Hypernova Chronos is leading the way in Ultrasound High Level Disinfection

Presenter: Rick Salzar

Date: May 2023

r.salzar@germitec.com

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Germitec Hypernova Chronos UVC HLD System

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Germitec’s Chronos Technology

The following Technology is not yet Approved by the FDA

Germitec and the Hypernova Chronos is:

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• A UVC based technology for the Disinfection of Ultrasound Probes
• Available in Europe, Canada, Australia, etc.
• Germitec’s technology is under evaluation by the FDA under a DE NOVO classification
• Germitec’s USA operations are based in San Diego, County
• Focus Group Opportunities will be available in the coming weeks!!!!

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Overview of the Technology

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De Novo Classification means that no “previous technology” similar in application has been approved by the FDA prior to the Germitec Submission

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• Other UVC application products such as “Hospital Room Disinfection” systems are not Regulated by the FDA at the present time. The Germitec submission is being held to the same High Level Disinfection standards of other Chemical products used for such purpose

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Cross-Infection risks in ultrasound

Patients are 41% more likely to have positive bacterial cultures 30 days after a transvaginal scan where probes were low level disinfected and 26% (HR=1.26) more likely to be prescribed antibiotics.¹

Up to 17% of ultrasound probes were found to be contaminated with human DNA and HPV DNA after disinfection with low level wipes.²

Research shows that virtually all cervical cancers (more than 99%) are caused by high-risk HPV.^3-4

More than 80% of probe handles that were not disinfected had residual pathogens including MRSA.⁵

Up to 13% of condoms and 5% of commercial covers have tears pre and post-transvaginal ultrasound examinations.^6-9

Reducing ultrasound probe cross-infection risk can aid in reducing HAIs

Know when to HLD

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Defining Disinfection Levels

CRITICAL

All viable microorganisms

must be destroyed

All viable microorganisms

must be destroyed, except a small number bacterial spores

Kill most vegetative bacteria and some fungi as well as enveloped (lipid) viruses but do not kill mycobacteria or bacterial spores.

Spaulding Classification is determined by:

1. Ultrasound probe contacting the Patient’s procedure site
2. Level of cross-infection risk.

SEMI CRITICAL

NON CRITICAL

Under the Spaulding classification the ultrasound probe is classified into:

- critical probe = Sterilisation or HLD*

- semi-critical probe = HLD

- non-critical probe = LLD

* if not possible can be high level disinfected and placed inside a sterile cover to prevent the contamination of a sterile filed^1-3

Kill vegetative bacteria, most viruses and most fungi but not resistant bacterial spores.

Issues with Chemical Disinfectants

Manual disinfection risk

Manual soak (soaking bulk liquid disinfectants) method risk.

• Safety threat to patients as steps in the cleaning and disinfection process can be missed and lack of compliance.
• Risk of exposure to dangerous chemicals
• Global disinfection guidelines are favouring automation
• Manufacturer’s instructions are beginning to move away from manual HLD as an option.^1-2

There have been numerous cases of cross infection risks to patients due to manual ultrasound probe reprocessing:

• Patient contacting hepatitis C virus after transrectal prostate biopsy as part of an individual screening for prostate cancer.
• Patient contracting hepatitis B linked to improper ultrasound transducer disinfection that led to a fatality.^3-4

Hypernova Chronos

Leading the way in High Level Disinfection

When seconds count Chronos delivers

SAFE - Reduces Risk

Chronos is probe friendly and chemical free

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EFFECTIVE - Reduce Infection Risk

Chronos delivers UV-C HLD to inactivate microorganisms and proven effective through independent Microbicidal efficacy testing

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EFFICIENT - Reduces Cost

Chronos streamlines clinical workflows with an ultrafast 90 seconds HLD cycle time and automated verification system

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COMPLIANT - Streamline Audits

Chronos improves audit-readiness and removes paperwork

SAFE – Reduce Risk

Chronos is Probe friendly and chemical free that reduces risk

Probe friendly

• UV-C HLD energy is probe friendly
• Many leading ultrasound probe manufacturers have approved the use of Chronos
• Extensive probe compatibility testing.
• Easy probe loading and unloading mechanism reduces wear and tear on probe cable

Chemical Free

• Safeguards staff and patients by avoiding hazardous chemicals, fumes, and spills.
• No chemical residuals are left on the probe after disinfection, protecting the operator and patient from chemical burns (hand or face)
• Environmentally friendly examination room that is ideal for point of care ultrasound.

EFFECTIVE – Reduce Infection Risk

Chronos delivers UV-C HLD to inactivate microorganisms and proven effective through independent Microbicidal Efficacy testing to reduce infection risk

UV-C HLD

Chronos delivers UV-C high level disinfection (HLD) as particles and waves reflected from the chamber walls ensures there is no shadowing on the probe surface.

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UV-C HLD energy of the photons penetrates the cell walls of microorganisms destroying them

• bacteria,
• fungi,
• viruses,
• mycobacteria
• spores, which is

EFFECTIVE – Reduce Infection Risk

Chronos streamlines clinical workflows with an ultrafast 90 seconds HLD cycle time and automated verification system reduces cost

Workflow

Chronos streamlines clinical workflows to maximise patient throughput, whilst maintaining the quality of patient care.

This is achievable through:

• Simple plug and play design that minimising staff interaction and training requirements
• Ultrafast automated 90 seconds cycle time
• Single cycle disinfection of the probe and the cable section
• Mobile device within departments
• Ideal at point of care ultrasound to support quick diagnosis and assessment

EFFICIENT – Reduce Cost

Chronos streamlines clinical workflows with an ultrafast 90 seconds HLD cycle time and automated verification system reduces cost

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.

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An Independent control system validates the disinfection cycle based on the UV-C dose measurements of a third photodiode, declaring the disinfection cycle completed “CYCLE OK”.

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The Automated Verification system operates similar to Parametric Release providing extra reassurance and saves time in automatically validating every disinfection cycle.

COMPLIANT - Streamline Audits

Chronos improves audit-readiness and removes paperwork to Streamline Audits

Traceability

Data Access

Germitrac is an interface that visually displays all disinfection records through a web browser

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COMPLIANT - Streamline Audits

Chronos improves audit-readiness and removes paperwork to Streamline Audits

Integrated – with the hospital network

The digital disinfection records can be manually linked to a patient profile.

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Automated through a third-party software accessing Germitrac API web services to retrieve disinfection data and link it to a patient record, for example Electronic Medical Records (EMR) or Electronic Patient Record (EPR)

Human Papillomavirus (HPV)

HPV research is a major driver in changing clinical practice

Published research papers show ultrasound probes are a potential source of HPV transmission, posing a new challenge for infection prevention.^1&3

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Results suggest that healthcare facilities using endocavitary ultrasound probes need to strongly consider disinfection methods that are effective against HPV - adopting new technologies such as UV-C HLD.²

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UVC radiation as an effective disinfectant method to inactivate human papillomaviruses (HPV16 and HPV18 ) whereas OPA showed minimal efficacy^1-2

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UV-C High Level Disinfection

A Green Technology for a Better Tomorrow

• Soaking - Each soak station uses 30 litres* of chemicals per annum and disposal of personal protective equipment (gowns and eye glasses)
• Disinfectant wipes – Each examination room uses 3,600 wipes annum
• Storage – Chemical storage area
• Utility room – special ventilation room

Hypernova Chronos provides a unique, patented ‘greener’ High Level Disinfection technology, which removes the use of toxic chemicals in healthcare facilities around the world.

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With UV-C light as an alternative disinfection method it is generating an eco-friendly clinical environment and alleviating chemicals being dumped into the environment