Lost inside you - building a device database
When there is no national database, finding who's got faulty medical devices is a challenge
Every day, thousands of operations take place in which medical devices - pacemakers, artificial hips, deep brain stimulation systems - are placed inside the body and left there. Sometimes, there turns out to be a problem with such devices - and just as with faulty car parts, the NHS may need to recall them or at least warn patients that their health could be at risk.
So it was with vaginal or pelvic mesh, implanted in something like 100,000 women in the UK to treat conditions such as prolapse or incontinence after childbirth. After the mesh was found to be causing severe pain in some women, the procedure was paused in 2018 and some had operations to have it removed.
But finding out how many women were affected ran into a problem - there was no national database recording just who had had mesh implanted in them and where. And as I learned when I met Kelsey Flott and Phil Buckley, this is a wider issue, with little in the way of systematic recording of medical devices inserted into .patients.
Kelsey, Deputy Director of Patient Safety at NHS England, and Phil, from the public sector consultancy PSC, are part of a big drive to sort this out. That follows the 2020 Cumberlege Review into the NHS response to the vaginal mesh scandal and other problems with medicines and medical devices.
“My team is very focused on how do we make sure our digital technologies are safe. How do we use digital technologies to drive safety? " explains Kelsey - and her work with Phil is all about using pretty simple technology to address the data problem.
When the mesh scandal broke, individual hospital trusts had some records of patients who’d had implants, but, says Phil Buckley, accessing them and identifying people involved a huge amount of manual labour - “literally people going down into basements and opening filing cabinets to try and find out who they were and who was affected by this.”
What was needed was three things - for every item that was going to be put into a patient to have a barcode, for that barcode to be scanned and associated with a patient, and for data collected locally to be shared nationally.
Kelsey Flott says even when devices do have barcodes, in many hospitals the details are still painstakingly typed into a webform, rather than scanned. “You'll see in theatre people who are literally employed to type in barcode information - you can imagine the detail and the focus it takes to do that accurately.”
It’s not as if using a scanner is particularly hi-tech. as Phil points out, staff in any supermarket have been using them for years. But progress has been made - the duo reckon 95% of devices now carry a barcode, with around 40% being scanned.
Why does this kind of simple innovation which could boost productivity and save lives, take so long to roll out across the NHS? Part of the answer is the devolved decentralised nature of the system, a strength in some ways, but inhibiting the transfer across the service of knowhow from innovative hospitals.
But the biggest headache is around the movement of data from hospitals to the centre. Phil explains that creating a national registry of people who have pacemakers or artificial knees or any other device involves changing the law: “There's literally legislation to allow people to submit their data from an individual hospital trust over to the central database.” In the meantime, every trust is understandably paranoid about losing control of its data. But unless they share, a patient who has a device implanted and then moves to another area may be harder to trace when things go wrong.
Luckily for Kelsey Flott and Phil Buckley, the data sharing issue is being handled by others. Their mission is to share the good news that scanning is a very simple way for hospitals to acquire the high quality data needed to build national registries of medical devices in patients. That, however, will involve persuading dozens of hospitals to spend money buying equipment and training staff at a time when budgets are under pressure - not so simple .