Burst Tests Save Lives!

Burst Tests Save Lives

When you manufacture medical devices that play a key role in supporting surgery or administering treatments , the burst pressure test is a key diagnostic for any rigorous inspection process.

When lives are on the line, medical devices that contain air or liquid need to be carefully tested for their burst pressure. It’s key to understanding their efficacy and safety.

There are many products that fall into this category, including medical bags, valves, tubing, and connectors. The list includes blood bags, medical device pouches and packages, medical device trays and foil pouches.

In this blog we focus on the two most commonly burst pressure tested devices in any healthcare setting: medical catheters and balloons.

Catheters and the burst limit test

Catheters are commonly found in hospitals all over the world. They transport fluids into – or out of – your body. They’re manufactured in a variety of materials and can be left in place for several weeks. Once inserted, a small balloon device is inflated, which serves many lifesaving purposes.

Catheter balloons are often used in life-saving operations – where failure is not an option! To ensure reliability, a rigorous testing regime must be followed during the manufacturing and validation stages. This typically involves the tester putting the samples through different pressure cycles with specific sequences – including the burst test while closely monitoring leak rates and burst pressures.

Modern medicine relies heavily on intravascular catheters. As many as 90% of hospital patients will need some form of IV catheter therapy to deliver blood, medications, and nutritional supplements. Catheter designs evolve with every year and each new product must be assessed for safety and efficacy using burst testing.

The typical catheter burst test process begins at an initial pressure. This is then ‘stepped’ periodically over a set time period. Which is why you may have heard the same inspection referred to as a ‘step test.’ Any ruptures and rapid loss of pressure are noted by a burst leak tester and the burst test ends when the sample bursts!

Medical balloons and burst testing

Medical balloons and burst testing go hand-in-hand. The versatile balloon can be used for a wide variety of uses in a medical setting.

Impressively, they can be dilated to unblock heart valves and arteries, the oesophagus, or the urethra. You’ll find them used to deploy and post-dilate stents. And they can even be made to deliver drugs as an alternative to intravenous administration, fill body cavities and transfer heat or cold. This is why testing with an accurate burst leak tester that can guarantee its fit for purpose is so important.

Real world burst test bother

We hope you can see that effective burst testing of medical devices can be of life and death importance! Improperly tested balloons can not only hurt patients – they can damage your reputation and cost you money to deflate the problem too.

The significance of reliable burst testing is demonstrated in this real world example from the US. While there were no resulting deaths or injuries, in 2019 a global medical technology company had to recall multiple catheters. After receiving a number of reputation bursting complaints from its customers.

The unhappy end users reported that the catheter balloons supplied were bursting under the claimed rated burst pressure! Given that these catheter balloons were designed to open blocked or narrowed arteries that supply blood to the peripheral arteries, the faults had the potential to compromise patient safety.

The US Food and Drug Administration (FDA) investigated the case and it was reported that the affected products could lead to vessel injury, procedure delays, and balloon fragmentation in the patient.

Just one example of how important it is to take the burst test seriously and invest in accurate and reliable burst testing equipment.

Bursting to help your burst tests!

At Industrial Physics we are passionate about patient safety and can help with any burst testing and inspection requirement from across our portfolio of devices.

Whatever you need burst testing equipment for. From multi-lumen catheters, sealed medical devices, and respiratory breathing tubes to sterile barrier packaging – we have the reliable technology you need.

If you have questions about medical device burst testing and how you can get the most out of the products you make – we’re bursting to hear from you!

Contact us – Industrial Physics