• Regulatory NewsRegulatory News

    FDA: Custom Ultrasonics' Endoscope Reprocessors Still Unsafe

    The US Food and Drug Administration (FDA) on Wednesday said it is maintaining its recommendation against the use of Custom Ultrasonics' System 83 Plus automated endoscope reprocessors (AERs) to clean duodenoscopes after finding the reprocessors were not adequately validated last November. However, in a shift from FDA's previous recommendation in February, the agency now says healthcare facilities can resume using the devices to clean other types of flexible endoscopes. ...
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    Senate Investigation Blames Superbug Outbreaks on Poor FDA Oversight

    A Senate report released Wednesday finds that the US Food and Drug Administration's (FDA) post-market surveillance system for tracking medical devices is ineffective. The report found systemic issues related to device oversight and reporting, which contributed to at least 25 superbug outbreaks linked to closed-channel duodenoscopes that infected some 250 patients in the US and Europe between 2012 and 2015. Duodenoscopes made headlines in early 2015 after Carbapenem-resi...
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    Duodenoscope Makers Called on to Study Reprocessing Procedures

    The US Food and Drug Administration (FDA) is giving three duodenoscope makers 30 days to submit plans to conduct safety studies to help the agency understand the effectiveness of current cleaning instructions for these products. Background In recent years, insufficient cleaning procedures have linked duodenoscopes to several bacterial outbreaks. The most notable was an outbreak of carbapenem-resistant Enterobacteriaceae (CRE) at the Ronald Reagan UCLA Medical Center in ...
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    New FDA Guidance Hopes to Make Reusable Medical Devices Safer for Patients

    The US Food and Drug Administration (FDA) has issued new guidance requiring manufacturers of new reusable medical devices to more thoroughly test and label their devices to ensure patients are not inadvertently exposed to dangerous pathogens. Background The guidance follows an outbreak of drug-resistant bacteria linked to the use of a reusable device known as endoscopic retrograde cholangiopancreatography (ERCP) duodenoscope. The device—a flexible, lighted tube commonly...
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    After Investigation Reveals Deadly Flaws, FDA Issues Warnings About Duodenoscopes

    US regulators have issued a warning to healthcare providers about design flaws inherent in a type of endoscope which could increase the spread of harmful infections in surgery patients. Background The device, known as an endoscopic retrograde cholangiopancreatography (ERCP) duodenoscope, is a flexible, lighted tube commonly used in surgical procedures to inject contrast dye or to obtain tissue samples. "Unlike most other endoscopes, duodenoscopes also have a movable '...