Software allowing a digital video camera sensor to measure patients’ vital signs remotely has been approved as a Class IIa medical device in Europe in what is believed to be the first accreditation of its kind for this type of technology.
Developed by Oxford University spin-off Oxehealth, which is partly owned by Oxford University Hospitals NHS Foundation Trust, one of the UK’s Global Digital Exemplars, the device works similarly to a pulse oximeter that is used to measure the oxygen level of the blood, but it can be used remotely instead of needing to be attached to patients.
Oxehealth Chief Executive Hugh Lloyd-Jukes said the accreditation confirmed the software could "take spot measurements of pulse rate and breathing rate that are as accurate and safe as a device that you clip on the skin".
“Pulse oximeters are used in GP practices and hospitals every day. The difference is that we measure pulse rate and breathing rate entirely contact free, anywhere in the patient’s room. This will be hugely beneficial to public and private sector organisations that care for elderly and vulnerable people, whose staff cannot be present in every room or do not wish to interrupt the rest of the people they are looking after.”
The accreditation follows six years of work, according to Oxehealth, with initial clinical studies completed at the John Radcliffe Hospital in Oxford and further pilots the Broadmoor Psychiatric Hospital and Conventry and Warwickshire Partnership NHS Trust. The start-up said it completed a clinical pivotal study to prove the efficacy of its solution and built a medical device Quality Management system later reviewed by the British Standards Institute, who accredited Oxehealth’s software on behalf of the Medicines and Healthcare products Regulatory Agency.
“Looking after the elderly and vulnerable can be extremely challenging. Yet, in contrast to their peers in intensive care, the medical staff working in mental health, nursing homes and custodial settings have never had access to frequent, accurate vital sign measurements,” Lloyd-Jukes explained.
Oxehealth, founded in 2012 by Oxford University Head of Engineering Lionel Tarassenko, will now launch the vital signs tech as part of its Digital Care Assistant solution that uses an optical sensor to monitor patients, with the software sending alerts in case it identifies high-risk activity and generating insights that the company says can help staff understand patient behaviour or offer support in shift handovers. The solution is currently used in seven mental health NHS trusts, three care home chains in UK and Sweden and two police forces.