Sterilization & Disinfection
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.…
Research raises concerns about lubricants used in endoscopes
Current endoscope reprocessing methods are not consistently effective in eliminating organic soil or microbes, and the off-label use of products for defoaming, lubrication, and bleeding control may be contributing to reprocessing failures. Though endoscope manufacturers have cautioned against the use of these products, endoscopists still commonly use them, and many…
Joint Commission issues Quick Safety on disinfection of tonometers, other ophthalmology devices
Editor's Note The Joint Commission on May 21 issued Quick Safety 49: Disinfection of tonometers and other ophthalmology devices. The Joint Commission noted that the American Academy of Ophthalmology has reported that transmission of adenovirus and herpes simplex virus HIV, hepatitis C virus, enterovirus 70, Pseudomonas aeruginosa, methicillin-resistant Staphylococcus aureus,…
What should you do if your sterilizer fails?
A sterilization failure is a significant event. Receiving a positive biological indicator (BI) result from a sterilizer can be devastating and presents a patient safety concern because it could result in infection. This article addresses the proper action to take in the event of a positive BI result and biological…
Off-label use of simethicone, lubricants, and tissue glue contributes to endoscope reprocessing failures
Editor's Note The off-label use of defoaming agents, lubricants, and tissue glue is common, and these insoluable substances are not removed during reprocessing, this study finds. Of 69 fully reprocessed endoscopes examined in four hospitals, microbial cultures were positive for 50% or more. The researchers, led by Cori Ofstead, MSPH,…
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