According to the article “Disinfection and Sterilization in Health Care Facilities: An Overview and Current Issues” by William A. Rutala, Ph.D., M.P.H. and David J. Weber, M.D., M.P.H., published in ScienceDirect, achieving disinfection and sterilization through the use of disinfections and sterilization practices is imperative for making sure that medical and surgical instruments do not transmit infectious pathogens to patients.
Of course, it is not necessary, or frankly, even possible to sterilize all items related to patient care, hospital policies need to identify whether the items need cleaning, disinfection, or sterilization. Policies at facilities depend on the item’s intended use, manufacturer’s recommendations, and guidelines.
The article states that “When properly used, disinfection and sterilization can ensure the safe use of invasive and noninvasive medical devices. The method of disinfection and sterilization depends on the intended use of the medical device: critical items (contact sterile tissue) must be sterilized before use; semicritical items (contact mucous membranes or nonintact skin) must be high-level disinfected; and noncritical items (contact intact skin) should receive low-level disinfection. Cleaning should always precede high-level disinfection and sterilization. Current disinfection and sterilization guidelines must be strictly followed.”
Healthcare Purchasing News (HPN) interviewed two leaders on the differences between high-level disinfection (HLD) and sterilization, specifically. With hospitals and health systems being understaffed and overloaded, how are they handling education for staff? What are the challenges and trends today?
Educating staff
When it comes to educating staff on the difference between HLD and sterilization, Chasity Seymour, BSHM, CST, CHL, CRCST, CIS, AGTS, clinical education specialist, mid-southern region, STERIS says that “Healthcare facilities offer staff a variety of methods to learn about HLD and sterilization. Using IFUs, Wallcharts, and other manufacturer educational collateral is very common. Equipment and consumable vendor in-servicing, CE education (Webinars, Live presentations, conferences, seminars), and any regulatory recommendations or requirements received from credentialing and government agencies based on changes in the industry or infectious outbreaks also drive education into this area.”
She adds, “Few facilities require certifications of staff that would assist staff in understanding the differences related to HLD and sterilization. There are some exceptions where state regulators mandate staff be certified in Sterile Processing. HSPA and CBSPD provide certifications specific to endoscope processing.”
Jan Prudent, BA, CRCST, CIS, CER, CHL, CFER is sterile processing manager at Eastern Idaho Medical Center. She also currently serves as HSPA’s Secretary/Treasurer. Prudent says, “First of all, everything that can be sterilized is sterilized in our facility. We require all staff to obtain their CRCST certification. Once they have their base certification, staff are encouraged to obtain the CER and CIS certifications. We have in-services and trainings at least quarterly for equipment, endoscopes, quality audits and recording of data.”
Damien Berg, BA, BS, CRCST, AAMIF, HSPA’s VP of strategic initiatives, says, “It is always important to educate each employee about decontamination and sterilization basics as well as orient them to microbiology basics and the science behind the processes they will perform. This can be done by dedicated sterile processing educators or managers during employee orientation, upon hire and at set intervals, and manufacturer in-service training can also be beneficial. Specific to HLD and sterilization, technicians should be taught the key differences: HLD can be expected to destroy microbial organisms but not all bacterial spores. Sterilization, on the other hand, eliminates microbes, including bacterial spores, but will not be appropriate for all items being processed (based on the intended use or clearance of the device).”
Challenges
Seymour commented on the challenges and obstacles that occur when working with HLD and sterilization processes. She says, “Most common challenges are related to lack of education and training on both microbiocidal modalities, processes, equipment, products, and device compatibility. These areas often lack formal training and education systems on both modalities. Some may share educators with other departments who are unable to devote the time needed. Staffing shortages and turnover is a contributor to this as well. Staff may not receive training because experienced staff are not available to properly train on the processes.”
“Downtime due to repairs, poor utilities, and improper maintenance are additional challenges. Often instructions for use (IFU) are not followed. IFUs create challenges due to length, significant number of steps, and conflicting instructions from the device, equipment, and consumables. Reconciliation can often lead to situations where the practice conflicts with standards. Vendor in-services and training, a facility competency-based training program, and continuing education can help in the reconciliation process.”
Additionally, Seymour adds, “Manual processes continue to be a challenge. Manual cleaning and HLD is prone to misunderstanding. Every endoscope manufacturer and model has a unique IFU. Remembering all the steps and required accessories is difficult. Add to this the pressure to process endoscopes faster, which creates an opportunity to miss a step(s). Some solutions are easier to solve, increased inventory for example. Some changes look towards technology. Using validated automated processes and technologies help reduce human errors when using HLD or sterilization. Workflow software which defines and checks the steps of processing can also help reduce the educational hurdle facilities face.
And for solutions, Seymour states that “Ultimately, education and certification will remain a cornerstone for mitigating or eliminating challenges and obstacles in SPD and GI.”
Berg comments, “The most common challenges or obstacles found in sterile processing departments regarding the processing of medical devices, either by HLD or sterilization, are two-fold: time and complexity.
“When looking at the process and workflow needed to process devices accurately and safely, it is essential to understand how long these steps take—not just by following the IFU but also by working with the layout of the department, the staff members assigned, and any external challenges. One solution is to map out the process steps in the department, taking into consideration the entire workflow “current state” and then seeing what can be improved and done to mitigate the obstacles and, hopefully, remove unnecessary steps. This approach can make it easier to work in the department and free up valuable needed time so the team can perform the correct steps and processes for either HLD or sterilization.”
“The second issue our professionals face is the complexity of today's medical devices,” Berg adds. “It is not that we cannot process these devices or lack the sterilization/disinfection technology to do what is required, but there is a greater need for training—and maintaining employee competencies. In addition to the learning curve, these devices can also require additional or new equipment to align with the processing instructions. Understanding the complexity and needs that will challenge our processes and people will help in the development of an effective strategy. An effective approach is for sterile processing leaders to participate in the healthcare organization’s purchasing process; in doing so, they can be part of the review process and provide valuable input about the HLD and sterilization processes (to include departmental needs such as staffing, training and equipment).”
Jon Wood, MBA, CRCST, CST, clinical educator, HSPA, added his comments as well. He says, “There have been numerous media reports about contaminated surgical instrumentation making its way to the operating room. Whether you work in healthcare or not, this type of situation should be one of those never events. In a recent news article, there is mention of staffing shortages within the sterile processing department. As the article suggests, I feel staffing shortages are among the most common challenges sterile processing leaders face today.”
“In today’s sterile processing departments, technicians are processing more complex devices than ever before in history,” Wood adds. “In some facilities, there may be a lack of understanding concerning the complexity of instrumentation, along with the resources required to maintain medical devices. These devices require precise cleaning steps and instructions that, when done correctly, can require significant time (some key examples are the decontamination of endoscopes and robotic instruments). Internal and external visualization and testing is essential, precise and requires a time commitment, and no steps can be rushed or skipped.”
He says “All too often, the demands and expectations for medical device processing and turnover puts increased pressure on sterile processing—to the point where cleaning and processing steps start to suffer (such as skipping or rushing steps to meet demands of procedural areas). After a while, the missed steps and cut corners can become the new accepted practice, which obviously poses a risk to patient safety.”
Yet, Wood remains optimistic, “Hope is not lost, but it takes work and committed leaders, not only in sterile processing but within our operating rooms and other procedural areas. Surgeons and hospital leadership must also understand the complexity of the given task, collect data, streamline processes and ultimately determine the appropriate number of staff that will be able to safety and effectively process the medical devices. This is a continual process that needs to be consistently evaluated to ensure the department is meeting the demands of its customers and the needs of the patients.
Trends
When it comes to trends and what is up and coming in this realm, Prudent comments, “A huge win would include sterilization for all endoscopes. That would mean validation in a variety of sterilizers. The endoscope vendors and the sterilizer vendors need to work hand-in-hand with the end user instead of each of them trying to invent their own wheel. Sterilization is best practice for patient safety.”
Seymour added in her observations, she says, “I see an increase in the types of disposable components used in conjunction with flexible endoscopes. The industry continues to move away from reusable components like buttons/valves and water bottles to disposable.”
“With the challenges of staff turnover and the increased complexity of IFU, manual operations may be negatively impacted,” she adds. “Automated processes like endoscope flushing aids; automated endoscope reprocessors that include both cleaning and HLD ; and automated sterilization processors will provide the processing consistency facilities desire.”
Seymour says, “The continual advancement of procedures to minimally invasive robotic procedures may require additional knowledge, education, and preparation for new technology.”
Ensuring success
Regarding future success, Seymour concludes “Formal education or training, competency assessment, and continuing education will always help to ensure staff understand the processes; properly use and accurately interpret sterility assurance and HLD monitoring test results; and document properly. Periodic observation of all staff is critical. Leadership should observe staff several times throughout the year to correct process drifts. Competency should not be considered once a year or upon the hiring process but be done on an ongoing basis.
“Device manufactures should work to ensure devices meet standard high-level disinfection or sterilization cycles, provide clear concise cleaning instructions, provide more visual images to guide the user, and digital content in the form of in-service videos or electronic interactive IFUs. Moving away from manual HLD and implementing fully automated processes for disinfection or sterilization will remain a goal to help increase patient safety.”
