Deaths, injuries associated with Negative Pressure Wound Therapy

Staff and patient education critical to avoid complications

Six deaths and 77 injuries associated with the use of Negative Pressure Wound Therapy (NPWT) over the course of two years have prompted the U.S. Food and Drug Administration (FDA) to issue an alert to health care providers.

Bleeding was reported in the six deaths and in 17 of the injury reports. Other complications that resulted in injury included infection, and 32 reports indicated retention of foam dressing pieces that adhered to tissues or were embedded in the wound. Although injury reports came from hospitals, nursing homes, and home health agencies, the six deaths occurred in nursing homes or at home.

Although the alert did not change wound care protocol at Bayada Nurses in Towson, MD, an inservice program was given to all staff members, says Sue Grafton, RN, CWOCN, the wound care nursing specialist at the agency. "We provided up-to-date information on the use of negative pressure, and we reiterated the proper use of the device," she says. Even nurses with a lot of experience with NPWT benefit from updated inservices, she points out. When people become comfortable with a procedure or treatment, they can develop shortcuts or forget to pay close attention to details, she explains.

Staff members are reminded of contraindications for NPWT, says Grafton. "We don't want the patient to have a history of anticoagulation or to be on medications that prevent coagulation," she says. "We also don't want to use NPWT for a wound that may have cancerous cells in the margin," she adds.

Infection is also another concern, points out Grafton. "It is critical that no pieces of foam dressing or gauze be left in the wound after a dressing change," she points out. "We use contact layer dressings to prevent pieces of dressing adhering to the tissues," she adds.

A functional issue that eliminates a patient as a candidate for NPWT is the inability to manage the equipment, especially if there is no family or other in-home caregiver, says Grafton. "We need to know that there is someone who can help if the machine malfunctions at night," she adds. "We also do not recommend NPWT for patients at high risk for falls," she says.

Grafton educates nurses about NPWT at orientation and periodically through agency-wide inservices, but she also has small classes for nurses who were trained on the treatment modality but have not had a patient needing NPWT for a couple of months. "We'll have the nurses come in for a refresher course — just to make sure they can handle a patient who needs NPWT," she says.

At orientation, Grafton identifies nurses who have never administered NPWT, and in addition to the inservice, she goes on three home visits with NPWT with them. Even after the three visits, Grafton is available to help nurses who may have a case with which they are not comfortable. "If I'm not available to make the visit, our vendor provides someone to go with the nurse," she says.

In fact, the ability of vendors to act as back-up to the wound care specialist is an important feature to examine when evaluating vendors, suggests Sharon Burt, RN, CWOCN, director of wound, ostomy, and continence nursing at Physician's Home Health in Colorado Springs, CO. "Most home health agencies that have a certified wound, ostomy, and continence [nurse] on staff only have one," she says. This makes the availability of someone else, who can provide some teaching or additional consultation, critical, she adds.

Patient education ongoing

Although the information in the FDA alert was not "new" news to wound care specialists, Burt sees it as a chance to remind people that NPWT can have serious complications. "Even when a nurse is well-trained and experienced with NPWT, I don't believe that the potential for injury with this treatment is in the forefront of everyone's mind," she explains. "Not only is staff education important, but I also believe we need to improve patient education," she adds.

Patient education is always a focus of home health care, but there is a need to go in more depth when teaching patients and families about NPWT, says Burt. "We need to describe frank bleeding and how they should react," she says. If a patient or family caregiver sees blood, the machine should be turned off and the home health agency called, she says.

When teaching family and patients, don't assume that they will remember everything, warns Grafton. "We re-teach all aspects of NPWT at each dressing change," she says. "We keep the language simple, and we give patients a clearly written form that identifies signs of potential problems and tells them what to do," she adds.

Grafton has not had any patients ask about issues related to the FDA alert, but she says patients will question the need for NPWT if it is not suggested by the hospital or by physicians prior to admission to home health. "We have to explain the benefits of healing the wound more quickly and explain the process," she says.

At the same time, Grafton encourages her nurses to call physicians if they believe a patient for whom NPWT was ordered has one or more contraindications for the therapy. "Nurses must be empowered to evaluate the patient's ability to undergo treatment safely and to contact physicians if they see reasons to reconsider the treatment," she adds.

Although complaints about NPWT are not frequent, they typically relate to the device's interference with daily activities, says Grafton. "When a patient complains about the noises the machine makes, we can improve the seals or even cover the device," she says.

Complaints about the difficulty using a walker while carrying the machine required a little more creativity, Grafton says. "The complaints stopped after we found a way to create a little sling that hangs on the walker and holds the machine!"

SOURCES

For more information about Negative Pressure Wound Therapy, contact:

• Sharon Burt, RN, CWOCN, Director of Wound, Ostomy, and Continence Nursing, Physician's Home Health, 5085 List Drive, Suite 200, Colorado Springs, CO 80919. Phone: (719) 531-9585. E-mail: sharon.burt@gentiva.com.

• Sue Grafton, RN, CWOCN, Wound Care Nursing Specialist, Bayada Nurses, 1001 Cromwell Bridge Road, 3rd Floor, Suite 300, Towson, MD 21286. Telephone: (443) 509-4444. E-mail: ssajnacki@comcast.net.

Resources

To see a copy of the FDA alert, go to www.fda.gov, select "medical devices" on the left navigational bar, then choose "public health notifications" under the "safety, recalls and alerts" heading. Scroll down to "Serious Complications Associated with Negative Pressure Wound Therapy Systems" issued on November 13, 2009.