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Hi Kaylene/ Glenys
In response to Glenys’s recent posting compared to my earlier posting please note the distinction between two products. In my reply the link provided is for ANTIGERMIX E1 (AE1) – Light, germicidal, ultraviolet. (now attached) In Glenys’s attachment the listed device is for ANTIGERMIX S1 (AS1) – Light, germicidal, ultraviolet Product Type Medical device system Effective.
I cannot quickly determine if the devices are the same as their indications are different ie. one is indicated for TOE probes and the other seems for general. It’s a good example of not having a carte blanche approach but rather closely looking at device registration, device models, details and indications.
In your original email you didn’t differentiate to which ANTIGeRMIX model you are referring. Hopefully our respective views and others will help you find a safe solution to your original query.
Yours sincerely
Cath
Cathryn Murphy RN B. Photog MPH PhD CIC
Chief Executive Officer & Creative Director
Infection Control Plus Pty Ltd
QLD, Australia
E: Cath@infectioncontrolplus.com.au
M: +61 428 154154
W:http://www.infectioncontrolplus.com.au
Hi Kaylene,
The device you mention is regulated by TGA as a Class 11b “Medical Device” and is included in the TGA Australian Register of Therapeutic Goods (ARTG). See attached TGA “Summary for ARTG entry” and “TGA Summary of Disinfectant Regulations” at the following link https://www.tga.gov.au/summary-disinfectant-regulation
As mentioned by Cath Murphy note the intended purpose in the “Summary for ARTG entry” which states the following:
* “The ANTIGERMIX S1 (AS1) automaton is a dry disinfection process for ultrasound transducers. The AS1 device performs a High Level Disinfection on external or endocavitary ultrasound transducers. The process is based on UVC radiation as an alternative to a chemical disinfection process”.
Before using you should establish with the supplier/manufacturer of the transducer/s and the supplier/manufacturer of the Class 11b “Medical Device” [ANTIGERMIX S1 (AS1)] that they are compatible for the purposes of use and your warranty.
Regards
Glenys
Glenys Harrington
Infection Control Consultancy (ICC)
P.O. Box 6385
Melbourne
Australia, 3004
M: +61 404816434
E: infexion@ozemail.com.au
[Description: ICC Diagram ICCversion]
Good morning all
I am looking for some assistance with managing the high level disinfection of ultrasound probes. We currently use Trophon (hydrogen peroxide) but have found a few new small ultrasound transducers for the renal patients that have been brought into the system without an consultation with infection prevention. These have not been tested with the Trophon system and we do not have any other method to disinfect appropriately at this point.
Our biomedical team have distributed information to the teams that use ultrasounds suggesting they implement UV Antigermix system. Is there anyone using this?
Our team would appreciate any information that might help our choices.
Regards
[Barwon Health]
Kaylene Styles
Clinical Nurse Consultant | Infection Prevention Service | Barwon Health
Direct. (03) 4215 2323 |kaylenes@barwonhealth.org.au
Post. PO Box 281 Geelong 3220
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