PART I – Patient Safety
Since the hip and pip scandals, and the subsequent changes in the EU regulatory environment there is no denial that there are increasing clinical evidence demands for medical devices in Europe. But what is driving this increased need, and does the increase mean that more clinical data need to be collected or that ‘just’ the quality of the data collected needs improvement? Of the elements to be considered, by far the most important one concerns, to my opinion, the patient, and more specific their safety; After all we are all likely to become one at some point in time!
September 17th, WHO declared patient safety as a key health priority, and when dealing with medical devices, especially those supposed to function inside the patient’s body for years – think artificial heart valves, hip & knee prosthesis, meshes, etc –, sufficient clinical evidence should be present to be reasonably sure that patient’s safety is warranted before they are exposed to the device. However, due to the nature of some of the devices involved it may not always be possible to collect all the clinical data needed for the full product life time before it is brought to market (also see my previous blog post on this topic). In such cases, a Post-Market Surveillance program should be present to capture safety issues with long-term use, and nowadays EU device directives require this to include (pro-active) Post-Market Clinical Follow-up. Looking into the case of the metal-on-metal hip prostheses; the devices were brought to market without Pre-market clinical testing (mostly safety is then based on data from similar products), but a Post-Market study was set-up. When with time the device showed having issues though, due to sliding metal surfaces causing tiny metal particles to wear off of the device into the bloodstream, it seemed that the issues were picked up late in the process and many patients were not heard. The story on the pelvic floor meshes unfortunately shows similarties and a study published last year indicates that the
“web of equivalency claims”
may well be part of the problem and raised concerns over the efficacy of such regulatory options in ensuring patient safety.
On the other hand clinical trials and device approval processes are time-consuming, and especially when the medical device in question is about an unmet need and/ or last possible treatment option, or (maybe even worse) is approved for application elsewhere on the globe, it almost like the system is impeding patient’s access to new treatment options. It is not for nothing that crowfunding for medical therapies is on the rise, and that desperate patients arrange for an allegedly safe & effective treatment abroad out of their own pocket. In such cases I often wonder who defines what is an acceptable level of risk for the patient, and why do criteria seem to differ across the globe?
And, last but not least, there is the ethical aspect of redundant duplication of clinical studies to consider: Patients should not be ‘used’ as guinea pigs and participate in clinical trials with possible (additional) safety risks when not needed. Even when the designs are slightly different, we should ask ourselves whether the study under discussion is really needed and whether this need outweighes any possibles risks the study participants are exposed to. It is not for nothing that the new (draft) version of ISO 14155 demands a much tighter ongoing interaction with riskmanagement.
So although strongly depending on the type of device and the manufacturer’s approach, generally speaking, I believe, that to better guard patient safety more (pre-market) clinical evidence is needed with, in addition, better & faster controls, while carefully weighing & evaluating existing clinical evidence in light of the alternatives for the patient at hand.
Feel free reaching out case you would like to discuss any of the above and/ or need support developping your medical device clinical strategy.