seeking clarification on WD versus manual wash for scope accessories in an endoscopy day procedure centre

[Michelle Bibby]

HI Team

You may or may not be able to assist but I am seeking some clarification if possible please?

I have also posed this question to GENCA and NSQHS as I believe we have some duty of care to support these centres with best practice but not irrational over expenditure on unnecessary equipment and water testing.

With regard to a free standing endoscope day procedure centre, only doing gastroscopes and colonoscopes, what is the rationale for installation of a WD when all that is being washed are scope accessories?

Whilst I appreciate the push for the implementation of single use, for some centres this is not a cost effective alternative at this point in time, not until the market is held accountable.

The scope accessories are a semi critical device and the scope itself is undergoing HLD, so how can we rationalise installation of a WD and associated RO water systems and water quality testing?

Currently the accessories are manually washed, then go through an U/S, rinsed with RO water then visually inspected, dried and then sterilized.

The WDs can not actually improve the cleaning process, can they, other than the statement in 4187 which says along the lines of automated is more reproduceable

Whilst AS/NZS4187:2014 states that the correct cleaning pathway should be chosen, and manufacturers instructions are followed, it also goes on to say that manual cleaning of an RMD shall only be used where the manufacturers validated cleaning instruction requires manual cleaning and as a pre treatment.

Many of the man instructions are lacking in detail and open for interpretation.

I am providing advise, I would like to be able to provide a sensible rationale as to how installation of a WD will actually improve the cleaning process, but more importantly improve the patient outcome.

Any advise/opinions gratefully accepted

Michelle

Michelle Bibby

Infection Prevention Australia

+61 429 071 165

Michelle@infectionprevention.com.au

http://www.infectionprevention.com.au

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.

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[Anonymous]

Hi Michelle,

Back in the early days of the roll out of AS4187 and where facilities were using AERs that only performed the disinfection step of the reprocessing procedure, I may have been guilty of making a similar recommendation as I grappled with the application of Clause 5.1.2 and Clause 6.2.3 in environments that were endoscopy only, or in facilities that also undertook minor procedures like vasectomy or excision of haemorrhoids as well as endoscopy.

Given that in 2016 the ACSQHC mandated compliance with AS4187 by December 2021, facilities with AERs not compliant with ISO15883-1 and ISO15883-4 needed to plan to upgrade their equipment to washer-disinfectors that used chemical disinfection to process thermolabile endoscopes, replacing older machines that only performed the chemical disinfection step of the process.

This, in my humble opinion helped with respect to ensuring facilities were required to plan to upgrade to ISO15883-1 &4 compliant AERs. Therefore facilities with these compliant AERs can at least, subject buttons to an automated cleaning and disinfection process, prior to further processing.

Therefore, I would suggest that these facilities could manually pre-clean the buttons according to the manufacturers IFU and then process them in the ISO15883-1 & 4 compliant washer-disinfector, along with the endoscope, prior to drying, packaging and sterilizing of the buttons. That way you can say that the buttons have undergone automated cleaning and [chemical] disinfection prior to sterilization.

It is interesting to note however, that in the USA it is expected that the scope and the buttons are treated as one unit to ensure traceability, whereas in Australia our approach is very different and we require semi=-critical RMDs that can be sterilized, to be sterilized instead of only high level disinfected between uses.

Hopefully, both manufacturers reprocessing instructions, specialist guidelines and the Australian Standard will provide clearer guidance on this issue in future.
Kind Regards
Terry McAuley
Director
MSc Medical Device Decontamination

PO BOX 2249, Greenvale VIC Australia 3059
Mobile: +61 (0)438 109 692
Email: terry@steamconsulting.com.au
Website: http://www.steamconsulting.com.au

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From: ACIPC Infexion Connexion On Behalf Of Michelle Bibby
Sent: Tuesday, February 26, 2019 12:44 PM
To: ACIPCLIST@ACIPC.ORG.AU
Subject: [ACIPC_Infexion_Connexion] seeking clarification on WD versus manual wash for scope accessories in an endoscopy day procedure centre

HI Team

You may or may not be able to assist but I am seeking some clarification if possible please?

I have also posed this question to GENCA and NSQHS as I believe we have some duty of care to support these centres with best practice but not irrational over expenditure on unnecessary equipment and water testing.

With regard to a free standing endoscope day procedure centre, only doing gastroscopes and colonoscopes, what is the rationale for installation of a WD when all that is being washed are scope accessories?

Whilst I appreciate the push for the implementation of single use, for some centres this is not a cost effective alternative at this point in time, not until the market is held accountable.

The scope accessories are a semi critical device and the scope itself is undergoing HLD, so how can we rationalise installation of a WD and associated RO water systems and water quality testing?

Currently the accessories are manually washed, then go through an U/S, rinsed with RO water then visually inspected, dried and then sterilized.

The WDs can not actually improve the cleaning process, can they, other than the statement in 4187 which says along the lines of automated is more reproduceable

Whilst AS/NZS4187:2014 states that the correct cleaning pathway should be chosen, and manufacturers instructions are followed, it also goes on to say that manual cleaning of an RMD shall only be used where the manufacturers validated cleaning instruction requires manual cleaning and as a pre treatment.

Many of the man instructions are lacking in detail and open for interpretation.

I am providing advise, I would like to be able to provide a sensible rationale as to how installation of a WD will actually improve the cleaning process, but more importantly improve the patient outcome.

Any advise/opinions gratefully accepted

Michelle

Michelle Bibby
Infection Prevention Australia
+61 429 071 165
Michelle@infectionprevention.com.au
http://www.infectionprevention.com.au

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

To send a message to the list administrator send an email to admin@acipc.org.au

You can unsubscribe manually from this list by sending ‘signoff acipclist’ (without the quotes) to listserv@aicalist.org.au

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

To send a message to the list administrator send an email to admin@acipc.org.au

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[Anonymous]

Michelle

I will attempt to answer some of this for you. I can understand if it does seem like overkill, I am still learning 6 months into a project on helping my organisation become compliant.

First you mention that you are only going gastroscopies & colonoscopies I take it to mean that you are looking only? The challenge comes further if you are doing biopsies, injections, polyp removals etc, as these procedures then become critical procedures under Spauldings Classification. This changes the ball game with how we look at endoscopy. At the FSRACA conference last year, Alberto Csap from Vancouver spoke about how they have moved to sterilisation (low temperature) of all endoscopes. While slightly different from your question, he did pose the very interesting question of – if biopsy forceps are considered to be critical devise and need to be sterile, how can we then thread them down a HLD only device and expect that they remain sterile? (a copy of his presentation is available on the FRSACA site).

As to the use of a WD, I can understand some of your frustration, but it is not until you start to look at some of the literature, that we begin to understand. There are a number of studies that explain why automated cleaning is better than manual cleaning. I have attached a couple of references. While they are not specific to endoscopy, the concepts can be extrapolated. Manual cleaning involves the human element, which is difficult to control. People invariably take short cuts, or forget all steps required, and endoscopy cleaning is very complex!. Your validation processes will either support continued manual washing, or identify that automated processes are better. Plus has the manufacturers provided you with validated cleaning instructions, and is manual cleaning acceptable in these instructions?

* Alfa, M. J., & Nemes, R. (2004). Manual versus automated methods for cleaning reusable accessory devices used for minimally invasive surgical procedures. Journal of Hospital Infection, 58(1), 50-58. doi:https://doi.org/10.1016/j.jhin.2004.04.025
* Lopes, L. K. O., Costa, D. M., Tipple, A. F. V., Watanabe, E., Castillo, R. B., Hu, H., . . . Vickery, K. (2018). Complex design of surgical instruments as barrier for cleaning effectiveness, favouring biofilm formation. The Journal Of Hospital Infection. doi:10.1016/j.jhin.2018.11.001

Finally water quality, we are all eagerly awaiting an update to the water quality component (table 7.2) in the Standards. As the is variability in water quality from site to site, you wont know unless if you test. The purpose of the testing is to:

1. ensure that the process does not add to the contamination of the reusable medical devices (RMD) you need to know if your final rinse water has microbial contamination
2. water quality will affect your cleaning process including chemical consumption, temperature and overall cleaning time
3. That the water is not causing damage to the RMD or the reprocessing equipment

Sorry about the length response. I agree it is all about patient safety, I hope this helps.

Kind regards,

Mandy Davidson
RN; GCert Inf Pre & Cont; MPHTM; Cert III Sterilisation; Cert IV TAE; Immunisation cred; CICP-A

Clinical Nurse Consultant 4187 Implementation project

Infection Prevention & Control

[cid:image001.png@01D3A193.4E4B0480]

T

07 4433 1873 | 0402 987 432

E

Mandy.Davidson@health.qld.gov.au

W

http://www.health.qld.gov.au/townsville

Townsville Hospital and Health Service

100 Angus Smith Drive, Douglas, QLD 4814

[Facebook-Icon] [Twitter-Icon] [Linkedin-Icon]

Townsville Hospital and Health Service acknowledges the Traditional Owners of the land, and pays respect to Elders past, present and future

From: ACIPC Infexion Connexion [mailto:ACIPCLIST@ACIPC.ORG.AU] On Behalf Of Michelle Bibby
Sent: Tuesday, 26 February 2019 11:44 AM
To: ACIPCLIST@ACIPC.ORG.AU
Subject: [ACIPC_Infexion_Connexion] seeking clarification on WD versus manual wash for scope accessories in an endoscopy day procedure centre

HI Team

You may or may not be able to assist but I am seeking some clarification if possible please?

I have also posed this question to GENCA and NSQHS as I believe we have some duty of care to support these centres with best practice but not irrational over expenditure on unnecessary equipment and water testing.

With regard to a free standing endoscope day procedure centre, only doing gastroscopes and colonoscopes, what is the rationale for installation of a WD when all that is being washed are scope accessories?

Whilst I appreciate the push for the implementation of single use, for some centres this is not a cost effective alternative at this point in time, not until the market is held accountable.

The scope accessories are a semi critical device and the scope itself is undergoing HLD, so how can we rationalise installation of a WD and associated RO water systems and water quality testing?

Currently the accessories are manually washed, then go through an U/S, rinsed with RO water then visually inspected, dried and then sterilized.

The WDs can not actually improve the cleaning process, can they, other than the statement in 4187 which says along the lines of automated is more reproduceable

Whilst AS/NZS4187:2014 states that the correct cleaning pathway should be chosen, and manufacturers instructions are followed, it also goes on to say that manual cleaning of an RMD shall only be used where the manufacturers validated cleaning instruction requires manual cleaning and as a pre treatment.

Many of the man instructions are lacking in detail and open for interpretation.

I am providing advise, I would like to be able to provide a sensible rationale as to how installation of a WD will actually improve the cleaning process, but more importantly improve the patient outcome.

Any advise/opinions gratefully accepted

Michelle

Michelle Bibby
Infection Prevention Australia
+61 429 071 165
Michelle@infectionprevention.com.au
http://www.infectionprevention.com.au

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

To send a message to the list administrator send an email to admin@acipc.org.au

You can unsubscribe manually from this list by sending ‘signoff acipclist’ (without the quotes) to listserv@aicalist.org.au

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Any unauthorised use, alteration, disclosure, distribution or review of this email is strictly prohibited. The information contained in this email, including any attachment sent with it, may be subject to a statutory duty of confidentiality if it relates to health service matters.

If you are not the intended recipient(s), or if you have received this email in error, you are asked to immediately notify the sender by telephone collect on Australia +61 1800 198 175 or by return email. You should also delete this email, and any copies, from your computer system network and destroy any hard copies produced.

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Unless stated otherwise, this email represents only the views of the sender and not the views of the Queensland Government.

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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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[Robyn Lawson]

Great response Mandy and I totally agree with your comments. Nothing sits alone. The near future will be sterilisation for scopes.

Robyn Lawson

OR Consulting
PO Box 465
Dianella
Western Australia

0408871624
roblily49@gmail.com
Fellow ACORN

Sent from my iPhone

On 27 Feb 2019, at 6:22 am, Mandy DAVIDSON <Mandy.DAVIDSON@health.qld.gov.au> wrote:

Michelle

I will attempt to answer some of this for you. I can understand if it does seem like overkill, I am still learning 6 months into a project on helping my organisation become compliant.

First you mention that you are only going gastroscopies & colonoscopies I take it to mean that you are looking only? The challenge comes further if you are doing biopsies, injections, polyp removals etc, as these procedures then become critical procedures under Spauldings Classification. This changes the ball game with how we look at endoscopy. At the FSRACA conference last year, Alberto Csap from Vancouver spoke about how they have moved to sterilisation (low temperature) of all endoscopes. While slightly different from your question, he did pose the very interesting question of – if biopsy forceps are considered to be critical devise and need to be sterile, how can we then thread them down a HLD only device and expect that they remain sterile? (a copy of his presentation is available on the FRSACA site).

As to the use of a WD, I can understand some of your frustration, but it is not until you start to look at some of the literature, that we begin to understand. There are a number of studies that explain why automated cleaning is better than manual cleaning. I have attached a couple of references. While they are not specific to endoscopy, the concepts can be extrapolated. Manual cleaning involves the human element, which is difficult to control. People invariably take short cuts, or forget all steps required, and endoscopy cleaning is very complex!. Your validation processes will either support continued manual washing, or identify that automated processes are better. Plus has the manufacturers provided you with validated cleaning instructions, and is manual cleaning acceptable in these instructions?

* Alfa, M. J., & Nemes, R. (2004). Manual versus automated methods for cleaning reusable accessory devices used for minimally invasive surgical procedures. Journal of Hospital Infection, 58(1), 50-58. doi:https://doi.org/10.1016/j.jhin.2004.04.025
* Lopes, L. K. O., Costa, D. M., Tipple, A. F. V., Watanabe, E., Castillo, R. B., Hu, H., . . . Vickery, K. (2018). Complex design of surgical instruments as barrier for cleaning effectiveness, favouring biofilm formation. The Journal Of Hospital Infection. doi:10.1016/j.jhin.2018.11.001

Finally water quality, we are all eagerly awaiting an update to the water quality component (table 7.2) in the Standards. As the is variability in water quality from site to site, you wont know unless if you test. The purpose of the testing is to:

1. ensure that the process does not add to the contamination of the reusable medical devices (RMD) you need to know if your final rinse water has microbial contamination
2. water quality will affect your cleaning process including chemical consumption, temperature and overall cleaning time
3. That the water is not causing damage to the RMD or the reprocessing equipment

Sorry about the length response. I agree it is all about patient safety, I hope this helps.

Kind regards,

Mandy Davidson
RN; GCert Inf Pre & Cont; MPHTM; Cert III Sterilisation; Cert IV TAE; Immunisation cred; CICP-A

Clinical Nurse Consultant 4187 Implementation project

Infection Prevention & Control

[cid:image001.png@01D3A193.4E4B0480]

T

07 4433 1873 | 0402 987 432

E

Mandy.Davidson@health.qld.gov.au

W

http://www.health.qld.gov.au/townsville

Townsville Hospital and Health Service

100 Angus Smith Drive, Douglas, QLD 4814

[Facebook-Icon] [Twitter-Icon] [Linkedin-Icon]

Townsville Hospital and Health Service acknowledges the Traditional Owners of the land, and pays respect to Elders past, present and future

From: ACIPC Infexion Connexion [mailto:ACIPCLIST@ACIPC.ORG.AU] On Behalf Of Michelle Bibby
Sent: Tuesday, 26 February 2019 11:44 AM
To: ACIPCLIST@ACIPC.ORG.AU
Subject: [ACIPC_Infexion_Connexion] seeking clarification on WD versus manual wash for scope accessories in an endoscopy day procedure centre

HI Team

You may or may not be able to assist but I am seeking some clarification if possible please?

I have also posed this question to GENCA and NSQHS as I believe we have some duty of care to support these centres with best practice but not irrational over expenditure on unnecessary equipment and water testing.

With regard to a free standing endoscope day procedure centre, only doing gastroscopes and colonoscopes, what is the rationale for installation of a WD when all that is being washed are scope accessories?

Whilst I appreciate the push for the implementation of single use, for some centres this is not a cost effective alternative at this point in time, not until the market is held accountable.

The scope accessories are a semi critical device and the scope itself is undergoing HLD, so how can we rationalise installation of a WD and associated RO water systems and water quality testing?

Currently the accessories are manually washed, then go through an U/S, rinsed with RO water then visually inspected, dried and then sterilized.

The WDs can not actually improve the cleaning process, can they, other than the statement in 4187 which says along the lines of automated is more reproduceable

Whilst AS/NZS4187:2014 states that the correct cleaning pathway should be chosen, and manufacturers instructions are followed, it also goes on to say that manual cleaning of an RMD shall only be used where the manufacturers validated cleaning instruction requires manual cleaning and as a pre treatment.

Many of the man instructions are lacking in detail and open for interpretation.

I am providing advise, I would like to be able to provide a sensible rationale as to how installation of a WD will actually improve the cleaning process, but more importantly improve the patient outcome.

Any advise/opinions gratefully accepted

Michelle

Michelle Bibby
Infection Prevention Australia
+61 429 071 165
Michelle@infectionprevention.com.au
http://www.infectionprevention.com.au

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

To send a message to the list administrator send an email to admin@acipc.org.au

You can unsubscribe manually from this list by sending ‘signoff acipclist’ (without the quotes) to listserv@aicalist.org.au

********************************************************************************

This email, including any attachments sent with it, is confidential and for the sole use of the intended recipient(s). This confidentiality is not waived or lost, if you receive it and you are not the intended recipient(s), or if it is transmitted/received in error.

Any unauthorised use, alteration, disclosure, distribution or review of this email is strictly prohibited. The information contained in this email, including any attachment sent with it, may be subject to a statutory duty of confidentiality if it relates to health service matters.

If you are not the intended recipient(s), or if you have received this email in error, you are asked to immediately notify the sender by telephone collect on Australia +61 1800 198 175 or by return email. You should also delete this email, and any copies, from your computer system network and destroy any hard copies produced.

If not an intended recipient of this email, you must not copy, distribute or take any action(s) that relies on it; any form of disclosure, modification, distribution and/or publication of this email is also prohibited.

Although Queensland Health takes all reasonable steps to ensure this email does not contain malicious software, Queensland Health does not accept responsibility for the consequences if any person’s computer inadvertently suffers any disruption to services, loss of information, harm or is infected with a virus, other malicious computer programme or code that may occur as a consequence of receiving this email.

Unless stated otherwise, this email represents only the views of the sender and not the views of the Queensland Government.

**********************************************************************************

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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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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