The Royal Australian and New Zealand College of Ophthalmologists (RANZCO) has made two submissions to the Australian Therapeutic Goods Administration (TGA), which is trying to bring Australian regulation of medicines and medical devices in line with the European Union and broadly with other parts of the world.
RANZCO is supporting the re-classification of active implantable medical devices and their accessories into a Class III category (medical devices).
The second RANZCO submission rejects the proposed change which would see the TGA reclassify proprietary eye irrigation solutions from Class I - sterile (low to medium risk) to Class IIb (medium to high risk) and would increase the minimum requirement to obtain approval. In its submission, RANZCO said the appropriate emergency eye irrigation solution at the time and place of chemical eye injury, usually before transfer to a healthcare facility, is tap water which of course does not require TGA classification. Should proprietary eye irrigation solutions be necessary at other times and places for chemical injury and any other indication, RANZCO said it believed they should remain “Class I sterile” since they are not intended for absorption into the body, the particular feature that would require reclassification.
