What is Sterile Processing?
Sterile processing refers to the process that is used to clean, prepare, sterilize, store and track reusable medical and surgical instruments throughout their lifespan. Ensuring this process is completed entirely and correctly is critical to both patient safety and hospital compliance, as instruments that aren’t properly sterilized may contain harmful bacteria or chemicals that can negatively impact patient outcomes.
“Sterile processing is the most underrated department that there has ever been,” said Amanda Kobel, former sterile processing technician and a client manager at Censis. “If we don’t do our jobs or if the sterilizer goes down, surgery does not happen. Everything is shut down. For example, moms cannot have a C-section to bring their babies into this world if the sterile processing department isn’t functioning.”
According to the Centers for Disease Control and Prevention (CDC), surgical site infections continue to be a substantial cause of morbidity, extended hospitalizations, and death. These infections:
- Account for 20% of healthcare-associated infections (HAIs).
- Are associated with a 2- to 11-fold increase in a patient’s risk of death.
- Are directly responsible for 75% of deaths associated with surgical sites.
- Extend hospital stays by an average of 9.7 days.
- Are the most expensive type of HAI, increasing hospitalization costs by more than $20,000 per admission (an annual cost of $3.3 billion).
While these statistics are strikingly high, progress is being made thanks to advancements in sterile processing procedures and new technologies. The CDC also reports that in 2020, there was a roughly 5% decrease in the surgical site infection standardized infection ratio compared to the year before.
The importance of sterile processing has never been up for debate, but it is often overlooked. Here, we’ll take a deeper dive into how sterile processing works, training requirements for sterile processing technicians, and how new technologies, such as surgical instrument tracking software, can continue to improve patient care.
A Day in the Life of an Instrument Tray
Sterile processing often begins with an instrument tray. Surgical instrument trays contain all the tools needed to complete a specific type of surgery. Keeping these instruments bundled together makes it easier to safely transport them to and from the operating room, keep them organized and store them when they’re not in use.
Sterile processing is typically conducted in a centralized sterile processing department (SPD). Before these departments were established in the 1940s, each hospital department was responsible for sterilizing its own equipment, making it difficult to form standardized procedures and putting patient safety in jeopardy. Now that dedicated sterile processing departments exist, the sterilization process for all instruments can be monitored from start to finish to ensure institutional and regulatory policies are being followed.
When an instrument tray returns to a health system’s sterile processing department following a surgical procedure, each instrument must be processed for sterilization according to certain regulations before it is stored for future use or returned for another procedure. The exact sterilization process may vary slightly between instruments based on the materials they’re made of or specific instructions from the manufacturer, but the sterile processing cycle generally consists of four main steps including quality assurance checks performed during each step:
- Assembly and packaging
- Storage and distribution
When an instrument tray arrives in the sterile processing department, the first step is to clean the instruments. This may be done manually by sterile processing technicians or by using mechanical cleaners and washers that use a variety of chemicals for cleaning, rinsing and lubricating.
“All instruments are hand-washed before going through an ultrasonic and mechanical washer. The ultrasonic is similar to the ones used to clean jewelry but on a much larger and more powerful scale,” said Kobel, who worked in sterile processing departments for 9 years. “After ultrasonic cleaning, instruments are washed in a mechanical washer. Some may compare this washer to a dishwasher, but mechanical washers are specialized, more powerful machines with specific cycles based on the item being cleaned.”
Decontamination is critical because harmful microorganisms can’t be fully killed until an instrument is clean of all substances, including detergents, saline and substances encountered during surgery. This step is also crucial for protecting the sterile processing technicians who are handling the instruments on the cleaning side.
Assembly and Packaging
Once the instruments have been effectively decontaminated, they are inspected and assembled for a set or peel packed. Utilizing proper containment devices for the instruments helps to keep them sterilized until they are ready for reuse.
Sterilization is the process of ridding the instruments of microorganisms or viruses. This is achieved by subjecting microorganisms and viruses to conditions or chemicals that they can’t survive. Two common sterilization methods used by sterile processing departments include:
- Steam: Steam is the most widely used sterilization method. When heat, moisture and pressure are combined to a certain threshold, no living organism can survive.
- Low-temperature technologies: Some medical devices may not be able to be exposed to heat or moisture without resulting damage, which is an instance when vaporized hydrogen peroxide technology might come into play. This gas plasma technology, which works with a temperature below 50 degrees Celsius (140 degrees Fahrenheit) directly removes hydrogen peroxide residual from the instruments. This system can also be used for instruments that are able to withstand heat. Another important low–temperature technology is ethylene oxide, which is used for certain polymers, metals, glass or devices with hard-to-reach places.
The sterilization method used is based on the material of the instrument and institutional, regulatory or manufacturer guidelines and policies.
Storage and Distribution
When sterilization has been assured, the instrument container and peel packs are placed into an environmentally controlled sterile storage area for future surgical procedures.
Sterilization Quality Assurance
Throughout each step in the sterilization process, it’s imperative to confirm the process worked. While most sterilizers will indicate when a cycle wasn’t able to be fully sterilized or if there is a technical malfunction with the equipment, the results still need to be double-checked. Routine monitoring may include chemical, mechanical, visual and biological indicators, but biological process indicators are currently the only way to be sure sterilization parameters have been accomplished.
Training for Sterile Processing Technicians
For several years there has been a shortage of trained SPD technicians, largely due to increased demand.
The field has become more complex as surgical procedures, instruments and sterilization equipment become increasingly complex. This has resulted in additional processing steps, new and increased surgical procedures, and more attention to detail.
“It’s fairly similar to the nursing shortage right now,” said Kobel. “A lot of technicians left to go travel. This makes it difficult to hire new people because travel technicians earn more money than facility staff, and facility staff may be required to work overtime and may be held to a higher standard.”
According to the U.S. Bureau of Labor Statistics (BLS), there were 56,870 sterile processing technicians in 2020, and only 42,340 of those technicians worked in general medical, surgical or specialty hospitals. However, the BLS also projects an 8% increase in the number of trained technicians between 2020 and 2030.
“Despite the staffing shortage, sterile processing departments are still expected to process all the instruments and equipment with the staff they currently have,” said Kobel. “If you overwork your sterile processing technicians, exhaustion happens, which can lead to mistakes and disastrous outcomes. Not all administrations understand how important it is.”
Sterile processing technician training isn’t standardized, so requirements may vary by state. Some states don’t require certification, while others only require a high school diploma.
In general, the steps to becoming a sterile processing technician may require you to:
- Earn a sterile processing certificate or degree.
- Complete a hands-on clinical internship.
- Pass a certification exam.
Kobel advocates for more on-the-job training as well as more advertising to younger generations about what sterile processing is and how it is a critical behind-the-scenes part of health care.
“I believe there should be more advertising in high schools so that young people going into the workforce are aware of the opportunities in the sterile processing field,” said Kobel. “I think it should be a bigger focus and that it could help the staffing shortage.”
Advantages of Sterile Processing Tracking Systems
Because sterile processing can be complex and directly impacts patient outcomes, documentation down to the instrument level is crucial. Meticulous tracking of surgical instruments is essential for patient safety, yet many health systems continue to document these devices on paper, leaving plenty of room for human error.
New technologies such as surgical instrument tracking software can track each instrument in a set and even alert technicians if they have missed a step in the sterilization process, giving them more control over their surgical inventory.
Sterile processing tracking systems give SPD staff key information they need to do their jobs. This could include access to details about specific instruments and their cleaning instructions, which saves SPDs time by eliminating the need to track down special care instructions. Surgical instrument management systems can also cut time assembling case carts by more than a third. Electronic documentation is completed with the click of a button or by selecting from a drop-down menu, which is quicker than writing and eliminates concerns about legibility and ink fading.
Sterile processing tracking systems are less prone to human error than paper methods. Each instrument is tracked for its entire lifespan, including patient touchpoints, helping to reduce the likelihood of them ending up inside patients.
Surgical instrument tracking technology holds institutions accountable to regulatory and compliance policies by documenting each step in the process, creating alerts if a process is missed and barring technicians from moving to the next procedure if the previous has not been completed.
“The OR has better visibility into the processes of the sterile processing department because they can see where instruments are in real-time. The OR can also be assured that their patient is going to receive the best care because they can see the sterile processing department is hitting all the steps required for patient safety,” said Kobel.
Sterile processing is an integral piece of patient safety, and new technologies like sterile processing tracking systems are making it easier than ever to meet rigorous compliance standards. The function is only improving, and these advancements pave the way for fewer infections and surgical errors for the benefit of patients everywhere.