U.K. Issues Medical Device Alert for Smith & Nephew's Renasys Wound Care Device

The UK's Medicines & Healthcare products Regulatory Agency issued a medical device alert for Smith & Nephew’s Renasys negative-pressure wound therapy device, following a field safety notice the London-based company issued in October.

The Jan. 21 alert cautions that use of the device can result in maceration, infection, loss of negative pressure or unrecognized bleeding in wounds if there is a blockage in the vacuum system of the device. The alert reiterates S&N’s request that customers discard older consumables used with the device.

According to the alert, if a blockage in the system isn't recognized, fluid from the wound can build up and leak from the dressing. Affected devices won’t detect these blockages, even if the dressing has visibly lifted from the wound, the MHRA says.

Renasys hasn’t been available in the U.S. since June 2014. The FDA told Smith & Nephew to seek new premarket clearance before the device can be sold again.

View the MHRA alert at www.fdanews.com//01-28-15-SNMedDeviceAlert.pdf. — Kellen Owings