Scenario: an outer tray of a sterile implant is opened adjacent to a sterile field in the OR. The inner tray is immediately dropped onto the sterile field. If the inner tray has a sterile breach, would the product's sterility be considered compromised even though the outer tray is in tact and the inner tray opened in a sterile environment?

Many thanks in advance!

Gracie -

How is the inner tray labeled? If the inner tray carries a "Sterile" claim, then any breach of the barrier is unacceptable. Also, if the user facility assumes that the inner tray is a sterile barrier, there is a possibility that the outer tray may be opened some where else - far from the sterile field. The inner tray, believed to be a sterilie barrier, would instead allow the device to become contaminated.

Why would the inner tray be compromised? If the same people who validated the outer tray sealing process also validated the inner tray sealing process, I would be suspect about the overall quality of the product.

Paul J. Sordellini