My Lords, I will speak to Amendment 97 in the name of my noble friend Lord Kakkar, to which I have added my name. Before I do so, I have a comment in response to an important question asked by the noble Baroness, Lady Cumberlege, which my noble friend Lord Kakkar answered. How do you test the effectiveness of a device which is an implant, and is likely to remain in the body permanently? This is opposed to implants such as pacemakers—as I alluded to on Monday—where, in one example, a device was unsatisfactory after having gone through testing, but was then implanted in 1,400 patients before its faults were clearly recognised. In that case, it was possible to remove the device, and put in one which functioned better. The testing of an implant which is
likely to be permanent must be more rigorous, in terms of its tissue reactivity, in the training it will require, and in the possible harm it can do. This is particularly true for things like mesh that are likely to be embedded into the tissue. People claimed that that mesh was safe because it had been used by surgeons for years for hernia repairs. As I said on Monday, I have never used mesh for any of the surgery I did, so I do not know its performance. The question of the noble Baroness is quite right: it does not mean that we do not have to progress with finding new medical devices which would be effective; it means that we need to ask significant questions, depending on the device we are talking about. I may not have answered her question, but I have tried to identify ways we might do that.
My noble friend Lord Kakkar has made a very important point about the need for medical devices to be tested for their effectiveness in the functions they are supposed to provide prior to their being granted full market approval. Generally, the design of a medical device is regulated by its essential principles of safety and performance with respect to its design and construction. Less attention is paid to its clinical effectiveness throughout its expected life, whatever that might be. Medical devices play an important role in enhancing patient quality of life, but there is a need for improved methodology to obtain evidence for their safety, performance and efficacy. The UK, with its strong research base, and with the NHS at its core, is well placed to generate the high-quality evidence needed. Guidance is needed to generate, implement and produce the evidence required to foster innovation. Adopting engineering principles of continuous monitoring, reporting of accidents or near misses—similar to post-market surveillance of medical devices—is important. In developing medical devices, dialogue between clinicians, manufacturers, and end users—the patients—to identify which devices need to be developed is valuable, but not often followed.
While not as robust as a randomised control trial, observational studies are important in identifying rare, catastrophic and delayed harm. Furthermore, medical devices are less amenable to controlled trials, being part of a complex system of care, involving people in other systems. The UK has an opportunity to develop specialised medical device trial centres and clinical networks to oversee early to late-phase trials. That initiative would benefit patients and put the UK in a lead position to develop safe and effective medical devices.
The Royal Academy of Engineering and the Academy of Medical Sciences, of which I am a fellow, have much to offer in such an initiative. With his amendment, which rightly promotes the requirement that medical devices should demonstrate their clinical effectiveness prior to a full market authorisation licence, my noble friend Lord Kakkar has also provided an opportunity for the UK to develop leading-edge medical device regulation, and be a place for developing safe and effective medical devices.