Outpatient Surgery Magazine

OR Excellence Awards 2016 - September 2016 - Subscribe to Outpatient Surgery Magazine

Outpatient Surgery Magazine, providing current information on Surgical Services, Surgical Facility Administration, Outpatient Surgery News and Trends, OR Excellence and more.

Issue link: http://magazine.outpatientsurgery.net/i/726435

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Page 27 of 146

goes back to normal state and the product is not the product you test- ed. … That was a consensus amongst the engineers and scientists." MicroCool gowns today Is the problem fixed yet? It's hard to say. In testimony, K-C scientist Jascomb said the problems were fixed by late 2014 or early 2015. But Halyard Health declined to provide evidence to Outpatient Surgery that the gowns now meet the AAMI standards, citing ongoing litiga- tion. In January 2016, Halyard filed an adverse event report with FDA: "I was called to a room to speak to a resident involved in a trauma case. The resident reported to me that during surgical intervention, the patient's blood permeated the resident's surgical gown (AAMI 4 obtained from the multi trauma pack, from Kimberly-Clark) via the sleeves. The blood ran down her arms and entered her gloves." According to Halyard expert witness Dr. Rutala, whatever the per- formance of the gowns, no harm was done. He testified that there were "no instances in the peer-reviewed literature of gown failure resulting in transmission of a bloodborne pathogen … The risk of transmission of HIV, HBV and HCV as well as Ebola via a surgical gown is essentially zero even if there was some failure. … (That's because) the factors necessary for disease induction include: dose, a portal of entry, susceptibility of the host, virulence and a pathogen. The bloodborne pathogens have been demonstrated to be transmitted to HCP via percutaneous injury or mucosal exposure. … Healthy, intact skin does not allow viruses ... to get into the body." "There are no reports of infection due to a breach in barrier protection from any surgical gown," says Halyard's statement. Since the gowns were introduced, "we have sold over 65 million ... without a single complaint of injury due to barrier protection. MicroCool gowns continue to have an 2 8 • O U T PA T I E N T S U R G E R Y M A G A Z I N E • S E P T E M B E R 2 0 1 6

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