I read with interest the report describing a complication with a double-lumen tube used in combination with a Frova Intubating Introducer .
The Frova Intubating Introducer is a CE-marked device. As the authors correctly state, since 2005 the manufacturer's Instructions for Use that accompany every Frova Intubating Introducer supplied within Europe, the Middle East and Africa has included the instruction that the Frova device is not intended for use with double-lumen tubes. This instruction is stated under the ‘Intended Use’ section of the Instructions and repeated under ‘Warnings’.
In 2009 further revisions were made to the Instructions supplied with every Frova device dispatched from our European warehouse to clarify proper use: “Ensure proper sizing of the endotracheal tube to be used in combination with the Frova Intubating Introducer.” and: “Care must be taken when introducing/removing the catheter introducer from the endotracheal tube; contact with sharp edges on the internal surface of the endotracheal tube may cause small fragments to be shaved off the catheter during introduction/removal.”
Cook Medical's records show a global complaint rate of < 0.002% related to the complication reported by Drs Huitink and Bisschops.
Instructions for Use serve to communicate safety and performance-related information to users of medical devices. They are designed to inform the user on how to use the device safely taking into account the knowledge of the user. Such Instructions are frequently subjected to change. While manufacturers are responsible for ensuring their Instructions are current and accurate, users of medical devices are also responsible for ensuring they read and familiarise themselves with the accompanying documentation before use of the medical device in question.
The EU Regulatory Committee on Medical Devices has recently approved the draft Regulation on electronic instructions for use of medical devices. This proposal has potential to address concerns raised by Drs Huitink and Bisschops regarding the current application of Instructions for Use.