interviews

A new system for tracking high-risk medical devices and implants

The PIP breast implant scandal caused shockwaves around Europe, and health minister Earl Howe ordered a review into the MHRA’s involvement in and handling of the situation. A year on from the publication of that review and its 15 recommendations, NHE spoke to MHRA director of medical devices John Wilkinson to establish what progress has been made.

The safer monitoring, identification and tracking of medical devices and implants, especially those in the high-risk category, is necessary both for individual patient safety but also, in the long term, for epidemiological research into products’ performance.

The events surrounding the PIP breast implant scandal, and to a lesser extent the issues with metal-on-metal hip replacement, highlighted the necessity to do more in this area.

Four NHS hospital trusts are now running pilots of a new tracking system to improve the monitoring of such high-risk devices as breast implants, heart valves pacemakers.

Standardising a complex system

John Wilkinson, director of medical devices at the MHRA (the Medicines and Healthcare products Regulatory Agency), told us that efforts to improve such monitoring and tracking is both global and local. On the global scale, there is an initiative to ensure every device has a UDI, or unique device identifier. This, consistently and properly applied, would be “a very important step forward”, Wilkinson told us. “Any device that appears at any hospital in the world would have this coding on it, which when you scan it – if you have the right IT system you can link to a database – will give you all of the information about that individual product.

“All the manufacturers are lining up and starting to label their products with these specific standardised codes. Previously, there were all sorts of different codes in different countries with different systems.”

But there’s a second, more localised element of this, which is the best way to attach information about a device to a particular patient’s record.

“What is the most effective way of capturing that information? That sounds like a simple question, but actually it’s quite complex,” Wilkinson said. Currently, it’s often in paper form – you peel a label off and stick it in the patient’s paper record, for example. Doing that more effectively means doing it digitally, securely – and ideally making such devices searchable for research purposes, while still having in place appropriate information governance and privacy standards.

Wilkinson said: “Some hospitals are already doing a good job in that area, in terms of local clinical governance. Some are not. We’re working on a strategy with the right incentives for people locally to collect this information, so it’s useful for them, but it also allows us to get hold of that information should we need to.

“This could facilitate recalls of products, if there’s a problem, or, eventually, once there’s a well-established database, we can use the CPRD (Clinical Practice Research Datalkink), which is linked to increasing numbers of GP records, to do epidemiological studies in relation to implants. Researchers could, for example, see if patients fitted with ‘implant x’ do better than patients fitted with ‘implant y’. There’s a lot of opportunity here, but clearly it requires a re-wiring of the system to be more integrated than it is now.”

Practical steps

In looking to develop a new strategy, he said, the MHRA is keen to look at what constitutes good local practice and build it “from the bottom up”, rather than just imposing something. “We think that’s likely to lead to more successful implementation.”

Clearly collecting the information in a standardised form depends not just on the coding but the kit – a simple barcode reader might work well for a supermarket, but might not be quite as simple in a sterile operating theatre, for example. “We’re trying to find the practical steps we can implement to make this an easy process,” he said.

NHE will report on progress made at the four hospital trusts piloting device tracking in a future issue.

Increased reporting

The MHRA progress report also notes a recent jump in adverse incident reporting. Wilkinson said this was part of a long-term trend, in which manufacturers especially have been getting better at acting on their obligations and reporting incidents more systematically, and in which there are simply “more devices out there, particularly in the higher risk categories, driven by population demographics and activity in the NHS”. Some of the increase, he said, was also down to the PIP scandal specifically, and partly the metal-on-metal hip replacement stories.

“Those certainly raised awareness of issues relating to devices. I think there was a spillover, and people started to realise how important it was to report these things.

“We’re interested in the long-term trends. We want to see consistently higher levels of reporting, particularly from users in the NHS, and increasingly from patients as well. Patient reporting has been very low historically.”

The MHRA tries to make it easy to report adverse incidents – for drugs, there is the yellow card system (recent developments with which were covered extensively in the March/ April 2013 edition of NHE), but device-related incidents are also easy to report via the MHRA website, for example.

It is important that such reports give details of the precise device involved, Wilkinson noted.

Across borders

Another of the Earl Howe report’s recommendations following the PIP scandal was for more and better collaboration between national regulators – and on this front there has been “huge progress”, Wilkinson reported.

The relevant legislation is changing, which is a slow process, but behind the scenes there have been two important developments, he said. “One is the introduction of joint audits of notified bodies, which we believe is probably the most powerful tool we can bring to bear to improve the performance and consistency of the system.

“In the UK, we pushed extremely hard for that to be introduced, and indeed it was a UK-notifi ed body that was first to be subjected to this joint audit.

“Joint audits involve three parties: the national authority responsible for certifying and auditing the notified body (the MHRA in the UK); another competent authority in Europe, or more than one; and the European Commission, which has been building up its capacity to oversee this process, with their own staff at the Food & Veterinary Office in Dublin.

“It starts to ensure there’s an even approach. There’s a programme for 16 or 17 of those audits to take place this year. It’s very good news.”

The other big development over the last year has been monthly conference calls on vigilance matters between European regulators, which Wilkinson said most member states are now dialling into.

“It’s a fixed agenda, and we raise issues of concern, some of which are very concrete and need Europe-wide collaboration to deal with, while some are at the other end, where we have suspicions that we wonder if anyone else has picked up on.

“Those two elements have meant a profound step forward: there’s lot more to do of course.”

Pilot project

Four NHS hospitals are in the process of piloting a new method of device tracking with the MHRA:

• The Freeman Hospital in Newcastle
• The Christie Trust in Manchester
• Leeds General Infirmary
• Birmingham University Hospital

Mr Bryon Jaques, the clinical lead for this project in the Freeman Hospital, Newcastle, said: “We are excited to be involved in this very important pilot with MHRA and recognise the importance to patient safety. The ability to collate information from many sites in real time will allow recognition of potential problems and alert patients and healthcare providers in a more timely fashion.”