The British Medicines and Healthcare Products Regulatory Agency (MHRA) has announced the recall of Smith & Nephew Renasys negative pressure wound care devices because of the risk of maceration, infection, loss of negative pressure, or unrecognized bleeding in wounds if there is a blockage in the vacuum system of the affected devices.
A negative pressure wound therapy (NPWT) device is an electric pump system that applies a vacuum to chronic, deep cavity wounds. The systems use disposable components such as foam or gauze dressings and tubing. If a blockage in the system is not detected, fluid from the wound can build up and leak from the dressing, according to the MHRA. The affected devices may not detect blockages and the alarm will not sound even if the dressing has visibly lifted from the wound.
The affected devices are the Renasys Go, Renasys EZ, Renasys EZ Plus, and Renasys EZ Max.
The MHRA alert is addressed to anyone who uses or handles the devices, including hospital and nursing home staff and those who care for patients at home. Smith & Nephew advises users to be aware of the amended instructions for use of the devices, including the importance of checking the wound frequently and checking the device to be sure it is working properly. The MHRA advises users to contact a local Smith & Nephew representative to arrange for a replacement.