THE CMG VOICE

FDA advisory committee recommends improved cleaning for duodenoscopes after outbreaks of superbug infection in Seattle and Los A

You may have heard of the recent outbreaks of infection (“superbugs”) at Virginia Mason and another hospital in Los Angeles. These outbreaks occurred because scopes used by doctors to look inside portions of a patient’s digestive tract were either not properly cleaned or designed in such a way as to make it very difficult for them to be properly cleaned. As a result, the infections spread from patient to patient with the use of the particular scope (in this case a duodenoscope).

Recently the FDA advisory committee has weighed in on the subject: duodenoscopes don’t provide “reasonable assurance of safety and efficacy” because of this difficulty (or inability) to be properly cleaned.

You can read an article about this FDA advisory recommendation here:

[FDA advisory committee says duodenoscope cleaning must be improved to provide assurance of safety](http://www.fiercemedicaldevices.com/story/fda-advisory-committee-says-duodenoscope-cleaning-must-be-improved-provide/2015-05-18?utm_medium=nl&utm_source=internal)

Locally there is litigation over the harm caused by the unclean duodenoscopes. Although it’s unclear whether patients ultimately blame Virginia Mason for their harm (and in some cases death), or the manufacturer of the scopes. At least one reported plaintiff has decided to work with VM against the maker of the scope, Olympus, in part because VM states that it followed the manufacturers directions for cleaning the scopes, and was misled by Olympus about how the scopes could spread bacteria even after following directions.

You can read a story in the Seattle Times about that lawsuit here:

[Virginia Mason joins with ‘superbug’ widow to sue scope-maker](http://www.seattletimes.com/seattle-news/virginia-mason-joins-with-superbug-widow-to-sue-scope-maker/)

These situations highlight the need for a strong civil justice system in place that allows injured people to bring cases and recover for their losses, not only for purpose of compensation, but also for accountability and deterrence. There is hope that change will occur – and future duodenoscopes will be safer and cleaner – as a result of either the hospital, the manufacturer, or both being held responsible for their actions.