A proposed cleaning classification system for reusable medical devices to complement the Spaulding classification

Abstract

A central tenet in infection prevention is application of the Spaulding classification system for the safe use of medical devices. Initially defined in the 1950s, this system defines devices and surfaces as being critical, semi-critical or non-critical depending on how they will be used on a patient. Different levels of antimicrobial treatment, defined as various levels of disinfection or sterilization, are deemed appropriate to reduce patient risk of infection. However, a focus on microbial inactivation is insufficient to address this concern, which has been particularly highlighted in routine healthcare facility practices, emphasizing the underappreciated importance of cleaning and achieving acceptable levels of cleanliness. A deeper understanding of microbiology has evolved since the 1950s, which has led to re-evaluation of the Spaulding classification along with a commensurate emphasis on achieving appropriate cleaning. Albeit underappreciated, cleaning has always been important as the presence of residual materials on surfaces can interfere with the efficacy of the antimicrobial process to inactivate micro-organisms, as well as other risks to patients including device damage, malfunction and biocompatibility concerns. Unfortunately, this continues to be relevant, as attested by reports in the literature on the occurrence of device-related infections and outbreaks due to failures in processing expectations. This reflects, in part, increasing sophistication in device features and reuse, along with commensurate manufacturer's instructions for use. Consequently, this constitutes the first description and recommendation of a new cleaning classification system to complement use of the traditional Spaulding definitions to help address these modern-day technical and patient risk challenges. This quantitative risk-based classification system highlights the challenge of efficient cleaning based on the complexity of device features present, as an isolated variable impacting cleaning. This cleaning classification can be used in combination with the Spaulding classification to improve communication of cleaning risk of a reusable medical device between manufacturers and healthcare facilities, and improve established cleaning practices. This new cleaning classification system will also inform future creation, design thinking and commensurate innovations for the sustainable safe reuse of important medical devices.

Keywords: Cleaning; Disinfection; Hospital-acquired infections; Patient risk; Reusable medical device; Spaulding; Sterilization.