Mark Wasmuth the CEO of the GMDN Agency (www.gmdnagency.org/), the international not-for-profit body, explains the functions of the UK Medical Device Information System.
Following Brexit and the subsequent passing of The Medicines and Medical Devices Act 2021 (or M&MD), the UK now has a new framework for regulating medical devices.
Part of this was from 1st January 2021 all medical devices placed on the market need to be registered by their suppliers on the MHRA’s Device Online Registration System (DORS), as part of a UK-wide Medical Device Information System (MDIS). This will, for the first time, provide a valuable national resource for government departments, hospitals, patients, and suppliers to identify and manage the medical technology they use. This public database will meet the growing need of stakeholders to find more accurate information about the devices they are carrying around with them and supports recommendations from the recent Cumberlege Review on effective medical device regulation.
Importantly, the database will feed accurate device information to the systems used by the NHS. For example, it will for the first time allow all departments in a hospital network to get accurate clinical descriptions for the devices available on the whole UK market. The slow take up of new technology by clinicians has long been the challenge for manufacturers, and more comparative products information will enable clinicians to be more aware of the options.
Further, as use of all devices is recorded more accurately, it is envisaged that more data on where they are used, when they are used and how they are used will become available to track use trends in real time, something existing implant registries, such as the National Joint Registry, can only manage to do annually from data which is a lot older.
This new MDIS is going to prove to be a hugely valuable resource, particularly for any medtech company or researcher looking to compare similar medical devices from different producers, whether for epidemiological, procurement, benchmarking or other purposes.
The trouble with the old way of recording device use is that the accuracy of the data collected was poor and prone to errors, like keying errors, especially when reliant on hard-pressed clinical staff at the end of a busy shift to type into spreadsheets or even worse, paper forms. We can now scan barcodes directly from the product or its packaging and use a database, like the MDIS, to quickly validate the scan with accurate product descriptions displayed to the user, just like in the supermarket.
Data driven healthcare will provide clinicians with ‘real world evidence’ to support the decisions they make about the choice of device for their patients. But also allow those who plan healthcare to have a better overview of trends related to patient care collected from the whole NHS and even private clinics.
With more information about how devices are being used in practice, regulators and manufacturers will be able to assess the application of new technology faster and promote more effective and safer devices to a wider audience. Also, the use of this data will support claims from manufacturers who make similar products, known as regulation by the equivalence route, where a manufacturer can demonstrate sufficient equivalence with another device that is already cleared for safe use, thus cutting down on the costs of unnecessary clinical trials.
There is a reliance on being able compare products that have similar clinical characteristics, and this is where the GMDN (Global Medical Device Nomenclature) provides a common description. The good news is the GMDN is used all over the world by regulators to support their approvals process and all manufacturers are familiar with its use and help keep it up to date with the latest technology.
This means that GMDN data and vocabulary, which is already used by the MHRA and FDA, is especially valuable as it can, for instance,dramatically smooth the approvals process.
For example, large healthcare publishers like Elsevier now use the GMDN in their Embase clinical research product, which is used by companies looking to find research to support their claims of compliance, especially useful now that regulations need manufacturers to show evidence that their product is both safe and effective.
Unlocking the valuable data that is held in national institutions, like the NHS was one of the key drivers in the UK government’s National Data Strategy and the reason for setting up the NHSX to “drive the digital transformation of care” and Health Data Research UK who “manage and analyse very large amounts of different datasets across our health and care systems” to empower clinical research. But quick analysis requires the use of structured data standards, otherwise comparisons are very difficult and requires a lot of resource.
As the GMDN is now at the heart of the MDIS, providing strong and structured data for those that need to measure the safety and performance of product, as well as being able to help with identifying any gaps in a company’s product portfolio, or with stimulating new ideas for innovation.
As we all know, better data makes better decisions…. and the MDIS will provide medtech with new and insightful data that is both current and accurate.
