Draft Medical Devices (Amendment) (Great Britain) Regulations 2023

Emma Hardy Excerpts

Monday 22nd May 2023 General Committees

[Emma Hardy (Kingston upon Hull West and Hessle) (Lab)]

These are hugely significant regulations. As co-chair of the all-party parliamentary group on surgical mesh, I want to focus my contribution on vaginal mesh.

The Minister will be aware of how medical devices have harmed and disabled tens of thousands of women, leaving them in excruciating pain and unable to live the lives that they lived previously. It has been a national scandal. I recognise a previous Prime Minister’s interest in this area: the right hon. Member for Maidenhead (Mrs May) commissioned the work by Baroness Cumberlege that culminated in the report entitled “First Do No Harm”, which looked at the scandal of the use of vaginal mesh. It feels like the regulations could have been an opportunity to address some of the difficulties that her report found.

As I said, the use of vaginal mesh, due to the plastic that it is made from, has harmed tens of thousands of women. I know that the Minister is aware of the issue, because I have corresponded with her at length on it. The use of mesh was suspended in 2018, but the problems inherent then are still inherent now. The yellow card system for reporting difficulties with medical devices still is not working in the way it should, and not enough women or people are aware of it. There is concern that some medical devices are being approved based on previous approvals and therefore they are going through on the nod, without the detailed scrutiny they require.

The Government could look at creating a database of everyone with permanently implanted medical devices, including details of the device type, so that they could be tracked. We have a system at the moment whereby many different medical devices are used in our bodies. The women I have been referring to were treated like guinea pigs. These products were tested inside them and then, when they reported problems, they were ignored and belittled. There was no way of identifying the exact type of medical device that was inside each woman. No information was available about the composition of the plastic that was used.

Paragraph 6.9 of the explanatory memorandum is about the MHRA’s public consultation on the future regulation of medical devices. Are we going to start looking at barcodes or tracking numbers on devices that are put inside people, so that when someone reports a problem they can be told, “Okay, we know exactly what you have inside you and exactly what it is made of,” and we can therefore identify groups of women, in this case—or of anybody—that have been impacted by the specific device?

Another issue is how to report a problem with a medical device. At the moment, it is a lottery what ends up inside you, because different things are approved, and it is a lottery whether you are told about the yellow card system and how to report. In the future regulation of medical devices, are we looking at an automatic reporting system where people are given the information? Personally, I want to get rid of the yellow card system altogether. Those are the kinds of questions that I would like the Minister to respond to.

[Maria Caulfield]

I will do my best to respond to the points made by hon. Members. The hon. Member for Bristol South asked a number of questions. She is right: there is a long list of devices, which fall into various classes of device that the MHRA regulates, and there are different rules for the different types of devices. The MHRA has taken a wide-ranging approach in consulting with the industry and the medtech sector. The consultation that was developed between September and November 2021 is still being looked through. That is why we have this SI: because the MHRA has taken on board some of the concerns and suggestions of the industry.

The final regulations will be operational from 2025. We have set that date so that we have a lead-in period, and then a transition time up to 2030. The MHRA regularly engages with trade associations, for the very reasons that the hon. Lady set out. The recent consultation received more than 900 responses. The explanatory memorandum includes a contact at the MHRA; any industry people listening who have concerns or suggestions and did not manage to take part in the consultation can still make contact with the MHRA, which will be able to give guidance and support on the plans. When we are further down the road to 2025, the MHRA will issue guidance to the industry as well.

Further regulations will be introduced later this year in relation to the long-term changes, and we will keep Members updated on that. This is a big change and the MHRA is doing a significant amount of work in this space. It is taking steps to ensure that, in implementing the further changes to medical devices regulations, it has the capacity and capability to continue to perform, as it always has, to the highest level, putting patient safety first but supporting the industry as well.

The hon. Lady talked about future realignment. As part of our wider work to reform medical devices regulation and take advantage of Brexit opportunities, we will make provision for alternative routes for medical devices to reach the GB market. That will involve possible recognition of devices with approval from other trusted regulators. We will keep Members updated on that as we work towards it.

[Emma Hardy]

I am concerned about the point about other trusted regulators. Different countries have completely different rules for medical devices. I will not mention vaginal mesh again, but the rules in the USA are quite different from those across the European Union. The community would be incredibly concerned if we were to accept other countries’ criteria for what is considered safe or not. I hope that the Minister will explain that we will have a stricter and more thorough system for regulating what goes inside our bodies.

[Maria Caulfield]

I take the hon. Lady’s point, and that is exactly the point that I wanted to make: we want to have the safest regulations possible. However, that does not close the door to recognising the work of other regulators. As I say, we will keep Members fully informed of those decisions as we go forward.

I know that this is slightly out of scope, Mr Stringer, but on the use of mesh, that was done while we had the existing EU regulations for CE-marked devices. There is now the possibility to track devices—they have barcodes on them—such as breast implants or replacement hips, and we have certainly accepted almost all the recommendations of the Cumberlege review, which looked specifically at mesh. I do not wish to test the Chair’s patience by going outside the scope of the draft SI, but that is why it is important that when we set the new UK mark, we learn lessons from the past. The CE mark has served us well, but there were instances of safety being compromised.

[Emma Hardy]

I thank the Minister for giving way again, and I thank you, Mr Stringer, for your generosity. Will the Minister indulge me by commenting quickly on the yellow card system and on how people can report more effectively?

[The Chair]

Order. I have allowed the debate go beyond the scheduling and timing of the draft regulations, because I did not want to restrict it, but if hon. Members now focus on what the statutory instrument says, that will be helpful.