RESUMO
Orthopaedic surgeons have a strong legacy for the early of adoption of new technologies that promise to advance patient care. Such technologies are being developed at an extraordinary pace, leveraging advances in orthobiologics and cartilage restoration, surgical navigation, robotic surgery, 3-D printing, and manufacturing of customized implants and sensors. The functionality provided by this revolution is impressive, promising substantial benefits for patients. However, the value of these technologies resides not in their "newness" but in the ability to improve outcomes for patients and reduce overall costs of care. Deciding whether a new technology brings value to an orthopaedic practice can be difficult, especially in an environment of rising health care costs, abundant choice, competition, consumer pressures, variable quality in supporting data, and a shifting regulatory landscape. In this article, we explore the drivers for orthopaedic companies, institutions, and care providers to develop, evaluate, and incorporate new technology. We outline the technology innovation cycle and the major demographic and psychosocial characteristics of adopter groups. We introduce factors considered in evaluating new technologies, such as patient safety, product efficacy, regulatory issues, and their value. Finally, we summarize the ethical concerns associated with new technology, alongside education and training, network security, financial remuneration and informed consent. This article aims to empower orthopaedic surgeons with a balanced and critical approach to ensure the adoption of new technologies in a safe, effective, and ethical manner.
Assuntos
Ortopedia , Custos de Cuidados de Saúde , Humanos , Consentimento Livre e Esclarecido , Invenções , Segurança do PacienteRESUMO
BACKGROUND: In response to the increased volume, risk, and cost of medical devices, in 2001 Kaiser Permanente (KP) developed implant registries to enhance patient safety and quality, and to evaluate cost-effectiveness. METHODS: Using an integrated electronic health record system, administrative databases, and other institutional databases, orthopedic, cardiology, and vascular implant registries were developed in 2001, 2006, and 2011, respectively. These registries monitor patients, implants, clinical practices, and surgical outcomes for KP's 9 million members. Critical to registry success is surgeon leadership and engagement; each geographical region has a surgeon champion who provides feedback on registry initiatives and disseminates registry findings. RESULTS: The registries enhance patient safety by providing a variety of clinical decision tools such as risk calculators, quality reports, risk-adjusted medical center reports, summaries of surgeon data, and infection control reports to registry stakeholders. The registries are used to immediately identify patients with recalled devices, evaluate new and established device technology, and identify outlier implants. The registries contribute to cost-effectiveness initiatives through collaboration with sourcing and contracting groups and confirming adherence to device formulary guidelines. Research studies based on registry data have directly influenced clinical best practices. CONCLUSIONS: Registries are important tools to evaluate longitudinal device performance and safety, study the clinical indications for and outcomes of device implantation, respond promptly to recalls and advisories, and contribute to the overall high quality of care of our patients.