Author Solutions, Indie book publishing, iuniverse, self publishing, writing

iUniverse self-published book leads FDA to change law

Not every book has to be a bestseller to be successful. Take the self-published book Deadly Powder on Medical Gloves; A Wake-Up Call to the Food and Drug Administration. It is not a title you will likely see appear on the New York Time bestseller list, but this book has helped change a long-standing law in our land and eliminate a potential health risk to many.

The book, written by  Richard F. Edlich MD. PHD (with Julie A. GarrisDeadly Powderon BS and Heather N. Smith), and self published through iUniverse, draws attention to an important health care matter. In the words of the authors:

 “When medical/surgical gloves were devised, the manufacturer had to provide a powder on the glove surface that enhanced the donning the glove before use.  During the last decade, a wide variety of glove coating surfaces have been developed to eliminate the need of the deadly powder on glove surfaces.  Scientific studies have documented that the deadly powder on gloves increases wound infection, causes adhesions that can compress the bowels, and spreads tumor cells throughout the cavity.  Our book was written to convince all health care professionals to use only powder free gloves. 

After publishing, the authors sent multiple copies of the book to the FDA, along with a petition to have them ban the corn starch powder from all medical and surgical gloves.  On July 3, 2013, they received the following attachment by email from the FDA confirming they were going to ban the powder from all gloves sometime during the next 18 months. 

Extract of the FDA Ruling

 “Title: ●Proposal to Ban Powdered Natural Rubber Latex and Powdered Synthetic Latex Surgeon’s and Patient Examination Gloves 

Abstract: FDA has determined that a subset of surgeon and patient exam gloves that are powdered and that represent a modest share of the market present a substantial risk of illness that cannot be corrected by a change in labeling. These gloves are Powdered Natural Rubber Latex Surgeon’s Gloves, Powdered Synthetic Latex Surgeon’s Gloves, Powdered Natural Rubber Latex Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove.

“Consequently, FDA is proposing to ban these devices”.

One of the great things about self publishing is it allows voices who otherwise might not be heard to have a platform. That means there is opportunity to impact people in ways that otherwise would not be possible.  This book is a great example of what can happen when you pursue the goal of publishing.  Congratulations Dr. Erlich for showing us what is possible if you believe in your work.

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