Moving forward
So what now? How do facility leaders ensure the safety of devices deemed so
difficult to clean by so many experts? Is a redesign necessary? "That's a really
good question that doesn't have a really good answer," says Dr. Petersen. "It
remains to be seen how well the new validated instructions from Olympus per-
form and what impact the anticipated FDA-revalidated reprocessing instruc-
tions will have."
Dr. Petersen believes the new guidance will help curb the outbreaks, but con-
cedes that duodenoscope reprocessing is a multi-step process where the risk of
bacterial load is high, partly because of the instrument's complexity and partly
because of variations in reprocessing protocols at individual facilities related to
staffing levels, time pressures and case volumes.