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

Debate between Emma Hardy and Maria Caulfield

Monday 22nd May 2023 General Committees

[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?

Oral Answers to Questions

Debate between Emma Hardy and Maria Caulfield

Wednesday 25th January 2023 Commons Chamber

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

2. If she will hold discussions with her Cabinet colleagues on NHS waiting lists for gynaecological care.

[The Minister for Women (Maria Caulfield)]

Tackling NHS waiting lists, including for gynaecology, is a priority for the Government, which is why we are spending £8 billion on clearing our backlog. For gynae procedures specifically, we have opened 90 surgical hubs, 90 community diagnostic centres and women’s health hubs, which will all help to tackle gynaecology backlogs.

[Emma Hardy]

Some vaginal mesh-injured women have been left waiting four years for mesh removal, and I have already highlighted women’s concerns that the surgeons they go to for mesh removal are trained only in implanting the mesh and not in removing it. These women fear that, once again, they are being used as test subjects. When will mesh-injured women get the redress that was recommended in Baroness Cumberlege’s review, “First Do No Harm”?

[Maria Caulfield]

I thank the hon. Lady for her work in this space. I recognise that while we have set up nine specialist mesh centres to tackle mesh removal and seen a number of women come forward and receive their surgery, there are still a number on the waiting list. I am meeting some of the campaigners on mesh removal next week. We were at the Health and Social Care Committee hearing just a few weeks ago, and I heard some of their concerns then. I recognise that there is still progress to be made in this space.

Oral Answers to Questions

Debate between Emma Hardy and Maria Caulfield

Tuesday 1st November 2022 Commons Chamber

[Maria Caulfield]

I thank my hon. Friend, who raises a good point. He does a huge amount of campaigning in Harrogate and Knaresborough on this issue. We recognise there can be long waits for diagnosis both for ADHD and autism, and that is why we refreshed our national autism strategy last year, backed by more than £74 million to help to reduce diagnosis waiting times. NHS England is now setting out the process of how children, young people and adults might receive a diagnostic assessment much more quickly.

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

Delayed discharge from mental health beds is preventing people from getting the treatment that they need. In fact, in Humber NHS trust 42% of learning disability beds are taken by people with delayed discharge, 5.5% of secure beds have patients in waiting for adult social care, as do 70% of adult mental health beds, 22% of CAMHS beds and 27% of community beds. To deal with the problem in mental health, we need to deal with the problem of lack of adult social care placements. When will the Government be able to fix that?

[Maria Caulfield]

The Government actually started working on the plans around delayed discharges this summer, because of course they affect mental health services. They also affect a range of acute beds. With the winter coming, we know that there will be additional pressure on those beds, and that is why we are working with local government social care services and integrated care boards which have responsibility for that in their local areas.

Oral Answers to Questions

Debate between Emma Hardy and Maria Caulfield

Tuesday 19th April 2022 Commons Chamber

[Maria Caulfield]

My hon. Friend is quite right in his question and is campaigning hard to increase dental activity in his constituency. One of the key pieces of work is being done through Health Education England, which set out a range of recommendations in its “Advancing Dental Care” review. That will do a number of things, such as increase the skill mix and scope of practitioners across dental teams, and we may well require legislation to bring some of that work forward. Health Education England is also introducing more flexible routes into dental training and doing some workforce modelling to identify the parts of the country with the biggest gaps in provision, so that we can establish centres of dental development in those areas. I will look at Ipswich in particular.

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

My constituent contacted me to tell me that when she broke her canine and went to contact her NHS dentist, she found she had been kicked off the list and was facing a bill of £4,000, which she simply does not have, to have the work done privately. Will the Minister speak to some of the dental practices about the possibility of relaxing their rules on kicking people off their dental lists, especially as covid has meant that patients might have had legitimate reasons for missing appointments?

[Maria Caulfield]

I am sorry to hear about the hon. Lady’s constituent’s experience. There is not actually a list system for dentists as there is for GPs, so patients can see any dentist when they have a dental issue. With that said, we have asked dental practices to update their availability for NHS patients on the website. This morning, I looked at the website to see what availability there was throughout the country and saw that many dentists still have not updated their availability, so I will ask officials—particularly in her constituency—to update the lists so that patients can access NHS dentistry more easily.