Duodenoscope Manufacturers Issued Warnings by the FDA

Posted By Paulson Coletti Trial Attorneys PC || 18-Aug-2015

It was recently discovered that duodenoscope may cause disease and infections that can prove fatal. The device is used during endoscopic retrograde cholangiopancreatography (ECRP) procedures. It was reported that two patients died because of infections supposedly caused by contaminated duodenoscopes. As such, manufacturers needed to update processing procedures for the device.

During facilities searches in the spring, the FDA found three major manufacturing companies in violation of regulations and reports for the medical device. Olympus, Hoya Corporation, and Fujifilm have all been issued warnings for not sending acceptable reports of infections caused by duodenoscope and for not being able to prove their recommended reprocessing instructions were satisfactory. The following warnings were issued to the three companies.

Olympus was issued a warning because:

  • They did not notify the FDA within 30 days that their scope may have caused or influenced serious injury or possibly death
  • They allegedly knew of 16 people who were negatively affected by the device in May 2012 and did not report the cases until 2015

Hoya Corporation was issued a warning because:

  • They were supposedly testing sterilization instructions on models other than the ones being marketed
  • They were allegedly not implementing procedures for corrective or preventative actions
  • They purportedly did not tell the FDA about the dangers in a timely manner

Fujifilm was issued a warning because:

  • They allegedly did not maintain adequate test cleaning procedures
  • They reportedly did not develop, conduct, monitor, or control production processes to make sure the devices met specifications

Taking the reports of duodenoscope contamination very seriously, the FDA and Olympus have both issued new safety and cleaning processing regulations that go beyond the existing information. All three companies are taking their warnings seriously and are working to rectify the claims made against them.

In June, doctors and experts gathered by the FDA asserted that the procedures of handling duodenoscopes need to be re-examined. However, completely eliminating the device from use will have a greater negative impact on the public than it would a positive.

If you have been a victim of duodenoscope contamination or know of someone who has, call Paulson Coletti today! Our premier trial attorneys can help distinguish if you have a case.