February 21, 2022
For the medical device industry, ISO 11607 plays in important role in the design requirement for packaging. According to the standard, the design of the package must be able to maintain sterility of the device throughout its entire lifetime. However, with the 2019 update, a major change was introduced in the Usability Evaluation for Aseptic Presentation section
According to the update, manufacturers are required to determine the following through usability evaluation:
- The ability to identify where to begin opening a sterile barrier system
- The ability to recognize and perform the technique required to open the sterile barrier system without contaminating the contents
- The ability to subsequently present the contents aseptically
This requires additional information be provided to the end user, which could increase packaging costs through labeling or extra inserts.
TEQ recognized there might be a need for a different solution for the industry. So we got to work developing a way to be able to prove aseptic presentation without extra labeling or inserts. We partnered with a strategic partner to create an innovative solution we’re calling TEQcode.
We were able to create a package that has a readable code imbedded into the plastic when formed. This code is read very similarly to a QR code. Once read, the code will bring up a link to tap on. Right now, we’ve got our package directly linking to our new website. But this could also link package tracing information, a readable digital guide with more information about the medical device in the package, or even video instructions on how to aseptically present a medical device in an OR.
We are going to be introducing out TEQcode package to the industry at MD&M West 2022.
Tells us what you think! If your trays could talk, what would they say? Because now, we can give them a voice and tell your story.