Standardization Gaps in Instrument Reprocessing: A Comparative Review of U.S. and International Sterile Processing Practices

Abstract

Abstract
Sterile instrument assurance is the basis for safety during surgical procedures, but standards for instrument processing lack standardization at both the global and national levels. The objective of this paper is to perform a gap analysis of sterile processing (SP) between the United States (US) and comparable, high-resource nations through a focused literature review. Recommendations are offered with an eye toward future regulatory improvements in the US. The US system is based on voluntary professional guidance issued by the Association for the Advancement of Medical Instrumentation (AAMI), which forms the core for practices that are not otherwise prescriptively mandated by state or facility policies. In contrast, other developed nations, most notably Germany, the United Kingdom, and Canada, have centralized and national standards with which SPs must comply. This paper reviews literature on the characteristics of each model and provides insights into the structural and educational differences that impact how SP departments are staffed, accredited, held accountable, and incentivized to adopt innovative equipment and technology. The current voluntary structure in the US results in vulnerabilities that are avoidable and contribute to preventable patient harm. The authors propose a shift in regulatory structure that considers best practices from global partners to promote more standardized practices across hospitals to enhance safety.