The use of load controls in the sterilisation process

Cindy Graham Tuesday October 16th 2012

Patient Safety C. Graham Oct 2012

Objectives

Patient Safety C. Graham Oct 2012

Importance of monitoring your sterilisation process Importance of instant result Options available Most diagnostic technology Relevant standards Conclusion

Learning Objectives
are achieved decontamination reprocessing

Present the importance of ensuring sterility assurance levels

Discuss how to manage and control the risks associated with

Identify the differences between options available in line with current standards

Patient Safety C. Graham Oct 2012

Sterility Assurance
What is sterility assurance? What is it based on? What does it give you and the patient?
Patient Safety C. Graham Oct 2012

What is Validation ?
predetermined conditions.

Validation is the documented procedure for obtaining,recording and interpreting the results required to establish that a process will consistently yield product complying with And shall include Installation Qualification Operational Qualification Performance Qualification
5
Patient Safety C. Graham Oct 2012

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 Safety C. Graham Oct 2012

First Minute of Cycle at 134C

No. of Micro-organisms

3 Mins.

Patient Safety C. Graham Oct 2012

106 105 104 103 102 101 100 0 10-1 10-2 10-3 10-4 10-5 10-6

Assumed Bioburden of 106 Micro-organisms

Second Minute of Cycle at 134C

No. of Micro-organisms

2 SAL 10-6

Mins.

Patient Safety C. Graham Oct 2012

106 105 104 103 102 101 100 10-1 0 10-2 10-3 10-4 10-5 10-6

Assumed Bioburden of 106 Micro-organisms

No. of Micro-organisms

Safety Time
106 105 104 103 102 101 100 10-1 0 10-2 10-3 10-4 10-5 10-6 Assumed Bioburden of 106 Micro-organisms

SAL 10-6 Minimum of 1 Min. Safety Time

Patient Safety C. Graham Oct 2012

3 Mins.

EN ISO 15882/ EN ISO11140-1

Patient Safety C. Graham Oct 2012

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bound to give this Standard a national standard status by March 2009 and any conflicting National standards should be withdrawn.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 indicators and is intended mainly for the use of manufacturers of chemical indicators

10

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
Patient Safety C. Graham Oct 2012

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.

11

Resistometers EN ISO 15882

the user to replicate the manufacturers label claims.

Hospital sterilizers typically do not have the same response characteristics

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

Therefore it is suggested that third party independent laboratories with resistometers are used to verify manufacturers claims.

Patient Safety C. Graham Oct 2012

12

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

ISO11140 Classifications
Class 1: Process indicators Class 2: Indicators for use in specific tests
Patient Safety C. Graham Oct 2012

Class 3: Single parameter indicators Class 4: Multi-parameter indicators Class 5: Integrating indicators Class 6: Emulating indicators

14

ISO11140 - Class 5 Integrating Indicators

Also known as chemical biological indicators Must react to all critical parameters of a given process G. stearothermophilius in steam as per ISO 11138 part 3 For steam the tolerances are; time +0%, - 15% temperature +0, -1C
Patient Safety C. Graham Oct 2012

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

15

Class 5 indicators at 270 / 273 F

No. of Micro-organisms

3 Mins.

Patient Safety C. Graham Oct 2012

106 105 104 103 102 101 100 0 10-1 10-2 10-3 10-4 10-5 10-6

Assumed Bioburden of 106 Micro-organisms

16

Class 6

A Class 6 indicator would prove that all parameters of a given process were present as per values stated on the indicator.
Patient Safety C. Graham Oct 2012

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

17

No. of Micro-organisms

Class 6
106 105 104 103 102 101 100 10-1 0 10-2 10-3 10-4 10-5 10-6 Assumed Bioburden of 106 Micro-organisms

SAL 10-6 Minimum of 1 Min. Safety Time

Patient Safety C. Graham Oct 2012

3 Mins.

18

In Pack Monitoring

Generally using a class 4,5 or 6 chemical indicator placed in the tray or wrapped item.
Patient Safety C. Graham Oct 2012

The classification of the indicator would determine the level of assurance offered by this indicator. Classifications are set out in and ISO 11140 - 1

19

Patient Safety C. Graham Oct 2012

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 for routine monitoring. Chemical indicator PCDs are currently the most common form of Load control

Load Control

20

Indicators for use in Process Challenge devices EN ISO 15882 6.4

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.

Patient Safety C. Graham Oct 2012

Process Challenge devices have been developed to represent a penetration challenge to the sterilization process.

21

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
Patient Safety C. Graham Oct 2012

22

What does load control offer the CSD or unit manager

It provides the assurance that the correct parameters for effective sterilization were present in the Chamber. This physical evidence can be retained and stored with the cycle printout providing proof for your records. Therefore providing an element required for Accreditation and record keeping
Patient Safety C. Graham Oct 2012

23

Load control only as good as the indicator

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

Patient Safety C. Graham Oct 2012

24

 Load control calibrations 134C 3.5 min 4 min 5.3 min 7 min 121C 15 min 20 min

Cycle specific load controls

Lets compare the two

Load Control Assurance of the load. Physical evidence inspected and retained 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
Patient Safety C. Graham Oct 2012

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

26

Conclusion

Patient Safety C. Graham Oct 2012

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

27

Patient Safety C. Graham Oct 2012

Thank you

Questions???

28

References
En ISO standards
EN ISO 15882 EN ISO 11140-1
All classifications of indicator
Patient Safety C. Graham Oct 2012

29