TCC-CASEMIX has created a unique infrastructure to provide total traceability of medical device performance. This infrastructure is supported by The Association of British HealthTech Industries [ABHI].
We refer to it as an 'Open Registry Infrastructure' for medical devices.
It is 'open', because unlike existing clinically focused registries, which are 'closed', we enable wide searches across the registries connected into it.
It is 'open' because registries will 'declare the content' (I don't know what I don't know, so how can I search for what I don't know?)
Access to this infrastructure is through a Data Access Portal which is being configured for the specific needs of each stakeholder group.
We are seeking interest from patient groups who would like to join an Advisory Board to help specify how data should be presented to patients in a way that is relevant and meaningful. Our vision is to link this portal into an enhanced pre-operative assessment process, and to transform patient informed consent.
We are currently developing the Open Registry infrastructure in South West England, and are bringing together medical device manufacturers (from the world's largest to the smallest) and NHS trusts, with their surgeons that already have relationships with specific manufacturers.
Using the system: a patient example
Imagine that you are in a consultation with your surgeon, who advises that the mitral valve in your heart needs to be repaired. Your surgeon advises that this procedure can be done with minimally invasive surgery. They recommend using Device-X and you ask, "Why, what evidence do you have that this will work best for me?" Your surgeon replies, "This is the best knowledge that we have."
You and your surgeon would then access the Portal. You would search for Device-X, maybe with a specific Unique Device Identification number (UDI) and/or a GMDN code (all of this is presented in a browser to help you search for the correct device). You find from this search that Device-X has been used in patients in three different European countries. You also find that the latest evidence is that it is best suited for patients with large frames, indicating that you may well be better suited to Device-Y. In searching for Device-Y, you also search for the generic description of this device, and find that manufacturers A, D, J and P, all make similar devices of this size, suitable for your needs.
Now you search for Adverse Incidents corresponding to Device-Y across all of these manufacturers, and find that there are incidents associated with manufacturers D and P. This enables you and your surgeon to make a better-informed choice about the device that is right for you.
How do we acquire medical device data?
We have developed a unique capability to acquire data in real-time during surgery, and in association with device manufacturers. Our tech pushes appropriate data into a local registry and this becomes the foundation of data acquisition across Europe. We are already working in Central and Eastern Europe, and are planning a major initiative in Ireland.
The Advisory Board comprises:
Medical device safety experts
Regulatory and Compliance experts
Cyber security and data protection experts
Patient advocacy experts (unfilled)
Notified Bodies (unfilled)
The board is chaired by an expert who has been chief executive of two NHS Trusts and worked for NHS England. It is coordinated by a trained anaesthetist and clinical safety expert.
The board is also supported by a roundtable of medical device manufacturers, who are committed to making this work happen. They are also committed to total transparency of data. They are funding this work. The support we have been receiving from medical device manufacturers has been astonishing.
This is a major opportunity to contribute to patient safety and help transform the patient consent process. If you are interested in finding out more, please contact
[email protected]
This blog from Matthew Bacon, CEO of TCC-CASEMIX Ltd, looks at why a multi-factorial dataset is needed to create holistic understanding of medical device performance and is the only effective means for determining the multi-factorial causes of failure. The Department of Health and Social Care has proudly announced that it has mandated the tracking of high-risk medical devices within NHS trusts – all in the name of avoidance of harm to patients. So, the Cumberlege report is now sorted! Advocates of patient safety need to be far more critical. I for one am astonished by the nativity of this simplistic strategy. A recent article in the New York Times suggesting that medical device makers have bankrolled a cottage industry of doctors and clinics that perform artery-clearing procedures that can lead to amputations is a great example of why I hold this opinion. The central point of failure here was not so much the failure of the medical devices (for example, stents, guidewires and catheters), but the procedural method associated with use. There will also be patient risk factors that are pertinent to the failure as well. The loss of a limb is the direct consequence of the surgical intervention. At TCC-CASEMIX Ltd we do not only identify each use of the device (Class IIb & Class III), but we also acquire a multi-factorial dataset to create holistic understanding of medical device performance. A few examples of the datasets that we consider are critical are: Patient risk factors (a few pointed out in the article New York Times article). We correlate these factors presented through the electronic patient record, with post-intervention outcomes following a procedural intervention tracking the use of the medical devices. This is how patient learning becomes part of the feedback loop to inform which devices, aligned to specific methods and outcomes, enable predictive safety. Procedural method. The best medical device used inappropriately (often with lack of evidence to inform the decision making by the health professional) can substantially increase the risk of harm to the patient. In many different interventions there are a variety of alternative procedures and associated medical devices available, each of which can be correlated to different patient complexities (risk factors). Human factors. Research shows that there can be repeated failures of the devices because of the incorrect/ inappropriate medical device selection. For example, for the less experienced healthcare professional, the choice of the correct size of stent, guidewire or catheter will be critical to the success of the outcome. Incompatibility between any of these devices can lead to an adverse event. Literature clearly identifies that the majority of device failures go unrecorded. This data acquisition platform records exactly what happens during a specific (atomic level) procedure associated with a specific devices or multiple devices used for it and is an effective means for determining the multi-factorial causes of failure. Routine data acquisition beyond simply identifying which device has been used with which patient is clearly insufficient. It will do nothing to improve patient safety.
