• 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. ...
  • Regulatory NewsRegulatory News

    FDA Reaffirms Endoscope Washer Recall After Company Tries to Correct Devices

    The US Food and Drug Administration (FDA) has reiterated its recall of Custom Ultrasonics' automated endoscope reprocessors (AERs) after the company had proposed to correct, rather than recall the AERs, which FDA rejected as the devices fail to adequately wash and disinfect endoscopes. Duodenoscopes Duodenoscopes are a type of endoscope manufactured and sold in the US by Fujifilm, Pentax and Olympus and are notoriously difficult to clean. Customs Ultrasonics AERs, whic...
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    Bacterial Infections Push FDA to Recall Certain Endoscope Washers

    The US Food and Drug Administration (FDA) on Friday again ordered a recall of all Custom Ultrasonics’ Endoscope Washer/Disinfector models, also known as Automated Endoscope Reprocessors (AERs), to mitigate the risk of patient infection. FDA said its most recent inspection of the Custom Ultrasonics’ facility in April documented continued violations and that the company’s AERs “have been used in health care facilities that reported the transmission of serious bacterial in...
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    FDA Takes Aim at Cross-Contamination in Colonoscopies

    US regulators are hoping a new set of recommendations will cut down on cross-contamination caused by flexible gastrointestinal (GI) endoscopes, a type of medical device. Background In a new draft guidance document issued by the US Food and Drug Administration (FDA) on 16 January 2015, regulators take aim at cross-contamination, which they note is often caused by improper use of flexible GI endoscopes. "During colonoscopy or esophagogastroduodenoscopy, clinicians often ...