Philips gets FDA clearance for MR suite patient monitor
February 16, 2016
The Expression MR400 from Dutch company Philips, which monitors patients undergoing magnetic resonance imaging (MRIs), has received 510(k) clearance from the US Food & Drug Administration (FDA). The MR400 provides ICU-comparable, bedside quality monitoring in the MR suite for all patients, including those with serious medical conditions or who require anaesthesia.
In the MR suite, strong electromagnetic fields make it impossible for clinicians to use traditional patient monitors without causing complications with the monitor or degradation of the images. The lack of adequate monitoring is particularly problematic for patients, including children, who require anaesthesia when getting an MRI. Without the ability to track key vital signs reliably, clinicians may not know a patient is in distress until it is too late.
"When a patient is under anaesthesia, it's incredibly important to keep a close eye on their condition so that clinicians can intervene early to prevent any complications," said Carla Kriwet, CEO of Philips’ patient care and monitoring division. “Clinicians often compare monitoring anaesthetised patients in the MR suite to piloting a plane in the fog with limited instrumentation. The MR400 gives clinicians comparable detail to patient monitors in the ICU and other wings of the hospital, providing them with increased confidence on the condition of their patients."
The MR400 is designed not to create image artefacts or other interference from the electromagnetic fields when used according to the labelling, ensuring that patients receive the level of clinical care and monitoring they need. It monitors the same vital signs that are tracked in the operating room and in the intensive care unit, including heart rate, oxygen and carbon dioxide levels, body and surface temperatures, and blood pressure, and also includes advanced ECG monitoring. Patients with serious medical conditions, including critical care patients or patients undergoing cardiac procedures, can also be monitored with the MR400, regardless of whether they are under anaesthesia.
Similar to traditional patient monitors, the MR400 uses intelligent alarms to warn clinicians of severe patient changes, including desaturation, apnoea, and extreme bradycardia and tachycardia. Clinicians and staff are able to customise the monitor settings for each patient to prioritise warning signals to reduce alarm fatigue. The monitoring system uses a touchscreen with the same interface as other Philips' monitors, making it easier for clinicians to view and respond to patient data.
Section 510(k) of the Food, Drug & Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance.
The MR400 uses wireless technology, connects with the electronic healthcare record, and shares information with IntelliBridge Enterprise to send and receive patient information seamlessly across the hospital, ensuring that all care team members have access to the same patient information.
Philip’ MR patient monitors are used in each of the top ten children's hospitals in the USA.