FDA Panel Seeks Answers About Effective Reprocessing of Endoscopes


In mid-May, the Food and Drug Administration (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 previous communications, the FDA has expressed its concerns regarding the risks to patients if flexible endoscopes and their accessories are not cleaned properly and reprocessing guidelines not followed. The agency has also held several stakeholders' meetings and workshops, including with the Association for the Advancement of Medical Instrumentation (AAMI) that focused on factors affecting reprocessing of reusable medical devices and established clarion themes that began to outline key challenges and priority actions. In addition, in mid-March, the FDA issued its Final Guidance that addressed mandates for manufacturers relating to validation methods and labeling of medical devices that are reprocessed.

By Kelly M. Pyrek

In mid-May, the Food and Drug Administration (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 previous communications, the FDA has expressed its concerns regarding the risks to patients if flexible endoscopes and their accessories are not cleaned properly and reprocessing guidelines not followed. The agency has also held several stakeholders' meetings and workshops, including with the Association for the Advancement of Medical Instrumentation (AAMI) that focused on factors affecting reprocessing of reusable medical devices and established clarion themes that began to outline key challenges and priority actions. In addition, in mid-March, the FDA issued its Final Guidance that addressed mandates for manufacturers relating to validation methods and labeling of medical devices that are reprocessed.

The mid-May meeting was designed to address the FDA’s questions regarding effective reprocessing of duodenoscopes in endoscopic retro-grade cholangiopancreatography (ERCP) procedures in hospitals and to further inform rigorous reprocessing protocols that will enhance the safety margin of ERCP procedures. Discussion focused on five elements: the effectiveness of cleaning, high-level disinfection and sterilization methods; the amount and type of premarket validation data and information needed to support labeling claims and technical instructions; the appropriate use of other risk mitigations such as surveillance cultures; best practices and guidelines for reprocessing duodenoscopes and endo-scopes at user facilities to minimize the transmission of infections; and recommended approaches for ensuring patient safety during ERCP procedures, including a discussion of appropriate patient selection. To be as comprehensive as possible, the stakeholders who gathered for this meeting also addressed duodenoscope design features and the manual reprocessing steps as instructed by the duodenoscope manufacturers, as well as the role of automated endoscope reprocessor (AER) devices for cleaning, high-level disinfection or liquid chemical sterilization as performed at many healthcare institutions.

To put the importance of this meeting into perspective, the FDA presented data from its examination of the Manufacturer and User Facility Device Experience (MAUDE) database for medical device reports (MDRs) associated with adverse events and/or infections on all endoscopic de-vices received by the FDA's CDRH between Jan. 8, 1997 and Feb. 17, 2015; and Automatic Endoscope Reprocessors (AERs) received by CDRH between Jan. 1, 1992 and March 11, 2015. For duodenoscopes overall, a total of 433 endoscope reports related to a patient infection, exposure or device contamination were received during the aforementioned timeframe. Of these endoscope reports, 146 were associated with ERCP devices (duodenoscopes). Of these 146 reports, 142 were received since 2010. A total of 152 MDRs were received for AERs associated to patient infection, patient exposure to an infectious organism without disclosure of patient infection, and device contamination without disclosure of patient exposure.

The panel discussed recent reports and epidemiologic investigations of the transmission of infections associated with the use of duodeno-scopes, as well as to provide scientific and clinical opinion related to reprocessing of duodenoscopes and automated endoscope reprocessors based on available scientific information.
On the first day of the meeting, Dr. Stephen Ostroff, acting FDA commissioner, provided introductory remarks emphasizing the importance of the meeting and the agency’s commitment to ensuring patient safety in procedures involving reprocessed duodenoscopes and other endoscopes.

As Ostroff noted, "Duodenoscopes aren't devices that get used once and then disposed of. They are high-performance, high-tech, and high-cost. As is the case with other scopes, they are intended to be reused and reprocessed, that is, cleaned and disinfected or sterilized between patients. As we've seen, while the unique design of duodenoscopes makes them effective, it also poses significant reprocessing challenges. And like the instrument itself, the steps necessary for proper reprocessing are also complex. Performing the rigorous cleaning and high-level disinfection or sterilization between uses to prevent the transmission of infection must be done right, and it must be done well. We know that there is very little margin for error."

The FDA provided an overview presentation on FDA’s timeline of events associated with ERCP infections as well as a broader perspective on the agency’s long-term efforts related to challenges in reprocessing of medical devices. As Ostroff explained, "Unfortunately, the potential for infections from improperly or incompletely cleaned scopes, including duodenoscopes, has been known for some time. In most instances in the past, these could be traced to user error, including not correctly following the reprocessing instructions for the device. In 2009 we issued a warning about the risk to patients if flexible endoscopes and their accessories were not cleaned and disinfected or sterilized properly and sug-gested steps that could reduce these risks. But in the fall of 2013, we were informed by the CDC of disease clusters after use of duodeno-scopes, where infections appeared to have occurred despite confirmation that the facilities were correctly following the cleaning and disinfection or sterilization instructions established by the manufacturers, raising questions about whether their existing reprocessing instructions were adequate. After learning of these outbreaks, FDA initiated a comprehensive review of available information to better understand the chain of events that could have produced the outbreaks and determine what steps needed to be taken to minimize patient exposure to infectious agents. A number of these steps have been detailed previously, and I won't repeat them, but suffice it to say that a great deal of our efforts have focused on the reprocessing procedures themselves. Much of the work has focused on the manufacturers of duodenoscopes. We have scrutinized their studies that are intended to validate, with a high degree of assurance, that their cleaning and disinfection instructions will consistently and effectively reduce microbial contamination."

Ostroff continued, "If our assessment is that the studies aren't rigorous enough, we've been asking for new ones. If the studies appear to be adequately designed and performed but the results are disappointing, we have asked them to develop additional cleaning and disinfection instructions. More recently we've begun a similar line of inquiry with the manufacturers of automated endoscope reprocessors (AERs), which are used by many facilities for high-level disinfection of duodenoscopes. In short, our approach has been to examine this problem from A to Z, and we're starting to yield some encouraging results, including a possible path forward on a validated protocol for studying whether reprocessing instructions can work, even in worst-case scenarios."

The FDA also provided an introduction to ERCP, an overview of duodenoscopes and reprocessing procedures as well as automated endoscope reprocessors and sterilization and medical device adverse event reports.

According to the FDA, "The duodenoscope has a complex device design which presents a particular challenge to cleaning and high level disinfection. Unlike most other endoscopes, duodenoscopes have a movable “elevator” mechanism at the tip. Raising the elevator mechanism changes the angle of the accessory instrument exiting the instrument channel, which is what allows the accessory to access and treat problems with fluid drainage from the bile ducts or pancreas. However, an engineering assessment conducted by FDA and a growing body of literature have identified design issues such as the elevator mechanism as features that make reprocessing of duodenoscopes challenging. For example, one step of the manual cleaning instructions in the device’s labeling is to brush the elevator area. The moving parts of the elevator mechanism, however, introduce microscopic crevices that may not be reached with a brush. Failure to remove all body fluids may result in persistent microbial contamination of the device. Microbes may survive in residual body fluids and organic debris despite immersion of the duodenoscope in high-level disinfectant solution, potentially exposing subsequent patients to serious infections.

Duodenoscopes have a long thin wire that connects the elevator control mechanism (on the control handle) to the elevator at the distal tip of the endoscope (the distal end of the endoscope is inserted into the patient). That wire is housed in a very narrow channel called the elevator wire channel, which spans from the distal tip to the control handle. To move the elevator at the distal end of the endoscope, the elevator control on the control handle is actuated, which moves the elevator wire, which in turn moves the elevator. In some models of endoscope, patient soil can enter the elevator wire channel (an open or unsealed elevator wire channel). That open elevator wire channel requires reprocessing by flushing detergent into the channel for cleaning, and flushing high level disinfectant into the channel for high level disinfection. In currently marketed models, duodenoscope manufacturers have closed or sealed off the elevator wire channel, which is intended to prevent soil from enter-ing this channel. Consequently, the elevator wire channel in those duodenoscopes is no longer reprocessed."

At the meeting, Shani Haugen, PhD, a microbiologist in the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, explained that, "In early versions of duodenoscopes, the elevator wire channel was exposed to patient soil. In those open elevator wire channel duodenoscopes, the elevator wire channel needed to be cleaned and disinfected after use. Because the elevator wire channel is very narrow, reprocessing this channel was and is technically challenging. To avoid having to reprocess the elevator wire channel, duodenoscope manufacturers sealed the elevator wire channel with one or more O-rings. This seal is intended to prevent soil from entering the elevator wire channel. Consequently, the elevator wire channel in these closed elevator wire channel duodenoscopes is no longer cleaned and disinfected. Please note, though, that there are still open elevator wire channel duodenoscopes being used in the U.S. There are three manufacturers of duodenoscopes in the U.S.: Fujifilm, Olympus and Pentax. Previously, we knew that the long narrow channels in an endoscope posed a challenge for cleaning and disinfection. Device manufacturers focused their efforts on demonstrating that those channels could be cleaned and disinfected. We recently found that the distal tip of duodenoscopes also poses a challenge for reprocessing."

The open public hearing session included presentations from professional societies such as the American Society for Gastrointestinal Endoscopy (ASGE), Association of periOperative Registered Nurses (AORN), the International Association of Healthcare Central Service Material Man-agement (IAHCSMM), the Society of Gastroenterology Nurses and Associates (SGNA) and the Society for Healthcare Epidemiology of America (SHEA). The invited speakers on day one included: Margreet Vos, MD, PhD, of Erasmus Medical Center (Netherlands), Zachary Rubin, MD, of UCLA Medical Center, and Andrew Ross, MD, of Virginia Mason Medical Center. Each hospital provided their perspective on current methods implemented to mitigate the risk of patient exposure to bacteria from a reprocessed duodenoscope. In addition, Alexander Kallen, MD, MPH, discussed the CDC’s outbreak investigation on duodenoscopes. Finally, day one concluded with a presentation by Michelle Alfa, PhD, a researcher from University of Manitoba discussing her research on reprocessed duodenoscopes. On the second day of the meeting, FDA-invited speakers included Matthew Arduino, MS, DrPH; William Rutala, PhD, MPH; and Timothy Leighton. Arduino presented CDC’s interim protocol for surveil-lance of duodenoscopes after reprocessing; Rutala discussed his experience in shifting from disinfection to sterilization for gastrointestinal endo-scopes; and Leighton presented on behalf of the Environmental Protection Agency and discussed worker exposure and associated risks of ethylene oxide.

The panel was asked to consider six FDA discussion questions and it provided the following recommendations:

1. Based on the methodology and criteria for acceptance of cleaning, high-level disinfection, and sterilization validation testing for both manual and automated processes, the panel concluded that duodenoscopes and AERs do not provide a reasonable assurance of safety and effec-tiveness. The panel believes that manual cleaning is a critical component in the process and needs to continue. The majority of the panel also believes it is necessary to reclassify duodenoscopes based on the Spaulding Classification from semi-critical to critical and support the move from high level disinfection toward sterilization. However, some panelists maintained that high-level disinfection is adequate, if done properly. The panel unanimously agreed that ERCP is an important procedure and the use of duodenoscopes during this procedure is safe and should continue from a public health perspective. The benefits of the procedure for the population outweigh the potential risks associated with the use of duo-denoscopes.

2. The panel discussed the role of pre-market human factors testing in reprocessing instructions and concluded human factors testing is important and should be a part of the pre-market assessment.The panel supported a guide of best practices and competency assessments for ensuring user adherence with manufacturer’s reprocessing instructions.

3. The panel discussed cleaning agents and brushes differing from the duodenoscope manufacturer’s instructions and concluded that brushes or other cleaning agents should meet the manufacturer’s specifications. The panel also agreed it is necessary to receive data from the manufacturer on the efficacy of brushes or other cleaning agents as well as the need for development and validation of cleaning verification assays

4. The panel discussed CDC’s interim guidance for surveillance for bacterial contamination of duodenoscopes after reprocessing and conclud-ed the guidance is not sufficient in the current form to be implemented by healthcare facilities as a best practice. The panel believes more data and validation testing is needed before a surveillance program should be implemented by healthcare facilities. Despite its limitations, the panel agreed the guidance provides a well-documented outline for healthcare facilities.

5. The panel’s recommended approach for ensuring patient safety for ERCP is to discuss the informed consent with patients and to provide information on the risk of infection from the procedure and to disclose if the health facility has had an issue with infections. Patient selection is also critical for ensuring patient safety. Patients should also be informed of the effects of foregoing the procedure and provided alternatives to the procedure.

6. The panel discussed temporizing measures the FDA should consider when the FDA has a medical device concern but not enough infor-mation to determine the most appropriate action towards a resolution. The panel urged the FDA to provide early communication of the facts to the public. The panel also stated the FDA should work with professional societies in an effort to disseminate a consistent message to healthcare providers.

During the open public hearing portion of the meeting, a number of professionals from the sterile processing and infection prevention communities shared their perspectives.

Susan Klacik, representing the International Association of Healthcare Central Service Materiel Management (IAHCSMM), addressed human-factors issues: "We've talked a lot today about the ERCP scopes and the complex designs, but also we're concerned with some of the complex IFUs we have. In central sterile, we don't just process one type of scope. We process a multitude of different types of scopes, not just the duo-denoscopes, but we have the gastroscope, colonoscope, bronchoscope, sigmoidoscope, etc. The duodenoscope. It takes over 120 steps just to process that scope, so it takes a lot of training and competency to be able to do that properly. One of the human factors that happens quite often with processing flexible scopes and other products is we get a lot of interruptions; we get interruptions constantly from surgery because maybe they need another instrument set. So what happens is personnel may start to process a scope and be interrupted several times for sev-eral different reasons. And so, of course, we have to go back and remember, what was I doing before I was interrupted? It's a very busy place. It's very noisy in the decontam room. We have high humidity. Techs have PPE on. Often the visualization is cloudy because our eye protection fogs up. We have thick rubber gloves on, so it's hard to perform manipulations. We have a problem with staff turnover and that staff doesn't -- not all staff stay in the CS for long periods of time. The pay isn't all that good, and so staff tend to leave the department to go elsewhere. There is a pressure to turn the scopes. Down in CS we're pressured. Up in endoscopy labs they need these scopes turned, and maybe it's because they don't have enough scopes. So the question of human factors is, if I'm turning these scopes constantly, am I performing all the correct tasks? You know, am I being pressured too much to process the scopes? When we're talking about instructions for use, we're not only looking at the scopes but also all of the accessories that go on with the scopes. We have the valves. We call them the buttons. There's a lot of cleaning of other accessories. We have our cleaning implements, and some of them  have specific cleaning instructions and disinfection instructions. We also have detergent that we have to monitor. It's important to recognize that detergents have to be diluted properly, and some detergents have specific temperature recommendations that we have to follow. We also have to follow the IFUs for the AER and the disinfectant and sterilant. So there's quite a bit of coordination that goes into this."

Klacik continued, "There was a study performed by Cori Ofstead who found that 75 percent of the people who process scopes feel pres-sured while processing them that they have to turn them quickly for the next procedure; 37 percent observed procedural delays due to processing. In other words, the cases were delayed because it takes so much time to process the scope properly. And 53 percent of her study re-ported discomfort due to working with scopes."

Also sharing her perspective at the meeting was Sharon Van Wicklin, a perioperative nursing specialist with AORN, who emphasized, "Relative to the effectiveness of cleaning, high-level disinfection, and sterilization methods for flexible endoscopes and duodenoscopes, effective high-level disinfection and sterilization cannot occur without effective cleaning. Debris or bioburden remaining on the device may prevent high-level disinfection or sterilization from occurring. When cleaning of endoscopes is performed using only manual methods, important steps may be skipped. Therefore, automated cleaning should be recommended as best practice because it provides a greater assurance that the endoscope has been effectively cleaned. The use of rapid cleanliness indicators may also be helpful in verifying cleanliness of a device. The use of aldehyde disinfectants such as glutaraldehyde and ortho-phthalaldehyde, and the associated hazards and potential for bacterial resistance and for these disinfectants to act as fixatives, making bioburden and biofilm more difficult to remove, should also be further explored. The use of ethylene oxide sterilization, rather than high-level disinfection, has been discussed in the literature as one solution for preventing transmission of infection via flexible endoscopes. However, if there is debris or bioburden in the lumen, the sterility of the device remains in question. Ethylene oxide is not readily available in most facilities. Likewise, the repeated use of certain sterilization technologies, such as ethylene oxide, may be harmful to the device."

Van Wicklin added, "With regard to best practices and guidelines for reprocessing duodenoscopes and endoscopes at user facilities in order to minimize the risk of transmission of infections, it is critically important that personnel who are processing flexible endoscopes receive the nec-essary education and complete competency verification activities initially upon hire, annually, and whenever remediation is necessary or new devices or products are purchased for use at the facility. At a minimum, this education should include the need for strict adherence to the man-ufacturer's instructions for use, the value of thorough pre-cleaning of the device at the point of use, and the importance of meticulously clean-ing all lumens, channels, and other components of the endoscope, particularly the elevator channel with the duodenoscope as well as the endoscope accessories. Education should include the need for using the appropriate cleaning devices and products, wearing the appropriate personal protective equipment, and not reprocessing devices such as valves and caps that are intended for single use. Relative to future considerations, in order to reduce the potential for infection transmission via flexible endoscopes, it is imperative that manufacturers design devices that can be disassembled for more effective cleaning and that they also consider the development of single-use endoscopes."

Zachary Rubin, representing SHEA, addressed the updated FDA guidance, and noted, "As far as approaches to cleaning, SHEA recommends that currently there are a variety of approaches in use, but manufacturers' instructions should ensure that thorough cleaning is done of a de-vice. And then manufacturers' instructions should also indicate the device's appropriate microbicidal processes. It should be technically feasible, comprehensive, and understandable and simplified as much as possible. They should be tested and validated among a group of intended users. Routine endoscope evaluation and maintenance schedules should be included in the approval processes for these devices. And one thing that's not mentioned here but was discussed is that the functional lifetime of these scopes also should be identified and reasons to potentially stop using these scopes. The margin of safety is important as well and has been mentioned. Instructions that are given by the manufacturers must take into account the probability of human error, because if you've seen people processing these scopes, it's very complex, and there are many steps, and if you -- you know, currently, we feel that if you miss even a couple of those steps, you may not be able to entirely clean the device, and that needs to be improved. The FDA should urge manufacturers to design scopes that are cleanable and/or have disposable parts."

Rubin continued, "In the absence of evidence, SHEA continues to support thorough manual cleaning as a critical step in duodenoscope re-processing, as well as strict adherence to manufacturers' recommendations for cleaning, disinfection, and sterilization of specific device types. And responding to the culturing of scopes, the CDC currently recommends culture methodology as an interim guidance, but it is currently in many places being used as a final recommendation. And there are cases that exist where a misinterpretation has already occurred and may occur in the future with drug commission and other organizations. The concern about this guidance, from SHEA's standpoint, is that the sensitiv-ity of culturing scopes has not been clearly established. A protocol for culturing duodenoscopes and sampling methods has not been validated with a large number of trials. And the same problems in cleaning scopes that exists for culturing, such as debris accumulating in inaccessible recesses that lead to bacterial growth, may also make it difficult to actually culture the part of the scope that is most important. Additionally, commonly used disinfectants like OPA may inhibit cultures, and this needs to be evaluated and stated in the CDC guidelines. And there are pos-sible unintended consequences from this type of culturing, including false positives from equipment coming into contact with the skin or tech-nique of the people actually doing the culturing. And guidance is needed as the next steps for patient notification when a positive culture is found after it's been in a patient, especially if it's only being cultured after a certain number of trials. Like if more than one patient is being ex-posed and then the cultures are positive, what do you do about all those other patients that have undergone procedures before that positive culture? Rapid culturing systems do exist. ATP and other rapid indicators have been investigated for monitoring the effectiveness of repro-cessing, particularly of the manual cleaning step. The evidence to date is limited and does not support the routine use of these methods."

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.

"What is unique about these outbreaks is that they have occurred while there has been adherence to the manufacturers' recommendations and adherence to the professional organizational guidelines. What is also unique is the presence of a very unusual pathogen resulting in an in-vestigation and the recognition that these duodenoscopes were the source of the outbreak. We know that inappropriate cleaning and high-level disinfection has led to cross-transmission. What you may not know is there have been more outbreaks of infection associated with endoscopes than any other reusable medical item in healthcare, by far. There have been roughly 50 outbreaks associated with gastrointestinal scopes and about 50 outbreaks associated with bronchoscopes. And if you look at those outbreaks, you'll find that each of those outbreaks are traced to deficient practices. The deficient practices have included inadequate cleaning, inappropriate/ineffective disinfection, a failure to follow recommended disinfection practices, and of course, the flaws and complexity in either the design of the endoscopes or the automated endo-scope reprocessors. But that probably represents the tip of the iceberg, because endemic transmission probably goes unrecognized; we have excellent surveillance of inpatient procedures, but inadequate surveillance of outpatient procedures."

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 es-sentially 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 in-struments. 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 Spauld-ing 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."

Reference: Food and Drug Administration (FDA). Executive summary: Effective Reprocessing of Endoscopes Used in Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedures.


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