Negative Pressure Wound Devices Draw FDA Notice, Advice

Negative Pressure Wound Devices Draw FDA Notice, Advice

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Reports of Injuries, Deaths
FDA Recommendations
The Food and Drug Administration (FDA) has notified health professionals, and advised patients, about rare but serious complications—including deaths—from the use of negative pressure wound therapy (NPWT).

Negative pressure wound therapy devices can help in the healing and closure of wounds. They create negative pressure (a vacuum) at well-sealed wound sites that can help remove fluids and infectious materials and draws wound edges together.

FDA issued a notification to health professionals and advice for patients regarding the complications with NPWT on Nov. 13, 2009.

In the notifications, the agency alerted the public and health professionals that serious complications, especially bleeding and infection, have been reported in some patients using NPWT devices. These complications can occur wherever NPWT is used, including hospitals, long-term care facilities, and at home.



Reports of Injuries, Deaths
Over the past two years, FDA has received six death and 77 injury reports associated with NPWT devices. Most deaths occurred at home or in long-term care facilities. Bleeding was the most serious complication, occurring in all six deaths and in 17 of the injuries.

According to these reports, extensive bleeding has occurred in patients


with blood vessel grafts in the leg
with breastbone or groin wounds
receiving medication for blood clots
during removal of dressings attached to the tissues
The reports also included cases of infections from original open infected wounds worsening due to pieces of dressing that remained in the wound, and of injury from foam dressing pieces and foam sticking to tissues or clinging to wounds. Most of these patients required surgery, additional hospitalization, and antibiotics.

FDA is addressing these problems and will continue monitoring adverse events associated with NPWT devices.



FDA Recommendations
The reports of the adverse events led FDA to issue recommendations for patients using negative pressure wound therapy. If it is determined that you are a candidate for using NPWT at home, you should do the following:

Receive adequate training from a health professional (for example, your doctor, a nurse, or a home health care provider) so that you understand how to use your NPWT device. Demonstrate to your trainer that you know how to use the device properly.
Find out how long you should expect to use the device.
Understand the possible complications that may be associated with using the device. Know the warning signs so you can recognize complications early. Watch especially for bleeding, which can be life-threatening. If you see signs of bleeding, seek medical assistance immediately.
Before using NPWT at home, ask your health professional what to do if complications do occur. Find out
who to contact
how to recognize bleeding and serious infection
how to recognize if your wound condition is worsening
Get NPWT patient instructions (labeling) from your doctor, home health care provider, NPWT distributor, or the manufacturer’s Web site. Keep these instructions where you can easily find them.
Let your health professional know if you do not feel capable of managing the NPWT device at home. He or she might recommend that you be assisted by an appropriate caregiver.
Ask your health professional whether you need to stop taking aspirin or any other medications that affect bleeding or blood clotting, and what the associated risk is of stopping or avoiding such medicines.
Health professionals and consumers may report adverse reactions related to negative pressure wound therapy to FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.

Online
Regular Mail: Use FDA postage paid form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 800-FDA-0178
Phone: 800-FDA-1088
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Date Posted: Dec. 10, 2009

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Negative Pressure Wound Devices Draw FDA Notice, Advice