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

Abstract

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

Can Bar Code Scanning Improve Data Capture in a National Register? Findings from the Irish National Orthopaedic Register

“…The MDR legislation mandates that a plain-text version and an Automatic Identification and Data Capture form (bar code) are displayed on device packaging. Therefore, UDI scanning, recognition of the UDI against a known implant library, and subsequent insertion of implant parameters in the electronic operating note and national register is possible for all implants, reducing the manual input burden and the risk of input error [1,2,3,7,11]. National and international implant catalogues are available for device recognition, with the INOR using the purpose-built and maintained Irish National Component Catalogue.…”

“…In 2014, the INOR became the first national arthroplasty register to introduce automated implant data using UDI bar code scanning. Comparable to the 2013 FDA requirements [6], new European Union legislation (Medical Device Regulation [MDR]) now requires all medical implants to display a UDI [3, 5]. The MDR legislation mandates that a plain-text version and an Automatic Identification and Data Capture form (bar code) are displayed on device packaging.…”

“…The creation of a similar bar code-affiliated registry catalogue was achieved by the German Arthroplasty Register in 2015 [2,7]. The Dutch Arthroplasty Registry also introduced bar code scanning upload of implant data in 2015 and has since quoted a 96% to 97% implant completeness rate [3]. The United Kingdom's National Joint Registry has similarly eliminated manual implant data entry using bar code scanning.…”

Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review

“…For orthopaedic devices for instance, the International Society of Arthroplasty Registers (ISAR) has proposed a global registry library in 2019 to ensure the same classification of orthopaedic devices across registries. 80 Also, this problem of using different implant libraries can be solved if registries document the unique device identifier for each implant.…”

“…[77][78][79] Another aspect to consider before outcomes across registries can be pooled, is whether registries use the same implant library to classify implants by relevant device characteristics. 80 The European Medical Device nomenclature is a generic classification intended for this purpose, but more detailed libraries are used by registries to capture their specialty-specific characteristics as well. For orthopaedic devices for instance, the International Society of Arthroplasty Registers (ISAR) has proposed a global registry library in 2019 to ensure the same classification of orthopaedic devices across registries.…”