Regulators in the U.K. last week issued a medical device alert on the Renasys negative-pressure wound therapy device, following on a field safety notice issued last October by Smith & Nephew (FTSE:SN, NYSE:SNN).
The U.K.’s Medicines & Healthcare Products Regulatory Agency’s Jan. 21 alert reiterates Smith & Nephew’s notice to customers last fall of design changes to the Renasys device. The British wound care giant also asked Renasys customers to discard older consumables used with the device.
The safety notice also advises caregivers to carefully monitor the status of wounds to ensure that discharge isn’t accumulating under the dressing.
"If a blockage in the system isn’t recognized, fluid from the wound can build up and leak from the dressing. Affected devices may not detect such blockages and won’t alarm even if the dressing has visibly lifted from the wound," according to the MHRA’s alert.
In an email to MassDevice.com, director of communication Susan Myers wrote that it’s unclear why the MHRA waited until this year to post an alert, noting that German and Irish regulators put up their own alerts "some time ago."
"There is nothing new in what MHRA has published; it is a formal re-presentation guiding users and customers to our original notification," Myers wrote. "Whilst the majority of our customers in the U.K. have responded to this [field safety notice], we are still working to increase the response rate. This may be why the MHRA has taken this step."
Smith & Nephew in June 2014 put a temporary halt on U.S. sales of Renasys to seek new premarket clearance, as requested by the FDA. Myers said the company is still seeking a nod from the safety watchdog to get Renasys back on the U.S. market.
"In the U.S. we continue to work collaboratively with the FDA to secure the necessary 501(k) clearances for Renasys. The EU FSN does not impact the regulatory clearance of Renasys in affected countries," she wrote.