Controversial catheters: Industry reacts to criticism

Recent controversy has brought the catheter sector into the spotlight. Lu Rahman looks at the criticisms being thrown at the industry and how it has hit back

A recent report on the BBC’s website column Scrubbing Up highlights the weaknesses in the urinary catheter market.

Mandy Fader, professor of continence technology at the University of Southampton, said that in 80 years, catheter design had changed little adding that the industry was at fault of poor investment and weak regulation.

According to a recent report on the urinary catheter market by Transparency Market Research, the global urinary catheters market will reach US$2.37 billion in 2020 from US$1.66 billion in 2013. A range of factors is contributing to the growth of the market including an increase in urinary disorders and the growth of chronic disorders. Figures from the World Health Organisation (WHO) say that more than 200 million people globally suffer from a bladder control problem that requires a urinary catheter. In the UK alone 3-6 million people required a urinary catheter in 2013.

According to the BBC, Professor Fader believes there is evidence that catheters are over-used but her main issues surround their design and the materials used. Instead of this medical device having what she says should be a ‘state-of-the-art’ design, she argues that the product hasn’t changed sufficiently in the last 80 years. Part of the problem for this she says, is weak regulation. She told the BBC: "Unlike with new drugs, manufacturers do not need to show that any changes they make to catheters actually work on patients."

Fader goes on to point the finger at catheter manufacturers saying that they need to invest more in new catheter design and materials that resist infection. According to the report she says that the devices have represented “easy money” due high demand. However, she says that while this has been the case, the industry has lacked innovation and improvement.

These comments didn’t meet with approval from the Urology Trade Association, which represents manufacturers of urology products including catheters, rejecting Faders’ claims that the sector lacks innovations and investment.

The association has argued that Professor Fader’s assertions ignore continued investment by manufacturers, along with innovation to minimise the risks of infection and improve the quality of intermittent catheters and people’s quality of life. The association has also expressed concern that Professor Fader’s claims might pre-judge research she is leading at the University of Southampton to assess the utility of single-use catheters, currently the standard products for patients, and catheters that can be washed and reused.

Chris Whitehouse, chairman of the Urology Trade Association, said: “Professor Fader’s claims ignore substantial and continued innovation and investment in catheter products by industry, particularly over the last 20 years. Manufacturers continually talk with patients and healthcare professionals, and the development of catheters is led by what patients want and need.

“The simple fact is that it is now possible to get catheters that are easier to use than ever before. Some are designed to look like consumer products to make them more discrete for Professor Fader to then claim that innovation and investment isn’t taking place is quite clearly incorrect. These claims are particularly concerning given that she is undertaking research into catheters that could affect what products patients have access to in the future."

The Medicines and Healthcare products Regulatory Agency (MHRA) joined the debate and a spokesman for the agency was reported as saying that the MHRA has no evidence “to

suggest that urinary catheter materials used in the UK do not meet the requirements of the Medical Device Directive."

Innovation continues

Clearly the debate remains but meanwhile those supplying healthcare with catheters and catheter-related products are continuing to innovate and make advances.

Earlier this year NICE announced plans to recommend a technology to hold catheters in place and reduce infection risk. Draft guidance proposed the use of the 3M Tegaderm CHG IV securement dressing for catheters inserted into central veins and arteries. Tegaderm CHG dressing is a sterile transparent semi-permeable polyurethane adhesive dressing, with an integrated gel pad containing the antibacterial agent chlorhexidine gluconate (which is a widely used antiseptic and disinfectant). The draft guidance says that the Tegaderm CHG dressing should be considered for use in critically ill patients who need a central venous or arterial catheter in intensive care or high dependency units.

The device manufacturer claims that the benefits of the Tegaderm CHG dressing include a 60% reduction in the incidence of catheter-related bloodstream infection in critical care patients with intravascular catheters, and reduced risk of death from this type of infection.

Cutting death rates

Recently MPN reported on the Uterine Balloon Tamponade from the Cambridge Design Partnership which addresses the issue of Postpartum Haemorrhage (PPH). It is the leading single cause of maternal mortality and is thought to be responsible for approximately 57,000 deaths each year worldwide, nearly all of which occur in developing regions. 

Commercially available UBTs can cost as much as $200 each and need to be carefully inserted in theatre by trained clinicians. These factors prohibit their use in low resource areas, where currently a makeshift alternative assembled by tying a condom to a urinary catheter – the ‘condom catheter’ – is being trialled.  Whilst this device is certainly cheaper, it still requires careful assembly, significant training and skill to be successful.

The new UBT designed by Cambridge Design Partnership bridges the gap between the more expensive versions used in the West and the ‘condom catheter’.  Its novel design combines features that make it intuitive and effective to use, to enable patient safety even in the hands of less experienced users – as well as ensuring cost effectiveness for manufacture.

Lucy Sheldon, human centred design specialist, Cambridge Design Partnership said: “To be effective in low resource settings, medical products such as UBTs must be affordable and available; optimized for the intended conditions of distribution, storage, and use. To meet these needs we applied a human centred approach to the innovation process - combining expertise in human factors, risk management and interaction design - to the development of our device. Our aim was to maximise usability in the hands of minimally trained birth assistants and lower the overall costs of the intervention, through reducing the medical professionals, equipment and training required to safely and effectively use the device - to ultimately save lives.”

Other innovation comes from Vygon (UK), the UK subsidiary of the specialist single-use medical devices group, which recently announced that patients returning home from hospital with long-term catheters or receiving intravenous treatment can now buy online a disposable disinfection device, Curos Port Protector.

Curos Port Protector is a disposable, passive disinfection device. Studies have shown it reduces Central Line Associated Bloodstream Infections (CLABSI) and Catheter Related Bloodstream Infections (CRBSI) in hospitals. Its effectiveness was tested in vitro against Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa and Candida glabrata.

The device has an integrated, disinfecting pad impregnated with 70% isopropyl alcohol, which cleans the IV or catheter access port, killing bacteria in three minutes – and providing ongoing protection for up to seven days.

“Curos Port Protectors are a proven way of reducing infection risk for those patients who continue to receive treatment at home through intravenous needle-free devices and catheters,” said Brett Hughes, homecare manager at Vygon (UK).

“A patient’s home is not as well-equipped as a hospital, Curos helps meet the challenges faced in providing quality healthcare in a domestic environment.”

Allegations against the catheter industry are clearly unwelcome and the sector continues to innovate and push boundaries to help improve safety and infection issues. However, the conversation can be seen as a positive step to help boost product design and drive forward ideas and new ways of thinking. Already offering new and ground breaking devices and technology, the catheter industry has much to shout about and no doubt will continue to advance over the coming years.