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Can new regulations help ensure manufacturers perform effective post-market surveillance?

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In this online exclusive, Stephanie Ward, a quality assurance engineer at technology and product design firm Cambridge Design Partnership looks at the new European medical devices regulation in more detail and the impact these may have on manufacturers.

As the complications of vaginal mesh implants make headlines again, the need for patients to be reassured by the medical device regulations is more important than ever. With routes to markets and manufacturer responsibility in the spotlight, can the European Medical Devices Regulation (MDR) help ensure manufacturers are not overlooking their products – and the patients they treat – once they are on the market?

The words ‘post-market surveillance’ (PMS) appear 129 times in the new European MDR. This repetition is not accidental. The requirements for manufacturers to ‘actively and systematically’ gather, record and analyse relevant data for the lifetime of each device they market is work most companies had not been conducting effectively – and the European Commission wants that to change.

PMS is the proactive activities carried out by manufacturers to establish, implement and keep up to date a systematic procedure to collect and review experiences of their devices on the market. The purpose is to identify any need to apply corrective or preventive actions.

The MDR significantly increases the role of PMS, requiring a ‘post-market surveillance system’ to be an ‘integral’ part of a company’s quality management system.

Stephanie Ward, a quality assurance engineer at technology and product design firm Cambridge Design Partnership

And, in my opinion, PMS is integral to ensuring a successfully marketed device – but, more than that, a device that is effective and de-risked as far as possible for the benefit of patients.

What can manufacturers do to establish an effective PMS system?

The MDR specifies that the manufacturer must plan, establish, document, implement, maintain and update a PMS system. The manufacturer is required to produce a PMS plan, specific to each of its products. This is key to the beginning of a successful, non-intrusive PMS system that can contribute to the development and long-term stability of a manufacturer’s device.

The plan must outline how to collect information from sources such as:

A company can use existing processes, or implement new ones, to achieve the above. These could be:

The data gathered is to be used in ensuring the quality, performance and safety of the device beyond the original pre-market data obtained. The manufacturer must produce a periodic safety update report (PSUR), which summarises the results and conclusions of its PMS, demonstrating continued safe and effective use. For high-risk devices, these are to be produced yearly and reviewed by the notified bodies for evaluation and reporting to the competent authorities. Any trends towards a significant increase in the frequency or severity of incidents could see actions being required to be carried out by the manufacturer — or ultimately the device being removed from the market.

The consequences

Speedy reaction to the possibility of adverse incidents will ensure any potential risk to public health is minimised, and a well-designed system to enable this is key.

Slow and reactive response to post-market data can be costly — in more ways than one.

The recent media coverage of the vaginal mesh implants has shown what slow follow-up from manufacturers can lead to. The mesh had been predicated onto the market as the same material had been used for hernia repairs. It is estimated that up to 10,000 women within the UK receive the implant a year, along with thousands more around the world. For some, the implant has caused pain after the device began to erode into the surrounding tissue and organs, also causing infections and other complications. The mesh cannot be removed simply, with many additional complications coming from attempted corrective surgery. Currently in the US, UK and Australia, hundreds of thousands of women are involved in lawsuits against the mesh producers. One manufacturer – Johnson & Johnson’s Ethicon — has since stopped selling the product.

This is not the only case of devices being recalled after thousands of patients have been exposed to the device before any adverse incidents have been realised.

The PIP breast implants scandal in 2012 showed regulators the issues with the vigilance and post-market clinical feedback systems in place at the time. The fraudulent change of the silicone grade in the implants — from the medical grade original approved for the market — went unnoticed until it was realised that the implants had double the rupture rate of other implants, but only after an estimated 400,000 women had the implants.

In 2010, St Jude Medical stopped selling its Riata defibrillation leads after the silicone coating insulating the electrical conductor wires within the leads was found to erode prematurely — sometimes leading to a malfunction of the life-saving device. Also in 2010, DePuy removed its metal-on-metal hip implants from the market after the rate of failure of these implants was determined to be greater than the polyethylene acetabular hip implant.

Will new regulations help?

The European MDR has been written with the knowledge of these previous complications. Surgical meshes, breast implants and joint replacements are now classified as Class III devices — the highest risk classification there is.

But what about other devices? Do we have to wait for a device to go wrong before regulations catch up?

The MDR has attempted to prevent any repeat events by requiring PMS for all classes of medical devices. With the oversight of the notified bodies, the competent authorities and the European Commission, updates to the instructions for use (the main port of call for users to find information on side effects), the manufacturing process, labelling and even the design itself are likely to be seen on a more frequent basis.

And, due to the requirement of a PMS plan being included in the device documentation pre-approval, manufacturers are required to design a system that answers how they are going to proactively collect data and ensure the continued benefit of the device over any risk. Visibility of this can only help to reassure the public that the industry has a ‘patient first’ outlook.

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