Bac-Track™ and MicrobeCare™ Three step treatment programme – Test, Treat & Track. (#1975)

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Idea Description
Supplementary Information
Innovation 'Elevator Pitch':
Bac-Track MicrobeCare reduce outbreaks of communicable infection control incidents, bed stays caused by Healthcare Associated Infections & costs associated with Primary/Secondary care outbreaks, facilitating compliance with CQC guidelines & EPIC 3
Overview of Innovation:
Test: In a room or facility undergoing the treatment programme, nominated locations recognised for high propensity to retain bacteria are tested using Adenosine Triphosphate (ATP). All nominated locations are given a unique code & the readings are uploaded onto the Bac-Track™ Dashboard.
 
Treat: The nominated rooms are then treated with MicrobeCare™ using an electrostatic sprayer, which unlike mist sprayers, negatively charge the particles to ensure uniform coverage across all surfaces. The advanced formulation of MicrobeCare™ has a very short (3-minute) dwell time to ensure swift decontamination is undertaken & its unique residual killing power, delivers a continuous long term antimicrobial & antibacterial surface protection killing bacteria for a minimum of 1 year.
 
MicrobeCare™
  • is an odourless, colourless, non-leaching, long lasting antimicrobial & delivers a permanently bonded antimicrobial barrier
  • kills bacteria, viruses, fungi, algae & yeast without dissipation 
  • permanently bonds to all surfaces, protecting them against further microbial contamination
  • does not wash off the surface it is applied to
  • does NOT allow for the adaptation into superbugs
  • does NOT transfer into the environment
  • clinically tested & EPA* approved. *United States Environmental Protection Agency (EPA)
  • is not designed to replace current cleaning protocols. By treating surfaces with MicrobeCare™ bacteria & virus levels will dramatically decrease & remain so for a minimum of 1 year following treatment. This could significantly reduce the potential for cross contamination & healthcare acquired infections (HAI) stemming from contaminated surfaces
Track: Bac-Track™ dashboard provides accurate data of a clinical facility & the equipment therein, monitoring comparative ATP results on an ongoing basis. This provides a unique, simple & affordable way to track contamination levels within a facility & reduce HAIs’. Bac-Track™ provides access 24/7 to monitor bacteria levels, monthly trends & cleaning effectiveness.
With this valuable information the user is able to pinpoint where the highest risk areas are for contamination & keep track of changes in the location of equipment. Bac-Tag also allows facilities to track bacteria & maintenance levels on their equipment. This tag is linked to the Bac-Track system enabling the user to see history, including treatment/maintenance schedules.
Stage of Development:
Close to market - Prototype near completion and final form may require additional validation/evaluation and all CE marking and regulatory requirements are in place
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Innovation 'Elevator Pitch':
The urinary catheter has remained unchanged for fifty years or more, yet is associated with burden for millions of patients worldwide due to bacterial colonisation and biofilm formation. We will assess novel materials to oversome these shortcomings.
Overview of Innovation:
Urinary tract infections (UTI) are the second most frequent cause of healthcare-associated infections in hospitalised patients across Europe, with 60% caused by the use of indwelling catheters. The long-term (≥ 30 days) use of indwelling catheters results in an almost permanent bacterial colonisation of the urine; up to 50% of these users will experience encrustations and blockages leading to trauma and discomfort, and to high healthcare demands. The catheter surface, both external and lumen, provides an interface allowing biofilm development, which may be the cause of persistent, chronic infections and recurring blockages. Numerous bacterial species can cause UTIs, but encrustations are generally due to the presence of urease-producing bacteria, particularly Proteus mirabilis. When present, P. mirabilis causes microcrystal formation and subsequent encrustation of the lumen. Studies also show an increase in multi-drug resistant strains in both infection- and encrustation-causing species. 

The study of catheter-associated biofilms has generally relied on the use of scanning electron microscopy, yet SEM has a number of inherent limitations. Using episcopic differential interference contrast (EDIC) microscopy, Wilks et al. (2015) have tracked biofilm development by P. mirabilis and the formation of crystalline encrustations over time. EDIC microscopy allows non-contact, non-destructive, rapid imaging of samples with no need for potentially damaging sample preparation. This technique also provides qualitative information on surface topography and roughness of different materials. Using this method, four distinct stages to crystalline biofilm formation have been identified.

Using EDIC microscopy and methods to quantify  bacteria, a systematic comparison of different materials is proposed. This could include different grades of the same material, or the use of different manufacturing processes. Each test material will be examined under EDIC microscopy prior to use to provide qualitative assessment of surface topography. Using a selection of clinical strains of commonly found uropathogens (e.g. Escherichia coli, P. mirabilis, Enterococcus faecalis, Pseudomonas aeruginosa, Staphylococcus spp.), a simple six-well plate model will be used to track biofilm development in the laboratory. 
Stage of Development:
Evaluation stage - Representative model or prototype system developed and can be effectively evaluated
WMAHSN priorities and themes addressed: 
Long term conditions: a whole system, person-centred approach / Wellness and prevention of illness / Wealth creation / Innovation and adoption / Patient and medicines safety
Return on Investment (£ Value): 
N/A
Return on Investment (Timescale): 
N/A
Ease of scalability: 
N/A
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Innovation 'Elevator Pitch':
Catheters cause 250,000 serious infections, 3,000 deaths & up to £500m in healthcare costs a year research reports. UroShield prevents bacterial biofilm formation, increases antibiotic efficacy & decreases pain & discomfort of urinary catheter use.

Overview of Innovation:
90,000 Britons are fitted with a urinary catheter each year. Catheters are essential for a wide range of conditions that compromise the ability to empty the bladder effectively, such as prostate cancer patients and those with incontinence and neurological conditions like multiple sclerosis and spinal injury.
 
Indwelling catheters serve as an environment for bacterial attachment, biofilm formation and subsequent urinary tract infections (UTI). Biofilm formation is a thick, bacterial ‘glue’ that sticks to the surface of the catheter plastic and is highly resistant to antibiotics, making infections difficult to treat. Such catheter-acquired infections are one of the most common iatrogenic complications and may lead to increased mortality rates, extended hospital stays and increased medical costs for healthcare providers.
 
UroShield uses soundwaves to ‘shake’ away bacteria, protecting patients from painful and potentially life-threatening bladder infections. It is composed of 2 components: A disposable actuator which clips onto the external portion of the catheter and a portable battery powered driver.



The device sends out low-frequency ultrasound waves (Surface Acoustic Waves) which run longitudinally along both the inner and outer surfaces of the catheter. These surface acoustic waves prevent bacteria from docking and adhering to the catheter and subsequently prevent the formation of biofilm.
 
If there is a biofilm already present or one does form, the ultrasound waves help to break up the normally impenetrable biofilm matrix to allow access of the antibiotic to the biofilm. This increases the antibiotic efficacy by working synergistically so that patients may have a shorter course and lower dose of antibiotics.


In addition, independent studies from leading Universities have shown that the UroShield device enhances the immune systems’ ability to fight biofilm. In further studies the Uroshield device achieved a 90% reduction in the presence of common bacteria most likely to cause infection including E. coli and Staphylococcus epidermidis.
 
The action of the ultrasonic waves on the surfaces of the catheter interfere with the attachment of bacteria, prevents infections developing, reduces catheter encrustation and blockages and decreases or eliminates the need for antibiotics, reducing risk and improving patient outcomes. This in turn reduces the costs associated with indwelling catheter complications that may lead to increased medication and extended hospital stays.
Stage of Development:
Market ready and adopted - Fully proven, commercially deployable, market ready and already adopted in some areas (in a different region or sector)
WMAHSN priorities and themes addressed: 
Wellness and prevention of illness / Innovation and adoption
Benefit to NHS:
Reducing health care-associated infections (HCAIs) remains high on the Government’s
safety and quality agenda and in the general public’s expectations for quality of care.
 
Patients with invasive devices such as urinary catheters are at a greater risk of developing a HCAI (NICE, 2012). In addition to increased costs, each one of these infections means additional use of NHS resources, greater patient discomfort and a decrease in patient safety.
 
UroShield is a breakthrough device to prevent or treat catheter-related trauma.
 

 
Once the urinary catheter has been placed into the patient’s bladder, the actuator is clipped on the extracorporeal part of the catheter and the device is activated. UroShield harnesses the known therapeutic effects of ultrasound such as tissue healing and muscle relaxation to significantly decrease catheter-associated pain and discomfort. This is extremely easy for nurses to use and maintain, with a simple clip around the catheter to be changed monthly and disposed of in standard waste.
 
UroShield could have huge implications for reducing A&E admission rates as 224,670 admissions for UTIs were reported in 2009 and 2010 and since then numbers have continued to increase, with 43-56% of all UTIs being associated with indwelling. Between 2013/2014, the NHS spent £434 million treating 184,000 hospital admissions for a UTI.
 
UroShield could play a key role in achieving CQUIN targets for CAUTI rates and the reduction in E. coli Bloodstream Infections through the initial prevention of infection.
 
E. coli is one of the main pathogens responsible for causing UTIs and CAUTI, of which Gram-negative CAUTIs are often a source of bacteraemia. E. coli account for 55% of all BSIs and of these UTIs are responsible for 45% of E. coli BSIs. E. coli BSIs have increased by 20% over the last five years and the trend is still rising, which is of grave concern.
 
E. coli BSI are therefore a huge patient safety issue and are set to cost the NHS £2.3 billion by 2018. These contributed to over 5,500 NHS patient deaths in 2015 and there is £45 million quality premium which is incentivised by Ruth May to reduce healthcare associated Gram-negative BSIs by 50% across the NHS by 2021. The goals are to: prevent the need for antibacterial prescription, to reduce the dose or length or antibiotics as a minimum, and to reduce hospital admissions and HCAIs.
Initial Review Rating
5.00 (1 ratings)
Benefit to WM population:
Over 1 million patients a year have a catheter for a short time while in hospital & those using them at home for longer periods have them changed every 3 months & infections can be missed between changes.
 
An untreated urinary tract infection (UTI) may spread to the kidney, causing more pain & illness & lead to sepsis, a life-threatening reaction to an infection.
 
Long-term catheterisation carries a significant risk of symptomatic UTI, which can lead to serious complications such as bloodstream infections (NICE 2012). The diagnosis of a CAUTI increases the use of antibiotics which will increase the burden & development of antimicrobial resistance (DH, 2007).
 
Recurrent lower UTIs have a detrimental effect on patients quality of life. Patients experience a psychological burden because they live with the anxiety of sudden acute episodes. The resulting social handicap is known to induce feelings of self-devaluation or culpability, which can lead to clinical symptoms of depression.
 
UroShield could protect thousands of patients from painful & potentially life-threatening bladder infections reducing the psychological burden & anxiety patients experience.
 
The innovation is currently being trialled in NHS hospitals with leading urologists including a consultant & surgeon at the Royal Marsden in London describing the device as ‘game-changing’.
 
Uroshield comprises an electronic driver (8-hour battery life) weighing 5g & a disposable clip that fits around the catheter tube, the driver transmits continuous ultrasound waves to the clip via a small cable. The rechargeable device can be switched on & off & a small screen on the driver indicates power supply & battery life.
 
Clinical trials have shown the acoustic sound waves generated by the UroShield device along the urinary catheter result in a significant decrease in catheter-associated pain & discomfort.
 
Click the image below to read the full article.


 
UroShield significantly reduces bladder washouts in catheterised patients & thus could reduce visits from district nurses to generate significant cost & time savings. For example, one patient required daily bladder washouts & since UroShield no longer requires any at all. Patients can have greatly extended catheter life, reducing the frequency of catheter change & maintenance & nurse callout time associated with this. Alongside freeing time & resources, UroShield could also assist Infection Prevention Nurses in achieving CQUIN targets based on catheter-associated infection rates.
Current and planned activity: 
We are speaking with over 80 primary and secondary care sites with regards to UroShield. We currently have 6 NHS sites evaluating UroShield in small scale patient service evaluations alongside a double-blind randomised controlled trial producing positive data proving the efficacy of UroShield.
 
We are also working to provide Health Economic Data which will further support the use of UroShield across various healthcare settings. To support this we are looking to work with a NHS partner in the West Midlands to undertake a small-scale (service) real-life evaluation of UroShield to demonstrate patient and fiscal benefits of using the device.
 
UroShield can help you to support the delivery of the national ‘reducing the impact of serious infections (Antimicrobial Resistance and Sepsis’ CQUIN by creating a new, improved pattern of care for patients, reducing their risk of painful and potentially life-threatening bladder infections.
Return on Investment (£ Value): 
high
Return on Investment (Timescale): 
1 year
Ease of scalability: 
2
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