Sterile surgical kits provide critical consumable tools that surgeons rely on while performing often life-saving operations. It is essential that these kits consistently contain their full compliment of tools. When a manufacturer of these kits discovered multiple production runs were potentially missing key components, they were faced with the prospect of scrapping over 200,000 units. When they reached out to the team at Creative Electron, it quickly became apparent that the problem was not going to be solved by simply putting these samples, one at a time, into a manual X-ray system. And so, once again, we got creative.
Because the packaging of the surgical trays in question was opaque, visually inspecting the kits would require opening and manually inspecting each to confirm its contents. Trays would then have to be sterilized again and resealed. The cost of such a process would have exceeded their value. Manual X-ray inspection provided excellent inspection results without compromising sterilization but was still too slow and costly. The only solution was to automate inspection and incorporate artificial intelligence (AI) to provide autonomous validation.
Automating the inspection process resulted in rapid (2.5 sec/unit) validation and quarantining of suspect trays. Operators were only needed for introducing the product on a conveyor. AI was trained to reliably identify each component of the trays, and note their presence/absence regardless of position or orientation within the package. Not only could the AI make a determination, suspect/not suspect, but it could call out the specific component(s) that were missing. Fast and highly accurate, automated X-ray inspection with autonomous decisions making eliminated the need for slow, costly, and fallible human inspectors. The system aided in the recovery of the vast majority of the surgical trays in question, and more importantly, kept incomplete surgical kits from being distributed to medical professionals. Upon completing the recovery of the suspect inventory, the custom TruView™ Fusion X-ray system was incorporated into the manufacturing process, insuring ongoing product quality.
The team at Creative Electron regularly solves complex inspection challenges for medical device manufacturers. We offer a full line of standard X-ray inspections, as well at the ability to incorporate sophisticated custom features. What’s your inspection challenge?
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