Negative Pressure Wound Therapy: Use with care
MedSun: Newsletter #53, October 2010

FDA Medical Device Safety

New device and dressing features have been added that make Negative Pressure Wound Therapy (NPWT) safer, more efficient, and more user-friendly in care settings other than hospitals, such as in long-term care facilities, rehab centers, and even patients' homes. Although many patients have benefited from NPWT, adverse events – including deaths and serious injuries - have been reported to the FDA. Precautions healthcare professionals can take when using these devices are discussed.

Additional Information:

FDA Medical Device Safety. Negative pressure wound therapy: Use with care. September 2010.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm225038.htm

FDA Patient Safety News (video). Serious Complications with Negative Pressure Wound Therapy. January 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=94#2

FDA MedWatch Safety Alert. Negative Pressure Wound Therapy (NPWT) systems - Preliminary Public Health Notification. November 16, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190704.htm

Advice for Patients: Serious Complications with Negative Pressure Wound Therapy Devices. November 16, 2009.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm190476.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun