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FDA Approves Expanded Use of Sharpx®Atlanta, Ga. July 31, 2002-In a letter issued June 12, 2002, BioMed has received approval for a PMA supplement, expanding Sharpx's ® "safer medical device" status to include 18-30 gauge syringes. This ruling expands potential use in the healthcare workplace, safely reducing needlestick risk, reducing cost, and acting in accordance with OSHA's Guidelines. BioMed's products and devices are designed to deliver complete and comprehensive solutions for health providers seeking compliance with the Federal Needlestick Safety Prevention Act of April 18, 2001. As recorded in the Congressional Record, October 26, 2000, "OSHA has long required employers to protect employees from bloodborne pathogens through the use of engineering controls which include sharps disposal devices such as sharps destruction devices?OSHA has allowed and intends to continue to allow employers to use sharps destruction devices to help reduce needlestick injuries." (Charles Jefferies, Assistant Secretary, OSHA.) As indicated in the Congressional Record Joint Statement of Legislative Intent on HR5178, "It is not the intent of this legislation to disturb OSHA's existing determination that?. specific types of devices, such as catheter securement devices or sharps destruction devices can reduce the incidence of needlestick injuries." The FDA has previously approved the Sharpx® NDD, allowing the claim, proven though extensive testing, that Sharpx® reduces the incidence of needlestick injuries, eliminating downstream needlesticks and promoting a safer medical workplace. In doing so Sharpx® has been approved as effective by the FDA, unlike other devices that have been merely cleared for use. BioMed CEO Michael W. Smith calls these changes very significant, stating "this decision broadens our range of application, making the Sharpx® NDD uniquely qualified as a safer medical device." He noted "our corporate goal continues to be the development of safer medical devices and systems for the medical workplace."
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