Commonly Asked Questions
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- What is Antigermix AS1 & Hypernova Chronos Microbicidal efficacy?
- How is UV-C HLD efficacy positioned compared to other classical HLD products?
- Has UV-C HLD been proven to work on Reusable Medical Devices (RMDs) in a clinical setting?
- What are the Occupational Health and Safety benefits of using UV-C HLD?
- How does the UV-C HLD mitigate environmental impact?
- What UV-C dose is needed in order to adequately High Level Disinfect?
- How is the UV-C dose measured?
- What quality Monitor is in place for the Optical Diodes?
- How often is calibration of the photodiodes recommended?
- What training and accreditation is offered for the Antigermix?
- How does the Antigermix compare to other methods of HLD?
What Microbicidal effectiveness has been proven for the Antigermix AS1 & Hypernova Chronos?
Having undergone vigorous testing against a wide range of microorganisms and validated in line with global standards you can have complete confidence in the Germitec technology.
Germitec High Level Disinfection Medical Devices are independently tested and complies with testing requirements set by different regulators (TGA). Germitec works with leading laboratories and scientific centres in France, the United Kingdom, Germany and the United States.
To obtain TGA approval, is based on efficacy evidence submitted and assessed by TGAs Biologics team. The CE mark documents are not perceived as proof of effectiveness for a HLD device. The Hypernova Chronos ARTG is Class IIb
How is UV-C HLD efficacy positioned compared to other classical HLD products?
Independent tests have been carried out to compare Antigermix to other classical HLD chemical soaking products intended for ultrasound probes, and show that UV-C HLD is much more efficient than most of them (study 2345.GER.14):
Evolution of the number of viable Bacillus subtilis ATCC 19659 spores on the carrier tests according to contact time with UV-C in the ANTIGERMIX S1 (GERMITEC) unit or with high level disinfectants (Sporox, Cidex glutaraldehyde, Cidex OPA)
Result of comparative sporicidal testing (Bacillus subtilis ATCC 19659) of AS1 and candidate predicate HLD products.
Has UV-C HLD been proven to work on Reusable Medical Devices (RMDs) in a clinical setting?
There are several clinical research papers that demonstrate UV-C HLD effective on Reusable Medical Devices (RMDs) in a clinical setting. The latest clinical papers are:
This study was performed with current version of Antigermix AS1 with a 90 seconds cycle. 15 ultrasound probes used in anaesthesia for block placement were exposed to a large inoculum of 3 bacteria : Staphylococcus aureus, Escherichia coli, and Enterococcus faecalis. All probes were infected after inoculation (>150 colony-forming units) but were considered sterile (<10 colonyforming units) after disinfection. Moreover, for the authors, this method could obviate the use of sterile probe covers, which can improve echogenicity.
Maxime Pichon, Karine Lebail-Carval, Geneviève Billaud, Bruno Lina, Pascal Gaucherand and Yahia Mekki (2019) Decontamination of Intravaginal Probes Infected by Human Papillomavirus (HPV) Using UV-C Decontamination System. J. Clin. Med, 8, 1776; doi:10.3390/jcm8111776.
Lyon (2nd largest public group of hospitals in France) have performed an in-use study on vaginal probes (AS1, 90 seconds cycle) showing:
- 100 probes after UV-C HLD are not contaminated by HPV DNA nor Human DNA
- On 47 probes, after cleaning with the wipe and before UV-C HLD, 7 were Human DNA positive and 1 was positive with HPV-51 (High Risk HPV), these 8 probes were negative after UV-C HLD.
To Germitec knowledge, with this report, UV-C HLD 90 seconds cycle is the only disinfection for ultrasound probes that has been proven efficient against HPV both in laboratory and in real usage conditions.
What are the Occupational Health and Safety benefits of using UV-C HLD?
UV-C HLD uses no chemicals therefore there is no need to manage staff exposure and risks associated with processing chemicals is eliminated.
There are no risks associated with high temperatures, and chemical burns on users face or hands. Since UV-C HLD has now chemical residue or toxins from vaporised microorganisms there is no need for rinsing or wipe the probe after the disinfection cycle. This also reduces the risk of cross contamination and the need for special ventilation requirements such as fume cabinets and air quality monitoring to remove chemical fumes or remove airborne toxins produced from chemical deactivated microorganisms.
The Antigermix and Hypernova ranges of products are a safe solution for both staff and patients.
How does the UV-C HLD mitigate environmental impact?
The UV-C HLD is the safest environmental choice of HLD available for the following reasons:
- No consumables, no waste products.
- No chemical waste or residuals,
- No water waste in washing excess chemical residuals left on equipment.
- No refrigeration needed for storage and transport as no chemicals are required.
This no waste and no chemical approach is central to Germitec’s ecological and environmental protection philosophy. The system itself is also fully recyclable. Germitec and distributors provide a guarantee to take back the system at the end of its useful life for recycling.
What UV-C dose is needed in order to adequately High Level Disinfect?
The disinfection is achieved when the probe has received a sufficient germicidal UV-C dose. The dose required was determined by:
- Results from microbiological tests (see reference sheet).
- Accuracy of the effective dose measuring sensors.
Shading factor related to the presence of the probe in the Antigermix enclosure. Using a dose threshold guarantees that an adequate disinfection level has been achieved.
How is the UV-C dose measured?
Chronos’ Automated Verification System replaces the manual process of checking chemical indicators and test strips, thus saving time and reducing cost. This breakthrough technology consists of a monitoring and an independent control system.
- The monitoring system consists of two photodiodes that continuously measure the UV-C dose to operate the disinfection cycle to ensure High Level Disinfection efficacy is achieved. This takes approximately 90 seconds.
- The Independent control system validates the disinfection cycle based on the UV-C dose measurements of a third photodiode, declaring the disinfection cycle completed by displaying “CYCLE OK”.
The Automated Verification system operates similar to Parametric Release providing extra reassurance and saves time in automatically validating every disinfection cycle.
What quality Monitor is in place for the Optical Diodes?
The 2 optical diodes are each calibrated using a medical calibration device. (See calibration of Photodiodes paper for detailed information)
The Maximum deviation from the medical calibration device and the photodiode is a stringent Coefficient standard deviation.
How often is calibration of the photodiodes recommended?
The medical calibration device is performed when the system has one of the following
- Annual calibration check
- Preventative Maintenance
- Any change of parts
What training and accreditation is offered for the Antigermix?
Applications training for staff on the use of the Antigermix products or Hypernova Chronos is conducted during the installation. On-line training is available Germitec training plus a comprehensive e-training presentation with a Competency Assessment checklist.
How does the Antigermix compare to other methods of HLD?
Rapid Review Panel Recommendation Listing – Click Link: RRP
Germitec’s Antigermix (AS1) product scored a recommendation level of R2
R2 Basic research and development has been completed and the product may have potential value; the RRP recommends in use evaluations/trials to demonstrate improved efficiency or efficacy in improving infection and control to reduce healthcare associated infections are considered within an active NHS clinical setting.
The Hydrogen Peroxide Mist product scored a recommendation level of R5
R5 Insufficient clarity and/or evidence presented to enable a full review of the product. Therefore, the evidence presented does not demonstrate that the product is more efficient or efficacious at improving infection prevention and control to reduce healthcare associated infections.
A comprehensive literature review of all published journal articles on the available methods of High Level Disinfection was conducted by the NHS Scotland and Health Protection Scotland.
This paper compared available evidence for the use of ultraviolet light systems, hydrogen peroxide devices and manual wipes for the decontamination of Semi-Critical probes. This covered specifically; semi-invasive probes (SIUPs) and non-invasive ultrasound probes in semi-critical procedures.
Guideline Reference: NHS Scotland Guidance for Decontamination of Semi-Critical Ultrasound Probes; Semi-invasive and Non-invasive Ultrasound Probes March 2016 (PDF, 1489KB)
Levels of evidence
The following grades were given to the available evidence within the literature review using SIGN methodology.
- 1+ Well conducted meta analyses, systematic reviews of RCTs, or RCTs with a low risk of bias
- 2 Well conducted case control or cohort studies with a low risk of confounding, bias, or chance and a moderate probability that the relationship is causal
- 3 Non-analytic studies, e.g. case reports, case series