Peter Münger about national implant registries

Mr Münger, what are arthroplasty registries used for and by whom?

Peter Münger: Arthroplasty registries can have a wide variety of uses depending on the perspective from which they are viewed. The focus is usually on quality in arthroplasty. In most national registries, it’s not only the implants themselves that are evaluated – the results of the entire intervention are documented. How many operations does the clinic perform? What technique is used to insert the prosthesis? Was there a revision? Patient-specific data is also collected. Registries are therefore useful for making statements about the quality of a prosthesis, a doctor or clinic, a technology and, to some extent, the requirements placed on patients.

As a manufacturer, what’s your view of the national arthroplasty registries?

Peter Münger: Registries are exceedingly important for us. We’ve always had very high expectations regarding the quality, and therefore also the longevity, of our products. Indisputable statements about lifespans over years or even decades can really only be made using registry data.

Registries also act as an early warning system. We can recognise, for example, whether we have an increased failure rate due to early complications and, as a company, we can then respond by offering additional training or, if needed, making changes to the instruments or surgical technique. Key figures like these are recorded by most registries. We can also see clearly what happens to the prostheses following their market launch: how often are they used? Who are the typical users? For which patients are they used? We can also identify ‘off-label use’, for example, and take targeted action against it. We also work intensively with the data in other ways. For legal reasons, we need it for our recertification: the EU legislation for medical devices, the Medical Device Regulation (MDR), requires this data and once a year, we report to our notified body and provide updates on our clinical data, including the data from registries.

‘Registries are an early warning system for Mathys: is everything functioning well? Do we need to make changes?’

What’s the current state of the national registries? Is high-quality data to be had everywhere?

Peter Münger: Yes – not to the same extent everywhere, but mainly so. There are differences between countries, of course. A good registry captures the data from at least 90 to 95 per cent of all interventions performed in the country. Some countries in Europe manage this, as do Australia and New Zealand, for example. With regard to quality, there are differences in the data that is recorded and published. The Swedish registry is very transparent, for example – patients can check it themselves to determine which clinics have lots of revisions and which have just a few. In what I regard as a positive development, more and more registries are measuring the success of therapy, i.e. PROM’s Patient-Related Outcome Measures. It’s therefore increasingly about the patients’ quality of life and their satisfaction with their implant, and not just about how long an implant stays in the body before an additional operation is required.

Is there also an international registry that pools the data across national borders?

Peter Münger: No, not yet, but there is the International Society of Arthroplasty Registries, which organises annual congresses that focus on the methods of registry evaluations, the results from registries and many other topics. We’re regularly represented there, so we can learn from new findings and maintain our relationship with the registries. The Society is also working on the issue of standardisation of the data to be recorded in the registries.

 

How satisfied are you with the current quality of data?

Peter Münger: The available data already allows very good conclusions about the quality of the prostheses and operations to be drawn. Of course, there’s always room for improvement: the more data that is collected, the more statements can be made. However, the main aims of the registries – avoiding revisions and identifying outliers in order to make data-based recommendations – are already being achieved with the available data.

‘Despite registry data, the decision whether to go for a prosthesis is still an individual one’

What do you think about the fact that patients can look at registry data and draw their own conclusions?

Peter Münger: I don’t see any great danger there. In practice, clinics and doctors carry out an intensive informed consent consultation and the advantages and disadvantages of the prostheses are discussed individually for each patient. Certainly, patients can read up and find out which prosthesis needs fewer revisions and which needs more. But it might be the case that a patient has a specific anatomy or other special requirements and, in these situations, the supposedly lower-rated prosthesis might be the better choice. I trust in the expertise of the doctors to discuss these things individually and responsibly with the patient.

Is there a national registry that you favour?

Peter Münger: At the moment, there are two registries that offer a special service. One is the Australian registry, and the other is the British one. In Australia, we as manufacturers can log in any time we want to and see the registry data, which is updated daily. This enables ongoing monitoring, and that’s particularly important in the initial phase of a new product launch. It’s a great service! In the UK, we get highly informative quarterly reports for all our products sold in the UK. In other cases, registries provide reports once a year, usually in the autumn, but the data in these applies to the previous year. It would be good if registries could speed up the reporting processes so we have faster access to the data.

Are there any other limitations to the registries?

Peter Münger: Yes. For example, it’s often not possible to answer specific questions. Clinical studies are still required for that. Also, registries don’t collect X-ray images, which would sometimes be very helpful to us. In some countries, poor registry data also has consequences for users or clinics if the data is clinically relevant but below average. Or, for example in Australia, there can be requests for follow-up training, which very few doctors want. For us as a manufacturer, though, this can be seen as added value.

I’m firmly of the opinion that, in the future, findings from registries will become more important to our healthcare system both economically and medically.

Mr Münger, many thanks for your time!