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.
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.
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.
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.
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.
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.
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).
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.
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.
End-of-life (EOL) testing requirements for reusable medical devices continue to cause confusion in the medical device industry. Regulatory expectations from U.S. and European Union authorities differ, particularly regarding whether manufacturers must conduct EOL testing or if a cautionary statement in the instructions for use is sufficient. ISO 10993-1:2021 mandates biological safety evaluations for the maximum validated number of processing cycles. Similarly, ISO 17664-1:2021, regulation (EU) 2017/745, and Food and Drug Administration guidance require manufacturers to determine whether repeated processing causes degradation that could limit a device's usable life. However, these documents provide limited direction on how to perform such assessments, leaving a gap in standardized methodology. This study aimed to develop a practical and reproducible protocol for EOL evaluation, reflecting real-world clinical use and manufacturer-recommended processing instructions. The primary objective was to assess whether biological or chemical residues remained on devices after repeated use and processing. A theoretical estimate of 100 use and processing cycles was used, representing a reasonable service life based on routine clinical conditions. A simulated 100-cycle protocol, including soiling, cleaning, and sterilization testing, revealed negligible to nondetectable residual contaminants on both surrogate coupons and actual devices. These results suggest that even under worst-case conditions, devices can be processed effectively without substantial accumulation of contaminants, supporting the selected EOL threshold. This approach offers a reproducible framework for manufacturers to evaluate and validate EOL claims, addressing a critical regulatory and practical challenge.
Objectives: This study sought to investigate whether and to what extent fluid strikethrough for disposable isolation gowns is underreported and to identify areas for improving healthcare worker (HCW) understanding of gown performance. Methods: Researchers developed a confidential, qualitative, online disposable isolation gown user experience survey with an intended audience of HCWs with experience either wearing disposable isolation gowns or selecting them for purchase. The unrestricted survey link was distributed from February to March 2024. Results: A total of 211 individuals completed the survey. When asked about selection, purchasers most frequently chose to purchase level 2 isolation gowns for patient care during nonsurgical applications. More than 40% of wearers stated that they did not have a choice regarding gown protection levels when donning personal protective equipment for patient care, and 34.3% experienced fluid strikethrough (i.e., penetration of fluid through a disposable isolation gown), yet nearly one-half never reported this problem. Discussion and Conclusion: To enhance safety, the healthcare community must work together to improve guidance on gown performance and selection based on fluid exposure risk. Frequent, underreported strikethrough incidents highlighted confusion among HCWs regarding gown classification and appropriate usage. A need exists for a unified, task-based framework that clearly links gown performance with clinical risk. Fostering a culture that normalizes reporting issues-while minimizing staff burden-combined with targeted education and streamlined reporting mechanisms, will enable more informed decision making and reinforce infection prevention efforts.
In ethylene oxide (EO) sterilization processing, products can be released based on the growth responses of biological indicators or by using a parametric release (PR) process that relies on the monitoring and control of process parameters. Both methods must be used in combination with process data, in accordance with ISO 11135:2014. Process parameters can be classified as control, monitor, or both. Control parameters can be altered directly to change the readings of monitoring variables, which can't be directly controlled themselves. Currently, ISO 11135:2014 does not allow PR based on control parameters for EO concentration and humidity (calculated via pressure increment). Sterilant concentration and relative humidity (RH) can only be measured using gas analyzer probes (or similar), despite the challenges of data variance and range, calibration, redundancy, and increased sensitivity to deviations involved with use of such probes. The current article sought to experimentally determine the capacity of statistical process control to detect changes in the process, to act as an early-warning system for an out-of-specification result, and to demonstrate the use of more reliable process data for the purpose of PR. Process data from 100 routine cycles were used to trend the achieved levels of chamber RH, temperature, and EO concentration (measured by gas analyzer probes or similar), and process derived data were compared with data provided by gas analyzer probes. Process trending of routine runs was found to predict process failures, and calculating EO/water concentration via pressure increment was determined to be a viable alternative to measurement by gas analyzer probe. Further, reduced variability in key parameters enables a reduction in sterilant use.
The temperature of the water used in vacuum pumps of steam sterilizers has the potential to cause failures in sterilization processes due to reduced efficiency and compromised vacuum levels. This study measured the impact of water temperature on a liquid ring vacuum pump (monobloc design) in a steam sterilizer. A sterilizer with a 566-L chamber was used for the tests. The water temperatures tested were 10°C, 20°C, 30°C, 40°C, and 50°C, and the following outcomes were analyzed: vacuum depth achieved in the drying phase (mbar), total cycle time (min), vacuum rate in the conditioning phase (mbar/s), and water consumption (L). Water temperature influenced the performance of the vacuum pump in all outcomes analyzed. Considering total cycle times, the performance with water at 10°C can be up to 50% better compared with performance with water at 50°C. The highest vacuum rates were obtained with water between 10°C and 20°C (up to 13 and 20.24 mbar/s, respectively). In cycles performed at 10°C, average water consumption was 33.3 L. In contrast, for cycles carried out at 50°C, the average water consumption increased to 94.2 L. The temperature of the water used in vacuum pumps influences the efficiency of sterilization cycles, which can result in longer cycles and higher water consumption.
Objective: The processes of evaluating and selecting health technologies in hospitals have been extensively explored. However, few studies have been specific to U.S. hospitals, and none has approached the subject from the perspective of clinical engineering (CE)/healthcare technology management (HTM) professionals. This study specifically explored the intraorganizational phenomenon of how electronic medical equipment (EME) is evaluated and selected in U.S. hospitals from the perspective of CE/HTM professionals. Methods: The study was qualitative, incorporating semistructured interviews conducted with 10 CE/HTM professionals. Interviews were carried out via Internet conferencing and recorded. The recordings were transcribed and the transcripts analyzed using the constant comparative method and grounded theory. Results: Participants were able to describe details of the intraorganizational processes used to evaluate and select EME within their hospitals. Themes that emerged included coronavirus disease 2019 impact, growing influence over time, multidisciplinary committees, negative outcomes, organizational factors, and process definition/exceptions. Conclusion: This study found a variety of recurring themes associated with the evaluation and selection processes for EME from the perspective of CE/HTM professionals in U.S. hospitals. Participants had varying degrees of power and influence with the processes. The themes may inform CE/HTM professionals seeking to grow their involvement with such processes.
Background: Persistent microbial contamination of flexible endoscopes has been linked to infections and outbreaks. Valid and reliable sampling methods are critical for monitoring processing effectiveness in flexible endoscopes. In this study, the effectiveness of protein extraction via turbulent fluid flow (TFF) sampling was compared with flush-only sampling in manually cleaned gastrointestinal endoscopes. Methods: A crossover study design, in which both sampling methods were used in alternating order during each endoscope encounter, was utilized to assess protein levels after colonoscopes and gastroscopes underwent manual cleaning. Endoscope channels were sampled with 20 mL sterile water using TFF and flush-only methods. Protein levels were quantified using a spectrophotometer. Results: Protein samples were collected during a total of 40 encounters with 20 unique endoscopes (19 colonoscopes and 21 gastroscopes) following procedural use. More effluent was captured following TFF (20-30 mL) compared with flush-only (19-21 mL) sampling. Zero samples had detectable protein after flush-only sampling, and nine samples (22.5%; two gastroscopes and seven colonoscopes) had detectable protein following TFF sampling (range 1-4 μg/mL). Of those, four exceeded the 2 μg/mL study threshold for recleaning after the first cleaning and three of four dropped to 2 μg/mL or less after recleaning. Conclusion: TFF sampling of the entire suction-biopsy channel allowed the detection of residual protein in nine gastrointestinal endoscopes, whereas no protein was detected in samples obtained by manually flushing the instrument channel. More research is needed to characterize the real-world utility of using the TFF system to verify whether soil and bioburden have been effectively removed during processing. Numerous studies have documented that a majority of fully processed, patient-ready endoscopes harbor microbes.1-8 Microbes found in endoscopes include high-concern organisms (e.g., multidrug-resistant microbes and pathogens) that have been linked to endoscopy-associated outbreaks.9-12 In these outbreaks, visible residual soil was discovered during the outbreak investigation. Current guidelines and standards note that effectively cleaning endoscopes is critical to the success of high-level disinfection (HLD) and sterilization.13,14 Several studies by Ofstead and colleagues6,15,16 have documented high protein levels on endoscopes. A study involving colonoscopes and gastroscopes detected protein on 100% of manually cleaned endoscopes (range 3-11 μg/mL).6 Other studies also found protein in 100% of manually cleaned bronchoscopes (range 2-30 μg/mL) and sterilized ureteroscopes (range 9-32 μg/mL).15,16 These contamination levels were higher than positive controls, which were dirty gastroscopes that had not been manually cleaned. Microbes were found on 12.5% to 60% of fully processed endoscopes, including potential pathogens such as Pseudomonas aeruginosa, Escherichia coli, and Micrococcus luteus.6,15,16 This reinforces the need to verify that endoscopes are clean prior to undergoing HLD or sterilization. Evidence shows that protein can persist through multiple rounds of cleaning.17,18 Despite efforts to clean the endoscope, harvesting samples from surfaces that remain contaminated with soil can be challenging because sampling commonly uses the same tools as cleaning (e.g., brushes or swabs and flushing). Residual soil or bioburden may also be encased in a biofilm matrix that has been hardened through exposure to harsh chemicals used during HLD and/or sterilization and repeated cycles of drying,19,20 thereby increasing the difficulty of capturing a sample. Hervé et al.21 noted that protein deposits in endoscopes were able to resist brushing and flushing, especially in the presence of wear and damage. Historically, flush-only ("flush") sampling was used,22,23 but this method often was limited to the instrument channel and captured lower yields compared with more robust methods.4,24,25 As the effectiveness of sampling affects the validity of results of tests for organic soil and microbial cultures, more robust sampling methods may be required.26 Guidance on sampling for microbial cultures provided by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) involves incorporating a brushing step and an additional flushing step ("flush-brush-flush") to dislodge and flush out microbes.27 This method has been found to be more effective than flush sampling,3,24 but brushes cannot access every endoscope channel and may leave behind bristles. Researchers have reported that the FDA/CDC sampling method is cumbersome, time consuming,28 and prone to contamination.7 Even when using recommended sampling methods, investigators have reported needing to rely on external experts and destructive sampling to effectively harvest samples that ultimately revealed the outbreak pathogen.10,11 This underscores the importance of robust sampling methods, both to avoid false negatives from failing to capture soil or bioburden that is present and to avoid false positives from environmental contamination.7,29 Given the challenges associated with current sampling techniques for organic soil testing and microbial cultures, this study was conducted to evaluate a method that could potentially improve sample validity and reduce the influence of human factors on sampling. The automated turbulent fluid flow (TFF) system pumps a mixture of air and water through the suction and instrument channels from the suction connector to the distal end and into a sterile collection cup that is sealed during sampling to maintain a closed system. The turbulent flow provides friction to endoscope interior surfaces without needing to use a brush.30 In this study, protein extraction via TFF sampling was compared with flush sampling in manually cleaned gastrointestinal endoscopes.
During a 12-year period (2011-23), the number of staff in the Clinical Engineering (CE) Department at the Children's Hospital of Eastern Ontario (CHEO) increased from five to more than 20 biomedical equipment technicians/technologists. However, despite this increase in staff, processes did not evolve and procedures that used modern technological and shipping advances were not implemented. The absence of standardized procurement and inventory processes for parts created discrepancies between on-hand inventory and the computerized maintenance management system (CMMS). Owing to inaccurate CMMS information and unsystematic parts documentation, time and money were wasted. This situation led to a lack of confidence in CMMS data, causing staff disengagement, loss of accountability, and limited parts tracking. The current article describes a project that used Lean methodologies and use of the define, measure, analyze, improve, and control structure, including tools such as interviews, a survey, process mapping, and Gemba walks, to create a list of prioritized problems. A total of 16 problems were formulated, four of which were identified as prerequisites to be implemented regardless of prioritization. The four prerequisites described the scope of each problem and potential solutions. The goal of this process was to create a workflow that could save time and money while improving the morale of stakeholders involved in the parts procurement and inventory process.
The advancement of novel materials and manufacturing technologies offer opportunities to explore new applications in the space of medical devices. Among these advances, biobased polymers with antimicrobial activity can be used to develop prototypes by additive manufacturing, thereby enabling further exploration with benefits to time and cost. The objective of this research was to assess the effectiveness of polylactic acid (PLA) biopolymer embedded with a copper-based composite (active PLA) to reduce and prevent bacterial growth of microorganisms of concern that may lead to the formation of biofilms. The research was carried out by manufacturing coupons of active PLA using additive manufacturing to test the growth or lack thereof of microorganisms known to form biofilms in medical devices, particularly those with narrow lumens. Testing showed 99.99% antimicrobial effectiveness in reducing Pseudomonas aeruginosa (9027), Escherichia coli (8739), and Klebsiella pneumoniae (4352) growth after 24 hours of exposure. The results confirm the effectiveness of active PLA in preventing microbial growth, which opens the possibility of its use for other medical device applications. Further testing is required, particularly regarding toxicological aspects and potential concerns about the size of copper particles.
