Jun 15, 2021

 NHS trials test that predicts sepsis 3 days in advance 

sepsis
MachineLearning
clinicaltrial
blooddisorder
2 min
Queen Alexandra Hospital is trialling a new sepsis test by Presymptom Health that uses machine learning to detect the onset of the disease

A new test that can predict sepsis before the patient develops symptoms is being trialled at a National Health Service (NHS) hospital in the south of England. 

Clinicians at Portsmouth’s Queen Alexandra Hospital are leading medical trials of the blood test, which they hope will help them save thousands of lives a year. 

The test is being developed by government spin-out company Presymptom Health, but the research began over 10 years ago at the Defence Science and Technology Laboratory (Dstl). This included a study of 4,385 patients and more than 70,000 samples, the largest study of its kind at the time. 

From the samples taken, a clinical biobank and database were generated and then mined using machine learning to identify biomarker signatures that could predict the onset of sepsis. The researchers found they were able to provide an early warning of sepsis up to three days ahead of illness with an accuracy of up to 90%.

Unlike most other tests, Presymptom Health identifies the patient’s response to the disease as opposed to detecting the pathogen. This is an important differentiator, as sepsis occurs as a result of the patient's immune system’s overreaction to an infection or injury, which can then cause life-threatening organ dysfunction. 

Worldwide, an estimated 49 million people a year contract sepsis, while in the UK almost two million patients admitted to hospital each year are thought to be at risk of developing the condition. If Presymptom's test is effective, it could save billions of pounds globally and improve clinical outcomes for millions of sepsis patients.

The initial trials at Queen Alexandra Hospital will last 12 months, with two other sites planned to go live this summer. Up to 600 patients admitted to hospital with respiratory tract infections will be given the option to participate in the trial. The data collected will be independently assessed and used to refine and validate the test, which could be available for broader NHS use within two years. 

If successful, this test could also identify sepsis arising from other infections before symptoms appear, which could potentially include future waves of COVID-19 and other pandemics.

Dr Roman Lukaszewski, the lead Dstl scientist behind the innovation, said: “It is incredible to see this test, which we had originally begun to develop to help service personnel survive injury and infection on the front line, is now being used for the wider UK population, including those fighting COVID-19.”

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Jul 24, 2021

A guide to labelling compliance for medical devices

medicaldevices
Technology
healthcare
Compliance
Susan Gosnell
4 min
A guide to labelling compliance for medical devices
Susan Gosnell, Product Manager at Loftware, explains labelling compliance for small medical device manufacturers

Small medical device manufacturers often find themselves scrambling to achieve the necessary compliance and validation, risking costly mistakes.

Validating systems and processes including labelling, to ensure they are compliant with stringent regulatory standards is tough and can be expensive. Indeed, compliance with the EU’s Medical Device Regulation (MDR) will cost more than 5% of annual sales, according to 48% of 101 companies polled by the German company Climedo Health, in July and August 2020 about their MDR-readiness.

But if companies bungle the software validation process or put incorrect and uncompliant data on the labels themselves, the penalties are likely to be more severe than just making corrections. Health and safety may be put at risk and fines imposed for failing to comply. When it comes to compliance, they may become overwhelmed with regulations in other geographic regions that focus on device traceability, each with a unique device identifier (UDI-like) component to it. 

On the validation front, companies may not be familiar with the software validation process and the multiple tests and documentation necessary for validation are demanding if companies only have a small IT team that is very busy.

Putting a plan in place

MDR-compliant labelling, however, brings with it certain requirements which differ from what is demanded under the FDA’s Unique Device Identification (UDI) system rules. Under MDR, for example, manufacturers must ensure the label specifically states the device is a medical one using an MD symbol in a box. This is only one of many stipulations that usually require redesigned labels.

Small medical device manufacturers who rely on time-consuming and error-prone manual or legacy labelling processes to facilitate these label updates run the risk of mislabelling which can lead to non-compliance.  They may have limited staff and no structured processes around roles and responsibilities when it comes to label design, changes and approval. As project leads work toward a compliant labelling process, it is therefore important to establish defined roles and access for each stage of the process.

When dealing with a compliance initiative, up to date, correct and compliant labelling is imperative. This involves having all the relevant label design elements in place to comply with the EU MDR or FDA regulations. Many times, label templates are hard coded, meaning IT must be involved in making changes. And with IT staff often being tasked with multiple mission-critical projects in the organisation, labelling projects can be delayed. For many small medical device manufacturers who have limited resources, finding a solution can be a challenge.

Why labelling in the cloud offers a roadmap forward

Validation-ready cloud labelling solutions have now emerged to ease compliance with regulations and time-consuming validation requirements. These solutions, built with the needs of regulated companies in mind, digitise the quality control processes and facilitate compliant labelling with role-based access, approval workflows and electronic signatures. Outside of compliance, carrying out labelling in the cloud drives scalability and productivity for small medical device manufacturers and boosts overall efficiency.

The latest cloud labelling solutions integrate with other cloud solutions, allowing for seamless functionality and minimising the need for local infrastructure resources and cost.

When it comes to validation, as with many labelling systems, those hosted in the cloud have vendor-supplied documentation that streamlines the process and significantly eases the burden when it comes to installation qualification (IQ). The manufacturer itself has a much lighter burden and a streamlined path to a validated system and process.

A more relaxed software release schedule eases the validation burden on life sciences companies because the software is updated once a year rather than multiple times. This gives them a continuously updated and maintained labelling solution without increasing the validation workload on their IT staff.  

Future-proof technology

The manufacturer would of course need to work closely alongside the vendor and review the documentation, but, if needed, the vendor is able to do much of the work for them, providing not only the full validation acceleration pack but also professional services to assist with the validation process.

While some medical device manufacturers choose to tackle validation on their own, the vendor supplied validation acceleration pack or documentation helps to simplify the process. Consultancy and advice around validation is usually available from the vendor, tailored to the business’s specific needs.

Given the immense hassles of compliance for small device manufacturers, cloud-based labelling systems offer the benefits of a full label management system while easing compliance and validation. This is a future-proof technology. With a cloud-based labelling system, medical device manufacturers can be confident that they are running the most up-to-date software, enabling them to address the fast-changing new regulations and cope with whatever comes their way. And especially in the current pandemic, when face-to-face meetings are still problematic, it is a perfect way to keep labelling operations moving forward.

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