August 25, 2021

Provide the necessary education, tools and equipment for hardworking staff.

Knoxville Orthopaedic Surgery Center
GO WITH THE FLOW One way to optimize efficiency in sterile processing departments is to house washers near decontamination sinks.

Every sterile processing department knows the importance of diligent disinfection and sterilization of the instruments used by surgeons and physicians, but that doesn’t mean they have everything they need to properly do their job.

"Sterile processing technicians are thirsty for knowledge about how they can best perform their jobs, and how they fit into the patient care continuum," says Casey Czarnowski, BA, CRCST, CSPDT, CIS, CER, interventional platform educator for sterile processing at Stanford (Calif.) Health Care. "It's our job as leaders to make sure they have the tools and resources they need to properly clean and sterilize instruments. That includes making sure they have easy access to instructions for use, safety data sheets and the facility's reprocessing policies."

Updates and reviews on proper instrument care should be ongoing, and leaders should offer refresher courses on how to find and access this information. "That way, when new processes or instruments come into the department, reprocessing technicians can assimilate them rapidly, and can find the references they need when necessary," says Mr. Czarnowski.

He adds that it is also important to pay attention to your facility's instrument flow. "An efficient SPD moves dirty instruments in one direction from the cleaning and decontamination area to sterilization and then finally into storage," he says. No single area in the department is more important than another. "For example, proper use of cleaning chemicals in the decontamination area ensures instruments are free of gross soil that prevents proper sterilization and safe to handle during inspection."

Consider implementing a surgical instrument tracking platform, which can keep tabs on surgical instruments from use in surgery through the sterilization process and the return to ORs. "This technology helps SPD managers understand throughput and volumes, and how these numbers fluctuate significantly throughout days, shifts and weeks," says Mr. Czarnowski. "They provide precise data on when the greatest volume of instruments arrives in the department, so they can staff up or down as needed."

Instrument surfaces that aren't properly cleaned can’t be properly sterilized.

Pamela Bevelhymer
FIRST THINGS FIRST Instruments should be cleaned before receiving low-temperature sterilization.

Soiled instruments jeopardize the effectiveness of low-temperature sterilization, says a team of researchers at the University of North Carolina at Chapel Hill. The researchers tested the effectiveness of steam sterilization and vaporized hydrogen peroxide, ethylene oxide and hydrogen peroxide gas plasma on simulated surgical tools contaminated with bacteria commonly found in healthcare settings — Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus, vancomycin-resistant Enterococcus, Mycobacterium terrae, or spores of Bacillus atrophaeus, Geobacillus stearothermophilus or Clostridioides difficile.

The sterilization failure rate was 76.3% in vaporized hydrogen peroxide and 1.9% in ethylene oxide and hydrogen peroxide gas plasma, according to the findings, which were published in the journal Infection Control & Hospital Epidemiology. Steam sterilization had no failures.

William A. Rutala, PhD, MPH, director of the North Carolina Statewide Infection Control and Epidemiology Program and lead author of the study, says sterilization technology is capable of killing billions of microorganisms on instruments, but low-temperature sterilization can be rendered ineffective if instruments are improperly cleaned before cycles are run.

Decontamination can be difficult to perform properly on complex instrumentation, some of which is heat sensitive and requires low-temperature sterilization. "Sterilization failure is possible if instruments are not properly cleaned before being placed in a low-temperature sterilization technology," says Dr. Rutala. "Effective cleaning, and the removal of visible soil and microbial contaminants from objects, must precede sterilization to ensure tools are thoroughly and optimally sterilized."

In times of uncertainty, there’s little room for error and a real need for "real-world" reprocessing.

Concerning evidence exists that endoscope reprocessing may frequently be error-prone, ineffective and potentially represent danger of contamination exposure to patients. In a recent publication in the American Journal of Infection Control, Cori L Ofstead, MSPH, examined the challenges in achieving effective high-level disinfection in endoscope reprocessing.¹ He detailed multiple potentially alarming points of failure repeatedly observed during real-world endoscope reprocessing scenarios.

According to Ofstead, these factors represent hidden points of failure that may contribute to ineffective endoscope reprocessing:¹

• Human factors contributing to non-adherence to guidelines, standards and manufacturer instructions for use (IFU)
• Clinical use of endoscopes with visible damage
• Use of products that may interfere with reprocessing
• Presence of residual soil after manual cleaning
• Rinse-water quality issues
• Retained moisture in fully reprocessing endoscopes

Examples of improper high-level disinfection (HLD) practices observed by Ofstead's team included use of expired products, improper HLD temperature, inadequate testing for the minimum effective concentration of HLDs and improper storage of MEC test strips.

On alert

The pandemic has put everyone on alert to the implications of ineffective endoscope reprocessing. According to the World Health Organization (WHO), SARS-CoV-2 airborne transmission may be possible in procedures or support treatments that produce aerosols such as endotracheal intubation and bronchoscopy. Airborne transmission is different from droplet transmission as it refers to the presence of microbes within a droplet nuclei – and these can remain in the air for long periods of time and be transmitted to others at a distance greater than one meter or 3.28 feet.²

The risk of infection resulting from improper reprocessing of endoscopes is causing alarm among leaders in pulmonology and otolaryngology.¹ The SARS-CoV-2 virus has a lipid envelope structure that makes it more resistant to cleaning by enzymatic detergents.³

Endoscopes must be disinfected, according to manufacturer IFUs, after pre-cleaning by detergent. Due to the resistance of the virus to pre-cleaning, it decreases the safety margin to achieve appropriate HLD. While HLD is an acceptable reprocessing modality of semi-critical endoscopes such as bronchoscopes, there is evidence for the consideration to shift from HLD to sterilization of these scopes.

The case for sterilization

Given the implications regarding potential hidden points of failure in high-level disinfection of flexible endoscopes, it is possible that infection control teams in facilities are considering the option to sterilize flexible endoscopes where feasible. The difference between sterilization and HLD is the fact that a sterilization process must inactivate a broad spectrum of microorganisms, including resistant bacterial spores, whereas HLD eliminates microorganisms but not bacterial spores.⁴

ASP STERRAD^® Sterilization Systems use low-temperature hydrogen peroxide gas plasma to terminally sterilize a wide range of instruments. The STERRAD NX^® System and STERRAD^® 100NX System offer a technology capable of penetrating long and narrow lumen, yet gentle enough to reprocess delicate and heat-sensitive instruments such as flexible endoscopes.

ASP STERRAD^® Systems technology, coupled with ASP’s robust device validations "worse-case" methodology, provides the margin of error necessary for real-world reprocessing.Today, there are hundreds of flexible endoscopes from leading manufacturers that have been validated for use in STERRAD^® Systems.

Note: For a list of flexible endoscopes that have been validated for sterilization in STERRAD^® Systems, please see the STERRAD^® Sterility Guide (SSG).

A proactive approach and consistent attention to detail keep this busy facility humming.

Community Endoscopy Center in Indianapolis has a fleet of more than two dozen flexible endoscopes that need to be reprocessed multiple times daily to keep the 60 patients the facility cares for each day safe from infections.

"Despite the time crunch, we never cut corners and haven’t had a single patient infection during the nine years I’ve been working here," says Tammy Richardson, RN, BSN, MHA, the facility's executive director.

The well-oiled reprocessing process starts at the bedside, where staff nurses pre-clean scopes shortly after procedures conclude with water and detergent for two to three minutes, then use rigid containers to transport the fragile devices to the decontamination area next to the procedure rooms. The clear plastic transport containers are disinfected after each use.

Reprocessing techs place scopes in a sink full of clean water and connect them to wall-mounted leak testers. They then perform manual cleanings in the sink, flush the channels and run the scopes through a 26-minute high-level disinfection cycle in an automated endoscope reprocessor. When the cycle finishes, techs bring the scopes to the facility's clean equipment room, dry residual fluid on the outside of the channels with a lint-free cloth and hang them in a dedicated storage cabinet that meets appropriate ventilation requirements.

The center employs six reprocessing techs, three of whom are assigned to the decontamination room. The other three rotate through dual functions and also work in the patient care area, where they help turn over rooms, stock supplies, bring patients to the procedure room and assist patients to their cars after cases.

The center's scopes are in their sixth year of service and are scheduled to be replaced next year. It takes a lot of preventive maintenance to keep them in good working condition, says Ms. Richardson. At least two scopes are sent out for repairs each month and vendors regularly service them as well. The center also purchased protective shields that have decreased distal tip damage during transport and reprocessing. As an extra precaution, every scope at the center is regularly pulled from circulation to undergo ATP testing for microbial contamination. The scopes return to the regular rotation if they pass. If they don’t, they’re recleaned and retested for residual bioburden in the channels.

"We don't do these tests because we're having safety issues — they're a proactive measure," says Ms. Richardson. "None of our patients have suffered an infection, and we intend to keep it that way. My mantra for every extra step or precaution is, 'If I'm the patient, I would want this place to be doing this.'"

Students from Africa are becoming SPD techs through Purdue partnership.

Forty-six students from 10 African countries are taking a three-month course at Purdue Online to become certified sterile reprocessing technicians thanks to a partnership between Purdue University and the Safe Surgery Initiative. The students emdash from Nigeria, Sierra Leone, Ghana, The Gambia, Liberia, Rwanda, Tanzania, Uganda, Kenya and Ethiopia emdash will then take certification tests administered by the International Association of Healthcare Central Sterile Materiel Management (IAHCSMM).

The certified sterilization specialists will help hospitals in Africa, where workers trained in how to properly reprocess surgical instruments are in short supply, putting patients at higher risks for potentially life-threatening infections.

The Safe Surgery Initiative is a nonprofit that helps improve the quality of surgical instruments used in low- and middle-income countries. As the group was looking for ways to keep the instruments in these countries clean and sterile, Keith Miles, the organization’s executive director, discovered Purdue’s online course on the IAHCSMM website. Smile Train, an organization that provides resources for mostly cleft-based surgeries, provided the money for the 46 students to attend the Purdue course.

"We're hoping to expand it in 2022," says Mr. Miles. "We're trying to do at least 600 students a year."

Many hospitals in Africa don’t have departments dedicated to cleaning, disinfecting and sterilizing surgical instruments, and lack trained personnel if they do. OR nurses generally do the best they can to clean the instruments when they’re not providing direct patient care. Often, bleach or other harsh chemicals are used for the job, damaging the instruments and shortening their lifespans.

"That ends up creating more infection across the hospital and across the patients," says Mr. Miles. "It's a never-ending cycle of unsafe practices that have been going on for decades."