MD Scientific, LLC (MD Scientific), announces Food and Drug Administration clearance to market EndoTool Glucose Management System. EndoTool is an intravenous insulin dose calculator, designed for critical care applications where tight blood glucose control is desirable.
According to the Centers for Disease Control and Prevention in Atlanta, each year over 2 million patients acquire infections in U.S. hospitals, resulting in 90,000 deaths and costing an estimated $50 billion in medical charges. High blood glucose levels compromise the immune system and leave patients vulnerable to infections. Controlling blood glucose for patients in critical care has been shown to reduce infections and death.
"Since 2003, the MD Scientific team has been focused on giving physicians and nursing staff the tools needed to control blood glucose," states Shade Mecum, President of Charlotte, NC-based MD Scientific. "This FDA clearance is a testimony to the hard work and steadfast vision of our team."
The role of uncontrolled blood glucose in infection rates is well documented and a nation-wide effort by the Center for Medicare and Medicaid Services (CMS) and the Center for Disease Control and Prevention (CDC) has targeted controlling glucose as one improvement to prevent complications caused by surgical infections and cardiovascular surgeries. The risks of infection secondary to uncontrolled blood glucose are high for patients with diabetes and higher for patients without diabetes.
The EndoTool Glucose Management System is a solution to the problem of how to effectively and safely control blood glucose for critically ill patients after surgery. EndoTool has been operating in thirteen intensive care units and operating rooms with over 100,000 insulin dose calculations annually. The software leads to prompt control of the glucose level and has a hypoglycemia incidence of less than 0.1 percent of total calculated doses administered.
The software is HIPPA compliant, provides printed and digital records, is user friendly, reduces physician work load, requires no calculations by nurses, allows for local control of many parameters, can provide medical director directed transition to subcutaneous insulin orders, and is associated with an incidence of hypoglycemia well below all published reports of tight glycemic control protocols.
The software runs on any PC or server with Windows 2000 or higher operating system and is provided under license from MD Scientific. On-site installation, in-service, and 24/7 technical support is included in the license fee.
"Blood glucose management has been outstanding with this software, infection incidence has dropped dramatically, and this computer system approach has been well received by the staff and is easy to use," says Joseph Cook, MD, Chief of Thoracic and Cardiovascular Surgery, Carolinas Medical Center, Charlotte, NC.
SureID to Deliver ePedigree
Automation Solution
SureID, a leader in ePedigree automation demonstrated its PharmaSURE solution for use in drug trials. With PharmaSURE integrated into the trial management system, companies benefit from accelerated trials, regulatory compliance, automated investigator activities, improved patient safety and outcomes.
PharmaSURE is one example of how Microsoft technologies can help meet regulatory requirements and streamline operations. The solution, developed using Microsoft Visual Studio 2005, uses SureID Wave intelligent appliances running Microsoft .NET 2.0 and Windows XP to automate data collection and distribution tasks. Investigator reporting is streamlined using standard RFID tags and PharmaSURE automation software running Windows Server 2003 and Microsoft SQL Server. Patient journals are automatically logged using SureID's Intelligent Caps, which securely communicate using standard RFID infrastructure. Collected data is securely stored in Microsoft's SQL database for ease of collaboration and reporting.
"Technology can enable companies to be agile and competitive in a changing business environment," said Steve Shihadeh, general manager, healthcare and life sciences at Microsoft. "Through its use of Microsoft technologies, SureID is helping its customers to better connect, collaborate and make more informed decisions, which helps them to drive overall business success."
"Our company helps stakeholders in the pharmaceutical supply chain cost effectively deliver the safest medication to their customers. Our PharmaSURE solution not only improves safety, it improves efficiencies and productivity with real-time visibility and automated execution of processes." stated Steve Casey, CEO of SureID. "Improving the top and bottom lines while leveraging regulatory expenses is a win-win for everyone."
The PharmaSURE capabilities that improve drug trials are also used to improve Pharmacy operations and assist in meeting regulatory requirements. The FDA's recent report lifting the stay on ePedigree regulations and guidance on targeted RFID deployment has increased the need for solutions such as PharmaSURE. "While I was a guest panelist at the FDA workshop in February and in speaking with other stakeholders, it became apparent that the FDA was going to put pressure on the industry" noted Steve Casey. "Although the FDA seldom specifies a technology, the consensus was that RFID would provide tremendous benefit in a phased approach. Our PharmaSURE solution specifically addresses these ePedigree challenges while targeting high-value medications prone to counterfeiting, shrink, and medication errors."
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