Practices are being offered a free trial of Duo OPH – a chlorine dioxide foam formulation for high-level disinfection of ophthalmic instruments distributed by Tristel.
Duo OPH was developed specifically for ophthalmic devices, including those that make direct contact with the eye. It can replace non-compliant solutions such as alcohol or soaking, and is approved by the Therapeutic Goods Administration (TGA) and in line with the relevant Australian Standard.
Duo OPH has been recognised by international and local peak bodies, including in Optometry Australia’s recent Infection Control Update
Many Practices Don’t Use Approved Solutions
Ash McMaster, Tristel’s Australia Managing Director, believes a lack of knowledge and outdated practices often dictate how practices and clinics reprocess devices that touch the eye, including tonometer prisms, diagnostic lenses, pachymeters and A- and B-scan ultrasound probes.
He said the majority of practices use alcohol wipes, dilute hydrogen peroxide or sodium hypochlorite, which neither meet requirements in Australia for device disinfection, nor demonstrate sufficient microbiological efficacy. Some may be an infection control risk and have been known to damage equipment.
According to Mr McMaster, Australian Standards state medical devices that touch a mucosal surface – such as the eye – are required to undergo high-level disinfection with a product recognised by the TGA. They are classed as ‘Class IIb Medical Devices’, which Duo OPH falls under, aligning it with AS/NZS-4187.
“The unique foam formulation passes local regulatory requirements as a high-level disinfectant, with efficacy against required organisms, and is approved by most major device manufacturers,” he said. “Duo OPH has been recognised by international and local peak bodies, including in Optometry Australia’s recent Infection Control Update.”
Mr McMaster said alcohol wipes and dilute hydrogen peroxide were not TGA-approved for disinfection of medical devices. While sodium hypochlorite has recently been discussed as effective against SARS-CoV-2, this chemistry is not approved for medical devices and is deemed ‘off-label’ use.
Additionally, he said most alcohol-based products claim to be effective against viruses in a five-minute contact time, and in some cases, this is achieved with soaking carriers in a test tube. However, this was not reflective of real-world use of alcohol wipes, where residual alcohol evaporates before being effective.
“Medical device disinfectants must be tested under real life scenarios, in worst-case testing on actual devices,” he said.
“Chemistries listed on a device’s Instructions For Use have passed material compatibility, not demonstrated efficacy in line with local requirements. Prolonged use of these chemistries can lead to damage to devices, such as scratching or clouding, or fixing of proteins.”