Testing equipment device required for moist heat sterilisers during performance qualification

[Kylie Robb]

Hi everyone,

Office based dental practices primarily utilise small benchtop sterilisers. Under 4815 these sterilisers are subject to an annual validation that requires successful performance qualification (PQ), this includes physical and microbiological qualifications run concurrently over three consecutive tests.

Usually steriliser technicians will conduct this process for dental practices.

I’m interested to know if anyone can provide guidance on whether the steriliser technician should be monitoring each of these three cycles with their testing equipment (in addition to the three x Type 5 indicators) rather than just the first cycle with the indicators and the testing equipment and the other two with just the indicators (and no technician testing equipment).

Thanks everyone, I’d be interested to hear your thoughts.

Kylie

Kylie Robb MHSM (Clinical Leadership), CICP-P
ADA NSW Practice Services Manager
Infection Prevention and Control Professional (CICP-P)
Conjoint Lecturer – University of Newcastle – Oral Health School of Health Sciences – Faculty of Health and Medicine
ACIPC Board Director | SHEA International Ambassador

Level 1, 1 Atchison Street, St Leonards, New South Wales 2065
t: 02 8436 9936 m: 0438 628 664
E: kylie.robb@adansw.com.au | W: http://www.adansw.com.au | LI: http://www.linkedin.com/in/kylierobb/

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[Liberali, Sharon (Health)]

Hi Kylie,

There is detailed information within AS/NZS 4187 in section 7.4.5 related to the specificities of PPQ and MPQ for sterilisers, and referencing the relevant ISO 17665.1. It states that the PQ needs to include at least 3 consecutive successful exposures of the load to the process to demonstrate reproducibility of the process.

It is important to understand that he intention of PQ is to ensure the performance is robustly demonstrated for real world load conditions so there is confidence the intended sterilisation will occur on each and every occasion the parameters are used.
PQ is intended to protect patients from ultimate failure in the sterilisation processes, therefore it is important that the full assortment and range of RMD’s which are intended or likely to be sterilised are included in the PQ process.
The PQ results contribute to ensuring robust evidence supports the normal operation of the steriliser.

In the practices I take responsibility for the PQ of our sterilisers is only provided by a qualified instrument technician. Within the PQ process the steriliser is tested through 4 cycles with the instrument technician present for the whole process and monitoring each of the four cycles with their testing equipment (in addition to the three x Type 5 indicators). The requirement of the PQ validation report is also documented in AS/NZS 4187 and includes

* diagrammatic depictions of probe placement

* photographs of loaded chamber

* biological and chemical indicator results of all cycles with cycle numbers provided

* summary data of test results for all cycles

* temperature and pressure charts for all cycles

* validation certification in accordance with AS/NZS 4187 (2014).

While on quick perusal of AS/NZS 4187 today I couldn’t find where it specifically states that the technician needs to be monitoring all 3 cycles with their equipment (it may in the ISO standard) under 7.5.2 (j) the validation report needs to report the parameters used for each cycle and a copy of the specification for each process.

I would be extremely concerned if the technicians were not monitoring all cycles tested with their equipment. If there were differences between the cycle results, the reason would not be able to be answered without the information provided by the testing equipment.

Sharon Liberali
Chair, ADA Infection Control Committee
Member of HE-023 Committee of Standards Australia

A/Prof. Sharon Liberali
BDS(Adel); Grad.Dip.Clin.Dent; MScMed (OFP); D.Clin.Dent (SND);FRACDS (SND); FICD; FPFA.

Specialist, Special Needs Dentistry
Director, Special Needs Unit, Adelaide Dental Hospital, SA Dental Service.
Program Convenor, Special Needs Dentistry, School of Dentistry, University of Adelaide.

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Hi everyone,

Office based dental practices primarily utilise small benchtop sterilisers. Under 4815 these sterilisers are subject to an annual validation that requires successful performance qualification (PQ), this includes physical and microbiological qualifications run concurrently over three consecutive tests.

Usually steriliser technicians will conduct this process for dental practices.

I’m interested to know if anyone can provide guidance on whether the steriliser technician should be monitoring each of these three cycles with their testing equipment (in addition to the three x Type 5 indicators) rather than just the first cycle with the indicators and the testing equipment and the other two with just the indicators (and no technician testing equipment).

Thanks everyone, I’d be interested to hear your thoughts.

Kylie

Kylie Robb MHSM (Clinical Leadership), CICP-P
ADA NSW Practice Services Manager
Infection Prevention and Control Professional (CICP-P)
Conjoint Lecturer – University of Newcastle – Oral Health School of Health Sciences – Faculty of Health and Medicine
ACIPC Board Director | SHEA International Ambassador

Level 1, 1 Atchison Street, St Leonards, New South Wales 2065
t: 02 8436 9936 m: 0438 628 664
E: kylie.robb@adansw.com.au | W: http://www.adansw.com.au | LI: http://www.linkedin.com/in/kylierobb/

[cid:image001.png@01D3ABC9.C7D11160] [cid:image002.png@01D3ABC9.C7D11160] [cid:image003.png@01D3ABC9.C7D11160]
[cid:image008.png@01D674AB.7E1B3430]

This e-mail may contain confidential information. If you are not the intended recipient, please notify the sender immediately and delete it from your system and do not disclose or use the email’s content. Any opinions expressed in this email may not represent those of the Australian Dental Association (NSW Branch) Limited (ADA NSW). ADA NSW does not guarantee that email transmission is secure or error or virus free and ADA NSW accepts no liability arising out of the transmission or receipt of this email.

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[Andrew Ellis]

Hi Kylie,

The technician should be using the same physical sensors in all of the cycles used for PQ, and not omitting them after the first cycle.

Appendix F of AS/NZS4815:2006 includes several requirements which would support this;

> PQ must demonstrate heat penetration into the chosen load contents using thermocouples deployed in a specific fashion i.e. to reflect the coolest parts of the chamber identified during OQ, using no fewer thermocouples in PQ than in OQ, and at least one thermocouple placed adjacent the temperature sensor controller. Per F4(e).

> Placement of biological indicators in test loads is recommended as being “adjacent to the temperature sensors within the chamber and packages”, indicating that the thermocouples would be expected to be present. This is stated in the same section which cites the need for “three consecutive replicate cycles” so that supports their use for the entire process.

Clauses F5(a-h) specify the required content of the PQ report and this includes the placement of the thermocouples per F4(d).

Regards,

Andrew Ellis
Sterilising and Reusable Medical Device Reprocessing State Coordinator
Infection Control Service | Communicable Disease Control Branch
Health Regulation & Protection
Department for Health and Wellbeing | Government of South Australia
Level 3 | Citi Centre | 11 Hindmarsh Square | Adelaide SA 5000
HCW infection prevention: http://www.sahealth.sa.gov.au/infectionprevention
General public: http://www.sahealth.sa.gov.au/hospitalinfections

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Hi everyone,

Office based dental practices primarily utilise small benchtop sterilisers. Under 4815 these sterilisers are subject to an annual validation that requires successful performance qualification (PQ), this includes physical and microbiological qualifications run concurrently over three consecutive tests.

Usually steriliser technicians will conduct this process for dental practices.

I’m interested to know if anyone can provide guidance on whether the steriliser technician should be monitoring each of these three cycles with their testing equipment (in addition to the three x Type 5 indicators) rather than just the first cycle with the indicators and the testing equipment and the other two with just the indicators (and no technician testing equipment).

Thanks everyone, I’d be interested to hear your thoughts.

Kylie

Kylie Robb MHSM (Clinical Leadership), CICP-P
ADA NSW Practice Services Manager
Infection Prevention and Control Professional (CICP-P)
Conjoint Lecturer – University of Newcastle – Oral Health School of Health Sciences – Faculty of Health and Medicine
ACIPC Board Director | SHEA International Ambassador

Level 1, 1 Atchison Street, St Leonards, New South Wales 2065
t: 02 8436 9936 m: 0438 628 664
E: kylie.robb@adansw.com.au | W: http://www.adansw.com.au | LI: http://www.linkedin.com/in/kylierobb/

[cid:image001.png@01D3ABC9.C7D11160] [cid:image002.png@01D3ABC9.C7D11160] [cid:image003.png@01D3ABC9.C7D11160]
[cid:image008.png@01D674AB.7E1B3430]

This e-mail may contain confidential information. If you are not the intended recipient, please notify the sender immediately and delete it from your system and do not disclose or use the email’s content. Any opinions expressed in this email may not represent those of the Australian Dental Association (NSW Branch) Limited (ADA NSW). ADA NSW does not guarantee that email transmission is secure or error or virus free and ADA NSW accepts no liability arising out of the transmission or receipt of this email.

MESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO NOT REPRESENT THE OPINION OF ACIPC.

The use of trade/product/commercial brand names through the list is discouraged by ACIPC. If you wish to discuss specific reference to products or services by brand or commercial names, please do this outside the list.

Archive of all messages are available at http://aicalist.org.au/archives – registration and login required.

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MESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO NOT REPRESENT THE OPINION OF ACIPC.

The use of trade/product/commercial brand names through the list is discouraged by ACIPC. If you wish to discuss specific reference to products or services by brand or commercial names, please do this outside the list.

Archive of all messages are available at http://aicalist.org.au/archives – registration and login required.

Replies to this message will be directed back to the list. To create a new message send an email to acipclist@acipc.org.au

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