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TUC Safety Valve

Paving the way for safer foley catheterisation  

The Foley (balloon) catheter was first introduced in 1935 and remains the indwelling catheter of choice in 75 - 130 million catheterisations annually worldwide. However, catheterisation is a blind procedure (meaning the medical professional cannot see where the balloon is inflated) and despite improvements in education and training the ever-present risk of catheter balloon injury (CBI) of the urethra remains as the Achilles’ heel of the Foley catheter.

What is the Trans-Urethral Catheterisation (TUC) Safety Valve?

The (TUC) safety valve has been designed to prevent the recurring problem of Catheter Balloon Injury (CBI) of the urethra associated with catheterisation. The device is a pressure relief valve interposed between the catheter balloon inflation port of a catheter and any inflation syringe at the time of catheterisation. The threshold pressure for valve opening of 150 kPa has been determined by a series of published bench studies in both animal and human urethral tissue and validated in a published first-in-man study.

Why the need for the TUC Safety Valve?

Approximately 7 in every 1000 patients continue to be injured during catheterisation. TUC Safety Valve will reassure both the patient and the catheterising practitioner that the risk of CBI has been virtually eliminated. This novel device also allows for healthcare professionals to have the peace of mind that they themselves will not injure the patient and worsen their outcome.

Urethral injury prevention

In the NHS UK & Northern Ireland (NI) there are 1.7 million catheterisations per year. We have shown an incidence of Catheter Balloon Injury (CBI) of the urethra of 6.7/1000 (0.67%) catheterisations equivalent to 1.3% of all male catheterisations. A British Association of Urological Surgeons (BAUS) Survey highlighted that the perceived incidence was 5.4% and in our Clinical Study it was 7.0%. Extrapolating and using a more conservative incidence figure of 0.55% estimated for catheterisations of all ages and gender, this generates a figure of over 9,000 injuries/year in the UK equivalent to over 1,000 injuries/year in the Republic of Ireland. 

Effective solution | safer procedure | affordable 

The built-in flow restrictor in the TUC Safety Valve slows the balloon inflation time of even the most heavy handed syringe users thereby preventing any risk of a brief pressure surge bypassing the valve before opening. It also prevents inflation pressure from exceeding the valve threshold opening pressure and thereby causing a false positive valve activation and inability to inflate the balloon even when correctly placed in the bladder. Our conservatively estimated cost per injury of €10,000 increases the cost of every catheterisation 10-fold.

Extensively tested    

The TUC Safety Valve has been extensively tested in both the laboratory, hospital and patient settings. Class Medical has completed the assessment for ISO 13485 and the product has been CE marked for sale in Europe.

€20.00
€20.00
 
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Shipping

Once ordered, Class Medical will ship the orders via An Post or DPD from Limerick. For delivery in Ireland, we offer next-day shipment service. You order today, and you get your devices tomorrow! All orders to the United Kingdom will take approx 7-10 business days. You will not regret choosing us as your Foley Catheterisation partners as we make things much more efficient than ever before! Improve your healthcare services with our assistance and provide your patients with the absolute best!

Returns

You may return most new, unopened items within 30 days of delivery for a full refund. We'll also pay the return shipping costs if the return is a result of our error (you received an incorrect or defective item, etc.).

You should expect to receive your refund within four weeks of giving your package to the return shipper, however, in many cases you will receive a refund more quickly. This time period includes the transit time for us to receive your return from the shipper (5 to 10 business days), the time it takes us to process your return once we receive it (3 to 5 business days), and the time it takes your bank to process our refund request (5 to 10 business days).

If you need to return an item, simply login to your account, view the order using the 'Complete Orders' link under the My Account menu and click the Return Item(s) button. We'll notify you via e-mail of your refund once we've received and processed the returned item.

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