Dear Doctor,
We would like to bring to your attention that on 24 February 2011, the U.S. Food and Drug Administration (FDA) issued an update on serious complications from the use of Negative Pressure Wound Therapy (NPWT) systems, and provided new recommendations on their use.
NPWT promotes healing in various types of open wounds by removing wound fluids and debris through the creation of a vacuum at a well-sealed wound site. It may also help with wound healing by drawing wound edges together. Though rare, complications especially infection and bleeding can occur wherever NPWT systems are used, including hospitals, long-term health care facilities, and at home.
According to the update, FDA has received a total of 12 deaths and 174 injury reports since 2007. Wound infection occurred in more than one third of cases, the majority of which were related to the retention of dressing pieces in the wounds. On the other hand, bleeding was the most serious complication and was reported in 9 deaths. Bleeding occurred in patients who had blood vessel grafts, wound infection, those receiving anticoagulant, and during removal of dressings attached to the tissues.
FDA recommends healthcare providers to select patients for NPWT carefully, after reviewing the most recent device labeling and instructions; and thorough consideration of contraindications for certain wound types and patient risk factors. Healthcare providers should also be vigilant for potentially life-threatening complications, such as bleeding, and be prepared to take prompt action if they occur. For more details of FDA's recommendations to healthcare providers, patients and their caregivers, please refer to the following links:
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm244211.htm#recommendations1
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm244211.htm#recommendations2
More information is also available on the FDA website:http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm244211.htm.
Thank you for your attention.
Yours faithfully,
(Rachel YUE)
for Director of Health
Medical Device Control Office, Department of Health, HKSAR Government