Frequently Asked Questions
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- What Microbicidal effectiveness has been proven for the
Chronos®? - How is UV HLD efficacy positioned compared to other classical HLD products?
- Has UV 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 HLD mitigate environmental impact?
- How is UVC High Level Disinfection achieved?
- How is the UVC 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 Chronos®?
- How does the Chronos® compare to other methods of HLD?
- What ultrasound probes are compatible with the Chronos®?
- Has the Hypernova Chronos been tested against high risk Human Papillomavirus and who performed the efficacy test?
What Microbicidal effectiveness has been proven for the 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 comply with the testing requirements set by different regulators such as the TGA. Germitec works with leading laboratories and scientific centres in France, the United Kingdom, Germany and the United States.
To obtain TGA approval, efficacy evidence is submitted and assessed by the TGA’s Biologics team. The Chronos® ARTG is Class IIb. Devices marked with the CE label alone, are not perceived as proof of effectiveness for a HLD device.
How is UV HLD efficacy positioned compared to other classical HLD products?
Independent tests were carried out to compare the Chronos® UV-C HLD process with
three FDA chemical sterilants (i) CIDEX OPA Solution, (ii) SPOROX II Sterilizing and Disinfection
Solution and (iii) CIDEX Activated Dialdehyde Solution against Bacillus Subtilis.1
The microbiology carrier tests were conducted to demonstrate the sporicidal effectiveness of HLD products/processes. Results were based on European Standards (EN) or the AOAC Official Methods (used by the FDA and TGA). The EN for sporicidal effectiveness requires a 4-log (99.99%) reduction, while the AOAC requires a 6-log (99.9999%) reduction.1
Results
The results indicate that the UV-C disinfection process killed spores within a 90 secs cycle time
- within a 18 seconds exposure time achieved 4.8 Log (99.99) reduction compliant to the EN standards and
- within a 84 seconds exposure time achieved 6.2 Log (99.9999) reduction compliant to the AOAC standards.
- For both standards the sporicidal efficacy was substantially higher than the chemical sterilants used according to manufacturer instructions for HLD.1
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:
Bloc S. and al., Evaluation of a new disinfection method for ultrasound probes used for regional anesthesia: ultraviolet C light. J Ultrasound Med. 2011 Jun;30(6):785-8.
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.
This is the first In-Use Study of Human Papillomavirus (HPV) Conducted in a Clinical Environment.
- The aim of this study was to determine if ultraviolet light – C spectrum (UV-C) disinfection is more efficient than low level disinfection (LLD) in routine clinical conditions, especially against HPV.
- The more rigorous protocol consisted of performing high level disinfection (HLD) on a probe that was partially cleaned but would appear visibly clean to the probe user.
Results showed the following outcomes:
1ST PHASE: No probes (0/100) were found positive for HPV or human cellular DNA after UV-C HLD (with AS1).
2ND PHASE: All 47 probe covers were intact (no visible damage) and positive for human and HPV DNA.
- The UV-C HLD procedure was found to be statistically
more efficient than LLD (eight contaminated
probes versus no contaminated probe, p < 0.05).
3RD PHASE: All 15 probe covers were intact and found to be positive for human DNA and HPV DNA. After probe cover removal, one probe was positive for high-risk HPV 16. This HPV contamination remained after LLD but was eliminated with UV-C disinfection (AS1).
Conclusion
UV-C disinfection is a relevant and easily adaptable solution for use within a clinical healthcare environment.
What are the Occupational Health and Safety benefits of using UV-C HLD?
UV 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 HLD mitigate environmental impact?
The UV 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.Â
How is UVC High Level Disinfection achieved?
Germitec emits an energy wavelength of 254 nm of UV-C
The dosage emitted inside the chamber is part of a proprietary algorithm owned by Germitec. Extensive testing has been completed by independent laboratories, under strict Regulatory Standards. This is to ensure the dose emitted inside the disinfection chamber meets all High Level Disinfection (HLD) requirements across the full spectrum of microorganisms, as outlined in Germitec Microbial Efficacy Marketing Materials.
Engineering Controls are in place to ensure that sufficient energy is generated on every successfully completed cycle to meet HLD requirements. This breakthrough technology is known as the Automated Verification System. It consists of a monitoring and independent control system to measure the UV-C dose. It automatically validates every disinfection cycle replacing the manual process of checking chemical indicators and test strips. Further saving time, reducing human error and costs.
How is the UVC dose measured?
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 Chronos®?
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 Chronos® compare to other methods of HLD?
Further information
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 chemical 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, chemical 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.
Level of Evidence from a comprehensive literature review
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
The evidence from the literature review shows:
- There is high level (1+ and level 2) published evidence to support the use of Ultra Violet light systems for decontamination of SIUPs
- There is low level published evidence (level 3) to support the use of automated chemical systems for decontamination of SIUPs
- There is low level published evidence (level 3) to support the use of a manual detergent/ disinfection/ rinse (multi-wipe ) system for decontamination of SIUPs
The HSE Guidance for Decontamination of Semi-critical Ultrasound Probes stated that ‘Manual Multi-Wipes is their less preferred option. They also stated that a national survey of TOE, TV and TR Ultrasound Probes across NHS conducted by Health Facilities Scotland (HFS) in 2012, concluded that there is an ongoing risk to patient safety with regard to decontamination of these SIUPs.
Note: HLD using the manual multi-wipe system is the least preferred option for disinfecting SIUP’s. Internationally, it is recognised that the use of an automated validated process for decontaminating RIMD will provide enhanced risk reduction of infection transmission. It is recommended that a local risk assessment is performed if this option is to be used as an interim measure prior to implementation of an automated process. Reference: HSE Guidance for Decontamination of Semi-critical Ultrasound Probes; Semi-invasive and Non-invasive Ultrasound Probes QPSD-GL-028-1
Antigermix S1 (AS1) and Chronos are the same medical device with identical chambers and core technology delivering ultraviolet-C (UV-C) high level disinfection (HLD). The clinical in-use study confirms how Chronos UVC HLD patent technology achieves efficacy by ensuring there is no shadowing on the ultrasound probe surface.
What ultrasound probes are compatible with the Hypernova Chronos?
The utilisation of plastics has gained popularity in medical device assembly because of their strength, weight, cost savings, aesthetics and performance properties. Medical Grade Polymers are commonly used to manufacture and assemble surgical instruments, catheters, endoscopes, ultrasound probes and other medical devices. These medical-grade polymers are designed specifically for use in medical applications that enable the medical devices to be capable of withstanding repeated cycles of ethylene oxide (ETO), radiation (UV-C), chemical sterilants and autoclaving.1
Germitec’s probe compatibility testing process:
Germitec products comply to the European Directive 93/42/CEE and lists all the Medical Devices (External, TV and TR probes) which are compatible with Antigermix (AE1) and Hypernova Chronos.
The compatibility between Medical Devices can be demonstrated in several ways:
Germitec conducts various tests in collaboration with probe manufacturers to ensure probe compatibility is achieved. These include (i) tests in laboratories on probes or on materials provided by manufacturers; (ii) tests in laboratories on materials representative of those used in the probes; (iii) documentary studies; (iv) field observations of probes in real use.
With some probes, UV-C can cause slight discolouration of the housing and the cable. However, slight discolouration does not affect the performance of the ultrasound probe and these changes can be minimised by proper cleaning prior to each UV-C cycle. Cleaning of the device is a necessary part of the decontamination process.
In comparison, chemical disinfectants are also known to cause discolouration to the surface of ultrasound probes. Also, as with UVC such discolouration change does not impact the performance, safety or lifetime of the probe. For example, Cidex OPA IFU states signs of surface discolouration can occur after 7 days or more.2 Chemical system may cause discoloration of exposed areas to Vscan Air™ probes.3
The Collaborative Probe Compatibility Program provides confidence that over 1,000 probes from major manufacturers have been tested, approved and endorsed for use with Hypernova Chronos and AE1.
Probes listed in Germitec’s Ultrasound Probe Compatibility List have shown UV-C to be non-corrosive to the sensitive medical-grade polymers found on ultrasound probes and their probe cables. This is why the length of probe cables can also be high level disinfected within Hypernova Chronos and AE1.Â
The Ultrasound Probe Compatibility list continually evolves and is updated regularly following tests performed by Probe Manufacturers and/or Germitec.
References:
1. Adhering Medical Grade: Polymershttps://www.masterbond.com (medical-grade-polymers)
2.https://www.usamedicalsurgical.com/content/Cidex%20OPA/Cidex%20OPA%20Instructions.pdf
3.https://www.gehealthcare.com/products/ultrasound/ultrasound-transducers
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Compatibility with Leading Manufacturers
Note: Discuss probe compatibility requirements with your Germitec representative prior to purchase.
Has the Hypernova Chronos been tested against high risk Human Papillomavirus and who performed the efficacy test?
The Hypernova Chronos high level disinfection system has been rigorously tested to kill high-risk cancer strains 16 and 18 of Human Papillomavirus (HR-HPV). The HR HPV cancer strain is known to cause 90% of cervical cancer and greater than 60% of other anogenital cancers and is responsible for a significant portion of oropharyngeal cancers.g.1
The HR HPV efficacy testing was performed by Dr. Craig Meyers, of Penn State College of Medicine.
Dr. Meyers is a distinguished Professor of Microbiology and Immunology, Obstetrics and Gynecology, and the Director of the Training Program in Viruses and Cancer. His team was the first to grow native (natural, infectious) HR-HPV in high enough quantities for laboratory testing. Dr Meyers has been working on producing HR-HPV high titer, mature viruses, for over 35 years. He knows how the virus needs to be mature and structurally stable. He has published several research papers on disinfectants commonly used on ultrasound probes. These studies also indicate the clinical importance of using native HR-HPV for disinfectant and microbicide testing in contrast to surrogate viruses and virus like particles (quasi virions and pseudo virions).
In the Hypernova Chronos efficacy study Dr Meyers used the hard surface carrier test method based on the ASTM E1053-11 standard test method suitable for assessing virucidal activity on non-porous surfaces. The study methodology is in line with Federal Drug Administration
(FDA) guidelines for assessing virucidal efficacy of high-level disinfectants. To claim that your high level disinfection system is effective in killing HR-HPV, it needs to demonstrate that it can achieve a 4-log (99.99%) reduction.
The Hypernova Chronos achieved a greater than 4-log (99.99%) reduction for both the HR-HPV16 and HR HPV18, therefore demonstrating that it is effective in killing the HR HPV. In contrast, OPA showed minimal efficacy.1-2
