Health regulation on reuse and reprocessing of single-use medical devices: an international overview

The reuse of single-use products is a global reality and implies technical-operational, economic, environmental, legal, political and ethical problems. This study aims to analyze the regulatory system for the reprocessing of single-use medical products at national (Brazil) and international levels. This article presents an integrative literature review, without any time or language restriction, using data bases with specific descriptors. At the international level, there is a variety of regulatory levels of reuse policies of medical single-use products, aiming at preventing damage. The regulations range from well-structured protocols as the American, Australian or German ones, to others less-regulated in developed countries like Canada, Japan and some of the European Union. Existing regulatory controls have large gaps that hinder their implementation by the health services and the manufacturers. An alternative approach might be the creation of a process-centered regulatory system contrasting the current product-centered regulatory system.