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FDA Approval for the Sharpx®
The Sharpx® NDU uses a rechargeable 7.2-volt NiCad battery to deliver a current between two electrodes, incinerating the needle and capturing the debris in a replaceable aluminum-lined drawer. Needle debris is emptied by the operator into a sharps disposal container. Weighing only two pounds and constructed of high-impact, lightweight molded plastic, Sharpx® is equipped with the Sharpx® battery charger and 12 aluminum drawer liners, or debris drawers. The NiCad battery can be recharged within 45 to 90 minutes. With its ergonomic design, the Sharpx® NDU is easy to use and offers the newest practical method of needle disposal in the health care industry. This portable device can reduce the risk of needlestick injury by rapidly destroying sharps at the point of needle use. The company is currently accepting orders for Sharpx® with shipments beginning sometime in the last quarter of this year. The Sharpx® NDU will be leased to health care organizations in an effort to reduce industry capital expenditures. In concert with the introduction of the Sharpx® NDU, BDI will offer a Technology Integration Engineering Program (TIE) to health care providers. TIE was developed in conjunction with international human resource directors, professional trainers and occupational safety consultants with incident management as its primary focus. TIE is a combination of technology and behavior modification using training programs specifically tailored to each organization’s requirements. “By modifying the healthcare worker’s behavior through proper training, we seek to reduce the incident rate within the facility. We believe that Sharpx® combined with TIE will become a standard of care in the healthcare industry,” said [redacted]. Formed in 1996, Biomedical Disposal, Inc. specializes in advanced, cost-effective technology products and services for the disposal of hazardous biomedical waste for the health care industry. Sharpx® is FDA approved. Click here for the website: www.fda.gov/cdrh/pma/pmaaug98.html
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Atlanta (Aug. 17, 1998)
– Norcross-based Biomedical Disposal, Inc. (BDI) has announced that the U.S. Food and Drug Administration (FDA) has
approved its Sharpx®
Needle Destruction Unit (NDU) – a portable device designed to destroy 19- to 27-gauge hypodermic needles, 1/2 inch to 2 inches
in length. Sharpx® is intended for use by health care professionals in outpatient and inpatient treatment settings and clinical laboratories. 
