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By Gary Evans, Medical Writer
In reporting continuing problems disinfecting complex duodenoscopes, FDA officials recently sought input from an infection control advisory panel at the Centers for Disease Control and Prevention (CDC). They received it in no uncertain terms.
“I am deeply uncomfortable with the period that has gone on with us being aware of this level of risk and the inability to disinfect these devices,” said Lisa Maragakis, MD, MPH, co-chair of the CDC’s Hospital Infection Control Practices Advisory Committee (HICPAC). “It really does call for a disposable product or a complete paradigm shift and redesign,” she said at the meeting, held May 16-17 at the CDC in Atlanta.
Duodenoscopes became a national concern in 2014, when the CDC reported1 a 2013 outbreak of carbapenem-resistant Enterobacteriaceae (CRE) linked to the devices. The intricate scopes are used to assess the pancreas and other organs in endoscopic retrograde cholangiopancreatography (ERCP).
Over the ensuing years, there has been a series of FDA actions and alerts, device recalls, modifications, and new reprocessing instructions. According to the FDA, the levels of exposures, infections, and deaths linked to the devices have declined since 2015.
However, post-market surveillance of the devices reveals that roughly 3% to 5% of reprocessed duodenoscopes remain contaminated with potentially infectious organisms, Shani Haugen, PhD, microbiologist at the FDA Center for Devices and Radiological Health, said at the HICPAC meeting.
Committee members raised the issue of informed consent, asking Haugen what patients should be told before undergoing procedures with duodenoscopes.
“FDA believes that with appropriately selected patients — patients that need to have ERCPs conducted — the benefits of the procedure outweigh the risk of infection,” she said.
The response was somewhat equivocal, considering the FDA recommended in 2015 that clinicians “inform patients of the benefits and risks associated with ERCP procedures, including the risk of possible infection.”2 In any case, informed consent for these procedures is a gray area because clinicians would essentially be telling patients that the device being used on them cannot be reliably disinfected.
“You don’t do a surgical procedure and say, ‘There is a chance that the scalpel I use may be contaminated,’” said HICPAC member Deverick Anderson, MD, of Duke University Medical Center. “You don’t do a central line and say, ‘Five percent of the time, the central line is not going to be sterile.’ That is just not part of the conversations we have.”
Maragakis concurred, saying, “It is fundamentally different from a side effect of a medication or the risk of a procedure. This is really a safety flaw in the device itself if it cannot be adequately cleaned and disinfected.”
Haugen underscored the sheer scale of the issue, reminding that some 500,000 ERCPs using duodenoscopes are performed annually in the U.S. The comment drew a response from a patient safety advocate, HICPAC liaison member Paul Conway, of the American Association of Kidney Patients in Tampa, FL.
“The volume of the number of procedures done is less relevant when we are talking to a federal agency,” he said. “What’s more important is understanding that the patient interest starts with the first patient — patient number one. The onus is on all stakeholders in this process to raise the question and educate patients on both the risk and the exact device that is being used. Informed patients can make important decisions.”
The issue is difficult because the relative risk of using duodenoscopes must be weighed against the alternative of doing open abdominal surgery to assess the organs.
“As an individual patient, I would be willing to consider a modest risk if my life was at stake and this was the alternative to open surgery to assess my gallbladder. But I would like to know what that [risk] is,” said Michael Bell, MD, a CDC medical epidemiologist and designated federal officer on HICPAC.
The FDA issued warning letters in March 2018 to duodenoscope manufacturers for failing to comply with a prior order for post-market surveillance studies of the devices in use. The FDA is now receiving more of these reports, and the results presented at HICPAC seem troubling.
“Up to 5.4% of properly collected samples tested positive for high-concern organisms, which are more often associated with disease, such as E. coli and Pseudomonas,” Haugen said.
Another 3.6% of the scopes tested positive with low- to moderate-concern organisms, likely related to environmental contamination, she said.
“These interim data tell us that improvements are necessary, and the FDA is committed to taking additional steps to reduce infections and contamination further,” Haugen said.
The FDA post-market surveillance studies mirror contamination levels that have been reported in the literature.3,4
“In general, in larger studies, a contamination rate of about 2% to 5% is frequently observed and is consistent with the [FDA] post-marketing surveillance results,” Haugen said.
The clear conclusion was that the standard protocol at many hospitals of reprocessing these scopes with high-level disinfection (HLD) — even if it is performed twice consecutively5 — leaves patients at risk.
“Current practices for reprocessing duodenoscopes are not sufficient to avoid all infections,” Haugen said.
“FDA is concerned that high-level disinfection is not sufficient to ensure the safe use of these devices in all cases. With that said, however, in appropriately selected patients, the benefits of using a duodenoscope still outweigh the risks of infections.”
In the name of transparency and quality improvement, some HICPAC members urged the FDA to make the contamination data presented at the meeting available to patients and consumers.
“These reports are publicly available, and so someone should be able to come up with the same numbers if they do a deep dive into our database,” Haugen said.
The FDA should go beyond saying the data are available on the internet and clearly disclose the information to patients, emphasized HICPAC member Jan Patterson, MD, director of the Center for Patient Safety and Health Policy at University of Texas Health San Antonio.
“It would be important to have the contamination rate in the post-market surveillance publicly available by device, by manufacturer,” she said. “Public reporting of these types of things is very powerful in terms of finding solutions. It needs to be publicly available in something other than reports that are buried on the internet.”
Haugen asked committee members to express their level of concern with the current situation and give the FDA input on future action.
“The data that you have shown us are highly concerning, and would be concerning to anyone that saw them,” Maragakis said.
Other HICPAC members concurred without a formal vote, and Haugen said she will communicate this concern to her colleagues at the FDA.
“We will take back the input that you provided, and we are going to continue to have discussions,” she said. “The FDA is committed to further reducing infections associated with these devices.”
HICPAC members also favored the idea of requiring that manufacturers demonstrate the scopes can be decontaminated in real-world conditions before shipping them out — not in post-market surveillance.
“I think it is disingenuous for manufacturers of a device not to test if it can, in fact, be cleaned and disinfected by following the instructions for use [before] sending it out to facilities,” said HICPAC member Hilary Babcock, MD, MPH, medical director of occupational health at Barnes-Jewish and St. Louis (MO) Children’s Hospitals. “They should be responsible for demonstrating that the scopes can be decontaminated before they send it to my facility and make it my responsibility to fix something that I cannot fix.”
With so many different designs and multiple manufacturers, it is difficult to correctly follow the reprocessing procedures, said Darlene Carey, MSN, RN, a HICPAC liaison member for the Association for Professionals in Infection Control and Epidemiology.
“The steps are so convoluted that it is difficult, at best, for a technician that has spent 20 years doing this to come out successful,” said Carey, an infection preventionist at Gwinnett Medical Center in Lawrenceville, GA.
This perception has been confirmed in FDA “human factor” studies that looked at efforts to reprocess the scopes, Haugen said.
“Some reprocessing staff missed one or more steps in the process and needed additional training to complete the process properly,” she said. “The descriptions of some of the processing steps in the user manuals were unclear. FDA is considering these data as we develop our next steps in this area.”
HICPAC member Elaine Dekker, RN, an IP at Zuckerberg San Francisco General Hospital and Trauma Center, said the variety of devices and different reprocessing instructions point to the need for more standardization of duodenoscopes.
“I know companies are competing for business, but I think there needs to come a time where they are not competing to have the best product but working together to make a safe product,” she said.
Reprocessing instructions, some of which have as many as 40 steps, further endanger patients by raising the likelihood of a breach in aseptic technique at any point in the process.
“If you look at your scope reprocessing room, you would be amazed at the number of charts hanging on the walls that they have to flip through to get the right scope for what they are doing,” Dekker said.
“It is a hard process, and the scope manufacturers need to take that into account as well.”
The failure to adequately disinfect the devices has been linked to outbreaks of CRE and other pathogens, several of which have been stopped after facilities went to more stringent reprocessing measures such as ethylene oxide (EtO) sterilization.
Appearing before HICPAC to tell of her husband’s death in 2013 after an ERCP procedure led to CRE infection, Carla Warner of Statesville, NC, humanized the issue and called for all scopes to be sterilized.
“I watched as a man who was once strong and innovative became unable to lift himself off the couch or do even the simplest of tasks for himself,” she said.
“I saw his knuckles turn white as he clenched the sheets in excruciating pain. I listened as he gasped for air as his oxygen levels plummeted. I heard him crying out to me not to leave his side due to the hallucinations he experienced during his delirium.”
In calling for more stringent sterilization measures, Warner said she will continue to speak out in the name of her late husband, Bill.
“I am doing my part by spreading the word, and now, I’m asking you do to yours,” she told HICPAC during the public comment period. “Help push for the only right answer in this scenario, which is sterilization of all scopes.”
In August 2015, FDA issued voluntary supplementary measures, including EtO sterilization, use of liquid chemical sterilant processing system, and repeat HLD.
However, only 12% of 249 facilities responding to a 2018 survey6 reported using EtO sterilization.
In addition, 63% used repeat HLD, 53% conducted surveillance via microbiological culturing, and 35% were using liquid-chemical sterilization.
“In general, ethylene oxide sterilization provides a higher margin of safety than either high-level disinfection or liquid chemical sterilization,” Haugen said.
“[EtO] sterilization of duodenoscopes led to cessation of outbreaks in at least three different healthcare facilities.”7,8
Additional sterilization technologies are in development for duodenoscopes, but “currently, there are no FDA-cleared terminal low-temperature sterilizers,” she said.
Asked about the processes used by the facilities that reported the scope contamination data, she said the vast majority were using the manufacturer’s recommended cleaning process and then high-level disinfection.
“To my knowledge, none of these samples were from ethylene oxide sterilized devices [or those] that were subjected to chemical sterilization,” Haugen said.
“Some of these facilities do conduct double high-level disinfection. However, this initial interim analysis indicates that it did not have an impact on contamination rates.”
While EtO appears to be the obvious alternative, challenges include costs, particularly for small hospitals. The process also reportedly shortens the “use life” of the scopes and can contribute to long wait times in the sterilization process.
“When we talk about EtO sterilization and chemical liquid sterilization, we are talking about long times, like 12 hours, 24 hours,” said Karen DeKay, MSN, RN, CNOR, CIC, a HICPAC liaison member for the Association of periOperative Registered Nurses.
HICPAC member David Henderson, MD, a hospital epidemiologist at the National Institutes of Health Clinical Center, also pointed out that using EtO “eats them up pretty fast.”
The FDA’s Haugen said, “Yes, we have received anecdotal reports of device damage after EtO sterilization.”
HICPAC member Loretta Fauerbach, MS, CIC, an infection preventionist, traced the root of the duodenoscope contamination issue back to the historical perception that some infections are the inevitable result of patient care.
“We allowed certain device-related infections to become the norm,” said Fauerbach, an IP consultant in Gainesville, FL.
“We thought we could not get to zero. In applying that to duodenoscopes, we know that very vulnerable patients may be exposed to this 5% contamination rate.”
The situation makes it imperative that the FDA “help to force the technology to sort of reboot the human factor, because you always have someone who may make a mistake or not do the process thoroughly,” she said.
The FDA should require devices that can be readily accessed for cleaning be sterilized before use on the next patient, she added.
“That is going to be a lot of work for the FDA and the manufacturers to address, but knowing that you can reach zero [contamination], I think we should reach zero for complications as well,” Fauerbach said.
Financial Disclosure: Peer Reviewer Patrick Joseph, MD, reports that he is a consultant for Genomic Health, Siemens, and CareDx. Senior Writer Gary Evans, Editor Jesse Saffron, Editor Jill Drachenberg, Nurse Planner Patti Grant, RN, BSN, MS, CIC, and Editorial Group Manager Leslie Coplin report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study.