What kind of products can be leak tested in medical devices?

• Catheters: Catheters are commonly used medical devices for fluid drainage, infusion, or monitoring. Leak testing ensures that catheters maintain their integrity, preventing unintended fluid leakage into or out of the body.
• Bags and Tubing: Bags and tubing deliver fluids (such as saline, medications, or blood) to patients. Leak testing ensures that these components are free from leaks, preventing contamination or fluid loss.
• Blood Bags: Blood bags store blood for transfusions. Leak testing ensures that blood bags remain sealed and sterile, preventing any leakage that could compromise patient safety.
• Medical Pumps: Infusion pumps, insulin pumps, and other medical pumps deliver precise amounts of fluids or medications. Leak testing ensures that these pumps function correctly and do not leak
• Blister Packs: Blister packs are commonly used for packaging pharmaceuticals. Leak testing ensures that the blister packs are sealed properly, maintaining the sterility and efficacy of the enclosed medications.
• Implantable Medical Devices: Devices like pacemakers, cochlear implants, and neurostimulators are implanted inside the body. Leak testing ensures that these devices are hermetically sealed to prevent fluid ingress or leakage.
• Ventilators and Respiratory Devices: Leak testing is crucial for ventilators and respiratory devices. Proper sealing prevents air leaks, ensuring accurate pressure delivery and patient safety.
• Balloon Catheters: Balloon catheters are used for procedures such as angioplasty. Leak testing ensures that the balloon remains inflated without any leaks during medical procedures.
• Multi-Lumen or Multi-Flow-Path Devices: Devices with multiple lumens or flow paths (e.g., multi-lumen catheters) require leak testing to verify each channel’s integrity.
• Stopcocks and Flow Controllers: These components regulate fluid flow in medical devices. Leak testing ensures their proper functioning and prevents unintended leakage.

ATEQ is Available to Provide Testers and Consulting For Ventilator Leak Testing Applications.

Flow Testing Up to 300 L/min
Differential Transducer Measurement Down to 50 Pa Full Scale 0.5 cm H2O
Leak Testing Down to 0.1 cc/min ventilator leak testing

Medical device manufacturers continue to increase the expectations of their quality standards in order to decrease and minimize risk. Therefore, medical device leak testing is of the utmost importance. ATEQ’s products are able to meet these demands. For example, our Leak Tester, allows for up to four separate channels of testing. Each leak test channel its own leak test transducer with less than 1.5 cc of internal volume.

Our products can be used in a manual or automated environment, and have secure features which limit who has access to entering and altering the testing parameters. ATEQ appreciates that when performing leak detection in medical devices, this may often include testing every single production piece. ATEQ’s leak detection equipment is built for high capacity testing, and includes quick access to calibrated leaks to verify that testing is progressing as expected

ATEQ’s products are in frequent use for medical device leak testing. End users require a high-degree of confidence in the medical field, like when leak testing ventilators, as they are often used to deliver or extract fluids to or from a specific part of the body.

If a leak existed, then fluids could be inadvertently sent to the incorrect location, or the wrong fluids could be removed. Either circumstance can result in dangerous consequences, and expose hazardous situations to healthcare professionals and patients. Ultimately, manufacturers can be held liable for the failures of their products.

Therefore, having a robust testing methodology can minimize these risks by identifying components that don’t meet established production standards.