Device vigilance, incident reporting and recalls
Under the EU Medical Device Regulation a manufacturer is required to gather information about its device on the market proactively, and to report serious incidents and the corrective actions taken through an electronic vigilance system shared by the member states. The number of reported incidents has risen, which one experienced device writer attributes mostly to new therapies, refined definitions and more thorough reporting, and manufacturers recall failing devices far more often than authorities do.
Post-market surveillance under the regulation
Under the device directives the EU relied on a decentralised approach to device surveillance: national regulators were responsible for collecting incident reports, and devices were reassessed if safety issues were raised. Post-market surveillance of devices relied on reactive data gathering.
The MDR mandates post-market surveillance for all devices and introduces new and expanded requirements that increase the compliance effort. Annex III of the regulation details these requirements. It is no longer enough for manufacturers to review and analyse the complaints registered in their own databases; they are required to be proactive in gathering information about their devices. They are also expected to feed the results back into design, clinical evaluation and the technical documentation, with the intent of using real-time data to anticipate risks. Their technical documentation now requires post-market surveillance, a post-market clinical follow-up plan and periodic safety update reports, which address two main concerns: whether the device is safe and performs its intended function, and how it can be improved. Ultimately, the regulation aims to bring post-market surveillance into a continuous cycle of product evaluation and improvement, linked to the risk management information in the European device database.
The vigilance system
The regulation addresses the need for a vigilance system, particularly for implantable devices. The Commission, with the member states, sets up and manages an electronic system to collate and process vigilance information. Manufacturers are required to report serious incidents and the corrective actions they have taken, and this information is shared with the national authorities of the other member states, and similar incidents are compared. The regulation sets timelines for reporting incidents. When the regulation was adopted, field safety notices and field safety corrective actions were expected to be made public. The vigilance documentation the regulation defines covers adverse event reporting during clinical studies, the summaries of safety and clinical performance, and the market surveillance reports.
Why reported incidents are rising
Press reporting on the "implant files" claimed that the number of events associated with devices is increasing. In the view of one writer from the device sector, the reported numbers may be rising, but not necessarily because there are more events: events are now reported more consistently, for several reasons.
- A decade before 2019, post-market surveillance and safety reporting for devices was poor and below the level of compliance reached since. Tremendous improvements have been made, and events that were not collected then are now reported more consistently.
- The definition of device relationship has slightly shifted. Events used to be mostly classified as device-related yes, unknown or no, and only events with a reasonably likely device relationship were reported. There are now five categories: not related, unlikely, possible, probable and causal relationship. Under the German BfArM guidelines, an event has to be reported as device-related as soon as a relationship cannot be ruled out, a much more conservative approach that has increased the number of events.
- The number of post-market device clinical studies is increasing. Collecting and reporting events to evaluate longer-term results and to identify late events, their causes and their device relationship is now key to maintaining commercial product availability. Potential incidents are thoroughly monitored, and so more events are reported.
- Only device-related events used to be commonly reported, and procedure-related events are now taken into consideration too.
- More new devices came into use in the decade before 2019, as device-based therapies were developed for patient populations for whom only medical therapy had been possible. Transcatheter heart valve therapy for severe aortic disease, for instance, began in elderly, high-risk patients whose multiple comorbidities prevented aortic valve surgery.
That writer concludes that the large increase in events is most likely due to new therapies, refined definitions and more thorough reporting, and expects the numbers to rise further as there will be more studies and post-market surveillance keeps improving.
Incidents that go unreported
The "implant files" reporting stated that not every case in which a device might have caused a life-threatening situation had been reported to the authorities, and one writer from the device sector holds that this is certainly true of cases outside clinical studies. That writer imagines that, after a long working day, physicians report only the cases they believe have an unexpected and likely relationship to the device. In the same writer's view, reporting of incidents outside clinical studies still has room for improvement, and that improvement lies not with manufacturers or notified bodies but with those who should report the events, mostly physicians. Patients can report such incidents to the competent authorities themselves, but they are frequently unaware of it.
Deaths attributed to devices
Under the claim that regulatory authorities rarely react, the "implant files" reporting stated that in Germany neither the Federal Ministry of Health nor the competent authority BfArM would say which product had caused the most deaths in the past ten years, calling the information confidential. One writer from the device sector holds that information to be irrelevant: a device relationship is claimed as soon as one cannot reasonably be excluded, so the number of device-related deaths also correlates with patients' comorbidities. In the US PARTNER study of transcatheter aortic valves, for instance, 19.6% of patients classified as high-risk and inoperable died of cardiovascular causes within one year, against a one-year mortality of 41.9% in the randomised comparator group given standard medical therapy.
Recalls by manufacturers and authorities
The "implant files" reporting stated that regulatory authorities rely on manufacturers to recall their device or issue safety warnings when it fails, which had happened around 10,000 times since 2010, against only 6 recalls by the authorities. To one writer from the device sector, these numbers seem to show that most device companies take their responsibility for patient safety and device quality very seriously. In that view, manufacturer recalls are logically more frequent than authority recalls:
- Companies know their product best and usually receive the relevant information first, so they start the recalls first.
- Companies frequently take action and start prophylactic recalls before something happens.
- A company can recall its device freely whenever it wants, but the competent authorities have to provide a justification.
Counting the devices in use
The "implant files" reporting claimed that there are no reliable facts on how many devices have been implanted. One writer from the device sector answers that under MEDDEV 2.7/1 revision 4 the clinical evaluation report of a device must be regularly updated and submitted to the notified body, including information on whether the device is currently on the market in Europe or in other countries, since when, and the number of devices placed on the market. Many countries have also established national registries to document the use of various devices.