We have a very good working relationship. We have regular contact so that any reports that come to us go into reporting systems and are investigated as necessary. As part of the process, we do not just investigate; we look at trends in reporting. For example, somebody might get a report in a particular location and to them, it is an individual report and is not a very strong signal. However, if 10 people in similar locations report the same kind of incident, we can see that there is a trend and that something is out of the ordinary, so we would investigate further.
We have daily or weekly meetings at which we look at individual reports and trending, and then we have higher-level supervision of the trending. I do not know whether members know about the type of people who work in the MHRA, but we have scientists, engineers, doctors, researchers and statisticians. Each of those groups brings something different to the equation. However, the common group in all the interactions is the clinical team. Certain aspects of devices are purely to do with engineering, biochemistry or whatever, but the key to all this is, as I said at the beginning, patient safety. We have to interpret the information from a clinical perspective. In the MHRA, we have some expertise, but we do not have all the expertise—that is not possible. However, we do have access to healthcare professionals who have expertise in all the clinical areas where we require extra advice. The clinical team takes in all that information, looks at it and then says, “This is the balance here.” When we investigate and take action, we have to be proportionate and work on the best scientific evidence that is available.
If we applied the strictest criteria to regulation, there would be no innovation and no products would come on to the market. Patients would not get early benefit from new devices and new technology—and technology is turning over so fast. There are 500,000 medical devices out there that we regulate, and something like 90,000 plus of them are highest-risk devices. That is why the systems that we have in place are about surveillance and about working with all the different groups.
For example, we will watch the trend of how a product that has recently come on to the market is performing. We might suddenly get a whole flurry of reports in, which might be due to a manufacturing fault or a bad batch going through the system. We can pick up that there is an issue and then we can investigate it.
In the not-too-distant past, we had such an incident. Suddenly, a whole group of reports about the failure of devices came into the agency from different sources. When we investigated, we asked the manufacturer what had changed and learned that it had moved its manufacturing facility from one country to another: it had a workforce that was not as highly trained as the previous workforce and the manufacturing tolerances had changed. We picked up those changes and went back to the manufacturer and said, “This is not good enough.” We said that the issue needed to be fixed within a specific period of time.
That was all about the manufacturing process and, between the manufacturer, the notified body and the MHRA, we agreed that the manufacturing would be brought back into proper tolerances. The number of incidents dropped as the old stock diminished. As it was not practical to remove all the old stock, we warned clinicians that there was a potential problem. If they experienced that problem, they needed to report to us and to stop using that batch.
We needed to make sure that there was constancy of supply and that the corrective actions were taken. It is always a balancing act—that is where proportionality comes in. We cannot suddenly pull a whole load of devices off the market if there is a small problem because if we do that, there may be nothing to use instead. It is a highly complex area—there are so many interacting factors that we have to make judgments on. That is why we engage with the widest possible community to make the balance a reality.