By Kelly M. Pyrek
When assigning blame for a number of outbreaks linked to contaminated and improperly processed duodenoscopes, a U.S. Senate report released in January pointed equally to hospitals, scope and equipment manufacturers and the Food and Drug Administration (FDA) for failing to act on known risks of infection. Duodenoscopes have been implicated in at least 250 patient infections with carbapenem-resistant enterobacteriaceae (CRE) between 2012 and the spring of 2015.
In the report, Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients, Sen. Patty Murray (D-WA), the ranking member of the Senate Health, Education, Labor, and Pensions Committee, and her staff assert that the failure of the FDA’s medical device safety reporting system put patient in jeopardy: “Without a comprehensive post-market device surveillance system that supplements self-reporting from hospitals and manufacturers, future device issues are likely to go undetected for far too long and with life-threatening consequences."
The Senate report said hospitals failed to quickly and comprehensively report problems with their devices to the FDA: "At least 16 domestic hospitals, primarily large, sophisticated health systems, identified outbreaks of antibiotic-resistant infections linked to ERCP, but none actually followed all of the required steps to promptly notify manufacturers or, in cases of death, FDA."
The agency requires hospitals to submit an adverse event report to a device manufacturer within 10 business days of becoming aware of information that reasonably suggests that a device may have caused or contributed to a serious injury or death. The hospital is supposed to report the information to the manufacturer, including a variety of information about the facility, the patient, and what happened, in order to help the manufacturer meet their own reporting obligations to the FDA. As the report observed, "Because they are on the front lines of treating patients, doctors and hospitals are often the first to recognize device related problems. Healthcare providers thus play a critical role in alerting manufacturers and federal regulators to suspected issues. However, conversations between Senator Murray’s HELP Committee staff and hospital staff, state and local health departments, and manufacturers have revealed a disconcerting lack of awareness that these reporting obligations even exist."
The report noted that hospitals were able to identify, track and contain antibiotic-resistant infections within their facilities, but not a single hospital that experienced infection outbreaks tied to the duodenoscopes appears to have sent the required adverse event form to the device manufacturers, and several hospitals appear to not have alerted the device manufacturer in any way. As the report noted, "Some hospital staff have explained they did not inform manufacturers, even after tracing infections back to ERCP procedures, because they could not demonstrate that a particular scope harbored contamination, or be entirely certain that a problem with a specific duodenoscope caused a particular illness or cluster of infections among ERCP patients."
The report says that hospitals’ slow or non-existent reaction to the infections left the FDA with an inaccurate picture of the frequency and severity of these events: "Reporting by the hospitals as a whole suggests that rather than collaborate to quickly alert regulators to a potential device problem, hospitals were reluctant to share unconfirmed information. Hospitals as a whole appear to have believed they had an obligation to report only what they could demonstrate beyond any doubt. Such narrow reasoning reveals a misunderstanding about hospital reporting requirements, which are triggered by information that reasonably suggests a device may have caused or contributed to a death or serious injury."
As the report noted, "Failures by device manufacturers and hospitals to quickly and completely disclose important information to FDA, and FDA’s outmoded adverse event system, hampered the agency’s ability to accurately assess and respond to the infections. Because FDA did not have prompt and complete information, it took the agency overly long to accept that duodenoscope-linked infections were not the result of hospital cleaning errors. As a result, contaminated duodenoscopes spread serious infections for at least three years before manufacturers and FDA alerted hospitals in the United States. FDA’s first safety communication regarding duodenoscope cleaning did not occur for almost 17 months after the agency first became aware of the spread of infections. In the interim, at least 68 patients were affected in seven different hospitals in the United States."
The FDA issued a safety communication on duodenoscope cleaning on Feb. 19, 2015, which acknowledged that the complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing and that duodenoscope-related infection might still occur even when the manufacturer's reprocessing instructions are followed.
The FDA's culpability in the issue did not escape the report staff's scrutiny. Murray says the Senate staff’s year-long investigation made it clear that current policies for monitoring medical device safety put patients at risk and allowed tragedies to occur that could have been prevented. As the Senate report says, "The investigation found that FDA’s current regulatory system for monitoring the safety of devices failed to quickly identify and resolve the spread of duodenoscope-linked, antibiotic-resistant infections. It took FDA almost a year and a half from the time the agency first became aware that closed-channel duodenoscopes could remain contaminated after proper cleaning to alert hospitals and the public. While responsibility for the slow response is shared among Olympus and the other device manufacturers, hospitals, and FDA, the investigation overall demonstrates that FDA’s device surveillance system is overly-reliant on device manufacturers and user facilities to make quick and complete reporting of safety issues over their own competing priorities. FDA relies on device manufacturers and hospitals to provide information so that FDA has the data it needs to assess the safety and effectiveness of medical devices. The regime relies on compliance with the law and self-reporting from device manufacturers and hospitals, ignoring the reality that manufacturers and healthcare providers have strong competing priorities that weigh against rapid and robust disclosure, such as moving new products to market quickly and avoiding costly litigation."
The current postmarket surveillance system relies on device manufacturers to self-monitor and self-report by: determining when it is necessary to submit design modifications to FDA for review; adequately testing that the devices work consistently in real-world settings; and reporting when adverse events occur. The report charges that "device manufacturers failed to fully comply with any of these three regulatory requirements, providing a vivid example of the flaws with the current system. FDA’s reliance on manufacturers and hospitals to quickly and accurately report safety concerns related to devices stands in contrast to FDA’s ability to independently monitor the safety of drugs …At this time, no similar system exists for devices. While the Food and Drug Administration Amendments Act of 2007 required devices to have a Unique Device Identifier (UDI) placed on medical device labels and packages comparable to the NDC number for drugs, and the Food and Drug Administration Safety and Innovation Act of 2012 required that Sentinel be expanded to devices, the UDI requirement does not go into effect for all devices until 2020. Of more significant concern, UDIs are not currently included in insurance claims, which contain the critical information necessary to draw conclusions about device safety and patient outcomes. Without widespread adoption of UDI in electronic health records and claims, FDA will remain overly reliant on information reported by manufacturers and hospitals and unable to utilize a Sentinel-like system to ensure critical information about problematic devices is rapidly identified."
In turn, healthcare professionals are blaming manufacturers for designing complex scopes that are difficult, if not impossible, to clean, disinfect and sterilize properly, especially in real-world healthcare environments where technicians lack adequate time, training and the right tools to do the job. The Senate report was critical of several scope manufacturers, especially Olympus, saying it knew of potential contamination issues as early as 2012 but did not disclose this information to the FDA. The report also addressed closed-channel devices manufactured by Pentax and Fujifilm that were also linked to six outbreaks and at least 53 antibiotic-resistant infections during this time.
In response to the Senate report’s release, Mark A. Miller, vice president of corporate and medical communications for Olympus Corporation of the Americas, issued a statement saying, in part: “We appreciate that the staff report noted Olympus' cooperation and that the report demonstrates the shared responsibilities of duodenoscope manufacturers, hospitals, manufacturers of automated endoscope reprocessors, and the Food and Drug Administration, each of which can contribute to increasing patient safety. Although we do not agree with all of the report's conclusions, we are closely reviewing the recommendations in the report as part of Olympus' ongoing efforts to increase patient safety associated with use of Olympus duodenoscopes." A new version of Olympus’s duodenoscope has just been cleared by the FDA. The updated device includes “modifications to the device’s design and labeling intended to help reduce the risk of bacterial infections,” according to an FDA press release. Olympus will voluntarily recall its original model currently being used in healthcare facilities and make the needed repairs as quickly as possible.
On Oct. 5, 2015, the FDA ordered the three manufacturers of duodenoscopes marketed in the U.S. to conduct post-market surveillance studies to better understand how the devices are reprocessed in real-world settings. The three manufacturers – Olympus America, Inc., Fujifilm Medical Systems, U.S.A., Inc., and Hoya Corp. (Pentax Life Care Division) – that market duodenoscopes sold in the U.S had 30 days to submit post-market surveillance plans to the FDA. These proposals must detail their plans to conduct studies to evaluate, among other things, how well healthcare personnel are following instructions to clean and disinfect duodenoscopes between patients and to better understand the rate of contamination of clinically used duodenoscopes. These studies are based on the FDA’s current understanding of factors that may be contributing to infection outbreaks following endoscopic retrograde cholangiopancreatography procedures (ERCP), as well as the information needed to help fill gaps in knowledge.
The goal of these studies is to collect useful data about the effectiveness of current reprocessing instructions and practices that can provide the FDA with information necessary to protect the public health, including taking action to help reduce the risk of duodenoscope infections. Specifically, the manufacturers’ studies are required to answer three important surveillance questions:
- Are user materials, such as user manuals, brochures and quick reference guides included in the manufacturers’ duodenoscope labeling and instructions for use, sufficient to ensure user adherence to the manufacturers’ reprocessing instructions?
- After use of the manufacturer’s validated reprocessing instructions, what percentage of clinically used duodenoscopes remain contaminated with viable microorganisms?
- For devices that remain contaminated after use of the manufacturers’ labeled reprocessing instructions, what factors contribute to microbial contamination and what steps are necessary to adequately decontaminate the device?
As there are no alternative devices for ERCP, the FDA said it believes at this time that the continued availability of duodenoscopes is in the best interest of the public health; however, the results of the post-market surveillance studies could help inform the FDA’s next steps and future risk mitigation strategies, such as informing new labeling for the devices to include different reprocessing instructions or other administrative or regulatory actions necessary to protect the public health.
Pentax, in a press release, indicated that it intended to cooperate fully with FDA and that the company is "committed to ensuring that our devices meet the highest standards of safety and quality. PENTAX Medical has been working closely with FDA, healthcare providers, industry leaders, CDC, and others to address concerns related to duodenoscopes and emphasize patient safety." Mark Koppel, chief medical officer for Pentax Medical – Americas said the company "shares the FDA’s objective of protecting the public health, including taking any necessary steps to help reduce the risk of infections that are related to duodenoscopes."
What makes the issue so disconcerting is that despite no lapses in the disinfection process recommended by the manufacturer being identified, duodenoscopes had bacterial contamination associated with an outbreak of a highly resistant strain of E coli, according to a JAMA study by Epstein, et al. (2014). In March 2013, NDM-producing Escherichia coli was identified from a patient at a teaching hospital in Illinois. Between March 2013 and July 2013, six additional patients with a history of admission to this hospital had positive clinical cultures for NDM-producing E. coli. In August 2013, Lauren Epstein, MD, MSc, of the Centers for Disease Control and Prevention (CDC), and colleagues launched an investigation to identify the source and prevent further NDM-producing CRE transmission at this hospital.
A medical record review revealed that a history of ERCP procedures involving the use of a duodenoscope was common among initial cases. In total, 39 case patients were identified from January 2013 through December 2013, 35 with duodenoscope exposure. In this outbreak, 39 patients with NDM-producing CRE were identified from January 2013 through December 2013, 35 with duodenoscope exposure in one hospital. Some of those patients had positive blood cultures, often an indication of infection and others were found to be colonized with CRE but did not have a CRE infection. NDM-producing E coli was recovered from a reprocessed duodenoscope and shared similarity to all case patient isolates. Based on a case-control study, case patients had significantly higher odds of being exposed to a duodenoscope. The authors write that the large number of exposed patients that ultimately had NDM-producing CRE isolated from clinical or screening cultures suggests that duodenoscopes were an efficient source of transmission.
An infection prevention assessment that focused on duodenoscope reprocessing (such as cleaning) was conducted, and it was found that the hospital followed all manufacturer-recommended procedures. After the hospital changed its duodenoscope reprocessing to a gas sterilization procedure, no additional case patients were identified.
“The complicated design of duodenoscopes makes cleaning difficult. It appears that these devices have the potential to remain contaminated with pathogenic bacteria even after recommended reprocessing is performed,” the researchers write. They add that another option for ensuring adequate duodenoscope reprocessing might be to conduct testing for residual contamination during reprocessing. “Many international professional societies recommend periodic microbiological surveillance testing of duodenoscopes after full reprocessing. Facilities should be aware of the potential for transmission of antimicrobial-resistant organisms via this route and should conduct regular reviews of their duodenoscope reprocessing procedures to ensure optimal manual cleaning and disinfection.”
William A. Rutala, PhD, MPH, and David J. Weber, MD, MPH, of University of North Carolina Health Care, Chapel Hill, commented on the findings of this study by Epstein, et al. (2014) in an accompanying JAMA editorial, "Gastrointestinal Endoscopes: A Need to Shift From Disinfection to Sterilization?:“Clinicians should be encouraged to report and publish cases of infectious diseases related to endoscopy, especially if current reprocessing methods were adhered to, so it can be determined if the report by Epstein et al. is the tip of the iceberg or an isolated occurrence. If the former, then revision of the endoscope reprocessing guidelines will be necessary to ensure patient safety. However, regardless of when these issues are resolved, endoscopy will remain an important diagnostic and therapeutic modality and should continue to be used while clinicians strictly adhere to current endoscope reprocessing guidelines.”
As Rutala and Weber (2014) observe further in the editorial, "The key concern raised by this study is whether current U.S. endoscope reprocessing guidelines are adequate to ensure a patient-safe gastrointestinal endoscope (one devoid of potential pathogens) or if endoscopes with their long, narrow channels, right-angle turns, difficult to clean and disinfect components, and heavy microbial contamination impossible to reliably high-level disinfect." They summarize, "What should be done to ensure the safety of these commonly used devices? The enforcement of best practices including equipment maintenance and routine audits with at least yearly competency testing of staff who use the reprocessing equipment is imperative. But if adherence to regulation is lax, more outbreaks will likely occur. Obtaining additional information on the frequency and level of microbial contamination of endoscopes that have been cleaned and high-level disinfected with strict adherence to current guidelines will be helpful in defining the extent of the problem. If endoscopes are found to be contaminated with potential pathogens, the clinical effects of such contamination need to be quantified. In addition, better approaches to assess the effectiveness of cleaning and high-level disinfection are needed. Although microbiological cultures are the gold standard, they cannot be used as a real-time monitoring process. However, based on the study by Epstein et al, it would be reasonable to perform periodic microbiological surveillance of duodenoscopes to assess microbial contamination."
Rutala and Weber (2014) raise the additional questions of:
- What cutoff should be used to define proper disinfection (e.g., 0 pathogens or a higher number, such as <10 colony-forming units of enteric pathogens per channel)?
- What sampling scheme should be used to evaluate gastrointestinal endoscopes (e.g., all or a sample of endoscopes)?
- Is the trigger for further action based on the level or the frequency of contamination (i.e., percent of endoscopes contaminated)?
- What actions should an endoscopy unit undertake if a positive trigger is reached based upon the level or frequency of contamination (i.e., patient notification with an offer of bloodborne pathogen testing, ethylene oxide sterilization of positive endoscopes, or ethylene oxide sterilization of all endoscopes)?
Rutala and Weber (2014) assert that "adequate resources must be provided by the manufacturers of endoscopes, AERs, high-level disinfectants, and sterilization technologies as well as federal authorities (CDC, FDA, and National Institutes of Health) to design and complete the necessary studies to determine the risks posed by current reprocessing of endoscopes and develop new reprocessing methods and practices. In addition, new endoscope reprocessing technologies need to be developed that reliably result in sterilization of gastrointestinal endoscopes via an FDA-cleared sterilization process, which would greatly improve the margin of safety. Alternatively, development of sterile disposable gastrointestinal endoscopes or a shift to other sterile diagnostic modalities should be considered. Ethylene oxide sterilization, which was used to terminate this cluster of endoscope-related infections, is not a long-term satisfactory solution as it has not been FDA-cleared for sterilizing gastrointestinal endoscopes, many hospitals no longer have ethylene oxide, and the sterilization and aeration time is long (12-15 hours). Finally, clinicians should be encouraged to report and publish cases of infectious diseases related to endoscopy, especially if current reprocessing methods were adhered to, so it can be determined if the report by Epstein et al. is the tip of the iceberg or an isolated occurrence. If the former, then revision of the endoscope reprocessing guidelines will be necessary to ensure patient safety. However, regardless of when these issues are resolved, endoscopy will remain an important diagnostic and therapeutic modality and should continue to be used while clinicians strictly adhere to current endoscope reprocessing guidelines."
As we have seen, at least two strategies have been proposed to mitigate the risk of transmission of CRE and other microorganisms via GI endoscopes: routine sterilization as opposed to HLD of endoscopes between patients; and culturing endoscopes for CRE and other bacteria after reprocessing, to ensure safety prior to use. An oral abstract presented at last year's IDWeek meeting provides a picture of what's happening with duodenoscope reprocessing currently.
Beekmann, et al. (2015) reported that a survey of the physician members of IDSA’s Emerging Infections Network (EIN) to determine institutional practices for endoscope decontamination and surveillance cultures revealed that 50 percent reported that their facilities used duodenoscopes and that 70 percent reported a single method of decontamination: automated endoscope washers with high-level disinfection by 57 percent; manual reprocessing using high-level disinfection by 11 percent; and ethylene oxide gas sterilization by 3 percent. Twenty percent of respondents reported two methods of decontamination, most often automated washers plus manual reprocessing by 14 percent. Three percent reported three methods. Respondents were asked to select all methods used to identify possible infections resulting from duodenoscopy in the last 12 months. The most common response was “None” by 31 percent. A single method was reported by 37 percent, most commonly surveillance cultures by 13 percent. Other surveillance methods included clinical cultures, microbiologic patient screening, and follow-up patient contact post procedure. Two surveillance methods were reported by 16 percent, and three or more methods were reported by 7 percent. Finally, 79 percent of respondents reported reviewing duodenoscopy policies and procedures currently or in the past three months.
As Beekmann, et al. (2015) concluded, "Our study shows that a minority of infectious diseases physician respondents reported that their institutions were using multiple reprocessing steps as recommended. In addition, about one-third of respondents reported that their institutions had not used any methods within the last year to identify post-duodenoscopy MDRO transmission or infections. These findings suggest the possibility that endemic bacterial transmission associated with duodenoscopy may occur and may go unrecognized."
Humphries and McDonnell (2015) point to a draft method for intermittent culturing of flexible endoscopes as part of the overall quality assurance program was recently suggested by the CDC and ECRI Institute: "Such surveillance cultures are performed weekly to annually, and results are used to assess endoscopy technician staff competency, as well as to identify problems such as process lapses or device damage. Note that current U.S. guidelines require that only individuals who can read, understand and implement reprocessing instructions and meet annual competency standards on the proper cleaning and high-level disinfection of endoscopes be given the responsibility for reprocessing. If cultures yield unacceptable results, the endoscope is reprocessed a second time, and a second set of cultures is performed. This cycle continues until endoscope cultures return negative. In addition, remedial action should occur, including review of reprocessing practices with appropriate re-training, as needed, if surveillance cultures are positive."
Humphries and McDonnell (2015) add, "There are many limitations associated with implementing endoscope culturing protocols at this time, including lack of standardized endoscope sampling techniques, culture methods, and interpretations for culture results. There are no data that demonstrate the overall sensitivity of endoscope culturing. As was mentioned above, in several of the CRE ERCP-associated outbreaks, the offending organism could not be isolated from the implicated duodenoscopes by culture. For this reason, use of endoscope cultures can never replace meticulous adherence to endoscope manufacturer reprocessing protocols and recommended quality control processes, nor should receipt of a negative culture from an endoscope under investigation as part of an outbreak rule out endoscopy-based transmission. Similarly, a negative culture does not indicate that the endoscope is ‘sterile.'"
In mid-May 2015, the FDA convened a special meeting of the Gastroenterology-Urology Devices Panel of the Medical Devices Advisory Committee as a continuance of its examination of end-user challenges associated with reprocessing endoscopes, including duodenoscopes. In his presentation before the panel, William Rutala reviewed the recent CRE outbreaks and their causes, how to improve the safety margin, how to prevent future outbreaks; and how to identify a shift from high-level disinfection to sterilization in healthcare facilities throughout the U.S.
Rutala indicated that outbreaks continue due to a lack of a margin of safety associated with reprocessing endoscopes, for two reasons: "These instruments are more microbially contaminated than any other instrument in healthcare. And the instruments are complex. We know from many studies that the contamination on these instruments varies from roughly 10 million to 10 billion microorganisms. Now, all 10 billion microorganisms have to be removed before the next patient uses that same instrument. We also know from studies that cleaning reduces essentially 2 to 6 logs, and high-level disinfection reduces 4 to 6 logs. So, essentially, you have a situation where you're going to eliminate some-where between 6 and 12 logs of microorganisms by using high-level disinfection. If you only have minimal cleaning and minimal high-level disinfection, you're going to have 4 logs left on this instrument, so as many as 10,000 organisms left before essentially next patient use."
Rutala continued, "We have very few instruments in healthcare that are as complex as the gastrointestinal scope. They're heat-labile instruments. They have these very long, narrow lumens, unlike most surgical instruments. They have right-angle bends. They have rougher pitted surfaces, which make exposure to a germicide more difficult. They have springs and valves. And they have sometimes damaged channels that may impede microbial exposure to the high-level disinfectants. There may be one other thing that adds to the complexity, and that is biofilms. It's unclear if this contributes significantly to failure of endoscope reprocessing, but certainly we need to know more. Essentially, a biofilm is a microbial community attached to a surface by exopolysaccharides. The reason they should not be present is, of course, biofilms require moisture, and if instruments are reprocessed properly and the endoscope is dry, that should leave little opportunity for development of biofilms. But we have to consider the possibility."
Rutala emphasized the importance of complying with current guidance as it pertains to reprocessing instruments, adding that "There is no single, simple and proven technology or prevention strategy that hospitals can use today to guarantee patient safety. But we need to do more than essentially comply with manufacturers' instructions and guidelines."
He recommended that sterile processing departments use enhanced methods for reprocessing duodenoscopes. "In infection control, we have what are referred to as standard infection prevention practices and enhanced practices," Rutala explained. "When the standards don't work, the standard practices don't work, we use enhanced methods."
Rutala recommended five enhanced methods: ethylene oxide sterilization after high-level disinfection with periodic microbiologic surveillance; double high-level disinfection with periodic microbiologic surveillance; high-level disinfection with scope quarantine until negative cultures are achieved; liquid chemical sterilant processing system with peracetic acid and periodic microbiologic surveillance; and high-level disinfection with periodic microbiologic surveillance.
"Each one of those enhancements have advantages and disadvantages," Rutala pointed out, "but the enhancement that we believe is a priority is the combination of high-level disinfection with ethylene oxide sterilization. At UNC hospitals, in the short-term, we're enhancing our reprocessing of duodenoscopes by high-level disinfection followed by ethylene oxide sterilization and performing microbiologic surveillance. To protect public health, we should shift endoscope reprocessing from high-level disinfection to sterilization. I believe the FDA should mandate that duodenoscopes used in healthcare facilities be sterile no later than 2018. There have been publications that have expressed urgency related to this issue and have suggested the need to shift from disinfection to sterilization, including a publication in the Journal of American Medical Association."
Rutala continued, "The way we can shift is to modify the Spaulding classification. I recommend that we consider for sterilization the critical items which directly or secondarily enter normal sterile tissue. So it doesn't have to directly touch, but secondarily touch sterile tissue would require sterilization. The way this could be done is the FDA, in collaboration with professional organizations and industry, could modify the Spaulding classification scheme. Of course, they would modify only the critical component of the Spaulding classification scheme, and it would say essentially that objects which directly or secondarily enter normal sterile tissue or the vascular system should be considered sterile. When manufacturers submit a new device for clearance that secondarily enters normally sterile tissue, the FDA should not accept high-level disinfection, but require sterilization. Eventually, to unify reprocessing and reduce infection risk, healthcare facilities would require sterilization of all gastrointestinal endoscopes."
In his presentation Rutala touched upon the potential future methods to prevent gastrointestinal endoscope-related infections. "First, we could have steam sterilization for gastrointestinal endoscopes, and hopefully, we could have a gastrointestinal endoscope that can actually be steam-sterilized," he said. "Alternatively, we could have new low-temperature sterilization methods that provide a sterility assurance level of 10-6, or we can optimize our current sterilization technologies. We could have a disposable sterile gastrointestinal endoscope. We possibly can improve the gastrointestinal endoscope design to reduce or eliminate challenges listed above, or we could essentially use non-endoscopic methods to diagnose or treat disease."
Rutala emphasizes that hospitals must select one of the five enhanced methods for duodenoscope reprocessing because "doing nothing is not an option." He says that in order to protect the public health and prevent ERCP-related outbreaks, there is an urgent need to shift from HLD to sterilization. Additionally, he says the FDA should modify the Spaulding classification to require sterilization of instruments that directly or secondarily enter normally sterile tissue, and that manufacturers that submit instruments to the FDA for clearance that secondarily enter normally sterile tissue need to offer a sterilization method.
Until there is definitive guidance on these issues, the Senate report (2016) recommends the following legislative and regulatory changes:
1. Congress should require and promote that unique device identifiers (UDIs) be included in insurance claims, electronic health records, and device registries.
According to the report, "The widespread inclusion of UDIs in medical data including claims data, electronic health records, and registries, is an absolutely essential piece of any fully functional, high-quality device surveillance system. Without widespread adoption of UDIs in claims and electronic health data, FDA is severely hampered in its ability to move forward to implement an improved device surveillance system. Congress should require that claims data include the UDI number associated with medical devices used in procedures in order to ensure FDA is not caught in the dark when the next medical device is linked to serious illness, injury or death."
2. FDA should evaluate whether modifications to the design of closed channel duodenoscopes are necessary to prevent the spread of infection, and if so, require manufacturers to rapidly implement any repairs through a phased recall to ensure that devices used by hospitals are safe for reuse.
3. FDA should update its guidance to clarify when manufacturers are required to submit a notification to FDA for 510(k) clearance before marketing modified devices.
According to the report, "Consistent with Food Drug Administration Safety and Innovation Act (FDASIA) FDA should issue updated guidance that clarifies important terms that may confuse manufacturers regarding whether a 510(k) clearance is required, and that makes clear that manufacturers should verify and validate any determinations that safety and effectiveness are not impacted by a device modification."
4. FDA should move faster to provide information to healthcare providers when the agency becomes aware of information suggesting that patient safety might be compromised by a medical device.
5. FDA should have clear authority to deny a 510(k) submission based upon insufficient reprocessing validation data.
6. Compliance with MDR reporting requirements should be a Condition of Participation in Medicare.
According to the report, "The investigation demonstrates that hospitals that performed exemplary public health work to identify and halt duodenoscope-linked antibiotic-resistant infections often failed to share that information with device manufacturers and to collaborate effectively with federal regulators. Hospitals that wish to participate in Medicare must meet certain conditions of participation specified and laid out in statute and regulation, including certain requirements for infection control and medical records services. In addition to enforcement efforts by FDA, Centers for Medicare and Medicaid Services should require that compliance with relevant medical device reporting requirements be included as a condition of participation in Medicare to ensure that state survey agencies and accrediting bodies such as the Joint Commission on Hospital Accreditation specifically examine whether hospitals are filing timely required medical device reports with hospitals or FDA."
7. Congress should fully fund a National Medical Device Evaluation System (NMEDS).
According to the report, "Widespread adoption of UDIs is an important step but is just one of many parts of a complete and robust device evaluation system. FDA must also facilitate a coordinating center to ensure interoperability between data sources and a governance structure to operate the system. Congress should provide sufficient funds for the agency to move toward these goals as rapidly as possible."
Recently, the Society of Gastroenterology Nurses and Associates, Inc. (SGNA) released its revised guidance document, Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes, which complements SGNA's Guideline for the Use of High Level Disinfectants and Sterilants for Reprocessing of Flexible Gastrointestinal Endoscopes (2013) and the new SGNA Standard of Infection Prevention in the Gastroenterology Setting (2015). The new SGNA flexible scopes guidance acknowledges the infections associated with duodenoscope reprocessing as well as the supplemental duodenoscope reprocessing measures suggested by the FDA, which included microbiological culturing, ethylene oxide sterilization, use of a liquid chemical sterilant, and repeated high-level disinfection. The new SGNA flexible scopes guidance outlines the expectations of reprocessing staff and management responsibilities, the reprocessing environment, the steps in reprocessing and rationale for their use, and quality assurance.
In addressing duodenoscopes, the SGNA guidance emphasizes, "Because the elevator channel of a duodenoscope is difficult to effectively clean, additional steps are required in all phases of reprocessing (CDC, 2015). Other specialty endoscopes such as an endoscopic ultrasound (EUS) gastrovideoscope and double channel endoscope may require additional steps and brushes to adequately clean manually; refer to the specific manufacturer’s instructions."
SGNA reviews its guidelines and position statements every three years, says Michelle Juan, MSN, RN, CGRN, the GI/Liver Nurse Manager, Digestive and Liver Disorders at Indiana University Health Physicians, and a member of the SGNA's board of directors. "Infection prevention was already being revised at the time of the outbreaks and the increased media coverage due to the FDA hearing," she says. "The new document, 'Infection prevention in the endoscopy setting,' was discussed before as we identified a gap in our previous document that was needed for our members. Our documents are thoroughly researched to bring information that is evidence-based."
"Providing research based best practices in scope and accessories reprocessing and infection control has always been the focus of SGNA," says LeaRae Herron-Rice, MSM, BSN, RN, CGRN, clinical manager at Vanderbilt Medical Center and a member of the SGNA's board of directors. "With the recent CRE outbreaks and incidents of infection breeches, it became apparent that this was the time for SGNA to expand these standards to provide our membership and GI community with the latest evidence- based information on infection prevention as it relates to the GI setting. In our new standard we focused on areas such as environmental requirements, employee safety, education and training, and the need for quality assurance and monitoring."
Juan says the general awareness level of infection prevention and control related to reprocessing issues is high, "especially with media coverage of the CRE outbreaks." Herron-Rice adds that the community is also taking advantage of the infection prevention and control resources that SGNA offers. "SGNA has long been a supporter of infection prevention and a leader on standards for GI reprocessing scopes and accessories," she says. "In 2010, SGNA held the first Infection Prevention Summit that brought together physician, nursing professional organizations, regulatory groups and industry to look at ways to improve infection prevention in the GI setting. Following this, SGNA developed an Infection Champions Program that focuses on staff member champions, management and infection control leaders working together to provide a safe environment for patients and staff in the GI setting. Today we have trained more than 240 champions in hospital, ambulatory and surgery centers."
When it comes to quality improvement in the GI setting as it relates to reprocessing, Herron-Rice observes, "Infection prevention is important in every aspect of our care for our patient and providing staff a safe place to practice, regardless of the setting it is performed in. Obviously, scope reprocessing and instrument design is a hot topic; however, training and guidelines play a vital part in infection prevention. Pursuing evidence-based research in the field of infection prevention is also something as an organization we have strived to obtain. SGNA Fellows and Scholars programs play a large part of this goal."
It is essential that infection perfectionists assist GI personnel and departments with carrying out the recommendations in the aforementioned SGNA guidance documents, as well as other industry guidelines. "It takes everyone working together to ensure that the GI setting is practicing good infection prevention activities," Herron-Rice says. Knowing the standards, the infection perfectionists can assist GI leadership and staff in developing action plans to ensure that the safe, evidence-based guidelines are in place in their GI setting. Infection perfectionists can also be the bridge to upper management to generate support to make sure these guidelines are implemented."
Juan adds, Collaboration and a team approach is needed. Bringing all the stakeholders at the table is crucial at a time where reprocessing issues are evolving; this creates a proactive and preventative approach rather than reactive one."
The Association of periOperative Registered Nurses (AORN) has released its new guideline, Processing Flexible Endoscopes. Sharon Van Wicklin, MSN, RN, CNOR, CRNFA, CPSN, PLNC, a perioperative nursing specialist for AORN who spearheaded the research and writing of this new guideline for more than a year, describes the project as an enormous undertaking: "Due to the vast amount of evidence that was reviewed during the development of this guideline, its writing was an experience like no other, that’s for sure. We started with 3,397 documents, reviewed 1,257 for inclusion, and ultimately cited 418 references in the guideline. I am very satisfied with the end product and confident with the evidence review and the recommendations we’ve made. By carefully following these new guidelines, we can help to ensure that flexible endoscopes are processed effectively and that transmissible infections related to flexible endoscopes are reduced or even eliminated."
Van Wicklin has high hopes for how this guideline can help clinicians improve their practice. "I would like those who use the guideline to know that they can be confident the AORN recommendations are truly evidence-based," she says. "We didn’t leave any stones unturned in our search for best practices. The recommendations are sound. They’ve been carefully and thoughtfully constructed for application in all areas where flexible endoscopes are used and processed. The recommendations have also been reviewed and approved by our Guidelines Advisory Board that includes perioperative practice experts and liaisons from APIC (Association for Professionals in Infection Control), SHEA (Society for Healthcare Epidemiology in America), ACS (American College of Surgeons), ASA (American Society of Anesthesiologists), AANA (American Association of Nurse Anesthetists), and IAHCSMM (International Association of Healthcare Central Service Materiel Management)."
Van Wicklin adds, "Although there are many specific recommendations that I would like to see practitioners take away from this guideline, I believe one of the most important and timely recommendations are those related to our processing personnel…who are some of the most important, but often neglected members of our perioperative team. AORN has long advocated for education and competency verification of perioperative, endoscopy, and sterile processing personnel, but this is critically important when it comes to processing flexible endoscopes. Flexible endoscopes and endoscope accessories should be cleaned and processed by qualified individuals who have received education and completed competency verification activities related to endoscope processing. The collective evidence shows that ensuring flexible endoscopes and endoscope accessories are processed by individuals whose primary duties are to clean and process flexible endoscopes minimizes variability and improves processing effectiveness, and may also reduce repair costs and extend the life of the endoscope."
In addition to having skilled and knowledgeable personnel processing flexible endoscopes, Van Wicklin says AORN recommends that:
• Processing of flexible endoscopes is performed in the same manner in all processing locations. In other words, the processing procedures followed in a satellite processing station should be the same as the processing procedures followed in the main endoscopy processing room.
• Sufficient time and numbers of personnel should be provided to permit thorough cleaning and processing.
• Endoscopy procedures should be scheduled to allow sufficient time for cleaning and processing of flexible endoscopes.
• An inventory of flexible endoscopes and accessories sufficient to meet the anticipated demand should be maintained.
• Flexible endoscopes used for procedures performed at the bedside or outside of normal operating hours should be processed in the same manner as endoscopes used during normal operating hours.
"These are extremely important recommendations that will help assure effective processing of flexible endoscopes," Van Wicklin adds.
There are a number of ways that infection preventionists can assist perioperative nurses and sterile processing professionals understand and implement the guideline's recommendations.
"Infection preventionists are the experts in infection prevention, and they can be so helpful in assisting periop nurses to better understand the mechanisms of infection, and thus more effectively prevent transmission of infection, and especially so when it comes to understanding and eliminating the multidrug-resistant microorganisms that can be transmitted by flexible endoscopes," she says. "The input we received from APIC and SHEA during the development of this guideline was invaluable." Van Wicklin adds, "A number of the recommendations in this guideline call for facility practice decisions to be made by a multidisciplinary team. Using the evidence review that AORN has provided, perioperative personnel and infection preventionists can work together to identify variables unique to their facility and then make the best decisions related to methods for auditing manual cleaning, determining maximum safe storage time, and performing microbiological culture surveillance."
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