Documentation


Clearly, MDT holds the promise of spared limbs and healed wounds. Documentation will demonstrate its value. A body of science is now being accumulated and evaluated.

Like most "new" treatments, there is much yet to be learned. Thorough documentation will be key to developing best practices. Every patient, current and future, will benefit from your accurate documentation.

Documentation should include the following:
1. Consent and photographic release forms
2. Skin ulcer flow sheet
3. Dressing change flow sheet
4. Wound measurement flow sheet
5. Multidisciplinary care plan
6. Nursing flow sheet
7. Patient and family teaching form
8. Discharge teaching form

The FDA granted medical device status to Medical Maggots™. Medical device status brings with it responsibilities for both the manufacturer and the user. Those responsibilities include the mandatory reporting of device-related deaths, serious injuries and reportable malfunctions. The quality of your documentation will necessarily affect the accuracy of your facility's mandatory reporting.

"The mandatory MedWatch Form 3500A is to be used by both user facilities and medical device manufacturers for the reporting of device-related deaths, serious injuries and reportable malfunctions required under the December 11, 1995 MDR regulation."

Additionally, medical personnel have the ethical responsibility to report adverse events, product use errors and product quality problems associated with: drugs, biologics, medical devices and nutritional products.

Healthcare professionals can get information regarding the voluntary reporting of serious adverse events, potential and actual product use errors, and product quality problems by visiting the U.S. Food and Drug Administration web site. https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm


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