Leak Testing Medical Devices Is Not For The Faint of Heart.
I think I have said this before; medical devices can present some of the greatest challenges in leak testing. That’s kind of ironic in a way, since they are often among the smallest things we are asked to test.
The sheer variety is mind boggling. You can easily be forgiven for wondering where they all go with a visit to just one manufacturer.
Because they perform vital often life saving functions, it’s no surprise that testing them correctly is vital. If even one bad part reaches a patient the consequences can be catastrophic. This leads us to the first challenge:-
One hundred percent inspection
In some industries although the quality engineer seeks perfection there can exist a compromise between inspection and throughput by using statistical sampling methods. In the medical device industry perfection and production objectives must be met without compromise. Therefore fast, one hundred percent inspection is expected and it demands multi channel leak testers as well as accurate and reliable fixturing.
Everybody knows that medical device manufacturing is a highly regulated industry. It’s for the safety and peace of mind of patients, not just in the USA, but around the world. No one would argue that’s not a good thing. However, it brings with it ever increasing requirements for capturing and storing data. Some devices are serial numbered, chipped, or bar-coded and that brings us to the next challenge:
Medical device leak testers must be capable of data collection and distribution. On the simplest level storing data on the tester and saving it to a USB drive is fundamental. The more sophisticated tester will interface with bar-code readers, chip readers, networks and client laboratory and enterprise data management systems.
Data must be protected from intentional and accidental corruption with password protection, electronic signature or other security measures.
Bringing it all together requires a supplier that understands the application or, if you like, the test specifications, as well as the pitfalls of testing small, often plastic, sometimes flexible, maybe fragile, and difficult to handle parts. There’s the next challenge:
The best suppliers should have the capability to design and produce fixtures, automatic or semi-automatic systems as well as fast, fully featured, leak testers. It’s unlikely that an industry newcomer can fit that bill. So, that narrows the choice to companies that have grown up with the medical device industry. But, just because they are well established doesn’t mean they are qualified. Medical device manufacturers need to know they have access to abundant technical support, certified calibration services, and staff engineers who can help troubleshoot when things go wrong.In this short blog I have identified three main challenges. If you’d like to read about this subject in more depth you are welcome to download our free whitepaper Eight Great Things Manufacturing Engineers Must Know About Leak Testing Equipment to Maintain Quality Control Without Sacrificing Production Speeds. You’ll be invited to join our literature club. It’s free and gives access to all our whitepapers, application notes and product literature. Click here to join https://uson.com/uson-literature-club/