Medical devices are often responsible for the transfer of fluids and gasses to and from a patient. From simple bag valve masks to complex respirators, and from basic catheters to advanced blood transfusion machines, it is imperative that these devices perform their task without leaks. For some medical equipment, a leak can severely impede effectiveness, while for others a leak can result in the contamination of fluids and gasses, which can lead to infections and other complications in the patient. It is therefore critical that devices perform leak-free.
To ensure that gasses and fluids are properly delivered, devices must be checked for leaks. Some can be checked with simple pressure tests. With medical instrumentation becoming increasingly complex, however, many require more advanced testing such as mass spectrometry leak detection. Some devices also need to be retested at regular intervals to maintain leak-free operation.
At Proven Process, we employ mass spectrometry leak detectors that can detect even infinitesimally small leaks. Mass spectrometers employ helium, an inert gas that is very rare in earth’s atmosphere (5.2 ppm), and therefore an ideal test gas for detecting leaks. Even in flexible devices or devices with multiple branching passageways, we ensure that the medical devices we manufacture or their components conform to the highest standards even under the most extreme conditions.