• 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 '...