Regulatory information

Regulatory information

All video laryngoscopes in this briefing have a Class 1 CE mark. Also, some single-use blades are supplied as Class 1 (sterile).

The following manufacturer field safety notices or medical device alerts have been identified.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued the following manufacturer field safety notices relating to the included technologies:

  • 2015/006/025/291/007 (June 2015) For the Verathon GlideScope, revision of the operations and maintenance manual's approved cleaning and disinfection methods for the reusable GVL and AVL blades.

  • 2016/002/015/291/002 and 2016/002/012/292/007 (February 2016) For the Verathon GlideScope, a recall of specific lots of Titanium single-use blades following reports of image flickering on the video display.

  • 2017/003/010/291/016 (March 2017) For the Verathon GlideScope, a recall of 1┬álot of GVL size 2 Stat single-use blades after being mistakenly packaged with GVL size 1 Stat single-use blades.