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Why is Litigation Related to Negative Pressure

by:Huawei     2020-09-02
Since the 1990s, wound care took a substantial leap forward. The new device was first marketed in the US by KCI (San Antonio, TX) in 1995 as the V.A.C. Therapy System. It efficiently provided a to be able to apply negative pressure (sub-atmospheric pressure) via the Vs.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 inside of wound.
Over the past 15 years, NPWT has gained widespread acceptance and use internationally. An involving other NPWT products (6 to date in North America) have been shipped to market. NPWT devices improve wound healing through an associated with different mechanisms: by improving local blood flow (perfusion, reducing swelling, removing drainage because of 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, gadget has been demonstrated to be cost-effective, in spite of the associated with supplies and pump rental costs. Inside of United States, NPWT is reimbursed by Medicare and Medicaid when ordered through physician for qualifying wounds. There may be more than 300 peer-reviewed articles in the literature providing a growing evidence-base for using of NPWT.
Litigation on the rise
Why is litigation associated with NPWT from the rise? The increased frequency of associated with NPWT for complex and difficult wound management, the possibility of adverse events is increased. Additionally, because NPWT devices have very specific and somewhat complicated guidelines for use, there is often a steep learning curve (as opposed to simpler wound dressings). With the complexity of use of the device, there is greater prospect of user failing.
In November 2009, the FDA issued a warning to medical professionals about NPWT entitled 'FDA Preliminary Public Health Notification: Serious Complications Associated with Negative Pressure Wound Therapy Systems'. The FDA document noted that 6 deaths and 77 injuries related to NPWT systems have been reported to the agency on the past 24 months. Most of the deaths occurred at home or in a long-term care facility. Bleeding and infection were the most serious health problems. 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. Information is specified globe FDA Video clip.
Wound care clinicians who use NPWT and legal professionals who review NPWT cases focus close to same standard of care issues when it comes to NPWT:
1. Will be the use of NPWT right for the patient and the patient's wound at this aspect in times?
2. Have device indications, contraindications, precautions and warnings been considered? Have other treatment options been considered and offered?
3. Are the members of the interprofessional wound team a master in the actual usage of of NPWT?
4. Has the physician ordered the device with appropriate settings and specifications (e.g. pressure in mmHg; continuous vs. intermittent; frequency of dressing change)?
5. Is suitable and functioning equipment being utilized (e.g. pump, canisters, tubing)?
6. Offer the correct dressing materials been ordered and utilized (e.g. foam, silver foam, contact layers, gauze, drapes)?
7. Have appropriate arrangements been made for use of NPWT inside the continuum of care (acute care, life time care, home care, outpatient)?
8. Have arrangements been turned for wound reevaluation come across when NPWT can be discontinued?
9. Offers the patient and his/her caregivers been trained in how to be able to the device, device alarms and in order to do and who to contact in case of problems or emergencies?
10. Hold the providers included appropriate documentation in the medical documentation?
NPWT could be effective when used properly with the best patient. Misuse may result in patient harm.
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