In the medical device manufacturing market, devices typically have a barrier and pathway-like function that requires keeping whatever is inside the device (such as a gas or liquid for example) inside while simultaneously preventing whatever is outside the device from getting inside it. These devices are commonly used to transport or extract fluids or gases to and from specific parts of the body. Due to the important function and nature of these devices, it is imperative that they undergo stringent and accurate leak testing to ensure each medical device functions as it should, is safe to use, and meets the highest standards of quality.
Using our previous example, if a leak existed in a medical device this could result in fluids or gases seeping or leaking out into the wrong parts of the body. This can result in severe consequences for the end users (patients and healthcare professionals) and can even be fatal! In addition, the manufacturer could also be held responsible for the failed medical component resulting in lawsuits, fines, and recalls which could cost the company millions of dollars.
Medical devices produced by manufacturers must meet ever-expanding quality and safety parameters to comply with the strict regulations and standards of the FDA and GMP. The best way for manufacturers to mitigate risk is by identifying components that don’t meet production standards using leak testing instruments that are accurate, scalable, and repeatable. Therefore, leak testing has become a critical part of medical devices production and assembly.
Why is air leak testing crucial for medical devices? Watch how leaks can develop
over time and impact safety and performance.
