Background: Sterile processing departments (SPDs) support safe surgical and procedural care through the cleaning, inspection, assembly, sterilization, storage, and distribution of reusable medical devices. Persistent staffing shortages can disrupt these functions and complicate onboarding of entry-level technicians. Methods: This descriptive program evaluation examined an SPD technician trainee program implemented across a multihospital health system. The SPD enterprise included approximately 216 full-time equivalent positions, and the program was developed to expand the technician pipeline and standardize onboarding during a period of workforce instability. The 10- to 13-week curriculum used a competency-based educational framework that combined didactic instruction, simulation, supervised clinical practice, competency validation, and certification preparation informed by Healthcare Sterile Processing Association (HSPA) educational content and ANSI/AAMI ST79:2017 principles. Results: Across seven cohorts, 92 trainees were selected and 88 completed the program (95.65% completion rate). Among completers, 63 applied for the HSPA's Certified Registered Central Service Technician examination and 51 passed (80.95% pass rate). Retention was lower, with 38 of 92 participants (41.3%) remaining in SPD roles at the time of analysis. Operational data also showed persistent baseline staffing strain and were used to assess vacancy trends and selected workflow indicators during implementation. Conclusion: A structured internal SPD training pathway was feasible to implement across a multihospital system and was associated with strong completion and certification outcomes. However, retention remained an important challenge, suggesting that training should be paired with broader workforce strategies focused on onboarding support, career development, and long-term workforce stability.

Water quality is a critical control variable for healthcare device processing and other high-purity applications. Many facilities rely on chemical treatments (e.g., salt-based softeners, sodium bisulfite for dechlorination), but these methods increase system complexity, generate chemical waste, and introduce risks to staff, patients, and downstream wastewater systems. These challenges are particularly noteworthy in healthcare settings, where both safety and environmental performance are tightly regulated. Filtration-based alternatives that reduce dependence on chemical dosing were evaluated in the current work. Technologies such as reverse osmosis, advanced carbon and particulate filtration, and ultraviolet or thermal disinfection could achieve high-purity water, including critical water, by removing dissolved ions, organics, particulates, and microorganisms. These approaches simplified operations, lowered chemical handling risks, and reduced waste generation while maintaining consistent water quality at a substantial cost reduction in equipment, installation, energy, and consumables. Through comparison of conventional chemical systems and low-chemical or chemical-free designs, the analysis showed that filtration-centered approaches can meet stringent performance requirements while improving safety, reliability, and sustainability. The findings supported the consideration of filtration-dominant water treatment as a practical, evidence-informed strategy to reduce chemical reliance, protect human health, and minimize environmental impact in healthcare facilities when implementation is supported by appropriate validation and monitoring.

Ultrasound probes, which are used routinely in clinical practice, can become contaminated after use. If not effectively processed, they may pose an infection control challenge. Understanding the extent to which microscopic surface topography of ultrasound probes may shield microorganisms is crucial, yet these features remain poorly characterized. This descriptive study used scanning electron microscopy (SEM) to investigate the microscopic topography of ultrasound probe surfaces. Characteristics such as grooves, notches, guide features, orientation markers, and seams were identified on endocavitary (n = 4) and surface (n = 1) probes. Gaps and crevices within these characteristics were assessed for their potential to harbor microorganisms. A total of 46 sites across 15 segments from the five ultrasound probes were examined using a tungsten-filament SEM under low vacuum at an accelerating voltage of 20 kV. Of the 46 sites imaged, 32 showed measurable gaps or crevices, with widths of 0.9 to 480.4 μm. The lens surface revealed microscopically rough texture with crevices as wide as 4.8 μm. Surface wear, such as a displacement scratch on an endocavitary probe shaft, had crevices large enough to shield pathogens. On probe shafts and handles, seam widths of 7.9 to 480.4 μm containing dried residue with gaps were observed. These gaps and crevices are large enough to harbor microorganisms and could be relevant when considering disinfection efficacy. These observations highlighted the relevance of probe surface microtopography as a consideration for future device processing research. Additional studies are needed to determine how cleaning and high-level disinfection processes interact with microscopic surface features across different ultrasound probe designs.

During the COVID-19 pandemic, many methods of decontamination were proposed to combat the severe shortages of disposable personal protective equipment (PPE), such as N95 respirators and gowns, for healthcare workers. Although several decontamination methods were granted emergency use authorizations for N95 respirators, no methods were granted for gowns. The main concerns for decontamination of disposable PPE are twofold. First, the method must adequately decontaminate the PPE, and second, the device must retain its performance requirements after decontamination. The current study examined autoclave sterilization and single-step gaseous ozone decontamination methods for decontaminating N95 respirators and gowns, while microwave-generated steam decontamination was also used for N95 respirators. We found that N95 respirators could undergo major deformation due to decontamination, but this deformation was not reflected in filtration efficiency, pressure drop measurements, or tensile strength measurements. These findings underscored the importance of other methods that define the protective performance of the product (e.g., fit testing) for assessing the impact of decontamination on N95 respirators. Surgical gowns maintained their protection level regardless of decontamination type, but not enough samples were tested for a proper acceptable quality level determination. For isolation gowns, autoclaving resulted in catastrophic material failure due to high heat, but the gentler decontamination method using gaseous ozone resulted in a lower failure rate for the material.

Background: Sterile processing departments (SPDs) play a vital role in patient care through the safe and effective cleaning, inspection, sterilization, and distribution of reusable medical devices and surgical instruments. Failure in device processing may compromise infection prevention efforts and contribute to healthcare-associated infections. The increasing complexity of surgical instrumentation, particularly lumened and multicomponent devices, has increased the operational demands placed on SPD staff. Methods: A qualitative organizational improvement study was conducted in the SPD of a level 1 trauma academic medical center. Semistructured interviews were performed among 13 participants, including 10 SPD technicians, two SPD managers, and one operating room liaison. The study was guided by Kotter's organizational change model, systems theory, and appreciative inquiry. Interview data were analyzed using thematic coding, with participant-level frequencies calculated to quantify the prevalence of key findings. Results: All participants recognized the role of sterile processing in supporting patient safety and infection prevention. However, 77% reported inconsistent adherence to established procedures, particularly during periods of high surgical volume. Operational inefficiencies were identified by 92% of participants, with training gaps and workflow variation reported by 69% and 62% of participants, respectively. Concerns regarding leadership engagement and the sustainability of improvement initiatives were also reported by 62% of participants, suggesting mixed organizational readiness for change and the need for stronger alignment among frontline workflow practices, leadership accountability, and standardized improvement efforts. Conclusion: Standardized workflows, workforce education, and interdisciplinary collaboration may enhance SPD reliability and operational efficiency, while structured change frameworks may support the sustainability of improvement initiatives.

Although intravenous (IV) smart pumps (IVSPs) are widely used to reduce medication errors, many IVSPs continue to depend on passive methods, such as an adequate hydrostatic head height differential (HHD), for the delivery of secondary medications. An adequate HHD ensures that the fluid level inside the secondary bag is sufficiently higher than the fluid level inside the primary bag, which is accomplished by lowering the primary bag with a supplied hanger to ensure the secondary medication is delivered preferentially. Poor clinical adherence to this requirement is common, conferring risk of medication dilution and subtherapeutic dosing. As prior observational studies have not quantified this risk, the current work sought to develop a laboratory protocol to measure delivered secondary medication concentration across three hanger configurations (full, half, and zero hanger) over a range of flow rates. Both hanger configuration (P < 0.0001) and programmed flow rate (P < 0.0001) significantly affected the delivered concentration. The zero hanger configuration, characterized by an HHD of zero, caused severe and statistically significant underdelivery of the secondary fluid, often delivering less than one-half of the intended concentration due to unintended dilution. The full and half hanger configurations maintained acceptable accuracy (±5% deviation) up to 250 mL/h, though concentration delivery accuracy decreased for the half hanger configuration at 400 mL/h. This study validated a method for directly measuring secondary medication delivery, providing evidence to inform safer clinical practice and device development.

The current work demonstrated inactivation of bacterial endotoxin by moist heat, electron beam, and gamma irradiation in dry, water, and saline conditions relevant to medical devices and pharmaceuticals. This study was intended to help manufacturers decide whether to test for bacterial endotoxin pre- or poststerilization. It demonstrated the feasibility of inactivating endotoxin by widely available sterilization technologies other than dry heat.

Few data have been published regarding the use of biological indicators (BIs) for nitrogen dioxide (NO2) sterilization. This article presents findings from a comprehensive series of studies conducted to assess BI performance across common circumstances: transport, shelf life, integration within self-contained BIs (SCBIs), poststerilization handling, and incubation. The results showed that BIs retained their performance characteristics after transport and for up to 12 months of storage postmanufacture. During sterilization, SCBIs functioned reliably as external process challenge devices (PCDs) for NO2 processes. Following sterilization, external PCDs could be held for up to 48 hours prior to activation and incubation without compromising results. BI growth outcomes can be finalized in as little as 42 hours, enabling timely product release. These findings confirmed the reliability of BIs for NO2 sterilization and support their use in validation and routine monitoring of NO2 sterilization processes.

Objectives: Electrical leakage from laparoscopic instruments with defective insulation places patients, surgeons, and perioperative personnel at risk of shocks or burns. The primary objectives of this multisite study were to determine the prevalence of insulation defects, characterize the location and nature of defects, and compare the effectiveness of visual inspection and an insulation integrity tester (IIT) for detecting nonintact insulation. Methods: Researchers assessed laparoscopic instruments in a tertiary care center, pediatric hospital, and ambulatory surgery center. Assessments included visually inspecting shafts and handles using the facility's normal methods and testing with an IIT. Defects were inspected and photographed at high magnification with a microscope. Results: A total of 259 instruments contained in 29 trays were evaluated. Defects were found on 13.1% (34 of 259) of instruments, and 58.6% (17 of 29) of trays contained at least one defective instrument. Of the 34 instruments with defective insulation, 9 (26.5%) had defects detected by both methods, 13 (38.2%) had defects found exclusively by visual inspection, and 12 (35.3%) had defects identified exclusively by testing. Defect prevalence varied by location on the instrument, with defects identified on 31.3% (15 of 48) of handles and 8.3% (20 of 240) of shafts. Visual inspection and testing required 11 seconds and 36 seconds (mean) per instrument, respectively. Conclusion: Given the high incidence of defective instruments found in laparoscopic trays and the potential risk for patient or personnel injury, healthcare facilities should consider implementing standardized quality assurance protocols that incorporate both systematic visual inspection and routine insulation integrity testing of all insulated instruments during sterile processing cycles. These protocols will require additional time and resources.

Background: Sterile processing departments (SPDs) are foundational to perioperative safety and play a critical role in preventing surgical-site infections and ensuring procedural reliability. Despite this essential function, SPD professionals often report limited organizational visibility and constrained decision-making authority. Many also experience insufficient integration into formal governance structures. Empirical literature examining the relationship among reporting structures, professional autonomy, and patient safety outcomes in SPDs remains limited. Methods: A convergent mixed-methods design was used in this study. A structured survey of 89 SPD professionals was conducted to quantify perceptions of reporting relationships, leadership support, and adherence to sterilization protocols. Open-ended responses were also collected to capture qualitative insights. Quantitative data were analyzed using descriptive statistics. Qualitative responses were examined through inductive thematic coding to identify recurring organizational and cultural factors influencing professional autonomy and operational performance. Results: Most respondents reported administratively reporting to nursing or supply chain leadership. Participants generally expressed low to moderate confidence in leadership's understanding of SPD workflows. In addition, 43% of respondents reported experiencing pressure to circumvent established sterilization protocols. Qualitative analysis identified 13 dominant themes. Key themes included the need for greater professional autonomy, formal leadership development, stronger interdisciplinary alignment, standardized credentialing, and improved professional recognition. Conclusion: The findings suggested that current governance structures may limit SPD operational authority and introduce potential risks to patient safety. Organizational restructuring may help strengthen SPD leadership and decision-making capacity. Establishing formal credentialing standards and leadership development pathways may also be beneficial. Greater integration of SPD leadership into executive decision-making processes could improve compliance with sterilization standards and support higher-quality perioperative outcomes.

Current methods for estimating average bioburden on medical device products, following ISO 11737-1:2018 with low bioburden or high limit of detection, present challenges for bioburden-based sterilization methods (e.g., radiation sterilization by ISO 11137-2:2013 or ISO 13004:2022). The inability to accurately estimate low bioburden counts per device can result in an overestimation of device bioburden and an artificially decreased challenge during validation. It can also force products to be sterilized at higher doses if the overestimation of bioburden prevents use of a lower dose than would otherwise be possible. This article describes a plate-counting technique for producing consistent and accurate estimates of low numbers of bioburden for products, even when tested as a sample item portion or with a high dilution factor relative to the average bioburden count.

Currently, manufacturers of cleaning agents are not obligated to verify the efficacy of formulations used in detergents. Because of a lack of standards, companies can market cleaning agents to healthcare systems for cleaning purposes without substantiated evidence that the agents meet minimum performance criteria, as validated by medical device manufacturers. Absence of standards and regulatory oversight on the performance assessment of cleaning agents exacerbates the risk to patient safety for reusable medical devices. The aim of the current work was to develop a standard test method for reliably assessing the performance of cleaning agents. Water was used as the test method control to normalize cleaning agent performance. Cleaning agents, which were advertised as economy (i.e., minimal performance) and premium (i.e., high performance), were challenged as independent variables in the test system. Control variables were modified for each experiment to isolate the highest performing variable combination, and robustness was evaluated by performance testing at multiple independent laboratories. By controlling variables such as soil type, application, drying, and exposure time, a standardized, reproducible test method for evaluating the performance of cleaning agents used in medical device processing was developed. This approach can allow for reliable comparisons of cleaning agents to empower medical device manufacturers and healthcare facilities to make informed choices, ultimately contributing to improved patient safety through more effective cleaning validation.

Guidelines for endoscope hang time following device processing do not provide a specific time frame; instead, they recommend conducting a multidisciplinary risk assessment for any changes in protocol. After undertaking a risk assessment, a proposal to move from a 7- to 14-day hang time was developed and approved at a pediatric hospital. Rigorous protocols were put into place to assess for endoscope contamination and to surveil for endoscope-related infections. In the 3 months following the protocol change, no instances of contamination were identified and no concerns related to endoscope-related infections were noted. Implementation of the increase in scope hang time was estimated to save more than $150,000 annually in equipment and staff costs. Modifying endoscope hang time can be accomplished safely and cost effectively by adhering to strict procedures and ensuring dedicated process oversight.

Reusable medical devices are intended to be subjected to multiple cycles of clinical processing throughout the life of the device in accordance with manufacturers' instructions for use (IFUs). IFUs should include practical information on the service life of the medical device. This laboratory-based study investigated an approach to support an indefinite lifetime for reusable devices, where the end of life depends on the visual inspection and functional verification provided in the IFU. To evaluate the design features over a broad range of surgical instruments, worst-case, representative devices were identified based on their cumulative features. The devices were subjected to repetitive cycles of processing (cleaning, disinfection, and sterilization). At different stages during the study, the devices were examined for visual effects over time. In addition, extracted levels of total organic carbon and cytotoxicity were assessed. Trend analysis over the study did not show noteworthy effects of device processing over time, including cytotoxic residuals. The results indicated that the effects of repeated cycles of processing on the device tested were negligible regarding physical damage and residual chemical levels. These findings support an indefinite device lifetime using end-of-life indications, based on the IFU and inspection requirements (for cleanliness, damage, and proper function).

Healthcare staff rely on isolation gowns to provide a degree of protection against cross contamination from blood or body fluids. Gowns that meet standardized liquid barrier penetration test methods provide staff with a presumed assurance of safety. However, these test methods-namely impact penetration and resistance to hydrostatic pressure-were not drafted with personal protective equipment in mind and therefore may be inappropriate for testing products intended for use in a healthcare environment. This study found that adjusting testing parameters to better simulate clinical conditions altered the measured performance outcomes of the gowns. Specifically, increasing the temperature of the gown material's preconditioning environment or test liquid resulted in statistically significant variations in results. Further, although hydrostatic pressure resistance is measured by the appearance of a third liquid droplet on the inner surface of the gown material, the first two droplets appeared at significantly lower pressures and likely would constitute contamination of healthcare staff. The results indicated that current isolation gown test protocols and regulations should be reevaluated to more accurately reflect healthcare scenarios and improve alignment with expected barrier performance.