Stella System: disinfection made simple

Tristel Pty Ltd
Thursday, 24 September, 2020



Infection prevention is at the forefront of day-to-day life more than ever before. COVID-19 has forced non-essential procedures to be put on hold in an effort to reduce the spread of infectious diseases and protect the population, consequently causing a backlog of patients waiting for treatment.

Hospitals and clinics must look to find innovative solutions that are standardised and regulatory approved to allow for timely reprocessing of reusable medical devices, reducing the lists of patients waiting for procedures.

This solution must be safe, cost effective, practical and proven to work.

The solution is Stella!

What is Stella?

Stella is a semi-automated system designed specifically for the reprocessing of heat-sensitive small and medium-sized, rigid and flexible, non-lumened and single-lumened endoscopes used in urology, gynaecology, IVF, cardiology, ENT, anaesthesiology, endoscopy and respiratory.

Stella combines the simplicity of manual soaking with the sophistication of an automated washer disinfector.

There are two options for the Stella System: Stella with Pulse providing semi-automated high-level disinfection; or Stella with Pulse and Cleaning providing semi-automated cleaning followed by high-level disinfection.

How can Stella help?

Cuts capital expenditure

Healthcare facilities may try to overcome slow device reprocessing by investing in a large device fleet to circumvent the slower turnaround times from central reprocessing. Stella is significantly cheaper than other automated systems available on the market.

Stella will high-level disinfect a device in five minutes. This allows healthcare facilities to reduce waiting lists and costs, achieving high patient through put.

Stella is the perfect option to increase the number of procedures carried out per clinic and to reduce costs.

Mobile & Lightweight

Stella has a small footprint and can be mobile depending on the user’s needs. This makes Stella the perfect solution no matter the space available in healthcare facilities.

Prolonged Device Life

Devices are commonly damaged when travelling from the area of use to the area where they will be reprocessed. Stella’s small footprint and ability to be mobile is the perfect way to overcome this costly issue.

Improved Health & Safety

Chemical safety is key when selecting the right disinfection method for medical devices. Neither patient nor clinician should be exposed to toxic chemicals that put them at risk. Stella uses Tristel Fuse for Stella for disinfection — a non-toxic chemistry with a proven health and safety track record, providing peace of mind for professional and patient.

Microbiology and Chemistry

Stella uses Tristel Fuse for Stella, Tristel’s proprietary disinfectant which utilises chlorine dioxide.

Tristel Fuse for Stella has been tested in accordance with EN 14885:2018, the European regulatory standard that provides guidance for chemical disinfectants to make efficacy claims. It is bactericidal, fungicidal, virucidal, mycobactericidal and sporicidal in accordance with EN 14885:2018 and the testing requirements of the Therapeutic Goods Administration (TGA). It has been subjected to numerous simulated in use device tests and clinical studies which have been published in scientific peer reviewed journals such as BJU International (Gilling et al., 2013).

How Stella Meets Regulatory Requirements

In Australia, Stella and Tristel Fuse for Stella are regulated as a medical device by the Therapeutic Goods Administration (TGA).

The regulatory pathway for each disinfectant depends on the claims made in the instructions for use, labelling and promotional material. Only instrument-grade disinfectants and sterilants can be used to disinfect medical devices.

These disinfectants must comply with the essential principles for quality, safety and performance. The manufacturer must provide a technical file, which documents the evidence that it meets the requirements of the essential principles, and must follow a conformity assessment procedure to demonstrate whether the requirements of this Regulation relating to a device have been fulfilled.

Stella and Tristel Fuse for Stella meet TGA requirements and are approved as Class IIb medical devices.

To learn more about the Stella System, please don’t hesitate to contact your local Tristel office, or visit www.tristel.com.

Reference

Gilling, P., Reuther, R., Addidle, M., Lockhart, M., Frampton, C. and Fraundorfer, M., 2013. A randomised single-blind comparison of the effectiveness of Tristel Fuse (chlorine dioxide) as an office-based fluid soak, with Cidex OPA (ortho-phthaldehyde) using an automated endoscopic reprocessor (AER) as high-level disinfection for flexible cystosc. BJU International, 112, pp.69-73.

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