Advisory Statement A19/02 - New Reference for Disinfection Requirements in Standard 1.6, Healthcare Associated Infection

Page last updated: 09 July 2019

Advisory Statement A19/02 - New Reference for Disinfection Requirements in Standard 1.6, Healthcare Associated Infection (PDF 299 KB)

Purpose

To advise practices of a new reference document relevant to the requirements in Diagnostic Imaging Accreditation Scheme (DIAS) Standard 1.6 - Healthcare Associated Infection (Standard 1.6), following the cessation of Therapeutic Goods Order No.54 – Standard for Disinfectants and Sterilants (TGO54) on 1 April 2019.

This Advisory Statement should be read in conjunction with Advisory Statement 18/06 – Requirement for High Level Disinfection of Ultrasound Transducers and also the requirements of DIAS Standard 1.6, in its entirety.

Issue

Standard 1.6 requires a practice providing ultrasound services to have a documented infection control policy setting out the requirements for disinfecting ultrasound transducers which is consistent with the requirements of TGO54 or its equivalent.

As TGO54 is no longer in force, it is no longer the correct reference document for the purposes of demonstrating compliance with Standard 1.6. The Therapeutic Goods Administration (TGA) has confirmed that the relevant sections of the Guidelines for the Evaluation of Disinfectants (the TGA Guidelines) are considered equivalent to TGO54 for the purposes of informing practices about the requirements for high level disinfection of semi-critical medical devices.

Requirements

Semi-critical medical devices must be subject to high level disinfection. The requirements for high level disinfection in the TGA Guidelines are the same as those previously in TGO54. Practices which are currently disinfecting semi-critical ultrasound transducers in accordance with the high level disinfection requirements of TGO54, are therefore meeting the high level disinfection requirements of the TGA Guidelines. Practices should, however, update their infection control policy documents by deleting references to TGO54 and replacing them with the reference to the TGA Guidelines. This will ensure that future accreditation applications include the correct information.

For more information

Practices should refer to the TGA Guidelines for the Evaluation of Disinfectants1 for further information about the requirements for high level disinfection methods.

Additionally, practices should refer to and consider advice in the DIAS Advisory Statement 18/06 regarding the requirements for high level disinfection of ultrasound transducers.

The DIAS User Guide for Practices Applying for Accreditation provides practices with further clarifying information about the evidentiary requirements for Standard 1.6, and practices should contact their Accreditor for further information and advice.

1. https://www.tga.gov.au/publication/guidelines-evaluation-sterilants-and-disinfectants

TitleNew Reference for High Level Disinfection Requirements for Standard 1.6, Healthcare Associated Infection
VersionVersion 1
Date of publicationJuly 2019
ReplacesNot applicable
StatusActive
ComplianceMandatory
Approved byDiagnostic Imaging Accreditation Scheme Advisory Committee
Review dateJuly 2021
Information in this statement applies toDIAS Accreditors
Providers of Medicare-funded ultrasound services
Relevant standardStandard 1.6 - Healthcare Associated Infection
Prepared bySecretariat, Diagnostic Imaging Accreditation Scheme Advisory Committee
Contact detailsPhone: 02 6289 8859
Email: dias@health.gov.au
Trim reference
Links to other statements or advisory documentsUser Guide for Practices Applying for Accreditation
DIAS Advisory Statement A18/06 – Requirement for High Level Disinfection of Ultrasound Transducers.
Notes (if applicable)N/A