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Dear all,
Please find attached a copy of the TGA Intended Use Statement for ARTG Number .
This statement was reviewed and released by the TGA on 3rd May, 2012.The Tristel Wipes System is intended to decontaminate and disinfect non-lumened medical devices including those that cannot be fully immersed in liquid disinfectant or sterilants and cannot be sterilised by heat. The system provides high level disinfection in less than 2 minutes. The Tristel Wipes System is not intended for use on critical medical devices which must be sterilised prior to use on a patient.
Further, TGA also undertook an independent review of the use of this product in March 2012 and returned the following findings- (these are on file at AshMed and I am happy to make them available upon request at: scott@ashmed.com.au)
The Tristel Wipes System is a Medical Device Included Class 2B-ARTG #182843. Device is a semi critical device designed specifically for use with heat sensitive reusable ENT scopes and Ultrasound probes. The instructions for use has been reviewed along with GENCA and GENSA Infection Control Guidelines for Endoscopy and Australian Standards AS/ANZ 4187 and there appears to be no disagreement in principles. Information available to the TGA does not conflict with the manufacturers claim of Chlorine Dioxide as an oxidising agent nor the intended use of the device. TGA does not therefore intend to take any further action but will continue its monitoring of the product in the market place.
Thank you for the opportunity to contribute to the current discussion around this product
Scott Pabst
National Sales Manager
AshMed Pty Ltd
(Local Agents for Tristel PLC, UK)
0435 843 950Messages posted to this list are solely the opinion of the authors, and do not represent the opinion of ACIPC.
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Dear all,
AshMed has received approval from the Australian Sonographers Association for Tristel Wipes use with Intra Cavity Ultrasound transducers, and a press release indicating approval by the Australian Society of Ultrasound in Medicine (ASUM) group has just been posted to the ASUM website.
Please find below links to both sites
A.S.A Website
http://www.a-s-a.com.au/fileRepository/files/Website/Public site/Quality Practice/ASA Guidelines/0295_ASA-Guideline_ID_Update May2012.pdf
A.S.U.M Website
I hope these are helpful in creating an informed understanding of the approved use of Tristel Wipes for the use with Intra Cavity Ultrasound Transducers
Yours Sincerely
Scott Pabst
National Sales Manager
AshMed Pty Ltd
Ph. 0435 843 950
E. scott@ashmed.com.au—–Original Message—–
From: Scott Pabst [mailto:scott@ASHMED.COM.AU]
Sent: Monday, 28 May 2012 3:37 PM
To: AICALIST@AICALIST.ORG.AU
Cc: Scott Pabst
Subject: Chlorine Dioxide Wipes TGA Intended Use StatementDear all,
Please find attached a copy of the TGA Intended Use Statement for ARTG Number .
This statement was reviewed and released by the TGA on 3rd May, 2012.The Tristel Wipes System is intended to decontaminate and disinfect non-lumened medical devices including those that cannot be fully immersed in liquid disinfectant or sterilants and cannot be sterilised by heat. The system provides high level disinfection in less than 2 minutes. The Tristel Wipes System is not intended for use on critical medical devices which must be sterilised prior to use on a patient.
Further, TGA also undertook an independent review of the use of this product in March 2012 and returned the following findings- (these are on file at AshMed and I am happy to make them available upon request at: scott@ashmed.com.au)
The Tristel Wipes System is a Medical Device Included Class 2B-ARTG #182843. Device is a semi critical device designed specifically for use with heat sensitive reusable ENT scopes and Ultrasound probes. The instructions for use has been reviewed along with GENCA and GENSA Infection Control Guidelines for Endoscopy and Australian Standards AS/ANZ 4187 and there appears to be no disagreement in principles. Information available to the TGA does not conflict with the manufacturers claim of Chlorine Dioxide as an oxidising agent nor the intended use of the device. TGA does not therefore intend to take any further action but will continue its monitoring of the product in the market place.
Thank you for the opportunity to contribute to the current discussion around this product
Scott Pabst
National Sales Manager
AshMed Pty Ltd
(Local Agents for Tristel PLC, UK)
0435 843 950Messages posted to this list are solely the opinion of the authors, and do not represent the opinion of ACIPC.
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 aicalist@aicalist.org.au
To send a message to the list administrator send an email to aicalist-request@aicalist.org.au.
You can unsubscribe from this list be sending ‘signoff aicalist’ (without the quotes) to listserv@aicalist.org.au
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