Sterile Processing Issues: Industry Experts Address Persistent Problems

Infection Control Today invited experts from industry to share their thoughts and advice addressing a number of pertinent issues that face sterile processing professionals.

Loaner Instrumentation
Bob Marrs, BA, CRCST, CIS, CHL, director of consulting services and field operations, Aesculap

Q: What are the lingering issues you see related to loaner instruments?
A: Vendors may not always provide adequate amounts of sets for multiple surgical procedures. There may be six total joints scheduled and a vendor may only provide one complete set of trays or two complete sets. This places an enormous burden on The CSD department. It also causes a ripple effect in these facilities.
- An inability to follow manufacturers' recommendations for cleaning and sterilization. Causing staff to perform shortcuts in order to get sets back to the OR for surgical procedures.
- An increase in Immediate Use Sterilization for routine turnover or facilities performing IUS on sets that are not validated for IUS.
- Inadequate training concerning cleaning disinfection and sterilization. Vendors should perform training for CSD departments prior to these trays being placed into service.
 
Q: Can you briefly summarize some best practices to help reduce loaner-related headaches?
A: The three Cs:
Communication: There can not be enough communication concerning issues related to loaner trays. A wise CSD leader will over communicate to all parties involved with these trays. Examples should include; OR leadership, physicians, vendors, CSD staff, infection preventionists in some cases
Collaboration: Again, working with the aforementioned parties to ensure that every patient is provided instrumentation that has been properly decontaminated and placed through terminal sterilization. This provides the same standard of care for all.
Control: Control through the use of a very robust policy and procedure. This is the most important aspect of dealing appropriately with these trays. This document will hold all parties accountable.

Q: What's key to take away from IAHCSMM's loaner policy?
A: It is the culmination of hours of work from numerous thought leaders in CSD who have dealt with and overcome many of the obstacles surrounding this issue.  This is an excellent document that provides a wonderful template for facilities to follow. The great news is that you do not have to reinvent the wheel. This document coupled with the Loaner Receipt document that was recently released by IAHCSMM will serve as great tools to serve the CSD, OR and patient. They are a win-win for all!

Reprocessing Complex Instruments
Chuck Hughes, vice president of infection prevention consulting services, Cantel Medical/SPSmedical Supply Corp.

Q: What are the most difficult instruments to reprocess and why?
A: The most difficult instruments to reprocess are those that have various validated instructions for use.  Sterile processing departments here in the U.S. and around the world, prefer to use  standardized cleaning procedures and in fact, need to do so in order to turn instruments quickly.  Unfortunately, many complex instruments or instrument sets, such as orthopedic, spine and/or  ophthalmic, as well as rigid container systems come with detailed cleaning and reprocessing instructions that vary widely from manufacturer to manufacturer. 

Q: Why is it critical to follow manufacturers' IFUs when reprocessing devices and instruments?
A: For patient safety, as following the manufacturer’s validated instruction for use is the only way a healthcare facility can ensure they are properly reprocessing the reusable device.  Not doing so can and has resulted in surgical site infections, accreditation Surveyor findings and unwanted national media attention.

Q: What are some best practices to remember when handling complex instruments?
1. Instrument reprocessing starts at point of use with pre-cleaning and timely transport to the Decontamination area. National standards are very clear regarding the need for wiping gross soil off instruments during the procedure and irrigating lumens.  This along with using a pre-clean foam or gel solution prior to transport keeps the blood from drying which facilitates effective and faster cleaning.
2. Decontamination personnel must follow manufacturers' cleaning IFU and to do so, must have access to them, along with the necessary resources to comply with them.  In my mind, this is the most common best practice violation I see when I conduct mock surveys of healthcare facilities. And, or course training and continuing education must be provided to all personnel in order for them to understand and follow each manufacturer's validated IFU. 
3. Each facility should encourage their healthcare workers to work with a questioning attitude, which means if you don’t know – ask?  Instrument reprocessing has become very complex and when healthcare workers  properly reprocess a reusable medical device they help save patient’s lives.  However, when there is a short cut in the reprocessing procedures whether intentional or not, then patient’s lives are put at risk.

Bioburden on InstrumentsRobert B. Dybec RN, MS, CPSN, CNOR, EMT-B, nurse manager of the operating room, Winthrop-University Hospital, for Ruhof Corporation

Q: How would you characterize the problem of bioburden being left on surgical instruments?
A: The problem of bioburden on surgical instruments has many issues. As instrument technology and manufacturing capabilities have developed we see more versatile, delicate and complicated instruments that have come to market. The construction of these instruments that contain moving parts, inner channels or lumens and other components makes them at times difficult to properly clean. This combined with the understanding that biofilm plays a major role in healthcare acquired infections today dictates that we must do everything possible to properly clean, disinfect and sterilize our instrumentation.

Q: What role does ATP play in determining bioburden levels?
A: ATP testing is a valuable tool to help us determine whether our cleaning and disinfecting practices have been effective. ATP is not typically used to measure levels of bioburden but the results will indicate high and low levels of possible contaminants.
Technicians, Nurses and other healthcare workers involved in the use and cleaning of surgical instrumentation should follow guidelines established by professional organizations and manufacturers of instrumentation when cleaning these devices. Initial education as well as continuing education is important.

Q: What are some best practices to ensure proper care of instruments/scopes following use?
A: Some of the key points should include:
- Immediate cleaning of instruments and scopes after use. If this is not possible then some type of humectants with enzymes should be sprayed on the device to prevent bioburden from drying on the instrument which also facilitates the development of biofilm.
- Use of an ATP testing device to check equipment after processing will validate cleaning and disinfecting practices. It is a quick and easy way to identify possible trends that can be corrected i.e. bad equipment, staff that require education or retraining, inferior cleaning products and ultimately will help reduce the risk of cross contamination of microbes between patients.

Sterilization Quality Control
Dorothy Larson, CSPDT, technical service representative, 3M

Q: What are some pieces of advice for successful sterilization monitoring?
Standards and recommended practices: Key to a successful sterilization monitoring program is the knowledge and understanding of the various sterilization quality assurance guidelines, outlined in ANSI/AAMI ST79, Section 10 and AORN’s RP for Sterilization, Sections V-VII and XX. One way to reinforce the steps of the steam sterilization process is by initiating a thorough review of the recommended practices. Engage staff members to lead a review of the various sections and then discuss as a group, focusing on the rationale for each recommendation.
Documentation: Surveyors are paying attention to proper documentation. Audit for compliance to policies and procedures and facility documentation. Record keeping systems must be complete, and the recorded information legible.
Reading cycle printouts: Learn how to read the detail of sterilizer cycle printouts. Verify the correct time and temperature, and air removal method.  A sterilizer labeled as ‘Pre-vacuum,’ does not always mean that all the cycles programmed are pre-vacuum . Printout tapes reveal the air removal method, such as pre-vacuum or gravity.  
Certification: Ensure that staff is certified in sterile processing and able to demonstrate competencies in all areas of sterile processing and distribution activities. All sterile processing staff, including supervisory personnel, should become certified within 2 years of employment.

Q: What are some best practices related to the use of BIs/CIs?
A: Frequency of Biological Monitoring
ANSI/AAMI ST79 recommends that a biological indicator process challenge device (BI PCD) be used preferably every day a steam sterilizer is used and in every load of implantables. It is recommended for implant loads to use a PCD containing a BI and Class 5 CI.
Running a BI in every load can provide valuable information about the condition of the sterilizer equipment, expertise of the operator, etc., and also affects what you have to recall in the event of a sterilization process failure.
Routine biological monitoring of “Combination” Sterilizers and IUSS cycles
The testing of “Combo” sterilizers [terminal, wrapped loads and Immediate-Use Steam Sterilization (IUSS) cycles are processed in same sterilizer], can be confusing;
- Terminal Loads:  Place the BI PCD in a full load. Test each different type of cycle with a BI PCD.
- IUSS cycles: Make a “user-assembled” challenge test pack that is representative of the most difficult-to-sterilize item. (E.g., place a BI and CI inside the empty container.) Test each type of cycle and tray configuration used.
Internal Chemical Indicators (CIs)
Use an internal CI that monitors all the critical variables of the sterilization process. AORN’s Sterilization RP states for IUSS cycles, a class 5 or class 6 CI should be used within each container/tray (VII.c.3.). For IUSS of implants, a BI and a Class 5 chemical integrating indicator should be run with the load (VII.f.1).

Q: What advice can you provide for handling recalls in the SPD?
- An effective recall hinges on immediate communications to appropriate personnel and departments responsible for the expeditious retrieval of the processed items suspected to be non-sterile. This interactive dialogue should involve SPD, OR, and infection prevention and control  professionals.
- Clear policies and procedures for handling the recall of items from issued or stored loads should be developed in cooperation with the IP&C committee and risk management. This includes making sure that the correct information is provided to the right people, so they can respond appropriately. Define persons responsible for initiating the recall of processed supplies and for the follow-up of the written report of the recall order.
- Sterilization process failures: Whenever there is a positive BI and the cause of the failure cannot be immediately identified, such as “operator error,” quarantine the load and recall all loads processed since the last negative BI. Items should be reprocessed. Remove the sterilizer from service, while investigating the cause of the failure. Best practice would be to quarantine loads until BI results are available. To avoid an extensive recall, run a BI in every load.

Instrument CareRick Schultz, chief customer officer, Spectrum Surgical Instruments Corp., a subsidiary of STERIS Corporation

Q: What are some suggestions for better instrument care?
A: Gaining a better understanding of instrument care can help hospitals reduce costs, allow for more efficient instrument processing and help improve patient safety through reduced hospital-acquired infections. When it comes to buying new instruments, purchase high-quality instruments and provide continuous education to your staff, which should include proper care and handling of surgical instruments. Additional steps than can be taken to improve instrument care include:
- Learning the differences between economy (floor-grade) instruments vs. operating room (German quality) instruments
- Maintaining enough instrument inventory to prevent “rush” processing as well as evaluating staffing, as understaffing can result in instrument processing errors
- Contacting your instrument vendor and employing a proactive preventive maintenance program, which can help identify minor instrument repair issues before they become major problems
- Utilizing instrument protection cases, which will prevent instrument damage and prevent costly repair or replacement
- Better instrument care begins with having the necessary cleaning tools and equipment from cleaning brushes, spray-on lubricant and cleaning solutions, to an ultrasonic cleaning machine and updated washer-disinfectors. Even proper lighting in decontamination and prep and pack will help ensure proper instrument processing.

Q: What is some advice relating to instrument evaluation and purchasing?
A: When purchasing instruments, be sure to get the vendor’s warranty in writing, including warranties for all instrument categories and clearly defined warranty specifics, such as coverage of defects, like cracking and pitting. Third-party repair organizations can save hospitals substantial sums versus the OEM, however, make sure that your instrument warranty will not be compromised if repairs are performed by a party other than the original manufacturer. If possible, bundling  instrument purchases with instrument repair programs is a great way to maximize cost savings. Other programs may also be available with the purchase of instruments, such as instrument consignment and continuing educational programs on the subject of instrument care and handling. Lastly, for substantial time savings, ask if the vendor can upload new instrument set purchases into your hospital’s tracking system and deliver complete instrument set purchases in tray format.

Endoscope Leak Testing
Tom Arcand, global group product manager, Medivators

Q: What are some best practices related to leak testing of scopes?
A: The most advanced, precise and accurate means of detecting endoscope leaks available today, is through the use of an automated, dry endoscope leak tester. This kind of device contains extremely sensitive electronics to detect a leak as small as 4/10,000 of an inch, which is equal to 1/10 the diameter of a human hair, in as little as 60 seconds. This proven technology replaces the existing labor-intensive manual leak testing methods which are rated to have an accuracy of ~65 percent, with an automated leak detection process having an astounding accuracy of ~99 percent. This extreme accuracy allows for early identification of endoscope leaks, which can reduce endoscope repair costs and the potential for patient cross-contamination. The use of an automated endoscope leak detection system provides a consistent, reliable and repeatable leak test process each and every time, establishes the highest and most accurate level of testing, and ensures compliance with endoscope leak test protocols. It also provides printed confirmation of all cycle test results, while establishing the best practice in endoscope leak detection.

Instrument Evaluation and Purchasing
Sydney Nye, RN, senior marketing manager of general surgery and reprocessing, Richard Wolf Medical Instruments Corp.

Q: What are some considerations for evaluating and purchasing endoscopic equipment?
A: It is always in both the OR and CS’s interest to choose the majority of endoscopy instruments from one supplier.  This leads to ease of educating the staff and they, in turn, are able to repeat the activities to successfully use them in the OR and CS will be able to repeat the reprocessing steps to ensure instruments in optimum working order.  Instruments can be modular or a single-piece design.  Variability in instrument design leads to mistakes – the OR with assembly and use, CS in cleaning and sterilizing. It is best to purchase the video equipment and endoscopes from the same supplier.  The supplier or manufacturer have designed the camera, video box, light source and endoscopes to work together for optimum picture and light quality.  And again, there is the opportunity to educate the OR on the use of the equipment so no matter what specialty is using the video and endoscopes, the staff will be able to use and successfully troubleshoot the equipment because it is consistent equipment and they are able to become comfortable with repeat use. The supplier can also offer the best pricing when instruments and equipment are sold in a bundle.  This equipment will need servicing, which can be negotiated at the time of purchase. 
Questions to have the supplier answer as you are contemplating the purchase:
- How easy is it to use the equipment?  Have any steps been eliminated with setup, white balancing or focusing of the video equipment?
- How easy is it to assemble the instruments in surgery?
- How easy is it to clean the instruments?
- Once the instruments have been cleaned according to the IFU, can you really ensure the instruments are clean?
- What type of warranty is there at the time of purchase?
- What will negate the warranty?

Q: What are some best practices related to the care of endoscopes?
A: Always refer to the IFU when caring for the endoscopes. Each scope may be different and the IFU will reveal these differences and ensure mistakes do not occur when handling the scopes.
Do not lay a scope into a tray without securing it into brackets or using a scope protector, if feasible, before transporting.  Ensure no heavy instruments are laying on them. 
Always check the fiber optic light carriers by holding the tip of the rigid endoscope up an overhead light and look into the light post.  If more than 30 percent of the light post is black, it is time to send the scope for repair. Some of the light fibers are broken and can compromise the ability to see the operative site.
Check the objective lens by viewing through the eyepiece an object 4-5 inches away the objective lens. This more mimics a surgical procedure and you will be able to see deformities or blurring using this technique, rather than viewing through the eyepiece while the scope is trained on an object across the room.
Always check the fiber optics in the light cable by holding one end of the light cable to an overhead light and viewing the other end of black spots.  If more than 30 percent, the light cable needs to be replaced.
Consider creating a service contract with the manufacturer of the endoscope. Sterility tests were conducted on the endoscope by the manufacturer and considered the epoxy and manufacturing steps taken to make the scope. To ensure the same parts and the same epoxy will be used to repair the scope, the manufacturer is the best repair company to keep the endoscope in optimum working order.

Cleaning and HLD of Endoscopes
Mary Ann Drosnock, MS, CIC, CFER, RM (NRCM), manager of the infection control program for Olympus America Inc.

Q: Why is cleaning the first and most important step in removing the microbial burden from an endoscope?
A: The proper cleaning and disinfection of medical equipment is equally as important as their proper use. According to SGNA, “Cleaning is the most important step in removing the microbial burden from an endoscope. Retained debris may inactivate or interfere with the capability of the active ingredient of the chemical solution to effectively kill and/or inactivate microorganisms (1)... Cleaning is essential for reducing bioburden and preventing the risk of cross-contamination. Studies indicate that mechanical cleaning alone reduces bioburden by an average of 4 logs (99.99 percent). In addition to removing microorganisms, cleaning removes debris that can shield microorganisms from contact with liquid disinfectant solutions. Mechanical cleaning is a multi-step process that involves specific accessories for brushing and flushing the endoscope channels and openings.  It is important that all surfaces, cracks and crevices be clean for effective HLD to follow.  The Multi-society Guideline for Reprocessing Gastrointestinal Endoscopes identifies mechanical cleaning as “essential before manual or automated disinfection,” and the guideline categorizes cleaning as a Class 1B recommendation, meaning that this practice is strongly recommended and supported by some experimental, clinical, or epidemiologic studies and a strong theoretical rationale.
References:
1. SGNA Practice Committee. Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes. 2012: 14.
2. American Society for Gastrointestinal Endoscopy. Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes. Infect Control Hosp Epidem.  2011;32: 527-537.

Q: What are some best practices related to high-level disinfection of endoscopes?
A: High-level disinfection or sterilization of endoscopes is listed as a requirement in all guidance documents, with high-level disinfection being the standard and minimum requirement. Reusable disinfectants begin to degrade once they are opened and activated. In addition, the rinse cycle at the end of the instrument wash leaves both the instruments and the reprocessing basin wet with residual water. This residual water slightly dilutes the concentration of the HLD when the instruments are disinfected. In addition, any residual bioburden contacted by the disinfectant can further degrade the disinfectant.  After repeated cycles, this aging, dilution and degradation accumulates to the point that the disinfectant is no longer effective. Therefore, it is recommended that the minimum effective concentration (MEC) of the active ingredient in the disinfectant be tested prior to each use according to the manufacturer’s instructions. Facilities should maintain and routinely review MEC logs to ensure proper disinfectant use. It is important to recognize that rinse requirements for high-level disinfectants will vary with different chemistries. Certain chemistries require extra rinsing. Ensure that your facility is performing the correct number of separate rinses with each use of the disinfectant. Rinse water should not be reused between reprocessing cycles. Some guidelines allow the use of tap water for the final rinse. Depending upon the quality of water used to rinse the endoscope, it may contain waterborne organisms. If sterile water is not used for rinsing, an additional alcohol purge followed by a forced air purge is required to thoroughly dry the endoscope and prevent recontamination. An alcohol flush is recommended to enhance drying whether or not sterile water is used during the final rinse.

Instructions for UseMatt Rechin, senior director of marketing strategy, STERIS Corporation

Q: What are the key principles that sterile processing professionals need to remember about microbiological kill and the need to follow industry/AAMI and manufacturers' guidelines carefully?
A: The most important point is to carefully read the instructions for use. Even similar sounding products can have different requirements for the preparation, use and testing of disinfectants, liquid chemical and gaseous sterilization processes, as well as different requirements for automated thermal disinfection and steam sterilization processes. Overall, the microbiological kill is based on standardized tests that need to be conducted and submitted by the manufacturer for regulatory clearance. These tests have been published by organizations such as AOAC International, ASTM or as defined by the FDA or EPA. It is important to note that there are different types of disinfectants or sterilization processes. These can be designed for specific purposes, such as for environmental surface or for use on medical device surfaces. In the U.S., environmental disinfectants are regulated by the EPA and medical device disinfectants by the FDA. These agencies have different requirements for the safe use or these products (including antimicrobial tests to meet the expected claims of the product and toxicity considerations). Microorganisms can present dramatic differences in their sensitivity to disinfection, ranging from enveloped viruses (like HIV and hepatitis B, considered very sensitive to inactivation) to bacterial spores (considered the highest resistance). Therefore, a wide range of tests are required to show that a product or process can meet the expected claims. This includes activity against various types of viruses, bacteria, fungi etc. The Spaulding Classification is then used to define what type of disinfection (low, intermediate, high) or sterilization should be applied.  It is expected that low-level disinfectants are expected to be effective against many types of bacteria, some fungi and some viruses in accordance with their stated claims. Intermediate-level disinfectants should are also be effective against other more resistant forms of viruses (non-enveloped, such as polio and noroviruses) and bacteria (mycobacteria, such as Mycobacterium tuberculosis). High-level disinfectants are expected to inactivate most forms of microbial life, including mycobacteria and some bacterial spores (although this may require extended time).   Sterilization should render the device sterile or free from microbial contamination.  However, two notes of caution. First, care should be taken to review the specific written claims made with the product. These can vary significantly, as well as the specific instructions of use (in particular exposure time).  Second, there has been some high-profile cases of certain types of disinfectants being found not to be effective against certain types of microorganisms, when they had been expected to be effective. This is particular highlighted with aldehyde (glutaralehyde and OPA)-containing disinfectants that may not be effective against certain types of viruses and mycobacteria. These reports in the literature may be a concern in some disinfectant applications.  A useful AAMI standard that discusses the use of chemicals for disinfection/sterilization for device is ST58 (revised in 2013) and similarly for ST79 for steam sterilization.  Requirement for thermal disinfection are found in AAMI/ANSI ST158831.                                                                                                                             
 
Q: Why is it critical that reprocessing products and technologies are used correctly in healthcare facilities?
A: Products and technologies are only as good or safe as those using them, which includes anyone handling the device or equipment in preparation for or direct use with a patient. There are many cases of patient infection or other complications, as well as accidents in the use of products and technologies with staff due to mistakes being made in correct use. These include failure to prepare disinfectants correctly, insufficient rinsing following chemical disinfectants, inadequate maintenance of equipment etc.  It is important that we learn from these reports. The correct processing of devices in accordance to instructions for use (to include those of the device manufacturer as well as any associated products/equipment that is used to process the device) is essential to reduce safety risks.

SPD Work Habits
Stephen Kovach, director of education, Healthmark Industries

Q: What are some suggestions for promoting good work habits in the SPD?
A: I have noticed that many department break rooms are filled with publications that have nothing to do with that particular department. This may not be all bad, after all the break room is a place where you can get away and relax maybe not think about the job. I believe that managers could be falling short by not providing SPD related material, like ICT or other publications in the break area. We need to make sure this type of information is available to employees. Some of the staff enjoy reading about issues in their field and may not have a subscription to industry publications. Managers need to make all types of publications available to their staff. I also think that it’s important to have flowcharts of the various works steps or processes in the departments. This will show the staff the proper way to do the task. You need  to have examples of proper execution. Besides the graphs and ’charts, examples of failures would be beneficial to the staff. This helps explain why something has failed or why it was dirty. Talking with the staff about this is a positive manner will prevent negative results happening again in the future. Be sure you have a place where you can post educational meetings and seminars that they can attend. If your facility is part of network of hospitals,  you may want to suggest that technicians visit other facilities in the system so ideas can be shared.

Q: How do you keep technicians from taking shortcuts or doing work-around the rules?
A: The approach that is most frequently used is having  the person think of their family when they are performing a task. After they complete that task, would they want their finished work used on a member of their family? As managers, we need to talk with our staff and ask them, “What do they need to be more successful in their job?” Feedback is so important in order to keep a balance in the department. The goal is to have your staff honestly share their needs knowing that some needs might not be able to furnish right away but with hope that  it can in the future so they can  perform their job the right way each and every time.

Q: What are the most common mistakes being made in the SPD and how can those be addressed?
A: Common mistakes are made by not understanding the term "best practice." If you strive toward “'best practice," you will reduce errors by result of the staff understanding what they do and why they do there job specific ways. This means understanding the role standards and manufacturers IFU play into the process of maintaining "best practice.” This is partially accomplished by continued training within the department. Be sure to continue training is available to your staff.  For an example, let’s say a new cart washer is bought for your department and the staff is given a proper in-service and training by the manufacturer. It usually ends there and you never see a company person again for training.  What needs to happen is have that company repeat the in-service annually (both new and old). By continued training, you will reduce errors and concerns with not only equipment, but your process in general. This is a good example of how to get your staff to understand why they are doing something. Not simply just pushing the button. By doing this, you're enhancing training by making sure that staff understands what documents are important to their work and how those documents interact with outcomes. Following the manufacturer's IFU are essential in order to properly using the equipment. For me, getting staff to understand the connection between "best practices” and how that applies to reducing mistakes, provides the best quality care  for their patient as possible. It’s about understanding the process, because when we think about it, staff don’t arrive to work making errors. They come in to do the best job possible. So, if we make sure the process is working, the staff understand the process and have the proper tools to perform the process; the amount of errors will decrease. Education and training are the keys to reducing errors.