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Shoring up Quality and Safety Foundations in Sterile Processing
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Journal Article
Shoring up Quality and Safety Foundations in Sterile Processing
2019
Overview
\"Endoscope technology has advanced from observational devices to being used in complex, minimally invasive surgical procedures in which the endoscope or endoscope accessories cross the membrane barrier into sterile tissue,\" stated Wiser. \"Because of this, experts are starting to recommend that the Spaulding classification be updated so that endoscopes are considered critical devices.\" Klacik highlighted comments by William Rutala, director of North Carolina's statewide program for infection control and epidemiology and professor of medicine at the University of North Carolina, who has said \"that when the Spaulding system was designed 50 years ago, semicritical items rarely, if ever, penetrated sterile tissue and healthcare did not have an adequate appreciation for the infection risk associated with endoscope reprocessing, with endoscopes used primarily for diagnostic purposes.\" Using data gathered from medical device companies, Joyce Hansen and Trabue Bryans (p. 38) evaluated methods for establishing a radiation sterilization dose, concluding that \"one may use Modified Method 2 for any application, while Method 2 may be used to obtain equally reliable results.\"
Publisher
Association for the Advancement of Medical Instrumentation, AAMI
Subject
