The technology

UroShield (NanoVibronix) is a disposable ultrasound device designed to reduce the risk of catheter-associated urinary tract infection (CAUTI). It reduces bacterial colonisation and biofilm formation on indwelling urinary catheters. UroShield should not be used for treating an active urinary infection. The technology works by generating and propagating low frequency low intensity ultrasonic surface acoustic waves throughout the catheter, which interferes with the attachment of bacteria. The waves are transmitted directly onto the indwelling catheters at frequencies of 90 kHz and propagate throughout the catheter's entire length on both its inner and outer lumens. According to the instructions for use, UroShield can be used with catheters made of any material and sized 14, 16, 18, 20, or 22 French Gauge (FG). The company states that the technology can also be used successfully with 12-FG catheters.

UroShield includes 2 components: a driver (battery- or AC-powered portable unit), which provides the power, and a single-use actuator which is clipped onto the external portion of any indwelling urinary catheter and generates the ultrasonic waves. The actuator component of UroShield can be used for up to 30 days before needing to be replaced. If a catheter is changed within the 30-day lifespan of an existing actuator use, the company states that the actuator can be removed and attached to the new catheter for the remaining days. The company also state that patients or carers can change the actuator component of UroShield themselves. UroShield is not MRI compatible, and should be removed from the catheter before entering an MRI suite.

Innovations

The innovative aspects are that it uses surface acoustic wave technology to prevent bacteria attaching to the surface of catheters. Alternative products designed to address CAUTI usually involve coating the surface of the catheter or adapting the catheter material (such as antibiotic-coated, silver-coated and antiseptic-impregnated catheters). The company claim that UroShield may have the potential to reduce antibiotic use, by reducing the patient's dose or shortening their treatment course. By minimising the exposure of bacteria to antibiotics, the technology has the potential to help reduce antibiotic resistance.

Current care pathway

According to NICE's guideline on healthcare-associated infections, the risk of blockages, encrustations and catheter-associated infections should be minimised through patient-specific regimens such as reviewing the frequency of planned catheter changes, increasing fluid intake, and documenting catheter blockages. Bladder instillations or washouts should not be used to prevent catheter-associated infections and catheters should be changed only when clinically necessary, or according to the manufacturer's recommendations. Prophylactic antibiotics should not be used routinely for catheter changes and only considered for patients who have a history of symptomatic urinary tract infection after catheter change, or who experience trauma during catheterisation.

Population, setting and intended user

UroShield is intended to be used to prevent CAUTIs in people with indwelling urinary catheters. The technology is likely to be used in hospitals, nursing homes and in a community setting. The technology would typically be administered by healthcare professionals who insert catheters. This may include registrars, general practitioners, urology nurse specialists, district and community nurses, and continence care nurses. The company states that after some training, many patients and carers can manage the device themselves.

Costs

Technology costs

The annual cost for the UroShield system is around £1,200 (£100 per month as a combined cost for the driver and actuator; excluding VAT). The driver component costs £498 and has a minimum life span of 2 years. The single-use actuators cost £80 per unit and are changed every 30 days.

Costs of standard care

The cost of treating a CAUTI has been estimated as £1,968 per episode (Loveday et al. 2014), however the authors note that this is not a robust estimate. For a patient with recurrent CAUTIs who experiences 3 or more episodes in a 12-month period, this could equate to an annual treatment cost of £5,904 or more.

According to NHS reference costs 2017/18, the average cost for a treating kidney or urinary tract infections with interventions was £3,871 (healthcare resource group [HRG]: LA04H-M, Kidney or Urinary Tract Infections with interventions; based on non-elective stays excluding excess bed days).

The type of indwelling catheter used may vary depending on the preference of the clinician. This is usually based on clinical experience, patient assessment and materials that induce the least allergic response (Loveday et al. 2014). Foley catheters can range in price from less than £1 up to around £15 depending on size, coating and technical specification (NHS supply chain, accessed July 2019).

Resource consequences

According to the company the technology is currently being used by at least 7 NHS organisations. There is the potential to release resources in the NHS if the average number of CAUTIs per patient per year would be reduced by the introduction of UroShield. The available evidence does not currently confirm that this would be the case. The company provides basic training free of charge to clinicians, carers and patients, when necessary.