Sterilization & Disinfection
FDA: System 83 Plus AERs complete validation testing
Editor's Note The Food and Drug Administration (FDA) on April 10 notified healthcare facilities that Custom Ultrasonics (Ivyland, Pennsylvania) has completed validation testing of the System 83 Plus (ie, System 83 Plus, System 83 Plus 2, and System 83 Plus 9) automated endoscope reprocessors (AERs) with specific duodenoscopes. The FDA…
Denver hospital breach may have exposed patients to HIV, hepatitis
Editor's Note Patients at Porter Adventist Hospital in Denver may be at risk for HIV or hepatitis after the hospital discovered a surgical instrument sterilization breach, the April 5 LiveScience reports. The process for precleaning surgical instruments was found to be inadequate, which may have put patients who had orthopedic…
Instrument handling in the OR shines after SPD training
Improving teamwork between OR and sterile processing department (SPD) staff is an obvious way to increase the safety and efficiency of surgical procedures, but getting everyone on the same page can be challenging. Often the staff have limited understanding of what takes place in each respective department. Firsthand observation has…
ECRI Institute releases top 10 patient safety concerns for 2018
Editor's Note The ECRI Institute on March 12 released its 2018 Top 10 Patient Safety Concerns for Healthcare Organizations. Topping the list is diagnostic errors, followed by opioid safety across the continuum of care. Eighth on the list is device cleaning, disinfection, and sterilization. The list is not representative of…
FDA warns duodenoscope manufacturers on postmarket study noncompliance
Editor's Note The Food & Drug Administration (FDA) on March 9 issued warning letters to all three duodenoscope manufacturers for failing to comply with federal requirements to conduct postmarket surveillance studies to assess the effectiveness of reprocessing their devices. Olympus failed to start data collection, and Pentax and Fujifilm failed…
Agencies issue voluntary protocols for duodenoscope surveillance sampling, culturing
Editor's Note The Food & Drug Administration, Centers for Disease Control & Prevention (CDC), American Society for Microbiology, along with other experts on February 26 released voluntary standardized protocols for duodenoscope surveillance sampling and culturing, which update a 2015 CDC interim protocol. For facilities that choose to implement duodenoscope surveillance…
New guideline focuses on high-level disinfection safety
The new year brings a newly updated Guideline for Manual Chemical High-Level Disinfection (formerly the Guideline for High-Level Disinfection). This AORN guideline, which is based on a comprehensive, systematic review of research- and non-research-based evidence, recommends best practices for safe and effective high-level disinfection (HLD) performed manually when automated methods…
Testing reprocessing procedures with PCR based method
Editor's Note A real-time polymerase chain reaction (PCR) sampling method for monitoring reprocessing of colonoscopes was successfully applied in this multicenter Italian study. PCR allowed identification of contaminated (59) and fully reprocessed (52) colonoscopes in 10 endoscopy units with high sensibility (98 %) and specificity (98%), within 3 to 4…
Study: Manual, automated cleaning equally effective for laparoscopes
Editor's Note In this experimental laboratory study, all cleaning and rinsing methods tested were effective in reducing the levels of organic residues on laparoscopic instruments. Four methods were examined: manual-only cleaning and rinsing with potable tap water manual cleaning and rinsing with potable tap water, followed by ultrasonic cleaning without…
Greater vigilance needed to combat ureteroscope contamination
A new study by Ofstead & Associates (St Paul, Minnesota) is the latest to raise concerns about infections associated with endoscopic procedures. The study, which focused on ureteroscopes, found that the techniques used to clean and sterilize or high-level disinfect flexible ureteroscopes are not sufficient and leave behind contamination including…
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