PATI ENT SAFE T Y
Optimising registries key to deliver safer care
The Cumberlege review into serious safety failures in healthcare, relating to medicines and medical devices, highlighted the absence of meaningful data. However, Richard Armstrong discusses why information gathering alone will never deliver patient safety.
The Cumberlege review1 published in July
2020 was the culmination of an in-depth investigation into three significant medical crises that have occurred within the last 60 years. These include the birth defects linked to the use of sodium valproate, an epilepsy drug and primodos, a hormonal pregnancy test, as well as the more recent pelvic mesh scandal which left many women with problems such as chronic pain, disability and urogynaecological damage. While Cumberlege praised NHS staff for their tireless commitment in responding to the ongoing COVID-19 pandemic, the review used words such as ‘disjointed, siloed, unresponsive and defensive’ to describe the health service in the way it responded to the crises under the spotlight. The findings made grim reading for all those who shape, work in and come into contact with our healthcare system. One of the issues raised was the lack of meaningful information available to the
review panel. The suggestion was that key data such as the number of patients affected and the detail relating to how they had been harmed was often either absent or difficult to source. This raises the question of how patient records and detailed information relating to the treatments and devices could be made more easily accessible to those who are responsible for protecting and supporting the journey of a patient through the healthcare system.
The critical information gaps When medical crises happen in the health sector, a new database or registry to collect information on clinicians, implants and treatments is often regarded as the most effective way of preventing them from reoccurring. Indeed, the sector has been moving in the direction of mandatory healthcare registries in recent years to help plug information gaps. The theory behind
this approach is that if data is available centrally, the health service can be alerted to failing implants, poor surgical procedures and even bad practice so that action can be taken before patients are harmed. However, the practice of simply gathering data should never be regarded as a silver bullet for avoiding clinical disasters. A health registry is only as good as the information it contains so creating the database alone is simply not enough. There are a number of critical success factors that ensure that a registry will deliver on the promises that they are so often setup to keep.
Product developers that are able to see accurate information on the longevity of joint replacements, though registries, can play their part in enhancing safety.
MARCH 2021
Shaped to fit The most important aspect is that a registry needs to ensure that all those required to contribute data can do so quickly and easily as part of their typical daily routine. If clinicians and others in the health service find the whole process of populating a registry with information too complicated or overly time consuming, they simply will not commit to it. For this reason, registries need to be designed around clinical practice so that healthcare settings don’t have to change the way they do things to suit the technology. The workflow should be shaped to fit the way health practitioners currently work. An outpatient clinic must be able to use the system as easily as the surgery staff so that all relevant clinicians can contribute if appropriate. Without this, a registry will lack that vital national picture. This can lead to poor medical practice being left unchecked or more lives blighted by the continual use of harmful devices. Once the right information is flowing into the system, then the focus should be on getting the right information out and ensuring that data is being actively used to inform decisions and effect change. This is the difference between a static database and a comprehensive registry that
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