from the editor
from the editor
Researchers Propose a New Cleaning Classification to Supplement the Spaulding System
new cleaning classification for medical
A instruments and devices proposed by researchers could supplement the Spaulding classification system , which is starting to show its age and may not be as relevant in 2024 as it was when it was created in the 1950s . As we know , Spaulding defined devices and surfaces as being critical , semi-critical or non-critical depending on how they will be used on / interact with a patient . Researchers are pointing out now that only a focus on microbial inactivation is insufficient to address modern healthcare ’ s challenges of meeting cleanliness standards .
As Kremer , et al . ( 2024 ) note , “ 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 microorganisms , 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 .”
The researchers ask a critical question of “ How clean is safe ?,” which is a query that our publication has frequently posed throughout the years . They note , “ At the time the Spaulding classification was widely adopted , the detailed measurement techniques or endpoints for determining cleanliness had yet to be established .
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Visual cleanliness was the expectation , and the Spaulding classification system was established with the foundational assumption that all devices would be visibly clean prior to the microbial reduction step of disinfection or sterilization . It was assumed that vigorous cleaning would always be performed , and , in many cases , devices ( and their associated features ) could be inspected quickly during or following the cleaning process . If the device was visibly clean , it was assumed that the residual soil level was sufficiently low to ensure that the antimicrobial process would be effective , even in the presence of some residual soil .”
They point to disinfection and sterilization standards that were developed after Spaulding ’ s debut , as well as note interest in defining the scientific endpoints for cleaning in the last 30 years and a concerted effort to gain an internationally harmonized consensus on cleaning requirements .
Kremer , et al . ( 2024 ) say their 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 efficacy . They add that , “ The introduction of a complementary cleaning classification system would allow for effective communication between medical device manufacturers and healthcare facilities on the proper risk mitigation for associated cleaning processes .”
They outline three classifications that consider the probability of risk for residual soil to remain on or in the various design features of a device following cleaning :
• Maximal : Complex device features with a high probability of soil accumulation with a medical device
• Moderate : Accessible device features that require specific intervention ( e . g . brushing or flow through lumens , mated surfaces requiring disassembly or opening / closing to ensure access )
• Minimal : Low-risk reusable medical devices where all features are exposed without specific intervention for cleaning
The researchers suggest the use of a universal set of symbols that convey visual communication of this classification to the healthcare facility to impart information about the device risk for cleaning , as well as alert healthcare institutions when special considerations for equipment or training are required to ensure effective and consistent processing . For example , the researchers say , a cleaning classification of maximal could lead the manufacturer to require enhanced visual inspection steps ( such as the use of borescope ) to assess it for cleanliness and mitigate risk .
Relatedly , in one of this month ’ s features , we report on a novel training program using borescopes to help sterile processing technicians learn critical skills of visualization of potentially contaminated and / or endoscopes . Innovative training efforts and new ways of classifying instruments and devices could be a vital continued step toward eliminating device-related infections in patients . Until next month , bust those bugs !
Kelly M . Pyrek Editor & Publisher Kelly @ healthcarehygienemagazine . com
Reference : Kremer T , Rowan NJ , and McDonnell G . A proposed cleaning classification system for reusable medical devices to complement the Spaulding classification . J Hosp Infect . Vol . 145 . Pp . 88-98 . March 2024 . DOI : https :// doi . org / 10.1016 / j . jhin . 2023.11.018
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6 • www . healthcarehygienemagazine . com • april 2024