Monday, November 30, 2009

FDA warning on negative pressure wound therapy

Negative pressure (wound vac) therapy was heavily promoted when the technology came out several years ago. It's easy to use and has become very popular. Now we have this warning from the FDA (via Medscape):

Negative pressure wound therapy (NPWT) systems have been associated with 6 deaths and 77 serious complications during the past 2 years, the US Food and Drug Administration (FDA) has announced.

...The FDA points out that NPWT systems are contraindicated for certain wound types (necrotic tissue with eschar present; untreated osteomyelitis; nonenteric and unexplored fistulas; malignancy in the wound; and wounds with exposed vasculature, nerves, anastomotic site, or organs). Several patient risk factors, including being at high risk for bleeding, should be considered before using NPWT.

My guess (and it's only a guess) is that, given the promotion, convenience and ease of use, these devices have been widely employed without proper expertise or attention to evidence.


N. Patel said...

Glad to see the uselessness and harm of vacuum therapy is finally being recognized. Its much easier to put a machine to work then to pay someone to do wound debridement.

Anonymous said...

Negative Pressure wound therapy is not a recognised method of wound debridement. Infact negative pressure wound therapy is contra-indicated in wounds which are necrotic or have any eschar present.
With regards to the FDA warning - were the results based on using foam as an interface or gauze.
Recent independant research, Borgquist et al, 2009, highlights the benefits of using gauze as opposed to foam.

Anonymous said...

A recent article by Kairinos et al, demonstrated that vacuum therapy reduces perfusion, which makes one wonder how often tissue necrosis has been caused by the device, particularly when used in the trauma situation. The physician's response to these situations is likely to be, "Oh well, the vacuum therapy didnt manage to salvage these tissues." With this new information we realise that it may actually have been the cause.