Advice
The technology
The technology
Lifelight First (xim Limited) is used for measuring indicative estimates of blood pressure, pulse, and respiratory rate. It records the face for less than 40 seconds with the camera in an Apple iPad 9.7 as a sensor. It detects tiny colour changes in facial skin each time the heart beats. The software uses algorithms to analyse the data to provide the measurement outputs. A stable internet connection is needed for Lifelight First to work. Because Lifelight First collects data using a camera, the person must be visible and well lit, and must stay still.
Lifelight First may be affected by some drugs, therapies, health and changes to the skin, including cosmetics, facial tattoos and excessive sweat. The company notes that Lifelight First should not be used for direct diagnosis or monitoring of vital physiological processes and does not replace traditional methods of diagnosis or treatment. This is consistent with the current class I CE mark and is likely to change if the device is re-classified as class II later in 2020 as planned.
The company is developing a newer version of the technology, Lifelight Home. This allows people to monitor their heart rate, pulse rate, respiratory life and oxygen saturation levels from home using a smartphone.
Innovations
Lifelight First is a contactless technology and is designed to avoid direct contact with people when taking measurements, and needs no medical hardware. A fixed artificial intelligence algorithm processes the camera data and calculates measurements. The technology is non-invasive, and the company notes that there is no similar technology available in the NHS. Contactless technology can prevent cross-contamination and improve infection control, such as in COVID‑19 cases. However, there is no evidence to support this. To use the technology the iPad should be held approximately 35 cm from the person's face.
Current care pathway
Since the introduction of the Quality and Outcome Framework in 2014, GPs review people with some common chronic conditions such as asthma, diabetes, obesity and hypertension on a regular basis. This involves monitoring any change in blood pressures, pulse and respiratory rates. In current practice, contact-based methods are used to measure these, but such methods may not be tolerated by some patients and may cause distress, and in some cases needs personal protective equipment to prevent cross-contamination.
The NICE guideline on hypertension in adults: diagnosis and management states that hypertension is diagnosed by measuring blood pressure either manually or with an automated blood pressure monitor. Readings are first taken in a clinic and can be followed by ambulatory blood pressure monitoring to confirm the diagnosis. Home blood pressure monitoring (usually done using an automated monitoring device) can be done between 4 to 7 days as an alternative if ambulatory monitoring is unsuitable for the person. Treatment options for hypertension include lifestyle changes or antihypertensive drugs, or both.
The NICE clinical guideline on acutely ill adults in hospital: recognising and responding to deterioration recommends that adult patients in acute hospital settings should have physiological observations recorded at the time of their admission or initial assessment. After admission, these physiological measurements should be monitored regularly (tracked) with predetermined response criteria to changes (triggers) to identify deteriorating physiological status or risk of deterioration.
NICE has produced a medtech innovation briefing on National Early Warning Score systems, which gives advice about scoring systems intended to alert to deteriorating patients in hospital. These scoring systems measure respiratory rate, oxygen saturation, blood pressure, pulse rate, level of consciousness and temperature.
Population, setting and intended user
Lifelight First is intended to give an indicative estimate of blood pressure (mmHg), pulse rate (beats per minute), and respiration rate (respirations per minute). The device is for adults who need their vital signs monitoring. It is not intended for children.
Lifelight First would be used by qualified healthcare practitioners in various healthcare settings, including hospitals, clinics and GP practices.
Costs
Technology costs
Lifelight First costs £12.50 per user per month (excluding VAT) as part of a subscription. A user refers to each individual healthcare practitioner with access to the technology, and has a unique login. There is no limit on the number of people the technology can be used on every month. The company offers training and support, including electronic health records integration and maintenance, at an additional cost. The cost of training depends on the size and complexity of the healthcare setting.
Costs of standard care
National 'track and trigger' systems can be automated or paper based. Paper-based early warning score (EWS) charts are free to download from the Royal College of Physicians website. Wong et al (2017) reported that it takes 3 minutes 35 seconds of nursing time to do manual observations and EWS calculations. Based on the agenda for change NHS pay scales 2019/20 band 4 nursing salary the cost of recording and calculating the EWS manually is £0.98 per patient.
The cost of the automated system ranges from £30,000 to £90,000 for system installation, configuration and set up, and costs a further £0.35 to £0.70 per acute bed, every day. Wong et al (2017) reports that automated EWS systems reduced nursing time to 2 minutes 30 seconds.
The cost of the equipment for measuring heart rate and blood pressure ranges from £20 to over £1,000. The cost of the Welch Allyn Connex Monitor, described in the evidence, is approximately £200 per unit, not including maintenance costs.
Resource consequences
The technology is being used in a small number of UK NHS trusts.
It costs more than standard care, but may be resource releasing because of faster consultations (releasing staff resource) and improved patient care. This is particularly relevant in cases when current care cannot be readily used, such as in mental health settings, or to avoid cross-contamination.
The company claims that the technology reduces the time for a GP to complete vital sign observations from 3 minutes to 1 minute. The company also claims the technology offers contactless monitoring and reduces the need for personal protective equipment to do clinical observations. However, there is currently no evidence to support these claims.