Encode Health response to the Cumberlege report, “First Do No Harm”​

Encode Health response to the Cumberlege report, “First Do No Harm”​

At Encode Health we believe in personalising healthcare and access for all. At the heart of everything we do, is keeping you, the patient, at the center of your own care.  As a community at Encode Health, we would like to say “we hear you”.

The review highlights the avoidable and harrowing accounts of how patients were adversely affected by the three treatments of hormone pregnancy tests (focusing on Primodos), the anti-epileptic medication sodium valproate and pelvic mesh implants used in women with urinary incontinence. These patients’ voices were not heard when life-changing complications occurred for them and their children.

We truly hope that the first five of nine recommendations are enacted by those who truly are inspiring and provide excellence in UK healthcare with support from the government, to redress those who were expecting better outcomes for themselves and their children. It is the sixth and seventh recommendations where Encode Health can help: 

  • The MHRA needs substantial revision, particularly in relation to adverse event reporting and medical device regulation. It needs to ensure that it engages more with patients and their outcomes. It needs to raise awareness of its public protection roles and to ensure that patients have an integral role in its work.
  • A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. This can then be linked to specifically created registers to research and audit the outcomes both in terms of the device safety and patient reported outcomes measures.

The review highlights the UK healthcare system’s technical inability to know how many people have been affected and how they were affected for the reviewed treatments. This is an ongoing issue for other treatments, with the confirming statement in the report: “The lack of such vigilant, long-term monitoring has been a predominant thread throughout our work. Its absence means that the system does not know the scale of the problems we were asked to investigate”. 

Encoding with Encode Health, any medication or device and voicing your concerns about your management, allows for a better and systematic examination of claims about performance of any treatment. This means a safer system of healthcare for you undergoing treatment and a safer warning system for those considering the same treatment after you. 

It has been a long time in recognition that teams and institutions such as MRHA, GIRFT and Scan4Safety, see the need for validated Patient Reported Outcome Measures (PROMs) and Patient Reported Experience Measures (PREMs) to support much needed and long-awaited data on the relative risks and benefits of different medications and insertable devices. The online yellow card system seems outdated and a live database that provides alerts and reports at a moments notice is what should be… the normal. This should happen without the need for patients and clinicians to actively insert a complex history about their treatment, but something as simple as pressing a button on your electronic health record. The Encode Healthcare passport uses SNOWMED codes to tag important clinical outcomes and “aligns the stars”, when important information is requested at a moments notice to help map out aggregate clinical pathways. 

We believe that ongoing clinical evaluation of all healthcare treatments, medication and devices should be a must and the audit process should be as easy as looking at the outcomes on a dashboard. The new Medical Device Regulations (MDR) which were set to be enforced in May of this year have still left many in the healthcare industry wondering how ongoing post market research will be implemented for their supply chains. This is particularly difficult as once a device is inserted it becomes part of a patient’s private healthcare records, so investigating possible problematic issues is costly, time consuming and requires engagement with GDPR or section 251 of the research obligations. As the UK exits the European Union it is especially worrisome as the market economics will impact medical supply chains and devices, stripping the NHS of the ability to procure the assets in the independent manner it currently does. Medication and devices that have a proven track record of safety, could be replaced very quickly as intellectual property rights may well be enforced with other countries as part of a trade deal, forcing the hand of procurement teams to buy specific products. Bad clinical outcomes are not only bad for patients, but also bad for industry reputations and so it makes economic sense to prevent ongoing issues and have the ability to audit products regularly and recall products whenever a negative clinical threshold is met. At Encode we can help the medical suppliers and providers simultaneously map out issues through our tailored dashboards and target focused interventions globally.

It is also important to note GS1 and interoperability standards to ensure that national registries at this scale can house and share unambiguous data. At Encode Health we provide the Encode Healthcare Passport as a highly secure digital identity that enables patients to identify themselves or to be identified by healthcare professionals quickly and effectively within care settings. Very importantly it enables patients to provide and control permissions to store, view and use anonymised data for research. The Encode platform has been designed to track and trace medical devices, from manufacture to patient and on through the device life-cycle. We enable real time data on implant usage, adverse incident recording and live supply chain management tools. We simplify this process and call it… ​“Encoding”​. 

As the review clearly stated: “We cannot take away their pain. But we can make sure that it doesn’t happen again. And the only way to do this is to make patients the beating heart of the healthcare system. And the shame of it is that thousands of women and children had to suffer first.” At Encode Health we hear you, and we will do our best to create a change in culture and to not let such avoidable suffering happen again.

Courses of action: The Encode community will be reaching out to the MHRA, Department of Health and Social Care, NHSDigital and others offering our services free of charge to patients immediately. We look to work with these organisations to improve upon their functions and give them tools to work with. For hospitals and other healthcare providing institutions we will be offering an Encoded device free of charge.

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