Despite superbug warnings years ago, FDA
mum till now
Health officials in Fla. pointed out risks in 2009
Peter Eisler
USA TODAY
State and federal health officials privately urged the Food and Drug Administration nearly six years ago
to alert hospitals about contamination risks from specialized medical scopes that have been tied to a
recent series of deadly superbug outbreaks.
The appeal in 2009 came after duodenoscopes were linked to drug-resistant infections in dozens of
Florida hospital patients, including 15 who died. In emails and a phone briefing, epidemiologists at the
Florida Department of Health and the Centers for Disease Control and Prevention warned that the
infections occurred because hospitals were having trouble cleaning the scopes properly, records obtained
by USA TODAY show.
“This is likely not an issue limited to FL hospitals and it’s quite concerning,” Arjun Srinivasan, a CDC
infection control expert, warned in an email sent to six FDA officials April 22, 2009. “Some type of
educational alert (to hospitals) will be useful. … It could be brief, but it would probably be best if the alert
came jointly from CDC and FDA. We also will likely want manufacturers to do an educational initiative.”
Seven months later, the agencies mentioned duodenoscopes in the 57th paragraph of a general advisory
on proper cleaning and disinfection of all medical scopes, including those used in colonoscopies and other
common procedures. The two-sentence passage noted that special care was needed to clean trapped
bacteria from a mechanism at the tip of the duodenoscopes, which are used in the USA about 650,000
times a year for procedures in the bile and pancreatic ducts.
It took five more years — until this winter
— for the FDA to issue a specific warning that duodenoscopes pose exceptional contamination risks that
can persist even after meticulous cleaning. By then, the scopes had been tied to superbug cases in
Chicago, Seattle, Los Angeles, Pittsburgh, Hartford and elsewhere. Scores of patients were sickened,
most with CRE, a drug-defying bacteria with mortality rates of 40% or more.
At least 15 of those patients died (in those cases, as in Florida, not all the deaths were attributed
specifically to CRE because some victims also had other serious illnesses.)
Roger Sanderson, a Florida epidemiologist who helped push for a federal alert on duodenoscope safety
in 2009, says he’d hoped for more than the passing reference in a general advisory on medical scope
safety. “What they had was down on page 6 or 7; how many people do you think got to that?” says
Sanderson, who is retired. The cleaning challenges with duodenoscopes were unique and especially
risky, he says. “We thought it was a problem, we talked about an alert. We were not talking about scopes
in general; we were talking about that scope.”
Officials at the FDA, which regulates medical devices, insist the reference to duodenoscopes in the
2009 advisory was adequate based on what was known at the time. They say it wasn’t until September
2013 that there was sufficient evidence of the scopes’ risks to consider a more detailed warning, and it
took 17 more months to evaluate what sort of advisory was needed.
“When the FDA had enough understanding of the issues we issued a safety communication in February
to communicate publicly and to provide recommendations to mitigate the risk associated with the
transmission of infections by duodenoscopes,” the FDA said in a written statement.
The revelation that the FDA was urged to issue such a warning years earlier adds a new layer to a
burgeoning debate over the speed and adequacy of the agency’s efforts to alert practitioners and patients
to the contamination issue. USA TODAY obtained the correspondence through an open records request
to the Florida Department of Health, which played a key role in the discussions in 2009 of
duodenoscopes’ risks.
“The FDA missed numerous red flags,” says Rep. Ted Lieu, D-Calif, who has requested congressional
hearings on the matter. “They knew for years that these scopes were difficult to clean, and when they
realized that, they should have begun issuing safety alerts.
“This isn’t one or two people dying,” Lieu says. “This is multiple people dying across America and ...
potentially thousands being exposed to superbugs.”
THE FLORIDA CASE
CRE was a newly emerging superbug when Sanderson investigated the outbreak at two central Florida
hospitals in late 2008.
Sanderson traced the infections to patients who had undergone a procedure called ERCP, in which a
duodenoscope is run down a person’s throat to treat upper-intestinal blockages, such as gallstones or
tumors. On Feb. 15, 2009, he relayed his initial findings in an email to Srinivasan at the CDC.
“Interesting outbreak,” he wrote, “and kind of scary.”
Sanderson found that technicians cleaning duodenoscopes at both hospitals did not properly clean the
“elevator” mechanism, which controls tiny tools that can remove blockages or insert stents in intestinal
ducts. The elevator channel must be purged of biological debris — a multi-step process in which the
elevator is set at precise angles and scrubbed with tiny, specialized brushes.
In a follow-up to Srinivasan, Sanderson reported that investigators had brushed the channel of a
duodenoscope at one hospital and pushed out a clump of tissue rife with bacteria, including CRE. Scores
of patients had been treated with the scope, he wrote, calling it “a serious problem that demands attention
now.” (The state hasn’t named the hospitals.)
Srinivasan included Sanderson in the email he sent to FDA officials a few weeks later to suggest
hospitals be alerted about the scopes’ contamination problems.
“Roger and I are worried,” Srinivasan wrote. “There is a real chance that these issues might be more
widespread.”
A HARD-TO-CLEAN SCOPE
Infection control experts have fretted for years about the cleaning hurdles posed by duodenoscopes,
which have been linked to infection risks for decades.
“No other instrument is as complex, no other instrument (gets) as heavily contaminated with
microorganisms — we’ve known this for 40 years,” says William Rutala, an infection control expert at the
University of North Carolina Hospitals. When it comes to cleaning and disinfection, “no other instrument
has such a narrow margin of safety.”
It was assumed that the scopes’ problems could be solved by complying strictly with cleaning and
disinfection guidelines, Rutala says. But the instructions, including dozens of steps, are too complex to
execute reliably in hospital environments, he says, and newer research shows 10%- 30% of
duodenoscopes remain contaminated after reprocessing.
Last week, an FDA advisory panel reached a consensus that duodenoscopes, as designed, cannot be
cleaned reliably under existing guidelines.
Still, panelists backed the FDA’s decision to continue use of duodenoscopes. There was agreement that
infection risks are low, and the scopes are the safest way to perform critical procedures.
Participants urged the FDA to press for safer scope designs. Several recommended that hospitals be
directed to sterilize the devices
— a higher standard than current disinfection requirements — and test for bacteria before reuse.
“Should the FDA and the CDC have moved more quickly?” Rutala asks. “That’s a fair question.”
THE CASE FOR AN ALERT
FDA officials were eager for more information after receiving the email from the CDC’s Srinivasan on the
CRE outbreak in Florida.
On June 29, 2009, FDA and CDC officials held a conference call on the duodenoscope problem,
including a “thorough” briefing from Sanderson and another Florida epidemiologist. The detailed warning
Sanderson hoped to see ended up as just the two-sentence mention in the general advisory on scope
safety the following November.
The FDA says it lacked enough evidence at that point to warrant a specific alert on duodenoscopes.
“The Florida outbreak, as with prior cases, was due to inadequate cleaning,” the agency said in a
statement to USA TODAY. Officials attributed the problem to user error and not an inherent device flaw
that warranted a stand-alone advisory.
Srinivasan says he supported the FDA’s decision, partly out of concern that a dedicated alert on
duodenoscopes might cause practitioners “to think that only ERCP scopes have challenges with
reprocessing.”
The FDA says the need for a specific warning on duodenoscopes didn’t begin to surface until September
2013, when the CDC tied the scopes to a CRE outbreak at Advocate Lutheran Hospital outside Chicago.
That case was a “pivot point,” FDA officials say, because the scopes caused infections despite being
cleaned and disinfected properly.
The FDA launched “a comprehensive review” of the problem, the agency says, “leading us to believe that
the design of these duodenoscopes creates significant challenges for reprocessing.”
The review took almost a year and half. The resulting alert, in February, came soon after a USA TODAY
investigation revealed the scopes’ problems.
“The complex design of (duodenoscopes) may impede effective reprocessing,” the multi-page advisory
said. “Meticulously cleaning duodenoscopes … should reduce the risk of transmitting infection, but may
not entirely eliminate it.”
The FDA lacks a defined policy on when to issue alerts as problems with medical devices come to light.
Last week, officials asked the advisory panel what to do “when we have a medical device concern but do
not yet have enough information to determine the most appropriate action.”
Last week, the FDA said the number of reports it received on duodenoscope-related infections climbed
from fewer than 10 in 2012 to nearly 70 in 2014 (each report can reflect multiple patients). In the first six
weeks of 2015, 40 more reports came in.
The FDA “could have issued a statement (in 2009) at least saying that these scopes are really hard to
clean,” Rep. Lieu says. “They say, ‘Well, we didn’t know until the fall of 2013 that these scopes could
cause outbreaks even if cleaned 100% correctly.’ ... There was still no reason why they waited until 2015
to act.”
In Wednesday’s State-by-State report, a Tennessee item misstated the status of exports of industrial
hemp seeds to Tennessee farmers. Governments in Canada and Australia have not yet approved the
exports, a state government spokeswoman said.
Enterobacter cloacae is part of the CRE family.
CENTERS FOR DISEASE CONTROL AND PREVENTION
ALISON YOUNG, USA TODAY
The FDA, headquartered in Silver Spring, Md., said it needed time to evaluate the risk of
duodenoscopes.