Erlangen, Germany-based Siemens Healthineers AG has secured U.S. FDA clearance for its Rapidpoint 500e blood gas analyzer. Available in CE mark countries since August 2019, the device is used to monitor respiratory distress in critically ill patients, such as those in acute care due to COVID-19.

Testing of blood gases can be critical for patients on ventilators and in respiratory distress, as well as certain diseases, to monitor for an oxygen/carbon dioxide or pH imbalance. The second in line of Rapidpoint 500 blood gas systems, the Rapidpoint 500e is intended for whole blood analysis of partial pressure CO2, partial pressure oxygen, pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total hemoglobin and fractions (FO2Hb, FCOHb, FMetHb and FHHb), and neonatal bilirubin.

Additionally, the system is designed for in vitro testing of pleural fluid samples for the pH parameter, an aid in managing patients with parapneumonic effusions resulting from pneumonia and other lung disorders.

The system includes the Siemens Healthineers-designed Integri-sense technology, a comprehensive series of automated functional checks and alerts designed to accurate results at the point of care. It also features rigorous data security controls, including a firewall and two-step authentication, hands-free automatic sampling and one-touch operation to streamline workflow and functionality, allowing clinicians to focus on the patient instead of the machine.

“Robust, automated defenses help maintain and safeguard institutions’ IT security, allowing health care providers to focus on patients without worrying about device intrusion or data theft,” Martin Berner, vice president of critical care in the company’s Point of Care Diagnostics unit, told BioWorld. “The analyzer also has an ability to transfer patient data to the POCcelerator Data Manager (our point-of-care informatics system) in an encrypted manner, providing an ability for users to have end-to-end data encryption.”

Seamless integration with hospital networks

The Rapidpoint 500e blood gas analyzer is designed to integrate seamlessly with hospital networks via Siemens Healthineers’ digital Point of Care Ecosystem, which allows operators and devices to be remotely managed across multiple sites. With 510(k) clearance in hand, the company said instrument production will commence next week.

“Point-of-care teams monitoring respiratory conditions in critical care settings need a blood gas testing solution that delivers fast, accurate results and increases workflow efficiencies. A safe operating environment amid growing concerns about cybersecurity threats is health care is also important,” said Christoph Pedain, head of Point of Care Diagnostics at Siemens Healthineers. “The Rapidpoint 500e blood gas analyzer has become a trusted instrument in Europe’s endeavor to combat COVID-19 and to help address an unprecedented demand for blood gas testing in affected respiratory patients.”

While the Rapidpoint 500e is not currently registered in China, where the pandemic began, two other Siemens Healthineers blood analysis systems were used to monitor COVID-19 patients – the Rapidpoint 500 and Epoc systems, Berner said.

COVID-19 headwinds

Businesses across the industrial spectrum have seen supply chain disruptions and shrinking sales as a result of COVID-19, and medical device manufacturers are no exception. U.K.-based Smith+Nephew plc recently withdrew its 2020 guidance, due to the global spread of COVID-19 and the slow return to elective procedures in China, where the pandemic began.

In a March 19 statement addressing the pandemic, Siemens Healthineers Bernd Montag said the company’s plants in China learned how to maintain operations under difficult circumstances during the outbreak in that country. “We have so far succeeded … in keeping our business stable overall,” he said, citing “significantly increased interest in our imaging equipment.”

Montag said the company is striving to ensure those devices, as well as blood gas systems for monitoring ventilated patients, are available for patients who need them.

For the first quarter of fiscal year 2020, ended Dec. 31, Siemens Healthineers reported revenue of €3.6 billion (US$3.97 billion), up 5.5% from €3.3 billion in the same period the prior year. Net Income dropped 12% from €345 million to €304 million.

In the diagnostics segment, which includes blood gas analyzers, first-quarter revenue exceeded €1 billion – up about 3% from a year earlier. The company largely attributed the increase to strong growth in China, citing only slight increases in the Americas and EMEA.