Surgical Instrument Traceability: Never Events
Outside of the sterile processing industry, there is a widespread belief that hospitals can trace each surgical instrument used on each patient. Outsiders presume that if they have surgery and something goes wrong, organizations can identify who the surgical instruments were used on prior. Infection control, risk management, and administrators often hold this same belief. When an investigation starts after a process failure (for example, positive biological result or bioburden on a tray in the operating room), leaders are often shocked when sterile processing and the operating room cannot trace trays between patients. This inability to trace surgical instruments between patients leads to organizations notifying large patient groups that they may have been exposed. For patients receiving this phone call from their doctor or a letter from their hospital, the best case is heart-wrenching anxiety until their exposure tests come back negative, and the worst is if their tests come back positive. Either way, they have been harmed by the industry promising to do no harm.
We can do better. Sterile processing leaders must lead the way in their organizations to achieve full traceability for every surgical instrument for every surgical patient. Let us start by tracing surgical trays, peel pouches, and wrapped instruments to the patient. Let us build up to tracing to the individual instrument level. This path is not easy because it takes significant buy in from the operating room and sterile processing front line teams; it takes investment from administration in systems and technology capable of tracing and tracking; and it takes consistency, determination, and a dedication to a cause many perceive as impossible to achieve. Full traceability can be achieved and must be achieved.
Positive biological events
With widespread use of every load biological monitoring, positive biological events occurring and trays reaching the operating room are rare. Additionally, the speed of biological indicator results has advanced significantly. In today’s sterile processing department, most facilities performing every load biological monitoring have biological tests that are read quickly, often before the trays are cool enough to transport to the operating room. When there is a sterilization failure, typically it is quickly identified in the sterile processing department. The sterilization load is recalled and the surgical instruments are reprocessed, having never left the department.
Not every facility has every load biological monitoring. Even when organizations claim to perform every load biological monitoring, they often really mean they perform every load biological monitoring for steam sterilization. For low-temperature hydrogen peroxide plasma or vaporized hydrogen peroxide sterilization methods and immediate-use steam sterilization, many organizations do not perform every load biological monitoring because of the high cost of the biological indicators and complexity with implementation. In these situations, there is an added risk when a biological indicator test result is positive. If it does, every load ran since the last negative result must be recalled. In departments with shortages of instrument trays and high volumes of turnovers, there is a high probability that the recall will not be successful, meaning recalled surgical instruments have already been used on patients. Without traceability of the surgical instrument trays to the patient level, every patient that the recalled trays may have been used on will need to be notified that they may have been exposed.
Surgical site infection investigations
Infection control practitioners routinely monitor for surgical site infections. When there is an increase or pattern of surgical site infections, infection control practitioners will typically initiate an investigation or root cause analysis. Without surgical instrument traceability between patients, it is nearly impossible to identify if there are any connections between affected patients through surgical instrument trays.
A few years ago, when the ERCP scopes were identified as a source of outbreak between patients at organizations nationwide, investigators were able to trace the infections to the scope level and the patient level, significantly aiding in identifying the root cause of inadequate cleaning and high-level disinfection of the ERCP scope elevator. One of the byproducts of what occurred is that investigators identified that even with ERCP scope traceability, full traceability was not occurring because the accessories were not traced patient to patient. During the investigations, microorganisms were identified on multiple patients that had used different scopes. This lack of connection initially slowed the identification of the root cause. Eventually, investigators identified that the accessories were the missing link connecting scopes and patients in the outbreak. Today, when scope valves and accessories are high-level disinfected, they are kept with the scope to ensure traceability. Similar industrywide patterned occurrences of surgical site infections have occurred with shavers and other surgical instrumentation.
Traceability of surgical instruments to the patient level greatly improves the capability for infection control practitioners and investigators to identify root causes during surgical site infection investigations. Being able to identify and solve the root cause quickly, ultimately reduces harm to our patients.
Sterile processing leaders have two primary callings: keep patients safe and keep employees safe. Sterile processing technicians work in one of the most dangerous departments in hospitals and surgery centers. Techs are tasked with handling reusable instruments contaminated with high-risk bloodborne pathogens. Instrument trays often are received in the decontamination area mixed together like spaghetti. Sharp scissors, hooks, and towel clips are intermixed with the other contaminated and biohazardous surgical instruments. Sterile processing technicians are tasked with donning their personal protective equipment, including thick mil decontamination gloves, and manually cleaning by hand these contaminated surgical instruments. Team members are trained and competent, but this is still high-risk work. When an employee is cut in the decontamination area, they are at high risk for exposure to bloodborne pathogens.
Early in my career, I was cut by a wayward towel clip left open inside a case cart on the shelf. I reached in to pull a contaminated surgical tray out, and the sharp points of the towel clip punctured through my gloves and cut my hand. I was exposed, and it was the scariest day of my life.
When a team member is exposed, a process starts. Typically, employee health is notified and the employee may go to the emergency department or the nursing supervisor to have blood drawn and to start testing. If the source patient is known, then an attempt will be made to get consent from the patient and test the source patient for bloodborne pathogens. This is the best case and the quickest way to know if the team member has been exposed. Without traceability of surgical instruments to patients, the source patient may not be able to be identified. The exposed team member may have to undergo prophylactic treatment, which can be hard on their body and health. Additionally, the team member will be under stress, fear, and anxiety, worrying about what they may have been exposed to.
As sterile processing leaders, it is our job through training and process improvement to prevent injury and harm to our team members. It is our duty to our team members to ensure that in the event they are harmed, we have traceability to the source patient.
Tracing surgical instrument to the patient level is achievable. Surgical instrument tracking systems can be implemented and interfaced with surgical scheduling systems. Surgical instruments can be scanned to surgical cases with unique identifiers, ensuring traceability. Existing technology has the capability to trace to the instrument level using dots or laser-printed barcodes. The industry is on the cusp of technological advances that will use new novel technology to make tracing intuitive and simple. We are capable of this achievement. We can trace surgical instruments to the patient level. We must trace surgical instruments to the patient level.
Marjorie Wall is a director of sterile processing at Kaiser Permanente and IAHCSMM board of directors member. As a sterile processing leader with over 20 years of industry experience, Marjorie pushes the boundaries for change and innovation in her organization and in the industry. Marjorie built her career turning around underperforming departments and is now an industry change driver as a writer and keynote speaker.
Marjorie has achieved a masters of organizational leadership from Azusa Pacific University, CRCST, CIS, and CHL certifications from IAHCSMM, and Six Sigma Black Belt Certification from the American Society for Quality. Marjorie has personally developed 12 frontline staff into SPD leaders and 13 SPD techs into Six Sigma Yellow Belts.
Marjorie Wall’s life philosophy is, “Sometimes you have to take a leap and build your wings on the way down.” We have to be willing to change and improve through the toughest challenges. We have to lead SPD.
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