Ever since Uson first developed the leak testing technology for the U.S. space agency NASA in 1963, the medical device industry has been using the same dry air leak testing technology. As the managing director of the company’s European operations, I regularly run into manufacturing engineers and other support staff throughout Europe who do not clearly understand the basic principles of leak detection for the medical device industry. As a result, they continue to run compromised assembly lines.
I recently saw a test station using a leak tester that was ideal for leak testing a single lumen catheter but was very inefficient when it came to testing multi-lumen catheters. What was really needed for this four-lumen application was a four-channel concurrent tester that is capable of switching between occlusion and leak testing on all four channels at once. Such a test process is much safer as each assembly is tested to the same pre-programmed rigorous test regime without the risk of a channel being missed, and you get the benefit of a much faster test.
Basic Leak Testing Steps You Should Take
Every member of the medical device manufacturing team must follow these basic steps of leak testing for medical devices:
- Select the right detection equipment by matching it with your application
- Create a reliable test program
- Match the test reports to record critical functions of the device to be tested
- Determine the level of test reports required to provide traceability
- Establish how to and how often to verify system integrity
- Protect the leak detector from contamination
- Protect the complete test station from the effects of fixture creep and ambient temperature changes to ensure good Gage R&R capability
Medical device leak testing technology of five years ago is no longer the best-match for many of today’s medical applications, such as endoscopic instruments where multiple tests at different pressures need to be performed and where state-of-the art multi-channel leak and flow testers would now make for better fits. Modern manufacturing and quality control processes require traceability of test results involving remote data logging and methods of attaching test results to the product being tested.
Attending national and international conference events is a great way to keep up with innovations. However, for the type of continuing education that matters most to hands-on implementation of new technologies with optimal Six Sigma impacts, nothing surpasses the detailed (usually free) course offerings from those who pioneer new technologies, such as Uson.
At Uson, we recognized this need and now offer free one to three day courses in leak testing with data management.