Foundation for Quality Assurance in Implant Surgery
Spirit and purpose of an implant registry
In Switzerland, around 44,000 hip and knee prosthesis implantations and 12,000 spinal procedures are performed annually by approximately 1200 surgeons. The implanted products are produced and/or distributed by around 35 companies.
Medical registries make a valuable contribution to assessing the long-term quality of implants and treatment and serve as an early warning system for product or process errors. The Swiss Federal Office of Public Health FOPH welcomes the establishment of an independent implant registry, consistent with the formal establishment of the obligation for quality assurance specified under Art. 58 of the Health Insurance Act.
Assessment of the hard end-point “implant replacement” enables national monitoring of prosthesis service life. Analysis of the collected data can be used to identify factors influencing service life.
Organisation of the SIRIS Foundation
The Foundation for Quality Assurance in Implant Surgery SIRIS is an independent, non-profit organisation. It was founded in August 2007 by Swiss Orthopaedics, SwissMedtech and santésuisse, and sub-sequently established the Swiss Implant Registry SIRIS. The aim of SIRIS is to develop a robust national database for quality assurance and to collect data that will also enable international comparisons in implantation surgery.
The foundation currently maintains two registries. In 2012, the implant registry SIRIS Hip & Knee was introduced, and in 2021, SIRIS Spine. Both implant registries are maintained under the same legal and organisational structure but with different registry operators (SwissRDL/Uni Bern and EURO-SPINE/NEC Software Solution).
SIRIS Foundation Board and organisational structure
The SIRIS Foundation Board is composed of delegated members of the participating professional associations:
The Swiss Hospital Association (H+) The umbrella organisation of public and private hospitals, clinics and care institutions is jointly responsible for the strategic development of the registry.
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santésuisse The industry organisation of Swiss health insurance companies is a founding member, has assisted in establishing the registry and also provides financial support.
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Swiss Medtech The umbrella association of Swiss medical technology is a founding member and an important hub for implant suppliers operating in the market. The association members provide the registry with the basis for a structured implant database
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Swiss Orthopaedics, the Swiss Society of Neurosurgery, the Swiss Society of Spinal Surgery These specialist medical associations are wholeheartedly committed to measures to improve quality and have played a major role in setting up the SIRIS implant registry. Swiss Orthopaedics is also a founding member.
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Contractual and project partners
ANQ The ANQ has been coordinating and implementing national inpatient quality assessments since 2009. The members of ANQ are the Swiss Federation of Hospitals H+, santésuisse, curafutura, the Swiss federal social insurers, the Swiss cantons and the Swiss Conference of Cantonal Health Directors. Under the service agreements with the cantons and collective agreements, all hospitals and clinics are obliged to enter into the ANQ National Quality Agreement.
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SwissRDL / ISPM / University of Bern Commissioned by the SIRIS Foundation, these are tasked with technical implementation, hospital support and data management. The analyses and statistical assessments for SIRIS Hip & Knee are performed in cooperation with the SIRIS Scientific Advisory Board.
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EUROSPINE The Spine Society of Europe (EUROSPINE), based in Switzerland, owns and manages the Spine Tango registry and has been commissioned by the SIRIS Foundation to develop, technically implement, support clinics and manage SIRIS Spine data. The SIRIS Spine analyses and statistical assessments are performed in cooperation with and according to the specifications of the SIRIS Spine Steering Group.
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NEC Software Solution International IT service provider that develops and operates the Spine Tango registry and SIRIS Spine on behalf of EUROSPINE. SIRIS Spine and Spine Tango share a common implant database and benefit from the data pool in statistical assessments.
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ISAR SIRIS is a full member of the International Society of Arthroplasty Registries (ISAR). This society organises endoprosthesis registries worldwide.
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Basis of the obligation and Funding
All hospitals and clinics that have entered into the ANQ’s National Quality Agreement and perform implantations in the areas defined by the ANQ are obliged to register. As a result, the SIRIS Hip & Knee implant registry has succeeded in registering over 90% of implantations, exceeding the standard mandated by the International Society of Arthroplasty Registries ISAR for full membership.
Clinics are obliged by the Swiss National Quality Agreement to meet the costs of registration (quality measure). In the case of SIRIS Hip & Knee, registrations are invoiced quarterly on the basis of delivery dates reported by the manufacturers (CHF 20.00 per registration). In the case of SIRIS Spine, based on a self-assessment of the number of procedures in the specified field, the clinics are invoiced every six months (CHF 50.00 per registration). The amount invoiced for SIRIS Spine is verified in the follow-ing year by comparing it with the Swiss FSO medical statistics.