London 2022

On the 23rd of March 2023, Beyond Compliance and ODEP hosted the 1st International Meeting of Spinal Registries at the Royal National Orthopaedic Hospital, in Stanmore, UK. This meeting brought together international registries from all around the world as well as other key stakeholders which included regulators, clinicians, and medical device manufacturers.

There were 41 attendees in the hall and 81 online.

The meeting started with the welcome address of Prof. Deborah Eastwood, President BOA (British Orthopaedic Association) that highlighted the importance of the national and international cooperation confirming that ISAR has been instrumental in defining what we are now.

Keith Tucker introduced the meeting. The purpose is to work to protect patient from harm, promote good practice, understand the new regulatory landscape and its demand, know the experience of the registries and start a joint cooperation.

All agreed in the need to internationally cooperate in order to define a core minimum dataset common to all the registries, allowing for future comparison of data.

Notified bodies highlighted the importance of registries as specific method and source of reliable data to support certification processes of legacy products, according to MDR.

Manufacturers drew attention to the fact that MDR has totally changed the approach — claiming device equivalence is no longer viable. Now there is the need to provide data for each indication and for each device variant. RCTs cost many millions of dollars; registries are a reliable source.

Rob Nelissen highlighted that MDR aim is to not circulate medical devices that might give harm and informed about the activities done by the EU expert panel (Clinical Evaluation Consultation Procedure, CECP).

Alan Fraser reported on the EU project CORE-MD to support the EU Commission with the advice of experts for high risk devices.

FDA and IMDRF described the IMDRF reports recalling the definition of Registry and showed the activities performed within the Coordinated Registries Network on different topics.

Keith Tucker described ODEP and Beyond Compliance (BC). ODEP started in 2002 following the Capital incident. Aim of ODEP is to work with manufacturers to improve quality of devices.

Notified bodies: BSI, TUV, RQM+

Industry: DePuy, MedTech EU, Medtronic, Nuvasive, ABHI UK, Stryker

Regulators: Clinicians members of CIE (Rob Nelissen, Alan Fraser), MHRA, FDA and IMDRF

Registries: British Spinal Registry (BSR), Spine Tango, Swiss spinal implant registry (SIRIS), FinSpine, Australian Spinal Registry, Norwegian Spine Registry, Italian Registry (RIDIS), Swedish Registry (Swespine), ASR (American Spine Registry), Hong Kong Registry, German Spinal Registry, Kaiser Permanente Registry

Benchmarking/monitoring: ODEP, Beyond Compliance

The discussion highlighted that it is central to provide data to improve patient safety and that the following needs should be satisfied:

• Combining data from different registries in order to detect failure much earlier
• Sustainability of registries well funded by governmental funds
• High level of coverage and completeness
• UDI to identify implanted devices
• Set up a common dataset common to all the registries to make data comparable
• Contribution by industry to get data
• Linkage between Hospital Discharge Records and Registries