John Wilkinson OBE, chair, Global Medical Devices Nomenclature Agency (GMDN), writes about the importance of master data sets for medtech organisations for achieving global collaboration, and why they, and especially regulators, should be working harder to create and exploit these.
If COVID-19 has taught us anything it is about the value of collaboration amongst the many communities that are charged with safeguarding public health. This coincides with the digital revolution which is transforming both the scale of information available and the way that organisations can both use and share data.
Global collaboration between regulatory authorities has always made sense as it reduces duplication and should enhance the development and deployment of common processes to manage risk in all aspects of healthcare delivery. It is less than easy to deliver as it demands mutual trust not just between regulators, but also political systems. Holding your local regulator to account is much easier than accepting that there is reliance on others beyond your control, although mutual collaboration and dependence has long been a feature of global supply chains and limited resources amongst authorities.
Medical device regulators, unlike peers in medicines, lack many of the global support mechanisms which can act as catalysts for collaboration whilst driving very real cost and effectiveness improvement for all stakeholders. Standards and guidelines play a very big role in helping organisations work together, share data and avoid high levels of variability of understanding, interpretation and subsequent response to public health threats.
Almost all major organisations are going through some degree of digital transformation in order to tap into the huge potential for new information technologies to help them manage an exponential growth in data. That growth in data provides both the opportunity to do things better, but also the threat of increasing complexity, to the degree that maintenance of systems and databases becomes an enormous burden to individual organisations.
A clear master data strategy can be a critical to reducing maintenance burden, whilst enhancing utility and supporting collaborative working. The Global Medical Device Nomenclature (GMDN) has its roots in such thinking and is increasingly being used as a master data source by a wide variety of stakeholders, not just regulators.
Lots of organisations need unambiguous definitions of products and ways of sorting those into manageable groups for a variety of purposes. If all organisations within an area of endeavour decide that they will use a common source for information or standard then that third party, provided that it is reliable and trusted, can save each individual organisation from the need to develop and maintain its own data management tools. GMDN is one such organisation in the medtech space and increasingly stakeholders (particularly authorities) are downloading the latest version of the truth that GMDN represents. This gives them several benefits:
- Elimination of need to establish and maintain their own structure and analytical architecture;
- Access daily to updates and visibility to new innovative technologies as they come to market;
- Assurance that information exchange between participating organisations is done on a comparable basis (one version of the truth shared by all).
Vigilance was at the core of the rationale for establishing the GMDN and it is in this area that there is the largest potential for utilising data sharing tools. Processing adverse event data and acting upon it is a primary responsibility of regulators worldwide. It is also often a rather poor source of information to help manage public health risk in relation to medical devices. Looking at larger public health data sets for signals and indicators of performance, both good and bad, is likely to be a better source of information in the future. This is because vigilance processes rely heavily on reporting and quite a lot of interpretation by intermediaries.
Large public datasets which surface variations in outcomes are more likely to provide early information about performance of health systems. These will help to sort out the often-knotty problems associated with failure and what was the causality. Was it the device, the process, the clinician, the patient, ancillary drug therapies, or something else? Hopefully this sort of information can also help us to shift from a tendency to try and apportion blame (often in a binary way) for what may be very complex multifactorial issues. All this would help to move from a culture of managing failure to one of driving for continuous improvement, which is at the heart of medical progress and always has been.
To achieve all this there will need to be an emphasis on harmonisation of standards and data management tools. In the devices area there has been quite a lot of progress dating back to the establishment of the Global Harmonisation Task Force (GHTF) right through to the recent agreement within the International Medical Devices Regulators Forum (IMDRF) to categorise adverse incident reporting. Unique Device Identification (UDI), complemented by GMDN, will be a critical tool in capturing and linking devices to patient records so that these can be mined for data in the service of better outcomes for patients. The more standardisation, the easier it is to pool and analyse information and share best practice. But it does all demand high levels of agreement, sharing and trust.
The recently published UK Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege, highlighted the need for systematic record keeping of both products on the market and, in the case of implantable devices, linking those devices to patient records, in a way that facilitates a better understanding of performance at both individual and population levels. Using well-constructed public databases and allowing safe access for research purposes, such as that facilitated by the UK Clinical Practice Research Database, offers to accelerate decision-making about adoption of new interventions as well as spotting those that are not working as well as expected and taking decisions to manage risk in a more effective and timely manner.
Strong leadership from stakeholder groups is needed in order to ensure that the suite of data management participants act in concert in the best interests of patients and set aside the not unnatural tendency of organisations to just see the world from their own perspective. Vehicles to enhance global regulatory development and harmonisation lie at the centre of addressing better outcomes and I hope that COVID-19 acts as a catalyst to this work.
