Issues for Device Combination Products

The development of medical device combination products convenience packages continues to present interesting technical and regulatory issues. Inclusion of pre-sterilized syringes and applicators as part of these products poses problems for manufacturers and distributors due to the opportunity for post sterilization residual contamination and/or plastic leachables/extractables.
Most device convenience kits are ETO sterilized and this can leave ETO residuals on applicators and syringes if they’re included in the paper convenience trays.
If manufacturers are to use these types of devices, then an alternative material of construction may be required to avoid the issues, or alternatively a modified sterilization cycle will be required which assures the removal of the sterilant. As a first step however, testing is needed to quantify the extent of the problem before the right strategy can be developed.

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