Sterilization/Disinfection

Latest Issue of OR Manager
December 2017
Home Sterilization/Disinfection

FDA: Pentax validates reprocessing instructions for ED-3490 TK Video Duodenoscope

Editor's Note The Food and Drug Administration (FDA) on February 19 announced that it had reviewed updated reprocessing instructions and validation data issued by Pentax Medical (Montvale, New Jersey) for its ED-3490 Video Duodenoscope. The FDA recommends that facilities train staff on the updated instructions and implement them as soon…

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By: Judy Mathias
February 22, 2016
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Proper packaging ensures integrity of sterilization

Sterilization packaging is considered a medical device and thus it must undergo validation testing before being used in healthcare facilities. To ensure proper packaging that will maintain the integrity of sterilization, consult the packaging manufacturers’ instructions for use (IFU) and follow the sterilization standards and guidelines from the Association for…

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By: OR Manager
February 19, 2016
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FDA posts updated information on duodenoscope reprocessors

Editor's Note The Food and Drug Administration (FDA) on February 1 posted updated information on which manufacturers of automated endoscope reprocessors (AERs) for duodenoscopes have completed validation testing with adequate results. There are five companies in the US that manufacture AERs labeled to reprocess duodenoscopes. Companies that have completed their…

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By: Judy Mathias
February 2, 2016
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Nearly 300 colonoscopy patients possibly exposed to HIV, hepatitis

Editor's Note Nearly 300 patients who had colonoscopies at Baystate Noble Hospital in Westfield, Massachusetts, may have been exposed to HIV and hepatitis because of a lack of adequate disinfection measures used to clean endoscopes, the January 23 Tech Times reports. The hospital started using new equipment that required a…

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By: Judy Mathias
January 25, 2016
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FDA issues final guidance for devices labeled as sterile

Editor's Note The Food and Drug Administration (FDA) on January 21 issued final guidance for “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile." The document updates and clarifies information regarding sterilization processes and details about pyrogenicity the FDA recommends that sponsors include…

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By: Judy Mathias
January 21, 2016
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Combine and conquer: OR/CSPD collaboration dramatically reduces IUSS rates

Using best practices to sterilize surgical instruments can help lower infection rates and, in some cases, prevent death. Over the past few years, staff at Banner Boswell Medical Center in Sun City, Arizona, have worked to reduce immediate use steam sterilization (IUSS) rates. Thanks to improved communication and workflow between…

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By: OR Manager
December 16, 2015
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Efficacy of sterile rigid containers vs wrapped instrument trays

Editor's Note Sterilized wrapped instrument trays demonstrated significantly greater protection than sterilized rigid containers against the ingress of airborne bacteria in this study. Of 111 rigid containers tested, 97 failed to maintain barrier performance, allowing bacterial ingress, while 0 of 161 wrapped trays had detectable contamination. Contamination rates of rigid…

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By: Judy Mathias
December 3, 2015
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Infection control noncompliance cited in high percentage of Joint Commission surveys

During the first half of 2015, the Joint Commission’s top “not compliant” survey citations stemmed from Infection Control IC.02.02.01, which relates to reducing the risk of infections associated with medical equipment, devices, and supplies. Surveyors cited critical access hospitals in 60% of the surveys, hospitals in 54%, and office-based surgery…

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By: OR Manager
November 18, 2015
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FDA orders recall of all Custom Ultrasonics automated endoscope reprocessors

Editor's Note The Food and Drug Administration (FDA) on November 13 ordered Custom Ultrasonics (Ivyland, Pennsylvania) to recall all of its automated endoscope reprocessors from healthcare facilities because of federal law violations and a consent decree entered with the company in 2007. The violations could result in an increased risk…

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By: Judy Mathias
November 16, 2015
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FDA posts safety alert on reprocessed flexible bronchoscopes

Editor's Note The Food and Drug Administration (FDA) has identified bronchoscopes as a subset of devices that pose a greater likelihood of microbial transmission and represent a high risk of infection if not adequately reprocessed. The FDA is proactively investigating these devices to determine if additional reprocessing steps should be taken.…

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By: OR Manager
September 17, 2015
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