Negative Pressure Wound Therapy Problems Linked to Deaths, Injuries
Published: November 17th, 2009 • Comments: 2
The FDA issued a MedWatch safety alert on Monday, warning healthcare providers about potential problems with Negative Pressure Wound Therapy (NPWT) systems, which have caused a number of people to bleed to death or suffer other severe injuries.
Negative Pressure Wound Therapy involves the application of negative pressure on a wound and maintaining a vacuum around it. This is done to extract fluids and infectious materials from the wound, and to cause it to dry out, or desiccate. Negative Pressure Wound Therapy is most commonly used with burns, flaps, ulcers and grafts, but it is contraindicated for several types of injuries, including wounds where there are exposed nerves, organs and vasculature.
The Preliminary Public Health Notification issued by the FDA indicates that healthcare professionals should carefully select which patients undergo Negative Pressure Wound Therapy, and warns them to closely monitor all patients, as many are sent home with the kits. The FDA has received reports of at least six deaths and 77 injuries associated with the Negative Pressure Wound Therapy systems over the past two years.
In all six deaths, and 17 of the injuries, the patients experienced severe bleeding. In other cases, the Negative Pressure Wound Therapy problems involved serious infection caused by the original wound or due to pieces of dressing or foam in the wound. Although many patients are sent home with Negative Pressure Wound Therapy kits, the FDA found these problems occurred just as commonly in hospitals and nursing homes.
The FDA warned health care professionals to take special care in determining which patients to give NPWT kits to use at home, and recommended that they take special care in making sure that patients or caregivers know how to use the systems, how to recognize potential problems, and what to do in case there is a complication.
The FDA also provided advice for patients using the Negative Pressure Wound Therapy at home. According to the FDA, patients should:
- Receive adequate training from your doctor, nurse, or home healthcare provider so that you understand how to use your NPWT device. Demonstrate to your trainer how to use NPWT to make sure you are doing it properly.
- Understand the possible complications that may be associated with using your NPWT device. Watch especially for bleeding, which can be life-threatening. If you see signs of bleeding, seek medical assistance immediately.
- Get NPWT patient instructions (labeling) from your doctor, home healthcare provider, NPWT distributor, or the manufacturer’s website. Keep these instructions where you can easily find them.
- Talk to your doctor if you do not feel capable of managing the NPWT device at home. He or she might recommend that you have help from an appropriate caregiver.
The FDA is continuing to review the safety of Negative Pressure Wound Therapy systems and is monitoring for more adverse events. The agency proposed no action, but said that it will make any new information available that might affect the use of such systems.
Image courtesy of Noles1984/Wikipedia from Public Domain. KCI Anti V.A.C. pump used to create negative pressure and used in conjunction with a variety of KCI dressings.
Comment by wanda on 27 January 2010:
I had Tram Flap surgery in 5/08. The incision dehissed 10 days after surgery. I was hopsitalized for 7 days 7/08 because of severity of the wound. I commenced home nursing care and regular weekly visits to the hospital wound care center for several months. There was a decision by the attending physician to have me use the KCI Wound Vac in fall of “09. I had constant problems with the Vac. Two weeks after Vac therapy commenced I developed “Tunneling” in many areas of my torso. The Vac was continued for more than a month more at which time I hemmoraged at home. The home nurse saw me. I also visited the hospital and was treated but recieved no answer as to why all of this was happening to me. The Vac was discontinued. I continued as a patient at the Wound Care Center for several more months. This was an impersonal experience. I was seen for five minutes every Monday morning by the same physician. Some time after the Vac had been discontinued the same attending physician was wondering out loud what to do next regarding my treatment, he turned to the nurse and asked “Why haven’t we used the Vac.” She never answered him. She gave him “a look.” I realized I needed to find treatment elsewhere. The home nurse was still visiting every day. I had a huge dehissed wound, and three or four draining holes in my torso. I visited the oncologist who was my breast surgeon, and he was aghast. He called a plastic surgeon who saw me immediately. Over the next six months this surgeon hospitalized me four times for procedures he explaied were to dibreed the “tunnels”. This was done under general anesthesia. There were, additionaly , many office proceedures to dig in the open wounds. Generally speaking the pain was severe and debilitating. I was bedridden. The home nurse visited every day. The new doctor performed a skin graft over the dehissed wound. Slowly it began to heal, but the “tunnels” persisted and worsened. On one occasion I was home alone when a huge solid blob, “spit ” from one of the holes in my torso. I immediately visited the doctor. In his office he used an instrument to pull a wad of something solid from that hole. I asked what it was, and he said it was sutures. I knew that the Wound Vac that had caused me great pain, and a hemmorage, and now considered that perhaps it had pulled the sutures used in my Tram Flap apart, caused infection and the tunneling, that had now resulted in nearly a year of great pain, confinement to bed, and daily nurse visits. This was and remains conjecture on my part, since I am not a physician, and have never received any explanaition from a physician.The doctor scheduled yet another general surgery for me to be done on June 24, 2009. But at my pre-op visit he abruptly announced he was cancelling the procedure – he did not think it would help. He told me that I should come back in a month. Up until that pre-op visit, I had been seeing him weekly. I stii had open, draining wounds on my torso, anfd felt ill every day. I was bewildered. I called a general surgeon for whom I had great respect, but had not thought of involving in what was happening to me. He saw me immediately, and in October of “09 he operated to try to retrieve the sutures that were causing infection, pain, malaise, and the inablilty for me to conduct my life. I had in October ‘09 been “ILL” and housebound for a year and a half. I began to heal. On January 21, 2010, I read your article that said the FDA has issued a Med Watch safety alert about Negative Pressure Wound Therapy. I would lkie to discuss what has happened to me with an interested and knowledgeable attorney. I currently have no open wounds, and I have resumed my life, but I am permanetly disfigured, I have a huge hernia that was caused by months of probing in one of the larger holes, and I have sutures that are surfacing and getting ready to “spit”. Additionally, I am numb from my pevlvic area to my ribs, and try to tolerate a 24/7 feeling of having a huge, much too tight girdle on me, that I constantly feel the urgency to remove.
Comment by MICHAEL on 8 February 2010:
im T-5 Paraplegic..I also developed tunnel after wound vac was used ..its been 2yrs now im still working on healing the wound…i have not went back to my wound clinic as after i questioned the staff at the clinic about this tunnel appearing after the vac was applied they discharged me stating they felt like i was not getting proper treatment…