Sterilization & Disinfection
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…
ECRI Institute opposes proposed ban of EtO sterilization
Editor's Note ECRI Institute on November 7 announced that it opposes a total ban of commercial ethylene oxide (EtO) sterilization operations because it could result in widespread shortages of sterile medical devices. Hospitals around the country reported device shortages after a large Illinois-based sterilization plant closed because of state environmental…
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…
EPA will require sterilization companies to provide data on EO emissions
Editor's Note Medtech sterilization companies were asked by the Environmental Protection Agency (EPA) to provide data that will help the agency craft new regulation of ethylene oxide emissions, the September 25 Medical Design & Outsourcing reports. The data will include specific sterilization facility characteristics, control devices, work practices, and costs…
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…
NYT: Experts call for single-use, sterilization or redesign of duodenoscopes, bronchoscopes
Editor's Note Contaminated duodenoscopes have transmitted drug-resistant infections to hundreds of patients, and now some experts are urging the Food & Drug Administration to force manufacturers to develop duodenoscopes that can be properly sterilized or single-use duodenoscopes or take duodenoscopes off the market, the August 6 New York Times Reports.…
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