The development of medical device combination product convenience packages continues to throw up interesting technical/regulatory challenges.
Inclusion of pre-sterilized syringes and other applicators as part of these products poses problems for manufacturers and distributors due to the possibility of post-sterilization contamination and/or plastic leachables/extractables.
Most device convenience kits are ETO sterilized and this can leave ETO residuals on the applicators and syringes if they’re included in the paper convenience trays.
If manufacturers are to use these types of device combinations, then an alternative material of construction may be required to avoid this issue or possibly a modified sterilization cycle will be required which provides assurance of the removal of the sterilant.
As a first step testing is needed to quantify the extent of the problem. Only when the size of this issue is understood can a resolution be developed.
These are complex issues which often can be best addressed using the experience of a pharmaceutical consultant to structure a creative path forward.
Whatever the testing results, however, manufacturers still need to know what their exposure is and the regulatory authorities will require evidence to show that practices are safe.
