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Correspondence  |   August 2008
Chipped Rail Gear of a Lightwand Device: A Potential Complication of Tracheal Intubation
Author Notes
  • Laerdal Medical AS, Stavanger, Norway.
Article Information
Correspondence
Correspondence   |   August 2008
Chipped Rail Gear of a Lightwand Device: A Potential Complication of Tracheal Intubation
Anesthesiology 8 2008, Vol.109, 356. doi:10.1097/ALN.0b013e31817fd6f8
Anesthesiology 8 2008, Vol.109, 356. doi:10.1097/ALN.0b013e31817fd6f8
In Reply:—
We commend Hosokawa et al.  and the University Hospital, Kyoto Prefectural University of Medicine, Kyoto, Japan, for the professional actions undertaken relating to patient care and incident reporting after postprocedural discovery of a plastic fragment separated from the rail portion of a Trachlight Tracheal Lightwand handle.
Details of the event have been sent to health authorities as prescribed under local country regulations and in accordance with international regulatory agreements. Both the handle and the plastic fragment were forwarded through Laerdal Medical Japan, Ltd., to the device manufacturer, Laerdal Medical AS of Stavanger, Norway, for technical evaluation.
Laerdal Medical was pleased to receive advice that no complications or adverse health effects to the patient have been realized. This event has heightened awareness within the reporting institution, and its examination of all similar devices constitutes a responsible protective action. Periodic review of the Trachlight Directions for Use, with special attention paid to cautions and warnings, inspections and functional checks/tests, would be another positive precautionary measure for users.
Upon examination of the subject handle, it was observed to have multiple signs of mechanical damage to its other plastic components as well as to the rail teeth. It is likely that the damage exhibited was incurred during its term of institutional use. In addition, microscopic examination revealed residues of unknown chemical origin on another remaining rail gear of the handle.
Trachlight handles are made of polycarbonate/acrylonitrile butadiene styrene polymer, a material with many desirable characteristics that is widely chosen for use in medical device applications. However, it is known that exposure to certain chemical compounds can cause it to become brittle. For this reason, a specific caution message appears several times throughout the Directions for Use: “Caution: The lubricant used on the endotracheal tube and the wand should not contain any topical anesthetics or other active ingredients. These chemicals will degrade the plastic in the handle.” Note: The 70% isopropyl alcohol is recommended for cleaning Trachlight handles because it is both compatible with polycarbonate/acrylonitrile butadiene styrene polymer materials and also capable of facilitating removal of noncompatible chemical residuals unintentionally deposited on handles during clinical use.
At this time, it is not possible to conclude exactly why the rail tooth broke away from the subject handle, but we believe it is most likely the result of a combination of unintended exposure to some chemicals, and some earlier mechanical impact. Although no trend has been observed for this type of damage, Laerdal will maintain its surveillance of all reports on Trachlight products and continue to promptly investigate any and all incidents related to its devices.
In conclusion, we thank Hosokawa et al.  for their letter to the editor reporting this occurrence, for providing a constructive product design suggestion, and for raising user awareness, thus reinforcing the importance of familiarity with and adherence to manufacturers’ instructions, cautions, warnings, preuse inspections, and functional tests for any medical device, and the importance to check that all handling processes within the user institution also support such compliance.
Laerdal Medical AS, Stavanger, Norway.