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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

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