58 results

• Surgical Infection Outbreaks Result in New FDA Guidance On Reusable Medical Devices

  March 13, 2015

  Irvin Jackson

  The FDA has finalized new guidelines for manufacturers on designing and coming up with cleaning plans that ensure reusable medical devices can be sterilized.

• Duodenoscopes Infection Lawsuit Filed By Over Contamination at Washington Hospital

  March 12, 2015

  Irvin Jackson

  A wrongful death lawsuit has been filed against Olympus Corp., alleging that improperly cleaned duodenoscopes caused an infectiont that contributed to the death of a Washington state man in 2013.

• Olympus Endoscopes Linked to UCLA Infection Outbreak Sold Without FDA Approval: Report

  March 5, 2015

  Martha Garcia

  A new report reveals that the makers of endoscopes linked to a superbug outbreak in California never got the devices approved by the FDA.

• ERCP Endoscope Testing By Companies Flawed, Advisory Hearing Planned: FDA

  March 3, 2015

  Martha Garcia

  The FDA is calling an advisory meeting to review endoscope cleaning protocols following deadly outbreaks and poor manufacturers' testing.

• ERCP Infection Lawsuits Filed Against Duodenoscopes Makers Over CRE Outbreak

  February 27, 2015

  Irvin Jackson

  A wrongful death lawsuit has been filed against Olympus related to a superbug outbreak spread during ERCP endoscopic procedures.

• Dirty Endoscopic Surgical Tools May Be Linked to Infections Reports in NC, Similar to UCLA

  February 24, 2015

  Irvin Jackson

  North Carolina health officials warn that a CRE "superbug" outbreak has killed 1 and sickened 18. It is the same infection that sickened 7 and killed 2 in California.

• Endoscopy Infection Lawsuit to be Filed Against Manufacturer of Device

  February 23, 2015

  Irvin Jackson

  A teen recovering from a severe hospital infection is suing a medical device manufacturer who made a type of endoscope which the FDA warns may be extremely hard to clean properly and has been blamed for an antibiotic-resistant outbreak.

• Endoscopy Cleaning Problems Result in FDA Warning After Infection Outbreak

  February 20, 2015

  Irvin Jackson

  Manufacturers of endoscopy tools, known as duodenoscopes, appear to have known for years that there are difficulties cleaning their devices,...