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OPERATING ROOM


suggests was potentially due to glove-gown channeling, not defec- tive product.


“Glove-gown channeling is a phenomenon that has been mistaken as strikethrough. Channeling can be observed in deep belly surgical cases, or trauma cases, where the surgeon may reach deep into the incision site and have significant exposure to bodily fluids around the glove-gown sleeve interface,” Lowery said. “Glove-gown channeling occurs when bodily fluids make their way between the surgical glove and gown sleeve as a result of a gap between the two. This causes fluid to get into the channel (ridges or folds) of gown sleeves, but the fluid does not pass through the fabric of the gown. Strikethrough, though, is when fluid passes directly through the gown, compromising the barrier. With MICROCOOL, reports of strikethrough are exceedingly rare with less than one complaint per million gowns sold.” In December, the FDA issued the final version of its guidance document, “Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings.”4


The docu-


ment is intended to clarify and describe the premarket regulatory requirements for gowns regulated under 21 CFR 878.4040 and the performance testing needed to support liquid barrier claims for gowns. Gown manufacturers claiming high level protection of its products will need to provide premarket clearance and proof/data that they do in fact live up to barrier protection claims per ASTM/ AAMI standards or an equivalent.


“Sample labeling should also be submitted; the provided label-


ing should clearly identify the level of liquid barrier protection claimed,” said Scientific Reviewer Lauren Lilly during an FDA Webinar earlier this year. “Prior to the existence of ANSI/AAMI


PB70, moderate or high barrier protection claims included, but were not limited to, wording such as prevents strikethrough; high fluid protection; impervious; fluid-proof; fluid-resistant; highest level of protection; and impermeable. Because of the lack of specificity with respect to performance characteristics and test methods, FDA now discourages the use of such language, and no longer clears products with such labeling claims. Instead, manufacturers are encouraged to specify the level of liquid barrier protection as per ANSI/AAMI PB70 on all labeling. Labeling should also include the directions for use, the indications for use and, if applicable, validated reprocessing instructions.”


Buford says the FDA’s guidance is a “great idea” and that manu- facturers should be held accountable for validating claims. “If a company can’t give you a satisfactory response, I’d suggest looking for a different product,” she said.


Gloves point in new directions Moving on to the glove front, the FDA announced another proposal earlier this year to ban most powdered gloves and absorbable lubri- cating powder because they can cause respiratory allergic reactions and other potentially serious adverse events, including severe air- way and wound inflammation and post-surgical adhesions. “These side effects have been attributed to the use of glove powder with all types of gloves,” stated the FDA in a March 21 press release. Edmund S. Tai, Assistant Vice President, Tronex Healthcare, says


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the powder debate has been going on for more than 20 years and that most recently the focus has been not only on powder but the quality of powder used. “There have been a number of incidents within the healthcare industry where the use of inferior-quality powder by manufacturers has been brought into focus with liability cases,” Tai said. “While Tronex Healthcare utilizes only highly regulated powder by featuring U.S. Pharmacopeia (USP) grade cornstarch, there are others in the industry who have not upheld such high quality standards. In the early stages of disposable glove manu- facturing, powder eased the effectiveness of donning, so gloves would not break from the force used to quickly don them, especially with damp hands. Tronex was at the forefront of the industry’s product advances in subsequent years, develop- ing highly evolved material formulations and implementing new manufacturing technologies, both of which ultimately led to powder-free exam glove options.” Tronex powder-free exam gloves come in a variety of styles and material blends and innovative finishing processes that mimic powder and make donning easy. Tai says the #3166 Series Latex Powder-Free, Fully Textured Exam Gloves are crafted from an innovative natural rubber latex material formulation for superior elasticity and barrier protection and feature a smooth interior polymer coating to ease wet and dry donning. Its NEW AGE Powder-Free Exam Glove has a unique stretch-vinyl compound that provides material memory for a superior fit, stretch, and high tensile strength. Tai says these products also deliver a favorable performance-to-price ratio. “With all of the advancements in exam glove materials and technologies available today, there are a wide range of excellent powder-free alternatives available for this small percentage of users to transition to in eliminating powdered exam gloves entirely.”


NEW AGE Powder-Free Synthetic Examination Gloves by Tronex Healthcare


Todd Karas, Senior Product Manager, Surgical Gloves, Cardinal


Health, says its glove customers started transitioning from powder more than a year ago and that glove selection is influenced primar- ily by industry recommendations and wearer habits. “Some clini-


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