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Changes to labelling and regulation of hard surface disinfectants (commencing 1 April 2019)
The labelling and regulation of hard surface disinfectants has changed as a result of consultation by the Therapeutic Goods Administration (TGA) on the regulation of low-risk products. These changes took effect on 1 April 2019 and will have an impact on healthcare facilities.
These changes are part of reforms by the TGA to the regulation of low risk products, to reduce regulatory burden for industry and allow sponsors and the TGA to focus on areas of risk with these products and higher-risk products.
Healthcare facilities are advised that:
- Some hard-surface disinfectants will no longer need an Australian Register of Therapeutic Goods (ARTG) entry, simplifying supply and procurement.
However, please note that:
- Chlorhexidine labelling has been updated to minimise the risk that these solutions are accidently misused as skin antiseptics.
- In light of reported injuries, health professionals are reminded to ensure they are using the correct disinfectant product for the intended purpose.
The TGA undertook consultation on the regulation of low-risk products, including hard surface disinfectants in 2017, and published outcomes of that consultation on the TGA website. Changes to the regulatory requirements for hard surface disinfectants took effect on 16 October 2018 in the Therapeutic Goods Regulations 1990. The changes included:
- Household/Commercial Grade and Hospital Grade hard-surface disinfectants with specific claims are now Listed Therapeutic Goods (which means they continue to be listed on the ARTG).
- Hospital Grade hard-surface disinfectants with no specific claims are now exempt from requiring an ARTG entry.
The TGA would recommend healthcare facilities review their procurement processes so that an ARTG entry is no longer required for Hospital Grade hard-surface disinfectants with no specific claims.
Further information on the regulation and specific claims can be found on TGA's website.
Therapeutic Goods Order 54 - Standard for Disinfectants and Sterilants (TGO 54) sunset on 1 April 2019 and has been replaced by Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019. Sponsors of all hard surface disinfectants must comply with TGO 104.
Please contact LowRiskDevices@health.gov.au for any queries regarding this downregulation.
Review of products containing chlorhexidine
The TGA reviewed chlorhexidine products registered in the ARTG after health professionals raised concerns with the unsafe use of such products.
The TGA has worked with sponsors to strengthen labelling requirements to minimise the risk that these solutions will be accidently misused as skin antiseptics. These labelling requirements took effect on 1 April 2019 (Noting a transition period to 1 April 2020).
Concerns have been raised with the TGA about the risk of accidental injection, related to the indistinct colouration, specifically of pink chlorhexidine. The TGA has received two adverse event reports related to this type of misuse of chlorhexidine; one event caused catastrophic injury when chlorhexidine was unintentionally injected in the patient's spine. The reasons advised for the cause of the events was that the tinting could not be distinguished clearly enough when placed in the procedural site or surgical field.
Chlorhexidine products are also supplied as a skin antibacterial or antiseptic and these are regulated differently to hard-surface disinfectants:
- Skin antiseptic products are regulated as over-the-counter medicines. They are required to be entered in the ARTG and have been assessed by the TGA to ensure the manufacturer has tested that they are appropriate for use on the skin.
- Hard-surface disinfectant products are regulated as Other Therapeutic Goods and depending on the claims may be exempt from entry on the ARTG. They have not been assessed by the TGA for use on the skin.
- Disinfectants that clean or disinfectant medical devices are regulated as medical devices and are required to be included on the ARTG. They are not assessed for use on skin.
- Antibacterial skin care products where claims are limited to general low level activity against bacteria (for example, "Kill 99.9% of bacteria") are exempt from entry in the ARTG. These products must not contain substances that are included in Schedule 2, 3, 4 or 8 of the Poisons Standard
Presentations of chlorhexidine may be tinted a range of colours including pink, red, blue and yellow in various degrees of shades.
The TGA sought advice from its Advisory Committee on Medical Devices (ACMD) who noted that it is likely that hard-surface disinfectant chlorhexidine products are being misused in clinical settings as skin antiseptics.
Advice for health professionals and healthcare facilities
The TGA encourages health professionals and healthcare facilities to:
- Check the label on the solutions used for hard-surface disinfection and skin antisepsis to ensure that you are using the correct product and the correct solution for your intended purpose.
- Check that when these solutions are purchased that the sponsor supplies solutions that are correctly listed in the ARTG according to the intended purpose.
- Use hard-surface disinfectants and skin antiseptics according to the intended purpose.
Consumers and health professionals are encouraged to report any problems with hard surface disinfectants. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.
Please contact IRIS@health.gov.au for any queries regarding chlorhexidine.