Interview with Markus Wälti, Head of Medical Devices Vigilance and Aurélie Drapela, Senior Scientific Officer “A report is not an admission of blame – it helps to improve the product”

What is the fundamental difference between materiovigilance and pharmacovigilance?

Markus Wälti: For one thing the immense variety of more than 500,000 medical devices that we deal with, from contact lenses to insulin pumps and endoscopes to cardiac pacemakers. Another difference is that there is no official authorisation process for medical devices. They undergo a conformity assessment, after which they can be marketed in the EU and in Switzerland simultaneously. The pace of innovation is more rapid in medical devices than in medicines because modifications can often be made more quickly.
Aurélie Drapela: For medicines there is a dossier for every product at Swissmedic – in contrast we only hear about some medical devices when we receive a report about them. This is why the “swissdamed” database is currently being developed to provide us with a better overview. All the medical devices available in this country will have to be registered in it to create transparency.

Despite these differences, though, the overriding objective is the same, isn’t it?

Aurélie Drapela: Exactly. Our concern is always patient safety. We want products on the market to be improved continuously.

How many reports of incidents do you get every year?

Markus Wälti: Last year around 5,300 incidents were reported to us. Anyone who manufactures or uses medical devices is required to report serious incidents – even if, fortunately, no-one was harmed. We receive individual reports from doctors’ practices and patients, but mostly from the manufacturers themselves and from the vigilance contacts in the hospitals.

“Our job is to identify signals and trends and to critically review reports.”

Is the number of reports growing?

Markus Wälti: It has increased more than tenfold in the past 15 years. One reason for this is presumably stricter regulation. At the same time, demographic changes and technological progress are probably also contributing factors. There are more people in Switzerland and they are getting older, which means more health problems and operations. The number of medical devices is also growing all the time, among them complex products such as surgical robots and all kinds of implants.
Aurélie Drapela: Swissmedic is also not exactly an innocent bystander in this process. In recent years we have done more to raise awareness, we have intervened more and carried out more inspections. If they can see that we have an eye on them, they are more diligent about reporting.

During this time your team has only grown threefold.

Markus Wälti: Digitalisation processes have helped us to almost halve the time needed to handle a case. There is a lively interdisciplinary exchange within our team, which currently numbers 19 employees. This “collective intelligence” and the team members’ many years of experience lead to efficiency and good results. One person is responsible for around 80 to 120 open cases. It can take from less than 10 minutes to several years to close a case. The challenge here is to document everything in detail, to remember things and to work carefully.
Aurélie Drapela: In Materiovigilance we have a risk-based approach. In simple terms, if an adhesive plaster is not sticking properly, the manufacturer doesn’t need to recall the entire batch. But if the batteries in a defibrillator are only lasting half as long as they should, those batteries need to be replaced urgently.

Looking at enforcement –
where does Materiovigilance come in?

Aurélie Drapela: We are at the start of the enforcement chain, involved in surveillance and clarification of the situation. It’s a stimulating and demanding job. If we get the feeling that something is not ringing true, or maybe that something is being covered up, then we dig a little deeper. It sometimes really is detective work. Our approach is not to apportion blame but to ensure that the correct conclusions are drawn from incidents. We do assess individual cases, but our focus is on the bigger picture.
Markus Wälti: Our task is to investigate the content of every report and to identify signals and trends. Patient safety has priority for us.

What actions can be ordered specifically to improve devices?

Aurélie Drapela: Field Safety Corrective Actions (FSCA) may be required. This means that the manufacturer takes measures to minimise potential health risks. The action may be a physical recall, for example, or a software update or improved user information. In extreme cases, and after thorough consideration of the risks, it may also be necessary to remove a device that has been implanted in the interest of the patient’s safety. An FSCA can certainly be triggered by our involvement because we ask so many critical questions. We then oversee the FSCA process: Are customers being informed effectively? Are the actions taken to improve the device sensible? Is the timeline being observed?
Markus Wälti: If we can’t find a common solution, the problem is taken to the next level. This may consist of an action ordered as part of an administrative procedure, possibly against the manufacturer’s wishes. Then the case is handed to the Swissmedic team in the Medical Devices Surveillance Division (MDS).