Lifecycle of surgical devices: Global, environmental, and regulatory considerations.

Abstract

Technological advancements, improved surgical access, and heightened demand for surgery have fueled unprecedented device and supply turnover impelling wealthy hospitals to upgrade continually and sell, donate, recycle, or dispose of used, expired, antiquated, or surplus goods. This paper reviews the issues related to device and supply lifecycles and discusses the opportunities and challenges they present for sustainable surgical growth in low- and middle-income (LMICs) countries. This review found, in LMICs countries, regulatory disparities persist that limit effective harmonization secondary to highly variable national policies and a lack of prioritized enforcement. Heterogeneity in the regulatory landscape, specifically in the classification, nomenclature, and identification of medical devices, encumbers effective regulation and distribution. Once devices are sold, donated, or reused in LMICs countries, complexities arise in regulatory compliance, maintenance, and appropriate use of these technologies. At the end of the lifecycle, waste management poses significant obstacles with limited resources hindering the implementation of best practices. There are major disparities in access to quality surgical equipment and supplies around the world. Improved communication between relevant stakeholders and harmonization of manufacture and disposal regulations will be needed to ensure adequate and appropriate responses to these challenges. Not applicable.