Has the physician ordered the device with appropriate settings and specifications (e. Has the patient and his/her caregivers been trained in how to monitor the device, device alarms and what to do and who to contact in case of problems or emergencies? 10. 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. 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. Have device indications, contraindications, precautions and warnings been taken into consideration? Have other treatment options been considered and offered? 3. With the complexity of use of the device, there is greater potential for user error.Since the 1990s, wound care took a substantial leap forward.C. The new device was first marketed in the US by KCI (San Antonio, TX) in 1995 as the V.g. Have the providers included appropriate documentation in the medical record? NPWT can be effective when used properly with the right patient. Conclusion 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: 1.A. pressure in mmHg; continuous vs. Bleeding and infection were the most serious complications. intermittent; frequency of dressing change)? 5. Therapy System.g. A number of other NPWT products (6 to date in North America) have been brought to market. entitled: Complex Wound Care with Negative Pressure Wound Therapy (NPWT): Adverse Events and Litigation by Diane Krasner.com For more information on this topic, join a Webinar from Med League Support Services, Inc.chronicwoundcarebook. Krasner PhD RN CWCN CWS MAPWCA FAAN dlkrasner@aol. Have the correct dressing materials been ordered and utilized (e. In the United States, NPWT is reimbursed by Medicare and Medicaid when ordered by a physician for qualifying wounds.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. Are the members of the interprofessional wound team properly trained in the use of NPWT? 4. There are over 300 peer-reviewed articles in the literature providing a growing evidence-base for the use of NPWT. Is appropriate and functioning equipment being utilized (e.com for further information, registration information, and references.MedLeague. Have appropriate arrangements been made for use of NPWT across the continuum of care (acute care, long term care, home care, outpatient)? 8. 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). 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 November 2009, the FDA issued a warning to healthcare professionals about NPWT entitled “FDA Preliminary Public Health Notification: Serious Complications Associated with Negative Pressure Wound Therapy Systems”. 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. Details are specified in the FDA Warning. pump, canisters, tubing)? 6. Most of the deaths occurred at home or in a long-term care facility. foam, silver foam, contact layers, gauze, drapes)? 7. 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. Diane L.A. cannabis packing Misuse may result in patient harm. Have arrangements been made for wound reevaluation to determine when NPWT can be discontinued? 9. It efficiently provided a means to apply negative pressure (sub-atmospheric pressure) via the V. Patients feel less pain when dressings are changed because NPWT devices make it less necessary to change dressings frequently. Go to www. Over the past 15 years, NPWT has gained widespread acceptance and use internationally.