A new universal, standardized implant database for product identification: a unique tool for arthroplasty registries

Blömer, W.; Steinbrück, Arnd; Schröder, Christian; Grothaus, Franz-Josef; Melsheimer, Oliver; Mannel, H.; Forkel, Gerhard; Eilers, Thomas; Liebs, Thoralf Randolph; Hassenpflug, J.; Jansson, Volkmar

doi:10.1007/s00402-015-2238-2

Cited by 25 publications

(17 citation statements)

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“…Collaboration between the EPRD and the NJR has led to the generation of a harmonized classification system covering all components used in both libraries. Each component is classified according to material, measurements, surface finish, type of bony fixation and equipped with a specific article number that is encoded in a barcode for optimizing hospital processing, documentation and completing fill orders for hospitals 1. This bar code is integral to the process of EPRD documentation and data collection.…”

Section: Methodsmentioning

confidence: 99%

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Orthopaedic registries: the German experience

et al. 2019

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National joint registries are gaining more and more importance in the fields of implant monitoring/outlier detection and quality of care. The German Arthroplasty Registry (EPRD) was established in 2010 for the purpose of observing the impact of primary hip and knee arthroplasty on the German population. Having now over one million documentations, we introduce the structure of the EPRD and detail the process of data collection. We report on some preliminary trends and contrast these with findings from other joint registries. We introduce the overhauled Arthroplasty Library, that resulted from an international collaboration with National Joint Registry of England, Wales and Northern Ireland. Cite this article: EFORT Open Rev 2019;4 DOI: 10.1302/2058-5241.4.180064

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Section: Methodsmentioning

confidence: 99%

“…The German Arthroplasty Registry (EPRD) was established in 2010 as an umbrella organization by surgeons and the German Association of Orthopaedics and Orthopaedic Surgery, comprising hospitals, public health insurance agencies and industry representatives from endoprosthesis manufacturing companies 1-3. The aims of EPRD are:…”

Section: Introductionmentioning

confidence: 99%

Orthopaedic registries: the German experience

et al. 2019

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“…A task force of representatives of the German Arthroplasty Registry (EPRD) published a universal, standardized implant database for product identification in 2015. 12 That system is now adopted by the National Joint Registry of the UK, Wales, Northern Ireland & Isle of Man and recently a regional registry in Italy. A second initiative is done by the International Society of Arthroplasty Registers (ISAR).…”

Section: Implementation Of the Implant Librarymentioning

confidence: 99%

Generic implant classification enables comparison across implant designs: the Dutch Arthroplasty Register implant library

et al. 2019

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In the Dutch Arthroplasty Register (LROI), the product and batch number of prosthetic components and cement are registered for traceability. Registration of the product number provides opportunities to extend the information about a specific prosthesis. All product numbers used from the beginning of the registration in 2007 were characterized to develop and maintain an implant library. The Scientific Advisory Board developed a core-set that contains the most important characteristics needed to form an implant library. The final core-set contains the brand name, type, coating and material of the prosthesis. In total, 35 676 product numbers were classified, resulting in a complete implant library of all product numbers used in the LROI. To improve quality of the data and increase convenience of registration, the LROI implemented barcode scanning for data entry into the database. In 2017, 82% of prosthetic components and cement stickers had a GS1 barcode. The remaining product stickers used HIBCC barcodes and custom-made barcodes. With this implant library, implants can be grouped for analyses at group level, e.g. evaluation of the effect of a material of a prosthesis on survival of the implant. Apart from that, the implant library can be used for data quality control within the LROI database. The implant library reduces the registration burden and increases accuracy of the database. Such a system will facilitate new designs (learning from the past) and thus improve implant quality and ultimately patient safety. Cite this article: EFORT Open Rev 2019;4 DOI: 10.1302/2058-5241.4.180063

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“…Scandinavian countries, United Kingdom). Over the last 15 years registries have expanded to many other parts of Europe creating the opportunity to harmonise [ 57 , 58 ] and extend data collection (e.g. International Society of Arthroplasty Registries (ISAR), Network of Orthopaedic Registries of Europe (NORE)) and to engage in multinational initiatives (Nordic Arthroplasty Register Association (NARA)) [ 59 , 60 ].…”

Section: Main Textmentioning

confidence: 99%

The role of national registries in improving patient safety for hip and knee replacements

Lübbeke

Silman

Prieto‐Alhambra

et al. 2017

BMC Musculoskelet Disord

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BackgroundThe serious adverse events associated with metal on metal hip replacements have highlighted the importance of improving methods for monitoring surgical implants.The new European Union (EU) device regulation will enforce post-marketing surveillance based on registries among other surveillance tools. Europe has a common regulatory environment, a common market for medical devices, and extensive experience with joint replacement registries. In this context, we elaborate how joint replacement registries, while building on existing structure and data, can better ensure safety and balance risks and benefits.Main textActions to improve registry-based implant surveillance include: enriching baseline and diversifying outcomes data collection; improving methodology to limit bias; speeding-up failure detection by active real-time monitoring; implementing risk-benefit analysis; coordinating collaboration between registries; and translating knowledge gained from the data into clinical decision-making and public health policy.ConclusionsThe changes proposed here will improve patient safety, enforce the application of the new legal EU requirements, augment evidence, improve clinical decision-making, facilitate value-based health-care delivery, and provide up-to-date guidance for public health.

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A new universal, standardized implant database for product identification: a unique tool for arthroplasty registries

Cited by 25 publications

References 20 publications

Orthopaedic registries: the German experience

Orthopaedic registries: the German experience

Generic implant classification enables comparison across implant designs: the Dutch Arthroplasty Register implant library

The role of national registries in improving patient safety for hip and knee replacements

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