Medical device leak testing is crucial for every healthcare and medical equipment manufacturing team!
Medical device leaks often lead to catastrophic consequences, including dilemmas like inaccurate drug deliveries, infections, device failures, and even patient deaths. This is why medical device leak testing is absolutely critical for healthcare teams to take seriously, and it’s a crucial part of the medical equipment manufacturing process that can’t be overlooked.
Leak testing helps ensure the safety, functionality and overall effectiveness of many different medical devices, and it’s also important to note how every medical device manufacturer faces all sorts of regulatory hurdles. Whether it’s through the FDA or the European Medicine Agency (EMA), these regulations require a thorough understanding of process validation, instrument calibration and data storage/collection.
Some of the most common medical devices that require leak testing include:
- Catheter bags
- Catheter tip seals
- Catheter luers
- Diagnostic reagent kits
- Multi-lumen catheters
- Fluid/Blood bags
- IV pumps
- IV administration sets
- One-way check valves
- Filters
- Ventilators
- Tubing sets
- Stopcocks
- Sensors
- Syringes
- Respiratory devices
- Cardiovascular balloons and devices
- Implantable devices (pacemakers, pumps, etc.)
- And much more!
Medical Device Leak Testing Methods
Medical device leak testing typically includes several different methods, and each method comes with its own unique advantages and limitations. Leak testing methods will often depend upon factors like the specific device that’s being tested, the device’s intended use, and many regulatory requirements pertaining to specific medical products.
Some of the most common medical device leak testing methods include:
Water Immersion/Visual Inspection Tests
This is a basic form of leak testing that involves immersing medical devices in water and identifying the presence of leaks through visible bubbles.
It’s important to remember that water immersion tests can often be time-consuming, subjective, and can lead to moisture buildup that’s not safe for certain types of medical devices and manufacturing facilities.
Pressure & Vacuum Decay Testing
Pressure decay leak testing and vacuum decay leak testing are two similar testing methods that both support healthcare and medical equipment manufacturing teams.
Pressure decay leak testing involves a pre-determined amount of pressure being applied to the device/component, and then subsequently measuring the decay rate once the applied pressure has stabilized. Vacuum decay leak testing creates a vacuum within the tested medical device, and then subsequently monitors any pressure increases over a specified amount of time. When pressure increases occur during these tests, it’s an indication that the medical device has a leak.
Pressure decay leak testing is known throughout the industry for being affordable and simple. It also makes it easy to detect large leaks within medical devices, and it’s important to note that small pressure losses will take longer to detect.
Mass Flow Leak Testing
Mass flow leak testing is another common method throughout the medical industry, and this testing method is somewhat similar to pressure decay testing in that a medical device is pressurized and tested during the stabilization period. But instead of simply measuring pressure loss, mass flow testers measure the amount of replacement air that’s needed to keep a medical device at a pre-established pressure level.
When replacement air is needed during these tests, it’s an indication that a leak is present. Mass flow testing is widely considered to be an affordable and easy leak testing solution for countless healthcare teams, and it’s the go-to method for medical devices that stretch when pressurized or vary in internal volumes.
Occlusion Leak Testing
Occlusion leak testing measures the amount of air that passes through a medical device, and it helps healthcare teams recognize whether an air passageway is clear or blocked.
This testing method involves medical devices being attached to upstream/downstream testing ports and filled with regulated air. Once desired pressure levels are met, the upstream port is closed and the downstream port is opened. Pressure losses are then measured to determine whether or not a leak is present.
Within the medical industry, occlusion leak testing is incredibly important for devices like:
- IV sets
- Catheters
- Tubing
- Check valves
- And much more!
Why Should Healthcare Teams Leak Test Their Medical Devices?
As is easy to imagine, medical device leak testing is incredibly important for every healthcare team. Some of the most important reasons why healthcare teams should leak test their medical devices include:
- Safety: The safety of the world’s medical systems largely depends upon properly functioning medical devices. Leaks undoubtedly compromise medical device performance, which can lead to dangerous accidents and potential medical malpractice litigation. Through leak testing, healthcare companies and equipment manufacturers can proactively address these types of issues.
- Durability: Medical equipment manufacturers can also guarantee the longevity and overall durability of their medical devices by identifying, fixing and safeguarding against leaks. This subsequently has a positive ripple effect on practitioners and patients.
- Regulatory Compliance: The FDA and EMA are just two of various regulatory bodies that oversee medical device manufacturing, and these agencies require specific standards that must be met for all medical devices. Leak testing is a big part of meeting safety and performance standards that no one in the healthcare industry can overlook.
Reach out to Zaxis to Learn More About Our Medical Device Leak Testing Systems!
Zaxis offers a broad selection of leak testing systems that are commonly used for medical devices, and our team is here to help you streamline your medical device manufacturing processes.
Reach out to us online or give us a call at 801-264-1000 to get in touch with our industry experts and learn more about how we can support your medical device leak testing requirements!
