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Patient safety


Why health registry data is critical to patient safety


Data from health registries already provides vital insight to clinicians and medical researchers. Now the time has come to share registry data more widely with the medical technology (MedTech) industry, to raise the standards of patient care, says Richard Armstrong.


The country took a big step forward in improving patient safety, earlier this year. In June 2025, new regulations on monitoring the performance of medical devices came into force. The regulations, from the Medicines and Healthcare products Regulatory Agency (MHRA),1


strengthen


the requirements for manufacturers to monitor the safety and performance of devices after they are placed on the market. The strengthening of post-market surveillance regulations aims to improve patient safety by ensuring manufacturers actively track their products, collect data on their performance, report incidents, and take faster action when issues arise. With tougher MHRA regulations, it should be easier to flag up problems with medical devices2


early so patients who use a health


monitoring device, or who have had a medical device implanted during surgery, can be assured that these devices are subject to ongoing surveillance. The regulations could also lead to improvements in the design of devices based on patient outcomes data. But for this to happen, manufacturers need accurate data on how their products are performing. Right now, the problem is that few manufacturers have information on their products once they leave the warehouse, unless something serious goes wrong – and by that time it’s too late.


How health registries can help There is a way to get that information into the hands of manufacturers, and the answer is through health registries.3


use of medical devices. Registry data is also actively supporting the wider medical research community. There has been a notable increase in the number of medical device registries since the Cumberlege Review4


in 2020. The review, which A health registry is so


much more than just a database. It’s a system that collects and monitors data on medical treatments, with the expert input of medical professionals. The data helps to evaluate outcomes to improve the quality of patient care. Registries play a vital role in supporting hospitals and healthcare settings, as well as the clinicians who carry out procedures or treatments, particularly when involving the


found that patients had suffered avoidable harm from hormonal pregnancy tests, sodium valproate in pregnancy and pelvic mesh, highlighted the need for a comprehensive device surveillance system. When the Hughes Report5


into redress


for those patients was published in 2024, it recommended that to avoid harm like this occurring again, there should be more patient- identifiable registries for devices and medicines. Some registries started operating long


before the Cumberledge review, and have been systematically collecting and analysing data on medical device performance and surgical procedures for some time. One example is the


40 www.clinicalservicesjournal.com I November 2025


National Joint Registry (NJR),6


which has been


monitoring and reporting on performance outcomes in joint surgery for more than 20 years. If registries are already providing a rich


source of data to clinicians, hospital authorities and medical researchers, the question is why are medical device manufacturers not benefitting more from this data?


The data sharing challenge The obstacles associated with sharing data with the MedTech industry have so far proved difficult to overcome. These obstacles are both cultural and technical, and they are hindering the use of valuable data and real-world evidence which could improve patient outcomes. Understandably, patient privacy is a concern for registries, as well as patients.7


Registries


are cautious about the release of sensitive information into commercial hands, while


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