Ruth P. Shumaker, RN, BSN, CNOR, a healthcare management consultant who focuses on both ambulatory surgery centers and hospital settings, discusses 10 ways to develop a strong sterile processing program in a surgery center.
Because the complexity of SPD has increased, Ms. Shumaker advises that surgery centers know the standards from the Association for the Advancement of Medical Instrumentation, the Association of periOperative Registered Nurses and recommendations outlined in the disinfection and sterilization guideline from the Centers for Disease Control and Prevention. She says while these 10 steps are essential, there are many aspects one must know to develop a strong SPD.
1. Prioritize the infection preventionist role. Ms. Shumaker says some ASCs may lack proper infection prevention policies because surgery center leaders do not prioritize the infection preventionist role. "I was recently at an APIC meeting, and there were a lot of hospital-based infection preventionists, but I did not see many who worked in ASCs," she says. She says many surgery centers struggle to staff a full-time infection preventionist on a limited staffing budget, but that does not mean the role should be overlooked. Surgery centers can assign infection prevention/surveillance duties to a nurse who can also head quality assurance, quality improvement and staff education. Based on the responsibilities of the role, the knowledge and skills required to be effective are diverse and specialized. Knowledge of microbiology, epidemiology, infectious diseases, sterilization, as well as disinfection, medication, vaccine and antibiotic usage, strategic and regulatory requirements, are essential.
2. Analyze case data to determine instrumentation needs. In order to run an efficient ambulatory surgery center, you must have adequate instrumentation, Ms. Shumaker says. "You need adequate instrumentation so that you can increase your turnover time and eliminate flash sterilization as much as possible," she says. "Flash sterilization should not be a routine modality." To make sure instruments are being sterilized thoroughly, the ASC must have enough instruments that staff will not be rushing the SPD department through the cleaning and sterilization process.
In order to supply the ASC with adequate instrumentation, Ms. Shumaker recommends looking at case data and determining which cases are performed most frequently. "As a consultant or an ASC administrator, it doesn't take me long to know the types of procedures I'm doing frequently," she says. "I've got the data in front of me just trending what type of procedures I do, and I just need to take an inventory of the instruments those cases use." Once you know which instruments the ASC uses most often, you will be able to plan for those cases by ordering adequate instrumentation.
3. Improve device reprocessing. Patient care depends not only on the effectiveness of the sterilization process, but also on the unit design, decontamination, disassembling and packaging of the device, as well as loading the sterilizer, monitoring, sterilant quality and quantity and the appropriateness of the cycle for the load contents. Manufacturers must provide complete and comprehensive written instructions on handling, cleaning, disinfection, testing packaging and sterilization of there instruments and devices. Ms. Shumaker says ASCs must follow manufacturer's guidelines when cleaning and sterilizing instrumentation
4. Don't let flash sterilization become the norm. Flash sterilization of instruments should not be the norm at your surgery center, Ms. Shumaker says. "You can flash sterilize if you adequately clean your instruments and use the proper time and temperature," she says. "It's when flash sterilization becomes the norm rather than the exception that you have a problem."
Flash sterilization is often used when there is insufficient time to process by the preferred wrapped or container method and inadequate instrumentation. AORN recommends that "use of flash sterilization be kept to a minimum … flash sterilization should be used only in selected clinical situations and in a controlled manner," according to AORN's Recommended Practices for Sterilization in Perioperative Practice Setting, included in AORN's Perioperative Standards and Recommended Practices.
The Joint Commission defines flash sterilization as the process of sterilizing unwrapped instruments using steam for three minutes at 270 F at 27-28 pounds of pressure. For flash sterilization, a chemical indicator should be placed next to the item being sterilized in the instrument tray or container. At the completion of the cycle, the indicator should be examined for the appropriate color change. Ms. Shumaker says she has seen surgery centers where the first instrument set of the day was cleaned and sterilized in SPD, but every instrument set after that is flash sterilized.
5. Require staff to document flash sterilization. Staff should document every single time they flash sterilize an instrument or set, Ms. Shumaker says. "You've got to absolutely make sure that your staff is documenting every single time they flash sterilize, as well as keep permanent records in the sterile processing department," she says.
Record keeping is essential, Ms. Shumaker adds. A log should be created that indicates the date, name of person who decontaminated the item, name or number of sterilizer, sterilization load number, type of sterilization cycle used, load contents, sterilization time and temperature, time the load entered and was removed from the sterilizer, person responsible for loading the sterilizer, patient name (optional per ASC policy) operating room number, result of chemical indicator and Bowie Dick type testing if applicable. Trending what your facility flash sterilizes is important so that you know how many times something is being sterilized," she says. Look at trending data over time to determine which instruments are flash sterilized more than others.
6. Pre-soak all instruments before sterile processing. Cleaning starts in surgery, when instruments are placed in a pre-soak solution, Ms. Shumaker says. "You should have a pre-soak solution or spray that you put on the instruments to start breaking down bio burden, blood and debris on the instruments," she says. "This makes it easier for SPD to clean the instrument."
She says many facilities are not adamant about pre-soaking, which can become a problem when the surgery center needs items turned around quickly or the instruments have been sitting around for a while. It takes time to properly clean instruments. "You should make it a policy that the instrument needs pre-cleaning, starting in surgery, before it ever hits SPD," she says.
7. Never reprocess single-use devices. Reprocessing single-use devices should be strictly prohibited in a surgery center, Ms. Shumaker says. In Oct. 2002, the FDA Medical Device User Fee and Modernization Act was signed into law, imposing a number of requirements to regulate the reuse of single use devices. Reusable devices are those that include guidance on reuse from the original manufacturer. She says staff may be tempted to reprocess single-use devices because of inadequate instrumentation or devices, but this should not occur unless you have the manufacturer's recommendation it can be reprocessed and how it should be cleaned and processed.
"I think at times, ASCs are at a tremendous disadvantage because they don't have as many on-hand instruments and supplies," she says. "You can't simply reprocess single-use items. There has been a big push to stop reprocessing single-use items in the hospital." In the past, single-use devices considered for reprocessing included "outdate" items.
8. Investigate reprocessing facilities before using them. Many ASCs outsource reprocessing because they do not have the resources in-house. The Association of Medical Device Reprocessors is a trade-based association representing companies that are third-party reprocessors of single-use medical devices. Membership in this organization is voluntary, and members of AMDR agree to be registered with the FDA and comply with all FDA regulations.
If your facility outsources reprocessing, Ms. Shumaker recommends investigating and even visiting the facility prior to making a selection. "I was in Los Angeles on a consulting contract, and I went to the facility to see what they were doing," she says. "I watched every step and looked at their entire operation, and I walked away feeling very, very comfortable." Ask the facility to show you their documentation and staff education processes so that you know what is happening to your instruments and/or devices when you send them for reprocessing.
9. Pay for SPD staff to undergo certification and re-certification. Surgery centers should hire qualified personnel specifically to work in the sterile processing department, and the surgery center should encourage and pay for them to undergo certification and re-certification, Ms. Shumaker says. SPD professionals can receive certification through the Certification Board for Sterile Processing and Distribution, a non-profit certification board that plans, develops and administers competency-based examinations for healthcare personnel performing cleaning, disinfection, sterilization and inventory management activities. The surgery center should pay for staff to undergo training and certification because requiring certification without providing funding may be cost prohibitive and put a financial strain on workers, Ms. Shumaker says.
10. Educate ASC nurses on sterile processing. ASC nurses should also be educated on sterile processing practices, Ms. Shumaker says. If your nurse education provider doubles as an infection preventionist, ask him or her to teach nurses about sterile processing. She says many surgery center nurses have not undergone adequate education on sterile processing. "The nurse has to spend some time in sterile processing," she says. "Nurses are involved in doing things quickly and getting instruments into the operating room, so we need nurses to have that knowledge." She says surgery centers should put nurses through an orientation phase that goes over flash sterilization and sterile processing and details which processes are acceptable for specific situations.
Related Articles on Infection Control:
HAP Issues Voluntary Recall of All Lots of Povidone Iodine Products
Johns Hopkins Temporary ED Staff Poses Increased Patient Safety Risks
JAMA: Discharged ICU Patients Face Higher Risk of Unintentionally Stopping Medications
Because the complexity of SPD has increased, Ms. Shumaker advises that surgery centers know the standards from the Association for the Advancement of Medical Instrumentation, the Association of periOperative Registered Nurses and recommendations outlined in the disinfection and sterilization guideline from the Centers for Disease Control and Prevention. She says while these 10 steps are essential, there are many aspects one must know to develop a strong SPD.
1. Prioritize the infection preventionist role. Ms. Shumaker says some ASCs may lack proper infection prevention policies because surgery center leaders do not prioritize the infection preventionist role. "I was recently at an APIC meeting, and there were a lot of hospital-based infection preventionists, but I did not see many who worked in ASCs," she says. She says many surgery centers struggle to staff a full-time infection preventionist on a limited staffing budget, but that does not mean the role should be overlooked. Surgery centers can assign infection prevention/surveillance duties to a nurse who can also head quality assurance, quality improvement and staff education. Based on the responsibilities of the role, the knowledge and skills required to be effective are diverse and specialized. Knowledge of microbiology, epidemiology, infectious diseases, sterilization, as well as disinfection, medication, vaccine and antibiotic usage, strategic and regulatory requirements, are essential.
2. Analyze case data to determine instrumentation needs. In order to run an efficient ambulatory surgery center, you must have adequate instrumentation, Ms. Shumaker says. "You need adequate instrumentation so that you can increase your turnover time and eliminate flash sterilization as much as possible," she says. "Flash sterilization should not be a routine modality." To make sure instruments are being sterilized thoroughly, the ASC must have enough instruments that staff will not be rushing the SPD department through the cleaning and sterilization process.
In order to supply the ASC with adequate instrumentation, Ms. Shumaker recommends looking at case data and determining which cases are performed most frequently. "As a consultant or an ASC administrator, it doesn't take me long to know the types of procedures I'm doing frequently," she says. "I've got the data in front of me just trending what type of procedures I do, and I just need to take an inventory of the instruments those cases use." Once you know which instruments the ASC uses most often, you will be able to plan for those cases by ordering adequate instrumentation.
3. Improve device reprocessing. Patient care depends not only on the effectiveness of the sterilization process, but also on the unit design, decontamination, disassembling and packaging of the device, as well as loading the sterilizer, monitoring, sterilant quality and quantity and the appropriateness of the cycle for the load contents. Manufacturers must provide complete and comprehensive written instructions on handling, cleaning, disinfection, testing packaging and sterilization of there instruments and devices. Ms. Shumaker says ASCs must follow manufacturer's guidelines when cleaning and sterilizing instrumentation
4. Don't let flash sterilization become the norm. Flash sterilization of instruments should not be the norm at your surgery center, Ms. Shumaker says. "You can flash sterilize if you adequately clean your instruments and use the proper time and temperature," she says. "It's when flash sterilization becomes the norm rather than the exception that you have a problem."
Flash sterilization is often used when there is insufficient time to process by the preferred wrapped or container method and inadequate instrumentation. AORN recommends that "use of flash sterilization be kept to a minimum … flash sterilization should be used only in selected clinical situations and in a controlled manner," according to AORN's Recommended Practices for Sterilization in Perioperative Practice Setting, included in AORN's Perioperative Standards and Recommended Practices.
The Joint Commission defines flash sterilization as the process of sterilizing unwrapped instruments using steam for three minutes at 270 F at 27-28 pounds of pressure. For flash sterilization, a chemical indicator should be placed next to the item being sterilized in the instrument tray or container. At the completion of the cycle, the indicator should be examined for the appropriate color change. Ms. Shumaker says she has seen surgery centers where the first instrument set of the day was cleaned and sterilized in SPD, but every instrument set after that is flash sterilized.
5. Require staff to document flash sterilization. Staff should document every single time they flash sterilize an instrument or set, Ms. Shumaker says. "You've got to absolutely make sure that your staff is documenting every single time they flash sterilize, as well as keep permanent records in the sterile processing department," she says.
Record keeping is essential, Ms. Shumaker adds. A log should be created that indicates the date, name of person who decontaminated the item, name or number of sterilizer, sterilization load number, type of sterilization cycle used, load contents, sterilization time and temperature, time the load entered and was removed from the sterilizer, person responsible for loading the sterilizer, patient name (optional per ASC policy) operating room number, result of chemical indicator and Bowie Dick type testing if applicable. Trending what your facility flash sterilizes is important so that you know how many times something is being sterilized," she says. Look at trending data over time to determine which instruments are flash sterilized more than others.
6. Pre-soak all instruments before sterile processing. Cleaning starts in surgery, when instruments are placed in a pre-soak solution, Ms. Shumaker says. "You should have a pre-soak solution or spray that you put on the instruments to start breaking down bio burden, blood and debris on the instruments," she says. "This makes it easier for SPD to clean the instrument."
She says many facilities are not adamant about pre-soaking, which can become a problem when the surgery center needs items turned around quickly or the instruments have been sitting around for a while. It takes time to properly clean instruments. "You should make it a policy that the instrument needs pre-cleaning, starting in surgery, before it ever hits SPD," she says.
7. Never reprocess single-use devices. Reprocessing single-use devices should be strictly prohibited in a surgery center, Ms. Shumaker says. In Oct. 2002, the FDA Medical Device User Fee and Modernization Act was signed into law, imposing a number of requirements to regulate the reuse of single use devices. Reusable devices are those that include guidance on reuse from the original manufacturer. She says staff may be tempted to reprocess single-use devices because of inadequate instrumentation or devices, but this should not occur unless you have the manufacturer's recommendation it can be reprocessed and how it should be cleaned and processed.
"I think at times, ASCs are at a tremendous disadvantage because they don't have as many on-hand instruments and supplies," she says. "You can't simply reprocess single-use items. There has been a big push to stop reprocessing single-use items in the hospital." In the past, single-use devices considered for reprocessing included "outdate" items.
8. Investigate reprocessing facilities before using them. Many ASCs outsource reprocessing because they do not have the resources in-house. The Association of Medical Device Reprocessors is a trade-based association representing companies that are third-party reprocessors of single-use medical devices. Membership in this organization is voluntary, and members of AMDR agree to be registered with the FDA and comply with all FDA regulations.
If your facility outsources reprocessing, Ms. Shumaker recommends investigating and even visiting the facility prior to making a selection. "I was in Los Angeles on a consulting contract, and I went to the facility to see what they were doing," she says. "I watched every step and looked at their entire operation, and I walked away feeling very, very comfortable." Ask the facility to show you their documentation and staff education processes so that you know what is happening to your instruments and/or devices when you send them for reprocessing.
9. Pay for SPD staff to undergo certification and re-certification. Surgery centers should hire qualified personnel specifically to work in the sterile processing department, and the surgery center should encourage and pay for them to undergo certification and re-certification, Ms. Shumaker says. SPD professionals can receive certification through the Certification Board for Sterile Processing and Distribution, a non-profit certification board that plans, develops and administers competency-based examinations for healthcare personnel performing cleaning, disinfection, sterilization and inventory management activities. The surgery center should pay for staff to undergo training and certification because requiring certification without providing funding may be cost prohibitive and put a financial strain on workers, Ms. Shumaker says.
10. Educate ASC nurses on sterile processing. ASC nurses should also be educated on sterile processing practices, Ms. Shumaker says. If your nurse education provider doubles as an infection preventionist, ask him or her to teach nurses about sterile processing. She says many surgery center nurses have not undergone adequate education on sterile processing. "The nurse has to spend some time in sterile processing," she says. "Nurses are involved in doing things quickly and getting instruments into the operating room, so we need nurses to have that knowledge." She says surgery centers should put nurses through an orientation phase that goes over flash sterilization and sterile processing and details which processes are acceptable for specific situations.
Related Articles on Infection Control:
HAP Issues Voluntary Recall of All Lots of Povidone Iodine Products
Johns Hopkins Temporary ED Staff Poses Increased Patient Safety Risks
JAMA: Discharged ICU Patients Face Higher Risk of Unintentionally Stopping Medications
