AAMI Updates Chemical Sterilization, HLD Standard

By Susan Klacik, BS, CRCST, CIS, CHL, FCS, AAMIf

This article originally appeared in the December 2024 issue of Healthcare Hygiene magazine.

The Association for the Advancement of Medical Instrumentation (AAMI) released its updated ST58 Chemical sterilization and high-level disinfection in health care facilities. The standard guides the selection and use of liquid chemical sterilants (LCSs), high-level disinfectants (HLDs) and gaseous chemical sterilizers cleared for marketing by the U.S. Food and Drug Administration (FDA) for use in healthcare facilities. Some of the key changes are addressed in this article.

One notable change is that ANSI/AAMI ST41 Ethylene oxide sterilization in health care facilities: Safety and effectiveness has been added to ST58:2024; therefore, AAMI has withdrawn ST41 from its available standards. Another significant addition, found in the Foreword, references the 2017 multidisciplinary stakeholders meeting hosted by AAMI that recommended sterilization of endoscopes used as semi-critical devices. Recent research shows that some pathogens are resistant to HLD. Additionally, medical devices and instructions for use (IFU) are becoming more complex, and new low-temperature sterilization methods make it possible to sterilize devices in roughly the same time or less as those exposed to HLD processes.

Water quality, drying and safety
ST58:2024 reflects the terminology “point-of-use treatment,” which aligns with other AAMI documents. Removing debris, flushing lumens, discarding single-use items, disassembling instrumentation, maintaining moisture on the devices, and placing items in the appropriate Occupational Safety and Health Administration-labeled biohazardous container are also emphasized.

Device instructions for use (IFU) often have a time requirement for cleaning, and research supports the need to initiate the cleaning process as soon as possible following the procedure. To align with IFU and recommendations, ST58:2024 addresses the importance of communication between clinical areas and the decontamination room, and a new section, 5.3.5, provides recommendations for the information to be communicated. Further, methods to minimize the time between use and decontamination have been added in another new section, 5.3.6.2, and section 5.4.7 provides recommendations for cleaning verification testing and borescopic examination.

Cleaning is one of the most vital steps for ensuring effective disinfection and sterilization; therefore, new sections have been added to ST58’s quality control section to assist with verifying device cleanliness and proper function of mechanical cleaning equipment. Section 8.2, Monitoring of mechanical cleaning equipment, recommends verification testing be performed on all mechanical cleaning equipment. The section details when testing should be performed, the types of test methods available, record keeping and key outcomes. What’s more, section 8.3, Verification and monitoring of the cleaning process, addresses inspection methods for medical devices. Recommended methods of visual inspection include the use of lighted magnification—and borescopes to inspect the inner channels/lumens—which is consistent with ANSI/AAMI ST91 Flexible and semi-rigid endoscope processing in healthcare facilities.

Hand hygiene is another essential aspect of medical device processing. The revised version of ST58 includes an expanded section about hand hygiene that addresses where sinks should be located. Specifically, it is recommended that handwash sinks remain separate from those used to process medical devices.
Previously, ST58 had two chemical sterilant classifications, LCS/HLD and gaseous chemical sterilants. ST58:2024 includes a third category: foam or gel. New sonicated hydrogen peroxide mists are included throughout the standard, and Annex K, Sonicated hydrogen peroxide mist, has been added for users seeking additional information about this new disinfecting technology. A brief discussion about the differences between manual and automated disinfection processes is included under the “General considerations” and “Liquid chemical sterilants/high-level disinfectant selection and use” sections. It states that manual HLD and LCS are subject to variability and inconsistency while explaining that automated processors are designed to deliver the LCS and HLD solutions to all medical device surfaces to achieve effective LCS or HLD. A new section has been added to ST58:2024 that addresses chemical spills.

All water references have been updated to the new standard ANSI/AAMI ST108:2023 Water for the processing of medical devices. This includes the type of water quality to use, such as critical water for the final rinse (a new section, 3.4.3, addresses water quality recommendations for specific uses). Another noteworthy addition in ST58:2024 is that as part of the facility water management plan, there should be a periodic microbial assessment of the automated equipment reprocessor (AER) and processing equipment to identify water contaminants or contaminated equipment that may contribute to recontamination of the device after HLD. Periodic microbial assessment of the water used for final rinse should be considered to identify any contaminants that can contribute to recontamination of the device after LCS or HLD.

Drying is a critical step in the HLD/LCS process and can reduce the risk of device recontamination. Based on this information, ST58:2024 added a new drying recommendations section (6.5.2.2). Research has shown that waterborne microorganisms, such as Pseudomonas aeruginosa, can pose an infection risk to a portion of the endoscopy patient population, and the presence of microorganisms—in conjunction with retained moisture—can lead to the development of biofilm, especially if tap water is used to rinse the endoscope following the antimicrobial process.

Consistent with other AAMI standards, ST58:2024 recommends lumened medical devices have their lumens dried with flowing pressure-regulated instrument air or HEPA-filtered air for a specified period and pressure according to the instrument manufacturer’s written IFU. Research has shown that a minimum 10-minute dry time is effective for drying flexible endoscope channels, for example. The correct-sized adapter should be used. Using syringes or a handheld compressed air gun for drying is not recommended.

After processing devices in an automatic processor, they should be removed at the end of the cycle. If they remain in the automatic processor for an extended period, such as an hour, they should undergo reprocessing before storage or use. The standards also reminds that critical devices, such as ureteroscopes, should be used immediately after processing (if not, they should undergo processing again before use). ST58:2024 features a new section, 6.5.2.3, Labeling of LCS/HLD items after processing, that provides recommendations to help identify patient-ready medical devices and prevent the use of unprocessed devices.

The packaging section has expanded to include criteria for selecting a sterile barrier system, which now includes EO sterilization; a table was added to clarify the types of packaging recommended for each type of gaseous sterilization. Additionally, device storage recommendations have been expanded in ST58:2024 to include additional methods for preventing microbial contamination. The section emphasizes the importance of storing completely dry devices. If drying cabinets are not used, dryness indicators can be used.

HVAC and cleaning updates
A section for environmental cleaning (3.2.1) was added to ST58:2024, mirroring the amendment in ANSI/AAMI ST79:2017 & 2020 Amendments A1, A2, A3, A4 (Consolidated Text). A cleaning schedule and checklist is recommended to demonstrate compliance with the cleaning schedule. Additionally, a method to measure the thoroughness of cleaning should be incorporated, which includes cleaning verification tools such as ultraviolet visible markers and adenosine triphosphate (ATP) bioluminescence.

Heating, ventilation and air conditioning (HVAC) operating parameters also require careful consideration. A new section, 3.4.4., provides recommendations for creating a safe working environment, guiding users on safe ventilation patterns and other environmental controls to prevent the spread of potentially dangerous microorganisms and toxic chemicals. Policies and procedures should be in place to monitor and maintain the HVAC parameters, and records showing the monitoring results should be maintained and accessible. Additional ventilation recommendations specific to chemicals are provided in section 3.5.9.

This article is only a high-level summary of the updates and additions to ST58:2024. SP professionals are urged to review and have access to the entire standard, which can be accessed at www.aami.org.

 

The High Cost of Improper Scope Handling and Transport

By David Taylor, MSN, RN, CNOR

This article originally appeared in the November 2024 issue of Healthcare Hygiene magazine.

Proper handling and transporting of flexible endoscopes between the examination room and processing areas is crucial for minimizing infection risks and preventing costly instrument damage. Achieving high reliability, consistency and safety when managing flexible endoscopes from user areas to processing departments requires a strong infrastructure that supports staff training, competency development, quality assessments, and active management.

The repercussions of poor endoscope handling, processing and transport procedures can be significant, impacting both patient health and the organization’s bottom line. Patients who develop infections due to inadequate processing and unsafe transport may require prolonged treatment and hospitalization, costing the facility thousands of dollars.

Legal fees, settlements and compensation for damages can result in further financial loss, from thousands to millions of dollars depending on the severity of the case. In addition, regulatory bodies may impose fines and penalties on healthcare organizations that fail to adhere to proper processing protocols. HAIs and other negative patient outcomes stemming from improperly processed and managed devices can tarnish a healthcare organization’s reputation by diminishing patient and community trust, often leading individuals to seek care elsewhere. Further, endoscopes are costly purchases, and inappropriate handling, transport and processing practices can contribute to exorbitant repair and replacement costs that could have been prevented.

Never rush (or ignore) critical steps.

Endoscope processing is a collection of crucial and, often, complex steps that should result in a device that is free from microbial contamination and rendered safe for patient use. Every step is inextricably linked, with the success of each preceding step required for subsequent processes to be effective. Although there is understandably strong emphasis on the cleaning and disinfection phases, all processes occurring before and after those stages must never be underestimated, rushed or skipped. Any compromise or breach in any process can potentially re-contaminate the endoscope or damage components, rendering the device unsafe for patient use.

Point-of-use treatment is an essential step of proper endoscope care and handling; as the name implies, it should be performed in the procedure area, before the endoscope is sent to the decontamination area. The treatment involves using an approved solution (enzymatic or nonenzymatic) to wipe the insertion tube of the device and flushing the solution through each channel immediately after use. Dried soils are a challenge to remove, compromising the effectiveness of subsequent cleaning steps, and potentially damaging the endoscope.

Safe transport processes should also be emphasized to any employees who transfer endoscopes to and from Endoscopy suites and sterile processing areas. Again, endoscopes are very delicate medical devices, and improper handling during transport can lead to infection transmission, damaged components, and shortened instrument lifespan. To mitigate these risks, endoscopes should be placed horizontally in puncture-resistant, enclosed and leak-proof containers labeled for clean or hazardous transport (approved disposable, sealable transport bags may also be used, but they should still be placed in a secure container for protection). Staff should be trained about the importance of never transporting endoscopes with sharps, which could puncture or scratch the delicate components, and they should never coil endoscopes tightly, which could result in severe device damage. Endoscope attachments should always remain with the endoscope but must be placed carefully in the transport container to prevent damage.

Leak testing is crucial before manual cleaning begins. This step helps verify the functionality of the device and whether damage to the external surfaces or internal channels occurred during its most recent use. Detecting damage early can prevent inadequate disinfection and further damage to the device. This helps improve patient safety and avoid costly repairs or replacements by addressing issues before they worsen.

Manual cleaning requirements can vary by manufacturer; therefore, it is vital to follow the manufacturer’s instructions for use (IFU) for each step in the process (including ensuring each of the channels and ports are brushed and flushed the appropriate number of times before the device undergoes high-level disinfection (HLD) or sterilization). The brushing and flushing steps are essential because residual organic material can harden and become difficult to remove. Failure to remove bioburden will reduce the effectiveness of HLD and sterilization and render the device unsafe for patient use. Manual cleaning should begin within one hour of a procedure’s completion to prevent extended processing times.

Visual inspection under lighted magnification is another critical step that must never be rushed or skipped because it helps ensure the endoscope and its accessories are free of debris and defects. Ideally, this step will also involve the use of a borescope to inspect internal channels for damage.

High-level disinfection (HLD) of endoscopes remains a widespread practice, but some manufacturers now recommend sterilization as the final step. Adhering to the manufacturers’ IFU for the disinfectants, sterilants, equipment and supplies used for processing is imperative. Proper drying is another vital step because it minimizes the risk of recontamination from waterborne microorganisms. Drying can be achieved by flowing air through all endoscope channels in a manner and for a duration specified by the device manufacturer. Note: Always follow the IFU closely as well as recommendations in ANSI/AAMI ST91:2021 Flexible and semi-rigid endoscope processing in healthcare facilities.

Additionally, endoscope storage practices are crucial for maintaining the integrity of equipment, reducing the need for costly repairs or replacements, and promoting effective drying. After processing, endoscopes and accessories should be stored in a manner that prevents recontamination and damage. Effective storage solutions include clean, closed cabinets comprised of a material that can be cleaned and disinfected. Note: Endoscopes placed in storage cabinets should hang freely and never touch other devices or the cabinet walls.

Quality assurance and hand-off documentation
Consistent, accurate and thorough documentation is essential for continued safety and effective endoscope handling and processing; it is also vital for quality assurance and regulatory compliance. The individual delivering the endoscopes should be knowledgeable about the devices in their possession.

Documentation for each endoscope may include but not be limited to:
• Procedure date and time
• Procedure end time
• Patient’s name and medical record number
• Endoscopist’s name
• Endoscope model and serial number or other identifiers
• Contact information for the department delivering the device
• Automatic endoscope reprocessor (AER) model and serial number or other identifiers
• Names of individuals who processed the endoscope, and the time processing occurred
• Evidence of equipment performance, concerns and identified damage
• Endoscope maintenance records and documentation that verifies high-level disinfectants were replaced appropriately

Maintaining detailed records supports patient tracing and helps demonstrate adherence to standards during regulatory surveys.
In conclusion, taking the necessary precautions when handling, transporting, processing and storing endoscopes helps promote patient safety and positive outcomes by minimizing risks for cross-contamination and impaired device function, while also preventing some common and costly device repairs. It is essential that all employees who handle, transport and process these delicate devices receive consistent, thorough training for each step in the process and always follow the manufacturers’ IFU and latest standards and guidelines for processing, care and handling.

David Taylor III, MSN, RN, CNOR, has served as a contributing author for the Healthcare Sterile Processing Association (HSPA) since 2019. He is an independent hospital and ambulatory surgery center consultant and the principal of Resolute Advisory Group LLC, in San Antonio, Texas.

 

Clean the Chamber Drain Strainer to Aid Autoclave Performance

By David Taylor III, MSN, RN, CNOR

This article originally appeared in the October 2024 issue of Healthcare Hygiene magazine.

Steam autoclaves are designed to use high pressure and high-temperature steam to kill microorganisms. For the steam autoclave to be effective, the materials to be sterilized must be saturated with steam. If there isn’t enough steam, or air pockets exist, effective sterilization will not occur. Despite being some of the most dependable systems available for sterile processing, autoclaves can create significant problems if they are not inspected, cleaned and maintained properly.

Three factors are critical for steam sterilization to be effective: time, temperature and steam quality. To ensure all three factors are met, the conditioning phase, exposure phase and exhaust phase must occur. Air inhibits sterilization and must be removed from the chamber in the first phase of sterilization, known as the conditioning phase. In a dynamic air removal-type steam sterilizer, air is generally removed from the chamber using a vacuum system. It can also be removed using a series of steam flushes and pressure pulses. In gravity-type sterilizers, steam displaces the air in the chamber and forces the air down the sterilizer drain.

Once all air is removed, the sterilizers drain closes, and steam enters the chamber, rapidly raising the temperature and pressure (this is the exposure phase). Finally, in the exhausting phase, the drain opens, and steam is removed, depressurizing the chamber and allowing the items to dry. For all the phases to be effective, the autoclave must function properly. Before operating the autoclave, daily maintenance should be performed. A critical step is checking the drain screen at the bottom of the chamber and ensuring it isn’t blocked with debris. If the sieve is blocked, a layer of air may form within the autoclave and prevent efficient operation.

Further, a clogged drain strainer can block the sterilizer’s drain line, slowing the exhaust steam. If left untreated, it may become completely blocked, preventing the autoclave from exhausting completely and preventing users from safely opening the chamber door.

How to clean the chamber drain strainer

The drain strainer should be cleaned daily, and it’s a process that should only take a few minutes to complete. It is important to perform this task on all sterilizers, regardless of their location (e.g., operating room and other procedural areas). Follows these steps:

Locate the chamber drain strainer. In most cases, it is located at the bottom (front center) of the autoclave chamber. With older autoclave models, the strainer may be in the center or rear of the chamber.
Remove any shelving units, racks or trays, if needed, to access the strainer.
Wear appropriate personal protective equipment (PPE). This could include an autoclave glove to prevent burns. Keep in mind, however, that if the screen needs more attention, eye protection and a gown may be necessary.
Removal of the strainer may differ depending on the age of the unit and its manufacturer. Some units will allow users to simply lift the strainer from its slot. Others may require unscrewing the strainer with an adjustable wrench. If the strainer cannot be easily removed, ask for assistance from the Biomedical team.
Once the strainer is removed, inspect it closely for damage.
Wipe loose debris from the strainer using a non-linting cleaning cloth. Strainers with excessive debris may require brushing with a heavy-bristled brush.
Reinstall the strainer to its proper location and replace any shelving, racks or trays.
For strainers with excessive debris, such as calcium deposits, more thorough cleaning may be necessary. In this case, steps may include flipping the strainer upside down and gently tapping it against a hard surface. For even more stubborn debris, rinsing the strainer underwater may be necessary, along with using a small tool to carefully extract the material. For strainers that have not been cleaned for some time and have significant calcium or debris buildup, soaking the strainer in an approved solution to loosen the debris may be necessary (check the instructions for use or ask the manufacturer for assistance). Strainers can also be placed into the ultrasonic; however, avoid missing metal types when performing this step. Then, reinstall the strainer to its proper location, along with any shelving, tracks or racks. If the strainer is broken, it should be replaced immediately to prevent damage to the autoclave.

In conclusion, sterilization process failures are the result of a series of events. Something as simple as checking the drain screen strainer is an often overlooked or mismanaged step. Investing just minutes a day can save the facility significant frustration, rework and money.

David Taylor III, MSN, RN, CNOR, has served as a contributing author for the Healthcare Sterile Processing Association (HSPA) since 2019. He is an independent hospital and ambulatory surgery center consultant and the principal of Resolute Advisory Group LLC, in San Antonio, Texas.

 

Loaned Instruments and Tray Management: Strategies for Success

By David Taylor, III, MSN, RN, CNOR

This article originally appeared in the September 2024 issue of Healthcare Hygiene magazine.

Surgical programs across the country are faced with staffing shortages, increased labor costs, decreasing reimbursements and changes in payer mix. To keep pace with these challenges, many healthcare organizations are growing their Surgical Services programs—and loaned (also known as consigned) instruments and trays are often part of that strategy.

Loaned instruments are any device (instrument or implant) not owned by the healthcare facility but are instead secured by the device manufacturer or another facility. These items are often needed for specialized procedures (e.g., orthopedic, spinal) or uncommon procedures that are designed around a manufacturer’s implantable devices. It is challenging for an organization to own all the instruments and sets needed to run their surgical programs due to costs and limited space requirements to store them. Loaned instrumentation offers healthcare organizations access to a variety of instruments and devices, without the high associated purchase costs and storage needs. Loaned items can eliminate both shortages and surpluses, while increasing overall procedural capacity.

Despite the benefits of loaned devices, managing them can be difficult. Doing so effectively requires a partnership based on mutual trust and collaboration across all parties—Sterile Processing leadership, surgeons and other operating room (OR) staff, and those who are loaning the devices. Managing loaned devices requires that controls be in place and policies followed consistently.

Steps to attain and manage loaned devices

Loaded instruments, critical and semi-critical medical devices, implants or other devices are used by a healthcare organization under an agreed upon arrangement with the device provider. In most instances, a procedure is scheduled, the device manufacturer is called, loaned items arrive for use, and they are processed and then returned within a specific time period. For example, an organization may be preparing for a large orthopedic spinal procedure that requires numerous implants that the facility does not have in inventory. In this scenario, the company associated with the implants provides the necessary instrument sets for that specific procedure and then picks up those items following the procedure.

If an organization performs many of the procedures, the company that owns the instrument sets may loan them to the healthcare organization for a period, with an agreed upon understanding. Loaned items stay within that facility and do not leave until the time determined in the agreement. Note: When items are loaned, they cannot be removed (by the vendor representative or their designee) from the healthcare organization without permission.

The process of scheduling a surgical procedure begins with surgeons or their designee (usually office staff). At this point, the loaned instrument process begins. The surgeon’s office contacts the vendor of choice to confirm the availability of the loaned devices or trays. The surgeon’s office then schedules the procedure with the OR.

OR’s role and responsibilities

The OR, especially the service coordinators, plays an important part in the management of loaned instruments. They should be actively involved with the sterile processing department (SPD) to ensure that the devices arrive in time (at least 24 hours before the procedure, but preferably 48 hours or longer) to ensure adequate time to process and prepare them for the patient use. As surgical procedures become more complex, more organizations require loaned instruments to arrive 72 hours prior to the procedure. A time clock that can stamp the date and time should be used to validate the arrival and departure of items.

It is vital that facility policy includes the need for manufacturers of loaned devices provide current instructions for use (IFU) so SP technicians understand how to process and handle them. The SP team should be provided with the date of the surgery, physician, procedure, type of loaned devices and the quantity needed.

In many facilities, the OR contacts the purchasing department, which handles the purchase order for the loaned instruments or trays. Those requesting the loaned items should specify the quantity needs and the estimated time for use and return. Restocking requirements should also be communicated to prevent the need for immediate use steam sterilization (IUSS). Note: If devices arrive too late to process thoroughly, IUSS should never be an acceptable alternative. In such an event, the procedure should be rescheduled to ensure patient safety.

Documentation and communication are vital

Once loaned devices are received, the SPD is responsible for cleaning, decontaminating and sterilizing the items according to the IFU and facility policies and procedures. Loaned devices deserve the same focus and care as any other device being handled in the SPD.

All loaned instruments and trays received from an outside source (vendor) will be considered non-sterile, regardless of their condition upon arrival (i.e., wrapped, containerized). Sets and items that appear ready for patient use could still harbor microorganisms that could pose a serious infection risk.

Loaned devices should be thoroughly inventoried and inspected in the presence of the vendor representative and documented accordingly; both the vendor representative and facility representative in charge of logging in the loaned items should sign or initial the documentation to verify the contents received, and their condition upon receipt. Missing, broken or malfunctioning items should be noted to prevent the healthcare facility from being held responsible for the damage. Items inspection can include but not be limited to tips, box locks, ratchets, and cutting edges, and the quantity of implants (screws and plates) should also be verified at the time of receipt. Devices should also be free of stains, rust and retained bioburden. Containers, baskets, and trays should also be inspected to ensure they are in good working order and free of damage, and they should seal appropriately and not have stickers, tape or other sticky residue on their surfaces. Many facilities take photographs of the loaned items during the intake process. This prevents unexpected costs or vendor reimbursements for missing or damaged items.

Trays should also be weighed upon delivery to ensure the tray and its contents do not exceed 25 pounds, the maximum recommended by the Association for the Advancement of Medical Instrumentation. Again, all loaned instruments delivered to the SPD should include manufacturers’ IFU for disassembly, cleaning, packaging and sterilization (including the appropriate methods and cycles). Loaned items should also include photographs of the product, provided by the vendor representative to help technicians reprocess unfamiliar items. If photographs are not on file with the organization, the vendor representative should be asked to provide them upon delivery. Any policy deviations or other challenges related to loaned devices and sets must be addressed prior to acceptance of the items. Failure to do so will result in a case delay or cancellation.

Upon completion of the surgical procedure, all loaned items are returned to the SPD for appropriate decontamination and high-level disinfection or sterilization according to manufacturer’s IFU. Once processed, the devices should be stored in a secure location until the designated time of pickup. In general, loaned items should be picked up within 24 hours (but ideally no more than two business days) post-procedure. The pick-up procedure should be communicated with the loaned device representative and should be documented and signed. A policy could state, for example, that any items not picked up within the designated time frame will be shipped to the company at their own expense. Designated pick-up times, such as 9 a.m. to 5 p.m. should be established, documented and enforced.

Upon pickup, the loaned items should again be inventoried and inspected. Discrepancies should be documented on intake paperwork and photographed, with acknowledgement from both the facility and company representatives. Both should also provide a final signature to notify the date and time of the pick-up.

David Taylor III, MSN, RN, CNOR, has served as a contributing author for the Healthcare Sterile Processing Association (HSPA) since 2019. He is an independent hospital and ambulatory surgery center consultant and the principal of Resolute Advisory Group LLC, in San Antonio, Texas.

 

Effective Conflict Management is Critical to SPD Quality

By Marie Brewer, CST, CRCST, CIS, CHL, CER, GTS, CLSSBB

This article originally appeared in the August 2024 issue of Healthcare Hygiene magazine.

In the fast-paced, demanding sterile processing (SP) environment, managers and supervisors encounter difficult situations that can be uncomfortable to address. As much as many leaders, especially less-experienced ones, might dread conflict, its effective management and mitigation is vital to preventing situations from worsening and contributing to poor performance and service quality, communication breakdown, and diminished employee and customer satisfaction.

The challenges leaders may face are many, but some more common examples that can cause conflict avoidance, communication breakdown and even dread include providing critical feedback to a team member, terminating employment, mediating conflict between department team members and interdisciplinary colleagues, taking accountability for errors, addressing process failures, reporting employee misconduct, and more. Leaders must realize that workplace problems rarely if ever resolve on their own.

Although leaders may have an emotional response to managing conflict, it is essential that they have the knowledge and confidence to respond to challenges appropriately, empathetically and effectively. For my personal leadership journey, I learned some excellent strategies through reading books, articles and studies about how to lead effectively. One resource that I especially found beneficial was the bestselling book Dare to Lead: Brave Work. Tough Conversations. Whole Hearts. I’ve revisited the author’s words to help formulate the best approach to handling difficult conversation and situations, both in the sterile processing departments (SPDs) I lead and with the healthcare customers we serve. Dare to Lead provides targeted approaches to help leaders become more courageous and effective in their roles. The author reminds readers that when leaders embrace uncertainty—rather than run away from it—they develop vital skills to face difficulties and even use them for growth and improvement opportunities.

Good managers lead by values, trust and accountability
When a leader’s intentions, communications and actions align with one’s values, success will be a far more likely outcome. More specifically, the best leaders remain aligned with personal and organizational values when receiving or giving feedback. Being on the receiving end of critical feedback can be even more challenging—but when values are shared and incorporated into conflict resolution within a department or across a health system, powerful and positive outcomes and improvements can be realized. Unfortunately, many facilities fail to train leaders effectively and provide them with the skills and resources necessary to uphold shared values. Setting and communicating clear expectations and providing essential educational resources and other professional support are essential for setting baseline expectations, promoting accountability and fostering a positive, supportive work culture.

Vulnerability stemming from challenges and experiences is often difficult for leaders to navigate. On the other hand, experiences (even the most difficult ones) can spur powerful change if managed by brave, thoughtful leaders. Committing to ongoing learning and personal, employee and departmental improvement can promote a more positive culture for the leader and their collective teams, while also helping to align the team for improved outcomes and accountability. Further, it can help increase a leader’s empathy, which helps boost communication, understanding and connection with employees and customers.

The book also shares the importance of trust for effective leadership. According to Dare to Lead, it is essential to set effective boundaries and expectations, promote reliability by never overpromising and underdelivering, and owning up to mistakes and working to ensure their do not continue to recur.

Resiliency is also tied strongly to effective leadership. Many leaders struggle to manage their own emotions in difficult situation, which can lead to them offloading their worries and angst onto others. Such an occurrence can erode relationships and trust, so it is vital that leaders work to adopt a positive curiosity for conflict mitigation and error mitigation. Learning to explore and better understand one’s one emotions is a worthwhile endeavor, as is learning and practicing stress-reduction and calming strategies.

Failure (or even the belief that one is failing) in the workplace can be emotionally painful, upsetting and uncomfortable, but every leader needs to remember that professional setback are part of their professional journey and present opportunities for personal and professional growth. Leaders should be proactive when teaching their staff members about resiliency instead of waiting until conflict or negative outcomes arise. Employees are more likely to embrace new opportunities if they are supported by leadership and can feel confident that they can safely recover from setbacks.

In conclusion, growing and thriving as a leader is not about perfection and avoiding failure (which, despite even the best efforts, can at times be unavoidable). Instead, leaders must be courageous enough to see vulnerability and even negative outcomes as opportunities for positive improvement—and they must also strive to nurture and cultivate that same understanding with their employees.

Marie Brewer, CST, CRCST, CIS, CHL, CER, GTS, CLSSBB, serves as sterile processing manager for St. Luke’s Hospital, Finley Hospital and Jones Regional Medical Center in Iowa. She has served as a columnist for the Healthcare Sterile Processing Association (HSPA) since 2022.

 

Sterile Processing Certification Promotes Quality, Safety and Professionalism

By Tony Thurmond, CRCST, CIS, CHL, FCS

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

For all sterile processing (SP) employees, regardless of their backgrounds, experiences or titles, a critical point must always be prioritized: it is never acceptable to cut corners or do the bare minimum, even when resources are limited and pressures are high. Promoting and demonstrating professionalism and excellence with each vital process is essential for patient safety, service quality and positive outcomes.

The success (or failure) of any profession or organization lies largely on the shoulders of the individuals doing the work and providing the service, as well as the leaders who support, mentor, educate and encourage their teams. To do our best as SP professionals—and maintain that level of quality— we must reach beyond personal limits and comfort zones and push for continued excellence, knowledge growth and skill development. Seeking and attaining certification is among the most beneficial ways to grow and thrive in the discipline and promote quality in the department and for the departments the SPD serves.

The Healthcare Sterile Processing Association (HSPA)’s Certified Registered Central Service Technician (CRCST) serves as the introductory certification and recognizes entry-level and existing technicians who have demonstrated the experience, knowledge and skills necessary to serve competently as an SP technician. The CRCST also serves as the sturdy foundation for secondary HSPA certifications such as the Certified Instrument Specialist (CIS) and Certification in Healthcare Leadership.

Some healthcare facilities require SP certification for technicians upon their hiring, while others organization offer a grace period such as within six months or a year after the hire date. Other facilities may not require certification at all; if you work for such a facility, I strongly urge you to seek certification on your own and encourage your teammates to do the same. While attaining and maintaining certification cannot guarantee that all tasks will be performed completely and correctly, it does demonstrate one’s job knowledge and provides a level of assurance that they can understand foundational concepts and correct practices and processes and also appropriate resolutions to address certain challenging situations. Completing tasks consistently and accurately ultimately comes down to an individual’s personal commitment to service excellence, continuing education and experience with mastering essential tasks.

Breaking down certification barriers

SP professionals may postpone certification due to test anxiety and fear of failure. Peer pressure can contribute to those pressures as well and cause some individuals to question the depth of their knowledge and assume they lack the understanding and experience to attain certification. As a veteran SP professional who has attained multiple certification, I assure any of my professional peers that they, too, can pass their certification exams, even if they haven’t been successful previously.

In my opinion, stepping confidently and deliberately onto the certification path is one of the best way to succeed now and in the future. This can be achieved by being dedicated and focused throughout the journey and leaning on the SP leader and competent colleagues to lend guidance and support. Some facilities have found success by providing in-department certification education and study groups for technicians on all shifts. This is a helpful way to learn, ask questions, and understand the science and reasons behind the processes and content, while also tapping the support and camaraderie of fellow peers. If your facility does not offer in-department certification training and support, consider asking the SPD educator (if your department has one) to assist you. In the absence of a dedicated educator, request a supervisor or manager’s assistance.

Certification study tips

It is important that those seeking certification carefully read each chapter of the HSPA Sterile Processing Technical Manual, with the focused intent of mastering the material. If questions arise, it is also important to ask for clarity to ensure correct understanding of the content. After reading each chapter, I recommend walking around the department to observe whether departmental practices align with the best practices and standards identified in the technical manual. If not, look to see how you can make the necessary changes to do it the correct way and bring the issues to the attention of the supervisor or manager. Such checks can help greatly with test taking because as one reads the question or scenario on the exam, they will be reminded how the material directly applies to everyday SP practices and processes.

Additionally, when reviewing chapters in the manual, it can be helpful to develop multiple-choice questions to test yourself. This is especially helpful for subjects in which you may have limited knowledge or experience, or certain tasks that may prove challenging within the department. Review the questions and reread the chapter to gain a clearer understanding of the content and what could be asked on the exam. Further, I encourage students who are seeking certification to think of the scenarios as they review the chapters.

Certification can increase professionals’ hourly pay and prepare technicians for future opportunities within the department. Above all, it helps demonstrate an employee’s commitment to serving as a proficient, quality-driven contributor who is focused on promoting quality service in the name of patient safety.

For more information about HSPA and its certifications, visit www.myhspa.org.

Tony Thurmond, CRCST, CIS, CHL, FCS, is an HSPA past-president and current columnist. He serves as the central service manager for Dayton Children’s Hospital in Dayton, Ohio.

 

New Guidance for Processing and Handling of Probes, Dilators and Accessories

By Susan Klacik, BS, CRCST, FCS, CHL, CIS, AAMIf

This article originally appeared in the June 2024 issue of Healthcare Hygiene magazine.

A new technical information report (TIR) from the Association for the Advancement of Medical Instrumentation (AAMI) offers guidance for the processing of ultrasound probes and dilators in health care facilities. The document, AAMI TIR99:2024 Processing of dilators, transesophageal and ultrasound probes in health care facilities, provides recommendation about the selection and use of cleaning, disinfection and sterilization systems that have been cleared by the U.S. Food and Drug Administration (FDA) to process the devices and their accessories. This article provides an abbreviated summary of the document’s content.

Cleaning and point-of-use treatment emphasized

Cleaning is among the most important steps in the device processing cycle, and the design and use of ultrasound devices present unique challenges to the cleaning process. Some transducers are designed and used in a manner that the handle and connector do not have direct patient contact (as opposed to the patient-contacting shaft and distal tip). Because of this, different methods are recommended for processing the patient-contacting and nonpatient-contacting components. Diligent adherence to the IFU is also essential to prevent device damage and infection.

Ultrasound transmission gel (USTG) and coupling agents, such as saline or lubricant, are critical for image quality. They are used with ultrasound-guided procedures and may be present on the device. During cleaning of contaminated dilators and ultrasound probes, personal protective equipment (PPE) should be worn. Further, policies and procedures should be developed and implemented to address all steps in the cleaning process, including point-of-use treatment, transporting from the point of use to the processing area, cleaning, rinsing and drying, and inspection.

A key difference with the processing of certain ultrasound probes is that the cleaning and disinfection process is performed at the point of use. This practice should be supported by a multidisciplinary risk assessment. TIR99 provides guidance on developing a policy to perform point-of-use treatment. This includes an algorithm for suggested workflow for transrectal, transvaginal and surface ultrasound device processing at the point of use. Recommendations are also provided for point-of-use treatment of the devices and their accessories to prevent soil from drying. The purpose is to reduce the level of bioburden and help prevent biofilm formation.

After point-of-use treatment is performed on probes and dilators, any devices not processed at the point of use are transported to the decontamination area. They should be transported in a collection system that meets Occupational Safety and Health Administration (OSHA) requirements (29 CFR 1910.1030) for transporting hazardous items. This includes labeling the devices with a biohazard label, placing them in a red bag, or other methods for distinguishing contaminated contents. When transporting contaminated probes used for a semicritical application, they should not have contact with the cable or plug, which does not undergo high-level disinfection. Separating the transducer from the cable and connector can be done by using a containment system with an impermeable divider or by placing the transducer inside a bag that then goes inside the rigid container. Before transport, probes should be prepared in a way that prevents organic soils from drying. It is possible to prevent drying by covering them with a water-moistened towel, applying a pretreatment product to only the area that can undergo immersion, or using a humidity chamber pack.

Once the probes and dilators are received in the decontamination room, the cleaning process begins. For transesophageal echocardiogram (TEE) transducers, a leak test should be performed before cleaning begins because immersing the probes in water with compromised integrity can damage the device. The leak test is to be performed according to the IFU, and the results of pass or fail should be documented. To prevent patient harm, TEE probes that have failed the leak test should be removed from service. Further, to prevent damage, TEE transducers should not be coiled too tightly.

TIR99 also includes recommendations for manual and mechanical cleaning. At the end of the cleaning process, the probes, dilators and accessory components should be visibly clean and inspected to verify that all visible soil was removed. The guidance document describes a different process for some components that do not come in direct contact with the patient. These components are addressed in the IFU and describe a manual cleaning process, followed by low-level disinfection (LLD) or intermediate-level disinfection (ILD). After a probe or dilator has been cleaned thoroughly, it then undergoes disinfection or sterilization. TIR99 provides guidance about the different types of disinfection and sterilization and how to ensure the processes are performed safely and effectively. Automated HLD systems are preferred over manual HLD processes because they are more reliable, reduce human errors and reduce the risk of personnel exposure to chemicals.

Drying, transport, storage and more

After HLD, the probe or dilator must be thoroughly dried to prevent waterborne pathogens, such as pseudomonas aeruginosa and other microorganisms, from surviving and thriving with resistant biofilm formation. All surfaces should be thoroughly dried with a clean, lint-free cloth or non-linting wipe before storage or use. Parts that are inaccessible or have lumens should be dried with pressure-regulated instrument air or HEPA-filtered air. A designated station or area to dry the probe or dilator is recommended.

HLD-processed probes or dilators should be visibly marked as “clean” or “patient ready” and then transported on a clean surface. Again, it is important to stress there is a certain way to transport probes with a cable or plug that has not undergone HLD, and those parts may be attached to a component that has undergone HLD. Again, the high-level disinfected probe portion of the equipment should be separated from the cable or plug by covering the probe with a visibly clean storage cover or using a containment system.

When storing the devices, avoid mixing contaminated items with cleaned, disinfected or sterilized items. Further, probes and dilators should be stored under environmentally controlled conditions, in a manner that protects them from contamination. TIR99 provides recommendations for storage in accordance with the Spaulding classification. An accepted maximum storage time for HLD-processed ultrasound probes and dilators to be considered safe for patient use is not provided in the guidance document. Therefore, it is recommended that a multidisciplinary team be developed (i.e., Sterile processing professionals, infection preventionists, risk management staff and other clinical personnel). The team should conduct a risk assessment to determine the maximum storage time for an ultrasound probe or dilator before it is no longer safe for patient use. ANSI/AAMI ST91:2021 provides a list of considerations that should be reviewed in the risk assessment.

Documentation is another critical step in medical device processing, including for probes and dilators. Such documentation can be paper-based or automated (digital). Documenting all steps in the process provides information that the cycle parameters have been met, while also elevating accountability. Most importantly, documentation can be used to trace a device to a source of an infection and determine whether a recall is necessary—and the extent of a recall. Note: Every healthcare facility should have a policy and procedure for product recalls. For improved traceability, probes and dilators that have undergone HLD or sterilization should have the documentation linked to the associated patient record.

Quality assurance programs are embedded in all SP activities, and TIR99 provides recommendations for a quality assurance program for probes and dilators. More specifically, the guidance identifies performance measures and process monitors that can be used for continuous quality improvement (CQI) programs for the entire process. This includes a CQI matrix that describes the visual observations and fundamental process that selected personnel should perform as part of the quality improvement process within their areas. Performing a risk analysis is part of a quality assurance program. Risk analyses are performed to determine gaps in practices and processes that are harmful to patient safety.

TIR99:2024 is available for purchase at www.aami.org (under the “store” tab).

Susan Klacik, BS, CRCST, FCS, CHL, CIS, AAMIf, serves as a clinical educator for the Healthcare Sterile Processing Association (HSPA).

 

Are Your Endoscopes Clean? Tapping the True Power of Visual Inspection Tools

By David Taylor, MSN, RN, CNOR

This article originally appeared in the May 2024 issue of Healthcare Hygiene magazine.

Outbreaks of endoscope-related infections represent a global problem, and the clinical implications are sobering. Numerous peer-reviewed investigations have linked various problems, including infections and deaths, to visibly contaminated or damaged endoscopes.1-6

The Association for the Advancement of Medical Instrumentation’s (AAMI’s) revised standard, ANSI/AAMI ST91:2021 Flexible and sim-rigid endoscope processing in healthcare facilities, underscores the critical importance of proper cleaning, and important new updates and recommendations are incorporated. The previous version of the standard had a conditional recommendation that internal channels may be inspected with a borescope. The 2021 version features stronger language, recommending the use of a clean borescope to visually inspect accessible channels of flexible endoscopes before sterilization or high-level disinfection (HLD).

Common problems associated with the internal channels during endoscope processing (e.g., gastroscopes, colonoscopes, duodenoscopes and more) include but are not limited to:

corrosion
cracks and scratches
other physical damage
debris
discoloration
moisture
foreign objects (e.g., lint, fibers, brush bristles and particles, and clips)
The use of a small-diameter borescope for inspecting internal channels should be part of a comprehensive visual inspection program to identify internal defects, damage or bioburden that would otherwise go undetected. Small-diameter borescopes serve as way to examine the full length of each channeled lumen. Not only does that help protect patients but also provides critical insight into an endoscope’s condition, which can prevent further damage, costly repairs and premature device replacement. Note: Visual inspection should include outside examination of the device with a magnifier or microscope (ideally, with lighted magnification), with internal channel inspection performed with a borescope.

It is recommended that the person performing the borescope inspection be adequately trained and competent in the task. Use of the borescope should always be aligned with the borescope manufacturer’s instructions for use (IFU). Healthcare organizations should identify high-risk flexible endoscopes, such as duodenoscopes, bronchoscopes, ureteroscopes and cystoscopes, and ensure they undergo appropriate cleaning verification testing after each use. The test results should be consistently recorded and maintained.

If an endoscope does not pass the cleaning verification test, the endoscope should be re-cleaned and re-tested. If the device repeatedly fails cleaning verification testing, it should be removed from service and clearly labeled as needing repair to prevent further use. Damaged endoscopes, along with their unique device identifier and patient identification information, should be reported to Infection Prevention and Quality personnel, in accordance with the organization’s policy.

In conclusion, borescopes are useful tools for inspecting endoscope channels and interior components and detecting debris and other flaws that otherwise would likely be undetected; however, it is essential that those responsible for visual inspection receive proper training and education to not only use the tools effectively, but also understand the defects detected and how to address them. Using quality visual inspection tools to identifying issues with endoscopes and other lumened devices, such as residual bioburden and cracks, scratches and other problems, is a prudent practice that will greatly improve patient safety and outcomes and reduce the risk for costly device damage, malfunction and, above all, infections.

References:

Ofstead CL, Hopkins KM, Eiland JE. Borescope inspection of endoscope working channels: Why and how? Endosc Int Open. 2022 Jan 14;10(1):E109-E111. doi: 10.1055/a-1512-2813. PMID: 35047340; PMCID: PMC8759935.
Ofstead CL, Hopkins KM, Smart AG, Eiland JE, Wetzler HP, Bechis SK. Reprocessing Effectiveness for Flexible Ureteroscopes: A Critical Look at the Evidence. Urology. 2022 Jun;164:25-32. doi: 10.1016/j.urology.2022.01.033. Epub 2022 Feb 3. PMID: 35123986.
Ofstead CL, Buro BL, Hopkins KM, Eiland JE, Wetzler HP, Lichtenstein DR. Duodenoscope-associated infection prevention: A call for evidence-based decision making. Endosc Int Open. 2020 Dec;8(12):E1769-E1781. doi: 10.1055/a-1264-7173. Epub 2020 Nov 17. PMID: 33269310; PMCID: PMC7671768.
Galdys AL, Marsh JW, Delgado E et al. Bronchoscope-associated clusters of multidrug-resistant Pseudomonas aeruginosa and carbapenem-resistant Klebsiella pneumoniae. Infect Control Hosp Epidemiol. 2019;40:40–46.
Rauwers AW, Troelstra A, Fluit AC et al. Independent root cause analysis of contributing factors, including dismantling of 2 duodenoscopes, to an outbreak of multidrug-resistant Klebsiella pneumoniae. Gastrointest Endosc. 2019;90:793–804.
Kumarage J, Khonyongwa K, Khan A et al. Transmission of MDR Pseudomonas aeruginosa between two flexible ureteroscopes and an outbreak of urinary tract infection: The fragility of endoscope decontamination. J Hosp Infect. 2019;102:89–94.

 

Sterile Processing Leaders: Are You Keeping Track of IFU and Manufacturer Updates?

By David Taylor III, MSN, RN, CNOR

This article originally appeared in the April 2024 issue of Healthcare Hygiene magazine.

Today’s medical devices are increasingly sophisticated and complex, and with up to thousands of items being processed through the sterile processing department (SPD) each day, it is essential that sterile processing (SP) professionals have access to—and diligently follow—manufacturers’ most current instructions for use (IFU) and other pertinent updates about their products.

As a consultant who travels the country to assist with SP operations, I often witness departments that are not keeping up with their IFU. As a result, they are either processing devices incorrectly or devices are being used for a purpose other than their intended and approved purpose. When I have questioned these practices, the answers are typically the same: “We have always done it that way” or “We didn’t know we were using it incorrectly.”

Here’s just one example: Nearly nine years ago, Parks Medical Electronics Inc. issued a letter to their customers outlining the appropriate use of their doppler probes. The items are classified by the U.S. Food and Drug Administration (FDA) as Class II medical devices (noninvasive), which are deemed moderate to high-risk. Class II devices are not for subcutaneous use (under the skin). Despite the manufacturer’s notification, nearly every hospital I have visited still uses these devices inappropriately. More specifically, I have witnessed the probes being used for vascular, cardiac and urological procedures—not their intended purposes.

Of course, the probe misuse is just one example of many. Many facilities use needle holders as pliers, for example, to pull pins and twist wire, which can cause cracks and render the instruments nonrepairable.1 There are other incidents where recalled products are still in use. Whatever the case, misusing devices and equipment poses a significant safety risk to users and patients. It can also void manufacturer warranties, cause premature product replacement, and increase liability for the healthcare facility.

Understand and follow device classes

In 1939, Earle H. Spaulding devised a rational approach to disinfection and sterilization of patient care items and equipment. His deep study of disinfection and sterilization refined the classification of appropriate treatment of medical devices based upon how the devices are to be used. He proposed a strategy for sterilization (or high-level disinfection) of inanimate objects and surfaces based on the degree of risk involved for their medical use. Known as the Spaulding Classification, the risk-based system includes three categories for medical devices: critical, semi-critical and non-critical.2

Critical items are equipment and instruments that penetrate the skin or enter sterile tissue or the vascular system. They can include surgical instruments, cardiac or urinary catheters, implants, and ultrasound probes. These items require sterilization (i.e., steam, ethylene oxide, hydrogen peroxide gas plasm). Semi-critical items contact mucous membranes or nonintact skin. This category can include respiratory therapy and anesthesia equipment, some endoscopes, laryngoscope blades, esophageal manometry probes, cystoscopes, among other devices. At minimum semi-critical items require high-level disinfection (HLD) using chemical disinfectants (i.e., glutaraldehyde, hydrogen peroxide, ortho-phthaladehyde, or peracetic acid with hydrogen peroxide). Note: Because of device complexity, sterilization is being recommended for more semi-critical devices.

Non-critical items are those that only contact intact skin (not mucous membranes) and pose the least risk for infection transmission. This category can include items such as blood pressure cuffs, stethoscopes, bedpans or crutches. In most cases, cleaning followed by disinfection with an Environmental Protection Agency-registered, hospital-approved disinfectant is sufficient for processing.

Understanding device classification helps provide the “why” behind the IFU. The IFU, of course, will reflect the device classification and should clearly outline how to handle, disassemble, inspect and process the item. If product-related updates occur, customers should receive updates directly from the manufacturer—and those should then be promptly reviewed and relayed to all SP professionals. Any questions about the revised IFU or other manufacturer notification about their devices, equipment, supplies or services should be shared directly with the company for clarification.

There may be times when a notification or update from the manufacturer is missed or accidentally overlooked. Any time a vendor representative enters the department for education or support, it is prudent to ask about any important updates or changes they can share. If IFU have been updated but those changes weren’t received, be sure to ask for a copy of the revised material. If further guidance or clarification is needed, SP leaders can ask their vendor rep to provide targeted education to address concerns and ensure all technicians understand the recommendations.

To ensure that devices and equipment are used correctly and safely, manufacturers regularly update their IFU and, at times, may issue customer notifications to alert them to changes, concerns or other new information about their products. All devices being processed, regardless of how long they have been in use, may require changes to the way they are used and managed. Therefore, SP leaders must also ensure that technicians across all shifts have access to and understand all IFU updates—just as is necessary for the latest standards, guidelines and best practices.

Healthcare organizations are responsible for ensuring their patients receive the safest, highest quality care. Therefore, it is imperative that devices are managed and processed consistently according to each manufacturer’s current IFU. Patients expect clean, sterile, safe and well-functioning devices, and surgeons and other clinicians expect that instruments and equipment coming from the SPD will meet those critical expectations. SP professionals must always remember that when releasing a device or instrument set for use, they are essentially stating to their end users that the items are safe for patient use. Following IFU to the letter and seeking guidance from the manufacturer whenever any recommendations are unclear are among the best ways to ensure they are indeed safe.

References
1. Schultz, R. Scissor and Needle Holders 101. PROCESS. January/February 2020. Pp. 82-84. HSPA.
2. Centers for Disease Control and Prevention, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Healthcare Quality Promotion (DHQP). A Rational Approach to Disinfection and Sterilization. https://www.cdc.gov/infectioncontrol/guidelines/disinfection/rational-approach.html#:~:text=Spaulding%20believed%20the%20nature%20of,in%20use%20of%20the%20items.

David Taylor III, MSN, RN, CNOR, has served as a contributing author for the Healthcare Sterile Processing Association (HSPA) since 2019. He is an independent hospital and ambulatory surgery center consultant and the principal of Resolute Advisory Group LLC, in San Antonio, Texas.

 

Run the SPD Like an Efficient, Effective Business

By David Taylor III, MSN, RN, CNOR and Robert Leenan, BS, CRCST, CIS, CCSVP

This article originally appeared in the March 2024 issue of Healthcare Hygiene magazine.

Sterile processing (SP) professionals help ensure quality patient care, infection prevention and safety through the provision of clean, well-functioning, sterile and on-time instruments. In fact, the role successful, effective and efficient sterile processing departments (SPDs) play in day-to-day business operations can be a strategic differentiator, allowing organizations to boost outcomes, reduce costs and gain a competitive advantage.

Every department within a hospital or health system plays a key role in the financial success of the organization; therefore, each department is like running a small business within a business.

To run the SPD like the business it is, leaders should assess how they provide the highest quality products and services consistently. As consultants, we often ask ourselves how SP leaders can be more strategic—effectively managing the core of their business while remaining open to necessary changes and adapting to new standards, products, equipment, policies and more. It is important for SP leaders to ask: Would the work our SPD produces be competitive in an open market? The best SP leaders show up on time, set goals for themselves, their employees and their departments, and plan diligently to create an operational structure that produces consistent, high-quality products and service.

Metrics and standard work
The cost of production and ability to adapt—all while providing a consistent product—is vital for the success of any business, including a healthcare department like the SPD. Paying close attention to the metrics relevant to the SP discipline is prudent; without metrics, it is impossible to know whether operational functions being measured yielded the intended result (quality).

Understanding the importance of quality and having the knowledge and ability to optimize costs and process outcomes are critical for increasing workflow efficiencies across device processing functions. Equally essential is understanding the impact of proper labor utilization and equipment capacity, setting time and quality expectations, and ensuring adequate resources to meet customer requirements—all variables that help the SPD provide the highest quality products, without compromising integrity. The bottom line: If one knows how to control costs and understands the variables to those costs, they can better control quality outcomes.

When improving SPD workflow, two factors must be considered. First, it is necessary to create standard work for each process while incorporating quality steps into that standard work. Next, leadership standard work should be established and comprised of tasks and routines that support conformity to each process. Standard work is defined as the documented steps for performing a job task and outlines who is going to perform the task as well as when and how. Note: In the absence of this standard work guidance, a veteran employee with decades of experience could easily introduce their personal preferences, leading to variations and inefficiencies that cost significant time and money and negatively affect quality.

Applying lean methodology can help businesses drive efficiencies in some or all operational areas by finding and eliminating wasteful, non-value-added steps within processes. Waiting for something that is delayed or requires reworking can be extremely frustrating for SP and end-user employees. Frustrations become further magnified when the challenge could have been avoided. A lean memory device acronym, known as TIMWOODS (Transportation, Inventory, Motion, Waiting, Overprocessing, Overproduction, Defects and Skills) can help identify eight wastes. In everyone CSPD’s processes, one or many of these inefficiencies can add up, creating unnecessary work to complete a task.

Note: See the March issue for Figure 1: CLICK HERE to access.

The difference in time standards and what is lean (and not lean) can be attributed to all types of wasted effort. In the SPD, handling items multiple times, having to perform rework due to defects, failing to complete work correctly, and misplacing trays and instruments that require multiple staff members to search for them are all common examples.

Leaders cannot assume that all employees will consistently follow process standard work. There may be valid reasons for deviations at times; however, without a standardized process, leaders cannot effectively evaluate or control quality. Leadership standard work helps ensure compliance, monitor effectiveness, identify improvement opportunities, and implement countermeasures.

Again, using Figure 1 as an example, using 300 trays processed in a 24-hour period would add 6.0 full-time equivalents (FTEs) to the budget to complete the same amount of work.

Leaders can set expectations with frontline leaders allowing them to manage those expectations with their staff. With a standardized process and effective communication, SP leaders can expose weaknesses in their operations. For example, it could take 20 minutes of actual work to assemble one tray and become part of the planned process. Whatever the starting point, identifying all forms of waste and eliminating it will lead to improvement. When SP leaders reach this point of the process, they have achieved the initial steps of establishing a continuous improvement structure for their department. In time this structure will keep identifying opportunities, and leadership will implement countermeasures to identify all waste in the process. This will be comprised of all value-added steps or essential steps for this process—and when that process is multiplied by the number of instruments and trays in one’s operations, the benefits will be significant.

SP leaders are required to balance consistency and responsiveness to run their business successfully, safely and efficiently. It is essential to define, measure and improve quality of services by utilizing processes, standard work, and data to influence positive outcomes.

David Taylor, MSN, RN, CNOR, is an independent hospital and ambulatory surgery center consultant and principle of Resolute Advisory Group LLC, in San Antonio, Texas. He has served as a contributing author for the Healthcare Sterile Processing Association (HSPA) since 2019.

Robert Leenan BS, CRCST, CIS, CCSVP is a sterile processing improvement consultant and managing partner at SPD Solutions LLC.

 

Preventing High-Risk Exposures in Sterile Processing

By Tony Thurmond, CRCST, CIS, CHL, FCS

This article originally appeared in the February 2024 issue of Healthcare Hygiene magazine.

The patients and healthcare workers Sterile Processing (SP) professionals serve each day rely on clean, high-level disinfected or sterilized medical devices and equipment. Many, however, are largely unaware of the routine dangers and risks SP professionals are exposed to in the departments in order to provide those necessary services.

During a typical workday, SP technicians face risks from chemicals, bloodborne pathogens, excessive temperatures, sharps exposure, musculoskeletal injuries and slip-and-fall risks, among other dangers. Each can be detrimental to employee health and safety and, potentially, even to subsequent patients. Fortunately, such incidents can be mitigated with collaboration and broad-scale involvement from the SP team and, as appropriate, interdisciplinary teammates. Medical facilities have an obligation to keep employees safe, but it is also up to each departmental leader to train in safe practices and ensure adherence to them.

Documenting competencies
The decontamination area poses the greatest risk for SP employees. The Occupational Safety and Health Administration’s (OSHA’s) Bloodborne Pathogens Standard (29 CFR 1910,1030) requires that each facility has an exposure control plan that outlines the potential dangers that employees may encounter on the job. When performing decontamination duties, employees must wear appropriate personal protective equipment (PPE) that includes gloves, a gown or jumpsuit with sleeves and a fluid-resistant barrier, fluid-resistant shoe covers and mask, and eye-protection (goggles or a face shield) that protects from splashes. OSHA requires these items to be provided by our facilities for employee protection.

Every SP professional must fully understand how to use chemicals safely and effectively in the department, and they must also know the risks involved when used incorrectly. While these products may do a great job in cleaning and removing soil from instruments, they can be dangerous if used improperly or when a spill occurs. A safety data sheet (SDS) must be readily available to technicians to address spills or other exposures. Most facilities have SDSs stored electronically on workstation computers, while others may depend on a written copy of the SDS to guide them. All SP employees must know where the SDSs are kept and be able to access them readily.

SP professionals should also receive initial orientation of the required PPE for their department, and also know the proper policies and procedures for handling workplace exposures. This includes documented orientation, continued education offerings and a competency to physically demonstrate the necessary actions if an exposure occurs. Continuing education and reviews or competencies should be reviewed periodically and documented for each employee.

Addressing eye and sharps risks
Every SP employee must know where the eye wash station/shower is located and how to use it correctly. There are specific requirements for eye wash stations set forth by the American
National Standards Institute, including the need to have an eye wash/shower available within 10 seconds of travel time, with unobstructed access for areas where potentially dangerous chemicals are used. Eye wash sinks should not be a sink used for decontamination. According to ANSI/
ISEAS Z358.1, they should be tested at least once a week and for an established period to verify operation and ensure the flushing is lukewarm (between 60 and 100 degrees Fahrenheit or between 15 and 43 degrees Celsius). This routine testing should be documented.

Statistics show that 25 percent of healthcare worker sharps exposures happen to support staff such as SP professionals. Most sharps-related injuries are documented in the operating room (OR) from cuts with the scalpel or needlesticks. SP professionals who have worked in the discipline for any length of time have likely seen a sharp come to decontamination from surgery alongside the soiled instrumentation (such as a knife blade, suture needle, drill bit, saw blade). SP leaders should communicate such incidents with those in the OR so they understand the risks.

Handling instruments in decontamination creates opportunities for injuries as well. At times, items used during procedures are placed in the case cart in an unsafe manner, which introduces the opportunity for injury. It is important to never reach into a pile of mismanaged, disorganized instruments. It is also important to lift each instrument tray individually and always use the handles of the tray. As each tray is removed, it is essential to visually inspect the tray to look for missed needles, blades or instruments protruding from the tray.

Other departmental areas, beyond decontamination, can pose notable employee risks as well. When running the test for sterilization cycles, technicians must wear protective PPE while activating the biological test ampules. Changing the cartridge or bottle for low-temperature sterilizers may seem like a simple task, but also can introduce the risk for dangerous exposure; therefore, proper gloves, masks and eyewear are essential (and required).

Additionally, to prevent unnecessary exposure to contaminated devices, case carts must be designated as “clean” or “soiled.” If a case cart arrives in the SPD unmarked, the contents inside should always be considered soiled.

Preventing workplace exposures is everyone’s responsibility, from SP professionals to the surgeon, surgical tech, OR nurse, transporter and employees in other procedural areas of the facility. Ongoing communication and education are critical in keeping the SP professionals and others safe from avoidable harm.

Tony Thurmond, CRCST, CIS, CHL, FCS, is a past-president of the Healthcare Sterile Processing Association (HSPA) and an HSPA columnist. He serves as sterile processing manager at Dayton Children’s Hospital.

 

Measuring SPD Productivity Vital to Safety, Quality

By Tony Thurmond, CRCST, CHL, CIS, FCS

This article originally appeared in the January 2024 issue of Healthcare Hygiene magazine.

Many sterile processing (SP) professionals understand the frustration of giving their best effort every shift while still failing to meet daily demands. Adding to that struggle is that some SP leaders struggle with how to measure productivity effectively, especially when there are opposing views about what productivity means. Often, productivity is tied to profit or loss—with the focus on output instead of actual demand for products and services. This is challenging because an employee or team can be productive, even if they struggle to meet customer demands and requirements. Put simply, a technician might feel satisfied by their efforts and output but still fail to keep up due heavy procedural volume and limited instrumentation and other resources.

Certainly, productivity varies across departments and disciplines, but understanding the basic definition will serve as an essential first step in establishing a plan to measure it. Merriam-Webster defines productivity as the quality or state of being productive and the effectiveness of productive effort, especially in industry, as measured in terms of the rate of output per unit of input. Using that definition, SP productivity would calculate the number of products produced as well as all tasks associated with their production.

When assessing SP productivity, surgical volume and each associated task should be measured.

Many organizations measure SPD productivity solely on surgical case volume—an outdated method that leads to inaccurate calculations. A base rate must be factored for each patient and procedure. A minor procedure requiring only two instrument trays, for example, will require less productivity than is required to process devices for a total hip revision.

Individual tasks should be defined, and a time study should be performed and the degree of difficulty and possibility for interruptions should also be factored into the measurement. When timing the decontamination process for robotic instruments, it would be necessary to consider the length of time required to correctly clean and disinfect the device and any attachments according to the instructions for use (IFU). Routine tasks, such as answering phone calls, emptying the cart washer, or delivering an item to the procedural area, must also be calculated using a time study to determine averages. It is important to capture true minutes spent on various tasks. For example, delivering items to one user area may take longer than another due to the physical distance from the SPD.

Every task should be included that captures the team’s daily efforts. Author’s note: In my facility, we list our breaks and lunches and time spent restocking workstations, answering the door or phone, changing detergents, filling supplies, emptying washers, and the list goes on. Each task is measured and documented. Time studies should also be conducted to assess the length of time needed to process trays from decontamination and preparation to their delivery at the point of use. Tracking productivity metrics also requires consistent input and compliance from all SP staff members, and SP leaders should provide data to demonstrate metrics, improvements, and opportunities for change. Instrument tracking systems can be invaluable for automatically capturing productivity metrics. Employees should be trained to input tasks as they are performed, and this productivity data will be essential for leaders to share with facility executives. SP leaders are often asked to justify their staffing, even when replacing a budgeted position. Some organizations collaborate with consultants to further reduce labor costs—the primary expense for healthcare organizations today.

Recently, when such a consultant visited our SPD, I asked which metrics they needed. I showed the tasks we perform daily, along with the average time and employees needed to complete each task properly. I was prepared to show productivity for each area, from decontamination through sterilization, distribution and storage. Even after showing our productivity, the consultant focused on the number of employees staffed in each area of the department. Without considering any of the key metrics we documented and shared, the consultant then questions why we needed two to three people working in decontamination. I explained that several items being decontaminated require timed cleaning processes that involved far more than simply spraying water and running the devices through the washer. I also stressed that each instrument is washed manually and inspected, and that the tray must be organized so the washer’s manifold arms can effectively clean what may have been missed during manual cleaning—all steps that require added time and employee focus. Finally, we shared the IFU, which further justified our resource requirements. The consultant acknowledged their lack of understanding of how time and resource needs are best calculated and seems impressed by the level of detail and metrics we provided to support our requested needs.

In conclusion, capturing true productivity offers significant benefits for all SPDs. SP leaders should work with their teams to assess productivity and resource requirements that will help ensure the departments have what they need to meet customer demands safely, consistently and in accordance with IFU, and the latest standards, guidelines, and best practices.

Tony Thurmond is the central service manager at Dayton Children’s Hospital in Dayton, Ohio. He is also a columnist for the Healthcare Sterile Processing Association (HSPA), past-president and board of director member who currently serves on HSPA’s Editorial and Fellowship Committees.