My submission / response to the Consultation on the future regulation of medical devices in the United Kingdom

This follows on from my earlier blog post published Sun 21 Nov 2021
Open to all but closing 25 November 2021 - Consultation on the future regulation of medical devices in the United Kingdom, which has a full list of the questions. 

The consultation closes on 25 November 2021 and is open to everyone (patients, healthcare professionals, industry, academics, anyone). I've focused solely on the questions for members of the public in Chapter 17 and have replied as a member of the public. I previously worked on the CHI+MED project (which looked at ways of making medical devices safer) but not as a researcher. 

You might read my answers and think I've got something wrong or misunderstood something. If so, the best thing you can do is to fill in the consultation survey yourself as my answers can't be changed now (all submitted).

(1) You can read Chapter 17 "Questions for members of the general public" as a web page or download it as a PDF.

(2) You can give your views online here. 

(3) The full consultation (all chapters) is here. 

 

My responses
Here are my answers to the questions where a written response was possible. They were usually preceded by Yes / No / Not sure responses, which I've left out.

Q78.1 Do you think these products should be regulated under the UK medical devices regulations? (Yes/No/No Opinion/Don’t Know)

Q78.2 If you have answered ‘yes’ to question 78.1, which products should be regulated under the UK medical devices regulations (please select all those which apply) [see list in web page or PDF linked above in (1)]

Q78.3 Please provide your reasoning for your answers to questions 78.1-78.2 or any general comments on key considerations for the regulation of products without a medical purpose.

I hadn't realised liposuction tools weren't regulated and am surprised. I can only hope that the people who use them are regulated in some way, and have appropriate training in their use.

Some of the devices listed sound like they could be dangerous if used by poorly trained people but I expect that's out of the scope of your consultation. Genomic tests seem to be pretty harmless while being used but the advice given out alongside them is probably what's more concerning, so it's hard to separate the technical aspects from the way they're used to make decisions etc.

What about phone apps that offer vaguely medical support? I don't know if they're regulated, or if they should be - but probably outside your remit.

Q78.4 Do you think the classification rules for general medical devices and IVDs should be amended as above? (‘Yes’ / ’No’ / ’Don’t Know/No Opinion’)  

Q78.5 Please provide your reasoning for your answer to question 78.4 or any general comments on the classification of medical devices (including ideas for other ways classification may need to change).

I'm between YES and DON'T KNOW as this seems a bit too technical for me, and I don't know what it is about some of these devices that makes them riskier (eg is the thing inherently risky or is it the way it's used - I've no idea how to do surgery so could probably do a lot of harm with a replacement joint that would be fine in competent hands).

What about devices that are used in quackery? For example bioresonance machines are Class IIa and don't seem to do anything useful. Alternative therapists who use them highlight the fact that they're Class IIa, which suggests they hope to benefit from the implication that they're 'approved' and 'a bit medical'. I'd suggest a new category - Class X (Entertainment) for those types of things ;)

Hearing aids that don't have lockable battery components should be in a higher risk class as button batteries can kill.

Q79.1 Do you think that health institutions should be required to meet certain requirements for ‘in house’ manufactured devices, such as those laid out above? (‘Yes’ / ’No’ / ’Don’t Know/No Opinion’)

Q79.2 If you have answered ‘yes’ to question 79.1, please choose which requirements should be met by health institutions (select all those which apply from the list below): [see list in web page or PDF linked above in (1)]

Q79.3 Please provide your reasoning for your answers to questions 79.1 and 79.2, or any general comments on the rules that should apply to ‘in house’ manufacturing of medical devices.

I really don't know much about this, nor about the scale of manufacture (how often it occurs) or of modification (a minor tweak or a big change). It seems sensible that smart, technically-minded competent people - working within an appropriate healthcare framework - should be free to adapt things, within reason, to suit their needs without this being onerously regulated, but given that it's possible to do harm while intending to solve a problem I think records need to be kept as a bare minimum.

I think, as with 'official' devices, that near misses should be reported as well as actual incidents - and that these should also be fed back to the manufacturers. 

Q79.4 Do you think that medical device importers/distributors should meet additional requirements such as those outlined above? (‘Yes’ / ’No’ / ’Don’t Know/No Opinion’)  

Q79.5 Please provide your reasoning for your answer to question 79.4 or any general comments on rules applying to importers/distributors of medical devices in the UK

I'm a bit surprised that this isn't already the case(?).

Q79.6 Do you think manufacturer should be required to assign UDI numbers to medical devices before they enter the UK market? (‘Yes’ / ’No’ / ’Don’t Know/No Opinion’)

Q79.7 What types/classes of medical devices should be included in the requirement for UDI storage (select only one)? [see list in web page or PDF linked above in (1)]

Q79.8 Please provide your reasoning for your answers to questions 79.6-79.7 or any general comments on UDI requirements for medical devices.

I thought devices already had unique IDs, possibly given by the hospital or other care setting. It seems like a good idea but I suppose there's the possibility of giving people an awful lot of work in managing it. Q79.6 asks only about UDIs for devices entering the UK but it seems sensible to have this for devices made in the UK too, unless I am missing something about the scale of this (there are millions of medical devices!). Don't bandages have lot numbers? I'm doing regular LFTs and each one has its own QR code...

As part of modifications mentioned in 'Health Institutions' above is it possible that a component from one medical device might be transferred into another (if one breaks, using spare parts I mean)? I'm not sure how that would work with UDIs.

Q80.1 Do you think the UK medical devices regulations should include stricter requirements for claiming equivalence? (‘Yes’ / ’No’ / ’Don’t Know/No Opinion’)

Q80.2 If yes, should it be the requirements above or other? [multi-choice options of the above requirements plus other – please specify

Other: It seems like manufacturers should have to first prove that Device B *is* equivalent to Device A first, rather than claiming it.

Q80.3 Please provide your reasoning for your answers to question 80.1 and 80.2 and/or any general comments on rules that you think should apply to claiming equivalence to another medical device as set out above.

 This feels quite far beyond my knowledge of how this might play out in practice. I agree with the first three statements of Q80.2. I am not sure if the first statement is really just the same as my 'other' comment (might be). For the second statement (documentation) I think it would also be necessary to have access to some information about any underlying software too, as devices can differ in the ways they're programmed to do stuff, also if two similar devices have slightly different modes or states.

I don't know, for statement 4, where the cut-off should be, but agree that there should be a point at which manufacturers can't claim equivalence.

Q80.4 Do you think the UK medical devices regulations should introduce the requirement for an SSCP for medical devices? (‘Yes’ / ’No’ / ’Don’t Know/No Opinion’)

Q80.5 What types/classes of medical devices should require a SSCP (select all that apply)?

[I picked Other]: I think all medical devices (not medical spoons, bandages though) should have this.

Q80.6 Please provide your reasoning for your answers to questions 80.4-80.5 and/or any general comments on introducing a requirement for medical devices to have SSCPs.

This seems like a good idea. Definitely needs to be understandable by non-medical people. Seems useful to let many eyes look at stuff too. Again I would include information about any underlying software in this (I remember people trying to get hold of this sort of info for their implanted defibrillators and the companies were reluctant to share that info).

Any SSCP should be uploaded to and held by MHRA (with version control, should be possible to see earlier versions and what's changed). It should not be a link in case the document is moved / the URL is changed and no redirect set up.

Q82.1 Do you think manufacturers should be required to consult with patients when investigating device incidents? (‘Yes’ / ’No’ / ’Don’t Know/No Opinion’)

Q82.2 If you have answered ‘yes’ to question 82.1, how do you think manufacturers should consult with patients when investigating incidents (you may want to consider: how the manufacturer would find patients with lived experiences, methods of communication, how the manufacturer would demonstrate that they have taken into account patient views).

82.1 says Mfrs must submit reports to MHRA under certain circs. Does that include near misses? Do healthcare professionals report problems directly to the MHRA too?

I don't know if there's value in consulting with patients & public during the *technical* investigation. Possibly their input could be useful in gathering info about how the device is being used in the real world (may differ from expected). That said as 'someone who flies' I'd not expect to be consulted on an aircraft accident investigations - perhaps this analogy only works if the medical device is used BY patients, rather than ON patients by healthcare prof's.

I'd assume consultation would be sensible at the FSN stage, to ensure the info made sense and was unambiguous. As far as I know Patient Information Leaflets are 'road tested' in this way (at least I thought they were!), there's also an entire genre / industry of people ensuring the readability and applicability of patient information.

Finding patients with lived experience
Companies may want to use a third party if they're not allowed to chat directly with the public (I'm thinking about ABPI regulations on pharmaceutical companies, not sure if that applies here). People are pretty easy to find on Twitter / Fb etc though that does open up the possibility of negative publicity if replies are negative. There are charities and patient support groups for almost every possible illness or condition, Google or Charity Commission should uncover them, also healthcare professionals would be able to suggest patients or patient groups. The Association of Medical Research Charities covers a couple of hundred larger medical charities. I think going through healthcare professionals would be a good place to start as there is already a familiar, trusted relationship. Mfrs should reimburse costs.

Methods of communication
Patient comms infrastructure is in place for patient and public involvement in medical research (eg NIHR, Wellcome). The Patient Information Forum (PiF) provides relevant advice, NHS Digital ensure info on the NHS website is language-appropriate and readable at lower literacy levels. There are plenty of science communicators and people working in public engagement with science who could help here too.

Demonstrating patient views considered
Not sure. Paying 3rd party facilitator to find patients, undertake consultation & report patient views might work, as then facilitator could sign off on it (if patients don't wish to be named).

Q82.3 Please provide your reasoning for your answers to questions 82.1-82.2 or any general comments on patient and public engagement during incident investigation.

I think patients harmed during the use of a medical device, and those who might be harmed by its continued use (until investigation produces a solution) should be *invited* to be involved in the investigation, and certainly to have sight of any report before it's submitted. I'm just not sure about how involved they'd want or need to be in technical aspects (eg discussions about software used in a blood glucose meter might not be that relevant to someone with diabetes who's not very familiar with programming, but I think it's helpful for manufacturers to be open and invite patients in).

Presumably usability experts and other designers would also be involved at the investigation stage, as they may have input on improvements to design and also in spotting what might have gone wrong. Probably these types of people are automatically included in a root cause analysis anyway.

The output document from the EPSRC-funded CHI+MED project might be of use too https://chimedblog.wordpress.com/2016/01/29/making-medical-devices-safer-insights-from-the-chimed-project-funded-by-epsrc/.

Here is a list of communities of practice; the focus is on science communication more widely but there are several medical-based groups within it that may be able to offer advice https://scicommjobs.wordpress.com/2021/01/30/scicomm-communities-of-practice/

Both of those links will rather give away who's filling this submission in but I am going to blog my answers so feel free to make this public / no need to redact the links etc.

Q83.1 Do you think that the UK medical devices regulations should include the requirements for manufacturers and health institutions to provide patients with implant information? (‘Yes’ / ’No’ / ’Don’t Know/No Opinion’)

Q83.2 If you have answered ‘yes’ to question 83.1, is there any other information which should be included within the implant information? If so, please outline below.

Who to contact in case of questions (it may just be "contact your consultant" of course).

Q83.3 Please provide your reasoning for your answers to questions 83.1-83.2 or any general comments on patient implant information.

It sound like patients aren't already getting some info about their implant (which surprises me as I assume everything comes with a patient info leaflet). It might be helpful for these various information sheets to be held centrally by MHRA as packet leaflets are easily lost (and PILs and SPCs are easily findable on the internet).

Q83.4 Do you think the MHRA should introduce a tailored pathway to market approval for: ...

Q83.5 Please provide your reasoning for your answers to question 83.4 or any general comments on possible pathways to approval to bring a device to the UK market.

I don't think I have enough knowledge or information to answer this one. I'm not really sure what a tailored pathway would involve. I'm also not certain about the difference between A and B. It does seem sensible to accept other jurisdictions' approvals (with some checks and balances of course) and not make companies repeat largely similar work for each territory. 

C Innovative Devices seems to have come out of nowhere and I'd assume they could be handled by either A or B, so I'm not sure I've understood this question.