Risks of placing complex implants in a general healthcare system: lessons from real-life experience

Abstract

Abstract Surgical implants, such as joint replacements, are used for many serious conditions. Innovation continues to supply new implants, including outputs of the soft robotics revolution. However, they carry risk of complications with potentially devastating consequences. We present an opinion paper providing the reflections of two surgical technologists on present challenges to safety, efficacy and broad implementation of medical implants. We highlight lack of familiarity with implant surgery in healthcare services, with concomitant risk. First-in-human application of new implants is not sufficiently standardized and regulated. IDEAL-D is a structured framework for medical devices (Idea, Development, Exploration, Assessment, Long-term study). Once CE-marked and approved for mainstream use, there are problems with the implementation. ‘Early adopter’ surgeons and centres face cultural inertia, lack of funding support and issues around training, especially learning curves. Patient selection may not be well-defined, and complications inaccurately reported, affecting implant dissemination detrimentally. The Cumberlege report showed how harmful this can be. There is need to standardize early clinical studies. Implementation of implantable devices requires changes to whole-team training, funding and post-implementation reporting. The IDEAL-D framework represents an important step, but other system-wide changes are required if implants are to achieve their intended clinical impact.

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