cindy graham

8/13/2019 Cindy Graham

1/29

The use of load controls

in the sterilisationprocessCindy GrahamTuesday October 16th 2012 Pa

tient

SafetyC.

GrahamO

ct2012

1


2/29

Objectives

Patient

SafetyC.

GrahamO

ct2012

2

Importance of monitoring your sterilisation process

Importance of instant result

Options available

Most diagnostic technology Relevant standards

Conclusion


3/29

Learning Objectives

Patient

SafetyC.

GrahamO

ct2012

3

Present the importance of ensuring sterility assurance levels

are achieved

Discuss how to manage and control the risks associated with

decontamination reprocessing

Identify the differences between options available in line with

current standards


4/29

Sterility Assurance

Patient

SafetyC.

GrahamO

ct2012

4

What is sterility assurance?

What is it based on?

What does it give you and the patient?


5/29

What is Validation ?

Validation is the documented procedure for obtaining,recording

and interpreting the results required to establish that a

process will consistently yield product complying with

predetermined conditions.

And shall include

Installation Qualification

Operational Qualification

Performance QualificationPatient

SafetyC.

GrahamO

ct2012

5


6/29

Sterility Assurance

The Sterility Assurance Level, or SAL, is a measure of the

confidence in the attainment of sterility

a probability of 1 unsterile load in 1,000,000

Patient

SafetyC.

GrahamO

ct2012

6


7/29

First Minute of Cycle at 134C

106105

104

10310210110010-110-210-310-410-510-6

0 1 2 3 Mins.No.ofMic

ro-organisms

Assumed Bioburden

of 106

Micro-organisms

Patient

SafetyC.

GrahamO

ct2012

7


8/29

Second Minute of Cycle at 134C

106

105

104

103

102101

100

10-1

10-2

10-3

10-4

10-5

10-6

0 1 2 3 Mins.

No.ofMicro-organisms

Assumed Bioburden

of 106 Micro-organisms

SAL 10-6

Patient

SafetyC.

GrahamO

ct2012

8


9/29

Safety Time

106105104103102101100

10-110-210-310-410-510-6

0 1 2 3 Mins.

No.o

fMicro-organisms

Assumed Bioburden


SAL 10-6

Minimum of 1 Min.

Safety Time

Patient

SafetyC.

GrahamO

ct2012

9


10/29

EN ISO 15882/ EN ISO11140-1

All EU member countries were bound to give this Standard a

national standard status by March 2009 and any conflicting

National standards should be withdrawn.

EN ISO 15882 provides guidance on the use of indicators as

described in the ISO 11140 series of standards - ISO 11140

specifies the performance requirements of chemical indicatorsand is intended mainly for the use of manufacturers of chemical

indicatorsPatient

SafetyC.

GrahamO

ct2012

10


11/29

EN ISO 15882

Section 3 - General requirements 3.2 states that the value of the information provided by a

chemical indicator is dependent on the class of indicator ,

number and location of indicators being representative of

conditions throughout the load or the chamber.

3.7 Class 3,4,5 and 6 all require one or more Stated Values or

SVs these are based on the outcomes of testing undertaken in

a resistometer by the manufacturer.Patient

SafetyC.

GrahamO

ct2012

11


12/29

Resistometers EN ISO 15882

Hospital sterilizers typically do not have the same response characteristics

or accuracy of exposure conditions as resistometers it is very difficult for

the user to replicate the manufacturers label claims.

Therefore it is suggested that third party independent laboratories with

resistometers are used to verify manufacturers claims.Patient

SafetyC.

GrahamO

ct2012

12


13/29

BIER Vessel Biological Indicator Evaluation Resistometer

Chamber size of 10 -20 litres (less than 1 cu ft)

Sterilization temperature reached very quickly

Very accurate temperature control


14/29


15/29

ISO11140 - Class 5

Integrating Indicators Also known as chemical biological indicators

Must react to all critical parameters of a given process

Follow the death curve of a given spore population, e.g.

G. stearothermophilius in steam as per ISO 11138 part 3

For steam the tolerances are;

time +0%, - 15%

temperature +0, -1CPatient

SafetyC.

GrahamO

ct2012

15


16/29

Class 5 indicators at 270 / 273 F

106105

104

10310210110010-110-210-310-410-510-6

0 1 2 3 Mins.No.ofMic

ro-organisms

Assumed Bioburden

of 106

Micro-organisms

Patient

SafetyC.

GrahamO

ct2012

16


17/29

Class 6

A Class 6 indicator would prove that all parameters of a given process

were present as per values stated on the indicator.

Monitoring all 3 critical parameters of Time, Temperature and Steam

Cycle emulating

For steam the tolerances are;

time +0%, - 6%

temperature +0, -1C

Some examples :270 F for 4 min , 273 F or 134 C for 3.5 , 134 for 4, 7,

9, or 18 m 250 or 121 C for 20 min

Patient

SafetyC.

GrahamO

ct2012

17


18/29

Class 6

106105104103102101100

10-110-210-310-410-510-6

0 1 2 3 Mins.No.o

fMicro-organism

s

Assumed Bioburden


SAL 10-6

Minimum of 1 Min.

Safety Time

Patient

SafetyC.

GrahamO

ct2012

18


19/29

In Pack Monitoring

Generally using a class 4,5 or 6 chemical indicator

placed in the tray or wrapped item.

The classification of the indicator would determinethe level of assurance offered by this indicator.

Classifications are set out in and ISO 11140 - 1

Patient

SafetyC.

GrahamO

ct2012

19


20/29

Load Control

This takes the form of a biological indicator in the

U.S.

However, globally biological indicators now tend to

be used specifically for validation. purposes not forroutine monitoring.

Chemical indicator PCDs are currently the most

common form of Load control

Patient

SafetyC.

GrahamO

ct2012

20


21/29

Indicators for use in Process

Challenge devices EN ISO 15882

6.4

Process Challenge devices have been developed to

represent a penetration challenge to the sterilization

process.

There is no PCD that can be used for all sterilizer types

and sterilization procedures.

The performance of the PCD is the combined effect of

the chemical indicator and the PCD components.

PatientSafetyC.

GrahamO

ct2012

21


22/29

EN ISO 15882 PCDs 6.4 cont

most commercially available PCDs are designed to assess the

penetration of a reference load. Attention must be drawn to

the fact that these PCD challenge the process and do not

represent the sterilization load.

Different products, eg. Hollow loads ( beakers tubing etc )

porous loads ( linen, dressings, textiles ) and non porous loads

( solid and surgical instruments) can be represented by

different PCDs

PatientSafetyC.

GrahamO

ct2012

22


23/29

What does load control offer the

CSD or unit manager It provides the assurance that the correct

parameters for effective sterilization were present inthe Chamber.

This physical evidence can be retained and storedwith the cycle printout providing proof for yourrecords.

Therefore providing an element required forAccreditation and record keeping

PatientSafetyC.

GrahamO

ct2012

23


24/29

Load control only as good as the

indicator

PatientSafetyC.

GrahamO

ct2012

24

The dimensions of most hollow lumen load controls are based

on the specifications of EN 867-5 ( 1.5m x 2mm inner

diameter. The cap has to be 6 % of the total volume of the

tube)

The conformity of the ink used for the indicator must say EN

ISO 11140-1 class 2

There are new load control systems using class 6 technology

but requirements for the standard stipulate the label claims

As per the earlier slide class 6 is the most diagnostic and can

be calibrated for specific cycles

Always ask for technical certification to ensure your load

control is truly effective for your needs


25/29

Cycle specific load controls

Load control calibrations 134C

3.5 min

4 min 5.3 min

7 min

121C

15 min

20 min


26/29

Lets compare the two

Load Control

Assurance of the load.

Physical evidence inspected andretained within the CSSD before

the load is released

Recordable evidence at source

(CSSD)

Indicators are generally classified(class 2 ) - important to demand all

certification of technology

calibration

.

In pack monitoring

Assurance of the pack or tray.

Physical evidence is inspected by

the end user and retained at

point of use.

Indicators classified according

to their performance and

characteristics

PatientSafetyC.

GrahamO

ct2012

26


27/29

Conclusion

To have piece of mind regarding sterility assurance use the

most comprehensive combination of decontamination

monitoring systems available to you

Use the standards when choosing the technology you use

Ensure the product is calibrated to your cycle

Document the results for your records

PatientSafetyC.

GrahamO

ct2012

27


28/29

Questions???

PatientSafetyC.

GrahamO

ct2012

28

Thank you


29/29

References

En ISO standards

EN ISO 15882

EN ISO 11140-1

All classifications of indicator

PatientSafetyC.

GrahamO

ct2012

29

cindy graham

Documents