Posted by Bill Sandweg on 22 December 2015.
The story of the endoscopes that sickened and killed patients just keeps getting worse and worse. When I first wrote about it, I focused on the actions of the Seattle hospital that discovered it was transmitting deadly infections to patients by using endoscopes that were not properly sterilized. The infections were so serious that nearly half the people who got them died as a result. The hospital unconscionably hid its medical negligence from its patients and their families. If you got sick at that hospital from an infection transmitted by an ineffectively sterilized endoscope, you were going to have to find out on your own that the hospital gave you the infection. Too bad if you died.
Then came the discovery that the problem was not limited to the Seattle hospital alone. There were similar outbreaks at hospitals in Los Angeles, Pittsburgh, Chicago and Pasadena. At least 21 people have died across the country. The FDA weighed in with a warning to all hospitals to carefully follow the manufacturer’s sterilization instructions. Later the FDA issued a warning to manufacturers of the scopes concerning their products and the likelihood of harm. I reported that story here.
In the latest development in the story, it appears that the manufacturer of the endoscopes involved in most of the problems, Olympus, learned of defects in the design of its scopes in 2012 when it investigated an outbreak of infections in the Netherlands. The Los Angeles Times reported on the issue in a story which appears here. According to the Times story, an Olympus technician found cracking in a ring which was to keep bacteria away from a joint in the scope. Olympus and the hospital jointly hired an investigator who concluded that there was a design defect in the scope which could allow bacteria to be spread from patient to patient. He called upon Olympus to conduct a worldwide investigation into the issue and to recall its scopes, if the problem was widespread. Olympus did neither of those things. Instead, it clammed up. When infections began to occur in the United States, it asserted that these outbreaks of deadly infections were unrelated to each other. It said it was a hospital problem resulting from the hospitals not properly disinfecting the scopes. It was not until recently that the FDA found out about the prior knowledge of Olympus, knowledge that Olympus was supposed to have reported to the FDA years ago. When it did report infections associated with its endoscope, Olympus had reported them as separate, unrelated incidents. It was not until February of 2015 that it sent a warning to its hospital customers alerting them to 95 related infections.
Olympus is being investigated by the FDA and by Congress. It is being sued by the Seattle hospital for fraud. It is being sued by the survivors of many patients who died as a result of deadly infections they claim resulted from the defective design of the Olympus endoscope. Undoubtedly, there will be more news about this story in the weeks and months to come.
No one comes out looking good here. Olympus hid the fact of its likely product defect from the FDA and the hospitals to which it sold its scopes. Some of the hospitals hid the pattern of infections, which they believed were due to their negligent sterilization attempts, from their patients and their families. The FDA failed to follow up on information it had which suggested a problem. Everyone let down the patients whose safety should have been their primary goal.