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by Stephanie Ward
The words ‘post-market surveillance’ (PMS) appear 129 times in the new European Medical Devices Regulation (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.
And, in my opinion, PMS is integral to a successfully marketed device and business.
What does a successful PMS system need?
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:
information from vigilance, including trend reporting
records referring to non-serious incidents and data on any undesirable side effects
information from specialist or technical literature, databases and/or registers
information from feedback and complaints, provided by users, distributors and importers
publicly available information on similar medical devices
Reviewing of these sources of information must be systematic, and is required to be carried out within the manufacturer’s organisation by a person responsible for regulatory compliance.
A company can use existing processes, or implement new ones, to achieve the above. These could be:
checking of competent authority websites for information on adverse events or recalls of similar devices
post-market clinical follow-up (PMCF) studies
setting up key-word alerts on search engines
feedback from users (via email/website/surveys)
The data gathered is to be used in ensuring the quality, performance and safety of the device. This is achieved through analysis of the information to assess for any significant increase in the frequency or severity of incidents that are not serious incidents or expected undesirable side effects. An assessment needs to determine if the new information could have a significant impact on the benefit-risk analysis conducted in the original risk analysis for the device. This is done by updating and improving the risk-management documents – for example, post-market data collected may indicate a risk has a higher probability of occurrence than first estimated. An update to the risk analysis may then initiate an update to the design, manufacturing process, labelling and/or instructions for use of the device.
Challenges and consequences
One of the main challenges is the design of a quality management system which is conducive to the potential of multiple updates to processes, technical documents and even devices themselves. Speedy reaction to the possibility of adverse incidents will ensure any potential risk to public health is minimised.
Slow and reactive response to post-market data can be costly – in more ways than one.
The recent media coverage of court cases involving Johnson & Johnson’s pelvic 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 (see ‘The end of grandfathering?’ for insight into how the MDR is stopping devices being placed on the market without complying with the regulation). It is estimated that up to 100,000 women worldwide received the implant, which in some women has caused pain after the device began to erode into the surrounding tissue and organs, causing infections and complications. The mesh cannot be removed. A trial involving 700 Australian patients against three Johnson & Johnson companies continues in a federal court, as well as action in other countries such as the US. Johnson & Johnson 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. In 2010, St Jude Medical stopped selling its Riata defibrillation leads after the silicone coating insulating the electrical conductor wires within the lead 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.
What you need to do
The MDR’s emphasis on PMS could be seen as an additional burden on medical device manufacturers. But if you begin planning for the increased workload now, you can establish a PMS plan early, and revise and improve it throughout the three-year transition period. When the date of application (26 May 2020) comes round, you will then have an integrated, compliant system. And, in turn, a device that is safe, effective and performs as you intend it to.
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