FDA alerts patients and orthodontists regarding burn risk from handheld electric dental devices

October 6th, 2010
FDA alerts patients and orthodontists regarding burn risk from handheld electric dental devices

Alerts have again been issued by the US Food and Drug Administration (FDA) to orthodontic professionals regarding the risk of patient burns from electric dental handheld devices.  The handpieces have left patients requiring reconstructive surgery after experiencing first-degree to third-degree burns after use, but since the FDA’s primary 2007 Public Health Notification, further reports have been received concerning users being burned by the appliances.

Severe burns are likely to happen when the electric dental devices overheat during use, but may not be apparent to either the patient or operator until after damage to the tissue has occurred.  Due to the anaesthetic numbing the patient’s tissue and the operator protected by the insulation from the heated apparatus, neither party would feel the heat until post-operation.

In continuing efforts to resolve this ongoing matter, the FDA has taken steps to communicate any issues to the dental device manufacturers – such as letters asking for support with correcting errors connected to the handpieces, with requests including:

–       determining the initial cause of the overheating danger;

–       ascertaining if the handheld device is labelled appropriately so users can clearly understand any necessary instructions, and if additional maintenance is viable;

–       acknowledging risk mitigation measures such as altering designs, affixing an overheating alarm, warning labels, operator training to help prevent overheating, or altering use of the devices.

Should any adverse effects or side effects occur during use of these products, the FDA strongly urge orthodontic professionals and patients to report any irregularities immediately.

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