Medtech Innovation Briefing: Farco-fill Protect

Inflation device could help reduce complications associated with urinary catheter balloons

  • Farco-fill Protect, manufactured by CliniMed, is used for inflating Foley urinary catheter balloons
  • It contains a broad-spectrum antimicrobial agent (triclosan) with the aim of reducing bacteriuria that occurs in urinary catheters and then cause catheter blockage due to encrustation
  • The intended place in therapy would be for use by any clinician responsible for inserting or changing an indwelling urinary catheter
  • The evidence summarised in the briefing ais from a German randomised controlled trial, a German and Switzerland before-after study, and a UK case series across in a total of 142 patients.
  • There is some evidence to suggest that Farco-fill Protect may reduce the level of bacteriuria and decrease the frequency of premature catheter removal
  • The cost of Farco-fill Protect is £4.80 per unit

Farco-fill Protect is the subject of a Medtech Innovation Briefing

Am innovative technology aimed at reducing infections in patients fitted with suprapubic Foley catheter balloons is the subject of the latest Medtech Innovation Briefing from the National Institute for Health and Care Excellence (NICE).

The briefings aim to support NHS and social care commissioners and staff who are considering using new medical devices and other medical or diagnostic technologies.

The information provided includes a description of the technology, how itís used, and its potential role in the treatment pathway.

They also include a review of relevant published evidence and the likely costs of using the technology, but they are not NICE guidance and do not make any recommendations on the value of using the technologies. Whether or not to use the products described is entirely the choice of local staff.

However, they will help to avoid the need for organisations to produce similar information, so saving staff time, effort and resources.

The latest briefing explores the potential impact of using Farco fill Protect, a sterile solution that comes in a ready-to-use syringe.

It is used to inflate urethral and suprapubic Foley catheter balloons to hold the catheter in place.

It contains 0.3% triclosan, a broad-spectrum antimicrobial agent and is used in catheters that may remain in-situ for up to four weeks.

There is a controlled release of triclosan from the solution in the balloon into the urine over time.

Farco fill Protect differs from catheter balloon solutions, often simply sterile water, in that it contains the antimicrobial agent, triclosan. This is designed to protect the outer surface of the catheter from bacterial colonisation and subsequent encrustation when in place over a long time.

Long-term catheterisation is rarely free of complications. The most-common complications are blockage and leakage; recurrent blockage occurs in 40% to 50% of long-term catheters. These complications can also occur in short-term catheterisation, especially in some patients with complex medical conditions.

Farco fill Protect is intended for use in adults who need an indwelling Foley urinary catheter and who have a history of their catheters becoming blocked because of encrustation.

It could be used in primary, secondary or community care settings or in the home and by clinicians trained in the appropriate catheterisation technique. Healthcare professionals would not need any additional training to use it.

The briefing provides findings from three trials, with some evidence to suggest that Farco fill Protect may reduce the level of bacteria in the urine and decrease the frequency of premature catheter removal.

However, uncertainties remain around a lack of comparative studies, whether the outcomes measured such as level of bacteria in the urine are of clinical importance, and if the use of Farco fill Protect extended the patency of catheters or reduced the number of catheter-associated urinary tract infections.

To read the briefing in full, click here.

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