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Endoscope Maker Tried to Water Down FDA Safety Guidelines

Medical device manufacturer Olympus has found itself in the press recently because an endoscope it sells has been tied to cases of a deadly superbug in Los Angeles. Similar problems have popped up across the country. The problem is that people who are treated with these scopes are getting sick, not because of healthcare provider errors, but because despite medical professionals’ following cleaning protocols the endoscopes are not getting clean. Rather than accept responsibility for causing the deadly outbreak the medical device manufacturer is urging the FDA to change its rules so as to relieve Olympus of at least some responsibility for the problem.

Olympus Urges FDA to Change Rules

Bloomerg Business reports that Olympus asked the U.S. Food and Drug Administration (FDA) to “water down” its guidelines on cleaning medical devices. The FDA proposed these guidelines four years ago, but they have not been finalized. These guidelines, if finalized, would set non-binding recommendations for many medical device manufacturers including duodenoscope manufacturers like Olympus. These purpose of the guidelines is to help manufacturers prove their cleaning methods and instructions are effective. Olympus’ problem is that it may very well be impossible to effectively clean their scope.

Olympus argued in its comments on the FDA proposal that the manufacturer should not be solely responsible for making sure the method of cleaning the scopes it produces is fully effective. Instead they want the FDA to hold the companies that make the devices used to clean the scopes responsible. If the FDA went down that road, then scope manufacturers like Olympus would only have to show that their scopes are compatible with the cleaning materials. So in a case like we have with these scopes Olympus would be perfectly fine saying just that their scopes are compatible with cleaning materials, when in reality the scopes may very well be impossible to effectively clean.

Olympus Also Takes Issue With FDA’s Proposal to Make the Devices Safer

In the draft guidelines the FDA proposed that hard to clean devices like these scopes “will need to be disassembled in order to be completely cleaned.” This would require innovation on the part of the manufacturer to solve the problem that has so far contributed to over a dozen deaths and many more illnesses across the country. Olympus balked at this suggestion in its comments, saying that the “FDA should not be imposing guidance which limits and restricts device design, development and innovation, and future clinical applications.”

The problem that Olympus fails to acknowledge is that failure to ensure adequate cleaning of medical devices results in patient deaths. Hospitals are filled with sick people, sick people are treated with medical equipment, and if it is impossible to clean that medical equipment then disease spreads. Perhaps these regulations would make designing the next scope more difficult, if the end result is that the scope hurts fewer patients then it is worth it.

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