Negative Pressure Wound Devices Draw FDA Concern
FDA says it has received six death reports, 77 injury reports associated with NPWT devices.
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 help in the healing and closure of wounds, by creating negative pressure (a vacuum) at well-sealed wound sites that can help remove fluids and infectious materials, while drawing wound edges together.
In a notification to health professionals and advice for patients, the FDA alerted that serious complications, especially bleeding and infection, have been reported in some patients using NPWT devices.
Over the past two years, the FDA says it has received six death and 77 injury reports associated with NPWT devices. Most of the 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; or
- 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.
The FDA says it is addressing the problems and will continue monitoring adverse events associated with NPWT devices. In the meantime time, it released a number of recommendations specifically for patients using NPWT at home:
- 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, and how to recognize if the 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.
The FDA has set up a reporting system for providers and patients to report adverse NPWT reactions via its MedWatch Adverse Event Reporting program. Reports can be submitted online, by regular mail, fax or phone:
The full FDA Consumer Update article, can be read on the FDA’s consumer update site at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm193277.htm