Ingenious safety device watches over patients on haemodialysis

Ingenious safety device watches over patients on haemodialysis

Redsense Medical’s site monitoring innovation delivers improved safety and quality of life for patients in clinics and at home.

Redsense Medical is a medical device innovation company with its roots in Halmstad, Sweden, which has made it its mission to improve the safety and quality of life for dialysis patients worldwide.

Redsense Medical’s main product, the patented Redsense Alarm system, is a safety device for use in connection with essential haemodialysis treatment: approximately four million patients around the world undergo haemodialysis several times a week, either at home or in clinical settings.

Rapid, fibre-optic detection

With the help of patented fibre-optic technology, the Redsense system continuously monitors the blood access site during treatment, ready to alert patients and caregivers to  any sign of the presence of blood, which would be indicative of an emergency. During treatment, an absorbent, disposable sensor patch is applied over the access point (either to the venous needle or the central venous catheter), connecting to the alarm device with a fibre-optic cable. The cable carries a signal of red light to the sensor embedded in the patch and back to the device. If any blood leakage occurs, the patch absorbs the blood and the alarm unit immediately recognises a decreased level of red light in the return signal. This triggers an audio-visual alarm.

Solving the issues with built-in safeguards

During haemodialysis, the blood of a patient is drawn from a vascular access site, pumped through a dialysis machine outside the body for purification and finally returned to the patient’s bloodstream. Occasionally, if the needle is not properly attached or the bloodline is pulled, the circuit is broken and blood starts to leak; due to the high rate of blood flow during treatment, such leakages must be addressed within minutes by turning off the dialysis machine’s pump to avoid the onset of haemorrhagic shock.

Haemodialysis machines generally, as a built-in feature, monitor the venous pressure for pressure drops that could indicate a dislodgement – but since the pressure often varies over the course of session to a degree similar to the acute decrease during an incident, any built-in monitoring will suffer from an inherent trade-off between full detection and avoidance of repeated false alarms that cost time, drain resources and cause annoyance.

Reliable, FDA cleared, CE marked and proven in clinical practice

Other external sensors have been developed in attempts to detect leakages by observing different parameters, such as electricity changes due to a presence of conductive liquid (such as blood) – but to date, Redsense’s solution is unique in its ingenious use of red light to determine that blood is present, which gives it an unparalleled accuracy and specificity. As a result, Redsense is the first – and, so far, the only – regulatory cleared product on the market able to reliably safeguard against the threat of venous needle dislodgement (VND) and central venous catheter blood line disconnection.

As such, the company has seen an impressive journey since the first patent for the monitoring technology was filed in 2004: the technology obtained clearance from the US Food and Drug Administration (FDA) in 2007, and is today cleared for both in-centre and at-home use. By 2011, it was used in clinical practice in 13 countries; and by now, more than 250,000 treatments are carried out with the Redsense system yearly, a number which has seen surging growth as more and more operators and dialysis providers have become aware of the product’s life-saving capacity, ease of handling and tremendous cost effectiveness.

The company’s ultimate, overarching goal has always been to establish the blood loss alarm as the standard patient safety measure in conjunction with haemodialysis care. Now, when all of the top five dialysis providers – operating more than 6,000 clinics between them – are already using Redsense, with many smaller chains following suit, that vision is quickly becoming reality.

Integrates with the dialysis machine

One of the major advantages of Redsense is that the product is designed to allow integration with almost every dialysis machine on the market. In accordance with the PAS 63023 specification the product is easily connected to a port on the dialysis machine via a cable, allowing the machine’s blood pump to stop automatically when the Redsense alarm goes off.

The alarm unit can even be fully integrated into the dialysis machine. Thus far, dialysis machine manufacturers Nikkiso and Physidia have already implemented PAS 63023, effectively minimising the risk of severe blood loss during treatment.

Clamping the bloodline automates intervention

In parallel, Redsense is exploring other options for decreasing the dependency on manual intervention in treatments where the machine in use does not support direct integration.

The Redsense Clamp, currently in prototype testing, is a novel accessory device to the Redsense Alarm which will enable an automatic stop to the blood flow irrespective of the type of dialysis machine being used. By clamping the bloodline automatically as soon as blood leakage is detected, the machine’s blood pump is prompted to stop immediately. Equipped with this innovation, the Redsense solution becomes an automatic life-saving system in itself, without having to rely on human response to alarms or the availability of specific dialysis machines.

To ensure rapid attention, a new, updated version of the Redsense device will also be able to connect to the nurse call system of the clinic; this feature is currently being tested in clinics in the Netherlands.

Other applications of Redsense’s proprietary technology platform for optical measurements are also under development, such as a low-cost, disposable sensor layer measuring blood and exudate in wound dressings, a product aimed at the advanced wound care market.

Additional advantages

The performance of the Redsense system derives from the fact that it focuses on one thing only: its sole function is to detect blood loss, and the optical sensor reacts at any point that it comes into contact with blood – always alert, without the trade-offs of pressure monitoring and without the risk of false alarms posed by other means of detection. It keeps the electronics at a safe distance from the open wound; and the sensor patch – the only disposable part of the system – is made entirely out of plastic, which keeps the overall cost at a minimum.

The safety solution needed for confident at-home treatment

The Redsense alarm is particularly valuable for high-risk patients, nocturnal treatments and patients receiving haemodialysis at home, where there is a greater risk of an emergency going unnoticed. The US department of Veterans Affairs (VA) has made the use of Redsense mandatory for its high-risk patients.

Today, the majority of haemodialysis treatments are conducted in clinics, but home haemodialysis is growing very rapidly – particularly in the US. To combat skyrocketing Medicare payments for kidney care, a new US policy initiative has been adopted to promote disease prevention and encourage a massive transformation to in-home dialysis by means of modified payment structures.

Patients who do not have to visit a clinic for every treatment soon begin to appreciate the convenience of being able to stay in the comfort of their own home, and to cherish the opportunity to lead a more independent life with more freedom and more quality time. Since home treatment is associated with more favourable clinical outcomes, it is hardly surprising that it often becomes the preferred choice of patients as well as physicians when the option is available.

As a result, leading providers are now engaging in large-scale efforts to provide the education and assistance required for at-home modalities of care – but for this reform to be successful in harnessing these promising possibilities and improving the quality of life for patients, it has to be supported by smart use of technology, such as the Redsense alarm, to put the patient’s mind at ease and ensure that the less restricted environment does not come at the expense of safety.

Redsense promotes patient safety, prevents suffering and provides a highly cost efficient life assurance which facilitates a much more convenient, accessible and comfortable haemodialysis treatment in a variety of settings, close to the patients and with their benefit in mind.

This article is from issue 16 of Health Europa. Click here to get your free subscription today.

Contributor Details

Sebastien Bollue

Director Commercial Operations
Redsense Medical AB
Website: Visit Website
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