FDA updates alert concerning negative pressure wound therapy

The FDA recently released an update to a November 2009 Preliminary Public Health Notification and Advice for Patients on serious, but rare, complications, including bleeding and infection, from the use of negative pressure wound therapy systems.

The agency also provided the latest results of its research into negative pressure wound therapy (NPWT) since its preliminary alert in late 2009.

“The FDA is issuing this update to inform you about its activities to date involving NPWT, as well as to provide new recommendations and information about pediatric use. In addition, this communication provides a summary of additional reports received by the FDA since issuing the Preliminary Public Health Notification and Advice for Patients,” FDA officials wrote in the latest notification.

Since its previous preliminary warning, FDA has received reports of six additional deaths and 97 more injuries associated with NWPT treatment. Three of the deaths were in individuals who were treated in-home with NWPT. According to the notification, 12 deaths and 174 injuries have been reported with these systems since the FDA’s investigation began in 2007.

A preliminary alert by the FDA issued on Nov. 13, 2009, reported six deaths and 77 injuries associated with NPWT systems.

In the new report, agency officials said more than half of the new injuries were infected, and many of those treatments occurred in the home-health setting or a long-term care setting. Bleeding occurred in 12 patients, which included three of the additional deaths.

FDA also stated its position on pediatric use of NWPT treatment: “The safety and effectiveness of NPWT systems in newborns, infants and children has not been established at this time and, currently, there are no NPWT systems cleared for use in these populations.”

The FDA will continue to monitor adverse events associated with NPWT systems and report new information on their use or related complications. Physicians, other users and patients should use the MedWatch system to report any adverse events with the use of NPWT systems.

References:
www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm244211.htm
www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm190658.htm

Editor’s note: This is a corrected version of the original article that ran on March 1, 2011.

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