Author: Timothy S. Snow, DO
Philips received FDA approval for the EarlyVue VS30 on 10/27/2019.
The EarylVue VS30 is a vital sign monitoring device utilized in clinical patient care settings for adults, children, and neonates. The platform uses Philips’ Early Warning System (EWS) to help recognize signs of patient degradation prior to the presence of identifiable symptoms. This device calculates risks through algorithms specific to the patient and care facility and alerts the clinical staff of potential subtle changes in patient status, which permits quicker intervention. These point-of-care alerts enhance communication to promote efficiency and can reduce the prevalence of errors to improve patient outcomes.
The monitors can be observed and interfaced through the patient’s room or at the nursing station. The secure data is automatically updated into hospital EMR systems. It includes typical hemodynamic assessments such as temperature, heart rate, blood pressure, oxygen saturation, respirations, CO2, and other parameters using Masimo signal extraction technology (SET). The system touts the ability to better identify patient status changes and allows more expedient care to prevent serious medical events. This, in turn, can decrease inpatient complications, limit ICU transfers, and reduce lengths of stay. With clinical workflow and staffing at institutions becoming a concern in today’s healthcare environment, use of this device can alleviate some of the stresses placed on hospital systems.
The FDA has determined this device to be substantially equivalent to a predicate device (predicate device: Philips SureSigns VS4 Vital Signs Monitor, reference Device: Philips Efficia CM patient monitor). The EarlyVue VS30 successfully passed all verifications, testing, and validations and meets all safety, effectiveness, and performance requirements. It is as safe, as effective, and performs as well as the predicate device SureSigns VS4.
The EarlyVue VS30 is indicated to measure, display, alarm, and record physiological information of adult, pediatric, and neonatal patients. The device may be used in hospitals or in out out-of-hospital patient care settings, such as clinics, outpatient surgery centers, long-term care facilities, and physician offices. The administration of care using the device must be delivered by a healthcare professional. Additionally, the device may be used to monitor patients during transport within a healthcare facility.
The EarlyVue VS30 is not intended for transport outside of a healthcare facility and for use in the home setting. It is also not intended for other mobile settings such as ambulances and aircraft.
