Editorial | Which Medical Device in Conversation with the MHRA | Which Medical Device

The Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices used in healthcare in the UK. The agency ensures both work safely and can undertake investigations into harmful incidents. The MHRA also looks after blood and blood products, working with UK blood services, healthcare providers and other relevant organisations to improve blood quality and safety.

This month, our Editor at Which Medical Device was in conversation with John Wilkinson, Director of Devices (pictured) at the MHRA. Mr Wilkinson took up the post on 6 February 2012 having joined the agency from Eucomed, the European medical technology industry association where he was Chief Executive. His earlier experience included the role of Director General of the Association of British Healthcare Industries and a number of roles in the medical devices industry both in the UK and the USA.

Our Editor had an opportunity to put questions to Mr Wilkinson which will be of interest to the clinician community in the UK. 

Which MD: What is the role of the MHRA?

JW, MHRA: The MHRA is responsible for the introduction and safe management of both medicines and devices on the UK market. In the device area, this is in respect of European legislation so we share responsibility with our European colleagues, the National Authorities around Europe and the European Commission. 

Which MD: To what degree can a clinician rely upon the CE Mark to determine if a device is safe and effective for patients?

JW, MHRA: The CE Marking process is very specific to medical devices so it should not be confused with CE marks that appear on other products. It’s a risk-based system devised to cover the huge range of medical devices from a typical tongue depressor through to an MRI scanner or a cardiac implant. Clearly there’s a range of actions that need to be taken by manufacturers in order to ensure that devices are safe and do what they are required to do. So, validation is about safety and performance which are the key elements. Performance is about ‘does a product do what it is designed to do and is it acceptably safe’. This depends on the product and the scale of risk of which there are 4 categories. At the high end, a substantial amount of clinical evidence is required before a product can be put onto the market.

Which MD: Do clinicians understand the distinction between a CE Mark that they may see on a medical device and that which may appear on a child’s toy?

JW, MHRA: I suspect that they don’t. The CE mark reflects a legislative, regulatory framework that can cover a whole range of products. A car seatbelt has a CE mark but clearly the criteria used to insure that it is fit for purpose and safe is very different to those which would appear on a plastic duck for instance which would also be a CE marked product. The whole system is designed to be flexible enough to work on a pan-European basis and specific enough to provide an appropriate level of safety and security according to the product. It is very complex and I’m quite sure that the average man-on-the-street, let alone a clinician, would not easily grasp all of the details around it. 

Which MD: Presumably, the MHRA does not make clinical decisions about devices?

JW, MHRA: The MHRA doesn’t make decisions about devices – we oversee a system whereby much of the regulatory work is done by third parties and notified bodies such as the British Standards Institution so the evidence that has to be developed in the dossier before the company can affix a CE mark will include clinical evidence to ensure the device will not damage the patient but also that it does what it says it will do on the package. The risk-benefit assessment of any intervention which uses a device is in the hands of the clinician although evaluating whether a product is safe will involve the similar risk-benefit assessment before a product is approved. 

Which MD: When should a concern about a device be registered with the MHRA and is it as complex a process that some clinicians may perceive it to be?

JW, MHRA: The reporting process is actually very simple. On the MHRA’s website, there are three large buttons for medicines, medical devices and blood products. Users can click through to a simple reporting portal. We are very keen to receive reports as we’re reliant upon them to warn of adverse incidents, one of the key components to identify when things have gone wrong. Often, healthcare professionals don’t report because they feel someone else may have done it or the problem is already known but from our perspective, it’s a numbers game. The more reports we receive, the more likely we are to identify a problem early and initiate an investigation with the manufacturer. 

Which MD: Once a report is submitted, would a clinician be involved in any follow-up?

JW, MHRA: The reality is that last year, we received in excess of 13,000 adverse reports and to provide customised, tailored responses to each report would be challenging for the MHRA. However, it’s equally important that clinicians know that we have received the report and are acting upon it – it’s one of the dilemmas that we face. We do endeavour to ensure that reporters receive an appropriate response.

Which MD: Once someone has made a report, do you go back to them and do they have to then expand on their concern or is their work done at that point?

JW, MHRA: It’s very much dependent upon the nature of the report. If it’s a very clear problem, such as the device has broken or failed in some way and the manufacturer acknowledges it, there is a sequence of events to respond to such an instance after which the reporter will get a formal response, although not necessarily a detailed one, but enough to know their report has been acted upon. 

Other types of reports can prompt a range of actions. In many cases, if it’s a complex incident, then we would very definitely go back to the reporter to get more information or more often, the manufacturer will go back to the reporter, because, the way the legislation is designed the onus is on the manufacturer to complete an investigation. Sometimes products go wrong where a finite percentage of devices have failed for no obvious or apparent reason and where it’s considered an accepted low level failure rate which is down at the bottom of the scale of adverse incidents and where no further action is required other than recording the event. 

As an agency, we just don’t have the capacity or the expertise to undertake detailed analysis of every product failure that happens. There are over 500,000 medical devices on the European market and most are on the market in the UK. In order to have the technical expertise to do diagnostic analysis of every category of product, we would have to employ hundreds, maybe a thousand scientists and engineers and effectively be duplicating the expertise that resides within the manufacturers. The legislation is designed the way it is because of the huge diversity of products available and the enormous number of potential failure claims which manufacturers are the best equipped to analyse rather than an independent party like ourselves.

If we are not satisfied with a manufacturer’s response to an incident report, we will engage in our own investigations. We may well land on the manufacturer at very short notice and audit what is going on in their premises so we have powers and if we feel that the investigation is not proceeding according to a reasonable plan, we can escalate it. However, the majority of cases, manufacturers act responsibly and have an interest in making sure that the products that they put on the market work effectively and that they deal with any potential problems. 

Which MD: Who can report on a device?

JW, MHRA: The situation in the UK (it’s different in other parts of Europe) is that manufacturers have a statutory obligation to report adverse incidents that are over a certain threshold of risk. So if a fuse blows and it has no impact on a patient or safety then they don’t have to report it; if it blows and it does impact on patient safety and leads to a serious adverse incident then they have to report it to us - that’s an obligation on their part. Thereafter, clinicians or any other parties are under no statutory obligation to report to us. Although GMC guidance has recently been upgraded and places a heavy onus on clinicians to report but it isn’t statutory. The MHRA encourages reports from anybody who feels they have information about a product’s safety and which they feel we should know about. 

Increasingly, that means patients, because they are using medical technologies or medical devices and buying them over the counter to use at home - an environment which isn’t traditionally where medical intervention takes place. We are looking at ways to encourage more of the public to report as that gives us more information on which to work out whether there is a problem or not and also identify any problem sooner. 

Which MD: Is a medical device recall undertaken in conjunction with a manufacturer? 

JW, MHRA: The way that the system works is that adverse incident reports are received and we will analyse whether this is a rare event relating to a device and doesn’t necessarily constitute a systematic risk, or, whether it does and in that case, we will have a dialogue with the manufacturer. Manufacturers generally initiate recalls themselves often, as a result of a dialogue with us. On rare occasions, when we do not agree with the manufacturer’s response, our powers enable us to issue a prohibition notice which effectively stops the manufacturer from supplying the product to the market. That is used extremely rarely because most manufacturers will initiate the necessary actions themselves or as a result of conversations we have had with them. 

Which MD:  How much does the MHRA gain intelligence from anecdotal reporting of problems with devices? 

JW, MHRA: We have a general market surveillance role and it’s one of the reasons that we have links with the professional bodies which we’re currently trying to foster and improve because the kinds of information that we have access to are a major part of what we do. We have a range of information coming through, from soft signals where there is a suspicion that a product might not be delivering or a procedure might not be giving the result that was anticipated right through to the National Joint Registry, for example, which gives us hard analytical data on the performance of hip, knee and shoulder implants in patients. 

Our actions are science based so ultimately we have to have statistically reliable data as a basis for action. We act on the basis of evidence and create an audit trail so we can be confident if someone were to review us after an event as they did in the case of the Howe Review, we can evidence our activity. Lord Howe’s Review was very exhaustive and looked at all aspects of what we had done over a 10 year period. So, our action is based on science and scientific analysis, taking the best advice that we can get. 

Which MD: What is the risk to clinicians who report a device? Could it affect their professional reputation? Might it lead to legal action against the clinician if a patient has been harmed? 

JW, MHRA: I understand this concern but I think that’s outside of the scope of our work with medical devices. I think there are parallels with outcomes and measures generally as well as transparency in clinical performance which is interesting. If you look at the National Joint Registry for instance, it reports not only on the performance of the devices but has a list of outlier hospitals. These outliers might be identified because of issues relating to professional consistency but there could be any number of reasons why a particular hospital is an outlier. Importantly, if we don’t get reports from clinicians and there is a problem with a device, then we run the risk of delaying actions which at a population level can impact on lots of other patients making the responsibility of reporting adverse incidents clear. The challenges that you allude to need to be addressed in order to encourage people to report but I think that this is slightly beyond the scope of the agency, per se. 

Which MD: How much information do you share with other regulatory bodies around the world?

JW, MHRA:  As far as our European partners are concerned, there are very formal processes for sharing information across Europe, again, everything from the soft signals where we think there might be something emerging, through to exchanging hard data. There is a major initiative with the revision of the legislation to improve the data handling, with a lot of information sharing in Europe underpinned by the legislation. We also have agreements with other regulators around the world to exchange information and we have regular contact and very strong relationships with the FDA in the USA and other regulators. There’s a global overt mechanism which is in place as well so for major events there’s a system which in theory should get to every regulator in the world when one regulator initiates a course of action. Actually, more needs to be done to enhance collaboration - it’s an evolving area. 

Which MD:  Do you have an opinion on GMDN coding as a global nomenclature for devices?  

JW, MHRA:  The GMDN code is the accepted coding system that most regulators sign up to and is evolving in terms of its usability. The code is a core tool we’re all using to communicate with each other. There is also another dimension which is also being played in at the moment which is around unique device identifiers, a global initiative to harmonise the information actually printed on packaging and indeed the device itself and which populates a database to link those codes to multiple information about individual devices so ultimately, every hip, every pacemaker, every heart-valve will be labelled with a code which will identify that individual product, where it’s manufactured, what batches, materials went into it, will all be captured in the code and the database that sits behind the code. That’s a global initiative which will bring a number of benefits, because, you can collect that information each time you use a product and feed it into patient records. It will make a whole raft of possibilities come into play, from simple execution of recalls, identifying patients that are at risk, demonstrating that a product may not to be working as well as it might right through to the potential for epidemiological studies which the MHRA is uniquely placed to develop capability in, largely because we house the Clinical Practice Research Datalink (CPRD) which has access to a large number of anonomised GP records so in an ideal world, we’ll begin to build the capacity to track the performance of devices from the point where they are placed inside a patient right through the life either of the product or the patient. That’s going to open up a number of new sources of information which can help us improve performance and safety of devices. 

Which MD:  What is the time frame for these to be measures to be implemented?

JW, MHRA:  The time frame’s quite lengthy because the UDI standards have been agreed but the UDI databases to support the system have yet to be built so that’s going to take some time. The fact that the standards are in place is helpful because you can start collecting information in a structured way but the full functionality of the UDI databases is probably going to take 3-5 years to construct. It’s a huge project with 500,000 plus products out there. 

The other element of the project involve working with the National Health Service and other providers on how you capture data in a way that isn’t overly burdensome and feeds into their own local governances so actually, there’s a real win-win here. There are obligations on clinicians and hospitals at a local level but if we can tap into the processes and capture the information for those purposes and we’re not creating an additional burden, we have the potential to look at things on a different scale.

Which MD:  Just reflecting on Lord Howe’s May 2012 review do you anticipate any changes within the MHRA that may arise? 

JW, MHRA:  There are a number of things that have already been done, some more significant than others but they all add up to being quite a change. In the areas where we are processing vast amounts of information about incidents, there is a continuous improvement component guiding what we do and which is a featured of the report, meaning we’re reviewing both our internal processes and the IT support. We’ve put some interim steps in place but actually, this is a major programme to help us to capture the data more efficiently as we get more and more reports. This combined with increasingly sophisticated IT tools will help us to improve signal detection because that’s the main issues. 

Of the 13,000 reports we receive each year, how do you identify patterns which constitute a trigger for action on our part? For us that’s a major area. We’re also currently in conversation with the clinical community in terms of very specifically, how should we engage with the new NHS landscape and a number of new safety committees which are emerging. So, there are some big pieces of work around which will hopefully enable us to work in collaboration with the clinical community, identify problems early and ensure that we resolve them together, through inter-changes with clinical practice. Metal-on-metal is quite a good example of how clinical practice actually changed ahead of regulatory action and I think that’s the sort of thing we need to increasingly work on. 

Which MD:  Do you have any views on Which Medical Device and how we are covering information about products?

JW, MHRA:  It’s interesting that you should say that - I think there are two strands here. One is about the application of products and training clinicians in use and then there’s one about the how the device is designed to work and does it do anything surprising. Increasingly these are complex interactions and I think that anything that helps to create dialogue around the spectrum of issues we have to deal with whenever anything goes wrong is very helpful.

Actually, I don’t think it’s just about when things go wrong, it’s very much about continuous quality improvement and installing quality systems in medical practice, MHRA can contribute to that. So, I think the by-word for the future is going to be about the transparency of performance of devices and systems, in terms of using devices within clinical interventions and hopefully, continuous improvement. Where registries have been brought in and have been more or less made public, performance of systems has improved and that’s ultimately what it’s all about. I don’t think it’s about focusing in on when things go wrong it’s about collectively moving quality and the delivery of healthcare in the future. 

It’s interesting to see how you are operating (Which Medical Device). We are interested in all forms of new media and how we can get our messages out and equally receive messages back as well. We’re working to become more effective in facilitating a dialogue amongst the stakeholders and we’re just one piece of a complex jigsaw and we are going to do our part to improve stakeholder engagement and dialogue. 

ENDS