Advice

Summary

Summary

The S‑Cath System is intended for use in people for whom a suprapubic catheter is indicated, and differs from conventional suprapubic catheters because a guidewire (the Seldinger technique) is used for improved placement. The available evidence is of limited quantity and quality. Three non‑comparative studies suggest that suprapubic catheterisation using the S‑Cath System is a safe procedure when carried out under appropriate conditions in a dedicated outpatient clinic, with low complication rates. In 1 of these studies, suprapubic catheterisation was moved from an inpatient to an outpatient setting. This was shown to be cost saving, however it is unclear if the S‑Cath System was a significant factor in these savings. The S‑Cath System costs between £36.39 and £41.92 (excluding VAT and carriage) depending on catheter size and type. The instructions for use state that the catheter is suitable for use for up to 12 weeks.

A Rapid Response Report by the National Patient Safety Agency (2009) recommends that ultrasound is used wherever possible to visualise the bladder and guide the insertion of suprapubic catheters. Ultrasound machines should be available in the relevant areas and staff trained in their use.

Product summary and likely place in therapy

  • The S‑Cath System is a suprapubic catheter (SPC) insertion set. It uses the Seldinger technique with a 3‑stage guidewire, which is designed to improve the safety and accuracy of catheter insertion.

  • It would be used as an alternative to conventional SPCs, which do not have a guidewire feature. The use of S‑Cath may allow SPC insertion in an out-patient setting. It is recommended that the insertion of any SPC is carried out under ultrasound guidance.

Effectiveness and safety

  • The evidence is of limited quality and is based on 3 studies; 1 clinician survey and 2 case reports. No comparative studies were identified. In total, 421 SPC insertions with S‑Cath were included.

  • One study of 45 patients with spinal cord injuries reported that 6 patients developed complications after SPC insertion using the S‑Cath System, including 2 with autonomic dysreflexia.

  • One study reported data on the technical success of 322 catheter insertions in a dedicated SPC clinic. Four people had complications, including 3 with bowel perforations.

  • One study reporting on setting change and technical success included 54 patients who had an SPC inserted using the S‑Cath System. The procedure failed in 4 patients and 3 other patients had complications.

  • A small survey of 6 clinicians found that using the S‑Cath System gave them greater confidence in SPC insertion compared with the standard trochar method as well as in its use by junior staff. Improved patient comfort was reported by 3 clinicians, and the 3 other clinicians reported equal patient comfort. Five clinicians reported improved patient safety but 1 reported worse patient safety.

  • Two single case reports described adverse events that are recognised complications of general SPC use.

Technical and patient factors

  • The National Patient Safety Agency published a Rapid Response Report in 2009 after reports of 3 deaths and 7 incidents of serious harm after SPC placement in England and Wales between September 2005 and June 2009. The techniques used could not be established. The report recommends that SPCs be inserted using ultrasound guidance.

  • The S‑Cath System is suitable for children, young people and adults of both sexes.

  • The device is designed to improve SPC insertion and removal. The variable stiffness guidewire is intended to reduce the risk of injury and enable safer placement.

  • The device is intended to be used in the hospital setting by appropriately trained clinicians. It is suitable for use with local anaesthetic so SPCs can be inserted in an outpatient setting.

  • The S‑Cath System should only be used for initial SPC insertion and not for replacement catheter insertion.

Cost and resource use

  • The S‑Cath System costs between £36.39 and £41.92 (excluding VAT and carriage) depending on catheter size and type. The instructions for use state that the catheter is suitable for use for up to 12 weeks.

  • In a UK study, moving suprapubic catheterisation from an inpatient setting (catheter type not specified) to an outpatient setting using the S‑Cath System led to an annual cost saving of about £100,000 in an NHS region.