Dental practices across ACT and NSW are being reminded to review their sterilisation monitoring processes, following ongoing concerns about the use of non-compliant Helix devices.
Effective reprocessing of instruments depends on the correct functioning of Type B benchtop sterilisers, including their ability to achieve adequate air removal and steam penetration. Air removal and steam penetration is tested with Helix type devices. Practices are reminded to check that their Helix type device is compliant because not all commercially available Helix devices meet the required international standards.
AS/NZS 5369:2023 requires the use of validated sterilisation monitoring tools. For Helix type devices, this means compliance with ISO 11140-6. Devices meeting this standard are tested against a reference hollow load, ensuring they accurately simulate worst-case sterilisation conditions.
Using non-ISO compliant devices may result in undetected sterilisation failures and increased risk for patients.
Check your Helix device:
Look for ISO Numbers: The packaging, device body, or instruction manual must explicitly state that it complies with ISO 11140-6 or EN ISO 11140-6.
Check the Indicator Type: The indicator strips used inside the helix should be classified as Type 2 indicators according to ISO 11140-1.
Manufacturer Information: Ensure the device identifies a reputable manufacturer and includes a batch or reference number (REF) for traceability.
What should practices do?
- Immediately cease use of any non-compliant Helix devices
- Contact their dental supplier and ask for an ISO 11140-6 compliant Helix Device
- Verify supplier documentation and validation data
- Ensure staff are trained in correct sterilisation monitoring procedures.
It’s essential to maintain accurate records of daily steriliser cycle information, including test and instrument cycles, as well as device compliance.
Get in touch with our Practice Services team if you have any questions on 02 8436 9927 or email practiceservices@adansw.com.au