FDA

WoundSource Practice Accelerator's picture
 Evidence-Based Product for Diabetic Foot Ulcer Management

By the WoundSource Editors

When determining the course of action for treating a given wound, it is important that wound care clinicians evaluate how advanced wound care therapies have been deemed evidence based and how the specific product technology works. Evidence-based advanced wound care products are required to be safe and effective based on epidemiology, etiology, and pathophysiology. However, safety and efficiency are not a 100% guarantee of effectiveness in clinical practice.

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WoundSource Practice Accelerator's picture
Advanced Therapies for Diabetic Foot Ulcers

By the WoundSource Editors

Advanced wound care technologies have come a long way in treating chronic wounds. However, diabetic foot ulcers (DFUs) can be challenging, and not every patient should have identical treatment. Utilizing a patient-centered approach is necessary for selecting appropriate treatments and achieving best possible outcomes. Understanding the specific patient’s needs and understanding the pathophysiology of diabetic wound chronicity are key elements in DFU management. The primary goal should be wound closure, while also preventing recurrence. To achieve both goals, clinicians must incorporate ongoing education and clinical support. Health care professionals should keep up on latest evidence-based research and practices to select the best advanced treatment for each patient.

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Industry News's picture

By the WoundSource Editors

Silver Spring – September 6th, 2017 – The final guidance, Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271," explains when it is necessary for manufacturers of certain human cells, tissues, and cellular and tissue-based products (HCT/Ps), which do not require FDA premarket review and approval, to report to the agency when infectious disease testing or determination of other donor eligibility criteria have not been performed properly. While this is not a new requirement, the final guidance seeks to provide greater clarity to industry on how to properly follow the regulations already in effect. Specifically, the FDA is issuing this guidance to provide establishments that manufacture non-reproductive HCT/Ps with specific recommendations and relevant examples for complying with the applicable requirements to investigate and report HCT/P deviations to the FDA.

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Janet Wolfson's picture
evaluating medical information resources

By Janet Wolfson, PT, CLWT, CWS, CLT-LANA

It is hard to read a newspaper (my preferred news source) or an online news site without discovering false information. I recently read an NPR article about how to vet news yourself and how to recognize this.1 The vulnerability I felt made me think about protecting my decisions from this reporting and even more, how I can help my patients weed out fake reports.

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Cheryl Carver's picture
off label drug prescription

By Cheryl Carver, LPN, WCC, CWCA, FACCWS, DAPWCA, CLTC

Providers may view off label drug use (OLDU) for wounds as the "new wave". However, if there is little or no scientific evidence supporting the practice, it can possibly lead to more problems than good. Keep in mind that not every health care setting embraces off label drug use. For example, state surveyors view OLDU differently in long-term care versus home care. Providers should avoid any risk of being involved in a pressure injury investigation. OLDU may be considered a factor in the event of such an investigation. Hospice patients are considered to be in more of a "dying with dignity" category, therefore OLDU may be considered more acceptable.

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Aletha Tippett MD's picture
medicinal leeches

By Aletha Tippett MD

I have written about biotherapy in the past, primarily about maggot therapy, but today I would like to discuss leech therapy. In the U.S., leeches are used frequently by plastic surgeons to save a surgical flap that is in danger of dying. Leeches in the U.S. are provided by Leeches USA and they keep leeches ready at the New York airport to ship out in an emergency 24/7. The leeches used actually come from France and are FDA approved. Monarch Labs in the U.S. is working to develop a U.S. leech, but has a ways to go to get FDA approval.

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Michel Hermans's picture

By Michel H.E. Hermans, MD

We, the wound care community, are doing it wrong! We are using FDA approved, expensive diagnostics and treatments while the solution for your diabetic foot ulcers, pressure ulcers, full-thickness burns and keloid scars are on the web and cost peanuts in comparison to a visit to your doctor.

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