Ethicon has issued an urgent warning notice to customers for its Evicel® fibrin sealant product, stating that if Omrix’s spray device is used incorrectly there is a significant risk of air or gas embolism with the potentially fatal consequences that entails.
Back in 2009, FDA issued a warning about the potentially dire consequences of using pressure-regulated spray devices to administer Ethicon’s Evicel fibrin sealant. Now Ethicon has chosen to remind users of the risk of air or gas embolism if application is applied at either the wrong (too high) pressure or in too close proximity to the tissue.
In a letter, which can be found here, the Ethicon, together with Omrix, is keen to point out that no emboli have been reported when the device has been used in accordance with instructions. Furthermore they are not recalling any products nor suggesting that there may be any product problems.
The correct settings are provided in the letter and the companies Ethicon is promising an instructional visit from their representative and a new sticker for the pressure regulator to reinforce the importance of applying the correct settings.
We’re curious. Ethicon has adopted a highly conscientious stance by issuing this advice, which is undeniably highly significant for all parties. It also makes a point of telling us in its letter that FDA has been informed. However we’re wondering whether the relevant EU authorities and customers have been told about it… it being life threatening and all that. There appears to be plenty of EU traffic on the subject from a couple of years ago, but so far nothing in the public domain at the present time.
Source: Ethicon, FDA