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  • Regulatory NewsRegulatory News

    Duodenoscope Reprocessing: Interim Study Results Indicate Higher Contamination Rates

    Interim results from the US Food and Drug Administration’s (FDA) mandated postmarket surveillance studies of duodenoscopes indicated a “higher-than-anticipated contamination rates after reprocessing,” FDA said in a safety notice released on Monday. The postmarket surveillance studies, including human factors studies as well as sampling and culturing studies, were set as requirements in 2015 on all three duodenoscope manufacturers on the US market amid a growing body of ...
  • 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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    FDA to Release ‘Emerging’ Safety Info on Devices

    As the US Food and Drug Administration (FDA) looks to catch signals of medical device safety issues earlier to prevent adverse events, the agency has put out draft guidance outlining how it will track and release such information publicly. The release of the new information -- for concerns that have yet to be fully analyzed, validated or confirmed by the agency -- will come in addition to the recall notices, safety communications and press releases that the agency alread...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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 '...