Technology | March 29, 2011

FDA Clears Wireless Point-of-Care Blood Testing System

March 29, 2011 – The U.S. Food and Drug Administration (FDA) cleared a wireless point-of-care testing system that allows real time transmission of diagnostic test results generated directly from the patient bedside.

The new i-Stat 1 wireless handheld, from Abbott, offers several types of test cartridges, including a cardiac troponin test. Blood is added to disposable cartridges that contain test reagents. The cartridge is then inserted in the analyzer and results are provided in minutes. In addition to cardiac markers, other tests include chemistries, blood gases, electrolytes and tests for lactate, hemoglobin, coagulation and hematology.

"With i-Stat 1 Wireless, caregivers are able to share critical test information electronically without leaving the patient's bedside," said Greg Arnsdorff, head of Abbott's point of care business. "By empowering nurses to stay at the bedside, the new i-Stat 1 Wireless supports a patient-focused approach to treatment, allowing for expedited decision making that helps minimize time to treatment."

The handheld analyzer can potentially save time by allowing caregivers to perform critical tests at the bedside and then transmit test results immediately. Physicians can then review the results from anywhere they have access to electronic records. Eliminating back-and-forth movement from the bedside to a desktop transmission terminal somewhere in the department gives staff the ability to better focus on the patient.

"With wireless, physicians can receive immediate test information in the electronic medical record, enabling them to act quickly when a patient's clinical status is rapidly changing," Arnsdorff said.

With the 10-minute cardiac troponin test cartridge, for example, emergency department staff can test, transmit and treat from the bedside. This helps healthcare providers maintain compliance with testing guidelines from the American College of Cardiology (ACC) and American Heart Association (AHA), which call for a turnaround time of less than 60 minutes. By sharing these test results via a hospital's existing wireless network, caregivers have rapid access to information that can help determine if a patient is having a heart attack.

The device is certified for compatibility with existing wireless networks. It is also is compatible with point-of-care data management systems used with earlier versions of the i-Stat System.

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