The MDCG published their PSUR guidance and template last December (see here if you haven't yet picked this up). I think this is a good thing, because with something relatively new like the PSUR, the industry needs nudging towards standardisation, and we would all benefit from some concrete feedback on whether our reports are up to scratch, particularly for lower risk devices and they are only assessed once a year (at best) by our Notified Body auditor.
But how should a good PSUR fit in your overall PMS and vigilance system? Is it a help, a hindrance or a minor annoyance?
If you already have a mature PMS system, I doubt the need for a PSUR has changed your ability to detect problems, but there are going to be choices you can make to ensure that it slots into your system and isn’t an additional paperwork headache. Annual PMS reports have always been needed, and many manufacturers will already have created two or three PSURs by now and will have a process for creating the report, but is it a fundamental part of the process? A bolt-on?
For those with newer devices or devices newly classified under the MDR, and where the PSUR may be part of a fresh challenge to build a better PMS system, I think it can inform moving towards a goal of an effective system that really works to find and help report safety problems. I’m not suggesting the new guidance is everything needed and has no flaws, but the principles and format of the data analysis suggested in the template PSUR certainly points in the right direction.
So how can the PSUR template inform a good post market surveillance system?
First, PMS findings should be directly connectable to risk analysis
Figure out exactly what customer problem tags or complaint tags in your CRM relate to hazards and causes, so you can easily search and count events, then understand the quantitative impact on risks and your overall benefit-risk case. There may be some grouping required here, as customers often don’t distinguish one failure mode from another, just that the device failed in some way. Create a mapping or translation of your failure modes and hazards into a customer support facing language and define your techniques and limits for assessing the data within your PMS plan to make the most of this. Done right, with will help you keep your risk analysis up to date in a frictionless way, and also develop a greater ability to detect and report trends in events.
The converse of the risk mapping to your CRM is true, as you can also use a concrete way to connect positive feedback from patients and customers with any claimed benefits or performance specifications for your device. With this in place, you can have a steadier stream of data feeding your PMS and PMCF in addition to the slower cadence of planned PMCF studies.
Second, complaints should align with the standard terminology
How is your complaint log and procedure organised? Is there any alignment of the data you collect and IMDRF problem codes expected in your vigilance reports? (The UK, EU and the FDA all use them.) Consider either using them directly, or develop a mapping between them and your CRM system and complaint procedure. With this in place, there should be a smoother transition from complaint handling to incident reports ready for regulatory submission, and also a greater alignment with the language of the PSUR.
Finally, make your PSUR a natural exhaust product of your real PMS and vigilance
The PSUR template suggests decent content for summarising both vigilance, PMS and PMCF activity, that should be part of any regular PMS analysis designed to do the “real work” of interrogating your post market data for any safety problems. Why go to the lengths of monitoring post-market data one way, and then regurgitate it in another format for your regulatory report? By using standard terminology and adopting patterns of analysis that align with the template, there is only one report to put on file that is both your active PMS report and a PSUR that should easily pass muster under audit.
In summary, with your risk management, PMS and vigilance systems connected up and speaking the right language, you should be able to:
effectively search for recurring problems and do the essential job of maintaining safety;
use real world events to quantitatively update your risk and benefit analysis;
establish any trends in problems, maintaining safety and triggering vigilance reporting at an early stage;
seamlessly translate your customer feedback and complaint data into vigilance reports ready for submission; and
quickly summarise your PMS data and vigilance data in a way that slots straight into your PSUR.