Lumicare
challenges the
notion of care.

Healthcare associated infections.

Healthcare Associated Infections (HAI) are those infections that are acquired as a direct or in-direct result of healthcare. Typically the same ultrasound equipment is re-used on patient after patient over many years and if exposed can become a critical factor in the transmission of HAIs. HAIs are potentially preventable and Lumicare has an important role to play.
Infection prevention and control such as regular High-Level Disinfection of ultrasound probes, particularly pre and post semi-critical ultrasound procedures is vital. Given Lumicare’s sustainable approach it is possible to disinfect all ultrasound probes after each use, every time.
Accurate records of disinfection cycle information is another key step. In the event of an outbreak, accurate contact tracing is necessary to ensure all potentially infected patients are notified as soon as possible. Lumicare’s Audit-Trail™ feature ensures that your disinfection cycle information is recorded easily and automatically.

When to
use HLD?

In diagnostic ultrasound, whenever the probe comes into contact with a mucous membrane or non-intact skin, (endo-cavity scans, injections or interventional procedures) this is considered a semi-critical procedure. It is commonly agreed that the probe now requires High-Level Disinfection.

Spaulding classification.

This is a widely used system for classifying the disinfection and sterilization levels of reusable medical equipment.

Different types of ultrasound examinations require different levels of disinfection as shown in the spaulding chart.

Sterilisation

Critical

Device contacts sterile
tissue or the bloodstream

High-Level Disinfection

Semi-critical

Device contacts mucous
membranes or non-intact skin

Immediate level disinfection

Non-critical

Device only contacts intact skin

Low level disinfection

How does UVC work?

What is UV radiation?

UV radiation is the portion of the Electromagnetic spectrum between X-rays and visible light. UV radiation energy is emitted by the sun in three forms, UVA, UVB and UVC. UVC is blocked by the earth’s ozone layer as it is extremely harmful to life.

What is UVC dose?

UV dose is the product of UV intensity (total UV energy per unit volume) and residence time (total time the target is in contact with the UV light), expressed by the equation D = IxT. Typically, UV dose is expressed in the units mJ/cm2

How does UVC kill germs?

UVC kills cells because of the accumulation of DNA damage.

UVC light penetrates cell walls of living organisms such as bacteria, spores, viruses, fungi and mycobacteria. UVC damages the DNA structures rendering the cell non-functional and unable to replicate. If a cell cannot reproduce it is therefore unable to spread infection. If the DNA damage is extensive the cell will die. That is the goal of High-Level Disinfection.

Disinfection to
the highest
international
standard

Australian & New Zealand Standards

Organisation
Name of Guideline/standard
Year
Description
ASUM
2017 ASUM Guidelines for Reprocessing Ultrasound Transducers
2017
Ultrasound transducers that come into contact with non-intact skin and / or mucous membranes and transducers that have had likely contact with blood / body fluids are considered as semi-critical medical devices due to the high risk of potential contamination. These transducers are reprocessed by cleaning followed by a High-Level Disinfection (HLD) method.
NSQHS Standards
AS.NZS 4187:2014
2014
Reprocessing of reusable medical devices in health service organisations.

United Kingdom Standards

Organisation
Name of Guideline/standard
Year
Description
British Medical Ultrasound Society (BMUS)
The Society & College of Radiographers (SCoR)
Effective and safe decontamination of ultrasound machines and transducers. Ultrasound Transducer Decontamination – Best Practice Summary.
2020

Using a cover on the transducer is not in itself an effective method of preventing contamination, as covers may have holes or contamination can occur when removing the covers or via a contaminated glove.

Best practice is the use of an automated system

Healthcare Infection Society
Guidance for the decontamination of intracavity medical devices: the report of a working group of the Healthcare Infection Society.

Bradley CR, et al., Guidance for the decontamination of intracavity medical devices: the report of a working group of the Healthcare Infection Society, Journal of Hospital Infection (2018).
2018

Automated disinfection would constitute best practice

There should be a documentation system that allows tracking and tracing of each probe to the patients it is used on and each episode of its decontamination

Intracavity devices can be expensive and delicate. Their expense limits the number of devices that a healthcare provider has, which in turn leads to the requirement for a rapid decontamination procedure to reduce the delay between sequential uses.

Health Facilities Scotland
NHS Scotland Guidance for Decontamination of Semi-Critical Ultrasound Probes; Semi-invasive and Non-invasive Ultrasound Probes
2017

Semi-invasive ultrasound probes and semi-critical probes should be decontaminated using a HDL method.

There is high level (1+ and level 2) published evidence to support the use of Ultra Violet light systems for decontamination of semi-invasive ultrasound probes.
There is low level published evidence (level 3) to support the use of automated chemical systems (hydrogen peroxide) for decontamination of semi-invasive ultrasound probes.
There is low level published evidence (level 3) to support the use of manual detergent/disinfection/rinse (multi-wipe) systems for decontamination of semi-invasive ultrasound probes.

European International Standards

Organisation
Name of Guideline/standard
Year
Description
European Society for Radiology (ESR)
Infection prevention and control in ultrasound - best practice recommendations from the European Society of Radiology Ultrasound Working Group.

Insights Imaging (2017) 8:523–535.
2017

All internal transducers (e.g. vaginal, rectal, transesophageal transducers) and intra-operative transducers, require a high-level of disinfection before they can be used in a new patient

Automatic processes such as... ultraviolet (UV) methods are preferred

Full documentation the disinfection process... (preferably in digital form)

European Society for Radiology (ESR)
Position statement and best practice recommendations on the imaging use of ultrasound from the European Society of Radiology ultrasound subcommittee

European Society of Radiology (ESR) Insights into Imaging. (2020) 11:115
2020

All ultrasound transducers need to be fully decontaminated after every patient contact, whether or not a transducer cover is used, due to micro-perforations and because of high contamination rates during cover removal

Following endo-cavity ultrasound examinations as well as after any interventional procedures (including ultrasound guided injections), High-Level Disinfection is mandatory.

European Committee for Medical Ultrasound Safety (ECMUS)
Best Practice recommendations for cleaning and disinfection of ultrasound transducers whilst maintaining transducer integrity.

© 2017 ECMUS
2021

All internal transducers (e.g. vaginal, rectal, transesophageal transducers) and intra-operative transducers, require a high-level of disinfection before they can be used in a new patient

Automatic processes such as... ultraviolet (UV) methods are preferred

NHS Ireland
Health Service Executive
Health Service Executive Guidance for Decontamination of Semi-critical ultrasound probes; semi-invasive and non-invasive ultrasound probes
2017

HLD using the manual multi‐wipe system is the least preferred option for disinfecting SIUPs. Internationally it is recognised that the use of an automated validated process for decontaminating RIMD will provide enhanced risk reduction of infection transmission.

A system must be in place to ensure probes are tracked through the decontamination process and linked to the patient on whom the devices have been used. The organisation should work toward implementing an electronic tracking system that will integrate with the National Electronic Track and Trace system for RIMD’s.

DEGUM
DEGUM Recommendations on Infection Prevention in Ultrasound and Endoscopic Ultrasound.

Müller T et al. DEGUM-Empfehlungen zur Hygiene in Sonografie und Endosonografie. Ultraschall in Med 2018; 39: 284–303
2018

The use of a latex cover for a vaginal probe does not meet the necessary requirements…as semi-critical medical devices. After removal of the cover, the probe must be cleaned as well as undergo bactericidal, fungicidal and virucidal disinfection.

It was able to be shown that the reduction in test organisims with simple wipe disinfection is not always sufficient. …Disinfection liquids used in the immersion methos e.g. gluteralderhyde, ethanol, isopropanol and phenol, were not able to inactivate HPV

DEGUM
DEGUM Recommendations on Infection Prevention in Ultrasound and Endoscopic Ultrasound.

Müller T et al. DEGUM-Empfehlungen zur Hygiene in Sonografie und Endosonografie. Ultraschall in Med 2018; 39: 284–303
2018

In the daily routine probes must be able to be cleaned and disinfected quickly and reliably to keep the time interval between examinations as low as possible.

Australian & New Zealand Standards
Organisation
ASUM
Name of Guideline/standard
2017 ASUM Guidelines for Reprocessing Ultrasound Transducers
Year
2017
Description
Ultrasound transducers that come into contact with non-intact skin and / or mucous membranes and transducers that have had likely contact with blood / body fluids are considered as semi-critical medical devices due to the high risk of potential contamination. These transducers are reprocessed by cleaning followed by a High-Level Disinfection (HLD) method.
Organisation
NSQHS Standards
Name of Guideline/standard
AS.NZS 4187:2014
Year
2014
Description
Reprocessing of reusable medical devices in health service organisations.
United Kingdom Standards
Organisation
British Medical Ultrasound Society (BMUS)
The Society & College of Radiographers (SCoR)
Name of Guideline/standard
Effective and safe decontamination of ultrasound machines and transducers. Ultrasound Transducer Decontamination – Best Practice Summary.
Year
2020
Description

Using a cover on the transducer is not in itself an effective method of preventing contamination, as covers may have holes or contamination can occur when removing the covers or via a contaminated glove.

Best practice is the use of an automated system

Organisation
Healthcare Infection Society
Name of Guideline/standard
Guidance for the decontamination of intracavity medical devices: the report of a working group of the Healthcare Infection Society.

Bradley CR, et al., Guidance for the decontamination of intracavity medical devices: the report of a working group of the Healthcare Infection Society, Journal of Hospital Infection (2018).
Year
2018
Description

Automated disinfection would constitute best practice

There should be a documentation system that allows tracking and tracing of each probe to the patients it is used on and each episode of its decontamination

Intracavity devices can be expensive and delicate. Their expense limits the number of devices that a healthcare provider has, which in turn leads to the requirement for a rapid decontamination procedure to reduce the delay between sequential uses.

Organisation
Health Facilities Scotland
Name of Guideline/standard
NHS Scotland Guidance for Decontamination of Semi-Critical Ultrasound Probes; Semi-invasive and Non-invasive Ultrasound Probes
Year
2017
Description

Semi-invasive ultrasound probes and semi-critical probes should be decontaminated using a HLD method.

There is high level (1+ and level 2) published evidence to support the use of Ultra Violet light systems for decontamination of semi-invasive ultrasound probes.
There is low level published evidence (level 3) to support the use of automated chemical systems (hydrogen peroxide) for decontamination of semi-invasive ultrasound probes.
There is low level published evidence (level 3) to support the use of manual detergent/disinfection/rinse (multi-wipe) systems for decontamination of semi-invasive ultrasound probes.

European International Standards
Organisation
European Society for Radiology (ESR)
Name of Guideline/standard
Infection prevention and control in ultrasound - best practice recommendations from the European Society of Radiology Ultrasound Working Group.

Insights Imaging (2017) 8:523–535.
Year
2017
Description

All internal transducers (e.g. vaginal, rectal, transesophageal transducers) and intra-operative transducers, require a high-level of disinfection before they can be used in a new patient

Automatic processes such as... ultraviolet (UV) methods are preferred

Full documentation the disinfection process... (preferably in digital form)

Organisation
European Society for Radiology (ESR)
Name of Guideline/standard
Position statement and best practice recommendations on the imaging use of ultrasound from the European Society of Radiology ultrasound subcommittee

European Society of Radiology (ESR) Insights into Imaging. (2020) 11:115
Year
2020
Description

All ultrasound transducers need to be fully decontaminated after every patient contact, whether or not a transducer cover is used, due to micro-perforations and because of high contamination rates during cover removal

Following endo-cavity ultrasound examinations as well as after any interventional procedures (including ultrasound guided injections), High-Level Disinfection is mandatory.

Organisation
European Committee for Medical Ultrasound Safety (ECMUS)
Name of Guideline/standard
Best Practice recommendations for cleaning and disinfection of ultrasound transducers whilst maintaining transducer integrity.

© 2017 ECMUS
Year
2021
Description

All internal transducers (e.g. vaginal, rectal, transesophageal transducers) and intra-operative transducers, require a high-level of disinfection before they can be used in a new patient

Automatic processes such as... ultraviolet (UV) methods are preferred

Organisation
NHS Ireland
Health Service Executive
Name of Guideline/standard
Health Service Executive Guidance for Decontamination of Semi-critical ultrasound probes; semi-invasive and non-invasive ultrasound probes
Year
2017
Description

HLD using the manual multi‐wipe system is the least preferred option for disinfecting SIUPs. Internationally it is recognised that the use of an automated validated process for decontaminating RIMD will provide enhanced risk reduction of infection transmission.

A system must be in place to ensure probes are tracked through the decontamination process and linked to the patient on whom the devices have been used. The organisation should work toward implementing an electronic tracking system that will integrate with the National Electronic Track and Trace system for RIMD’s.

Organisation
DEGUM
Name of Guideline/standard
DEGUM Recommendations on Infection Prevention in Ultrasound and Endoscopic Ultrasound.

Müller T et al. DEGUM-Empfehlungen zur Hygiene in Sonografie und Endosonografie. Ultraschall in Med 2018; 39: 284–303
Year
2018
Description

The use of a latex cover for a vaginal probe does not meet the necessary requirements…as semi-critical medical devices. After removal of the cover, the probe must be cleaned as well as undergo bactericidal, fungicidal and virucidal disinfection.

It was able to be shown that the reduction in test organisims with simple wipe disinfection is not always sufficient. …Disinfection liquids used in the emmersion methos e.g. gluteralderhyde, ethanol, isopropanol and phenol, were not able to inactivate HPV

Organisation
DEGUM
Name of Guideline/standard
DEGUM Recommendations on Infection Prevention in Ultrasound and Endoscopic Ultrasound.

Müller T et al. DEGUM-Empfehlungen zur Hygiene in Sonografie und Endosonografie. Ultraschall in Med 2018; 39: 284–303
Year
2018
Description

In the daily routine probes must be able to be cleaned and disinfected quickly and reliably to keep the time interval between examinations as low as possible.

Germicidal Efficacy

In order to obtain regulatory approvals Lumicare has undergone an extensive series of microbiological tests to prove germicidal efficacy. In addition to the mandated tests, Lumicare has gone above and beyond, testing its germicidal efficacy against many pathogens commonly found in modern healthcare settings.

Staphylococcus Aureus
Pseudomonas aeruginosa
Enterococcus hirae
Bacillus subtilis
Aspergillus brasiliensis
Mycobacterium terrae
Adenovirus Type 2
Candida Albicans
Aspergillus fumigatus
Bacillus infantis
Bacillus idriences
Bacillus licheniformis
Bacillus oceanisediminis
Bacillus pumilus
Bacillus safensis
Candida Auris
Clostridium Difficile
Herpes Simplex Virus Type 1
Murine Hepatitis Virus (surrogate for SARS-CoV-2)
Clostridium sporogeneses
Salmonella choleraesuis
Mycobacterium abscessus
Mycobacterium avium
Human papillomavirus (Type 16)
Human papillomavirus (Type 18)
Klebsiella pneumonia
Methicillin Resistant Staphylococcus aureus (MRSA)
Pseudomonas luteola
Staphylococcus cohnii
Staphylococcus warneri
Trichophyton Mentagrophytes
Vancomycin-resistant Enterococcus
Human Poliovirus 1

Mycobacterium terrae

Can be associated with tuberculosis, nontuberculous mycobacteria (NTM) pulmonary infections, other localized NTM or disseminated infections, leprosy, and chronic ulcers.

Pseudomonas aeruginosa

Can be associated with infections in the blood, lungs (pneumonia), or other parts of the body after surgery.

Aspergillus brasiliensis

Can be associated with allergic reactions, lung infections, and infections in other organs.

Staphylococcus aureus

Can be associated with bloodstream infections, pneumonia, or bone and joint infections.

Enterococcus hirae

Can be associated with urinary tract infections.

Bacillus subtilis

May indicate faecal contamination.

Adenovirus Type 2

Can be associated with diarrhea, urinary tract infections.

Candida Albicans

Can be associated with severe bloodstream infections.

Herpes Simplex Virus Type 1

Can be associated with encephalitis, meningitis.

Murine Hepatitis Virus
(surrogate for SARS-CoV-2)

Can be associated with fatigue, nausea, stomach pain, and liver disease.

Mycobacterium avium

May cause lung disease

Clostridium sporogeneses

Can be associated with diarrhea, colitis, sepsis.

Salmonella choleraesuis

May cause nausea, vomiting, abdominal pain, diarrhea, fever

Mycobacterium abscessus

May cause lung infections

Human papillomavirus
(HPV Types 16 & 18)

May cause cervical and other cancers

Aspergillus fumigatus

Aspergillus spores may cause an infection in the lungs or sinuses which could spread to other parts of the body

Bacillus infantis

Can be found in new born infants with sepsis

Bacillus licheniformis

A member of the Bacillus species. Bacillus spores are known to be an opportunistic pathogen in hospitalised patients

Bacillus oceanisediminis

A member of the Bacillus species. Bacillus spores are known to be an opportunistic pathogen in hospitalised patients

Bacillus pumilus

A member of the Bacillus species. Bacillus spores are known to be an opportunistic pathogen in hospitalised patients

Bacillus safensis

A member of the Bacillus species. Bacillus spores are known to be an opportunistic pathogen in hospitalised patients

Bacillus idriences

A member of the Bacillus species. Bacillus spores are known to be an opportunistic pathogen in hospitalised patients

Clostridium Difficile

May cause inflammation of the colon including diarrhoea, stomach pain and fever

Klebsiella pneumonia

Bacteria which can cause different types of healthcare-associated infections, including pneumonia, bloodstream infections, wound or surgical site infections, and meningitis

Methicillin Resistant Staphylococcus aureus (MRSA)

MRSA is responsible for several difficult-to-treat infections in humans.

Pseudomonas luteola

An opportunistic pathogen, found ubiquitously in damp environments.

Staphylococcus cohnii

May cause skin infections

Staphylococcus Aureus

May cause infections such as urinary tract infection, meningitis, orthopedic infections/osteomyelitis

Trichophyton Mentagrophytes

May cause skin diseases such as ringworm

Vancomycin-resistant Enterococcus

Can cause infections of the urinary tract, the bloodstream, wounds associated with catheters or surgical procedures, or other body sites

Human Poliovirus 1

Can cause poliomyelitis

Candida Auris

Often multi-drug resistant fungi which may cause serious bloodstream infections

Examples of clinical evidence demonstrating
the effectiveness of UVC disinfection

Using UVC Light-Emitting Diodes at Wavelengths of 266 to 279 Nanometers To Inactivate Foodborne Pathogens

Soo-Ji Kim, Do-Kyun Kim, Dong-Hyun Kang December 2015

“… we postulate that LED light is concentrated onto the target area and is thus more efficacious than light from a UV lamp"

Evaluation of a New Disinfection Method for Ultrasound Probes used for Regional Anesthesia - Ultraviolet C Light

Sebastien Bloc, MD, Luc Mercadal, MD, et al. December 2010

“Ultraviolet C disinfection seems relevant for ultrasound-guided regional anesthesia just before block placement. It offers simple, fast, and effective high-level dis-infection."

Evaluation of a new disinfection procedure for ultrasound probes using ultraviolet light

G. Kac a,*, M. Gueneret a, A. Rodi et.al October 2006

“UVC disinfection of ultrasound probe may provide a useful method for reducing the bacterial load under routine conditions."

Ultraviolet light for the disinfection of ultrasound probes: clinical effectiveness, cost -effectiveness, and guidelines.

Michelle Clark, Charlene Argaez May 2018

“Based on high level evidence, the guideline recommends the use of UV disinfection systems for the decontamination of semi-invasive ultrasound probes."

Examples of clinical evidence
demonstrating the need for HLD

Ultrasound probe use and reprocessing: Results from a national survey among U.S. infection preventionists

Ruth M. Carrico , Stephen Furmanek, et al August 2018

“Clinicians responsible for probe use and reprocessing, should review practices relating to ultrasound in their facilities. Where practice does not comply with guidelines, policy and training should be updated to ensure patient safety."

UVC radiation as an effective disinfectant method to inactivate human papillomaviruses

Craig Meyers, Janice Milici, et al. October 2017

“In the present study we used OPA as a negative control for HPV killing. Our results demonstrating that OPA and GTA, two commonly used hospital sterilants were incapable of killing HPV was cause for concern"

Evaluation of Ultraviolet C for Disinfection of Endocavitary Ultrasound Transducers Persistently Contaminated despite Probe Covers

Guillaume Kac, Isabelle Podglajen, PhD; et al. February 2010

“In conclusion, we have shown that endocavitary ultrasound probes may carry potential pathogens, including HPV, unless properly disinfected between examination sessions. The use of a cover does not alter the requirement for disinfection after each examination."

Advancing infection control in Australasian medical ultrasound practice.

Sue Campbell Westerway, Jocelyne M Basseal February 2017

“Results highlighted a significant need for updated guidelines and education on infection prevention and control in medical ultrasound."

Work health and safety.

Work health and safety is an extremely important issue for sonographers and clinicians. Ultrasound practitioners deal with a variety of physical and emotional pressures as a part of their everyday practice.
Due to direct feedback from sonographers and clinicians, Lumicare designed the Lumicare ONE with user health and safety as a key pillar.

No Chemicals

No one likes dealing with hazardous chemicals and with the Lumicare ONE you don’t have to. No more changing the chemical bottle, pouring new chemical solution into a container or handling chemical wipes. Lumicare’s cutting-edge LED UVC technology also means no mercury fluorescent tubes. With the Lumicare ONE your workplace is now chemical free.

No Burns

Thermal or chemical burns from traditional HLD methods are all too common. Residual chemicals on the probe have been known to cause skin burns whilst the oven-like temperatures of some HLD devices have caused burns to hands and arms. The Lumicare ONE’s CoolTouch™ technology means the internal chamber will always remain safe to touch.

Ergonomically Designed

The Lumicare ONE is compact and can be mounted on a bench or a trolley. Some other HLD devices are floor mounted and require the user to bend down for every disinfection cycle. They also take up precious floor space in an already crowded clinical setting. The Lumicare ONE can be placed in your most convenient and safe location such as a benchtop to ensure easy access and minimize physical stress to the user.

For a better future

Lumicare is committed to reducing the medical industry’s burden on the environment. We designed the Lumicare ONE using state of the art LED UVC technology making it the most sustainable High-Level Disinfection device for ultrasound probes available today.

Learn more