Subtheme | Quotations |
4a: Availability of UDIs for RWE Studies | ‘We know exactly…it was that device 100%, so it would be right with that UDI, and so we’re able to tie it to patients for longer-term patient outcomes than just, ‘Hey, I got out of the hospital without a problem.’ ‘If you wanted to do a research project on a specific device, you tell us what that device was, and we’ll find the device identifier that goes with that and be able to pull all of the data from our database, based on that device identifier.’ ‘If we’re having a problem with something…say our total hips had a big infection rate, we could track back and see [the] UDIs to see what specific devices were used. Or we’re having a problem in the cath lab with device failure, we would go back and trace them by that.’ ‘Before, it was largely done by catalog number….So, we would try to do the analysis, and there’s just a lot more…concern about integrity if you’re using a catalog number that we’re making some really important decisions on….Without a unique identifier that you can—you know was scanned or captured by the clinician when they implanted that, so you really run the risk of not capturing or attributing the wrong outcome to the wrong product.’ |
4b: Lack of UDI Availability for RWE Studies | ‘Almost every case of an MDEpiNet or a NEST project, you end up with a structured code version of the cohort, and then you have to either use manual chart review or natural language processing to actually ascertain the correct device exposures. And so, in either case, it’s expensive, and then it’s hard to scale that… as the community has UDI more widely available, you will see much more accurate identification.’ ‘[The] ecosystem for medical device research is so nascent and underdeveloped because we can’t do large database studies like this. We’re just – we’re always kind of roping forward, trying to do research. We’re ending up doing smaller studies. We could be doing much better, rigorous evaluations if we had this type of work - this type of information available to us.’ ‘When you’re considering potential device related issues, it would be very, very helpful to have the UDIs that you know specifically exactly what…device you’re dealing with. As opposed to the current system where you’re looking at classes of devices that have to do with either broad serial numbers, or broad labels. …It gives you a much more granular and detailed idea regarding exactly which devices the problems are related to, so there’s really no guessing.’ ‘I can’t imagine that we are so behind the curve. It’s a little curious to me, and a little disappointing that we have just not been approached in any way regarding this.’ |
RWE, real-world evidence; UDI, unique device identifier.