Today we may view the central sterile department of the ’70s, ’80s, and ’90s as primitive sterile processing. Reminiscing on the period, we performed supply chain duties such as distributing supplies to the nursing units, replenishing glass IV bottles, managing the linen carts that went to the floors, and preparing instruments for the operating room.
In the central supply area, our processes were simple, as all our instrument sets contained only soft-tissue instruments: scissors, clamps, needle holders, and retractors. The most sophisticated piece of equipment was the pneumatic power equipment. And, if the hospital had enough resources, we may have owned a flexible endoscope.
No disposables; lots of on-the-job training
We reprocessed round basins, kidney basins, and the infamous bedpans. There were no rigid containers or disposable wraps; everything was packaged using reusable linen wraps that had to be inspected under a lighted table. After inspection, we de-linted, marked the damage, and folded those wraps that were suitable for packaging our instrument trays. We managed the ethylene oxide (EtO) tanks and cleaned the gas chambers without wearing any monitors or safety badges.
Central supply staff learned little about inspection, except evaluating the scissors and sharpening those reusable hypodermic needles on a sharpening stone, as SPD education was on-the-job training. We processed lumened devices by simply flushing them without visually inspecting the inner channels. At the time, we did not know the meaning of instructions for use (IFUs), nor did we follow them. Those were the simple days of central supply processes.
Changing to SPD
Today, our department is called sterile processing, or SPD. We are technicians with the most sophisticated equipment for instrument reprocessing. In many hospitals, the responsibility for distributing supplies to the patient care units has been transferred to the supply chain department.
We have learned that we can no longer process devices blindly. We must follow the overly complex IFUs to ensure that the devices we are cleaning, packaging, sterilizing, or high-level disinfecting (HLD) have met all parameters and are safe to be used on patients.
In a few states, mandatory certification in the SP field is the law. The SPD technicians have evolved into trusted partners of the surgical team and endoscopy units. We are the facility reprocessing experts entrusted with the task of ensuring that devices with bioburden or debris never reach the surgical room.
Advancements in technology
Technological advances in surgery have made this task a challenge, as new devices are more complex with lumens that are difficult to clean and inspect with the naked eye. Yet the use of borescopes is still not a standard practice in the field.
For years, plumbers have conquered the task of inspecting long lumens with a device that allows them to snake through a pipe: a small camera to determine the cause of the pipe problem. These waterproof devices project the image to a small monitor carried by the plumber. They named this device a borescope.
Healthcare has borrowed this technology to help SPD technicians inspect medical devices designed with lumens. Although a borescope used in healthcare is designed to be much smaller, and some are intended to be sterilized, the function is the same: inspect lumened devices.
Proving a need
The need for purchasing a borescope can be difficult to explain without discussing the benefits of integrating borescope inspections into your process. In simple terms, if you put on a blindfold and proceed to decontaminate your instrument, you will miss spots and devices with bioburden will reach the operating room, potentially posing a safety hazard to the patient.
Perhaps you are not wearing a blindfold when decontaminating or assembling instruments, but if your processes do not include inspection of lumens using a borescope, you are processing instruments blindly. What are the steps for a quality process that includes a borescope inspection? Which items should be inspected using a borescope? And how can we support the need of a borescope? Let us discuss gastrointestinal flexible endoscopes and orthopedic shavers.
GI endoscope quality process
GI endoscopes are complex instruments that require numerous steps to render them clean before they are disinfected. They are complex instruments with long lumens, making it difficult to inspect the efficacy of the cleaning process without the help of a borescope. The manufacturer’s IFU outlines each manual cleaning step, and the scope should be thoroughly inspected before it is introduced into the high-level disinfection solution.
If soil is present on the scope, the HLD process was not successful. At the end of the manual cleaning process, the scope should be dried with a lint-free cloth and transferred to the quality audit workstation.
The first step is to visually inspect the scope with a lighted magnifying glass. This inspection is going to highlight damage to the body of the scope, controls, lenses, and elevator mechanisms. Once this step is completed, it is time to inspect the inner channels of the scope.
Inspecting for obstructions
Slowly introduce the tiny camera inside the channels and carefully inspect them. Look for abnormalities, scratches in the working channels, and any type of debris or bioburden. Figure 1 shows an obstruction found when inspecting an endoscope with a borescope. It took the technician several minutes to remove a cluster of seeds from the lumen of the endoscope. This is only one example of the many near-miss incidents that can be captured with the aid of a borescope.
Figure 1. Endoscope obstruction CREDIT: Mary Olivera
Figure 2. Residue in the channel of a shaver CREDIT: Mary Olivera
Is inspection using a borescope a requirement?
AAMI’s recommended practice states, “Inspection using enhanced visualization tools such as lighted magnification and video borescopes might identify residues not observable by the unaided eye. Visual inspection alone might not be sufficient for assessing the efficacy of cleaning processes.”¹ Regulatory bodies like the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) provide similar guidance.
Manufacturer’s IFUs for devices such as orthopedic shavers also include statements instructing us to visually inspect inner surfaces for residual bioburden. Figure 2 shows a sterile shaver inspected during a borescope demonstration. The borescope highlighted tissue that was not removed during the cleaning or inspection process. Bioburden left on surgical devices can cause infections, sometimes resulting in life-changing conditions for the patient. Now we can ask, is a borescope an essential inspection tool required in the inspection process? The answer is yes!
Today there are several types and brands of borescopes available in the market from which a healthcare facility can choose based on their budget. These especially important tools should be considered as important as steam or low-temperature sterilizers; without them, we cannot provide a sterile tray to the OR and without the borescope, we cannot be certain that lumened devices are completely clean.
How can we justify the purchase of borescopes?
The following steps can help prepare a proposal to support the need for a borescope.
- Write a statement about the current situation. Include what the current inspection process includes and the inability to ensure that internal channels are cleaned. If you’re writing the proposal for endoscopy, describe the scope, the complexity of the cleaning process, and why it is impossible to see what is in the channel of the scope.
- Give anecdotal accounts of incidents in which bioburden was found in lumens during a procedure. Be sure to also state the outcome of the incident (e.g., “During Dr. X’s hip procedure, the scrub tech found residual bone in the lumen of the reamers. The sterile field had to be taken down and the instruments reprocessed. The procedure was delayed for three hours”).
- Collect your support data. Attach articles that speak about dirty surgical instruments reaching the OR, infections caused by bioburden, and borescope trending news. State why using a borescope will be an effective tool in your process and include supporting statements of the risks the organization will take if a borescope inspection is not included in the process. It is important to include changes in the industry, regulatory agencies, and manufacturer’s IFUs that include visual inspection of internal channels.
- Conclude your proposal by giving your recommendations and next steps for the process. This is where you state your plan of action to address the situation. A draft of the implementation protocol should be included to demonstrate how the device will be incorporated in the process. Include how this tool is going to help the department achieve essential success in the process and how the new process will be sustainable. Be creative and factual.
Writing a proposal to obtain capital equipment can be overwhelming for a new manager. However, there are mentors in the SPD field who can help you through the process, so reach out. Furthermore, the vendor of the device you choose can help you by providing the documentation needed and a projected return on investment cost. Let us begin to change the outcome of the process by incorporating innovative tools that can help us inspect the lumens we were never able to inspect before.
Reference
- ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities, (Arlington, VA), 2017, 7.6.4.5.