By Kelly M. Pyrek
Following yet another highly publicized patient exposure to dangerous pathogens via contaminated endoscopes, the healthcare and sterile processing communities are examining their processes, re-evaluating their priorities, and digesting new guidelines issued by several federal agencies.
Medical devices intended for repeated use are commonplace in healthcare settings. They are typically made of durable substances that can withstand reprocessing, a multi-step process designed to remove soil and contaminants by cleaning and to inactivate microorganisms by disinfection or sterilization. While the majority of reusable devices are successfully reprocessed in healthcare settings, the complex design of some devices makes it harder to remove contaminants.
In the wake of media reports, on Feb. 20, 2015, UCLA Health announced that an outbreak of carbapenem-resistant Enterobacteriaceae (CRE) bacteria occurred at Ronald Reagan UCLA Medical Center during complex endoscopic procedures that took place between October 2014 and January 2015. UCLA Health System notified 179 patients on Feb. 18, 2015 that they may have been exposed last fall to CRE during an endoscopic procedure to diagnose and treat diseases of the liver, bile ducts and pancreas; a total of seven patients were infected; the infection was a contributing factor in the death of two patients. UCLA says that patients who underwent these endoscopic procedures from Oct. 3 to Jan. 28 are at risk of infection, and that those patients are being offered a free home testing kit for analysis at UCLA to determine if they carry the bacteria in their intestines.
UCLA clinical epidemiology and infection prevention staff identified a small group of infections with CRE that appeared to happen after endoscopic retrograde cholangiopancreatography (ERCP). After further investigation with the assistance of the Los Angeles County Department of Public Health, it was determined that the routine cleaning of the ERCP scopes as recommended by the scope manufacturer does not completely eradicate CRE as it does for other bacteria and viruses. After discussion with local and national public health officials, it appears that the ERCP scopes will require additional cleaning techniques beyond what is recommended by the manufacturer or significant redesign of parts of the scope.
In a statement, UCLA Health said, “UCLA followed both national guidelines and the sterilization standards stipulated by Olympus Medical Systems Group, the instrument’s manufacturer. However, an internal investigation determined in late January that CRE may have been transmitted by two of the seven Olympus scopes used by the hospital during the four-month period. UCLA immediately began reviewing every patient record to determine which patients underwent the procedure using this type of scope between October and January. In an abundance of caution, the hospital has notified all 179 patients who were examined with one of the seven instruments during that time. The two infected scopes were immediately removed from use for return to Olympus. UCLA currently performs a more stringent decontamination process that exceeds both the manufacturer’s standards and national guidelines. Hospital staff thoroughly clean the instrument and place it in an automated machine for disinfection. Then the instrument is sent off-site for a second sterilization process using a gas called ethylene oxide.” UCLA Health also noted that it has “instituted stricter sterilization procedures for the particular scopes that were used, so that we now have one of the most stringent scope protocols in the United States.”
In a letter to its customers, Olympus emphasized that it “continuously strives to improve our products for safe and effective use. This includes changes to device design.” It also explained that “Olympus markets the TJF-Q180V duodenoscope in the U.S. based upon applicable 510(k) clearance guidelines. Olympus modified our 510(k)-cleared duodenoscope in 2010 and determined that the resulting TJF-Q180V did not require a new 510(k) application according to the FDA policy on modifications to 510(k)-cleared devices. The FDA subsequently requested a 510(k) application with information regarding the modified device. Olympus submitted a 510(k) to the FDA and the company continues to cooperate with the agency.”
In an update to their Safety Alert, on March 4, 2015, the FDA stated the following: “The FDA has received inquiries from healthcare providers about whether they should cancel ERCP procedures, based on the fact that one specific model duodenoscope manufactured by Olympus (the TJF-Q180V) does not currently have a 510(k) clearance. FDA is not recommending that healthcare providers cancel ERCP procedures for their patients who need them. Olympus has a pending 510(k) application for this device, and the company continues to market the product while the application is under review. FDA is not taking action against Olympus regarding its device during our review of the application, because, based on the information currently available to the Agency, we believe that removal of the device from the market could lead to an insufficient number of available duodenoscopes to meet the clinical demand in the United States of approximately 500,000 procedures per year.”
The FDA’s analysis indicates that the reported duodenoscope-associated infections have occurred in patients who have had procedures with duodenoscopes from all three manufacturers. At this time, FDA has no evidence that the lack of a 510(k) clearance was associated with the infections.
The Olympus letter states that “The emergence of drug-resistant microorganisms is a challenge to the entire healthcare community. Olympus is working with relevant medical societies and our customers in research of this emerging issue and the development of additional safeguards to prevent infection associated with endoscopic procedures including ERCP … We continue to monitor this issue closely and work with the FDA, relevant medical societies and customers to address concerns, including the consideration of alternative cleaning and reprocessing methods.” In late March, Olympus issued new, validated manual reprocessing instructions for the TJF-Q180V duodenoscope to replace those provided in the original labeling. The FDA has reviewed these new reprocessing instructions and the validation data as part of its ongoing review of the 510(k), and recommends that any facilities that are using Olympus’ TJF-Q180V duodenoscope train staff on the new instructions and implement them as soon as possible.
Infections caused by CRE have been reported in North Carolina, Pittsburgh, Los Angeles, Chicago, and Seattle. According to the Association for the Advancement of Medical Instrumentation (AAMI), last month, the FDA said it had received 75 reports—involving approximately 135 patients—of CRE bacterial infections linked to reprocessed duodenoscopes between January 2013 and December 2014.
Outbreaks are Nothing New
Outbreaks that have been tied to contaminated, improperly reprocessed medical devices have been well documented in the press and in the medical literature. Lively dialogue in the sterile processing community was sparked in 2012 by a report in the mainstream media on dirty surgical instruments; the genesis of that coverage is a study in the December 2011 issue of Infection Control and Hospital Epidemiology by Pritish Tosh, MD, of the Mayo Clinic Division of Infectious Diseases, and colleagues, who reported on organ/space surgical site infections (SSIs) that occurred after arthroscopic procedures at a Texas hospital in 2009.
Tosh, et al. (2011) reported that cultures of environmental and surgical equipment samples were performed and selected isolates were analyzed. Surgical instrument reprocessing practices were reviewed, and surgical instrument lumens were inspected with a borescope after reprocessing to assess cleanliness. The investigators reported that they did not identify any significant patient-related or operator-related risk factors. All surgical instrument cultures showed no growth; however, the investigators said that endoscopic evaluation of reprocessed arthroscopic equipment revealed retained tissue in the lumen of both the inflow/outflow cannulae and arthroscopic shaver handpiece. No additional cases occurred after changes in instrument reprocessing protocols were implemented.
After this outbreak, the FDA released a safety alert about the concern regarding retained tissue within arthroscopic shavers.
Tosh and colleagues concluded that these SSIs were likely related to surgical instrument contamination with P. aeruginosa during instrument reprocessing and that retained tissue in inflow/outflow cannulae and shaver handpieces could have allowed bacteria to survive sterilization procedures. They observed the facility’s instrument reprocessing practices from the time that the instruments left the OR, through each reprocessing step, to packaging and storage for reuse. Autoclave and reprocessing logs from the main reprocessing areas were reviewed. Two flash autoclaves were located in the surgical pod where the majority of the case procedures were performed, and were used up to six times daily during the outbreak period. The investigators report that two of the case patients and four of the control patients had instruments that required flash autoclaving during their procedures. They found that logs of the flash autoclaves were not always complete with regard to the patient name, OR number and instrument name. Interviews of OR and instrument-reprocessing personnel revealed that the flash autoclaves had been used on rare occasions for routine sterilization. Low-temperature sterilization with hydrogen peroxide gas plasma was used for reprocessing of the arthroscope, the arthroscope light cord, and the arthroscope camera/power cord in accordance with manufacturer instructions for the recommended duration. The sterilizer logs revealed deficiencies in the documentation of biologic and chemical indicators that were performed on each load. After sterilization, packaged instrument sets were stored in a designated room adjacent to the instrument-reprocessing area. Before and during the outbreak period, it was common practice to place instruments on a rack within the OR pod on the evening before the procedures.
The investigators said that the reprocessing procedures used on the shaver handpiece were consistent with the manufacturer’s instructions, including brushing of the suction tube channel with a disposable bristled brush, immersion of the handpiece in enzymatic solution for more than one minute (per enzymatic solution manufacturer recommendation), and autoclave sterilization. However, endoscopic examination of the shaver handpiece suction channel after reprocessing revealed remnant tissue and brush bristles that were not visible on routine visual inspection in each of the evaluated handpieces. Endoscopic examination of shaver handpieces from a different manufacturer that were obtained from another hospital within the health system also revealed remnant bioburden.
The arthroscope-cleaning procedure involved wiping down the instrument following a brief submersion of the instrument in enzymatic solution before high-level disinfection. The manufacturer-recommended procedure for arthroscope reprocessing included gross decontamination with submersion in enzymatic solution for 10 to 15 minutes before low-temperature sterilization. The distal ends of the shaver handpiece and the camera/power cord were wiped down with enzymatic solution. The manufacturer-recommended reprocessing instructions for gross decontamination included capping the distal end (with the electrical contact points) and submerging the entire device in enzymatic solution for 10 to 15 minutes.
The discovery of the retained bioburden in the suction channel of arthroscopic shaver handpieces despite reprocessing according to the manufacturer’s instructions was the “most consequential aspect of this outbreak,” according to Tosh, et al. (2011) who note, “The bioburden was not apparent on routine examination and was detected only through endoscopic visualization of the suction channel. Hospital X performed endoscopic evaluation of the shaver handpieces by other manufacturers at other facilities within their system and found retained bioburden, which suggests that this problem is not specific to this institution or to a specific manufacturer.”
The hospital’s response to the outbreak in the Tosh study included closing the OR pod where the majority of arthroscopic procedures were performed, replacing the arthroscopic instruments, returning to use of more rigid suction tubing for arthroscopy, and changing the instrument reprocessing protocols. According to Tosh, et al. (2011), instrument reprocessing protocols were adjusted to include routine endoscopic evaluation of reprocessed shaver handpieces to ensure that the suction channel did not contain residual bioburden; use of a non-bristled brush to clean the lumen of the arthroscopic inflow/outflow cannulae; submerging the shaver handpiece in enzymatic solution for 10 to 15 minutes during gross decontamination; capping the distal end of the arthroscope camera and shaver handpiece power cord before submersion in enzymatic solution; prohibiting the storage of surgical instruments in areas outside of the designated storage room; and reinforcing policies restricting flash autoclave use to instances when a surgical instrument becomes contaminated during a procedure and needs to be quickly reprocessed for use in that procedure. In addition, the gross decontamination room was redesigned to improve workflow, instrument reprocessing staff received annual training and certification, and tracking of the individual instruments used in each surgery was initiated. The investigators reported that no further cases occurred among patients who underwent arthroscopic procedures after these changes were initiated.
Healthcare Professionals are Alerted About the Latest Outbreak
On Feb. 19, 2015, the FDA issued an alert regarding the complex design of ERCP endoscopes (duodenoscopes) that may impede effective reprocessing. As the FDA explained, “Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it … Although the complex design of duodenoscopes improves the efficiency and effectiveness of ERCP, it causes challenges for cleaning and high-level disinfection. Some parts of the scopes may be extremely difficult to access and effective cleaning of all areas of the duodenoscope may not be possible. In addition, a recent FDA engineering assessment and a growing body of literature have identified design issues in duodenoscopes that complicate reprocessing of these devices. For example, one step of the manual cleaning instructions in device labeling is to brush the elevator area. However, the moving parts of the elevator mechanism contain microscopic crevices that may not be reached with a brush. Residual body fluids and organic debris may remain in these crevices after cleaning and disinfection. If these fluids contain microbial contamination, subsequent patients may be exposed to serious infections.”
In the alert, the FDA made the following recommendations for facilities that reprocess ERCP duodenoscopes:
Follow closely all manufacturer instructions for cleaning and processing. The FDA recommends adherence to general endoscope reprocessing guidelines and practices established by the infection control community and endoscopy professionals. In addition, it is important to follow specific reprocessing instructions in the manufacturer’s labeling for each device. Even though duodenoscopes are inherently difficult to reprocess, strict adherence to the manufacturer’s reprocessing instructions will minimize the risk of infection. Deviations from the manufacturer’s instructions for reprocessing may contribute to contamination. The benefit of using cleaning accessories not specified in the manufacturer’s instructions, such as channel flushing aids, brushes, and cleaning agents, is not known.
Report problems with reprocessing the device to the manufacturer and to the FDA.
Follow these additional general best practices: Meticulously clean the elevator mechanism and the recesses surrounding the elevator mechanism by hand, even when using an automated endoscope reprocessor (AER). Raise and lower the elevator throughout the manual cleaning process to allow brushing of both sides. Implement a comprehensive quality control program for reprocessing duodenoscopes. Your reprocessing program should include written procedures for monitoring training and adherence to the program, and documentation of equipment tests, processes, and quality monitors used during the reprocessing procedure. Refer to the Multi-society Guideline on Reprocessing Flexible Gastrointestinal Endoscopes: 2011 consensus document for evidence-based recommendations for endoscope reprocessing.
Inform patients of the benefits and risks associated with ERCP procedures.
Thoroughly disinfect duodenoscopes between uses and have in place a comprehensive quality program for reprocessing.
Take a duodenoscope suspected of being associated with a patient infection following ERCP out of service and meticulously disinfect it until it is verified to be free of pathogens.
Submit a report to the manufacturer and to the FDA via MedWatch if you suspect that problems with reprocessing a duodenoscope have led to infections.
Nancy Chobin, RN, CSPM, vice president of sterile processing services at Barnabas Health System in New Jersey, says that they are following the recent FDA advisories and CDC guidance. “The FDA has received inquiries from healthcare providers about whether they should cancel ERCP procedures, based on the fact that one specific model duodenoscope manufactured by Olympus (the TJF-Q180V) does not currently have a 510(k) clearance. The FDA advised that since the ERCP scopes are used for critical procedures, FDA is not recommending that healthcare providers cancel ERCP procedures for their patients who need them. The FDA’s analysis indicates that the reported duodenoscope-associated infections have occurred in patients who have had procedures with duodenoscopes from all three manufacturers. At this time, FDA has no evidence that the lack of a 510(k) clearance was associated with the infections. Based upon this information we are following the FDA advisories and CDC recommendations for reprocessing ERCP scopes.”
Chobin says the sterile processing and the infection prevention staff ensure institutional policies are followed, one of the best practices for patient safety. ”We must follow the manufacturers’ instructions for use to the letter,” she says. “We also have administrative support for that policy. Cleaning is the most critical step. If I had to make the choice between something that was properly cleaned and not disinfected, or improperly cleaned and disinfected, I want that clean scope. There was a recent recommendation to use lighted magnification to check the elevator wire in the elevated position and in the down position, just to be sure there is no debris. We have taken it one step farther — even before the UCLA outbreak — we implemented a special interim protocol where every ERCP scope was to be completely manually cleaned regardless of the type of automated endoscope reprocessor used. Even though some do partial cleaning, then the machine does the rest — we said we want complete manual cleaning, then we conduct cleaning-effectiveness testing. We do cleaning effectiveness testing (with channel check) and unless the tests are negative, we go back and we re-clean the scope. We will not proceed to disinfection otherwise.”
“People are upset with the FDA for not pulling these devices off the market and are asking why the FDA isn’t doing more about it,” says Donna Swenson, president of Sterile Processing Quality Services, Inc., a member of the AAMI/International Association of Healthcare Central Service Materiel Management Sterile Processing Benchmarking Council, a member of IAHCSMM’s Certification Council, and co-chair of AAMI’s protective barriers and industrial moist heat sterilization committees. “You can’t just pull scopes off the market because it will leave a gaping hole in terms of providing diagnostics and therapeutics. People receive healthcare with some risk involved, and we know there will sometimes be adverse events. It should be explained to patients there are risks involved and infections are a possibility — and that it’s probably a better alternative than pulling the scopes off the market. Because if you do that, now you can’t do these procedures that can help diagnose disease early. The FDA is looking at the cost versus the benefit — and the benefits of using duodenoscopes far outweigh the potential of infection. We have seen five or six incidences around the country in a two-year span. While this is an issue that should be addressed, when you look at the hundreds of thousands of procedures that were performed, I don’t know that I would advocate pulling the scopes off the market. People need to be aware of the issue, and the people who reprocess these scopes need to take meticulous care. We should look at our cleaning processes and how well we verify those processes. If it wasn’t cleaned then it can’t be disinfected or sterilized. If it was improperly cleaned then disinfection or sterilization might not be achieved. You don’t know what’s going to happen — will you get a sterile device? Maybe. Maybe not. But you have a much greater chance you will get a sterile device if you know it was cleaned properly.”
To help facilities grapple with these pressing issues, in mid-March, the CDC released its Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing, with the instruction that this document was intended to supplement and not replace or modify manufacturer recommended reprocessing procedures. As the CDC acknowledged, “There is currently very limited information to guide the use of surveillance cultures to assess endoscope reprocessing outside of recognized outbreak settings. Surveillance cultures are not a replacement for appropriate training and oversight of endoscope reprocessing practices. Before initiating surveillance cultures, facilities considering their use should involve key facility staff, including the clinical laboratory director, clinical staff, infection prevention staff, hospital epidemiologists, and risk management staff to develop a plan for implementation, and response (e.g., patient notification) to surveillance culture results.”
Kovaleva, et al. (2013) outline the challenges associated with testing: “Routine microbiological testing for endoscopes and AERs remains a controversial issue in many guidelines. Microbiological surveillance of endoscope reprocessing has been recommended by several medical specialist organizations. It is appropriate to trace contaminations of endoscopes and to prevent contaminations and infections in patients after endoscopic procedures. The use of environmental endoscope culturing is a rapid and simple method to monitor the effectiveness of standard reprocessing procedures. Other organizations recommend microbiological surveillance of flexible endoscopes only in response to epidemiologic investigations when instruments may be microbial sources of healthcare-associated disease transmission or in the case of testing the effectiveness of new or modified cleaning or disinfection procedures. Microbiological surveillance systems have several important limitations. If there is a clinical demand for the reuse of an endoscope, surveillance culture results will not be obtained until after the endoscope is used on the next patient, because culture results take a minimum of 24 to 48 hours to be produced. Efficient sampling of flexible endoscopes and their accessories may be hindered by a complex design, materials, construction, and fragility or by the absence of a standardized sampling protocol or an appropriate technique for sampling of the surfaces and channels of the flexible endoscope.”
New Guidance from the FDA, Other Associations
In mid-March, the FDA announced new actions to enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses. The new recommendations are outlined in a final industry guidance aimed at helping device manufacturers develop safer reusable devices, especially those devices that pose a greater risk of infection. FDA’s guidance document, titled Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, includes recommendations medical device manufacturers should follow pre-market and post-market for the safe and effective use of reprocessed devices.
A device manufacturer’s reprocessing instructions are critical to protect patients against the spread of infections. As part of its regulatory review for reusable medical devices, the FDA reviews the manufacturer’s reprocessing instructions to determine whether they are appropriate and able to be understood and followed by end users. The guidance lists six criteria that should be addressed in the instructions for use with every reusable device to ensure users understand and correctly follow the reprocessing instructions.
The six criteria are as follows:
Labeling should reflect the device’s intended use.
Reprocessing instructions should advise users to thoroughly clean the device.
Instructions should indicate the appropriate microbicidal process for the device.
Reprocessing instructions should be technically feasible and include only devices and accessories that are legally marketed.
Reprocessing instructions should be comprehensive.
Reprocessing instructions should be understandable.
The guidance also recommends that manufacturers consider reprocessing challenges early in device design. Manufacturers will be expected to conduct validation testing to show with a high degree of assurance that their cleaning and disinfection or sterilization instructions will consistently reduce microbial contamination.
“Despite the recent concerns about multi-drug resistant bacteria infections associated with duodenoscopes, patients and health care providers should know that the risk of acquiring an infection from a reprocessed medical device is low” says William Maisel, MD, MPH, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “This guidance is an important step toward further enhancing the safety margin by outlining for manufacturers the steps they should undertake to make their reprocessing instructions effective and clear to the healthcare community that uses them. Doing so should provide greater assurance to patients that the devices used on them are safe and effective.”
The FDA issued a draft guidance discussing the reprocessing of reusable medical devices in 2011, and considered almost 500 comments before issuing the final guidance. The final guidance provides more clarity about testing protocols and what data should be submitted to the agency for a premarket submission, such as the data FDA needs to evaluate substantial equivalence for a 510(k) premarket submission. Manufacturers seeking to bring to market certain reusable devices, such as duodenoscopes, bronchoscopes and endoscopes, should submit to the FDA for review their data validating the effectiveness of their reprocessing methods and instructions.
The FDA also announced in the Federal Register that the agency’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee will hold a public meeting May 14-15, 2015 to discuss recent reports and epidemiologic investigations of transmission of infections associated with the use of duodenoscopes in ERCP procedures in hospitals.
Other guidance on the horizon is an update of its flexible endoscope guidance from the Association of periOperative Registered Nurses (AORN). The guideline’s authors are currently reviewing more than 1,200 papers in the medical literature.
Also coming out this spring is AAMI ST91, Comprehensive guide to flexible and semi-rigid endoscope reprocessing in healthcare facilities. In recognizing the need for additional guidance for healthcare facilities in the reprocessing of flexible and semi-rigid endoscopes, several years ago an AAMI working group decided to expand a technical information report (TIR) into a standard. Members of the Endoscope Reprocessing Working Group had proposed replacing TIR54, Processing of Flexible and Semi-Rigid Scopes, which was still in development, to a proposed American National Standard, titled ST91, Comprehensive guide to flexible and semi-rigid endoscope reprocessing in health care facilities. Initially, the working group had intended the TIR to serve as an educational document to help sterile processing and endoscope processing professionals work through some of the existing—and often conflicting—guidelines. During the group’s work, the document evolved into a format and structure similar to existing standards, and was more than just an education document. Chobin, who is co-chair of the group, explains that the AAMI Standards Board approved the request to upgrade it to a standard based upon the working group’s recommendation. “The working group felt that there was a need to publish a national standard on flexible endoscopes because of all the issues concerning reprocessing of these devices,” Chobin says. She adds that the working group has representatives from AORN, SGNA and APIC, all of which have examined the scientific evidence behind the recommendations in the document. “This document will set a standard of care for their practice,” Chobin says. “Facilities will now have a single source to reference for their flexible endoscope reprocessing practices. Manufacturers will also understand the standards facilities need to meet and will be able to help them in terms of education and products.” Interested individuals should check the AAMI webpage at www.aami.org for information when the new document is available for purchase.
The Reprocessing Challenge: The Experts Weigh In
Kovaleva, et al. (2013) summarize the challenge that SPD professionals face: “Flexible endoscopes may become heavily contaminated with blood, secretions, and microorganisms during use. These instruments are difficult to clean and disinfect and easy to damage because of their complex design, with narrow lumens and multiple internal channels. If the instruments are not properly cleaned, the disinfection and drying procedures can fail and increase the possibility of transmission of infection from one patient to another. In addition, the ability of bacteria to form biofilms in the endoscope channels, especially when these become damaged, can contribute to failure of the decontamination process … Since almost all outbreaks are related to breaches in reprocessing techniques, it is crucial that endoscope cleaning, disinfection and drying are performed according to a strict protocol.”
Those protocols were among the processes scrutinized in October 2011 during a summit convened by AAMI and the FDA in which stakeholders from all aspects of medical device reprocessing discussed the most pressing issues. Out of that summit came seven clarion themes:
1 Gain consensus on “how clean is clean” and on adequate cleaning validation protocols for reprocessing reusable medical devices.
2 Create standardized, clear instructions and repeatable steps for reprocessing whenever possible.
3 Pay early, iterative and comprehensive attention to reprocessing requirements throughout the device design process.
4 Make human factors and work environment factors priorities when developing reprocessing requirements.
5 Improve information collection and sharing to broaden the use of best practices in reprocessing.
6 Improve reprocessing competencies by strengthening training, education and certification.
7 Create a greater sense of urgency and understanding throughout the healthcare community about the consequences of inadequate reprocessing.
One expert points to what she perceives as a dismal lack of momentum since that 2011 summit. “We should be embarrassed,” says Cori Ofstead, MSPH, president and CEO of Ofstead & Associates, Inc., a multidisciplinary team that specializes in designing and conducting real-world studies to validate healthcare guidelines and product claims “That was four years ago and we have made no progress. Clarion theme No. 7 says to create a sense of urgency — well, here we are, facing another outbreak. The only progress that has been made is that by the media and the legal system jumping all over this, not by people who should be taking the lead in addressing these issues. It’s unfortunate that in public health, to get the attention, funding and prioritization necessary, you have to have a disaster — and here we are.”
Let’s take a look at some of these clarion issues more closely.
Clarion issue No. 1: Without definitive data, the concept of clean remains highly subjective. As Swenson (2015) notes, “When it comes to cleanliness there is no current consensus on how to measure cleanliness or what level of cleanliness is acceptable. Sterility is typically defined as acceptable if the process results in a sterility assurance level (SAL) of 10-6. This SAL can only be reached if the device is adequately cleaned first. This point cannot be stressed enough. Recently there have been problems in which devices that were not adequately cleaned were disinfected and then these devices resulted in patients getting an HAI. Choosing to sterilize these devices does not address the issue of inadequate cleaning. If a device is not clean then sterilizing it will not necessarily result in a sterile device. If during the cleaning process the microbial contamination on the device is not reduced to a level low enough for the sterilization process to work, then the device will not be sterilized. Both disinfection and sterilization rely on adequate cleaning. Sterilization does not override inadequate cleaning.”
“It will take years to develop a definition of what is clean in terms of medical devices,” says Swenson. “Outside of a very small handful of people, not a lot of research has been conducted. The definition of clean is years away.”
If we can’t yet define clean, we certainly can strive toward clean… or can we?
“We haven’t heard much since that arthroscope-related outbreak and I think it’s because we developed inspection techniques to be able to really determine if they were cleaned,” says Swenson. “Things like lighted magnifying glasses and lighted cameras with magnification have made a tremendous difference. A duodenoscope tip has semi-enclosed spaces that are going to be extremely difficult to get to, so how are you supposed to clean it? I’m not sure just looking at it, how you would redesign it so that it’s easier to clean and it would still function as it is supposed to.”
“Devices like ERCP scopes are extremely difficult to get clean, and so that is problematic,” Ofstead says. “We need to think about whether reprocessing techs can get things clean effectively and efficiently. My concern is that in a lot of these outbreaks it has been documented that techs have followed guidelines and protocols, so we can’t point to faulty reprocessing or bad behavior by techs. But I am certain that the guidelines don’t go far enough; they don’t provide the level of specificity or clarity needed, and there are so many contradictions between guidelines and the IFUs. For example, if it says clean something until there is no visible debris — well, we know that you can’t actually see microbes and you also can’t really see minute amounts of protein or blood. We should be smart enough to not have guidelines that say ‘clean something until you can’t see it.’ We know endoscopes are highly contaminated during use — we’re talking billions of microbes.”
Kovaleva, et al. (2013) confirm that scopes are dirty: “Natural bioburden levels detected on flexible GI endoscopes range from 105 CFU/ml to 1,010 CFU/ml after clinical use. Cleaning must precede HLD or sterilization to remove organic debris (e.g., blood, feces, and respiratory secretions) from the external surface, lumens, and channels of flexible endoscopes. Inadequate cleaning of flexible endoscopes has been frequently associated with microbial transmission during endoscopic procedures. Appropriate cleaning reduces the number of microorganisms and organic debris by 4 logs, or 99.99 percent.”
Clarion issue No. 2, which emphasizes standardized instructions, and Clarion issue No. 3, which indicates attention to reprocessing requirements throughout the device design process, are critical, according to Susan Klacik, BS, CRCST, ACE, FCS, CIS, the CSS manager at St. Elizabeth Health Center in Ohio and the International Association of Hospital Central Service Management (IAHCSMM) representative to AAMI. “I think what would help is the cleaning aspect of disinfection and sterilization process being addressed as part of the overall design of the medical device,” she says. “Everyone is talking about providing sterile processing personnel with more information, better training and improved competencies, and that’s what we need because the devices we see today are far more complex than ever. It’s no longer just the flat-hinged stainless steel instruments, we’re doing miraculous medical procedures now and the instruments that are used are extremely complex and difficult to clean. Manufacturers of these complex devices should partner with CSS to provide training. The objectives of both CSS and the manufacturer are fully aligned; we both want the medical device to perform exactly as it was designed and intended to every time, and the CSS tech is the last person to handle the medical device before it is opened for use on a patient. It takes a higher level of competency to process those instruments.” Klacik continues, “When I think of the inspection process in the old days it would be looking at a stainless steel instrument and saying, ‘Oh, it’s clean.’ Now, so many devices have lumens and channels with areas that we can’t visualize, and so the marketplace is now offering quality-monitoring tests and testing devices that are looking for protein and carbohydrates and other indicators of debris that has not been removed. It’s a sign for the profession that we are heading past mere visual inspection. With these complex devices we really need to go to the next level. Some people are still thinking it’s still the old days of simple instruments and we are so far beyond that now. Hospital administration must give us more resources for education and training, and we need the time to takes to perform our tasks properly — we can’t have people cutting corners.”
As Swenson (2015) writes, “In some cases it has been documented that the IFU for cleaning was not followed, causing a device to not be sterilized; and resulting in a healthcare associated infection (HAI). In other cases there are issues with following the IFU. Problems with cleaning medical devices include: the IFU is difficult to understand, the IFU is incomplete, the IFU is difficult (if not impossible) to follow, the person performing the cleaning process was not adequately trained, and the person performing the cleaning process did not follow the process. The format for creating an IFU is not standardized. This makes it difficult for reprocessing personnel to follow IFUs. When the steps for reprocessing seem to jump around it is difficult for a person to keep straight what he/she is to do. Potentially steps are missed because of the lack of standardization. IFUs for virtually identical medical devices made by different companies can be very different which makes it difficult for reprocessing personnel to remember how to process a particular device.”
Klacik says that Clarion issue No. 4, making human factors and work environment factors priorities, will be addressed with the publication of the aforementioned AAMI human factors-related TIR. “It will help manufacturers understand some of the issues that we have with medical device reprocessing,” she says. “Human factors is still a fairly new concept to a lot of people in healthcare, so we need to get more experience and more traction with it over time. Essentially human factors in the SPD relates to things like how it’s difficult to clean some of these devices just because of their design. It’s also factors like being in the decontamination room with limited communication to the other side, interruptions, or trying to follow IFUs when they are not clear — that’s on the manufacturers to provide.”
Clarion issue No. 6, which addresses reprocessing competencies, highlights the great need for improved education and training for SPD personnel. “I really hope those of us involved in infection prevention will take a more proactive stance and support the certification of sterile processing staff,” says Ofstead. “I would also like to see the professionalism of the role elevated, because we should honor them as much as we do other healthcare professionals. We have certified nursing assistants, but we don’t have a universal requirement for the technicians responsible for the key function of reprocessing to be professionally trained and certified.”
“If you want highly skilled employees that are always going to do things meticulously and follow instructions and do it right, you need to train them and you need to pay them accordingly,” Swenson emphasizes. “You can’t expect to have people doing precise functions like that and pay them like they are a step above housekeeping. They should be paid like the OR techs. I think it goes to the lack of academic credentials. The other professions just don’t look at sterile processing as a profession when you hire people off the street and teach them on the job.”
Klacik concurs that education, training and certification is essential: “There are at least 120 steps to process scopes, and so it’s a reminder of how critical certification of demonstrated competency is,” she says. “It should be mandated, emphasizing how vital it is to follow the IFUs and using the correct tools and chemistries in the proper way.”
“There are people who are certified and probably still don’t do a great job, so it’s not a magic bullet,” says Cynthia Spry, RN, MS, CNOR, an independent consultant in New York. “But it is a step toward doing what you do better, and it says you care. I think certification is a good thing.”
Swenson says sterile processing education and training must be elevated, but this can be hampered by the lack of a defined academic credential for what constitutes an adequate, let alone a progressive, sterile processing program. “I know people who are certified who have never set foot inside of a sterile processing department — how can that be?” Swenson asks. “It’s possible. People can go take a class, learn the concepts and theories, take and pass a test, and they are certified. I have interviewed people who are excited about getting into the field and couldn’t tell me the difference between a needle-holder and a clamp. Again, how can this be? We can’t push certification without establishing what the academic credentials should be. Otherwise, we will have people who are certified yet they can’t tell you the difference between two basic instruments. There are people who are becoming certified who don’t know the basics; they understand the theory but they see no more than a picture of a sterilizer and they have never seen the products you put into it and they have never actually loaded one.”
Swenson says she is in the process of starting her own sterile processing educational program as part of the launch of her own company last year. She says her program will offer classroom instruction supplemented with 200-plus hours of clinical lab time.
Even if every SPD tech were certified, some experts say the onus is on manufacturers to do everything they can to improve their devices’ ability to be cleaned and to improve their biocompatibility with the chemistries used for high-level disinfection and sterilization. Kovaleva, et al. (2013) outlines the challenges that medical device materials may pose to the disinfection and sterilization process: “Due to their material composition, most flexible endoscopes cannot be steam sterilized. They tolerate ethylene oxide and hydrogen peroxide plasma sterilization, which are expensive and are not preferred by most institutions. Ethylene oxide and hydrogen peroxide plasma sterilization have rapid and reliable efficacy compared to HLD; however, both sterilizers destroy chemical, biological and mechanical properties of instruments, including flexible endoscopes. Gas sterilization with ethylene oxide may fail in the presence of organic debris after inadequate cleaning and when biofilm has settled in internal endoscope channels.”
Spry points to a complex set of factors that complicates the issue. “ERCP scopes are marvelous diagnostic and therapeutic tools but they do not facilitate cleaning, and effective cleaning is critical,” she says. “If you look at the studies on the number of steps involved in processing a scope, and the number of steps that are missed, probably the majority of scopes are not reprocessed exactly according to recommended practice. That is operator error, but I also think it’s a design issue — these devices are not designed with cleaning in mind. Unfortunately, we have to wait until someone dies for this to be addressed again, especially because it’s something the healthcare community has known for a long time. I cannot believe that we can’t design devices that can be cleaned better, either some part of it that is disposable or removable. It’s a built-in obstacle to getting the cleaning done right. Think about laparoscopic instruments — we started with instruments that could not be taken apart and when you did actually disassemble them, you saw how filthy they were. Then we had a second generation of instruments where they came apart partially, and now we need something even better — I’m sure manufacturers are working on it but it should be an imperative.”
“I think the emphasis should be on not redesigning the endoscope, but designing a better cleaning process that works,” says Swenson. “There was a time when medical device manufacturers didn’t necessarily even think how you were going to clean, disinfect or sterilize their devices. It wasn’t high on their priority list or something that was well understood. Many medical devices were designed by doctors for whom cleaning and disinfection is not their forte. And they worked with instrument companies which weren’t familiar with cleaning processes. So devices were manufactured that were next to impossible to clean. I’m thinking we need to do more to investigate the cleaning process, not necessarily redesigning the device to make it easier to clean. When it comes to some endoscopes how do you get something that’s going to be flexible yet comes apart so you can clean it, and at a cost we could afford?”
As Swenson (2015) writes, “Medical devices are sometimes developed to perform a particular function. During the manufacturing design phase emphasis is placed on two things: how to make a device that will perform as desired and what materials should the device be made from so that it will perform as desired. Unfortunately some devices have been designed without considering how the device will be reprocessed, disinfected and/or sterilized after it is used. This has resulted in device designs that are very difficult to clean, disinfect and/or sterilize. One only needs to look at the early designs for laparoscopic instrumentation, Kerrison rongeurs and the current duodenoscope (to mention a few devices) to find a good example of this problem. Today laparoscopic instruments and Kerrison rongeurs are being designed with cleaning and sterilization in mind and the new devices are much easier to clean. Unfortunately many of these early design laparoscopic instruments and rongeurs are still being used. Another aspect of a design problem involves developing a reprocessing procedure that is difficult to follow. Some IFUs state that the medical device is supposed to be disassembled, then brushed with a small brush and at the end of the process reassembled. This can be difficult, if not impossible, when wearing protective attire. Decontamination gloves that provide adequate protection from sharps injury do not usually provide for being able to manipulate small components easily. Human factors need to be considered when designing a cleaning, disinfection or sterilization process.”
As Spry observes, “What came out of that AAMI/FDA summit in 2011 was an appreciation for the significance of cleaning. Everyone knows that if you can’t clean it, you can’t sterilize it — it’s a mantra by now, and it has changed the way we look at what previously was just one more step before the sterilization which was the big focus. Now we know that cleaning is key but we haven’t gone far enough. There are numerous tests with which we can monitor cleaning efficacy, but I think we need more guidance about when and how you test. They all have benefit, if they work, but they are all different and so you need to know which tool to use for your surveillance. Just telling people they should do periodic surveillance is not enough. We also need better and more precise guidelines that address unresolved issues. For example, there is no guidance on hang time for scopes — there are some studies out there, but not enough where we can say specifically you should hang it for a certain amount of time. We need additional research so we can give people more specific guidance.
Looking to the Future
It’s going to take a collaborative effort to achieve AAMI’s seven clarion themes, says Swenson. She points to the various stakeholders — regulatory agencies, manufacturers and reprocessors of medical devices, standards-setting organizations and test labs — that must work in concert if inadequate medical device reprocessing that contributes to infections is to be addressed and resolved. As Swenson (2015) writes, “The many stakeholders involved in this problem need to share the responsibility of ensuring that reprocessing procedures work and are followed. This process starts with the manufacturer of the medical device. When medical devices are developed the company has to submit the device for approval by the FDA before the device can be legally marketed in the U.S. When developing a reusable device the manufacturer needs to prove that the device can be adequately cleaned and if needed disinfected or sterilized. After developing the reprocessing steps that need to be taken the manufacturer needs to validate those steps and then needs to write the IFUs for the device user to follow. The processes for cleaning, disinfection and sterilization are frequently developed in conjunction with a test lab. Under laboratory conditions the test lab will verify and/or validate that the cleaning, disinfection or sterilization process is effective and achieves the goal of producing a cleaned, disinfected and/or sterilized device. All of this information is submitted to the FDA as part of the device approval process. The FDA will review the reprocessing verification information, validation information and IFU and will either approve, disapprove or request more information. Once a device is approved the manufacturer is allowed to sell the device in the market place. The facility or person who purchases that device is then responsible for following the IFU.”
Swenson observes, “What should be done will be difficult. And when does this become what you must do instead of what you can do if you want to? I don’t know if it really should become what you must do, but I do think something needs to be done to get everyone on the same page, because right now we are not.” Swenson continues, “People don’t realize there is a lot more going on behind the scenes that the general public doesn’t know about. I personally am encouraged by what I have seen in the last few years. I have been involved in AAMI for a long time and I am encouraged by what I see AAMI doing; I am also encouraged with what IAHCSMM is doing, too. Like many things, until we have some successes to show for it, it’s going to be difficult for others to get excited about it. We must be realistic — Is it all going to happen so that next year we won’t see any of these outbreaks again? No. I wish that weren’t the case. But we have to start somewhere.”
That somewhere, according to Swenson, is right now, with organizations developing standards that all stakeholders can follow, and manufacturers including cleaning, disinfection and sterilization as part of device design. Test labs are working to simulate real-world scenarios when developing cleaning and sterilization processes. And the FDA is examining more closely various reprocessing issues when approving reusable medical devices. As Swenson (2015) writes, “While these efforts are encouraging there is still the problem of devices that already exist and that continue to be sold. For these items device reprocessors need to be diligent to ensure that the devices are being adequately cleaned. This can be done by ensuring that manufacturer’s IFUs are scrupulously followed. Emphasis needs to be placed on ensuring that employees perform return demonstrations to show that they understand how to perform a particular cleaning procedure. Devices need to be closely inspected after cleaning. There are many inspection devices available today, e.g., lighted magnifying glasses, magnifying cameras, telescopes for looking inside lumens, etc., which can be used to ensure devices are visibly clean. If a device is not visibly clean then it should not be disinfected or sterilized. If following the manufacturer’s IFU does not result in a visibly clean device, this should be reported to the healthcare facility’s infection control and risk management departments. Potentially this also needs to be reported to the FDA. Risk management usually makes that decision. In addition to inspecting devices for visible cleanliness the cleaning process should be subjected to cleaning verification. There are many products available today that can be used to verify that a device is clean and/or that a cleaning machine functions correctly. A comprehensive cleaning verification process needs to be part of the overall cleaning process for all devices. Finally, more needs to be done to provide quality education, training and certification for the people who are expected to reprocess medical devices. Reprocessing of medical devices is a difficult, complex job that needs to be recognized as such. More hospitals are now requiring the sterile processing staff to be certified but if we expect to have universal practices and adherence to complex procedures we need to have certification required by all healthcare facilities.”
ASGE. Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes: 2011.
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