Why is Litigation related to Negative Pressure Wound Therapy (NPWT) on the Rise?
Posted Nov 03 2010 12:00am
Since the 1990s, wound care took a substantial leap forward. The new device was first marketed in the US by (San Antonio, TX) in 1995 as the V.A.C. Therapy System. It efficiently provided a means to apply negative pressure (sub-atmospheric pressure) via the V.A.C. pump ranging from 50 to 200 mmHg to the wound beds of both acute and chronic wounds (wounds, burns ulcers, flaps and grafts) – thereby promoting wound healing. NPWT is contraindicated in the presence of exposed anastomotic sites, exposed vasculature, exposed nerves, exposed organs, necrotic tissue with eschar present, untreated osteomyelitis, non-enteric and unexplored fistulas, and malignancy in the wound.
Over the past 15 years, NPWT has gained widespread acceptance and use internationally. A number of other NPWT products (6 to date in North America) have been brought to market. NPWT devices improve wound healing through a number of different mechanisms: by improving local blood flow (perfusion, reducing swelling, removing drainage from the wound, and by stimulating scar tissue formation. Patients feel less pain when dressings are changed because NPWT devices make it less necessary to change dressings frequently. By reducing the frequency of dressing changes, the device has been demonstrated to be cost-effective, in spite of the cost of supplies and pump rental costs. In the United States, NPWT is reimbursed by Medicare and Medicaid when ordered by a physician for qualifying wounds. There are over 300 peer-reviewed articles in the literature providing a growing evidence-base for the use of NPWT.
Litigation on the Rise
Why is litigation related to NPWT on the rise? With an increased frequency of use of NPWT for complex and difficult wound management, the chance of adverse events is increased. Additionally, because NPWT devices have very specific and somewhat complicated guidelines for use, there is a steep learning curve (as opposed to simpler wound dressings). With the complexity of use of the device, there is greater potential for user error.
In November 2009, the issued a warning to healthcare professionals about NPWT entitled “FDA Preliminary Public Health Notification: Serious Complications Associated with Systems”. The FDA document noted that 6 deaths and 77 injuries associated with NPWT systems have been reported to the agency over the past 2 years. Most of the deaths occurred at home or in a long-term care facility. Bleeding and infection were the most serious complications. Healthcare providers should carefully recommend selective patients for NPWT, knowing that NPWT systems are contraindicated for certain wound types, and thoroughly consider patient risk factors before using NPWT. Details are specified in the FDA Warning.
Wound care clinicians who use NPWT and legal professionals who review NPWT cases focus on the same standard of care issues when it comes to NPWT:
NPWT can be effective when used properly with the right patient. Misuse may result in patient harm.
Diane L. Krasner PhD RN CWCN CWS MAPWCA FAAN
For more information on this topic, join a Webinar from Med League Support Services, Inc. entitled: Complex Wound Care with Negative Pressure Wound Therapy (NPWT): Adverse Events and Litigation by Diane Krasner.