Observed rates of surgical instrument errors point to visualization tasks as being a critically vulnerable point in sterile processing and a significant cause of lost chargeable OR minutes.

BACKGROUND: The reporting of surgical instrument errors historically relies on cumbersome, non-automated, human-dependent, data entry into a computer database that is not integrated into the electronic medical record. The limitations of these reporting systems make it difficult to accurately estimate the negative impact of surgical instrument errors on operating room efficiencies. We set out to determine the impact of surgical instrument errors on a two-hospital healthcare campus using independent observers trained in the identification of Surgical Instrument Errors. METHODS: This study was conducted in the 7 pediatric ORs at an academic healthcare campus. Direct observations were conducted over the summer of 2021 in the 7 pediatric ORs by 24 trained student observers during elective OR days. Surgical service line, error type, case type (inpatient or outpatient), and associated length of delay were recorded. RESULTS: There were 236 observed errors affecting 147 individual surgical cases. The three most common errors were Missing+ (n = 160), Broken/poorly functioning instruments (n = 44), and Tray+ (n = 13). Errors arising from failures in visualization (i.e. inspection, identification, function) accounted for 88.6% of all errors (Missing+/Broken/Bioburden). Significantly more inpatient cases (42.73%) had errors than outpatient cases (22.32%) (p = 0.0129). For cases in which data was collected on whether an error caused a delay (103), over 50% of both IP and OP cases experienced a delay. The average length of delays per case was 10.16 min. The annual lost charges in dollars for surgical instrument associated delays in chargeable minutes was estimated to be between $6,751,058.06 and $9,421,590.11. CONCLUSIONS: These data indicate that elimination of surgical instrument errors should be a major target of waste reduction. Most observed errors (88.6%) have to do with failures in the visualization required to identify, determine functionality, detect the presence of bioburden, and assemble instruments into the correct trays. To reduce these errors and associated waste, technological advances in instrument identification, inspection, and assembly will need to be made and applied to the process of sterile processing.

Elastomeric half-mask respirator disinfection practices among healthcare personnel.

BACKGROUND: Disposable N95 respirator shortages during the COVID-19 and 2009 H1N1 influenza pandemics highlighted the need for reusable alternatives, such as elastomeric half-mask respirators (EHMRs). Two US medical organizations deployed reusable EHMRs during the COVID-19 response. In addition to wipe-based disinfection following patient care episodes expected per local policies at both organizations, postshift centralized cleaning and disinfection (C&D) was expected at one site (A), permitting shared-pool EHMR use, and optional at the other (Site B), where EHMRs were issued to individuals. Using a survey, we evaluated disinfection practices reported by EHMR users and predictors of disinfection behaviors and perceptions. METHODS: Surveys assessed EHMR disinfection practices, occupational characteristics, EHMR use frequency, training, and individual-issue versus shared-pool EHMR use. RESULTS: Of 1080 EHMR users completing the survey, 76% reported that they disinfect the EHMR after each patient encounter, which was the expected practice at both sites. Increasing EHMR use, recall of disinfection training, and work in intensive care or emergency settings significantly influenced higher reporting of this practice. 36% of respondents reported using centralized C&D, although reporting was higher at the site (A) where this was expected (53%). Confidence in cleanliness of the EHMR following centralized C&D was not influenced by individual versus shared-pool EHMR issue. CONCLUSIONS: Most EHMR users reported adherence with expected post-care individual-based disinfection of EHMRs but did not necessarily use standardized, centralized C&D. Future efforts to limit reliance on behavior related to respirator disinfection may improve EHMR implementation in healthcare to avert dependence on single-use, disposable N95 respirators.

Radiofrequency Identification Track for Tray Optimization: An Instrument Utilization Pilot Study in Surgical Oncology.

BACKGROUND: Surgical instrument tray reduction attempts to minimize intraoperative inefficiency and processing costs. Previous reduction methods relied on trained observers manually recording instrument use (i.e. human ethnography), and surgeon and/or staff recall, which are imprecise and inherently limited. We aimed to determine the feasibility of radiofrequency identification (RFID)-based intraoperative instrument tracking as an effective means of instrument reduction. METHODS: Instrument trays were tagged with unique RFID tags. A RFID reader tracked instruments passing near RFID antennas during 15 breast operations performed by a single surgeon; ethnography was performed concurrently. Instruments without recorded use were eliminated, and 10 additional cases were performed utilizing the reduced tray. Logistic regression was used to estimate odds of instrument use across cases. Cohen's Kappa estimated agreement between RFID and ethnography. RESULTS: Over 15 cases, 37 unique instruments were used (median 23 instruments/case). A mean 0.64 (median = 0, range = 0-3) new instruments were added per case; odds of instrument use did not change between cases (OR = 1.02, 95%CI 1.00-1.05). Over 15 cases, all instruments marked as used by ethnography were recorded by RFID tracking; 7 RFID-tracked instruments were never recorded by ethnography. Tray size was reduced 40%. None of the 25 eliminated instruments were required in 10 subsequent cases. Cohen's Kappa comparing RFID data and ethnography over all cases was 0.82 (95%CI 0.79-0.86), indicating near perfect agreement between methodologies. CONCLUSIONS: Intraoperative RFID instrument tracking is a feasible, data-driven method for surgical tray reduction. Overall, RFID tracking represents a scalable, systematic, and efficient method of optimizing instrument supply across procedures.

Using Real-Time Locating Systems to Optimize Endoscope Use at a Large Academic Medical Center.

Massachusetts General Hospital (MGH) manages a large inventory of surgical equipment which must be delivered to operating rooms on-time, efficiently, and according to a set of quality standards and regulatory guidelines. In recent years, flexible scope management has become a topic of interest for many hospitals, as they face pressure to reduce costs, prevent infections that can result from mismanagement, and are under increased regulatory oversight. This work conducted at MGH proposes a novel method for surgical equipment management in a hospital. The proposed solution uses a real-time locating system to track flexible scopes, a semantic reasoning engine to determine the state of each scope, and a user interface to inform staff about necessary interventions to avoid scope expirations while maximizing efficiency. This study aimed to accomplish three primary goals. First, the study sought to improve the hospital's compliance to quality standards in order to reduce risks of infection due to expired scopes. Second, the study aimed to improve the cost-efficiency of scope disinfecting processes through more efficient inventory management. Finally, the study served as an opportunity for the hospital to establish best practices for working with the newly installed real-time locating system. The system proposed in this work was implemented at MGH on a subset of the hospital's flexible scopes. The study results demonstrated a quality compliance increase from 88.9% to 94.5%. The study also showed an estimated $17,350 annual cost savings due to more efficient scope management. Finally, the study demonstrated the feasibility, increase in regulatory compliance, and cost savings that would make this technology valuable when scaled across the hospital to other types of scopes and medical devices.

Revealing complex interdependencies in surgical instrument reprocessing using SEIPS 101 tools.

Sterile Processing Departments (SPDs) must clean, maintain, store, and organize surgical instruments which are then delivered to Operating Rooms (ORs) using a Courier Network, with regular coordination occurring across departmental boundaries. To represent these relationships, we utilized the Systems Engineering Initiative for Patient Safety (SEIPS) 101 Toolkit, which helps model how health-related outcomes are affected by healthcare work systems. Through observations and interviews which built on prior work system analyses, we developed a SEIPS 101 journey map, PETT scan, and tasks matrices to represent the instrument reprocessing work system, revealing complex interdependencies between the people, tools, and tasks occurring within it. The SPD, OR and Courier teams are found to have overlapping responsibilities and a clear co-dependence, with critical implications for the successful functioning of the whole hospital system.

The utility of lighted magnification and borescopes for visual inspection of flexible endoscopes.

INTRODUCTION: Infections have been linked to damaged or contaminated endoscopes with visible defects. Endoscope processing standards and guidelines state endoscopes should be visually inspected every time they are used. This study evaluated a new visual inspection program using magnification and borescopes in an endoscopy department that had not previously utilized these tools. METHODS: Site personnel were given visual inspection tools and training before systematically examining fully processed endoscopes twice during a 2-month period. A risk assessment protocol was used to determine whether endoscopes required recleaning, repair, or other action. Findings were documented using log sheets, photographs, and videotapes. RESULTS: Visible damage and residue or debris were observed in 100% of 25 endoscopes at both assessments, and 76% required repair. Defects at baseline included scratches (88%); channel shredding or peeling (80%); adhesive band disintegration (80%); residual soil or debris (white 84%; black 68%; brown 40%; yellow/green 36%; and orange/red 8%); retained fluid (52%); and dents (40%). Findings were similar at follow-up. DISCUSSION/CONCLUSIONS: Visual inspection with magnification and borescopes identified actionable defects that could interfere with processing effectiveness in 100% of endoscopes. Infection preventionists have a critical role to play in supporting processing personnel now that standards, guidelines, and manufacturer instructions recommend enhanced visual inspection of every endoscope, every time.

Emergency Preparedness: Strategies for Maintaining Water Supply Quality and Access for Sterile Processing.

Sterile processing department (SPD) technicians are responsible for providing properly reprocessed surgical instruments for procedures. They use utility (ie, tap) water for precleaning, cleaning, and disinfection; and critical (ie, treated to remove impurities) water for the final rinse and steam sterilization. Water maintenance personnel should work with SPD personnel to ensure that the facility's water supply meets the quality parameters for hardness, pH, conductivity, chlorides, bacteria, and endotoxins. Inadequate water quality and quantity can affect SPD technicians' ability to reprocess instruments correctly and may result in pathogen transmission. When water quality concerns arise, SPD personnel should notify perioperative personnel. Health care facilities should have a water management program to address both normal and abnormal water operations and an emergency water supply plan. Pandemics, geopolitical conflicts, and natural disasters may disrupt water supplies. Proactive planning for water shortages should help facility leaders respond quickly and effectively when shortages occur.

Splash generation and droplet dispersal in a well-designed, centralized high-level disinfection unit.

BACKGROUND: Sterile processing personnel routinely decontaminate medical devices that are heavily soiled with blood, tissue, and secretions. Contamination may spread throughout processing areas, potentially exposing personnel and patient-ready devices, especially when there is insufficient separation between the dirty and clean areas. OBJECTIVE: This study aimed to identify activities that generate splash, determine how far droplets travel during manual cleaning, characterize the impact of practices on splash generation, and assess effectiveness of personal protective equipment (PPE) at preventing splash exposure to technicians and visitors in the decontamination unit. METHODS: Moisture-detection paper was affixed to PPE and environmental surfaces in a new processing department designed to optimize workflow and prevent cross-contamination. Droplet generation and dispersal were assessed during manual cleaning of a colonoscope and a transvaginal ultrasound probe. RESULTS: Splash was generated by most activities and droplets were detected up to 7.25 feet away. Transporting wet endoscopes dispersed droplets on a 15-foot path from the sink to the automated endoscope reprocessor. Extensive droplets were detected on PPE worn by technicians at the sink and observers 3-4 feet away. CONCLUSIONS: Manual cleaning of devices generated substantial splash, drenching technicians and the environment with droplets that traveled more than 7 feet. Engineering controls and better PPE are needed to reduce personnel exposure and risks associated with the potential dispersal of contaminated fluids throughout the facility.

Clean and Confident: Impact of Sterile Instrument Processing Workshops on Knowledge and Confidence in Five Low- and Middle-Income Countries.

Background: Proper sterilization of surgical instruments is essential for safe surgery, yet re-processing methods in low-resource settings can fall short of standards. Training of Trainers (TOT) workshops in Ethiopia and El Salvador instructed participants in sterile processing concepts and prepared participants to teach others. This study examines participants' knowledge and confidence post-TOT workshop, and moreover discusses subsequent non-TOT workshops and observed sterile processing practices. Methods: Five TOT workshops were conducted between 2018 and 2020 in Ethiopia and Central America. Participant trainers then led nine non-TOT workshops in El Salvador, Guatemala, Honduras, and Nicaragua. Interactive sessions covered instrument cleaning, packaging, disinfection, sterilization, and transportation. Participants completed pre- and post-tests, demonstrated skill competencies, and shared feedback. Peri-operative sterile processing metrics were also observed in Ethiopian hospitals pre- and post-workshops. Results: Ninety-five trainees participated in TOT workshops, whereas 169 participated in non-TOT workshops. Knowledge on a 10-point scale increased substantially after all training sessions (+2.3 ± 2.8, +2.9 ± 1.7, and 2.7 ± 2.5 after Ethiopian, Central American, and non-TOT workshops, respectively; all p < 0.05). Scores on tests of sterile processing theory also increased (Ethiopian TOT, +68% ± 92%; Central American TOT, +26% ± 20%; p < 0.01). Most respondents felt "very confident" about teaching (Ethiopian TOT, 72%; Central American TOT, 83%; non-TOT, 70%), whereas fewer participants felt "very confident" enacting change (Ethiopian TOT, 36%; Central American TOT, 58%; non-TOT, 38%). Reasons included resource scarcity and inadequate support. Nonetheless, observed instrument compliance improved after Ethiopian TOT workshops (odds ratio [OR], 1.47; 95% confidence interval [CI], 1.21-1.78; p < 0.01). Conclusions: Sterile processing workshops can improve knowledge, confidence, and sterility compliance in selected low- and middle-income countries. Training of Trainers models empower participants to adapt programs locally, enhancing sterile processing knowledge in different communities. However, national guidelines, physical and administrative resources, and long-term follow-up must improve to ensure effective sterile processing.

Droplet dispersal in decontamination areas of instrument reprocessing suites.

BACKGROUND: Personnel working in sterile processing or endoscope reprocessing departments are at high risk of exposure to tissue, blood, and patient fluids when decontaminating reusable medical instruments and equipment. The effectiveness of protective measures for reprocessing personnel has not yet been systematically evaluated in real-world settings. OBJECTIVE: This pilot project aimed to identify reprocessing activities that generate splashes, determine how far droplets can travel in decontamination areas, and assess personal protective equipment exposure during routine activities. METHODS: Moisture-detection paper was affixed to environmental surfaces and personal protective equipment in a sterile processing department. Droplet dispersal was assessed after personnel simulated performance of routine reprocessing tasks. RESULTS: Visible droplets were generated during every reprocessing activity except running the sonication sink. Droplets traveled at least 3 feet when filling a sink, brushing a ureteroscope, and using a power sprayer to rinse a basin. Some activities dispersed droplets up to 5 feet from the sink. Personal protective equipment was splashed during most activities and did not prevent skin exposure even when properly donned and doffed. CONCLUSION: This hypothesis-generating pilot project found that routine reprocessing activities generated substantial splashing, and currently recommended personal protective equipment did not adequately protect sterile processing personnel from exposure.

Guidelines in Practice: Instrument Cleaning.

Care of surgical instruments and devices is a multifaceted process that begins with an interdisciplinary team's prepurchase determination that the facility has the resources to correctly process the items. Processing encompasses point-of use removal of organic and inorganic material, transport to the processing area, use of chemicals and equipment to clean and decontaminate the item, and inspection for cleanliness and function. Failure to correctly clean and decontaminate surgical instruments can impede subsequent sterilization processes and place patients at risk for developing surgical site infections. The AORN "Guideline for care and cleaning of surgical instruments" provides general guidance for care of reusable medical devices. When processing instruments, perioperative team members should use the guideline in conjunction with the instrument manufacturer's validated instructions for use. This article discusses the guideline recommendations related to prepurchase evaluation, point-of-use treatment, transport, cleaning and decontamination, and education; it also includes a scenario to illustrate these topics.

Instrument Set Decontamination Workflows Designed for Success in Sterile Processing.

In sterile processing, several factors can result in confusion and unpredictable quality outcomes in surgical instrument sets, including the large number of instruments to manage, the complexity of certain instruments, and the multiple instructions for cleaning solutions and cleaning equipment for use. At a multihospital health system, the director of sterile processing had a vision that involved designing standard decontamination workflows and standardized cleaning pathways based on quality concepts to support patient safety. When there was a pause in elective surgeries in the spring of 2020 as a result of the spread of coronavirus disease 2019, sterile processing personnel became available to participate in a project to create and test these new standardized cleaning pathways and decontamination workflows. This article provides an overview of the inception and execution of this project and how instrument cleaning and decontamination was streamlined to promote a more efficient workflow for sterile processing.

Sterile processing in low- and middle-income countries: an integrative review.

BACKGROUND: Worldwide disparities in surgical capacity are a significant contributor to health inequalities. Safe surgery and infection prevention and control depend on effective sterile processing (SP) of surgical instruments; however, little is known about SP in low- and middle-income countries (LMICs), where surgical site infection is a major cause of postoperative morbidity and mortality. AIM: To appraise and synthesise available evidence on SP in LMICs. METHODS: An integrative review of research literature was conducted on SP in LMICs published between 2010 and 2020. Studies were appraised and synthesised to identify challenges and opportunities in practice and research. RESULTS: Eighteen papers met the inclusion criteria for qualitative analysis. Challenges to advancing SP include limited available evidence, resource constraints and policy-practice gaps. Opportunities for advancing SP include tailored education and mentoring initiatives, emerging partnerships and networks that advance implementation guidelines and promote best practices, identifying innovative approaches to resource constraints, and designing and executing quality assurance and surveillance programmes. DISCUSSION: Research investigating safe surgery, including SP, in LMICs is increasing. Further research and evidence are needed to confirm the generalisability of study findings and effectiveness of strategies to improve SP practice in LMICs. This review will help researchers and stakeholders identify opportunities to contribute. The burdens of unsafe surgery transcend geopolitical borders, and the global surgery and research communities are called upon to negotiate historical and present-day inequities to achieve safe surgery for all.

Improving sterile processing practices in Cambodian healthcare facilities.

BACKGROUND: Sterile processing practices in low-resource countries contribute to greater post-operative infection rates compared to high-resource countries. Provision of a sterile processing training program in Tanzania and Ethiopia demonstrated statistically significant improvements in sterile processing practice, a key requisite for safe surgical care. AIM: To determine if a sterile processing program in a South East Asia country would result in improved conditions and practice in urban and rural healthcare facilities. METHODS: In 2019, a mixed-methods study was conducted with two cohorts in Cambodia, involving a total of eight healthcare facilities and 43 healthcare workers. Quantitative data were collected using a sterile processing assessment tool and a multiple-choice test pre- and post-training. Qualitative data in the form of interviews were obtained several months post-training. FINDINGS: Test results showed statistically significant and sustained effect of training over a four-six month period, as well as a large positive effect on SP knowledge in both cohorts. Analysis of hospital assessment data revealed an aggregate improvement of 36% in sterile processing benchmarks. While all participants reported increased knowledge and confidence (quantitative), rural participants conveyed a lack of support (qualitative) to implement practice changes. CONCLUSION: The training course produced improvements in both rural and urban facilities. Findings highlight the importance of informing administrators of the rationale for needed improvements, ensuring funding is available to implement recommendations, and for governments to hold administrators accountable for improvements aligning with universally recommended sterile processing standards.

A Central Sterile Processing and Hospital Epidemiology and Infection Control Collaboration to Ensure Safe Patient Care.

Cleaning, disinfection, and sterilization (CDS) practices and protocols are the cornerstone of infection control and patient safety. Central sterile processing (CSP) leaders are responsible for updating policies and procedures for sterile processing and ensuring CSP staff members process instruments correctly. Monitoring staff member practices can be a demanding and difficult task, but it is critical for safe patient outcomes. The CSP and perioperative leaders at our facility found that regular consultation and collaboration with the Department of Hospital Epidemiology and Infection Control (HEIC) is an effective way to ensure that patient safety is at the forefront of CDS practices. These leaders established an oversight committee to address a variety of infection prevention concerns, including environment of care rounds, implementation of manufacturers' instructions for use, and CDS standardization. This article highlights how CSP and HEIC leaders and staff members partnered to implement and sustain CDS best practices and protocols.

Relocating Sterile Processing Activities to an Off-Site Facility: Cost, Design, and Project Management Considerations.

When space limitations prevent sterile processing department personnel from meeting the needs of the perioperative departments that they serve, leaders should consider expansion options. At one large multifacility health care system in Pennsylvania, leaders considering expansion assessed several factors, including the costs versus benefits, logistics, real estate space, regulatory requirements, and the overall effect on employees. After reviewing all of the information, the leaders decided to move the sterile processing department for two hospitals and two outpatient centers to an off-site location. They designed a space to accommodate the sterile processing of instruments for these identified facilities and, if needed, additional facilities in the future. This article highlights the issues that the leaders considered when preparing for the move and discusses the processes and project management structures used to complete the building design.

An Enhanced Kaizen Event in a Sterile Processing Department of a Rural Hospital: A Case Study.

Operating Rooms (ORs) generate the largest revenues and losses in a hospital. Without the prompt supply of sterile surgical trays from the Sterile Processing Department (SPD), the OR would not be able to perform surgeries to its busy schedule. Nevertheless, little emphasis has been brought in the medical literature to research on surgical instrument processing in the medical literature. The present study was done applies an Enhanced Kaizen Event (EKE) in the SPD of a rural hospital to identify sources of waste and minimize non-value-added steps in the SPD processes. The EKE consisted of three successive Plan-Do-Check-Act (PDCA) cycles, which focused on improvements at the departmental level first, then at an area level, and finally at the station level. The EKE yielded an improved streamlined workflow and a new design for the SPD layout, one of its areas, and a workstation. This paper aims at building a methodology, including identified steps. Results exhibited a 35% reduction in travel distance by the staff, eliminating non-value-added processes, reducing errors in the sterilization process, and eliminating cross-contamination for sterilized materials.

Design and implementation of the infection prevention program into risk management: Managing high level disinfection and sterilization in the outpatient setting.

Reusable, invasive medical devices within the outpatient setting pose a risk for patient harm. Ineffective disinfection of medical devices can potentially lead to transmission of pathogens between patients; and improper handling can lead to patient injury. A risk assessment was conducted, and the results strongly supported the necessity to develop a robust infection prevention program within the risk management department. This exclusive program was a proactive approach to preventing patient exposure within our healthcare system. Designing and integrating an Infection Prevention program into the Risk Management Department presented challenges, especially with the magnitude of devices and lack of standardization throughout our 33 clinics. Key components of the program included: capturing an accurate inventory of devices throughout the system, hiring a sterile processing expert, engaging support from senior leadership, adhering to rigorous auditing processes, and establishing a staff competency training structure. Since the program was launched 2 years ago, outcomes include: identification of high-risk practices with immediate resolution, increase in average clinic compliance to device reprocessing standards from 88% to 99%, elimination of 71% of scope reprocessing and 39% of instrument sterilization by clinic staff with allocation to central sterile processing departments, and development of a staff competency training structure.

Guideline Implementation: Sterilization.

Ensuring that reusable surgical instruments and medical devices have been sterilized is an important factor in preventing surgical site infections. The sterilization method for a particular device is based on the device design, material, packaging, compatibility with the sterilant, load limitations, and safety requirements. Perioperative team members must review the manufacturer's instructions for cleaning, packaging, and sterilizing the device to determine the correct sterilization process. The AORN "Guideline for sterilization" provides guidance for processing reusable medical devices for use in perioperative and procedural settings. This article elaborates on key takeaways from the guideline, including processing a device based on the intended use of the item, protecting sterile items during transport, reprocessing by immediate-use steam sterilization when certain conditions can be met, and educating personnel who perform sterile processing activities. Perioperative RNs should review the complete guideline for additional information and for guidance when writing and updating policies and procedures.

Using a systematic approach for adopting new technologies in sterile processing departments and operating rooms.

Technological advancements in health care can potentially have substantial benefits on efforts to improve patient care. Organizations are often hesitant to consider new devices or technologies, particularly if the new technology is expensive, not addressed in current standards, or affects multiple departments, such as the sterile processing department, operating room, and infection prevention. Organizations considering new technology should create a multidisciplinary risk assessment committee tasked with using a systematic approach to evaluate and make recommendations on new products or technologies.