The technology and hermeticity testing standards in use today by manufacturers’ of implanted Class III medical devices were originally developed by the military and space community over 40 years ago. The medical device industry adopted these standards and for years there was a free exchange of technical and scientific information between the two diverse industries. Today engineers at medical companies do not openly talk about failures and process related issues in public.
The devices placed in the body are often times laser welded titanium cases with hardened glass to metal feedthroughs, the same type of packages used in missiles and on space missions with 20 and 30 year lifetimes. If made properly these devices should not fail due to loss of hermeticity or excessive moisture.
Each failure and court case headline hurts each and every company in the medical device industry and increases costs across the board, for both the companies that manufacture the implants and the unfortunate recipients of defective implants. It also reflects poorly on the FDA and the high standards we subscribe to here in the United States.
Read the full story from USA Today.