Live Spores in

WD
Temperature T in
C

Ao in Seconds

Ao in mins

70

6000

100.00

75

1897

25.00

80

600

10.00

85

190

3.16

90

60

1.00

90

Ao (3000)

25 minutes

Hugh O'Connor AP

56

A o Trace of 3000 @ 93 c

Hugh O'Connor AP

57

Washer Disinfectors Issues

Oprator Safety (door interlocks)

Consistent Cleaning Effect (Tosi clean)
High Temp Wash Stage >= 90c@1 min
Consistent Detergent solution
Predetermined wash stages
Cycle will include drying stage
Independent monitoring of critical events

Hugh O'Connor AP

58

Water Quality

The water supply may be hard ,it may

contain environmental mycobacterium

Mycobacterium chelonae,pseudomonas,
and other Gram negative bacilli may
contaminate the instrument.
Sterile water ids recommended for the
final rinsing off all types of endoscopes.
Hugh O'Connor AP

59

Decisions on Water?
Two options to obtain a supply of water of
suitable microbial quality.
1.
The use of pre-sterilized (pyrogen free)
bottled water for stand alone machines
2.
The use of pre-treated pyrogen free water
connected to mains machines
The type of pre-treatment is determined by an
audit of the supply water.

Hugh O'Connor AP

60

Reversed Osmosis Filtered System for clean

water and clean steam!

Carbon Filter
Ionise Water
5,2,1 micron reduce
.1 micron final water
High rejection due to
High Conductivity
Require Potable/main <
150 msc
Heat remove NCGS and
residual air
Hugh O'Connor AP

61

Water Supply Factors

The

effect of the installation of any water

treatment device on these parameters
The

location of the water treatment

device
(Note: failure to perform routine
maintenance can undermine the
effectiveness of the washer/water supply)

Hugh O'Connor AP

62

List of Tests for Washer Disinfector EN15883

Daily/weekly

Quarterly/Bi-Annual Annual

Test
Efficacy

Temperature

Safety Tests

Verification on
instruments

Clean strainers

Chemical Purity

Chemical Dosing

Final Rinse BI
Test

Hugh O'Connor AP

63

How a Sterilizer Works !

Hugh O'Connor AP

64

Some of the Maths of Sterilization

Hugh O'Connor AP

65

Reduction in number of Live Spores in D values at 121 c

Spores of

D 121 c (minutes) Z- value

Clostridium
Botulinum

0.204

10

Clostridium
sporogenes

0.81.4

13

Bacillus
steramoph

2.0

Bacillus subtilis

o.4

10

IM0

2.5

18.6

Hugh O'Connor AP

66

Gravity Displacement Autoclave

Typical time/temperature cycles

15 min at 121C
3 min at 134C (WHO)
(temperature labile material)

Arrange load inside the

chamber and insert the
temperature probe
Close door
Open steam valve
Steam enters the chamber
Air and condensate pushed
through the drain
Temperature in chamber
increases
When load temperature
reaches required sterilization
temperature the timing
starts
When hold time is
complete the steam valve is
closed
Autoclave is allowed to
cool until temperature<80C

Steriliser Loading Area

Hugh O'Connor AP

68

How a Sterilizer Works !

A steam sterilizer uses steam as a carrier of

thermal energy or heat Latent Heat,enthalpy
The steam softens the outer layer of the
micros which permits the thermal energy or
heat to enter the organism and come in
contact with the proteins in the organism
Heating the proteins causes changes in the
in the nature of the proteins which is called
Denaturing,Coagulation or poaching of
proteins.
Hugh O'Connor AP

69

How a Sterilizer Works !

Just as an egg white changes from liquid to

solid when heated.
The proteins in side the cells also change
when heated (the cytoplasm membrane
rendering the cell no longer viable)
Firstly the proteins do their job feeding ,
programming the cells essential functions.
Now the thermal energy disrupts these
essential functions and ZAPS the reproduction
nature of the programming.
Hugh O'Connor AP

70

How a Sterilizer Works !

Sterilization with steam depends on properly

elevated Saturated Steam at a sufficient time
and temperature
90%95% dryness factor
Sterilization of steam depends on properly
elevated Temp,sufficent moisture and
sufficient time.
Just as it takes three mins to boil an egg then
in cooking and sterilization the higher the
compatible temperature the faster the task is
completed
Hugh O'Connor AP

71

How a Sterilizer Works !

The critical factor in the destruction of

microorganisms is the relationship
between
Temperature 134 c too 137 c
Pressure 2.12 bar gauge
Time of exposure 3 minutes too 3.5
Hugh O'Connor AP

72

How a Sterilizer Works !

Hugh O'Connor AP

Air Removal by
Vacuum pump that
draws air out while
injecting steam into
the chamber
As more pressure
enters the chamber
the steam and air
from a mixture
73

Condensation formation in the chamber of a

porous load steriliser during sterilizing.

Steam supply
2.2 barg
135.8c

Surgical instrument
Pack 7kg +-5%

chamber
Condensate
At 135.8c

Drain (condensate to condenser and steam trap

And vacuum pump at 20mb is flashed of

Hugh O'Connor AP

74

Mixtures of air and steam

According to Daltons law of partial pressures,

the pressure exerted by a mixture of gases is
the sum of the individual pressures which
each exert if occupied a given space alone.
For ex if a space containing steam and air at
4 bar this could be 3bg of steam and 1bg of
air.
The resulting tmp would correspond to 3bg of
saturated steam instead of required tmp for 4
bar
This is why air venting,steam traps,air
Hugh O'Connor AP
75
detectors are essential.

Reduction in number of Live Spores in D values at 121 c

Spores of

D 121 c (minutes) Z- value

Clostridium
Botulinum

0.204

10

Clostridium
sporogenes

0.81.4

13

Bacillus
steramoph

2.0

Bacillus subtilis

o.4

10

IM0

2.5

18.6

Hugh O'Connor AP

76

How a Sterilizer Works !

H
w

Hugh O'Connor AP

When a predetermine pressure

is reached (getinge
1.11 bg),the drain
opens and the
pressurized steam
and air rush from
the chamber
creating a Vacuum.
77

How a Sterilizer Works !

Sensor
drain
Hugh O'Connor AP

Raising ,heating time

Once the air is removed
from the load and
chamber,steam is
injected until the
thermal sensor probe
(drain) reaches the preselected temperature
(134 c)

78

Handpiece Failures Processing with N cycle

Hugh O'Connor AP

79

How a Sterilizer Works !

Exhausting time(postvacuum) Holding time
complete the vauum
will exhaust to > 70
milibar.
Steam injector closed
Vacuum stay open untill
cycle complete
Hepa bacterial filter
opens
Sterile filtered air is
injected untill 1.014 bg
atmospheric is reached
Hugh O'Connor AP
80

> 70mb

How a Sterilizer Works !

Hugh O'Connor AP

Exposure Time (Plateau

time)
When thermal sensor
registers (134.2c) the
steam injection will
close and the actual
sterilization time will be
activated.
Sensor drops bellow
134.2 c, the steam
injector opens and tops
up.
81

Steriliser Guidelines

EN 554/EN 17665 Planned and Documented maintenance

HTM 2010/HTMO5 PT2 & 4 guidance on maintenance
MDA DB200 Vacuum Sterilizers
MDA DB9605 Benchtop Sterilizers
EN 13060 European Standard < 60 litres
DB9804 Periodic testing
HTM2031 Clean steam for sterilization
COP HSE Part 5a,5b
Manufacturers Guidelines especially Type S
Hugh O'Connor AP

82

Test Description for HSE COP Pt 5b Pre

Evaluations and Audits

Vacuum
Autoclave

Yearly Safety Test

Non
Vacuum
Autoclave
Yes

Washer
Disinfector

Ultra
Sonics

N/a

N/a

Air Leakage Test (automatic)

n/a*

N/a

N/a

N/a

Air Leakage Test (manual- temp. and pressure

sensors connected)
Automatic Control Test

n/a

N/a

N/a

N/a

Yes

N/a

N/a

Door and Door Interlocks

Yes

N/a

N/a
N/a
Yes

Verification of Calibration of Autoclave

Instruments
Cleaning Efficacy Tests

Yes

N/a

N/a

N/a

N/a
N/a
Yes

Detergent Reproducibility Test

N/a

N/a

N/a

N/a
N/a
Yes

Function Test

N/a

N/a

N/a

Air Detection System Performance Test for a

Full Load
Thermometric Test for a Full Ld

n/a

N/a
N/a

N/a

N/a

N/a

Thermometric Test for Disinfection

N/a
N/a

N/a
N/a
Yes

Ultrasonic Activity Test

N/a

Porous Load Dryness Test

N/a

n/a
N/a
N/a

Yes

Tests for Performance Requalification (as

required)
Air Leakage Test (automatic) (sensors
removed)
Air Detection System Function Test
(automatic)
Steam Penetration Test

N/a

Load Dryness on Reference Load

Full Performance Qualification Test

N/a
N/a
Yes

N/a

N/a
N/a
N/a

N/a

N/a
N/a

n/a

n/a

N/a

N/a

n/a

N/a

N/a

N/a

n/a

N/a

N/a

N/a

N/a
N/a
N/a
N/a
N/a

n/a

N/a

Steam Quality Tests (Commission)

N/a

N/a
N/a

Water Quality (Ph,Hardnes,Cd)

Yes

N/a

N/a

N/a

Photographic Evidence

N/a
N/a
Yes

N/a

Hugh O'Connor AP

n/a

83

Test Description for HSE COP Pt 5b Post

evaluations and Audits (Annual)

Vacuum
Autoclave

Washer
Disinfector

Ultra
Sonics

Yearly Safety Test

Non
Vacuum
Autoclave
Yes

Yes

Yes

Yes

Air Leakage Test (automatic)

n/a*

Yes

N/a

N/a

Air Leakage Test (manual- temp. and pressure

sensors connected)
Automatic Control Test

n/a

Yes

N/a

N/a

Yes

Yes

Yes

Yes

Door and Door Interlocks

Yes

Yes

Yes

Yes

Verification of Calibration of Autoclave

Instruments
Cleaning Efficacy Tests

Yes

Yes

Yes

Yes

N/a

N/a

Yes

Yes

Detergent Reproducibility Test

N/a

N/a

Yes

Yes

Function Test

N/a

Yes

Yes

Yes

Air Detection System Performance Test for a

Full Load
Thermometric Test for a Full Ld

n/a

Yes

N/a

N/a

N/a

Yes

N/a

N/a

Yes

Yes

Yes

Yes

Yes

Thermometric Test for Disinfection

Ultrasonic Activity Test
Porous Load /Dryness Test

n/a

Yes

Yes

Yes

Full Performance Qualification Test

Yes

Yes

Yes

n/a

Tests for Performance Requalification (as

required)
Air Leakage Test (automatic) (sensors
removed)
Air Detection System Function Test
(automatic)
Steam Penetration Test

Yes

Yes

n/a

n/a

n/a

Yes

N/a

N/a

n/a

Yes

N/a

N/a

n/a

Yes

Load Dryness on Reference Load

N/a

Yes

Yes

Yes

Steam Quality Tests (Commission)

Yes

Water Quality (Ph,Hardnes,Cd)

Yes

Yes

Yes

N/a

Yes

Yes

Photographic Evidence

N/a

Hugh O'Connor AP

84

Validation a Planned and Documented Process

Hugh O'Connor AP

85

Sterilizer in Action

Hugh O'Connor AP

86

If not clean cannot be sterilized

Hugh O'Connor AP

All viable viruses and

contaminants removed
All detergents removed
Visualy clean
Test for protein presenc
Test for efficay of wash

87

Specifications for WD

Fully automatic pre-determined Wash Cycle.

Automatic/verfiable Detergent dosing.
Three rinses + final rinse (90 c at 1 minute).
Single manually/double glass door.
Electricaly /Steam heated/Stainless 314-sl.
Event type printout with independent sensor
(temp,cycle time,dose) for traceabilty.
Single Shot clean Final rinse system (R/O,DI)
Compliant to EN-158833-1-2, COP 5.
Hugh O'Connor AP

88

Specification AC

Fully automatic pre-determined Ster Cycle.

Steam generated internally/externally.
Full active Vacuum system.
Single manually/automatic opertated door.
Electricaly /Steam heated.
Event type printout with independent sensor
(pressure,temp) for traceabilty.
Air detector a posibility for ADFT.
Single Shot clean steam system (R/O).
Pressur vesel marked to EN61010-2-041.
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List of Tests for Sterilizer/Autoclave

EN285/COP HSE 5b
Test

daily

Weekly

Annual

Bowie Dick Test

Weekly Tests
Verification of
instruments

ACT

Vacuum Leak test

Not applicable to type

N cycle (non-vacuum)

If applicable

Air Detector Tests

Small Load Test

Full Load Test

(solid)

Pressure Tests

24 months

BI+ Steam Quality

commissioning
Ap sign off
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Management Responsibility
The fundamental cause of this disaster is to

be found in human failings, ranging from

simple carelessness to poor management of
men and plant.
(Sir Cecil Clothier on the report into the
deaths of five patients due to a faulty
sterilizer)
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Your Responsibility
Purchasing,maintenance and inspection.
Regulatory and legal aspects
Sources of further advice (AP) and information
Technical aspects and safety considerations
The hazards of circumventing safety aspects
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Key Information You Need

From the Supplier

Compliance of equipment with regulatory and

legal requirements.
Information on the technical and safety
aspects of steriliser.
Knowledge on the hazards of circumventing
safety features
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Key Issues for the User

The processing of wrapped goods.

The processing of instruments with lumens or
cavaties.
The processing of porous materials.
The hazards of infection resulting from
inadequate processing.
MDA (93/42/EEC) all medcial devices should
be safe and fit for their intended purpose.
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Traceability

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Independent Monitoring & Verification System

For EN Sterilization

Real time data logging & archiving of

microprocessor and independent data

Real time data comparison with automatic machine

alarm and shutdown

On-screen machine operation mimic

Spreadsheet and graphical data representation

Individual cycle / file storage with unique identifier

Bar coding interface facility options

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Requirements for Checks and Balances

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To State of Sterility & Grace

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If we dont the risk is

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Your Responsibilty
lets do a bungi jump

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Whats the legal Requirement

Just as in the case of patient charts, present German
regulations decree that results documentation be kept for 30
years. (German Civil Code - BGB; limitation period after
which compensation claims become statute-barred). Claims
from the doctor-patient contract or from the hospital admission
contract become statute-barred after 30 years pursuant to
Article 195 of the German Civil Code. Because German
legislation recognises the principle of shifting the burden of
proof, which states that hospitals must prove that no damage
was inflicted on the patient, this documentary obligation also
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applies for the CSSD.

Overall Advice

HSE COP Pt5b, NHS website gives clear guidance

on Steriliser/Sterilisation Guidance.
Need bench tops with one shot system.
Standards are varied but should be driven by user
professionals and patients.
Trial machines before purchase.
Thermometric tests supersedes biological tests.
PQ and validate new machine to reflect medical
device needs
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Summary

The current requirement of BS EN544,

HTM01/02, DB9804, and EN 13060/EN 15883
are that successful decontamination
management is achieved by a combination of
personnel who have responsibilities for audit,
maintenance, and validation of
decontamination equipment through its
working life.
You and Me
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Validation
Kill, Kill,Kill them all,
Until nothing is alive
Ghengis Khan

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List of Tests for Washer Disinfector

EN15883-1/COP5
Test

daily

Weekly

Annual

Efficacy test

Spray arms

Verification of
instruments

Sump strainers

MIS lumen test

Small Load Test

Full Load Test

Dose pump check

Pump tests

Final rinse water

tests

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