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CS CONNECTION Sponsored by Jagrosse points out how AAMI gives


guidance (13.7.5.1 section C) on how to handle a recall when sterilization failures occur.3 “It tells us that when there is a failure we are to recall all goods to the last known negative BI test,” said Jagrosse. “This can mean hundreds of items and potentially dozens of patients - I refer to this as a ‘win- dow of liability.’ To eliminate or close this window of liability, facilities can practice ELM with biological tests. From an ethical standpoint, why should some patients have


biological testing done on their instruments and some not? What would you want for your loved ones or yourself? ELM provides the safest patient care possible while ensur- ing an equal continuum of care.” According to Esquenet, visual verification following cleaning is a great way to exam- ine results, as noted in ANSI/AAMI ST91: Comprehensive guide to flexible and semi- rigid endoscope processing in healthcare facilities: “Careful visual inspection should be conducted to detect the presence of any residual soil.”4


The Ruhof Corporation’s Visual Inspec- tion Borescope (VIB) allows for instant visu- al detection of internal debris and damage inside the channels of an endoscope, reduc- ing the risk of device related infections. The Ruhof VIB’s advanced visual inspection system includes a state-of-the-art camera system and intuitive software providing high resolution, knowledge-based images to help quickly determine the condition of medical devices and instruments.


It all comes down to patient safety “When we talk about quality and steril- ity assurance, we are really talking about patient safety and the impact CS/SPD has on the ultimate quality measurement; surgical site infections (SSI),” said Gregg Agoston, MBA, VP Minimally Invasive Surgical Support, SpecialtyCare. Agoston explains how the CS/SPD directly affects patients’ risk of SSI in two ways, as defined by American College of Surgeons and Surgical Infection Society’s Surgical Site Infection Guidelines: Op- erative time and sterilization of surgical equipment.2


The CS/SPD can extend


operative times if instruments are not available or functional, and can impact patient safety if instruments are not prop- erly cleaned and sterilized or high-level disinfected (per the manufacturer’s IFU). “Unfortunately these goals are often not


met as there is a silent epidemic of non- sterile and/or non-functional instruments that make their way to the OR every day across the country,” said Agoston. “If it were not for antibiotics and other steps to minimize SSI, we would likely see this epidemic in the news daily. The reality is that our population is aging and more people will require surgery, bacteria are becoming more virulent and time to an- tibiotic resistance now is being measured in weeks and months versus years. This equates to a perfect storm that could result in many more SSI and patient deaths from them. For these reasons, CS/SPD must do all it can to meet its goals of instrument availability, functionality and safety for every patient.”HPN


References


1. ANSI/AAMI ST58:2013 (R2018), Chemical Sterilization And High-Level Disinfection In Health Care Facilities, September 2018


2. American College of Surgeons and Surgical Infection Society: “Surgical Site Infection Guidelines, 2016 Update,” January 2017, Volume 224, Issue 1, Pages 59-74


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3. ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, November 2017


4. ANSI/AAMI ST91: Comprehensive guide to flexible and semi- rigid endoscope processing in health care facilities, April 2015

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