Frequently Asked Questions | medisound

Frequently Asked Questions

Commonly asked questions about the Antigermix and UVC Technology

 

What TGA Microbicidal effectiveness has been proven for the Antigermix AS1 & Hypernova Chronos 90 seconds cycle?

 

 

 

 

 

 

 

 

 

How is UV 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 HLD is much more efficient than most of them (study 2345.GER.14):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Is the Antigermix TGA compliant?

To obtain TGA approval all evidence must be submitted and assessed by the TGAs Biologics team. The CE mark documents are not perceived as proof of effectiveness for a HLD device. The Antigermix ARTG is Class IIb (ARTG certificate is attached as Appendix 3). The TGA states:

“Sponsors who wish to import these disinfectants and sterilants for use on medical devices need to ensure that the Australian regulatory requirements for Class IIb medical devices have been met by the manufacturer Assessments performed for Europe for the purposes of affixing the CE Mark may not be sufficient for inclusion in the ARTG as a Class IIb medical device”.

To comply with the TGA requirements manufacturers are required to submit microbiological efficacy testing on mandatory micro-organisms. Germitec testing is conducted through external testing facilities to remove any bias. This is the gold standard in supplying HLD disinfection products Class IIb to the Australian healthcare market with microbiological efficacy testing documents supplied by independent testing facilities.

 

 

 

Has UV HLD been proven to work on Reusable Medical Devices (RMDs) in a clinical setting?

UV HLD has well documented evidence of efficacy for Ultrasound Transducers both in Simulated Use Tests and in clinical settings (In Use Tests).

In the research and development stages of photonics UV-C based HLD technology (UV HLD) Germitec products have become more efficient and effective in cycle times while ensuring required microbiological efficacy is achieved. Here are described few In Use Tests:

1. Evaluation of a new disinfection procedure for ultrasound probes using ultraviolet light. G. Kac and al. Journal of Hospital Infection (2007), Vol. 65, Issue 2, p163 – 168

This study uses a 10 minute cycle with Germitec first version of Antigermix (much less powerful), and compares UV disinfection against antiseptic wiping and dry wiping the ultrasound probe surface. The median microbial reduction was 100% for UVC, 98.4% for antiseptic wiping and 87.5% for dry wiping. The percentage of negative specimens was 88% for UVC, 16% for antiseptic wiping and 4% for dry wiping. After reprocessing, the only pathogen isolated was one isolate of K. pneumoniae after antiseptic wiping.

2. Evaluation of Ultraviolet C for Disinfection of Endocavitary Ultrasound Transducers Persistently Contaminated despite Probe Covers. G. Kac and al. Infect Control Hosp Epidemiol 2010; 31:165-170

This study mentioning 5 minute cycle was made on vaginal and rectal ultrasound probes, with a UV HLD chamber similar to the current Antigermix AS1& Hypernova Chronos chamber but running on a time based cycle, which is harder to control and having reached systematic HLD in a short time. Germitec systems later moved to a dose controlled cycle and substantial additional scientific work has been performed.

After removal of probe covers, contamination by pathogenic bacteria was found for 15 (3.4%) of 440 probes, and viral genome (including HPV) was detected on 5 (1.5%) of 336 probes. After cleaning with a towel impregnated with a disinfectant spray and disinfecting with UVC light, neither bacterial pathogenic flora nor viral genome was recovered from the probe.

3. 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 anesthesia 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 colony- forming units) after disinfection. Moreover, for the authors, this method could obviate the use of sterile probe covers, which can improve echogenicity.

4. Pending publication (report available upon request), the Hospices Civils de 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 HLD are not contaminated by HPV DNA nor Human DNA – On 47 probes, after cleaning with the wipe and before UV HLD, 7 were Human DNA positive and 1 was positive with HPV-51 (High Risk HPV), these 8 probes were negative after UV HLD.

To Germitec knowledge, with this report, UV 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 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 light 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. The system itself is also fully recyclable and Medisound and Germitec provide a guarantee to take back the system at the end of its useful life for recycling.

 

 

 

What UVC dose is needed in order to adequately High Level Disinfect?

The disinfection is achieved when the probe has received a sufficientgermicidal 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 UVC dose measured?

Germitec UV HLD systems have an inbuilt quality assurance check to reliably measure the UV-C dose, and detect any potential error.

The dose measurement is conducted through two independent optical sensors (photodiodes) with a spectral sensitivity focused on 254 nm (germicidal wavelength).

The system declares the disinfection “COMPLETE” only when the photodiodeshave measured the target UV-C dose. Each diode reads the dose independently. If there is too much variance between the two measures from each of the diodes or if the target dose is not reached before the time limit, the disinfection cycle is stopped with an alarm message.

 

 

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. A comprehensive e-training presentation will also be available as well as a Competency Assessment checklist.

 

 

 

How does the Antigermix compare to other methods of HLD?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Probe compatibility compliance Program

Germitec product Antigermix AS1 complies to the National Safety and Quality Health Service Standard and the European Directive 93/42/CEE. These regulations in-forces, the Germitec Company lists the Medical Devices (External, TV et TR probes) which are compatible or non-compatible with its products (Antigermix AS1). The concept of compatibility between Medical Devices needs to be stated and that a proof of compatibility between two Medical Devices has to be realised.

 

It points out that several approaches do exist to determine this compatibility:

  • Medical Device manufacturers claim together compatibility in their respective IFU.

  • One manufacturer can claim on its own compatibility with other manufacturers Medical devices. It must then demonstrate the compatibility with the Medical device with whom it is associated

     

In order to do so, the Company Germitec performs:

  • Tests in laboratories on the probes themselves or on materials given by the manufacturer

  • Tests in laboratories on material representing the one used on the probes

  • Fields observations of probes in real use

  • Documentary studies

     

This list evolves and is updated regularly following tests performed by Probes Manufacturers and/or Germitec.

In achieving Full transparency with its customer base, the Company Germitec has published a list of compatible probes in 3 different categories:

  • Category 1: Probes which have been jointly approved by the probe manufacturer and Germitec. In the enclosed list, they are identified with a Blue square.

  • Category 2: Probes which have been approved by the Company Germitec and are waiting for Probe manufacturer tests. In the enclosed list, they are identified with a Green square.

  • Category 3: Probes which are not considered as compatibles by the Germitec Company (This category does include also probes which are not meant compatible by the probe manufacturer). In the enclosed list, they are identified with an Orange square.

If the probe you are looking for is not in the list, it doesn’t mean it is not compatible, it can be under testing.

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