ONE TRAY® was cleared in 2006 by the FDA with a validated 48-hour storage period following steam sterilization on a 4-minute prevacuum cycle at 270 degrees with no dry time required. The FDA has acknowledged that the product was cleared with this storage period within which processed devices should be used.
Innovative Sterilization has conducted testing after the 2006 clearance to demonstrate the containers’ ability to store the product for different lengths of time.
In 2014 IST made our first change to the IFU for the additional testing on shelf life. We moved from 48 hrs to 30 days. That resulted later in the year in a complaint from an anonymous source to the FDA.
The FDA did an inspection of IST in December of 2014 relating to the complaint about the 30 days. The company was asked by an inspector, how did we go from 48-hour storage to 30-day storage as was published in the 2014 IFU. The company explained we followed the FDA guidance document on the FDA website, we even gave the inspector the link to the website along with a hard copy of the information that was on the FDA website for changing a shelf life when you already have a shelf life. We said we followed the same shelf-life testing done for the 510(k) and we noted it in our design history file and updated the IFU for 30 days. The inspector looked at our documents, took additional information we presented and then we received out EIR (Established Inspection Report) for the inspection which is the closure of the inspection.
After that point we felt that the process we were following was acceptable by the FDA so we did a 180- and 365-day shelf-life test later. Those were added to future versions of our IFU, which now have been removed to only show our 48-hour storage which was in our 2006 clearance.
The FDA asked us to remove the additional performance testing from the IFU so we would not be misleading to our end user that the product was cleared with those additional tests. They only wanted to see in the IFU the 2006 shelf-life clearance of 48 hours.
If you have any questions, please reach out to us at 937.619.0138, or send us a message at www.onetray.com/contact
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