Endoscopes have been used by practitioners as early as the 19th century to examine the inside of the human body. Today, these devices are used to perform millions of endoscopy procedures every year. (In fact, one source reports that the global market volume was 222.9 million in 2021).
Thanks to new and emerging technologies, the endoscope is becoming increasingly more complex, allowing physicians to examine major organs and body systems closer than ever before.
As endoscopes become more complex, so too does the cleaning process. In order to maintain the cleanliness and safety of the devices, countries around the world have revised their guidelines surrounding endoscope reprocessing. Additionally, many hospitals and healthcare facilities are implementing the use of electronic tracking to ensure endoscopes are properly cleaned and stored before being used again.
Below, we’ll review the seven steps for proper flexible endoscope reprocessing — from bedside to storage — and how this process maintains patient safety and meets hospital compliance regulations. Additionally, we’ll discuss how electronic tracking software such as CensiTrac by Censis simplifies compliance management and inventory tracking.
According to the Society of Gastroenterology Nurses and Associates, endoscope reprocessing refers to the process of “cleaning, disinfecting, or sterilizing endoscopes and accessories.” While the exact process will vary depending on the country, there are typically seven steps associated with endoscope reprocessing.
1. Bedside Clean
Also known as precleaning, this clean takes place immediately after the procedure has been completed. The process involves removing any visible debris with the appropriate detergent solution and then passing air and solution through the inside of the device repeatedly. The outside of the device is also wiped down prior to moving to the decontamination room.
2. Documentation
The individual responsible for cleaning must document the time the procedure was finished and what time the initial bedside clean was performed. This is a critical step in the endoscope reprocessing process as individuals responsible for cleaning have one hour to start the decontamination process.
If the cleaning process starts an hour after the initial bedside clean is performed, the device must go through delayed processing. (More details about delayed processing will be provided in the next section.)
3. Decontamination
Prior to cleaning the scope, cleaners must perform a leak test. This involves thoroughly checking the flexible endoscope for any leaks by flushing air through the entire scope multiple times. Should a leak be detected, it’s critical the device is sent for repair immediately. Ensuring there are no leaks in the device protects patients from harmful infections and prevents liquid from damaging the device.
After the leak test has been performed, the endoscope, channels, and all subsequent accessories are continuously flushed with water and brushed both inside and out. Once this is done, a full rinse is completed. Should decontamination begin an hour after the initial bedside clean, the device will go through delayed processing. This process takes hours to complete and involves thoroughly soaking the device in cleaner and continuously flushing and brushing the device to remove any bacteria, biofilm, or other contaminants.
4. Cleaning Verification
After decontamination, technicians must test the device to ensure it’s been properly cleaned. The verification process varies depending on the hospital, with some using a pass/fail scale and others using a rating.
Should the device fail the verification, the process starts over. If it passes, cleaners can move on to the next step.
5. Automated Endoscope Reprocessor (AER)
Next, the technician connects the endoscopes to the AER. This device automatically performs another leak test, cleaning, and then the disinfecting process before rinsing and flushing the device and sending it on for drying.
Once the AER is complete, cleaners complete a chemical test strip to ensure the chemicals and disinfection process met the parameters required to properly disinfect the scope. If the chemical test strip fails the device must be reprocessed. If not, it can be sent for drying.
6. Drying
The technician then dries the outside of the scope with a lint-free cloth and connects the scope to forced air to dry the inside of the scope. This prevents water from damaging the scope, minimizes biofilm, and reduces the risk of bacterial growth.
7. Storage
Finally, the cleaned device is placed into a specialized storage cabinet that provides a continuous amount of air to the device to maintain integrity and deem it ready for patient use. The device is kept here until it is needed or reaches its maximum hang time.
Hang time is the maximum amount of time an endoscope can be stored before it needs to be cleaned again. The length of time varies between hospitals but is usually between 5-12 days.
Endoscopes that are not properly cleaned after each use pose a significant risk to patients. These devices are exposed to a number of harmful bacteria that can cause further health problems, infections, and, in serious circumstances, death.
For example, physicians rely on ERCP scopes to treat health problems such as gallstones, pancreatitis, trauma to bile or pancreatic ducts, cancer, and more. During these procedures, the scope is exposed to bile, fecal matter, and numerous other harmful bacteria. As recently as 2015, 13 patients died after contracting an infection with antibiotic-resistant bacteria at two different facilities. Both outbreaks were attributed to improperly cleaned scopes.
If done correctly, the reprocessing process ensures all contaminants are entirely removed from the device prior to being used again, protecting patients from further health complications.
The process also helps hospitals and other healthcare facilities remain compliant with changing healthcare regulations, including AAMI ST91, which was updated in 2021.
The flexible endoscope reprocessing process is lengthy. From the initial bedside clean to storage, the scope must pass through a number of steps prior to being used again. Many healthcare providers are turning to technologies like Censis’ CensiTrac and ScopeTrac Advanced solutions to efficiently track the cleaning, storage, and maintenance of endoscope devices.
CensiTrac provides real-time tracking of endoscopes down to which scope was used in which case. Users can quickly scan or input the serial number into CensiTrac starting with the bedside clean and use the system to track the device throughout the entire cleaning process. Our platform captures all sterilization records, enabling users to see when cleaning was performed and who helps ensure proper protocols are being followed. AERs can also directly interface with CensiTrac, ensuring entire teams have proper verification at all times.
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