November 10, 2021

Testing is the only way to ensure the complex devices are being cleaned properly.

CREDIT: Dartmouth-Hitchcock Medical Center
ERROR OPPORTUNITIES Failure points can take root in unexpected places under the rigorous and exacting protocols for endoscope reprocessing.

Recent FDA investigations of post-procedure infections and contamination issues involving endoscopes have reignited efforts to reprocess the devices properly.

"We've been performing risk assessments, educating teams and investing in enhanced reprocessing equipment for years to meet the many challenges involved in cleaning and high-level disinfecting these devices," says Alison Sonstelie, BS, CRCST, CIS, CHL, sterile processing lead coordinator at Sanford Health in Fargo, N.D., and president of NoCoast Consulting. "With this new round of attention, it will be helpful for administrators to refocus on basic reprocessing steps and identify potential gaps in the process."

Ms. Sonstelie lays out this roadmap:

Risk assessment. "Shadow your facility's reprocessing steps from start to finish, and solicit feedback from the frontline team members about the process," she says. "Observe bedside cleaning, manual cleaning and disinfection/sterilization practices, and compare them to your standard operating procedures and competencies." She suggests creating a multidisciplinary team to perform the risk assessment, and implementing a formal process, education plan, visual guides, checklists, points of contact and a monitoring plan.

Leak detection. "Leak testing has an important role in infection prevention because it can detect damage to the scope that may lead to fluid invasion, which increases the risk of cross-contamination," she says. "Unfortunately, it is one of the most misunderstood and frequently missed steps in endoscope reprocessing. Catching damage early will help lower the risk of cross-contamination and hopefully reduce repair costs." Automated leak testers, she adds, can help detect minor damage that may be missed during a manual leak test.

Cleaning confirmation. Adenosine triphosphate protein (ATP) testing helps to verify the effectiveness of the endoscope cleaning process. "The presence of ATP in a ‘clean' endoscope is an indicator that potentially pathogenic material is still present," she says. "To develop and implement a testing program, determine which endoscopes you'll monitor, the testing frequency, the pass-fail threshold and a standardized way to track results for process-improvement purposes."

Ms. Sonstelie says incorporating a verification program into your current practices can better identify trends and gaps in cleaning and disinfecting processes. Be sure to have a backup inventory of scopes available in the event contaminated scopes need to be removed from service, she adds.

"Endoscopes will continue to be challenging devices to reprocess," says Ms. Sonstelie. "It's imperative to first understand the standards, guidelines and best practices, and implement enhanced cleaning and disinfecting processes as needed. The ability to adapt to new recommendations and technology is the most effective way to prevent endoscope-related infections and ensure safe patient care."

Surgical leaders share three hacks that improve infection prevention efforts and operational efficiency.

CREDIT: Carson McCafferty
QUICK NOTE Providers at Eye 35 use a very simple tool to let reprocessing techs know when certain instruments need extra care.

Even when reprocessing protocols are robust and comprehensive, savvy surgical facilities are always looking to enhance them with minor tweaks that can pay major dividends. Three surgical leaders recently shared their great ideas.

Heads-up notes. Reprocessing techs at outpatient ophthalmic facilities don't deal with grossly contaminated instruments very often, but they need to be aware when such instruments need special attention. Eye 35 ASC in Schertz, Texas, simply but effectively uses a "heads up" system. "Enzymatic detergents aren't typically used on ophthalmic instruments, but when we perform cases such as pterygium excisions or some corneal procedures, the instruments need a deep clean," says infection control nurse Karen Dargan, BSN, RN, CNOR. In these situations, Eye 35 nurses include handwritten, disposable note cards that say "Use Enzymatic" in trays of soiled instruments that require it.

Countdown tech. Guidelines say dirty scopes should sit for no longer than an hour before reprocessing begins to prevent bioburden from hardening on the devices. OR teams at Baystate Medical Center in Springfield, Mass., let reprocessing techs know exactly how much time has elapsed by sticking small, single-use time strips to the tops of scope transport containers. Staff simply push an activation blister on the strips to begin a 60-minute countdown. "The strips take the guesswork out of knowing how long scopes sit idle after procedures and help to improve reprocessing practices," says Michael Gudejko, BS, MHA, former regional director of surgical support services at Baystate, who recently became director of operations for perioperative services at Tufts Medical Center in Boston.

Checklists. Reprocessing techs at Rogue Regional Medical Center in Medford, Ore., who prepare instrument sets use a seven-point checklist to ensure trays have been properly loaded and organized with chemical indicators in place. The assembling tech initials the form, and then a second reviews the conditions of the tray and signs their name on the "quality check" line if all elements on the checklist have been completed. The sheet is sent with the instrument set to the OR, where members of the surgical team can add their own feedback about the condition of the instruments, which is then shared with reprocessing staff. A leader at the center described the system as sterile processing's version of the surgical time out.

These three scenarios serve as a reminder that optimizing the process of reprocessing is a job that's never finished, but can be enhanced by sober situational analysis and creativity.

Help reduce patient risk by simplifying, standardizing and streamlining your facility's sterility assurance program.

Credit: 3M
3M Sterilization Assurance Monitoring, 3M Company.

Credit: 3M
Susan Flynn, BESc, CSPDT.

The daily demands in an OR facility never stop as the entire team is focused on keeping patients safe throughout the surgical journey. Patients exposed to contaminated instruments are at risk to develop surgical site infections. The risks are real with the following presented statistics: 1 in 31 hospital patients has an HAI¹ and a single SSI can cost up to $60,000 per patient.² This exposure risk, plus the rise of antibiotic-resistant bacteria and hard-to-clean medical instruments and devices, make the role of the Sterile Processing leaders especially critical.

The important role these healthcare professionals play involves training new staff, making sure every sterilization load is verified and staying in compliance with government regulations and industry standards. But no matter what challenges arise, there are solutions including critical training tools, advanced sterilization monitoring technologies, workflow strategies and experts to look to for guidance to help your facility be confident with your sterility assurance processes and help standardize workflows.

Reducing patient risk and advancing patient safety requires a unified force and the highest level of care possible. 3M has been helping Sterile Processing (SP) departments and healthcare facilities overcome the challenges they face for over 70 years with a holistic approach to sterilization assurance. The 3M^™ Sterilization and Cleaning Monitoring Program aims to help take a facility's monitoring practices to the next level. By implementing processes that support Every Load Monitoring and Cleaning Monitoring, an elevated patient-first mentality helps reach the goal that every healthcare facility strives to attain.

Four levels of support help make the dual goals of patient safety and the highest level of care possible. These include:

Sterilization assurance. 3M offers a comprehensive product portfolio that provides sterilization assurance monitoring solutions across three modalities: steam, vaporized hydrogen peroxide (VH2O2) and ethylene oxide (EO) with consistent equipment, interfaces and support to help reduce the risk of human error and help teams work more effectively. An industry leading technology, the 3M^™ Attest^™ Biological Indicator system helps ensure patients receive a high standard of care — no matter what sterilization method is used.

Cleaning monitoring. Your healthcare facility's reputation and patient safety are on the line when confronting the dangers of inadequately cleaned surfaces, endoscopes and other devices. The 3M^™ Clean-Trace^™ ATP Monitoring System provides rapid, real-time results and quantitative data and reporting to help you identify problem areas and develop more effective cleaning processes.

Digital monitoring and tracking. As real-time data accessibility and electronic record-keeping become more important to workflow and process optimization, 3M offers multiple ways for your data to be tracked and recorded. These include the 3M^™ Attest^™ Auto-reader Web App for real-time BI status and results and for digital record keeping; connectivity to select instrument tracking software systems; and cleaning monitoring quality management software for performance optimization.

EO sterilization. For the last 50 years, 3M has provided safe, effective ethylene oxide (EO) sterilization and abatement solutions. EO is the traditional gold standard for low-temperature sterilization for heat- and moisture-sensitive devices. The ability to penetrate complex medical devices and long lumens without condensing or decomposing and its excellent materials compatibility are the basis for its long-term use in both hospital and industrial sterilization practices.

With a mission of aiding facilities to become standardized, simplified and streamlined in their sterility assurance programs, 3M offers consistent equipment, interfaces, supporting materials, processes and training to help reduce the risk of human error and help teams work more effectively — along with 70 years of sterilization assurance experience. 3M backs its sterilization assurance technology and products with teams of technical and support experts including field-based clinical specialists and customized on-site education (with or without CE) when it matters the most. Additionally, sterilization professionals can access the SterileU Program (https://www.3m.com/3M/en_US/medical-us/3m-medical-education/), an online education site that offers CE webinars and videos. Ultimately, it's all about helping sterilization departments support patient safety.

Note: For more information, please go to https://www.3m.com/3M/en_US/medical-us/ambulatory-care/?utm_term=hcbg-msd-ooh-en_us-pa-epet-ona-adv-osm-learn-na-oct21-na

Susan Flynn is a Technical Applications Specialist with 3M's Medical Solutions Division in St. Paul, Minn. Her role at 3M includes providing education for customers and sales personnel on improving the performance of the sterilization process and implementing best practices. Susan is a Certified Sterile Processing and Distribution Technician (CSPDT) and a member of several AAMI Sterilization Committee working groups, AORN and IAHCSMM. Susan regularly speaks and writes self-study articles on topics related to device reprocessing.

Sampling scopes for residual bioburden is effective, but often not performed at the proper time.

The most difficult, and in many ways, the most crucial aspect of endoscope reprocessing is the manual cleaning performed by techs before the scopes are placed in an automated endoscope reprocessor (AER). Many facilities operate under the assumption that the AER will take care of bioburden the tech may have missed. According to Michelle Alfa, MSc, PhD, FCCM, president of AlfaMed Consulting in Winnipeg, that's a faulty assumption that could lead to contaminated scopes being used on patients.

Dr. Alfa says the manual cleaning stage is often compromised by surges in volume and the resulting pressure on techs to turn around scopes more quickly than anyone would prefer. "They know they have to speed up, so instead of doing all the steps meticulously 100% of the time, they sometimes cut down on the steps. For example, instead of brushing the channel three times they brush it one time."

That compromise, combined with the fact that many facilities don't monitor how well manual cleaning is performed, can lead to dangerous failures in the reprocessing system. Even in cases where the tech follows all of the steps, they still could miss something. "If you don't do the manual cleaning properly, the high-level disinfection isn't going to work properly," says Dr. Alfa. "The detergent will fix any organic material that hasn't been cleaned away onto the inner and outer surfaces. Over time, repeated rounds of that results in build-up."

To determine the effectiveness of manual cleaning, rapid tests such as adenosine triphosphate (ATP) are helpful. Scopes that fail the tests should be immediately recleaned manually before being placed in the AER, says Dr. Alfa. "Techs often want to do the testing after the scope comes out of the AER, but that's not the appropriate time," she says. "The test is not a way to assess whether the endoscope is free of microorganisms. It's a good way to monitor if the organic material from the patient procedure has been adequately removed by cleaning."

Some techs and supervisors in a reprocessing area say they don't have time to test scopes, but once they start doing the testing and realize they are not cleaning some of them properly, it opens their eyes, according to Dr. Alfa, who notes that loads of organic material in scopes can vary widely by individual procedure.

Dr. Alfa calls testing a quality systems approach that provides valuable feedback to techs about their manual cleaning practices. "I've been in reprocessing areas and asked the techs if they think their cleaning is adequate for the endoscopes they're reprocessing," she says. "They all say ‘Yes, we're doing a thorough job,' but they don't really know if they are or not if no monitoring is done."

They're superior to blue wrap, but one size does not fit all scenarios.

Rigid sterilization containers are reusable and eco-friendly. They protect instruments from damage much better than blue wrap does. They're stackable for easy storage.

Not all rigid containers are created equal, however. Nancy Chobin, RN, AAS, ACSP, CSPM, CFER, president of Sterile Processing University in Lebanon, N.J., offers these insights for administrators who are evaluating the various models available:

Specifications. Go beyond the flashy marketing brochures and dig into the details. "The onus is on you to read through the technical data of each container carefully, and make sure you understand whether you can actually use it for the instruments you need to reprocess," says Ms. Chobin, who recommends also ensuring the container meets relevant standards from the Association for the Advancement of Medical Instrumentation and the Association of periOperative Registered Nurses. "Learn about each container's validated cycles and ensure they were properly tested and approved by the FDA for the cycles your facility needs to run, and verify if it has been validated to hold silicone mats, surgical towels, lumens or power equipment," she adds.

Inserts and accessories. The container should match up with the instrumentation and devices you use regularly including video cameras, which need to be appropriately secured. "Many vendors offer specialty-specific trays and inserts that help you line up and organize instruments, cords and cables," says Ms. Chobin.

Ease of use. OR staff members and sterile processing techs should try out the containers before you purchase them. "How easy is it for surgical team members to open a container and remove the contents aseptically?" says Ms. Chobin "Can sterile processing techs easily disassemble the components, remove filter plates and clean them between uses?"

Cleaning requirements. Examine the IFU of each container for information on proper cleaning methods, which typically involve treatment with a neutral pH detergent and water either manually or in an automatic washer. "Consider how much workload and time are involved in cleaning each container," says Ms. Chobin.

Instrument identification. If your facility will use instrument identification tags on internal baskets and on the outside of the containers, make sure the tags are durable and easy to read. Adds Ms. Chobin, "Find out how long it takes to get replacements from the container company if the tags become dislodged and lost or damaged."

Sterilization testing. "Run the container through cycles with biological vials and chemical indicators in place to verify sterilization parameters are reached," says Ms. Chobin. "Manufacturers test their containers in a controlled lab setting, but you need to confirm the containers work effectively in your facility." Staff must receive education on the quality checks as recommended by the manufacturer after each use, as containers become damaged over time.

If your budget is limited, Ms. Chobin recommends buying containers to protect your most delicate and expensive items.