Sterile Storage Could be Compromising Patient Care, Safety

By David Taylor, MSN, RN, CNOR

This column originally appeared in the December 2021 issue of Healthcare Hygiene magazine.

Many factors need to be considered regarding sterile storage of instrumentation and supplies. Although sterile storage is a critically important aspect of sterile processing (SP), many SP professionals do not understand how the environmental controls that govern this process can dramatically affect patient safety and negatively impact the organization’s bottom line.

When developing infection prevention-related policies and practices for storage and supply areas, it is important that SP leaders not only know the infection prevention policies established by their institution, but also understand standards established by the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE), which can vary depending on the date the storage space was established.

The first step SP leaders should take is ensuring their organization is compliant with all building code requirements. Once this has been established, the next step is to satisfy the Centers for Medicare and Medicaid Services (CMS) requirements for ventilation. Note: Criteria for new or renovated spaces (versus existing space) may vary. Contacting the healthcare organization’s Facilities team should be sufficient to determine which standards must be met. Keep in mind, however, that industry standards and local building codes can vary, and one’s organization will need to meet the most restrictive of the two.

Supply storage areas that support SP’s mission must follow all building codes and satisfy CMS ventilation requirements, which include the following:1
• Positive air pressure relationship to adjacent areas
• Minimum outdoor air exchange (two per hour)
• Minimum total air exchange (four per hour)
• Maximum relative humidity (60 percent)
• Temperature range (71-78 degrees F; 22-26 degrees C)
Although this is not an exhaustive list, other things to consider regarding SP supply storage include:
• All patient care supplies should be stored away from the edge of a sink to avoid possible splash contamination.
• All patient-care supplies must be at least five inches from the floor. If fixed or mobile wired shelving is used, ensure the lowest level shelf is covered with a solid surface (plastic cover) to avoid possible splash contamination during cleaning.
• Storage must maintain an 18-inch clearance from the ceiling (or the sprinkler head if co-located) to allow for the proper function of the fire and safety sprinkler system. It is important to know that the 18-inche rule applies laterally, away from any sprinkler heads as well.
• Corrugated cardboard material delivered to healthcare areas should be unpacked and broken down and removed in a timely manner. Use of corrugated cardboard cartons in healthcare storage areas must be assessed by the healthcare epidemiology team to ensure that the use of such cartons does not compromise the cleanliness or sterility of patient supplies.
• Internal shipping boxes (not corrugated boxes) may be used to dispense sterile and clean supplies but should be discarded when the box has been emptied.
• Doors should remain closed to maintain temperature, humidity, air flow (positive) and air exchange compliance.
• Wooden pallets should be limited to the transportation use by logistics and delivery personnel. Only pallets made of synthetic material are allowed in storage rooms where patient care supplies are located.

Once items are sterile, care and extreme caution must be consistently taken to prevent them from becoming contaminated. Sterile packages must be protected by keeping items in a safe environment and ensuring all staff members engage in proper, standards-based practices for handling and storage.2

David Taylor III, MSN, RN, CNOR, is an independent hospital and ambulatory surgery center consultant and the principal of Resolute Advisory Group LLC, in San Antonio, Texas. He has served as an IAHCSMM contributing author since 2019.

References:
1. The Joint Commission. Temperature and Humidity Requirements—Guidance for Storage or Sterile Supplies. 2019. https://www.jointcommission.org/standards/standard-faqs/hospital-and-hospital-clinics/environment-of-care-ec/000001275/
2. International Association of Healthcare Central Service Materiel Management. 2016. Central Service Technical Manual. 8th Ed., pp. 341-356.

 

Sterile Processing Certification Legislation Updates: Current Status, 2022 Plans

By Julie E. Williamson

This column originally appeared in the November 2021 issue of Healthcare Hygiene magazine.

Sterile processing (SP) functions involve challenging work, focus, attention to detail, and acquired knowledge and skill sets to ensure each task is performed safely, effectively, and in line with best practices, standards/regulations, and manufacturers’ instructions for use. Healthcare organizations that prioritize certification for their SP professionals will help ensure improved service quality, patient safety and infection prevention.

The International Association of Healthcare Central Service Materiel Management (IAHCSMM)’s top legislative priority is ensuring certification of all SP technicians across the country. Connecticut, New Jersey, New York, Tennessee and Pennsylvania are currently the sole states to require certification of SP technicians; however, IAHCSMM’s Government Affairs Director and Advocacy Committee are working hard to get certification legislation passed in other states.

In 2020, Pennsylvania became the fifth state to require certification of SP technicians. Getting the bill across the legislative finish line was a five-year process and a big win for the profession considering the pandemic-related changes that impacted states legislatures. Pennsylvania state legislators were the only individuals allowed in the building for a period, and similar precautions were seen in other states. Testimonies were held remotely and some legislative sessions, such as those in Rhode Island, took place with legislators shielded by plastic partitions, explained Josephine (Jo) Colacci, Esq., IAHCSMM’s director of government affairs, during her Oct. 22 session at IAHCSMM’s 2021 Virtual Conference & Expo.

“We didn’t do as much in 2021 because of COVID-19. I was concerned how it was going to impact legislatures and a lot of state budgets got hit, too, so we pulled back a bit on our status for 2021,” she said.

In Colorado, IAHCSMM planned to reintroduce its legislation in 2021. Although the certification bill had passed the state Senate and the House Committee, Colorado’s legislators recessed in 2020 due to the pandemic. When they reconvened, only a couple weeks remained in the year. Colacci learned that the governor would potentially veto the legislation, so the remainder of 2020 and into 2021 saw IAHCSMM reworking the bill. When the governor’s office still indicated the governor would veto the legislation, Colacci decided not to reintroduce it at that time.

“There’s supposed to be a large piece of legislation introduced in January 2022 that is going to change how Colorado regulates professions. When that happens, we’ll then reintroduce our legislation.”

In Massachusetts, where IAHCSMM first introduced a late-file bill in 2014, the process has been slow. The certification legislation passed the state Senate twice and made it to the final reading in the House in 2016; however, progress stalled thereafter. Fortunately, IAHCSMM’s testimony during an Oct. 15, 2021, committee hearing with the Joint Public Health Committee proved promising.

“I gave them the history that we passed out of their committee three times,” Colacci said, adding that the committee chairwoman acknowledged that the wait had been long and thanked Colacci for continuing to bring the legislation and its importance to their attention. Massachusetts has a two-year legislative cycle that ends in December 2022, and Colacci is hopeful the bill will be signed into law before then.

In Florida, a bill is being drawn up and will be introduced as soon as the state legislature convenes in March 2022. Florida’s legislative sessions last only two months, concluding in April 2022. IAHCSMM is working with a lobbyist in Florida, and a sponsor for the bill has already been identified.

“We’re hoping all this prework will bode well for us when this bill is introduced,” said Colacci. Still, she reminds that whenever a new bill is introduced in a state, organizations tend to come forward to comment and, at times, challenge some bill language, which can slow progress.

“There’s a good change our bill will not pass in its first year, but at least we’ll be introducing it, so we’ll know which issues arise and we can redraft and reintroduce the bill for 2023.”

Colacci shared an exciting development at the federal level as well—legislation that would allow for COVID-19 hazard pay (for work done in 2020 and 2021). Currently, the legislation applies to a long list of professionals, including surgical assistants and surgical technicians, and IAHCSMM hired a lobbyist with the Association of Surgical Technologists to get sterile processors included in the legislation. The federal lobbyist’s first step will be arranging meetings between Colacci and some sub-committee members, so Colacci can explain why sterile processors should be included in that piece of legislation.

“Once we get that, and I believe we will, we will then ask them to move the legislation.” She cautioned that this piece of legislation may not move as a standalone bill. Smaller pieces of legislation often get packed into larger bill packages, and she expects that will happen to move this legislation. She urged IAHCSMM members to watch their emails for action alerts that will ask members to contact their federal elected officials (a simple process that requires little more than a couple keyboard clicks and an electronic signature). “This bill will be alive until December 2022, and we’ll need many people contacting their federal legislators to try and get them to push this bill forward.”

Julie E. Williamson is director of communications for the International Association of Healthcare Central Service Materiel Management (IAHCSMM).

 

Infection Prevention, Patient Safety Hinge on Multi-Department Collaboration

By Tony Thurmond, CRCST, CIS, CHL, FCS

This column originally appeared in the October 2021 issue of Healthcare Hygiene magazine.

Healthcare organizations and each of their departments aren’t successful because of a single idea or individual effort. In fact, the best results in terms of efficiency, efficacy and safety come from collaboration and ongoing interdisciplinary teamwork, with all members working toward a common goal of infection prevention and other positive outcomes.

Often departments -- or even individuals within those departments -- aim to complete tasks on their own—either failing to seek assistance from others due to a fear of relinquishing control or concerns of conveying inadequacy regarding the task at hand. Some may also avoid seeking input or help from others because they consider themselves the experts and don’t want others interfering with the way things are done. Whatever the reason, any actions that inhibit teamwork and collaboration can lead to negative outcomes for employees, their department, their customers and, of course, the patients on the receiving end of the services. Any sterile processing (SP) professionals who aren’t working collaboratively with others are missing out on opportunities for growth, improvement and long-term success.

Positive changes in sterile processing departments (SPDs) and other healthcare service areas often come from reaching out to allied department (or, in many cases, multiple departments) and putting collective minds together to drive best results. Many departments can help the SPD reach its peak performance, including the following:

Surgical Services: Many collaborative opportunities await between the SPD and the operating room (OR), and those opportunities often lie within some of the common challenges that exist for each department. While those challenges can lead to finger pointing between the two departments, it is important to remember that all SD and OR employees are on the same team and seek the same outcomes: quality service, infection prevention and safe patient care. Designating a champion in the OR who will work with the SPD (and assigning an SPD liaison to the OR) is a great way to improve quality teamwork. When looking to improve point-of-use instrument care at a previous facility where I worked, I recruited the help of an assistant manager in the OR. I shared examples of how instruments arrived in decontamination in disarray and explained how they were dangerous and difficult for our technicians to handle. I also showed photos of heavy items placed on top of delicate equipment and instruments and provided examples of soiled instruments with dried-on soil, which created a valuable teaching moment regarding the dangers of bioburden and how much more difficult it is to clean when allowed to dry and harden on devices. I then reminded them how point-of-use care is a practice recommended by the Association for the Advancement of Medical Instrumentation (AAMI), the Association of periOperative Registered Nurses (AORN) and the Association of Surgical Technologists (AST); this provided documented proof of what is universally recommended and expected.

The outcome of these teaching moments was a collaborative effort to educate all OR staff to begin treating instruments at the point of use (moistening soiled instruments with an approved spray prior to their being sent to the decontamination area). We also began monitoring trays sent to decontamination and recorded in our instrument tracking system whether they were sprayed/properly moistened. Our compliance rate jumped from 15 percent to more than 64 percent in just over five months.

To further advance our commitment to collaboration, we invited our SPD staff to witness a surgical procedure. This allowed our technicians to see firsthand how the instruments are used and how the OR team expects to receive the devices to provide safe and on-time patient care. One of our SPD technicians shared that the experience in the surgical suite helped her learn the importance of having the right instruments in the tray (and all instruments arriving to the OR clean, sterile and well-functioning).

Infection Prevention: SP professionals must understand that most IPs are eager to learn as much as they can from those in the SPD. It’s also worth noting that accreditation organizations will look to IPs to ensure they have a full understanding of the facility’s sterilization practices. SP professionals should ask IPs to come and work with or observe in the department for a day or two. Most IPs will be eager to learn the processes and serve as another set of eyes on SP practices, and their involvement could shed more light on process improvement opportunities. Working closely with IPs can also help ensure that SP has the tools and resources needed to work safety, effectively and in accordance with standards and guidelines.

Biomedical Engineering/equipment vendors: Collaborating with biomedical engineers and equipment vendors allows them to see how SP equipment is being used. At a previous facility where I worked, we were visited by both Biomedical Engineering and equipment vendors; during that visit, it was identified how an ultrasonic could be moved closer to a workstation to save steps and help deliver optimal results. This collaboration also helped us identify high-use equipment and rotate equipment cycles for improved utilization.

Environmental Services: Partnering more closely with environmental services (EVS) professionals can help the SPD determine the most appropriate cleaning schedule. If EVS does not know the SPD’s needs or understand the reasoning behind them, the service may not be viewed as a top priority. Working together builds a stronger relationship that helps sets proper expectations to improve patient and employee safety.

Units/Clinics: Point-of-use instrument care is not always taught or demonstrated, so employees from user departments or clinics may lack the information and tools needed to complete the important function properly and consistently. They may even falsely assume instrument care is the sole responsibility of the SPD. One example is when flexible bronchoscopes or other endoscopes are brought to the floors/units for procedures. Endoscopy professionals don’t always understand they have a responsibility for point-of-use treatment of the endoscopes following their use. If this point-of-care step is skipped, most endoscope instructions for use call for an extended cleaning process, which can add many more hours to the reprocessing of the device. Effective collaboration and education about the importance of point-of-use instrument care will help eliminate these types of challenges.

C-Suite: Hospital administrators don’t always know the needs and challenges of the SPD such as insufficient staffing, limited instrumentation inventories, outdated or malfunctioning equipment, and lack of current industry standards, to name a few. SPD leaders must communicate clearly and regularly with those at the administrative level. The more those in the C-Suite know about the vital needs of the SPD, the more willing they will be to meet those needs and recognize the value of the department.

Working in siloes will rarely deliver positive outcomes, especially in a healthcare environment where all departments play a critical and often connected role in delivering exemplary services in the name of patient care, employee safety, and infection prevention. The open pursuit of interdisciplinary collaboration will help bring success to the organization and the individual departments by encouraging open communication to discuss unique challenges and practical solutions.

Tony Thurmond, CRCST, CIS, CHL, FCS, is an IAHCSMM past-president and IAHCSMM fellow who serves as central service manager at Dayton Children’s Hospital.

 

Dental Reprocessing: Guideline, IFU Adherence Vital to Infection Prevention

By David L. Taylor, MSN, RN, CNOR

This column originally appeared in the September issue of Healthcare Hygiene magazine.

Sterile processing (SP) is the first link in the chain of infection prevention. Its role is to decontaminate, clean, inspect and sterilize instrumentation for future use; however, failure to do so can introduce pathogens into the clinical environment and increase the risk for infection.

Safe, thorough device reprocessing isn’t just critical in hospitals; it’s also vital across all environments of patient care, including dental clinics. Understanding the process of infection transmission and prevention helps ensure sterile devices and a safe work environment for patients and healthcare professionals, including dental healthcare providers (DHCP). Because SP processes are often overlooked and misunderstood, ECRI identified “infection risks from sterile processing errors in medical and dental offices” as No. 3 on its list of Top 10 Health Technology Hazards for 2020.1 The American Dental Association (ADA), in collaboration with the Centers for Disease Control and Prevention (CDC), have updated and supplemented their infection control recommendations since 1993 to not only reflect new scientific knowledge but to grow the understanding of the principles of infection control practices.

Historical perspective

The 2016 CDC document, CDC Summary of Infection Prevention Practices in Dental Settings: Basic Expectations for Safe Care,2 brought together recommendations from the CDC 2003 guidelines on infection prevention3 , along with tools and checklists to help DHCP follow infection prevention guidelines.

The ADA urges all practicing dentists, dental auxiliaries and dental laboratories to employ appropriate infection control procedures as described in the 2003 CDC guidelines, and the 2016 CDC summary. Additionally, the ADA recommends that all settings keep up to date as new scientific information and regulatory guidelines leads to improvements in infection control, risk assessment, and disease management in oral healthcare.

Along with the proper sterilization of instruments and materials, sterilizer monitoring is an essential part of any in-office/clinic infection prevention program. The CDC advises that dentists use only FDA-cleared dental handpieces and sterilize them in accordance with manufacturers' instructions for use (IFU). Following manufacturers’ instructions for sterilization and processing of all dental instruments and materials is critical to patient and employee safety. Sterilizer monitoring and efficacy testing is an essential part of this process.

Each step of instrument processing must be completed per IFU, accepted guidelines and recommendations—with no steps missed or altered in any way. DHCP who clean, inspect, package, sterilize and store instruments must have the skill sets and knowledge of each process and understand the science behind each step. Unfortunately, DHCP often have a myriad of other clinical responsibilities that can divide their attention. As a result, failure to consistently and effectively clean and disinfect or sterilize contaminated items before reuse can expose patients and DHCP to virulent pathogens and create a significant risk of disease transmission within the dental setting. Between 2003 to 2015, disease transmissions in dental settings, including patient-to-patient transmissions, has been well documented.4-7
Inconsistency in knowledge

The question that must be asked is whether all employees responsible for SP functions have adequate knowledge to mitigate errors and consistently deliver safe, well-functioning instruments and services to meet their customers’ needs. Unfortunately, in my personal experience as a consultant, the answer is often no.

With the complexities inherent to SP functions—and inconsistencies in design, equipment, material and processes found in dental practices and clinics—careful attention must be paid to ensure all employees are trained to the same standard and have the knowledge necessary to manage their SP duties safely and effectively.

Instrument processing areas

The instrument processing area should be centrally located within a healthcare facility and have a one-way/dirty-to-clean flow to reduce the possibility of cross contamination between dirty and sterile devices. In dental facilities, instrument processing can be located/performed in one space as long as there is a linear flow, without the risk for crossover between dirty and clean.

The instrument processing area includes the following four distinct areas, regardless of whether it is located in dental or traditional medical settings:
1. Receiving, cleaning and decontamination (three-sink system for hospital/medical settings)
2. Preparation and packaging
3. Sterilization
4. Storage

As a result of design, clinic acquisition or other factors, instrument processing areas can vary in size and can compromise DHCP’s ability to remain consistent with their processes and infection prevention strategies. Some dental SP areas are so small that DHCP have to create work arounds to complete certain tasks.

Water quality

Water quality is a concern in dental practices across the country. Water quality is critical for the sterilization process, and poor water quality can impact the sterilizer’s ability to function properly. Poor water quality can also damage and reduce the life expectancy of instruments and processing equipment. Critical water, such as distilled, is the recommended water type for use in countertop sterilizers; however, many dental practice clinics use various water filtration systems—with no assurance that these systems meet the recommended water purity standards.

It is highly recommended that water testing be conducted for all water sources to ensure it meets the water purity specifications or parameters outlined in the IFU. Note: If a filtration system meets all parameters for use, dental facilities should consider standardizing filters across their practice or clinic system, while also developing water testing methods, establishing testing frequency, and documenting the same going forward. If filtration systems do not meet water purity standards, it is essential that those filters are removed from use and that distilled water is provided.

Biological testing and instrument tracking

Biological indicator (BI) vials contain Geobacillus stearothermophilus bacterial spores and are intended for monitoring the efficacy of steam sterilization. Biological monitoring allows facilities to take control of their steam sterilizer testing and provides peace of mind that the sterilizer is functioning properly. It also helps organizations follow CDC guidelines, which recommend that steam sterilizers be monitored at least weekly. Although the CDC recommends weekly BI testing (at a minimum), the prefer method is to perform BI testing daily, as well as with every load that contains implantable devices. Dental SP professionals across the country have come under greater scrutiny by regulatory and government agencies; therefore, BI testing on every load is highly recommended (Note: BI monitoring for each load is not included in the standards; however, many facilities have gone to a higher level by performing BI testing for each load).

Instrument tracking

Instruments that are reprocessed and rendered safe for patient use should be traceable; however, in the dental environment, few offices or clinics can effectively track their instrumentation to a sterilization cycle. Once sterilized, those instruments are placed on trays, in bins and/or in cabinets for future use. In some cases, they are used immediately following sterilization.

If a BI test comes back positive, it is important that dental professionals have a way to track instruments and when they were reprocessed. If a positive BI result comes back from the lab and instruments from that particular day or subsequent days were used, the results could be catastrophic.

Individual instruments and sets should be logged for every sterilizer load. This allows organizations to track when instruments were processed, under what conditions, and whether parameters were appropriately documented. If a recall is needed (based on a positive BI test result or equipment malfunction, for example), instruments should be able to be located easily, in real time. Documentation can be as simple as a logbook or use of a record envelope. Some institutions and groups use a patient tracking card and document load specifics in the patient’s record.

Currently, The Joint Commission (TJC) is asking operating room (OR) and SP professionals across the country how they track their instruments to the patient (e.g., which instruments were used on which patients and when?). The surveyors are then retracing each step in the process back to SP and validating that all processes were met in the reprocessing of those items. All documentation is being reviewed to include (but not be limited to) date, time, parameters met or unmet, staff member(s) involved, and how those instruments are being stored (temperature and humidity). For the staff member who processed those instruments, TJC surveyors will review that individual’s competency, training and education. Note: TJC and the Centers for Medicare and Medicaid Services (CMS) are now sharing findings with one another. Depending on the severity of the TJC’s findings, CMS may initiate its own investigation and survey the organization/facility. Again, this is important because dental industry practices are coming under greater scrutiny these days.

Ultrasonic equipment cleaning and efficacy testing

Proper cleaning is the first step to effective instrument reprocessing. If debris (bioburden) is not removed, the instrument cannot be effectively sterilized. Automated processes such as ultrasonic cleaning aids in the proper cleaning of instruments. Ultrasonic cleaners are used to remove soil from difficult-to-clean areas such as joints and crevices, using cavitation. Cavitation is a process in which low-pressure bubbles in a cleaning solution burst inward and dislodge soil from instruments. Ongoing routine testing of equipment used to reprocess instrumentation is necessary to ensure each piece of equipment is functioning properly and as intended.

During my observations as a consultant, dental staff often report they are changing the ultrasonic fluid and using the correct type and amount of detergent (per IFU) twice a day or “as needed” as water becomes cloudy; however, when asked, many dental professionals could not answer how many individual instruments or cassettes may be processed before each water change or how long it took before water became cloudy. In addition, most dental offices and clinics do not keep logs showing when the units were cleaned, and/or they fail to document in-between water changes. In addition, cloudy water can be a subjective observation; therefore, leaving it (and the need for water change) up to the user’s interpretation is risky. If time pressures exist (which is not unlikely), dental staff may forgo a water change until the next batch of instruments—a decision that could jeopardize patient safety. ANSI/AAMI ST79, Section 7.6.4.4, states that when using an ultrasonic cleaner, each load should use a “fresh cleaning solution,” which includes detergent. Each time the sonic is filled, it should also be degassed. Further, the sonic should be cleaned each day in accordance with the IFU.

To ensure equipment is working properly, efficacy testing should be done routinely, and the results should be documented, per ANSI/AAMI ST79, Section 13.2. Ultrasonic machines are frequently used in dental practice. In my experience, many dental employees are unaware of what efficacy testing is and what it entails. When asked what the test results should look like when using that product, different answers are common (dented, pin hole, etc.). Also, when asked how they test the machine’s effectiveness, many state that they perform an aluminum foil test. Foil tests, unfortunately, do not ensure proper function of the ultrasonic device. If three different manufacturers of foil products were used for this type of testing, each test would be subjective and left up to the determination of the user, which is problematic.

Efficacy testing must be done daily, with the appropriate challenge test to ensure each unit performs cavitation and can remove soil. It is highly recommended that dental organizations incorporate appropriate monitoring of their ultrasonic machines and document testing results. There are commercial monitoring tests available that monitor cavitation, and a test that contains a test soil that mimics the presence of blood and tissue that may be found on an instrument after use. During the test, the monitoring strip assesses multiple variables of the cleaning process, including cavitation, time, temperature and detergent. The IFU of the test should be reviewed for what, specifically, it tests. Full removal of the test soil from the strip indicates an effective cleaning process and provides greater assurance that the equipment is functioning properly.

Steam sterilization integrator

Many dental practices forgo the use on an integrator and rely on a color dot located on peel packs as the final result. Type 5 multi-variable sterilization monitor integrators are designed to react to all critical variables in the sterilization cycle (time, temperature and the presence of steam). Indicator strips should be used in each peel pack and cassette that will undergo reprocessing.

Type 5 integrators that utilize a moving front indicator technology (an advancing color bar that moves from “reject” to “accept,” for example, and eliminates the need to interpret or match colors) are highly recommended. Because staff knowledge varies greatly, it is also recommended that an educational fact sheet be displayed in all SP areas to clearly identify an item that should be rejected and one that meets acceptable sterilization parameters.

Instrument packaging

Peel Packs/Pouches Versus Cassettes

The CDC guidelines state that items to be sterilized should be arranged in such a way to permit free circulation of the sterilizing agent (e.g., steam, chemical vapor, or dry heat).8,9 An instrument peel pack that is overfilled may compromise sterilization. In addition, overfilled peel packs have and increased risk of an instrument poking through the packaging, resulting in contamination and a greater likelihood of sharps injury.

It many dental practices, DHCP have a choice in the method in which they package their instruments. Some primarily use cassettes; however, some locations are instead opting for peel pack/pouches. For those that use peel pack/pouches, it is important to ensure instruments are placed properly and not overly crowded to ensure sterilant (steam) comes in contact with all instrument surfaces. The preferred orientation for sterilization peel pack/pouches is to place peel packs/pouches on their edge.

Note: When cooling hot instrumentation, the packages should remain in the basket or tray they were sterilized in to avoid touching the packages as they are removed from the sterilizer. Many DHCPs place items on an adjacent flat surface. The surface temperature of these areas can vary greatly from the instruments being removed from the sterilizer, which can cause condensation and result in contaminated instruments. An infrared device can be used to measure the temperature of the package before it is handled.

Conclusion

To reduce the risks associated with instrument reprocessing, governmental agencies and other professional associations have created recommendations, guidance and regulations that help healthcare organizations, including dental practices, to maintain safe environments for the patients they care for and the staff members who work in these areas. Due to its impact on patient outcomes and infections, the SP function is facing greater scrutiny. Device reprocessing has several necessary steps that must be done correctly every time in order to render devices safe and ready for use on subsequent patients. Monitoring the sterilization process must be done and documented appropriately to show compliance with current standards, guidelines, regulations and IFU. Not knowing is not an excuse and has caused organizations to fail inspections, suffer bad publicity from negative outcomes resulting from failed SP processes—and above all, negatively impact patient and employee safety.

Instrument processing is the most important component of an infection prevention program. It is a complex process that requires specialized equipment, adequate space, qualified personnel, and routine monitoring for quality assurance. As dental and medical personnel process instruments for safe patient care, it is imperative that they receive adequate and ongoing education and training from credible sources regarding the entire instrument processing practice, including but not limited to transport, cleaning, packaging, sterilization and storage.

Guidelines from the CDC continue to change and are the standard for infection control in dental settings. Clinicians should also consult the manufacturers’ IFU for reprocessing dental and medical instruments for each reusable instrument or device within service. Note: Other resources available include the Organization for Safety, Asepsis and Prevention, which offers an extensive online collection of resources, publications, FAQs, checklists, and toolkits to help dental professionals deliver the safest dental visit possible for their patients.10

David L. Taylor, MSN, RN, CNOR, is the principal of Resolute Advisory Group LLC, a healthcare consulting firm in San Antonio, Texas. He has served as an IAHCSMM author since 2019. For more information, email David@ResoluteAdvisoryGroup.com

References:

1. Special Report Top 10 Health Technology Hazards for 2020, Expert Insights from Health
Devices https://elautoclave.files.wordpress.com/2019/10/ecri-top-10-technology-hazards-2020.pdf
2. https://www.cdc.gov/oralhealth/infectioncontrol/pdf/safe-care2.pdf
3. https://www.cdc.gov/mmwr/PDF/rr/rr5217.pdf
4. Redd JT, Baumbach J, Kohn W, et al. Patient-to-patient transmission of hepatitis B virus
associated with oral surgery. J Infect Dis. 2007;195(9):1311–1314.
5. Radcliffe RA, Bixler D, Moorman A, et al. Hepatitis B virus transmissions associated with a portable dental clinic, West Virginia, 2009. J Am Dent Assoc. 2013;144(10):1110–1118.
6. Oklahoma State Department of Health. Dental Healthcare-Associated Transmission of
Hepatitis C: Final Report of Public Health Investigation and Response, 2013. Available at: http://www.ok.gov/health2/documents/ Dental%20Healthcare_Final%20Report_2_17_15.pdf.
7. Klevens RM, Moorman AC. Hepatitis C virus: An overview for dental health care
providers. J Am Dent Assoc.2013;144(12):1340–1347.
8. Kohn WG, Collins AS, Cleveland JL, Harte JA, Eklund KJ, Malvitz DM. Centers for
Disease Control and Prevention. Guidelines for infection control in dental health-care settings—2003. MMWR Recomm Rep. 2003;52(RR-17):1-61.
9. Centers for Disease Control and Prevention. Summary of Infection Prevention Practices
in Dental Settings: Basic Expectations for Safe Care.
https://www.cdc.gov/oralhealth/infectioncontrol/pdf/safe-care2.pdf. October 2016.
10. Organization for Safety, Asepsis and Prevention website. www.osap.org

 

Sterile Processing Week is October 10-16: It’s Not Too Early to Get Your IPs and C-Suite Involved

By Julie E. Williamson

This column originally appeared in the August 2021 issue of Healthcare Hygiene magazine.

Getting other disciplines involved in Sterile Processing Week events isn’t just good for sterile processing (SP) employee morale; it can also promote better communication, partnerships and support, long after the dedicated week off honor concludes.

While it’s important to invite surgical services members (and other departments the SPD routinely serves) to planned events, it’s essential to not overlook the facility’s infection preventionists (IPs) and administrators. IPs can be some of SP professionals’ greatest sources of support, and both sides can benefit significantly from a successful long-term partnership. SP leaders who haven’t yet forged an effective relationship with their IP(s) are encouraged to make those introductions now. From there, they should include them in various Sterile Processing Week functions that might be planned throughout the dedicated week and work together to build a framework for a more productive interdisciplinary partnership.

Prior to the week’s official kickoff, set up a meeting with the IP(s) to discuss the SPD’s challenges, successes and goals, and then work together to help effectively address them. Is the SP team functioning with too few full-time employees? Is the department’s processing equipment breaking down more frequently? Is the SPD’s standards library out of date or is the SPD being pressured to rapidly turn around the same set of instruments because inventory doesn’t match the increasing case volume? Has the SP team expertly managed increased service demand with exceptionally low error rates? These are all critical points to address with the IP who can then help go to bat for the SPD—with data in hand—to the operating room, facility executives and other department heads, as needed, to help instill positive, standards-based change. This IP-SP alliance could even help expand the SPD’s capital budget to better meet the facility’s/departments’ critical needs.

SP leaders should also ask their IPs to help honor Sterile Processing Week and the SP team by writing a brief statement about the department’s critical importance to patient safety and quality care, and then sharing some impressive statistics (e.g., low error rates, number of sets processed for the year thus far, how the department greatly reduced immediate use steam sterilization rates; employee certification, and so on) in the facility’s newsletter or in the SPD’s own materials created for Sterile Processing Week. SP leaders can also ask their IP(s) to lead a Sterile Processing Week educational session. The opportunities are endless!

Those in SP leadership positions will also serve their team (and the facility) well by inviting the healthcare organization’s top-level executives to the department for quality education and a tour of all that takes place within the SPD’s walls. This invitation can prove valuable because some C-level executives lack a firm understanding of the importance of sterile processing and may not know the extent of SP professionals’ contributions, successes and sacrifices; therefore, it’s up to SP leaders to make them aware.

What might that look like during Sterile Processing Week? Try reaching out directly to hospital administration, surgeons and senior leadership from all other departments that utilize the SPD’s services in the facility. Invite them to observe the intricate workflow processes that must be followed to promote positive quality outcomes and patient safety—and be sure to explain these steps and processes along the way. Additionally, consider sharing the future goals and objectives that the SPD is working on that align with the healthcare organization’s mission, vision and values.

Bear in mind that many SP professionals had to endure process changes and create standard operating procedures during the pandemic that were/are out of normal operational business routines. This has likely led to valuable stakeholder meetings, which (hopefully) opened doors to improved communication and interdisciplinary collaboration. It’s up to each SP leader to ensure those doors stay open and that the department/discipline holds a prominent seat at the table, all year long.

Note: Sterile Processing Week happens to fall during the 2021 IAHCSMM Annual Conference & Expo, and IAHCSMM is excited to celebrate attendees and the collective profession throughout that week. What better way to celebrate than with IAHCSMM and so many of your peers and fellow industry experts? If you haven’t yet registered for this year’s Conference & Expo, don’t wait as standard registration rates end Sept. 24. For more information and to register, visit: www.iahcsmm.org/GreatExpectations.

IAHCSMM also provides useful resources to help you celebrate Sterile Processing Week in some meaningful, memorable and inspiring ways (visit iahcsmm.org/about/sp-week.html). IAHCSMM is currently updating its free Sterile Processing Week celebration templates (including cards, posters and employee appreciation certificates) that can be customized, downloaded, printed and shared. The templates will be updated and ready for downloading in September.

Julie E. Williamson is IAHCSMM’s director of communications/senior editor.

 

Spotlighting Best Practices and Infection Prevention

By Julie E. Williamson

This column originally appeared in the July 2021 issue of Healthcare Hygiene magazine.

Sterile processing (SP) plays a vital role in care delivery, customer service, infection prevention and positive patient outcomes, so it’s imperative that SP professionals—who are responsible for cleaning, disinfecting, sterilizing, inspecting and delivering medical/surgical instruments to the operating room and other patient care areas—stay educated on best practices and the very latest standards and guidelines.

All who attend the 2021 IAHCSMM Annual Conference & Expo in October in Columbus, Ohio will have access to leading-edge education taught by the most knowledgeable and respected experts in the industry. They will leave the conference with new-found knowledge about the best practices to keep their departments running optimally and safely, and valuable steps to ensure the instruments they manage are properly cleaned, disinfected/sterilized and well-functioning.

The pandemic and its related uncertainties over the past year-and-a-half led IAHCSMM to move its Conference & Expo from May to October. IAHCSMM also embraced an innovative scheduling approach, with two back-to-back attendance options (Conference Option A takes place Oct. 9-11; Conference Option B takes place Oct. 12-14). Each conference option will have a different keynote speaker; however, all educational sessions and speakers will be identical for Option A and Option B. The two-day Expo will take place Oct. 11-12—on the final day of conference Option A and the first day of conference Option.

What follows is a summarized schedule of events for both conference options. A virtual conference option (Oct. 15-28) is also being offered for those unable to attend the in-person event. In-person attendees will receive complimentary access to the virtual conference.

Whichever option attendees choose, they can be confident they will receive the very best education and networking opportunities available to promote quality, safety and professionalism, and ensure they’re able to meet their healthcare customers’ and patients’ needs.

Julie E. Williamson serves as IAHCSMM’s senior editor and director of communications.

Option A Session and Event Schedule

Saturday, Oct. 9
10:30-11 a.m.: Opening Remarks
11 a.m.-12 p.m.: Opening Keynote (Steve Pemberton)
1:30-2 p.m.: Educational Session (Advocacy Update)
2:15-3:15 p.m.: Educational Session (Update on Sterile Processing Best Practices)
3:30-4 p.m.: Educational Session (Water Safety & Quality During Medical Device Reprocessing)
4:15-4:45 p.m.: Educational Session (Instrument Care & Handling: How to Care for Your Microsurgical Instruments in 5 Easy Steps)
5-6 p.m.: Educational Session (Is It Clean? Building a Quality & Audit Program Around Critical Elements Before Packaging)
7 p.m.: Opening Reception for Attendees

Sunday, Oct. 10
7:30 a.m.-8 a.m.: Educational Session (Infection Prevention 101)
8:15-8:45 a.m.: Educational Session (How to Evaluate Stains After Steam Sterilization)
9-10 a.m.: Educational Session (Are You Ready for the New AAMI ST91 for Endoscope Reprocessing?)
10:15-11:15 a.m.: Educational Session (Bringing Quality & Innnovation to Sterile Processing)
11:30 a.m.-12 p.m.: Educational Session (How to Tackle Steam Sterilization Failures)
1:30-2:30 p.m.: Educational Session (Sterile Processing Unscripted)
2:45-3:45 p.m.: Educational Session (Lessons from the Field: Preparing for the Next Pandemic)
4-5 p.m.: Educational Session (Fact or Facebook Fiction?)
5:15-5:45 p.m.: Educational Session (What You Should Know About the Physical Ergonomic Challenges Facing Sterile Processing Professionals)

Monday, Oct. 11
7:30-8 a.m.: Educational Session (Your Future Is in Your Hands: Building a Career Ladder in Sterile Processing)
8:15-8:45 p.m.: Educational Session (A Joint Commission Survey: What You Need to Know in Regard to High-Level Disinfection)
9-10 a.m.: Educational Session (Infection Control for the COVID-19 Era and Beyond)
10:15-11:15 a.m.: Educational Session (When Everything Goes Wrong: A Patient’s Perspective)
11:30 a.m.-12 p.m.: Educational Session (Understanding Enzymes and How to Get the Most out of Enzymatic Detergents)
1:30-2 p.m.: Educational Session (A Practical Guide for Disinfectants in SPD)
2:15-2:45 p.m.: Educational Session (Putting First Things First: What’s Your Priority?)
2-6:30 p.m.: Expo Open

Option B Session and Event Schedule

Tuesday, Oct. 12
10:30-11 a.m.: Opening Remarks
11 a.m.-12 p.m.: Opening Keynote (Jon Dorenbos)
1:30-2 p.m.: Educational Session (Instrument Care & Handling: How to Care for Your Microsurgical Instruments in 5 Easy Steps)
2:15-3:15 p.m.: Educational Session (Advocacy Update)
2-6 p.m.: Expo Open
6:30 p.m.: Evening Reception

Wednesday, Oct. 13
7:30-8 a.m.: Educational Session (Water Safety & Quality During Medical Device Reprocessing)
8:15-8:45 a.m.: Educational Session (Infection Prevention 101)
9-10 a.m.: Educational Session (Update on Sterile Processing Best Practices)
10:15-11:15 a.m.: Educational Session (Is It Clean? Building a Quality & Audit Program Around Critical Elements Before Packaging)
11:30 a.m.-12 p.m.: Educational Session (How to Evaluate Stains After Steam Sterilization)
1:30-2:30 p.m.: Educational Session (Are You Ready for the New AAMI ST91 for Endoscope Reprocessing)
2:45-3:45 p.m.: Educational Session (Bringing Quality & Innovation to SP)
4-5 p.m.: Educational Session (Sterile Processing Unscripted)
5:15-5:45 p.m.: Educational Session (What You Should Know About the Physical Ergonomic Challenges Facing Sterile Processing Professionals)

Thursday, Oct. 14
7:30-8 a.m.: Educational Session (Understanding Enzymes and How to Get the Most out of Enzymatic Detergents)
8:15-8:45 a.m.: Educational Session (A Practical Guide to Disinfectants in SPD)
9-10 a.m.: Educational Session (Lessons from the Field: Preparing for the Next Pandemic)
10:15-10:45 a.m.: Educational Session (A Joint Commission Survey: What You Need to Know in Regard to High-Level Disinfection)
11 a.m.-12 p.m.: Educational Session (When Everything Goes Wrong: The Patient’s Perspective)
1:30-2:30 p.m.: Educational Session (Infection Control for the COVID-19 Era and Beyond)
2:45-3:15 p.m.: Educational Session (The Future Is in Your Hands: Building a Career Ladder in Sterile Processing)
3:30-4:30 p.m.: Educational Session (Fact or Facebook Fiction)
4:45-5:45 p.m.: Educational Session (How to Tackle Steam Sterilization Failures)
6-6:30 p.m.: Educational Session (Putting First Things First: What’s Your Priority?)
7 p.m.: Closing Reception

To register for the 2021 IAHCSMM Annual Conference, visit: https://s6.goeshow.com/iahcsmm/annual/2021/index.cfm

 

Must-Have Standards for Every SPD: Value Letter Helps Ensure Budgets Allow for These Vital Resources

By Julie E. Williamson

This column originally appeared in the June 2021 issue of Healthcare Hygiene magazine.

Sterile processing departments (SPDs) operating in the absence of the latest industry standards, guidelines and recommended practices face the potential for numerous negative outcomes, including an increased risk to patient and healthcare worker safety, survey citations and fines, and devastating damage to their facility's reputation.

It's a message voiced by many experts—from sterile processing veterans, consultants, and surveyors from the Joint Commission (TJC) and Centers for Medicare and Medicaid Services (CMS), to litigators, representatives from healthcare associations and government agencies, and more. Unfortunately, many facilities lack these critical resources.

Sometimes, facilities don't have any version of certain standards; others may only have outdated versions – such as for ANSI/AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, which was updated in 2020.

Having current standards is not just vital for the SPD, but also for the collective facility. ANSI/AAMI ST79, for example, is a comprehensive document with valuable information for the SPD, operating room, infection prevention, safety, risk management, and engineering/facilities management, and it’s also the document by which surveyors are being trained.

Limited budgets are often to blame for the lack of standards in SPDs across the country. To help sterile processing professionals petition their facilities for the most current standards, guidelines and recommended practices needed for quality customer service and patient safety, IAHCSMM drafted the following Standards Value Letter, a template that sterile processing managers can customize and share with administrators and other executives.

We encourage any sterile processing manager who has struggled to attain the latest standards, guidelines and recommended practices to tailor this template to their own needs in an effort to drive best practices within their department—and we also recommend they lean on their organization’s infection prevention team for additional support, whenever needed, as infection preventionists can serve as a strong SPD ally.

Julie E. Williamson is editor/communications director for IAHCSMM.

Dear _____________________ (insert name of manager, administrative executive or other):

The Sterile Processing (SP) profession is ever evolving in terms of surgical instrumentation, processing equipment, and standard and best practices. To stay abreast of all these changes, it’s essential that our SPD and the professionals who comprise it have ready access to the most current standards and guidelines, such as those provided by the Association for the Advancement of Medical Instrumentation (ANSI/AAMI), the Association of periOperative Registered Nurses (AORN) and the Centers for Disease Control and Prevention (CDC).

Access to the latest standards helps ensure that our department is consistently following the most current recommendations and best practices that will promote patient and employee safety and keep us in check with The Joint Commission and Centers for Medicare & Medicaid surveyors (who are now being trained on standards such as ANSI/AAMI ST79: 2017 & 2020 Amendments A1, A2, A3, A4 (Consolidated Text), Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities.

Industry experts recommend the following key resources for every SPD:

1. ANSI/AAMI ST79: 2017 & 2020 Amendments A1, A2, A3, A4 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities
2. AORN Guidelines for Perioperative Practices, 2020
3. ANSI/AAMI ST58:2013, Chemical sterilization and high-level disinfection in health care facilities (Note: This document is currently under review)
4. ANSI/AAMI ST41: 2008/(R) 2018, Ethylene oxide sterilization in health care facilities (for facilities using ethylene oxide)
5. ANSI/AAMI ST91:2015, Flexible and semi-rigid endoscope processing in health care facilities
6. ANSI/AAMI ST90:2017, Processing of health care products - Quality management systems for processing in health care facilities
7. AAMI TIR 68:2018, Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces
8. AAMI TIR 67:2018, Promoting safe practices pertaining to the use of sterilant and disinfectant chemical in health care facilities
9. AAMI TIR 34:2014, Water for the reprocessing of medical device
10. AAMI TIR 63:2014, Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection
11. CDC Guideline for Decontamination and Sterilization in Healthcare Facilities, 2008
The CDC Guideline for Decontamination and Sterilization in Healthcare Facilities, 2008, is available free of charge on the agency’s website (https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines-H.pdf). Note: This version was updated in May 2019 and our SPD has this current version on file.

There is a charge for the other documents; however, I’m sure you will agree that budgeting for these documents is prudent given our healthcare organization’s desire to provide the very best patient care and quality customer service. Failure to have current standards on file in our department could prove costly for our facility if adverse events take place, such as surveyor citations/fines, costs associated with treating preventable infections or injuries to patients or staff, or litigation risks that could damage our facility’s reputation.

Diligent adherence to the latest standards and best practices will help drive patient and employee safety, advance infection prevention efforts, and keep exemplary customer service a top priority. It is my hope that you will support this request for budget dollars to allow for our department’s purchase of the most current standards as they become available.

Please let me know if you have any questions or concerns or require additional information. In the meantime, I’d like to thank you for your time and consideration.

Sincerely,

 

Competencies: Their Key Role in Sterile Processing Quality

By Tony Thurmond, CRCST, CIS, CHL

This column originally appeared in the May 2021 issue of Healthcare Hygiene magazine.

Competency is best defined as “a set of defined behaviors that provide structured guidance enabling the identification, evaluation and development of the behaviors in individual employees.” Put simply, it’s a term that relates to performance improvement, and professionals are expected to attain it through experience and an ability and desire to learn and adapt.

In the sterile processing (SP) realm, it’s important to examine how competencies are valued and applied. Are they viewed as a necessary evil or do SP professionals embrace the opportunities competencies can provide? ANSI/AAMI ST79, Section 4.2.2, states that “the responsibility of sterile processing should be assigned to qualified individuals who have demonstrated competence in all aspects of sterile processing.” Qualifications for SP professionals include demonstrated knowledge of and documented competencies in the tasks they perform, and a working knowledge of the work environment. Documentation is critical because if there must be evidence that proper training and demonstration of that training took place. Surveyors will ask to see employees’ orientation checklists and the documented competencies for each employee.

Develop a competency checklist
Thorough competency checklists must be created and maintained for each of the following areas of the SP department (SPD):
1. Decontamination: Competency must be shown in instrument sorting, disassembly/reassembly, manual and mechanical cleaning methods, microbicidal processes, equipment operation, standard- and transmission-based precautions, and engineering and work practice controls.
2. Instrumentation: SP professionals must know the names and descriptions of instruments in the organization’s inventory as well as the demonstrated inspection points of each device. Other competencies include proper preparation and packaging methods for sterilization.
3. Sterilization/High-level Disinfection (HLD): Competencies should cover all sterilization practices and principles, including steam, low-temperature, ethylene oxide, and HLD processes.
4. Worker Safety and Environmental Safety: SP professionals should understand and be able to demonstrate how to properly handle emergent situations, environmental hazards and other patient safety situations.

More competencies can be developed for specific equipment and instrumentation (to include proper cleaning techniques, sterilization and maintenance of each).

It’s important to note that a completed competency does not ensure a technician is competent, much the same way that holding certification does not ensure an individual’s competency. The proper skills learned and used effectively in day-to-day operations are what make for a competent technician. Some technicians can demonstrate the correct way of performing a task during a competency review, but then return to their bad habits after the review. Still, a competency checklist can benefit the department and facility in numerous ways, as the following paragraphs will demonstrate.

New employee checklists
When developing a competency checklist, equipment and departmental design will dictate the processes and workflow necessary to be completed. First, an orientation checklist must be developed and implemented for new SP employees. New team members should work with a competent technician who is willing to train and has the skills required to properly onboard the new employee. This orientation checklist is typically completed after 90 days of employment to verify the skills learned and the likelihood of the department continuing with the individual’s employment.

If the new employee demonstrates they have retained the training information provided and have the desire to continue to learn and broaden their skills, this growth should be documented by the SP leadership during the 90 days. If areas of weakness surface or it is determined certain information was not retained, the supervisor must review the training process and its effectiveness. The supervisor may need to review the preceptor or trainer to determine whether the proper information was given and whether certain aspects of the training process could be improved.

If no improvement is needed in the training process and the preceptor is providing proper, effective training, it must then be determined whether the new hire can be successfully trained and prepared for their role. Everyone learns at their own pace; however, the individual must demonstrate the desire to learn and do their best if they are to move past their 90-day review and continue to grow into a strong, proficient SP professional. It is recommended that new employees both verbalize and demonstrate the task(s) being evaluated. If, after completing the onboarding process and 90-day review, it is determined that the employee is not grasping the information and is showing little signs of succeeding in the role, it is best to inform this individual and not continue with their employment.

Be thorough and detail focused
Competency checklists must be written in the proper order of the process or workflow for the desired knowledge and skills being reviewed—and each item to be reviewed must be thoroughly understood and/or demonstrated. The checklist should indicate whether the demonstration is verbal or demonstrated, and it must be marked as “satisfactory” or “unsatisfactory” by the SP supervisor or manager. Each task/line item must be initialed by the person reviewing it to document that a thorough review was performed. Checklists should also include an area for comments (which can include suggested training or positive comments for technicians who demonstrated success and aptitude with a particular task).

Competency checklists must be reviewed at least once every six months to determine areas in need of improvement. Managers should ensure the checklist is current, taking into consideration any changes to equipment or internal processes, and whether any standards updates occurred that could require a change to current practices.

Most competency checklists should be completed at least once a year, or more often if a process is complex. If more errors have been identified in certain areas or for certain processes, an impromptu competency review may be necessary. Keeping a close eye on processes and employee training is necessary for promoting ongoing quality and safety.

Competency checklists may be developed from instructions for use of products or equipment, or from published standards such as those from the Association for the Advancement of Medical Instrumentation (AAMI), the Association of periOperative Registered Nurses (AORN) and others. Competency reviews of each technician must be reviewed by a competent technician, educator or manager who has also demonstrated working knowledge and expertise of the area being reviewed/assessed. The checklist must be signed by both the evaluator and the individual being evaluated. After the review, the competency must be placed in the employee’s file where it can be accessed for review as needed.

Competency checklists or reviews are considered a mandatory requirement in each department, and they allow departmental leaders to assess areas in need of improvement and gauge employees’ consistent adherence to best practices. Checklists can also lead to more standardization regarding how tasks and processes are performed, which can further lead to performance improvement and error reduction.

Examples of competency checklists are available free of charge to IAHCSMM members at https://www.iahcsmm.org/resource-documents/cs-sample-documents.html (members must log in to their member portal to access the documents). Another valuable resource is the IAHCSMM webinar “Understanding and Developing a Competency Program”(available until Sept. 30, 2021); members can view IAHCSMM’s webinars at no cost (non-member rate is $15).

Tony Thurmond, CRCST, CIS, CHL, is an IAHCSMM past-president and serves as central service manager at Dayton Children’s Hospital.

 

Peeling the Onion: How C-Suite Involvement, Consulting Can Spur Big Improvements in the SPD and Beyond

By David L. Taylor III, MSN, RN, CNOR

This column originally appeared in the April 2021 issue of Healthcare Hygiene magazine.

As the healthcare industry seeks answers to improve its “system of care,” an area often overlooked is sterile processing (SP). Far too often, administration fails to understand the importance of such a department, which supports and enables hospitals and health systems to focus on what they do best—delivering patient care. Without the SP function, a hospital can become paralyzed; therefore, it is vital that hospital administrators engage more readily with their SP professionals, so they can focus on improving processes and outcomes that impact the continuum of care.

One CEO did just that by engaging a team of consultants to improve both the operating room (OR) and SPD at two of his hospitals located in the Northeast—and the efforts were greatly rewarded. Initially, the SPD had been identified as a leading cause of the OR’s issues; however, after an intense multi-week assessment, it became clear that was not the case. While the SPD certainly had some issues that needed addressing, the OR team could not get out of its own way to realize they were part of the problem. More specifically, bullying behaviors from some in the OR were causing a divide between the two departments, which proved to be the root of the problems. Compounding matters further, after decades of neglect, understaffing, poor instrumentation maintenance and instrument set shortages, the SPD could not keep up with the demands placed upon them by the OR.

The fallout was significant. The SPD’s manager resigned, and the department had just failed its survey from the Joint Commission (TJC), and the SP team bore staggering responsibilities that included not just meeting the needs of the busy OR, but also all procedural areas (e.g., the Emergency Department, Intensive Care Unit, both onsite and offsite clinics, and an ambulatory surgery center). Additionally, the SPD was responsible for the cleaning, maintenance, storage and distribution of durable medical equipment, crash, trauma and hemorrhage carts, and it also was largely responsible for resupplying all nursing units and ancillary support areas with patient-related supplies through a modified materials management support system. The entire hospital relied on the SPD for nearly every aspect of patient care and yet the department had 10 full-time equivalent (FTE) vacancies, which greatly exacerbated the challenges of effectively and efficiently meeting organization-wide demands. The cause and affect due to the lack of staffing involved near-constant interruptions (occurring six times an hour, on average), staff burnout, errors and safety issues.

Through a collaborative effort with the hospital C-suite, a plan was implemented to address all issues identified during the assessment. First and foremost was addressing the TJC survey deficiencies that were levied against the SPD. To manage the improvement project, a new leadership team was needed. After an in-depth evaluation of the current staff, no one was identified who could step into a manager’s role. As a result, two interim managers and two supervisors were hired, one manager-supervisor set for each campus. Additionally, an interim SPD educator was employed to address educational needs at both campuses.

To address the survey deficiencies, an action plan was developed and each TJC issue was identified, prioritized and addressed. Areas identified included safety, cleanliness, clutter, employee skill level, and infection prevention issues. In conjunction, the leaders needed to evaluate and “know” their staff. Six-part folders were created for each employee, which allowed the interim leadership team to understand every employee’s employment history and better track their progress. Each folder contained:
• Hire date (work anniversary) and employee profile (job description, roles and responsibilities)
• A competency skills checklist and validation for each area in the SPD
• Mandatory training (BCLS, fire safety, etc.)
• Certifications held or in progress (e.g., CRCST, CIS, CER, CHL)
• Education and in-services, staff meetings, and continuing education credits; and
• Employee development (conference attendance, annual evaluations, counseling documents)

These efforts not only allowed the management team to create a feedback cycle (which demonstrated to each employee how they were contributing to their own department) but also allowed the SP team to more readily see how they and their department’s contributions impacted the organization. Put simply, it helped demonstrate their value to the organization—and showed that those in the C-suite also understood their importance. Further, the folders allowed the new management team to reconstruct every employee’s work history and have it at their fingertips. Some employees had worked in that facility’s SPD for more than four decades, yet no records were found in the department or with Human Resources (HR). The new folders allowed employees to take ownership in the process and they were asked to bring in copies of their certifications, continuing education participation, and more. As part of the ongoing assessment, training and mentorship, employees with strong skills were recognized and recommended for new service lead positions. In all, four of these new positions were created to accommodate day, evening, overnight and weekend shifts.

The educator began the process of validating the of skills of each employee, reeducating, as necessary. A new, on-the-job training program was developed to ensure current and new/incoming employees are trained to the same standard to meet current best practice standards. Competency checklists were created for each area of the SPD; all employees went through each task and their skills were evaluated. As a result, an action plan was created which helped generate ongoing education and in-service planning as well as the development of a formalized didactic training program that allowed employees to prepare for the certification exam.

Traveling technicians were also a part of the improvement plan. Because the SPDs at each campus had significant FTE vacancies, 10 traveling technicians were hired temporarily to fill in the gaps, each with their start dates staggered over several weeks. As a result, OR technicians who previously assisted with the workload in the SPD, despite being inexperienced in SP functions, were no longer needed.

To build a stronger bridge between the SPD and the OR, the interim management team began attending the OR’s morning huddle, which allowed the SPD team to hear firsthand any issues the OR was experiencing—and to be able to act on those issues in real time. Initially, the OR team seemed reluctant to have the SPD participate in their huddles, but they soon came to appreciate their presence. Over time, all SPD staff were brought to the OR to participate in the huddles. This helped them understand what occurred in the OR, while also allowing those in the OR to better know their partners in surgery from the SPD.

After each OR huddle, the SP professionals in attendance would round on every surgical suite to ensure each room had the necessary instrumentation to start their cases. When instrumentation was missing, the SP staff would search for those instruments, so the OR staff could continue opening their cases. This not only helped reduce frustration within the OR, but also helped those in the SPD uncover root causes to problems and more quickly work to remedy them.

The interdisciplinary huddles led to the following discoveries that were then addressed:
• Preference cards were out of date and did not represent the needs of the OR
• Lack of instrumentation for the number of same/similar cases scheduled for the day
• OR staff hoarding or hiding individual instruments and instrument sets because of mistrust
• Misuse of emergency carts, leaving them bare and not reporting their deficiencies to those in the SPD
• Using the majority of single-use peel packed instruments as user preference instead of adding necessary items to instrument sets

The need to find qualified SP candidates to permanently fill the vacancies was a top priority for the management team. Over several weeks, the leadership team interviewed candidates but were unsuccessful. To widen the pool for potential candidates, a plan was implemented to set up a job fair in a bordering state. The organization’s leadership knew it would need permanent, skilled SP professionals in order to make the process improvement changes sustainable. To entice the best candidates, they were offered paid relocation, a hiring bonus, a fair compensation package, and paid housing for 90 days after the agreed start date. Along with the compensation package, the hospital also agreed to provide a comprehensive training and education package and committed to pay for the employees’ certification.

The efforts paid off in spades. During the 12-hour job fair, 120 candidates were interviewed and 60 were offered a second interview. After the second round of interviews, 18 candidates were offered positions and 13 accepted. Upon completion of the employees’ orientation and training, 10 remained on the job and 100 percent became certified.

The six-month consulting project uncovered numerous issues and challenges that needed to be promptly addressed for the healthcare organization to continue meeting its patient care and service demands. This project also helped the organization’s administration see firsthand the hard work, skill sets, tenacity and vital contributions the SP professionals demonstrate each day.

It can be challenging to predict the wide range of situations a well-supported SPD will be able to support over time. Knowing the issues is the first step, but it is also important to understand that new issues will surface and need to be proactively addressed over time. It takes time to rectify sometimes decades of neglect; however, as this case study proves, a strong leadership and a team of skilled consultants to help steer the process can lead to significant improvements in a matter of months.

David L. Taylor III, MSN, RN, CNOR, is an independent hospital and ambulatory surgery center consultant and principal of Resolute Advisory Group LLC in San Antonio, Texas. He has been serving as an IAHCSMM author since 2019. He may be reached at david@resoluteadvisorygroup.com.

 

Advanced Certification Can Enhance Quality, Safety and Your Career

By Julie E. Williamson

This column originally appeared in the March 2021 issue of Healthcare Hygiene magazine.

The number of individuals who currently hold the Certified Registered Central Service Technician (CRCST) designation through the International Association of Healthcare Central Service Materiel Management (IAHCSMM) currently tops 34,800, and thousands more have chosen to advance beyond their CRCST by becoming a certified instrument specialist (CIS), certified healthcare leader (CHL) and/or certified endoscope reprocessor (CER). In fact, at the time of this writing, nearly 1,400 have attained three IAHCSMM certifications (known as Triple Crown) and nearly 500 more have earned all four IAHCSMM certifications (Golden Crown).

Many sterile processing (SP) professionals who have earned multiple certifications say they have seen their confidence, credibility and skill sets soar—and many also report that the additional certifications have helped them advance their professionalism and enjoy new career growth opportunities.

“One of the greatest gifts a sterile processing professional can give him or herself is a rewarding career,” says IAHCSMM education director Natalie Lind, CRCST, CHL, FCS. “Attaining additional certifications adds to their knowledge and skill set and in doing so, shifts the focus from having a job—with is a temporary mindset—to having a career, which is more of a lifelong philosophy.”
Attaining the foundational CRCST certification is a prerequisite before going on to earn the CIS and CHL designations; the CER, however, can be attained as a standalone certification. Whichever certifications an individual holds, many agree that the primary goal of attaining the professional distinction is to improve service excellence, safety and quality through broader knowledge and deeper understanding and skill development.

“Sometimes, I think we lose sight of the real goal of attaining certification,” notes Lind. “It’s a learning process designed to develop and enhance our skills and knowledge. Understanding the rationale for what we do makes us more confident and able to grow within the profession.”

Certification also helps ensure SP professionals stay current with best practices, standards and regulations—and for some, the decision to seek and attain advanced certifications is a deeply personal one, rooted in the desire to serve to one’s highest capability in the name of quality care and patient safety.

“I have challenged myself to be the best advocate for the patient I can. This is personal for me, not just a job,” says Jan Prudent, BA, CRCST, CIS, CHL, CFER, sterile processing manager at Eastern Idaho Regional Medical Center. She explained that to be truly successful in her role, she needed to learn the intricacies surrounding the services she and her team provided to their healthcare customers, and that meant also understanding the processes and reasons why the processes and steps were so important.

“[This] is essential to provide best practice to our patients and other customers. With that knowledge, I speak with authority, I am able to teach and coach others, and I am able to promote a profession that affects every facet of patient care,” she said. Prudent considers certification a measurement of success that serves as a baseline competency of knowledge and understanding that can grow and expand to drive improved technology and outcomes.

Planning ahead for one’s own career growth is always a wise move, and for SP professionals, certification can help them more easily reach the higher rungs on the career ladder.

“The time to prepare for a promotion is not when a position becomes available, but before, so when the opportunity presents itself, you are ready,” Lind said.

IAHCSMM past-president Tony Thurmond, CRCST, CIS, CHL, who serves as sterile processing manager for Dayton Children’s Hospital in Dayton, Ohio, first became a CST while serving in the U.S. Air Force; it was a role that also included serving as an SP technician. He wasn’t introduced to the CRCST until he was in the civilian sector, but he jumped at the chance to seek certification. “With IAHCSMM, I had the opportunity to gain multiple certifications to help elevate my career,” he said.

After attaining the CRCST, Thurmond found the opportunity to further advance his professional development was too good to pass up. He earned his CHL because he knew he wanted to move into a management role, and he was amazed how quickly he received unsolicited calls of interest from facilities across the country who were seeking SP managers.

In Prudent’s facility, a career ladder program was implemented for the department, with each certification serving as a “rung,” all the way through the supervisory role, which encompasses the CRCST, CIS, CHL and CER. The facility integrates the CRCST course work into new-hire shadowing and hands-on training.

For all the merits of certification, the most notable is the potential for improving customer service and patient outcomes. As Prudent points out, the mission for Eastern Idaho Regional Medical Center is to “improve the lives of those we touch.” It’s a mission she personally strives to perfect daily on the job.

“I cannot get there if I do not know how, and certifications are the stepping-stones to finding the way. You cannot fix what you do not know, and you cannot hold others accountable without first holding yourself to those standards.”

Julie E. Williamson is the director of communications/editor for IAHCSMM.

 

AAMI Updates ANSI/AAMI ST79; ASGE and Others Revise Multi-society Guideline for Flexible Endoscope Reprocessing

By Susan Klacik, BS, CRCST, CIS, CHL, ACE, FCS – IAHCSMM Clinical Educator

This column originally appeared in the February 2021 issue of Healthcare Hygiene magazine.

Last month, the Association for the Advancement of Medical Instrumentation (AAMI) released an updated version of standard ANSI/AAMI ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities. The revised document includes the following four amendments:

Amendment 1: Environmental Services/Fans/Food and Drink

A new section was added in section 3.2.1.1 Design considerations that specifically states that food and drink should not be permitted in any area where medical devices are processed, as they can contaminate prepared and sterilized items, and attract insects.

This new section also requires that the sterile processing department (SPD) or other areas that perform sterile processing functions should follow the same housekeeping procedures as those used to clean operating rooms and delivery rooms. It is recommended that floors and horizontal work surfaces be cleaned at least daily. Other surfaces in an SPD, such as walls, storage shelves and air intake and return ducts, should be cleaned on a regularly scheduled basis and more often, if needed. Stained ceiling tiles should be replaced. High-level environmental cleaning should also be routinely performed and include ceiling vents, tops of equipment and workstation lights. Low-level environmental cleaning should occur on surfaces such as base boards, sterilizer base and cart bottoms. Lighting fixtures or covers should be cleaned at least once every six months.

It is recommended that a cleaning schedule be implemented and followed. A cleaning checklist may be used to demonstrate appropriate cleaning is being performed. A sample of an environmental checklist has also been added to the revised standard.

Cleaning verification tools should be used to measure the adequacy of environmental cleaning on work surfaces. These tools include ultraviolet visible markers and ATP bioluminescence. The metrics from the cleaning effectiveness should be provided as feedback to personnel performing the cleaning task as providing this measurement can improve the quality of cleaning.

Additions were also made to section 3.3.5.5 Heating, ventilation, and air conditioning (HVAC) operating parameters. The ventilation recommendation was changed to direct the healthcare facility to identify which version of ANSI/ASHRAE/ASHE 170 will be used, based on when the HVAC system was initially installed or last upgraded. The healthcare facility should establish and implement systematic processes for monitoring HVAC performance parameters and a mechanism for identifying and resolving variances within the rooms throughout the facility where SP functions occur.

This amendment includes additional recommendations regarding the ventilation systems, including those pertaining to the use of fans and the effects of doors and windows. The environment used to process and store medical devices has an impact on the safety of the devices processed; for that reason, it is important to have control of bioburden and environmental contaminants. The use of down-draft-type air circulation systems limits contamination by carrying contaminants toward the floor and away from work surfaces. Fans are not permitted in any sterile processing area because they create highly turbulent airflow, which recirculates dust and microorganisms from the floor and work surfaces—this, interfering with designed airflow characteristics. Windows and doors that affect the ventilation and airflow should be kept closed to further limit the risk for environment contamination.

Amendment 2: Inspection of Insulated Instruments

Two new sections have been added to Section 8 Preparation and assembly of instruments.
Section 8.2 addresses the inspection process to emphasize the fact that damaged instruments or incomplete instrument sets/trays may cause a delay or cancellation of a surgical procedure, and/or increase risk of patient harm related to instrument malfunction. Several steps can be taken to prevent such incidents. It is recommended that every time a medical device is processed, it should be visually inspected for cleanliness and integrity. Enhanced inspection with magnification, borescopes or other inspection methods to verify cleanliness and integrity may be used. A method should be in place to ensure the cleanliness and integrity of every instrument and medical device. Upon inspection, medical devices with retained soil or residue should be subjected to repeated cleaning and decontamination processes until the device is completely clean. Damaged instruments should be removed from service (damaged instruments should be addressed according to the healthcare organization’s policies and procedures). Methods used to change instruments from their original state—such as using an engraver that can cause fractures or surface damage—should not be performed. To ensure the correct type of inspection equipment is available, it is recommended to review the equipment instructions for use (IFU); this should also be done when purchasing new devices.

Section 8.2.1 addresses the inspection of instruments intended to be used with electric current (otherwise known as electrosurgical instrumentation). Electrosurgical instruments are insulated and, typically, used in minimally invasive surgery. They are susceptible to physical and mechanical damage and degradation related to repeated use. Using insulated instrumentation with holes in the insulation or other defects places the patient at risk for significant harm. The holes may not be clearly visible; if they are not detected during instrument processing and the damaged instruments are used during a procedure, the insulation breach can result in an electrical current escape that can burn the patient.

Insulated instruments should be carefully inspected, including their cords, which can become damaged during normal use, processing, contact with sharp instruments, and use of high voltage electricity. It is recommended to organize instruments (such as in instrument sets) to protect them from damage.

To prevent patient harm, insulation testing for insulation integrity is recommended each time the instruments are processed, in accordance with the instrument manufacturer’s written IFU for inspection. There are different types of insulation testing methods and they vary with insulation tester type. There are also a variety of accessories to test specific instrumentation and cables/cords, based on their design. For that reason, it is vital to refer to the instrument and insulation tester manufacturers’ written IFU for their recommended procedures. Insulation testers are designed to detect small current leaks that can jeopardize patient safety. Any time instrument insulation does not pass inspection, the device should be immediately removed from service, and damage should be addressed according to the healthcare organization’s policies and procedures that address instrument evaluation, repair or replacement.

A table was added that addresses the inspection points and possible damage for various instruments/devices. This table lists the name of the instrument/device, followed by its inspection points, as well as the possible damage to the medical device, and methods to assist with inspection/testing. This quick reference inspection guide will be helpful as these instruments are processed.

Images of instrument and cord failures are also provided to help present the reader with a clearer understanding of what to look for in electrosurgical instrumentation and cord failure.
Education is the cornerstone of good practices. That fundamental understanding is reflected in this amendment, which recommends that personnel responsible for processing these instruments should receive education to ensure they understand how to use testing equipment safely and effectively. In addition, competency should be verified and documented before employees’ first assignment to use the equipment.

Amendment 3: Modification of Content Pertaining to Frequency of Cleaning for Routine Care of Sterilizers for Sterile Processing Areas in Health Care Facilities

This amendment changes the recommendations in section 12.4 Routine care of the sterilizers. The previous version recommended daily inspection and cleaning. The revised recommendation directs the user to follow the sterilizer’s IFU, which may require that weekly or other prescribed inspection and cleaning be performed (and it should be documented, per internal procedures).

Amendment 4: Content Addressing Recording Biological Indicator Lot Numbers in Sterilizer Records for Sterile Processing in Health Care Facilities

This amendment revises the wording in sections 13.8.2.3 BI PCD test procedure, 13.8.3.3 Test procedure and 13.8.4.3 Test procedure. The previous wording of these sections did not specifically state to record the lot number, only the “number of both test biological indicators (BIs) and control BIs.” To better clarify the specific “number” to document, the revised wording specifically states to document the lot number of both test BIs and control BIs.

The amended standard is available at www.aami.org/ST79. ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities will be automatically updated for users with an AAMI eSubscription. Those who previously purchased the printed version or have a PDF version will receive a PDF of the amendments via email at no cost.

Multi-society Guideline for Flexible Endoscope Reprocessing Updated

The American Society for Gastrointestinal Endoscopy (ASGE), along with members of the American Society for Gastrointestinal Endoscopy Quality Assurance in Endoscopy and Standards of Practice committees have updated the Multisociety guideline on reprocessing flexible GI endoscopes and accessories. This guideline was revised using evidence-based recommendations, based on rigorous review and synthesis of the present-day literature—using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. The GRADE framework is an all-inclusive and transparent system for the quality rating for the evidence and strength of the recommendations. What follows are highlights of this revised guideline.

This guideline states that staff training and competency of endoscope reprocessing skills are important aspects of infection prevention. It is recommended that reprocessing staff be trained on all the endoscope models they are expected to process and shown to have documented competency before being assigned to process them. The healthcare organization should then perform competency evaluations of endoscope processing personnel on a scheduled basis, as defined by the organization (typically, this occurs when one first assumes endoscope processing duties; at least annually; anytime a breach is identified; when a major technique or new endoscope or reprocessing accessory is introduced; and in the context of local quality control efforts).

The delayed processing of endoscopes has become a hot topic. This guideline recommends that manual cleaning begin according to the instructions for use (IFU), which is usually within an hour after the endoscope is released from the procedure. If cleaning is delayed beyond this time period, the manufacturer’s IFU for delayed processing must be followed. It is recommended that soiled endoscopes be transported immediately to the reprocessing area in a fully enclosed, puncture-resistant, leak-proof containers with a biohazard label.

It is recommended that only clean cleaning implements are used; if reusable cleaning implements are used, they must be cleaned and disinfected between uses. The guideline also recommends the use of fresh cleaning solution for each endoscope. If the cleaning solution falls outside the recommended temperature and dilution range, it is recommended that it be replaced.

If an endoscope undergoes high-level disinfection, it is recommended to perform this disinfection step in an automated endoscope reprocessor (AER) using a high-level disinfectant or sterilant that is compatible with the AER and sterilizer IFU. The importance of adhering to the endoscope manufacturer’s IFU was emphasized. Some duodenoscopes contain an elevator wire channel that may not effectively be disinfected by some AERs and that this step should be performed manually. In addition, the endoscope and components should be attached using only approved connectors, per the AER and endoscope manufacturer’s IFU to ensure contact of all internal surfaces with the high-level disinfectant solution. If the AER cycle is interrupted, the entire cycle should be repeated.

Recent research links incomplete endoscope drying to multiple outbreaks of waterborne organisms (data shows a reported endoscope contamination rate of 80 percent). This research signifies that the methods of drying flexible endoscopes need to change—and this multi-society guideline includes new drying recommendations. Prior to this newfound information, 70 percent to 90 percent ethyl or isopropyl alcohol was injected into the endoscope channels to dry the channels. Alcohol was recommended because it purged and promoted the evaporation of residual water within endoscope channels, thereby decreasing the chances for bioburden buildup. There is little data on the possible benefits of alcohol flushes. Based on research, this guideline recommends drying the endoscope channels and areas not dried with a cloth with forced, pressure-regulated filtered air— with a sufficiently prolonged flow of medical air through all accessible channels. For best results, it is ideal for this step to occur simultaneously for all channels and for a duration of at least 10 minutes. Flexible endoscopes should be completely dried after processing and before use. Note: This guideline recommends following manufacturers’ IFU regarding the use of ethyl or isopropyl alcohol for drying endoscopes. There was a case report that switched to suctioning 70 percent alcohol through a duodenoscope working channel, followed by compressed air during the drying phase. It was reported that this helped contain an outbreak of Pseudomonas aeruginosa. In addition, a conclusion from the pulmonary literature suggests that using alcohol for drying purposes significantly reduces bronchoscope contamination rates; however, the fixation properties of alcohol could lead to the retention of organisms within the endoscope. At this time, there is no data to strongly support or refute the use of alcohol flushes for the drying of endoscopes.

Proper storing of endoscopes is important to prevent contamination. This updated guideline includes information on proper endoscope handling, including the need for personnel to perform hand hygiene and wear clean gloves during all phases of endoscope handling. Endoscopes may be stored in drying cabinets or conventional cabinets, and always in a way that does not allow for moisture to collect on or within the endoscope.

Drying cabinets have connectors that force air through each endoscope channel. The endoscopes can be stored either vertically or horizontally. These storage cabinets use forced irrigation of endoscope channels with warm, filtered air during storage to achieve complete drying of the channels. This reduces the proliferation of Pseudomonas aeruginosa; however, these cabinets’ importance for keeping endoscopes free of contamination remains incompletely defined.

Conventional cabinets require endoscopes to hang vertically, and active or passive ventilation with filtered air helps prevent moisture from forming on or within endoscopes. Passive cabinets without airflow directed into all channels are not sufficient for drying the endoscope from a wet state.

Endoscope cabinets should be in a secure location that is near but not in the procedure rooms. Care and maintenance of the cabinet should be performed according to the cabinet IFU and the cabinets should be routinely inspected for damage and cleaned on a routine basis (and when soiled) with an Environmental Protection Agency–registered hospital disinfectant. This guideline does not provide a specific amount of time that endoscopes can be stored before being considered contaminated. It is recommended that Endoscopy units evaluate the available literature, perform an assessment regarding benefits and risks around the optimal storage time for endoscopes, and then develop a policy and procedure specific to their unit on endoscope storage time.

The multi-society guideline also addresses recommendations regarding the use of simethicone. It is recommended that the Endoscopy unit follow the manufacturer’s IFU on its addition in water bottles and irrigation devices, including cleaning and disinfection of endoscopes after its use.
The guideline also recommends that documentation be put into place to provide traceability of endoscopes, including those that are loaned.

This article has provided some highlights of the updated Multisociety guideline on reprocessing flexible GI endoscopes and accessories. The complete guideline is available on the ASGE website at www.asge.org (under the “ASGE guidelines” and the “Newly Published” tab).

Susan Klacik, BS, CRCST, CIS, CHL, ACE, FCS, serves as a clinical educator for IAHCSMM.

 

Poorly Managed Loaned Instruments Pose Potential Infection Risks

By Julie E. Williamson

This column originally appeared in the January 2021 issue of Healthcare Hygiene magazine.

Proper management of loaned instruments and trays ranks among the top challenges for many sterile processing (SP) professionals – and it’s an obstacle that’s only become increasingly difficult to hurdle in light of rising procedural volume (e.g., for orthopedic, spinal and endoscopy cases, to name a few) that commonly up the odds for more loaned instruments making their way into the SP department (SPD).

Loaned devices are often more complicated and sophisticated, and processing them properly and safely hinges on the availability of proper resources that include adequate time for advance staff training, proper types and amounts of equipment and supplies, ample storage space, ready access to the most devices’ current instructions for use (IFU), and the need for loaned instruments to be delivered far enough in advance of the procedure to ensure thorough processing can be performed. Unfortunately, far too many healthcare organizations and vendors aren’t doing their due diligence to ensure all those critical needs are consistently met. It’s a shortcoming that can jeopardize patient safety, increase infection risks and cost the facility dearly on numerous fronts.

“There are no easy answers or silver bullets, but having an understanding of why things happen the way they do in the loaned instrument world is critical, along with the understanding of how we as professionals can make it better, not only for the surgeons and patients but also for our staff,” said Damien Berg, BA, BS, CRCST, AAMIF, regional manager of sterile processing for University of Colorado Health, during his IAHCSMM Online Conference session, “Loaned Instruments: Proper Protocols and Challenges.”

Berg, an IAHCSMM past-president (2018-19) and voting member and co-chair for documents from the Association for the Advancement of Medical Instrumentation (AAMI), has spent more than 27 years working in the operating room (OR) and sterile processing department (SPD). Today, he oversees two large UCHealth medical centers and a surgery center, both of which regularly receive a steady stream of loaned instruments. In his many years of experience, he’s faced (and improved upon) numerous challenges related to loaned instruments and he’s now frequently asked by his SP peers to share his advice on how best to manage those devices.
What follows are some of his top tips:

1. Establish a detailed policy for managing loaned instruments throughout every step of the cycle – and ensure all stakeholders (SPD, operating room, purchasing, infection prevention, and vendors/distributors) comply and are held accountable. Numerous resources are readily available to help guide the policy development process, including AAMI Technical Information Report (TIR) 63, Management of loaned critical and semi-critical devices that require sterilization or high-level disinfection, and free sample policies and procedures on loaned instrumentation available from IAHCSMM (https://www.iahcsmm.org/resource-documents/loaner-instrument-template.html).
“These documents can help us with managing the process and ensuring we are covering all the critical pieces, as well as helping ensure we’re treating loaned instruments as well as would with our own instruments,” Berg explained, adding that it’s prudent that all stakeholders receive a copy of the facility’s/organization’s policy and sign off stating that they read the policy and agree to the outlined terms.

2. Have dedicated SP team members on appropriate shifts who are trained on the loaned instrument policy and how to properly manage receipt/release of loaned sets. It’s also important that all stakeholders understand that all loaned instruments that arrive to the facility will be treated as contaminated and always undergo full reprocessing, in accordance with IFU and industry standards. No instruments will ever arrive and head directly to the OR or other user area, regardless of how they were handled or transported prior to arrival.

3. Never rush the process. Time requirements and drop-off expectations for loaned instrument must be clearly outlined in the policy and then stressed to all parties to ensure compliance. While SP professionals are typically not part of the stage where loaned instruments are requested, they must be involved in the arrangement as soon as possible to ensure the SPD has the proper equipment, supplies, instructions for use, etc. to ensure they can safely and effectively process the items prior to the procedure (and within the timeframe stipulated in the policy).

During his session, Berg explained it this way: “If Dr. Smith is doing a total knee, for example, Company X will be bringing in a certain number of trays for the procedure, and we know that if the instruments are needed in the OR by Tuesday at 7 a.m., we’ll need those total knee trays received in the SPD by Monday at 7 a.m. because our facility’s policy states instruments must arrive at least 24 hours before the procedure.” He went on to explain that if a drop-off occurs last-minute or at any point under 24 hours, the time of actual delivery (as well as the reason for the late arrival) should be documented. Such documentation helps identify trends and, perhaps, gaps in communications or compliance, which can be more proactively addressed – and surveyors will also be looking to ensure receipt of loaned instruments is documented and comparing that to the facility’s written policy. “If you have a 24-hour or 48-hour policy on when loaned instruments need to arrive to your facility [in advance of the procedure], but surveyors discover that’s not being followed, you’ll be in violation of your own policy.”

4. Don’t let loaned sets tip the scales. Loaned instrument policies should also clearly address weight limits, which are reflected in the AAMI standards and Association of periOperative Registered Nurses (AORN) guidelines. Both recommend that instrument sets and trays prepared for sterilization not exceed 25 pounds, and that weight includes the container that holds the instruments. Berg recommends SP professionals not only state in the policy that 25-pound limit, but also working with vendors to determine how heavy sets can be brought down to a more manageable weight, perhaps by splitting the contents into two trays or working with the OR to determine if any instruments in the set that typically go unused can be removed from the tray and packaged separately.

5. No IFU or vendor education? No instrument acceptance. Without ready access to current instructions for use (IFU), SP professionals simply cannot properly and safely manage and process instruments. IFU and additional training requirements (as needed) should be directly stated in the loaned instrument policy, and they should then be reiterated with vendors. Ahead of all procedures where loaned devices are to be used, the SP team just also verify they have the proper equipment, supplies, IFU and other essential resources needed to reprocess those instruments safely and thoroughly. Not only should technicians understand the cycles needed to reprocess the loaned instruments, they must also have knowledge of how the devices are disassembled to facilitate proper cleaning.

“IFU need to be provided for all instruments, no exceptions,” Berg says. Once those instructions are provided by the vendor, copies must be made for SP professionals across all areas of the department, from decontamination and assembly to sterilization and storage.

6. Inventory carefully – and take photos as proof. At any point through the the use, handling or delivery cycle, loaned instruments can become lost or damaged, and that can prove costly for the user facility if diligent documentation isn’t happening at the point of instrument receipt and release. Berg said ensuring a manual or electronic count sheet is readily available at the location where loaned instruments arrive and leave the facility is crucial for tracking all set contents, and he stressed that list/count sheet should never be signed/approved without visual confirmation that all contents are not only in place and not damaged. Photographing set contents is a simple step that can pay big dividends.

“Pictures are worth a thousand words,” said Berg. “If an instrument turns up missing or obviously damaged after it’s left your facility, imagine the benefit of being able to visually show they were present and undamaged at the time of pick-up.”

Julie E. Williamson is the director of communications/editor for IAHCSMM.