Safe, Standardized and Sustainable

Modern sterilization and high-level disinfection practices every surgical leader should know.

Proper instrument cleaning and care are, of course, essential components of the surgical process. The keys to improvement in this area, especially in terms of workflow and productive relationships between OR and sterile processing teams, are effective communication and efficient standardization.

To further promote and solidify a culture of safety at your center, provide staff with clear goals and expectations to remove the guesswork from this vital aspect of surgical site infection prevention.

There are many resources available to assist you in this effort. Guidelines and recommendations from the Association of periOperative Registered Nurses (AORN), regulatory agencies and other organizations can help surgical leaders craft relevant policies that reflect the current challenges facing sterilization and high-level disinfection (HLD) in the modern outpatient surgery setting.

Consistent adherence to established sterilization and HLD protocols will ensure that your instruments are reliably free of microbial contamination while reducing patient infection risks. Leaders should regularly evaluate these processes to maintain compliance with best practices and quickly adapt to new technologies or emerging pathogens.

A quick living-history lesson

The foundation of sterilization comes from the Spaulding classification, which was established in 1957. While the system has served the surgical industry well for many decades, its tenets are being called into question. The U.S. Centers for Disease Control and Prevention (CDC) stresses that, given the innovations of newer instruments and materials, the Spaulding scheme needs to be modernized.

In her 2023 article, “Medical Device-Associated Healthcare Infections: Sterilization and the Potential of Novel Biological Approaches to Ensure Patient Safety,” published in the International Journal of Molecular Science, Mary Garvey, MSC, PGDip, BSC, a lecturer at Ireland’s Atlantic Technological University, writes, “The suitability of the Spaulding system, which is approximately 65 years old, for reprocessing novel, advanced and complex medical devices to eliminate emerging and multidrug resistant [MDR] pathogens is questionable.” Scrutiny of the Spaulding system particularly raises concern regarding semi-critical items where the question of sterilization versus high-level disinfection is raised.

The semi-critical debate

Sterilization eliminates all microbial life, including bacterial spores, while HLD eliminates all microbial life except bacterial spores.

Any instruments that contact body tissue or blood are deemed critical. Those that contact mucous membranes or non-intact skin are deemed semi-critical. Most surgical equipment falls under the critical category and thus requires sterilization.

Scopes are currently the subject of controversy in terms of their classification. According to the CDC, contaminated scopes have led to more healthcare-associated outbreaks than any other medical device.

“Improperly sterilized critical devices containing MDR species have been associated with endoscopy procedures,” writes Dr. Garvey.

Endoscopes, laparoscopes and arthroscopes are complex devices that are difficult to clean due to their high bioburden after use, their long, narrow channels and their many attachments and accessories. Additionally, scopes are often heat-sensitive. As such, standard sterilization methods like steam sterilization, the first-line technique recommended by AORN, may not be compatible with all scopes.

As a result, there is now robust debate pitting sterilization against HLD as the preferred method to reprocess scopes. The CDC maintains that HLD is the minimum recommended cleaning method. Proponents of sterilization respond that, due to the relatively higher risk of infection surrounding scopes, why not sterilize them?

The sterilization argument is bolstered by the continuing advancement of laparoscopic techniques that are facilitating more invasive procedures that come with higher infection risks. Sterilization proponents also point to cases such as those involving bleeding ulcers where scopes contact blood.

HLD advocates counter that the infection outbreaks we are seeing are not caused by bacterial spores and therefore would not have been prevented had sterilization occurred. The issue, they believe, is not that scopes should be sterilized, but that too many are not properly high-level disinfected.

Follow IFUs closely and contact the manufacturer with concerns regarding newer technology.

One practice in which the effectiveness of HLD commonly breaks down is the cleaning of the scope before disinfection to remove bioburden. Each piece of the scope must be removed and manually cleaned with water and a detergent prior to disinfection with a chemical agent or other method.

Automated endoscope reprocessors (AERs) can be advantageous investments for facilities that commonly use endoscopes, as they can enable the HLD process to become more streamlined, complete and time-efficient. AERs can remove variables from the process by automating most of the disinfecting steps. These machines have their own limitations, however, as regular monitoring is required to ensure appropriate disinfection levels and patient safety.

While sterilization may eventually become standard for scopes, the CDC says that more complete randomized controlled trials are required before it can reach a definite conclusion.

AORN guidelines, meanwhile, recommend that semi-critical instruments be sterilized if the manufacturer’s instructions for use (IFU) allow, taking the stance that HLD carries a higher transmission risk.

The modern era

ELBOW GREASE Manual cleaning is essential to making scopes safer for patient use.

AORN guidelines also address some newer technologies that facilities need to consider regarding their reprocessing. One is additive manufacturing or 3D printing, the use of which is increasing. This technology allows for implants and other equipment to be personalized to a patient’s exact dimensions and needs. In these cases, sterilization often falls to the facility, as manufacturers deliver them in non-sterile packages.

This newer medium also comes with a higher risk of deformation, with high heat levels required for sterilization, along with a higher risk for unintended residual manufacturer material on a device resulting from the manufacturing process.

Follow IFUs closely and contact the manufacturer with concerns regarding this newer technology. It is the manufacturer’s responsibility to test this equipment, provide sterilization instructions and remove any residual manufacturing material.

AORN recommends that this equipment be closely inspected after sterilization to ensure no deformity has occurred. This novel technology may require development of a separate policy using a multidisciplinary approach specifically for 3D-printed equipment to address its unique characteristics.

Environmental impact

Health care is a high-waste industry. Medical professionals have an ethical obligation to mitigate environmental harm, as human health relies on a healthy environment.

Instrument and device processing comes with a particularly heavy environmental burden. Sterilization techniques can include toxic chemicals, harmful emissions and high levels of resource consumption. AORN guidelines encourage facilities to examine areas of improvement to limit the environmental impact of sterilization processes.

Centers should thus evaluate strategies to responsibly deliver care while helping to ensure a healthy environment in the long term.

When making purchasing decisions, the overall environmental impact of the product should always be taken into consideration. Limiting single-use items to only necessary procedures is crucial to reducing waste. Individually packaged instruments carry a higher carbon footprint than those stored in a set.

Unfortunately, manufacturers are not being incentivized to make sterilization as efficient as possible. The more time-consuming the cleaning process is and the longer the dry times are of any given device, the more devices a facility will need to purchase in order to achieve turnaround times that maintain surgical workflow.

One practical strategy AORN suggests to reduce environmental impact is to shut down idle steam sterilizers, as studies show many sit unused nearly 50% of the time. By powering them down when they are not in use, facilities can conserve significant amounts of water and electricity while lowering operational costs.

Consider performing a risk/cost-benefit analysis to determine whether this approach is feasible within your workflow. When paired with thoughtful scheduling and communication across surgical and sterile processing teams, shutting down idle sterilizers can represent a simple, yet impactful, step toward a greener, more efficient practice.

Leadership guide

Surgical leadership carries a responsibility to ensure that high-level disinfection and sterilization processes work for their facility and their patients. By creating a culture of safety, leaders can emphasize that the cleaning of surgical equipment is a team effort. Clear policies and procedures using a multidisciplinary approach allow leaders to set clear expectations. OR and sterilization teams should be encouraged to voice any concerns about workflow and safety when addressing policy creation and updates. Staff must feel empowered to speak up about workflow breakdowns, instrument defects or near-misses without fear of punishment.

Quality and efficacy monitoring should be performed routinely. If a problem in the system is identified, staff should know the process for reporting and addressing the issue. Access to safety data sheets should be readily available in the event that a spill or exposure occurs. Because sterilization often includes toxic chemicals, leaders have a responsibility to disclose workplace hazards and provide proper PPE to keep staff safe.

Staff should have routine competency reviews, as manufacturer recommendations and technologies can change. They should be comfortable reporting an issue even if the surgical schedule will be interrupted. When an issue is identified, a full quality assurance and improvement plan should be implemented with clear goals for corrective action.

Sterilization and high-level disinfection remain cornerstones of safe surgical care, but success goes well beyond following technical steps. It requires a shared commitment from all members of the perioperative team that is grounded in clear policies, consistent education and collaboration across disciplines. By embracing updated evidence, scrutinizing manufacturer IFUs and considering environmental and financial impacts, leaders can build systems that protect both patients and staff.

Ultimately, the most effective sterilization programs foster a culture where safety, accountability and teamwork are regarded by all staff as inseparable from patient care.

There are many correct methods of sterilization and high-level disinfection. By following regulatory guidelines and manufacturers’ IFUs, leaders can create a system that works for them. OSM