Teleflex nasal drug atomiser device recalled

Following a medical device alert back on the 21^st April this year, LMA MAD Nasal has recalled their intranasal mucosal atomisation devices after complaints that the device failed to deliver medication properly.

The device provides an alternative administration of medication that otherwise may require a needle. Marketed as “safe, painless and rapidly effective treatment”, many may prefer the nasal atomiser over a sharp needle in the arm.

However, problems have arisen where the medication may not actually be delivered properly or at all, which can of course be incredibly dangerous for users relying on vital medication for their health.

The nasal medical devices take the shape of a syringe with a stopper in the place of a needle. The device can be filled with any soluble and concentrated medication.

The user or administrator inserts the tip of the ‘stopper’ into the nose and pushes the back of the plunger into the barrel towards the nostril, pushing the medication through to the nose. The liquid is then supposed to be atomised by the ‘stopper’ and inhaled by the user.

The device is commonly used for managing pain, agitation and seizures. Without the irritation of a sharp and often painful needle, the device can be much less invasive and intimidating. For the same reasons, children are often more inclined to take medication when presented with this method of administration as opposed to a needle.

Multiple reports of problems

Sadly, there have been multiple reports that the atomiser has been defective for some uses.

Reportedly, the detachable atomiser does not always work, resulting in an improper delivery of medication. For those who receive some of the medication in its liquid, rather than mist form, it may then be difficult to identify how much medication has been properly absorbed into the blood stream.

Instead of atomising the medication into a mist, the devices may “deliver a straight stream”, according to the MHRA. When atomised, the fine mist should turn the medication into small particles that can be directly absorbed into the nasal membranes, and then into the bloodstream. This method of administration can be highly effective; much more effective than using liquid drops or sprays.

But the potentially faulty devices may prevent carefully measured and concentrated medication from being administered properly.

Recall initiated

Manufacturer Teleflex has no alternative but to recall the medical administrator devices as several complaints have been made to the U.K’s Medicines & Health products Regulator Agency (MHRA). Some 66 batches of the medical devices are thought to be affected and are being recalled.

According to the MHRA, the atomiser:

“might not deliver a fully atomised plume of medication”

Without administering the necessary medication required, the device could lead to serious problems.

Locate and quarantine devices

Healthcare workers have been asked to locate and quarantine devices and contact Teleflex to return the products. Medical staff are being requested to acknowledge receipt of Teleflex’s field safety notice regarding the nasal devices, even if they don’t have any in stock.