Debbie Smoody expected a routine visit to Allegheny General Hospital in February 2015, when her mother was scheduled to undergo a specialized procedure in which a medical scope would be threaded down her throat to diagnose a blocked bile duct in her liver.
But little was routine that day, and the weeks that followed morphed into a nightmare.
Soon after Smoody’s mother, 76-year-old retired school teacher Elsie Florian, underwent the ERCP procedure involving a duodenoscope — a flexible, lighted tube with a tiny camera at its tip — she was diagnosed with severe sepsis, septic shock and acidosis.
Florian was admitted to the intensive care unit and, weeks after the procedure, a doctor called Smoody to deliver the news: Her mother had been infected with an antibiotic-resistant bacteria from a contaminated scope.
“I didn’t know what to do or think,” said Smoody, 54, of Munhall, Allegheny County.
By mid-April 2015, Florian was dead.
Florian was one of as many as 350 patients at 41 medical facilities in the United States and worldwide who were infected or exposed to contaminated scopes from Jan. 1, 2010, to Oct. 31, 2015, according to a U.S. Food and Drug Administration document obtained by the House Committee on Oversight and Government Reform and made public in mid-April.
In the Lehigh Valley, the region’s largest health system, Lehigh Valley Health Network, experienced a scare from a contaminated scope about a year ago, but it ultimately resulted in no definitive exposure. Other area medical facilities reported no incidents. All said their updated cleaning protocols, surveillance procedures and well-trained staff have kept patients safe.
Despite the negative attention scopes have received, medical experts caution patients not to cancel or postpone life-saving procedures involving the devices. The procedure, which is used to diagnose and treat conditions in the pancreas, bile duct and gallbladder, is performed more than 660,000 times a year in the United States and is seen as less invasive than traditional surgery. The scopes are not used for routine procedures like colonoscopies and endoscopies.
Patients should use the outbreaks as an opportunity to become educated and ask questions when their or a loved one’s appointment date arrives, experts said.
“I really do want to emphasize to the patients that these are life-saving procedures and that I really would not want anyone to be dissuaded from getting their procedure done,” said Terry Burger, LVHN’s director of infection control and prevention.
LVHN officials said the network disinfects its scopes twice before their next use and regularly tests the devices. Similarly, St. Luke’s University Health Network cultures the scopes for bacteria after the cleaning process is finished. Meanwhile, Sacred Heart Hospital said it follows patients for six weeks following the ERCP — endoscopic retrograde cholangiopancreatography — procedure, and Easton Hospital upgraded its scope washers.
The health systems also are following updated reprocessing instructions from Olympus Corp., which has its U.S. headquarters in Center Valley and manufacturers 85 percent of the duodenoscopes used across the country. The company is in the midst of a massive recall of its TJF-Q180V duodenoscope, a device that has come under scrutiny because its closed-channel design makes it difficult to clean and can trap and transmit bacteria from patient to patient.
Valley hospitals
In general, according to the results of a U.S. Senate health committee investigation released in January, hospitals that experienced infections linked to duodenoscopes failed to quickly raise alarms with the FDA, hampering the agency’s ability to assess and respond to outbreaks of carbapenem-resistant Enterobacteriaceae.
CRE, commonly referred to as a superbug, are a type of bacteria that are difficult to treat because they have high levels of resistance to antibiotics, according to the Centers for Disease Control and Prevention.
“Because they are on the front lines of treating patients, doctors and hospitals are often the first to recognize device-related problems,” the report reads. “Health care providers thus play a critical role in alerting manufacturers and federal regulators to suspected issues.”
LVHN didn’t dawdle when its ongoing surveillance program determined in late July and early August last year that two patients at its Cedar Crest hospital in Salisbury Township might have been exposed to a multidrug-resistant bacteria from one endoscopic ultrasound scope that tested positive, according to Burger.
An EUS scope, Burger said, is a highly specialized endoscope used by gastroenterologists to evaluate the lining of the walls of the upper and lower GI tract and other adjacent organs such as the pancreas and bile ducts.
While one of the patients tested negative for the bacteria, LVHN said the other patient may have had a bacteremia (presence of bacteria in the bloodstream) infection when the patient was transferred to the health network from another hospital.
That patient underwent an ERCP and EUS procedure at LVHN and tested positive for infection, Burger said. The ERCP scope used on the patient tested negative, spokesman Brian Downs said, and the patient became “well” and was discharged. To protect patient privacy, Downs said LVHN could not disclose details about the patient’s condition when the person left LVHN.
When asked whether the infected patient came to LVHN with the superbug and then contaminated the EUS scope during the procedure, Burger said: “The bottom line is we don’t know the answer to that. It’s a possibility. The patient was very sick when we got that patient.”
She added that unless the patient was tested at each hospital — along with that facility’s scopes — prior to the patient’s coming to LVHN, that’s a difficult question to answer.
The affected EUS scope was immediately returned to Olympus, which took apart, disinfected and re-cultured the scope before sending it back to LVHN, Burger said. In addition to Olympus, she said, the two patients and their families also were told.
Burger also said the health network filed a MedWatch notification with the FDA. But since the FDA strips all hospital names and locations from the public reports and LVHN declined to provide the report number, citing patient confidentiality, that filing could not be verified.
Burger added that LVHN did a look-back for several years and did not find additional patients who were potentially exposed. In addition, the health network said it hasn’t had any scopes test positive for the multidrug-resistant bacteria since last summer.
LVHN does 950 procedures a year at its Cedar Crest and Muhlenberg campuses using the ERCP and EUS scopes, with more of them using the EUS scope, Downs said.
The region’s second-largest health network, St. Luke’s, issued a three-sentence statement to The Morning Call and did not answer any follow-up questions.
“St. Luke’s continually reviews and adjusts its cleaning techniques to provide a safe environment for patients,” the statement reads. “After the scope cleaning process is complete, St. Luke’s cultures the scopes for bacteria. This follow-up monitoring process has never identified any bacteria problems.”
At the time of the outbreaks across the globe over the last few years, Sacred Heart Hospital in Allentown was using Olympus 160 series scopes for the ERCP procedures, said Barbara Wood, marketing coordinator. The hospital has started using the new, revised 180 series in the last couple months, she added.
To date, Wood said, there have been no superbug infections at Sacred Heart related to the procedure. Wood noted that Sacred Heart continues to “diligently follow” patients for six weeks after the ERCP procedure.
The story is similar at Easton Hospital.
The hospital said in a statement that none of its patients has experienced a superbug infection associated with the use of a duodenoscope. Easton Hospital uses Olympus scopes but not the model recalled by the company.
When the hospital’s staff is cleaning and disinfecting the scopes, they closely follow the manufacturer’s instructions and guidelines from the FDA and CDC, the statement reads.
In addition, Jacquelyn Heiserman, the hospital’s infection prevention director, said the facility bought new scope washers this year as a proactive safety measure.
“The safety of our patients — that’s paramount to everything,” she said.
The state Health Department does not maintain records on superbug infections in Pennsylvania hospitals, spokesman Wes Culp said.
When asked whether the Health Department is aware of any event in the Lehigh Valley that involved antibiotic-resistant bacteria that may have been associated with an endoscope, including a duodenoscope, Culp said the department can’t supply information on specific investigations for confidentiality reasons.
“When there is a public health concern or the department determines providing additional information to the public will help control the spread of disease, we may provide additional information,” Culp said.
The cases so far
Two reports released this year make it clear the number of patients infected with bacteria following scope procedures in recent years far surpasses the figure previously released by federal officials.
The first report — the U.S. Senate health committee investigation released Jan. 13 — found 25 outbreaks from 2012 through spring 2015 — including two each in the Philadelphia and Pittsburgh areas — linked to duodenoscopes, devices sold in the United States by Olympus, Fujifilm and Pentax.
The outbreaks infected at least 250 people in four countries and 10 states, the report states.
FDA officials had previously reported at least nine outbreaks tied to the scopes.
Then, a separate probe that looked at a longer period of Jan. 1, 2010, to Oct. 31, 2015, found as many as 350 patients at 41 medical facilities in the United States and worldwide were infected or exposed to contaminated scopes.
The rising number underscores what many have learned throughout this process: When an outbreak actually occurs is much different than when it becomes public, and that’s a problem for potential ERCP patients.
“There’s many reasons why the public needs to know about it,” said Lawrence Muscarella, a medical safety expert and president of LFM Healthcare Solutions in Montgomeryville, Montgomery County. “You need to know if a hospital is having a raging outbreak so you can go to another hospital. Unfortunately, what we’re learning is health care is much more of a business than we thought, and it’s much less transparent than we thought.”
For example, the Los Angeles Times, using a report discovered by Muscarella in the FDA database, reported in May that three patients had died in an outbreak last summer at Huntington Hospital in Pasadena, Calif., suspected to have been caused by contaminated scopes. Last August, the hospital confirmed to the Los Angeles Times that three patients were sickened but declined to say more about their condition.
This month, Pasadena health officials said 16 patients were infected with bacteria — 11 of whom later died — from medical scopes at Huntington Hospital from January 2013 to August 2015, the Los Angeles Times reported.
In another example, nine University of Colorado Hospital patients developed infections and three of them later died following ERCP procedures performed between Dec. 8, 2015, and Jan. 25 with an Olympus duodenoscope. The hospital and state confirmed the infection investigation after inquiries from the Denver Post and Muscarella.
While a case of the deadly bacteria being spread by duodenoscopes occurred as far back as 2008 in Florida, the majority of the cases the public now knows about occurred after August 2010, when Olympus introduced its TJF-Q180V duodenoscope.
The major change in the scope was a closed elevator channel. The design made the scope difficult to clean and could allow blood and tissue to become trapped, opening the door for patient-to-patient transmission.
The Senate report released in January detailed how Olympus knew of potential design flaws, which could prevent effective cleaning, in spring 2012 following an investigation of an outbreak in the Netherlands.
But, the report stated, Olympus and the FDA did not alert American hospitals to the risk posed by the devices until February 2015, after the Los Angeles Times reported on a superbug outbreak at UCLA’s Ronald Reagan Medical Center in which three people died.
Since February 2015, Olympus spokesman Mark Miller said, the company has communicated with customers safety information, updates to instructions for use and corrective actions to enhance the safety margin for reprocessing certain duodenoscope models.
In light of the outbreaks, several lawsuits have been filed across the country.
That includes the case of Florian, who died in April 2015, two months after undergoing an ERCP procedure at Allegheny General Hospital. The lawsuit was filed by her family against Allegheny General and Olympus, alleging wrongful death and negligence.
Allegheny Health Network spokesman Dan Laurent said he could not speak specifically about Florian’s case. But, he said, in response to national reports last year about scope-related infections, Allegheny Health Network reviewed the scope-processing techniques used at its hospitals and implemented additional procedures that “go above and beyond recommended scope-cleaning techniques.”
Muscarella calls what the system is going through now a “stress test.” As the ERCP procedures increase, he said, so should the regulation of the duodenoscopes, which hasn’t been happening.
“It’s not that anyone’s challenging the merit of the ERCP,” Muscarella said. “It’s that some may challenge inadequate oversight of the instruments used to perform the ERCP.”
The House Committee on Oversight and Government Reform recommended changes, including requiring manufacturers to notify the FDA when they change designs or reprocessing instructions and inform the FDA when they alert their foreign customers of problems with the design and cleaning of their devices.
What’s next?
Two days after the release of the Senate report, which recommended evaluating whether the design of closed-channel duodenoscopes needed to be changed to prevent the spread of infection, Olympus said it was recalling and redesigning the TJF-Q180V.
Miller said Olympus began the recall in February and remains on schedule to complete the action in August. There are roughly 4,400 of the recalled models used in health care facilities around the country, the FDA said in January.
In the recall, Miller said, Olympus is replacing the forceps elevator mechanism on the scopes with a new design consistent with the submission cleared in January by the FDA. According to the FDA, the new design creates a tighter seal, reducing the potential for leakage of patient fluids and tissue into the closed elevator channel.
In the meantime, Olympus and the FDA said health care facilities may continue to use the duodenoscope but should closely follow the manufacturer’s updated reprocessing instructions.
Miller said the scopes with the new forceps elevator design are manufactured in Japan. In the recall, the models owned by Olympus’ U.S. customers are repaired at the company’s facilities across the country, he added.
“Olympus understands and shares the public’s concern regarding reports of infections associated with duodenoscopes,” Miller said. “The matter continues to receive the highest level of attention at Olympus. We remain committed to understanding the potential root causes and are partnering with authorities and other stakeholders to address the causes to continually enhance safeguards.”
One area of confusion seems to be how much patients slated to undergo ERCP are being told, beyond the basic notification of “this procedure has an infection risk.” Muscarella said a discussion on how much patients should be told needs to take place, since health care facilities should be helping educate the patient and give them choices.
According to the CDC, patients undergoing procedures using duodenoscopes “should be informed during the consenting process that there is a risk of patient-to-patient bacterial transmission associated with the procedure, including uncommon transmission of a multidrug-resistant organism.”
At the FDA, spokeswoman Deborah Kotz said the agency wants patients to know the risk of infection from inadequate reprocessing is relatively low.
“The FDA does not recommend that patients cancel or delay any planned procedure without first discussing with their health care professional,” Kotz said.
Burger said all of LVHN’s gastroenterologists are instructed to educate their patients before the procedure.
Muscarella advised patients not to put off emergency ERCP but have discussions with their doctor about whether or not the procedure is necessary.
“If the doctor says, ‘Yes,’ absolutely go ahead with it,” he said. “But the precedent has to be established moving forward that the pendulum has to stop where it is and reverse now. We have to go back to more transparency, not less transparency.”
For Smoody, who lost her mother last April from a superbug infection, she hopes her story and her lawsuit raise awareness, motivating people to get educated and ask questions before undergoing the ERCP procedure.
After all, Smoody said, that’s what she would have done had she been aware of the full risk of the procedure early last year.
“You have to be your own advocate,” she said. “You have to be on top of things. You have to ask the questions. You have to basically make a pain in the butt out of yourself, and just get them to answer the questions.
“People need to know what’s going on,” she said.
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