Engineering standards for trauma and orthopaedic implants worldwide: a systematic review protocol.

ABSTRACT:

Introduction

Despite multiple scandals in the medical implant sector, premarket testing has been the attention of little published research. Complications related to new devices, such as the DePuy Articular Surface Replacement (ASR, DePuy Synthes, USA), have raised the issue of how designs are tested and whether engineering standards remain up to date with our understanding of implant biomechanics. Despite much work setting up national joint registries to improve implant monitoring, there have been few academic studies examining the premarket engineering standards new implants must meet. Emerging global economies mean that the markets have changed, and it is unknown to what degree engineering standards vary around the world. Governments, industry and independent regulatory bodies a

SUBMITTER: Henshaw F 

PROVIDER: S-EPMC6196807 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature