The contaminated medical scopes linked to a series of deadly bacterial outbreaks all had been cleaned and disinfected using high-tech appliances cleared by the government to kill the bacteria, according to an article on the USA Today website.
Many of the automated endoscope reprocessors (AERs) were cleared a decade ago by the Food and Drug Administration as meeting requirements that they remove 99.9999% of the bacteria the scopes might retain after being snaked down a patient's throat. Yet the FDA, which has been reviewing the scopes' infection risks for more than a year, did not approach manufacturers of the reprocessors until the past few weeks to ask for updated test data validating that the machines perform as required, the article said.
"If it turns out that hospitals are following manufacturers' instructions and (the AER) doesn't work, then shame on the manufacturers and shame on the FDA," Mark Duro, who heads sterile processing operations at New England Baptist Hospital in Boston and lectures nationwide on proper reprocessing techniques, said in the article.
The AERs are basically high-tech dishwasher, pumping disinfectant through and around the scopes, and the machines are far more effective if material caked inside of the instruments is removed beforehand, the article said.
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