Latest sterilization packaging guideline backed by evidence
In October 2019, AORN released its updated Guideline for Sterilization Packaging, which is based on evidence from peer-reviewed literature. This article includes recommendations from that guideline and addresses common misconceptions about sterilization packaging. Other resources for proper use of sterilization packaging include the Association for the Advancement of Medical Instrumentation…
Medline’s Illinois ethylene oxide sterilization facility hopes to reopen end of January
Editor's Note Medline Industries has not operated its Waukegan, Illinois, sterilization facility since December 13, 2019, when it was temporarily closed because it couldn’t meet Illinois’ new state standards for ethylene oxide, the January 21 MedTech Dive reports. A Lake County Health Department update on January 17 says Medline began…
Boston Scientific receives FDA clearance for single-use duodenoscope
Editor's Note Boston Scientific announced December 13 that it had received Food & Drug Administration (FDA) 510(k) clearance for the EXALT Model D Single-Use Duodenoscope for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures. The EXALT Model D, which was granted Breakthrough Device Designation from the FDA, eliminates the need for…
Sterilization trumps high-level disinfection for semicritical items
In the never-ending quest to improve patient care, we are always seeking better ways to process medical devices. Many leading experts now recommend transitioning from high-level disinfection (HLD) to sterilization for semicritical items. Semicritical items are instruments or objects that contact mucous membranes or nonintact skin of a patient, but…
FDA of device shortages because of sterilization facility closures
Editor's Note The Food and Drug Administration (FDA) on October 25 released a statement warning of possible device shortages because of interruptions in ethylene oxide (EO) sterilization services due to facility closures in Illinois and Georgia. In the statement, the acting FDA Commissioner, Ned Sharpless, noted that “at this time…
Proactive steps paramount for greater surgical stapler safety
Internal surgical staplers made headline news in 2019. Reports discussed the little-known US Food and Drug Administration database housing tens of thousands of stapler-related problem reports and covered the agency’s recent proposal to reclassify staplers as Class II devices, instead of the more lightly regulated Class I. ECRI Institute named…
Is point-of-use treatment an integral part of your sterilization process?
Providing sterile instrumentation for patient care is a basic fundamental of surgery, and ensuring sterility means that instrumentation must first be thoroughly cleaned, step by step. Point-of-use treatment, an important part of this process, is gaining the attention of accrediting agencies such as the Joint Commission, and it is included…
FDA sets meeting to discuss EO sterilization
Editor's Note The Food & Drug Administration (FDA) announced September 4 that it will hold a Medical Devices Advisory Committee Meeting in November to discuss ethylene oxide (EO) sterilization of medical devices, including methods to reduce EO emissions. The committee also will provide recommendations on reducing infection risks from reprocessed…
Surgical smoke exposure in OR personnel
Editor's Note This review article finds that surgical smoke is dangerous, but the severity of the risk has yet to be been determined. Therefore, no safe level is known. Though numerous studies have been performed on the chemical composition of surgical smoke, the components remain unclear. The variability is likely…
Inspections reveal need to overhaul bronchoscope reprocessing methods
Extensive research by Cori L. Ofstead, MSPH, and her colleagues at Ofstead & Associates (St Paul, Minnesota) has raised concerns about insufficient reprocessing of gastrointestinal endoscopes and ureteroscopes—even when recommended practices are followed—and their new study makes a compelling case for more stringent reprocessing of bronchoscopes as well. In their…
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