Advice

Technology overview

Technology overview

This briefing describes the regulated use of the technology for the indication specified, in the setting described, and with any other specific equipment referred to. It is the responsibility of health care professionals to check the regulatory status of any intended use of the technology in other indications and settings.

About the technology

CE marking

EarlySense was awarded CE marks for the following components in April 2009:

  • Class IIb for the EarlySense 1.0S (supervision of heart rate, respiration rate, bed exit, motion, patient rotation, and oxygen saturation). This covers the bedside unit and sensor.

  • Class IIa for the EarlySense CDS1.0S (EarlySense Central Display Station Software). This covers the software.

  • Class IIb for the EarlySense 2.0S (supervision of heart rate, respiration rate, bed exit, chair exit, motion, patient rotation, and oxygen saturation). This covers the bedside unit and sensor.

Description

The EarlySense system is based on a piezoelectric sensor integrated into a membrane plate (300 mm wide × 210 mm high × 2.5 mm deep), which is placed under the patient's mattress to detect mechanical vibrations. The sensor collects the signal and the system algorithms analyse it to extract the following:

  • Heart rate – by identifying the motion signal transmitted to the surface of the body resulting from the sudden ejection of blood from the heart with each beat.

  • Respiratory rate – by identifying the motion signal generated by movement of the chest during respiration.

The system can, with additional components, also analyse patient movement, bed exit and peripheral capillary oxygen saturation (SpO2); these uses are outside the scope of this briefing.

The sensor is connected to a wall‑mounted bedside unit (260 mm wide × 250 mm high × 110 mm deep) with a touch screen, which uses software to display the readings from the sensor and allows system configuration. This can display numerical values or graphical data for viewing trends. This software can also be installed on a 'gateway computer', which transfers the alerts to a pager or other handheld devices (such as mobile phones) and acts as a file server for archiving reports. The software is available in 3 packages, which each have specific features: All‑in‑One (early detection of patient deterioration, fall prevention and pressure ulcer prevention), Safety (fall prevention and pressure ulcer prevention) and Vitals (early detection of patient deterioration). The last of these, Vitals, is the focus of this briefing. Vitals continuously monitors heart and respiratory rate and displays the rates that have been averaged over the previous minute. The software generates trends that can be used to detect patient deterioration. It has both visible and audible alarms and the high and low threshold of each parameter can be adjusted for each patient.

EarlySense also offers these optional components and accessories:

  • A patient management centre, comprising a standard desktop computer with a 22‑inch touch‑screen and Vitals software. This displays the EarlySense readings from up to 36 bedside units at the nurse's station.

  • A hallway display, which is a 42‑inch LCD screen to display EarlySense readings.

  • A contact‑free chair sensor that uses the same technology as the sensor in the EarlySense system but which can be placed inside a specified chair seat cushion.

  • Transmitter and pager devices, which allow healthcare professionals to get direct alerts for their assigned patients.

The EarlySense system can be used with both passive and active mattresses. Before installation, on‑site testing is carried out on the different mattress types used by a facility to ensure proper performance of the system.

Setting and intended use

The EarlySense system is intended for use on non‑critical care wards where patients may be at risk of deterioration. This can include general (internal) medicine, surgical, acute medical or care wards for older people. This briefing does not cover the use of this device for pressure ulcer risk assessment and monitoring, fall risk or bed exiting.

Current NHS options

Current NHS monitoring for general internal medicine patients or patients recovering from surgery is standard nurse‑led monitoring. This does not include continuous monitoring with a device, but will be done as part of the ward's standard procedures. The Royal College of Physicians (2012) recommends that wards use the National Early Warning System (NEWS), which uses the following measurements: respiratory rate (observed manually over 1 minute by a nurse), oxygen saturation (measured by pulse oximeter), temperature (via ear thermometer), systolic blood pressure (using an electronic blood pressure monitor), pulse rate (observed manually over 1 minute by a nurse) and level of consciousness (patient response monitored by a nurse and classified as fully alert, voice responsive, pain responsive or unresponsive). Patients are assessed on admission and those with low deterioration risk scores have at least 12‑hourly monitoring. People with higher NEWS scores need monitoring from half‑hourly to 4‑hourly intervals, depending on the score.

Many acute medical wards have telemetry monitoring already in place, enabling continuous distant ECG monitoring. Specialist commentators have also stated that many acute wards already have bedside monitors for continuous monitoring.

Costs and use of the technology

The distributor (BES Healthcare, a division of BES Rehab) has confirmed that the EarlySense system can be bought in single‑unit packages, but offers packages tailored to individual NHS trust needs (for example in packs of 10 devices). Each device serves 1 bed.

The manufacturer used the example of 10 EarlySense systems (sensor and bedside unit) loaded with Vitals software package, which costs £35,000 (10 units at £3500 each, excluding VAT). This 10‑unit package also includes the components needed for full device functionality, namely a desktop PC (including the Vitals software), central display station, pager transmitter and 4 pagers.

Individual unit prices for the devices and components are as follows (excluding VAT):

  • The EarlySense system (with Vitals software) − £3500, including both a bedside unit and sensor.

  • EarlySense sensor − £475; the distributor notes that the sensor must be replaced annually.

  • Desktop PC loaded with EarlySense software (listed as 'gateway computer bridge') − £2250.

  • Central display station − £2450.

  • Pager transmitter − £1950.

  • Pager − £135.

The PC can be supplied by the hospital, but is included free of charge with the software. The LCD touch screen and the pagers can also be supplied by the hospital.

Maintenance and training packages are available. The distributor has stated that these are negotiable and will vary between NHS trusts according to their needs.

Likely place in therapy

The EarlySense system could be used for patients who are at risk of clinical deterioration but are not constantly monitored, for example, patients recovering after surgery.

Specialist commentator comments

Two specialist commentators were concerned that the upfront cost of the EarlySense system might be prohibitive for the NHS without clear data on the likely downstream savings, and noted that ongoing costs such as maintenance and calibration would further increase this. One commentator also noted that the device might be more suited to wards where each patient's bed is situated in an individual cubicle or private room, which is not typical in the NHS.

Two specialist commentators noted that the EarlySense system needed patients to be in bed for monitoring, pointing out that many patients are not nursed in bed continuously and this may limit the device's utility. One specialist commentator identified monitoring in patients who have recently had surgery and night‑time monitoring as situations where EarlySense might be useful.

Two specialist commentators pointed out that the NHS already uses the NEWS system, a manually administered assessment in which heart and respiratory rate, blood pressure, temperature, oxygen saturation and level of consciousness are periodically collated to detect patient deterioration.

One specialist commentator noted that they supported the use of a deterioration‑monitoring device in the NHS, but would like to see more robust data and a comparative study of the current devices and systems available.

In terms of costs to the NHS, 1 specialist commentator noted that more frequent monitoring of heart and respiratory rate alone might lead to more physiological measurements being made (such as temperature and blood pressure) and so increase the number of clinical interactions.

One commentator noted the risk of 'alarm fatigue' from early warning systems in general, in which staff ignore monitor alerts because of the perceived number of false alarms.

Equality considerations

NICE is committed to promoting equality, eliminating unlawful discrimination and fostering good relations between people with particular protected characteristics and others. In producing guidance, NICE aims to comply fully with all legal obligations to:

  • promote race and disability equality and equality of opportunity between men and women

  • eliminate unlawful discrimination on grounds of race, disability, age, sex, gender reassignment, marriage and civil partnership, pregnancy and maternity (including women post‑delivery), sexual orientation, and religion or belief (these are protected characteristics under the Equality Act 2010).

This device could be used in care wards for older people. Age is a protected characteristic under the Equality Act 2010.