[January 09, 2013]

GAO Sustains Protest by Bidder Offering US Medical Innovations, LLC's Product Against Federal Purchase of ERBE Product

On December 13, 2012, the U.S. Government Accountability Office (GAO) issued a decision in favor of a reseller of US Medical Innovations, LLC's products, Veterans Healthcare Supply Solutions, Inc. (VHSS). The GAO sustained VHSS's protest against the award by the Department of Veterans Affairs (VA) of a contract to Metro Medical Equipment & Supply Inc. (Metro), which offered to the VA products manufactured by ERBE Elektromedizin GmbH (Tuebingen, Germany).

The GAO's decision (File B-407223.2) states that the VA "unreasonably evaluated the protester's bid of an equal product under a brand name or equal solicitation conducted under simplified acquisition procedures where the solicitation lacked salient characteristics and the equal product [USMI SS-601MCa/Canady lasma® Argon 4 Coagulator] was not shown to be significantly different from the brand name [ERBE VIO 300D/APC (News - Alert) 2]."

The GAO decision states, "In short, in its written materials and in testimony presented at the hearing, the VA has not shown that VHSS's proposed USMI electrosurgical unit was significantly different from the brand name ERBE unit." The GAO recommends that the VA reevaluate the units, and conduct a new source selection or resolicit using a solicitation that identifies the characteristics in the brand name product that the VA views as salient characteristics, and evaluate the units against those requirements. The GAO also recommends that VHSS "be reimbursed the costs of filing and pursuing this protest, including reasonable attorney fees."

Commenting on the decision, Chief Executive Officer of USMI, Jerome Canady, M.D., said, "We are pleased to see that the GAO noted in its decision that the ERBE brand name product was designated a predicate device for the USMI model SS-601MCa offered by VHSS in the FDA's [Food and Drug Administration] determination that USMI's electrosurgical unit SS-601MCa/Argon 4 Coagulator is substantially equivalent to ERBE's VIO 300D/APC 2." GAO's decision is consistent with FDA 510(k) premarket notification that USMI's Canady Plasma® Electrosurgical Unit Series (#K10069) is equivalent in intended use, technological characteristics, and performance characteristics to ERBE VIO 300D, ERBE ICC 200 and ERBE VIO APC2.

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