What’s New in the Patient Safety World

 

December 2009

FDA Safety Alert on Negative Pressure Wound Therapy

 

Negative pressure wound therapy (aka “wound vac” or NPWT) has been being used much more frequently in recent years for managing a variety of wounds. There has always been considerable debate about the strength of evidence for its efficacy and the overall cost-effectiveness. All of us, however, have probably seen individual cases of difficult-to-heal wounds that dramatically improved after initiation of negative pressure therapy. But seldom in the debate about wound vac has there been much said about safety issues. Now the FDA has issued a preliminary safety alert about negative pressure wound therapy, based on reports of 6 deaths and 77 injuries reported over the past 2 years. Serious bleeding was the most serious complication. This was seen in patients with vascular grafts, sternal and groin wounds, and patients on anticoagulants. It was often noted during dressing removal where the dressings adhered to tissues. Multiple other reports dealt with infection related to retained dressing pieces.

 

They list several types of wounds for which NPWT is contraindicated including those with necrotic tissue with eschar present, untreated osteomyelitis, non-enteric and unexplored fistulas, malignancy in the wound, and those with exposed vasculature, nerves, organs or anastomotic sites.

 

They also go on to list risk factors that may predispose to these complications and make recommendations about ensuring that the patient and/or caregiver has been appropriately instructed on use of the system and how to recognize and address complications.

 

 

Reference:

 

FDA Preliminary Public Health Notification*: Serious Complications Associated with Negative Pressure Wound Therapy Systems

Date: November 13, 2009

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm190658.htm#table1

 

 

 

 

 

 


 


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