Becoming a vital member of the surgical team

The role of a central supply (CS) technician used to revolve around taking supplies to the medical units and washing utensils like bedpans and basins. We spent much of our time folding and delinting wrappers, distributing laundry, inspecting for holes in sealed packaging, and using the naked eye to check for contamination. While there were processes in place, there were not universal standards, and there certainly were not requirements to learn complex decontamination processes that adhered to manufacturers’ instructions for use (IFUs). In fact, we did not even know what IFUs were!

Thankfully, all that has changed, and thankfully, central supply is not what it used to be.

Today only six states in the nation require education and certification before technicians can work in the sterile processing department (SPD). A legislative process was required to make certification a requirement for those performing instrument reprocessing tasks. It was years before we saw education requirement changes for an essential group of technicians who perform critical tasks preparing and inspecting surgical instrumentation.

SPD evolution

However, the media continues to publish reports of hospitals placing patients at risk when stained, dirty, and substandard instrumentation reaches the surgical site. Fortunately, not all SPDs are in disarray or are being shamed by the media. The majority of SPDs have evolved, and they enjoy the innovative technologies and tools that help perform their tasks rapidly and safely. 

It is worth mentioning that SPD evolution has not only been through technology. We also have gone through a cultural shift, seeing ourselves as professional members of the surgical team rather than as people downstairs cleaning. We are encouraged to participate in daily huddles with the operating room (OR); we are no longer forgotten by the accrediting surveyors; and it is understood that failure in our processes can have major impact on the outcome of the surgery, patient safety, and the reputation of the organization.

Certainly, getting to this point was never an easy task and it has taken much effort and dedication by the trailblazers before us. They constantly found a way to raise the bar in instrument reprocessing and taught us to incorporate proven manufacturing concepts into our SPDs. Manufacturers produce thousands of devices, always following the same process with the goal of always producing items free of defects. Their processes are made simple, subjecting every item to rigid inspections and audits throughout production. They arrange workspaces to strategically eliminate unnecessary steps in the manufacturing process, thereby creating efficiency at every stage.

Taking a page from the manufacturing system, we should be inspired to transform our departments into manufacturers so that we can deliver to the OR surgical instrument trays that are 100% cleaned, 100% completed, and 100% on time 100% of the time. We must embrace the innovative technology available, such as robotics and artificial intelligence (AI), to make us more efficient.

Review procedures and set standards

A cost-efficient process that can get immediate rewards is to review your procedures and set internal standards. Cut down waste by removing unnecessary steps and streamlining processes. Then begin to use regulatory and accreditation standards to review published metrics by which quality can be measured.

Set goals to reach and key performance indicators to live by. The business dictionary defines manufacturing as “the process of converting raw materials, components, or parts into finished good that meet a customer’s expectations or specifications.” How can we begin to improve our processes to meet the customer’s—surgeons, nurses, and ancillary services—expectations without errors in the trays? Organizations must begin to adopt a risk prevention approach and invest in the necessary components to improve the process. SPDs must begin to implement continual quality improvement processes and use them as a preventive tool.

Regulatory and recommended standards set forth by AAMI, AORN, CDC, and FDA have made patients safer than ever from contaminated tools. An emphasis on instrument inspection, water quality, and process reengineering helps ensure that improperly sterilized tools do not leave the SPD and keep bioburden from reaching patients. Let us emphasize a few risk prevention tools for verifying instrument cleanliness and ensuring patient safety.

Chemical verification test

Countless hospitals use these methods in their quality audits for GI endoscopes before they are put through the high-level disinfection process. A swabbing process is used to measure levels of cleanliness of a surface or a cavity, and to verify the cleaning process for cannulated medical devices like orthopedic shavers.

  • Protein indicators: The presence of protein means that an instrument has not been fully decontaminated and is not yet safe for use in the OR. One of the most efficient ways to evaluate residual protein is a protein indicator test. The test requires swabbing the sample then introducing the test to a reactive solution that will change color in the presence of protein. There are a variety of commercially available products to chemically evaluate for and detect levels of protein on surfaces of medical devices that would otherwise go unseen. Others include the swab and reagent in one tool.
  • Adenosine triphosphate (ATP): The ATP process uses a special swab to take samples of the area being inspected for bioburden. The sample swab is inserted into an enzyme solution, which will produce a light signal if protein is present. This signal is measured in Relative Light Units (RLUs) by a handheld luminometer and is measured against pass/fail benchmarks established by the ATP test manufacturer. Usually, the passing value for an ATP test is 0–100 RLUs for scopes and surgical instruments. Depending on the manufacturer, ATP handheld devices may require calibration, and all require adherence to IFUs.
luminometer

Courtesy of Hygiena

Chemical tests like the ones above can often be synchronized to computer tracking programs that allow for straightforward data-driven quality audits.

Enhanced visual inspection and magnification

In recent years, rigid and flexible borescopes have transformed the inspection of cannulated devices and channels of medical devices. Borescopes are often used by plumbers and mechanics to inspect the internal channels of pipes. Medically adapted borescopes are used to visually inspect the internal channels of GI endoscopes and other medical devices. The visual inspection of the channel allows the technician to assess if bioburden or soil remains and if there is damage to the internal components of the endoscope.

Courtesy of Vividia

Visual inspection of the internal channels is performed after manual cleaning—to ensure there is no residual soil—and before high-level disinfection or sterilization. An SPD may also have borescopes in the decontamination area, where technicians inspect the channels of flexible scopes, power equipment, and channeled devices after cleaning. If residual soil is found, the device(s) go back to the first step of the cleaning process.

It is essential to prepare a maintenance protocol for cleaning, disinfection, and sterilization of borescopes. Follow the manufacturers’ IFUs to determine the frequency of each of these steps. Borescopes have proven to be an essential SPD inspection tool and have systematically reduced residual soil incidents, reaching near-perfect measures on quality audits. For many SPDs, these successful goals justify the excessive cost of these devices.

Work area illumination

Adequate lighting is one of the simplest ways to set up your SPD for success, and AAMI ST79 3.3.5.6 provides guidelines for proper lighting in inspection areas. After all, you cannot clean the bioburden if you can’t see it. Lighting should be based on the work environment, the age group of the individuals working, and the amount of light reflection. Some surfaces and colors absorb the light, while some, like stainless steel, reflect it, so it is important to choose the correct type of lighting and luminance.

Today, there are a variety of light fixtures available. Halogen is the most-used type of lighting in SPDs but fluorescent and LED lighting also may be beneficial in your workspace. Endoscopy areas may require additional lighting over the sinks where manual washing is performed to ensure soil is easily identified. The GI Endoscopy audit workstation also should have adequate lighting to provide the technician with the ability to inspect the scope lining for damage and bioburden. To further determine the departments’ illumination needs, the hospital can engage the services of an illumination engineer to ensure that critical inspection areas incorporate adequate lighting.

The inspection process during surgical instrument assembly is a critical step in the process, but visual inspection alone cannot determine if the cleaning process was successful. We should use enhanced visualization tools like protein indicator tests, borescopes, and innovative technology to “see” beyond what we ever have seen before.

Water quality for reprocessing medical devices

Water can affect the reprocessing of surgical instruments by depositing minerals, sediments, particles and most importantly, microorganisms. There are minimum quality requirements established by AAMI ST108 for water utilized for medical device reprocessing. It is the responsibility of the organization to ensure there is a team within it responsible for monitoring the quality of the water used in the SPD.

Water used in instrument reprocessing should be evaluated as recommended in ST108 for endotoxins, bacteria, and other particles as listed on ST108, Table 2: Categories and performance qualification levels of water quality for medical device processing. Poor water quality can result in residual toxicity, pyrogenic reaction, increased endotoxins, reduction of detergent efficiency, and deterioration of the material composition of the medical device. AAMI ST108, Table 6, outlines the frequency required for water quality monitoring at point-of-use and the criteria that should be measured.

We have come a long way from the central supply era. As sterile processing professionals we have improved our processes and become vital members of the surgical team striving for excellent patient care outcomes. Let us continue to improve quality outcomes, enhance audits, create solid benchmarks, and renew our commitment to a zero-defect product.