CNN: “FDA official says Olympus never got permission to sell its endoscope” — click here.

CNN and other news outlets including The Los Angeles Times are reporting that the type and model of the gastrointestinal (GI) endoscope linked to the UCLA’s recent CRE outbreak in California was never cleared by the FDA for sale in the U.S.

Seven of Ronald Reagan UCLA Medical Center’s patients, two of whom died, were infected with the deadly superbug CRE, also known as carbapenem-resistant Enterobacteriaceae, between October, 2014, and January.

Hospital officials have concluded that two of these GI endoscopes, which are manufactured by Olympus, remained contaminated with the deadly CRE despite being cleaned and disinfected according to Olympus’ instructions.

The validity of these reprocessing instructions is also now being questioned by the FDA – click here.

UCLA officials believe the patients were infected with CRE by these contaminated devices  during ERCP, or endoscopic retrograde cholangiopancreatography.

CNN reports that Olympus began selling this un-cleared endoscope model — the TJF-Q180V duodenoscope — in 2010, 5 years ago.

According to the FDA, it did not “notice” that this device had not received a legal clearance, as federal regulations require, until “late 2013 or early 2014.”

CNN reports that Olympus had not filed a pre-market application requesting that the FDA clear this endoscope model in 2010. Any change that could “significantly affect the safety or effectiveness” of a modified device or new model requires a new FDA clearance.

Qu0tes

FDA: 

  • “Why didn’t we notice it? I don’t know.”
  • “The company clearly made these modifications to make the device safer, but it seems to be that it wasn’t safer.”
  • “More than 500,000 of these procedures are done every year in the U.S., and the risk of bacterial transmission is actually really very, very low. … We believe the benefits outweigh the risks.”
  • The FDA adds that the other two duodenoscope manufacturers — Pentax and FujiFilm — were granted clearances to market models similar to Olympus’ TJF-Q180V prior to selling them.

Dr. Steven Nissen (chief of cardiovascular medicine at the Cleveland Clinic): “Can you imagine a prescription drug getting out on the market that didn’t go through the approval process? … Devices need to be regulated more vigorously. This is really disturbing.”

Diana Zuckerman: “It’s like with kids. How do you teach your children to behave if there are no consequences when they misbehave?”

Posted: 3/4/2015, Rev B

One thought on “CNN: “Deadly superbug-related scopes sold without FDA approval””
  1. Uh oh, time for the FDA to dump its collusion with Olympus. Doc, THIS one is too big for FDA to swallow so what do you do if you are a government agency of wimps that let Olympus get by with MURDER for 20+ years? You bail on them, If history is anything like it was in the bronchoscope recall, you can count on all the players to blame each other and eventually everything fades out of the news, a few people are paid off and the attorneys make a bundle. Many, many people never know what killed their husband, daughter or Dad. Poor trusting fools that think THEIR doctor would never do anything that might hurt them. Except these same doctors and facilities ARE protecting Olympus and themselves. This is the nature of the beast you see. If one of them goes down, they take everyone with them. Money will fix everything. My lawyer told me after he withdrew, urging me to settle for a pitiful sum that would pave his pockets, but do nothing for our family after Medicare took away their subrogation; He said, ” you have no gag order on you, you can tell your story anywhere to anyone.”
    I can tell it, back it up with Olympus’ own discovery product. I can prove FDA collusion, fraud, bribery and misrepresentation, but not in court, because the court dismissed my case without a trial after my attorney mysteriously withdrew from my case. Yes, I can tell it but no one listens. I have no venue. The public really does not want the truth. The one person that published my story, Paul Chen, mysteriously died in November and his blog was shut down. No, you may be right: Olympus may be too big to fail and they stop at nothing to shut down opposition. Woodford, their CEO who was fired fled Tokyo fearing for his life. His fear was based on some knowledge of what Olympus is capable of. He settled with them reportedly for $11 million to silence him. Woodford’s public whistleblower actions probably saved his life.

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