FDA clears Philips wearable Covid-19 monitor
June 2, 2020
Philips has received 510(k) clearance from the US Food & Drug Administration (FDA) for a wearable biosensor to help manage confirmed and suspected Covid-19 patients in hospital.
The wireless wearable biosensor enhances clinical surveillance in the Philips patient deterioration detection system to help clinicians detect risk so they can intervene earlier and help improve care for patients in lower acuity care areas. This has already received the CE mark, and is in use at the OLVG Hospital in the Netherlands to help manage the triage and clinical surveillance of Covid-19 patients.
“With the help of this new biosensor, we can continuously and remotely monitor patients, which is especially important on the Covid-19 wards,” said Florian van der Hunnik, chief nursing information officer of the Covid-19 ward at OLVG Hospital in Amsterdam. “Because we cannot walk in and out of the patient rooms without protective gear, we welcome this innovation as it helps improve how we can do our jobs better.”
The BX100 biosensor is designed to address a different approach to vital signs measurements, supporting surveillance of higher acuity patients moving from intensive care units into lower acuity general care areas of a hospital.
The lightweight, disposable biosensor is a five-day, single-use wearable patch that can be integrated with a scalable hub to monitor multiple patients across multiple rooms. Built to be incorporated into existing clinical workflows for mobile viewing and notifications, the device requires no cleaning or charging.
The medical-grade wireless wearable biosensor, for use by healthcare professionals on patients 18 years of age and older, adheres discreetly to the chest to collect, store, measure and transmit respiratory rate and heart rate every minute – the top two predictors of deterioration – as well as contextual parameters such as posture, activity level and ambulation.
OLVG, a clinical, referral and training hospital in the Netherlands, is responding to the Covid-19 situation by remotely monitoring patients in isolation rooms who are diagnosed or suspected of Covid-19, but don’t need ventilation. To meet the hospital’s need to support Covid-19 patients in isolation, OLVG has implemented Philips patient deterioration detection system comprised of data-driven intelligent analytics software (IntelliVue Guardian Software) for early warning scoring, patient monitors (EarlyVue VS30), and the BX100 wearable sensors.
“The BX100 helps provide rapid deployment for clinical surveillance to help decrease risk of exposure of healthcare workers while acquiring frequent patient vitals, and easing the demand for personal protective equipment,” said Peter Ziese, general manager at Dutch firm Philips. “The biosensor is an integral component in our patient deterioration detection which helps aid in the identification of the subtle signs of deterioration in a patient’s condition at the point of care, hours before a potential adverse event would occur.”