The Trans-Urethral Catheterisation (TUC) Safety Valve
Urinary catheterisation yields significant volume of iatrogenic injuries with serious short and long-term complications that have substantial morbidity/mortality, financial, resource, and medico-legal implications. Such injuries lead to an increased burden on resources, inpatient/ICU beds and workforce in the NHS.Up to 25% of all hospitalised patients undergo routine Trans-urethral Catheterisation (TUC). Approximately 1.3%-7% of patients receiving an indwelling catheter sustain urethral trauma during the insertion process through inadvertent balloon inflation whilst misplaced in the urethra. Many more patients outside of the hospital setting (ie. community care) rely on TUC as part of their daily lives, thus the scale of the issue at large is under reported.
In 2016, a prospective study in two hospitals from Republic of Ireland over 6 months highlighted that 37 urethral injuries occurred across the two hospitals during the placement of 2,750 catheters resulting in a healthcare cost of €335,377 exclusive of long-term complications, outpatient care and medico-legal costs. There were an additional 330 bed days and 17 ICU days required as a direct result of these injuries. This resulted in a cost in excess of €122 per catheter placed in these hospitals to cover the costs of iatrogenic injuries caused during the procedures. In 2019, a follow up study from the 37 patients who received urethral injuries highlighted 2 patients died as a result of urethral trauma related to TUC.
The patent protected TUC Safety Valve is an innovative technology preventing the risk of inadvertent inflation of the foley catheter retention balloon in a patient's urethra, instead of the bladder as intended. It uses an innovative safety pressure relief valve to indicate misplacement of the retention balloon during catheterisation, eliminating urethral damage. Once the valve has “popped” it will automatically deactivate once the user ceases depressing the syringe plunger so that it functions effectively throughout the procedure. Any patient undergoing TUC, using a Foley type of urinary catheter with a retention balloon, is eligible for the TUC Safety Valve to be used as part of their catheter insertion care. In the NHS, circa 2m catheters per annum are used across all care settings highlighting a potential significant volume of injuries, based on prevelance data, that are entirely avoidable.