1. What are the main issues surrounding patient safety in healthcare today?
Ensuring the safety of everyone that comes into contact with the health service is one of the most important challenges facing healthcare today.
Patients and their families should feel that a hospital is a place of care and comfort, somewhere they would be looked after. Instead they are now often seen as places fraught with risk of patient harm.
It is now widely accepted that 1 in 10 patients admitted to hospital will be unintentionally harmed in some way.1,2 The harm can be caused by a range of errors or adverse events. To put that into context in the extreme case: there are more deaths annually as a result of healthcare than from road accidents, breast cancer and AIDS combined. Some of these adverse events will be inevitable complications of treatment, however at least half of these events are thought to be preventable.
Although the 10% figure of harm happening to admitted patients is well known, this level of error is completely unacceptable in many other industries (for example, aviation) so when it comes to the healthcare industry, zero harm should be the target.
In the UK, reviews of case records have shown that last year there were 1.2 million reported care incidents,3 and in 2012/2013, there were 850,000 reported adverse events4 – these figures are reflected in similar records around the world. In 2012, deaths from potentially avoidable causes accounted for approximately 23% of all deaths registered in hospitals in England and Wales.5 While medical errors have not been as extensively studied in outpatient settings, it is estimated that as many as 35% of outpatients experience an adverse drug event6–9 and that 13% of all adverse events identified during hospitalisations occur during outpatient care.7,8
Recent financial estimates also suggest that adverse events cost the UK £2.5 billion in 2012/2013 in extra hospital days alone and £1.2 billion paid in clinical negligence. Other costs, such as suffering of patients, their families and the health care workers involved, are incalculable.9
Dealing with the effects of patient safety related issues is a very expensive diversion of healthcare funds. In addition to the ensuing distress for patients, families and frontline staff and the greater bureaucratic burden for management, the financial implications add enormously to the pressures on the NHS, limiting its ability both to treat more patients and to provide higher quality services.
2. How does the PSE work and why is it important?
Isansys Lifecare Limited is a new generation digital healthcare company that has developed an innovative, low cost and scalable patient monitoring platform. The Patient Status Engine (PSE) integrates a range of advanced medically certified wireless wearable vital sign sensors, developed by Isansys, with secure networking technologies and predictive analytics.
The PSE provides a complete end-to-end service to continuously and wirelessly capture, collect, interpret and securely store vital sign and other physiological data. It is also able to monitor and analyse subtle variations in vital signs that are early warning signs of many serious conditions, for example sepsis – a life threatening whole-body infection.
This data collected not only enhances the relationship between the patient and the physician, but ensures that the patient information in the database can then be securely transferred to any existing hospital information system and also delivered to any authorised user – anytime, anywhere.
3. How does it address the needs of healthcare today? What added benefits over manual patient observation does it deliver?
There is a pressing need to improve patient safety, the way patients are monitored and how patients’ data is collected and analysed. Except for those in intensive care wards, most patients in UK hospitals are inadequately monitored. Even high dependency patients often fail to receive the necessary higher intensity monitoring due to a number of factors including suitable beds and nursing resource.
Patients in general wards have their ‘obs’ taken at long (up to eight hourly) intervals during which time significant negative changes in a patients’ status can occur. Such infrequent monitoring makes it almost impossible to identify trends that might have been able to predict the patient’s deterioration.
The PSE provides a solution to all of these issues, as well as allowing the patient greater freedom and security. By significantly improving patient monitoring and providing robust and time early warning indicators, the PSE can also enable healthcare providers to deliver better care, improve patient safety, reduce the number of in-hospital avoidable deaths and adverse events, and to discharge patients earlier and with greater confidence.
4. Will it confer any cost savings to a healthcare system?
The economic impact of the Isansys platform is difficult to estimate but has the potential to be very significant. Of the estimated £5 billion costs to the NHS associated with patient safety, the adoption of the Patient Status Engine as standard care could potentially reduce this amount by 50% or more. The cost of widespread adoption of the PSE is £1 billion, leading to an annual net saving of £1–2 billion.
5. What are the other benefits of the PSE?
Through the acquisition of continuous real time physiological and other biomarker data sets from individual patients in either a hospital or home settings, large data sets are built up providing reliable and highly relevant data for immediate or subsequent analysis. The clinicians and nurses can then use these predictive algorithms as new tools to see what is happening to their patient and how their treatment can be altered or adjusted accordingly.
For the first time ever, the idea of real patient-centred care becomes possible because we can measure the patients’ physiological “image” and their responses to treatment in real time. No matter where patients are located, whether in hospital or at home, their current status including their responses to treatment will immediately be visible to their care team. In addition, through the power of data driven healthcare and predictive algorithms their future status is also able to be presented. This not only provides a new way to measure patient outcomes, but also gives clinicians a new set of quantifiable measures to optimise patient care.
6. What patient/clinical areas will it target?
The PSE is an unusual medical device in that it is not targeting one specific condition. The PSE is providing the basic tools and information that doctors and nurses have always used to care for their patients. It can be used for general in-hospital monitoring for early warning scores or for providing early warning indicators of deterioration in at-risk patients at home.
7. Where has the Isansys PSE been implemented already and what is the feedback?
The first generation PSE is being used in several UK hospitals and in two major hospital groups in India. The feedback from the doctors, nurses and patients using the first generation PSE has enabled us to develop a second-generation system, which is now being used as part of a ground-breaking research study at a large NHS hospital in England.
The study aims to transform the way patients are cared for. It uses the Lifetouch cardiac sensor to collect real-time data directly from the patient and analyses the ECG of every heartbeat to provide continuous heart rate, respiration rate, heart rate variability, and, at the push of an on-screen button, a real-time ECG set-up mode trace. This data is then analysed to predict when the patient’s condition may be deteriorating, providing an early warning system with the potential to save thousands of lives.
8. How will the technology be developed further with the aid of the second phase of funding from SBRI?
Following the news of our success with securing a £1 million second phase contract with the Small Business Research Initiative (SBRI Healthcare), Isansys is now increasing the functionality and extending the intended use of the PSE. This will not only meet the demands of healthcare providers for innovative, market-ready solutions, that can enable improved patient monitoring and alerting both in hospitals and at home, but it will also address crucial patient safety issues.
The second phase of SBRI funding is leading to the development of a new generation of body worn wireless sensing devices which in turn lead to more accurate and complete datasets from which better diagnostic and predictive algorithms are being developed.
Our ongoing development programme will also enable the costs of monitoring patients to be further reduced to the point where it becomes possible for every inpatient to be monitored safely, securely and automatically.
9. Does the rollout of the technology in a healthcare system require technical training for the staff? Can this be streamlined with the daily routine of patient wards?
Technical training for staff is minimal. The system has been designed to fit as seamlessly as possible into existing workflows. The user interfaces are intuitive touchscreens reflecting the experience of users of ubiquitous consumer technology devices such as smart phones and tablets.
- http://www.who.int/patientsafety/journals_library/Improving_Patient_Safety.pdf, page 4.
- http://www.health.org.uk/public/cms/75/76/313/2593/Levels%20of%20harm.pdf?realName=PYiXMz.pdf, page 4.
- Brennan TA et al. Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J Med 1991;324:370–6.