Newly Approved Medical Device Joins Battle Against COVID-19

US Food and Drug Administration approves RAPIDPoint 500e Blood Gas Analyzer from Siemens Healthineers to help COVID-19 frontline healthcare workers diagnose and monitor patients in respiratory distress.

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Image credit: Siemens

 

COVID-19 hotspots are popping up across the United States and filling emergency rooms and testing centers with people wondering if they are positive. Since the virus broke out, healthcare providers and hospital labs have been using a barrage of tests to understand their patients’ health and respond appropriately to this mysterious, highly dangerous virus.

One proven test used for patients with breathing problems, a symptom of COVID-19, is arterial blood-gas (ABG) analysis. Healthcare staff regularly test for ABG in patients who are in respiratory distress or are on a ventilator. These widely used tests measure oxygen and carbon dioxide in the blood and a body’s acid-base (pH) level.

In treating COVID-19, the ABG tests are often taken at point-of-care settings in emergency rooms, intensive care units, and operating rooms. Healthcare staff use a small needle to take blood from the wrist, groin, or near the elbow, and the vials of blood are stored in compartments in a box and analyzed by the medical device. The results provide critical information to the staff about how the lungs, kidneys, and heart are working.

Siemens Blood Gas Analyzer Earns FDA Approval

ABG tests come from a variety of medical devices leaders, and the U.S. Food and Drug Administration (FDA) recently approved a new one from Siemens that has been in use in Europe and countries that require the CE mark. Gaining approval is no easy task and demands lots of effort and resources to complete the process.

Siemens Healthineers, who is an Intel® Solutions Marketplace partner, gained FDA approval for RAPIDPoint 500e Blood Gas Analyzer in late March 2020. The blood-gas testing device provides staff with quick and accurate results for blood gas, electrolyte, metabolite, CO-oximetry, and neonatal bilirubin. All these measurements are needed to diagnose and monitor critically ill patients.

The RAPIDPoint 500e Blood Gas Analyzer has received positive feedback in the UK for helping to manage patients infected with COVID-19 and monitor their respiratory distress.  For patients on ventilators, it provides the status of the patient’s oxygenation levels, so healthcare providers can determine if the ventilator settings need adjustments or other treatments are required. Staff can get test results in 60 seconds, and a barcode scanner captures patient data.

In a Siemens statement, Dr. Daniel Martin, Royal Free Hospital, London, said, “As an ICU physician, I know that the values I am handed during an emergency allow me to confidently make life-saving decisions. The RAPIDPoint system is easy to use and allows me to not worry about the machine and focus my attention on my patients.”

In an add-on, the Siemens analyzer uses Integri-sense Technology, a comprehensive series of automated functional checks, such as readiness checks, clot and bubble detection, optical clarity test, calibration stability test, and temperature checks. It also has two-step authentication, encrypted patient data transfer, and anti-malware to protect against hackers looking for device vulnerabilities and sensitive data.

Blood Gas Systems

The RAPIDPoint® 500e Blood Gas System and epoc® Blood Analysis System are important analyzers supporting COVID-19 response efforts, where blood gas testing plays a critical role in managing infected patients and monitoring their respiratory distress. The analyzers integrate seamlessly into hospital networks with the Point of Care Ecosystem™, which offers remote management of operators and devices.