INDIANAPOLIS, Nov. 11 The U.S. Food and DrugAdministration has granted approval for the new Handheld Base Unit for theCoaguChek(R) XS Plus System, which provides connectivity between theanticoagulation meter and the RALS(R)-Plus data management system and enableshospital networks to easily capture, access and manage essential patient,operator and quality data for point-of-care PT/INR (clotting time) testing.
The connectivity capability with RALS-Plus allows for network-wide datamanagement and bi-directional data transfer with anticoagulation meters, whichcan help point of care (POC) coordinators and others ensure the accuracy ofpatient records and improve the safety of patients on blood-thinningmedications, such as Coumadin(R) (warfarin). The reporting and devicemanagement capabilities of RALS-Plus can also help hospital staff streamlinethe regulatory compliance process, capture reimbursable costs, and improvetheir organizational efficiency.
When the CoaguChek XS Plus System is docked in the optional Handheld BaseUnit, it seamlessly transfers data to the RALS-Plus system through thehospital's information network. The bi-directional data transfer capabilityallows POC coordinators or other staff to configure individual meter settingsfrom a central location. It also gives them convenient control and managementof quality and safety features like operator lockout (to help ensurecompliance with certification requirements) and quality control lockouts.
"With the growing influence of Pay for Performance and other quality-basedinitiatives in healthcare, hospitals are looking for data management solutionsto help them reduce costs and improve patient care," said Brian Gunderson,Director of Product Portfolio Management at Medical Automation Systems, whichdeveloped the RALS system. "RALS-Plus is designed to do both."
The most significant benefits of connectivity with RALS-Plus relate toenhanced patient safety and quality control, according to Robert Hach, Pointof Care Coordinator at Cleveland's MetroHealth System, which has been usingRALS-Plus to manage its POC blood glucose testing program for five years andserved as a test site for the CoaguChek XS Plus connectivity module. "Duringthe beta test, the connectivity to RALS-Plus allowed us to control the PT/INRmeters remotely, so we could manage operator certification and protocolcompliance from one location," he says. "That took away any worries about anunauthorized person using the meter, and helped ensure the safety of ourpatients."
RALS-Plus helps hospitals address quality initiatives by giving themcentralized control of point-of-care testing devices, including Roche's ACCU-CHEK(R) Inform system for blood glucose, according to Keith Snyder, Directorof IT Marketing at Roche. "Now facilities that use the CoaguChek XS PlusSystem can extend the benefits of centralized data management to point-of-caretesting in their warfarin clinics as well," he said.
The CoaguChek XS Plus System can store up to 500 patient and/or liquidquality control results that can be searched by patient ID, date, and time. Ituses two-level, built-in quality controls to help ensure the accuracy ofPT/INR test results, but also offers optional liquid quality controls forfacilities with policies requiring the use of external quality controlmeasures.
About Anticoagulation Monitoring
Patients with atrial fibrillation, a mechanical heart valve and otherconditions often require protection against thrombosis, or blood clots. Theyare typically put on lifelong oral anticoagulation therapy with Coumadin(warfarin) to thin their blood. Each patient reacts differently toanticoagulant medication, so it is imperative to monitor the therapeuticeffects to keep potential risks at the lowest possible level.
About the CoaguChek family of products
Physicians have been using CoaguChek instruments for POC PT/INR(Prothrombin Time/International Normalized Ratio) testing since 1994. Today,in the U.S., more PT/INR tests at the point of care are done using a CoaguCheksystem than with all other devices combined.(1) The CoaguChek XS Plus Systemrepresents the fifth generation of point-of-care anticoagulation monitoringdevices from Roche Diagnostics.
Headquartered in Basel, Switzerland, Roche is one of the world's leadingresearch-focused healthcare groups in the fields of pharmaceuticals anddiagnostics. As the world's biggest biotech company and an innovator ofproducts and services for the early detection, prevention, diagnosis, andtreatment of diseases, the Group contributes on a broad range of fronts toimproving people's health and quality of life. Roche is the world leader inin-vitro diagnostics and drugs for cancer and transplantation, and is a marketleader in virology. It is also active in other major therapeutic areas such asautoimmune diseases, inflammatory and metabolic disorders, and diseases of thecentral nervous system. In 2007, sales by the Pharmaceuticals Division totaled36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3billion francs. Roche has R&D agreements and strategic alliances with numerouspartners, including majority ownership interests in Genentech and Chugai, andinvested more than 8 billion Swiss francs in R&D in 2007. Worldwide, the Groupemploys about 79,000 people. Additional information is available on theInternet at www.roche.com.
About MAS and RALS-Plus
Medical Automation Systems is recognized as the leader in informationmanagement for point-of-care testing. For years, the name RALS has beensynonymous with point-of-care information management and widely recognized asthe leading connectivity system available on the market. Today, more than1,300 hospitals throughout the country manage their programs with RALS.
All trademarks used or mentioned in this release are protected by law.
CoaguChek is a trademark of Roche. RALS is a trademark of MedicalAutomation Systems. Coumadin is a trademark of Bristol-Myers Squibb PharmaCompany.
(1) 4th quarter 2007 total market share of projected distributor unitsales of the Point of Care Testing Coagulation Reagents and Kits product classby HPIS Market Intelligence, a division of the GHX Global Healthcare Exchange.For further information please contact: Wendy Baker-Stein Corporate Communications Roche Diagnostics Corporation Indianapolis, Ind. Phone: 317-521-2745 firstname.lastname@example.org
SOURCE Roche Diagnostics