MHRA alert: air or gas-pressurised spray devices for application of sprayable fibrin sealants in intra-operative haemostasis
Published date : 11 April 2012
Article date : 11 April 2012
The MHRA has issued a medical device alert for air- and gas-pressurised spray devices used in the application of sprayable fibrin sealants for intra-operative haemostasis.
The MHRA warns of a risk of life-threatening or fatal embolism occurring in patients during, or immediately after, application of fibrin sealants via air- or gas-pressurised spray devices. According to the MHRA, those adverse advents reported seem to be linked to use of the spray device in conditions not endorsed by the manufacturer: either at a greater pressure setting, or closer to the tissue surface, than recommended.
Devices currently available in the UK which may be affected by this issue:
- Evicel Fibrin Sealant (human) and spray device (Omrix Pharmaceuticals)
- Quixil Fibrin Sealant (human) and spray device (Omrix Pharmaceuticals)
- Tisseel Lyo Fibrin Sealant and Tisseel ready to use Solutions for Sealant (Baxter Healthcare) when used with EasySpray application devices (Baxter Healthcare)
Read the official MHRA alert including recommended actions for medical practitioners using this device here.
View more information on tissue products used with fibrin sealants here.
