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Dear Colleagues,
I am seeking your feedback on what you use to clean and disinfect non-critical ultrasound transducers.
Please see below message from NATA:
I have completed the review of your re-submission and I appreciate the diligence which has been demonstrated in the pursuit of patient safety regarding Healthcare Associated Infection (HAI) and the disinfection of ultrasound transducers. Unfortunately, there is still an issue with the disinfectant being used on non-critical ultrasound transducers (Matrix Wipes).
As previously discussed within section 1.6 of the questionnaire for LSPN 49, any disinfectant used to disinfect ultrasound transducers for the purposes of DIAS, must meet the requirements of the Therapeutic Goods Order No. 54 – Standard for Disinfectants and Sterilants or equivalent.
In August 2018, NATA queried with the Department of Health whether products other than Medical Device Included Class IIb disinfectant products were adequate to meet the requirements of TGO 54 for the disinfection of non-critical ultrasound transducers. We received a response from the Department of Health advising that any disinfectants used to disinfect ultrasound transducers (for the purposes of DIAS) must be Medical Device Included Class IIb (instrument grade) disinfectants. Subsequently, we sent the below e-mail out on the 30th August 2018 to all of our sites who perform ultrasound:
“NATA recently sought further advice from the Department of Health due to the number of queries we received following the release of the Advisory Statement 18/06 – Requirement for High Level Disinfection of Ultrasound Transducers. These queries related to the classification of disinfectants with respect to non-critical ultrasound transducers.
The Department of Health has provided us with the following response:
Only instrument grade disinfectants and sterilants can be used for the purpose of disinfecting or sterilising medical devices. Instrument grade disinfectants and sterilants include all low-level, intermediate-level, and high-level instrument grade disinfectants. These are regulated by the TGA as Class IIb accessories to medical devices.
In light of the Department’s clarification, it is recommended that you review your disinfection procedure for non-critical transducers and ensure that an ARTG-listed, instrument-grade, low-level or intermediate-level disinfectant is in use for the disinfection of any non-critical ultrasound transducers (download a copy of your detergent’s TGA Public Summary to check and record this review as part of your Standard 1.6 HAI audits).”
As you can see on the attached ARTG summary for Matrix Wipes, it is listed as a Medical Device Included Class 1 product. It is not listed as an instrument grade disinfectant (class IIb) and therefore, it does not meet the requirements of TGO 54 for the disinfection of ultrasound transducers.
Our transducer supplier has a large range of appropriate disinfecting options. I have been informed that there are only 2 suppliers of wipes that meet this regulation on the TGA and I am wondering how everyone else is tackling the issue.
If this applies to the DIAS (Diagnostic Imaging Accreditation Scheme) does this apply to non-critical ultrasound transducers used in other departments, eg. haemodialysis?
Thanks for your assistance in advance,
Kind regards,
[image001]
[image002] [image003] [image004]
Elizabeth Smith
Consultant
Infection Prevention & Control
GV Health | 69-71 Numurkah Road and Graham Street, Shepparton, Vic 3630
M: 0428 562 258
E: Elizabeth.Smith@gvhealth.org.au
Work Hours: Mon – Fri 8am-4:30pm[image005]
GV Health would like to acknowledge the traditional custodians of the land on which we live and work and pay our respects to elders past, present and emerging.
GV Health is committed to embracing diversity and welcomes all people.This communication is intended only to be read or used by the addressee. The information contained in this communication may be confidential information. If you are not the intended recipient, any use, interference with, distribution, disclosure or copying of this material is unauthorised and prohibited. The confidentiality attached to this communication is not waived or lost by reason of the mistaken delivery to you. If you have received this communication in error, please destroy it and notify the sender by return 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.
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Hi Elizabeth
Isn’t the advisory statement / TG054 referring to semi critical transducers rather than non-critical?
TGO54 requires all semi-critical medical devices such as ultrasound transducers which come in contact with broken skin, mucous membranes, blood or bodily fluids, to be reprocessed by cleaning, followed by high-level disinfection using an instrument grade disinfection method approved by the TGA.
Kind regardsSharon Stendt
Nurse Consultant Infection Prevention and Control
SALHN Infection Control Service
Sharon.stendt@sa.gov.au
Telephone 8204 6787
Internal extension 66787
Messagebank 65258 / 8204 5258Dear Colleagues,
I am seeking your feedback on what you use to clean and disinfect non-critical ultrasound transducers.
Please see below message from NATA:
I have completed the review of your re-submission and I appreciate the diligence which has been demonstrated in the pursuit of patient safety regarding Healthcare Associated Infection (HAI) and the disinfection of ultrasound transducers. Unfortunately, there is still an issue with the disinfectant being used on non-critical ultrasound transducers (Matrix Wipes).
As previously discussed within section 1.6 of the questionnaire for LSPN 49, any disinfectant used to disinfect ultrasound transducers for the purposes of DIAS, must meet the requirements of the Therapeutic Goods Order No. 54 – Standard for Disinfectants and Sterilants or equivalent.
In August 2018, NATA queried with the Department of Health whether products other than Medical Device Included Class IIb disinfectant products were adequate to meet the requirements of TGO 54 for the disinfection of non-critical ultrasound transducers. We received a response from the Department of Health advising that any disinfectants used to disinfect ultrasound transducers (for the purposes of DIAS) must be Medical Device Included Class IIb (instrument grade) disinfectants. Subsequently, we sent the below e-mail out on the 30th August 2018 to all of our sites who perform ultrasound:
“NATA recently sought further advice from the Department of Health due to the number of queries we received following the release of the Advisory Statement 18/06 – Requirement for High Level Disinfection of Ultrasound Transducers. These queries related to the classification of disinfectants with respect to non-critical ultrasound transducers.
The Department of Health has provided us with the following response:
Only instrument grade disinfectants and sterilants can be used for the purpose of disinfecting or sterilising medical devices. Instrument grade disinfectants and sterilants include all low-level, intermediate-level, and high-level instrument grade disinfectants. These are regulated by the TGA as Class IIb accessories to medical devices.
In light of the Department’s clarification, it is recommended that you review your disinfection procedure for non-critical transducers and ensure that an ARTG-listed, instrument-grade, low-level or intermediate-level disinfectant is in use for the disinfection of any non-critical ultrasound transducers (download a copy of your detergent’s TGA Public Summary to check and record this review as part of your Standard 1.6 HAI audits).”
As you can see on the attached ARTG summary for Matrix Wipes, it is listed as a Medical Device Included Class 1 product. It is not listed as an instrument grade disinfectant (class IIb) and therefore, it does not meet the requirements of TGO 54 for the disinfection of ultrasound transducers.
Our transducer supplier has a large range of appropriate disinfecting options. I have been informed that there are only 2 suppliers of wipes that meet this regulation on the TGA and I am wondering how everyone else is tackling the issue.
If this applies to the DIAS (Diagnostic Imaging Accreditation Scheme) does this apply to non-critical ultrasound transducers used in other departments, eg. haemodialysis?
Thanks for your assistance in advance,
Kind regards,
[image001]
[image002] [image003] [image004]
Elizabeth Smith
Consultant
Infection Prevention & Control
GV Health | 69-71 Numurkah Road and Graham Street, Shepparton, Vic 3630
M: 0428 562 258
E: Elizabeth.Smith@gvhealth.org.au
Work Hours: Mon – Fri 8am-4:30pm[image005]
GV Health would like to acknowledge the traditional custodians of the land on which we live and work and pay our respects to elders past, present and emerging.
GV Health is committed to embracing diversity and welcomes all people.This communication is intended only to be read or used by the addressee. The information contained in this communication may be confidential information. If you are not the intended recipient, any use, interference with, distribution, disclosure or copying of this material is unauthorised and prohibited. The confidentiality attached to this communication is not waived or lost by reason of the mistaken delivery to you. If you have received this communication in error, please destroy it and notify the sender by return 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.
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
You can unsubscribe manually from this list by sending ‘signoff acipclist’ (without the quotes) to listserv@aicalist.org.au
Hi Elizabeth,
I think the core issue here could possibly relate to terminology pertaining to cleaning and disinfection, including the labelling and intended use of cleaning agents and disinfectants.
The TGO 54 has definitions for hospital grade disinfectants and instrument grade disinfectants.
Hospital grade disinfectants are intended for hard surfaces. Instrument grade disinfectants are intended for use on medical devices.
Therefore, if a disinfectant is needed to be used on a non critical medical device it must be instrument grade.
If the non critical medical device requires cleaning between uses or cleaning prior to a disinfection process then the product used for cleaning should be a detergent intended for use on medical devices.
As far as I’m aware, the product mentioned is a cleaning agent intended for use on medical devices and the manufacturer does not state it is a disinfectant in the literature I’m aware of, hence the entry on the ARTG is as a cleaning agent.
Non critical reusable medical devices (RMDs) often only require cleaning between uses. Disinfection would only be indicated if the non critical RMD was contaminated with blood or body substances or if it was to be used on a critical aseptic field.
Thus the crux of the matter is, are you using the product as a disinfectant? If so that’s a problem for reasons outlined above.
If using the product as a cleaning agent and not using it for the purpose of disinfection, then perhaps clarification of the terminology with NATA is required.
Kind Regards
Terry McAuley
MSc Medical Device Decontamination
Director
STEAM Consulting Pty Ltd
E: terry@steamconsulting.com.au
M: 0438 109 692
W: steamconsulting.com.auDear Colleagues,
I am seeking your feedback on what you use to clean and disinfect non-critical ultrasound transducers.
Please see below message from NATA:
I have completed the review of your re-submission and I appreciate the diligence which has been demonstrated in the pursuit of patient safety regarding Healthcare Associated Infection (HAI) and the disinfection of ultrasound transducers. Unfortunately, there is still an issue with the disinfectant being used on non-critical ultrasound transducers (Matrix Wipes).
As previously discussed within section 1.6 of the questionnaire for LSPN 49, any disinfectant used to disinfect ultrasound transducers for the purposes of DIAS, must meet the requirements of the Therapeutic Goods Order No. 54 Standard for Disinfectants and Sterilants or equivalent.
In August 2018, NATA queried with the Department of Health whether products other than Medical Device Included Class IIb disinfectant products were adequate to meet the requirements of TGO 54 for the disinfection of non-critical ultrasound transducers. We received a response from the Department of Health advising that any disinfectants used to disinfect ultrasound transducers (for the purposes of DIAS) must be Medical Device Included Class IIb (instrument grade) disinfectants. Subsequently, we sent the below e-mail out on the 30th August 2018 to all of our sites who perform ultrasound:
NATA recently sought further advice from the Department of Health due to the number of queries we received following the release of the Advisory Statement 18/06 – Requirement for High Level Disinfection of Ultrasound Transducers. These queries related to the classification of disinfectants with respect to non-critical ultrasound transducers.
The Department of Health has provided us with the following response:
Only instrument grade disinfectants and sterilants can be used for the purpose of disinfecting or sterilising medical devices. Instrument grade disinfectants and sterilants include all low-level, intermediate-level, and high-level instrument grade disinfectants. These are regulated by the TGA as Class IIb accessories to medical devices.
In light of the Departments clarification, it is recommended that you review your disinfection procedure for non-critical transducers and ensure that an ARTG-listed, instrument-grade, low-level or intermediate-level disinfectant is in use for the disinfection of any non-critical ultrasound transducers (download a copy of your detergents TGA Public Summary to check and record this review as part of your Standard 1.6 HAI audits).
As you can see on the attached ARTG summary for Matrix Wipes, it is listed as a Medical Device Included Class 1 product. It is not listed as an instrument grade disinfectant (class IIb) and therefore, it does not meet the requirements of TGO 54 for the disinfection of ultrasound transducers.
Our transducer supplier has a large range of appropriate disinfecting options. I have been informed that there are only 2 suppliers of wipes that meet this regulation on the TGA and I am wondering how everyone else is tackling the issue.
If this applies to the DIAS (Diagnostic Imaging Accreditation Scheme) does this apply to non-critical ultrasound transducers used in other departments, eg. haemodialysis?
Thanks for your assistance in advance,
Kind regards,
Elizabeth Smith
Consultant
Infection Prevention & Control
GV Health
| 69-71 Numurkah Road and Graham Street, Shepparton, Vic 3630M:
0428 562 258E:
Elizabeth.Smith@gvhealth.org.au
Work Hours: Mon – Fri 8am-4:30pm
GV Health would like to acknowledge the traditional custodians of the land on which we live and work and pay our respects to elders past, present and emerging.
GV Health is committed to embracing diversity and welcomes all people.
This communication is intended only to be read or used by the addressee. The information contained in this communication may be confidential information. If you are not the intended recipient, any use, interference with, distribution, disclosure or copying of this material is unauthorised and prohibited. The confidentiality attached to this communication is not waived or lost by reason of the mistaken delivery to you. If you have received this communication in error, please destroy it and notify the sender by return 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.
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.auMESSAGES 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
Hi Terry
Thank you for the succinct summary of disinfectant/detergent types and uses, a topic which all is all too often misunderstood and made seem more complicated than need be. I have encouraged my colleagues to read your reply.
Regards
AlisonAlison Shoobert
CNC Infection Prevention Service – Mehi & Peel Sectors
Regular work days: Each Tues / Wed / Thur & alt MonHi Elizabeth,
I think the core issue here could possibly relate to terminology pertaining to cleaning and disinfection, including the labelling and intended use of cleaning agents and disinfectants.
The TGO 54 has definitions for hospital grade disinfectants and instrument grade disinfectants.
Hospital grade disinfectants are intended for hard surfaces. Instrument grade disinfectants are intended for use on medical devices.
Therefore, if a disinfectant is needed to be used on a non critical medical device it must be instrument grade.
If the non critical medical device requires cleaning between uses or cleaning prior to a disinfection process then the product used for cleaning should be a detergent intended for use on medical devices.
As far as I’m aware, the product mentioned is a cleaning agent intended for use on medical devices and the manufacturer does not state it is a disinfectant in the literature I’m aware of, hence the entry on the ARTG is as a cleaning agent.
Non critical reusable medical devices (RMDs) often only require cleaning between uses. Disinfection would only be indicated if the non critical RMD was contaminated with blood or body substances or if it was to be used on a critical aseptic field.
Thus the crux of the matter is, are you using the product as a disinfectant? If so that’s a problem for reasons outlined above.
If using the product as a cleaning agent and not using it for the purpose of disinfection, then perhaps clarification of the terminology with NATA is required.
Kind Regards
Terry McAuley
MSc Medical Device Decontamination
Director
STEAM Consulting Pty Ltd
E: terry@steamconsulting.com.au
M: 0438 109 692
W: steamconsulting.com.auDear Colleagues,
I am seeking your feedback on what you use to clean and disinfect non-critical ultrasound transducers.
Please see below message from NATA:
I have completed the review of your re-submission and I appreciate the diligence which has been demonstrated in the pursuit of patient safety regarding Healthcare Associated Infection (HAI) and the disinfection of ultrasound transducers. Unfortunately, there is still an issue with the disinfectant being used on non-critical ultrasound transducers (Matrix Wipes).
As previously discussed within section 1.6 of the questionnaire for LSPN 49, any disinfectant used to disinfect ultrasound transducers for the purposes of DIAS, must meet the requirements of the Therapeutic Goods Order No. 54 – Standard for Disinfectants and Sterilants or equivalent.
In August 2018, NATA queried with the Department of Health whether products other than Medical Device Included Class IIb disinfectant products were adequate to meet the requirements of TGO 54 for the disinfection of non-critical ultrasound transducers. We received a response from the Department of Health advising that any disinfectants used to disinfect ultrasound transducers (for the purposes of DIAS) must be Medical Device Included Class IIb (instrument grade) disinfectants. Subsequently, we sent the below e-mail out on the 30th August 2018 to all of our sites who perform ultrasound:
“NATA recently sought further advice from the Department of Health due to the number of queries we received following the release of the Advisory Statement 18/06 – Requirement for High Level Disinfection of Ultrasound Transducers. These queries related to the classification of disinfectants with respect to non-critical ultrasound transducers.
The Department of Health has provided us with the following response:
Only instrument grade disinfectants and sterilants can be used for the purpose of disinfecting or sterilising medical devices. Instrument grade disinfectants and sterilants include all low-level, intermediate-level, and high-level instrument grade disinfectants. These are regulated by the TGA as Class IIb accessories to medical devices.
In light of the Department’s clarification, it is recommended that you review your disinfection procedure for non-critical transducers and ensure that an ARTG-listed, instrument-grade, low-level or intermediate-level disinfectant is in use for the disinfection of any non-critical ultrasound transducers (download a copy of your detergent’s TGA Public Summary to check and record this review as part of your Standard 1.6 HAI audits).”
As you can see on the attached ARTG summary for Matrix Wipes, it is listed as a Medical Device Included Class 1 product. It is not listed as an instrument grade disinfectant (class IIb) and therefore, it does not meet the requirements of TGO 54 for the disinfection of ultrasound transducers.
Our transducer supplier has a large range of appropriate disinfecting options. I have been informed that there are only 2 suppliers of wipes that meet this regulation on the TGA and I am wondering how everyone else is tackling the issue.
If this applies to the DIAS (Diagnostic Imaging Accreditation Scheme) does this apply to non-critical ultrasound transducers used in other departments, eg. haemodialysis?
Thanks for your assistance in advance,
Kind regards,
Elizabeth Smith
Consultant
Infection Prevention & Control
GV Health
| 69-71 Numurkah Road and Graham Street, Shepparton, Vic 3630
M:
0428 562 258
E:
Elizabeth.Smith@gvhealth.org.au
Work Hours: Mon – Fri 8am-4:30pm
GV Health would like to acknowledge the traditional custodians of the land on which we live and work and pay our respects to elders past, present and emerging.
GV Health is committed to embracing diversity and welcomes all people.
This communication is intended only to be read or used by the addressee. The information contained in this communication may be confidential information. If you are not the intended recipient, any use, interference with, distribution, disclosure or copying of this material is unauthorised and prohibited. The confidentiality attached to this communication is not waived or lost by reason of the mistaken delivery to you. If you have received this communication in error, please destroy it and notify the sender by return 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.
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.auMESSAGES 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
Unless explicitly attributed, the opinions expressed in this email are those of the author only and do not represent the official view of Hunter New England Local Health District nor the New South Wales 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
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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