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BACKGROUND: Operating rooms contribute to over 40% of hospital expenses, with a portion attributed to waste from single-use, sterile surgical supplies (SUSSS). This research aimed to determine the amount of cost wastage due to not using SUSSS during laparotomy procedures. METHODS: A descriptive-analytical investigation was conducted in two prominent teaching hospitals in Mashhad, Iran 2018. Seventy-seven laparotomy surgeries were scrutinized, documenting both used and unused disposable devices, with their respective costs being assessed. Data analysis was performed using SPSS version 16 software. RESULTS: The study revealed that during surgery in the operating rooms, waste of SUSSS averaged 5.9%. Betadine solution and sterile Gauze types were the top two contributors to resource wastage. Sterile Gauze types incurred the highest cost loss. The study found a significant correlation between cost wastage and surgeon experience (r = 0.296, P < 0.001) as well as surgery duration (r = 0.439, P < 0.001). CONCLUSION: Inadequate management of available and commonly used disposable supplies leads to increased hospital expenses. Enhancing the surgical team's knowledge of sterile surgical supplies usage and making thoughtful selections can play a vital role in curbing health costs by minimizing waste of SUSSS in the operating rooms.

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BACKGROUND: The aim of this study was to estimate the carbon footprint and financial cost of decontaminating (steam sterilization) and packaging reusable surgical instruments, indicating how that burden might be reduced, enabling surgeons to drive action towards net-zero-carbon surgery. METHODS: Carbon footprints were estimated using activity data and prospective machine-loading audit data at a typical UK in-hospital sterilization unit, with instruments wrapped individually in flexible pouches, or prepared as sets housed in single-use tray wraps or reusable rigid containers. Modelling was used to determine the impact of alternative machine loading, opening instruments during the operation, streamlining sets, use of alternative energy sources for decontamination, and alternative waste streams. RESULTS: The carbon footprint of decontaminating and packaging instruments was lowest when instruments were part of sets (66-77 g CO2e per instrument), with a two- to three-fold increase when instruments were wrapped individually (189 g CO2e per instrument). Where 10 or fewer instruments were required for the operation, obtaining individually wrapped items was preferable to opening another set. The carbon footprint was determined significantly by machine loading and the number of instruments per machine slot. Carbon and financial costs increased with streamlining sets. High-temperature incineration of waste increased the carbon footprint of single-use packaging by 33-55 per cent, whereas recycling reduced this by 6-10 per cent. The absolute carbon footprint was dependent on the energy source used, but this did not alter the optimal processes to minimize that footprint. CONCLUSION: Carbon and financial savings can be made by preparing instruments as part of sets, integrating individually wrapped instruments into sets rather than streamlining them, efficient machine loading, and using low-carbon energy sources alongside recycling.

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The Covid-19 pandemic led to threatening shortages in healthcare of medical products such as face masks. Due to this major impact on our healthcare society an initiative was conducted between March and July 2020 for reprocessing of face masks from 19 different hospitals. This exceptional opportunity was used to study the costs impact and the carbon footprint of reprocessed face masks relative to new disposable face masks. The aim of this study is to conduct a Life Cycle Assessment (LCA) to assess and compare the climate change impact of disposed versus reprocessed face masks. In total 18.166 high quality medical FFP2 face masks were reprocessed through steam sterilization between March and July 2020. Greenhouse gas emissions during production, transport, sterilization and end-of-life processes were assessed. The background life cycle inventory data were retrieved from the ecoinvent database. The life cycle impact assessment method ReCiPe was used to translate emissions into climate change impact. The cost analysis is based on actual sterilization as well as associated costs compared to the prices of new disposable face masks. A Monte Carlo sampling was used to propagate the uncertainty of different inputs to the LCA results. The carbon footprint appears to be 58% lower for face masks which were reused for five times compared to new face masks which were used for one time only. The sensitivity analysis indicated that the loading capacity of the autoclave and rejection rate of face masks has a large influence on the carbon footprint. The estimated cost price of a reprocessed mask was €1.40 against €1.55. The Life Cycle Assessment demonstrates that reprocessed FFP2 face masks from a circular economy perspective have a lower climate change impact on the carbon footprint than new face masks. For policymakers it is important to realize that the carbon footprint of medical products such as face masks may be reduced by means of circular economy strategies. This study demonstrated a lower climate change impact and lower costs when reprocessing and reusing disposable face masks for five times. Therefore, this study may serve as an inspiration for investigating reprocessing of other medical products that may become scarce. Finally, this study advocates that circular design engineering principles should be taken into account when designing medical devices. This will lead to more sustainable products that have a lower carbon footprint and may be manufactured at lower costs.

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BACKGROUND: Large volume delayed sampling (LVDS) and pathogen reduction technology (PRT) are strategies for platelet processing to minimize transfusion of contaminated platelet components (PCs). This study holistically compares the economic and clinical impact of LVDS and PRT in the United States. STUDY DESIGN AND METHODS: A decision model was constructed to simulate collection, processing, and use of PCs and to compare processing strategies: PRT with 5-day shelf life, LVDS with 7-day shelf life (LVDS7), and LVDS with 5-day shelf life extended to 7 days with secondary testing (LVDS5/2). Target population was adults requiring two or more transfusions. Collection, processing, storage, and distribution data were obtained from the National Blood Collection and Utilization Survey and published literature. Patient outcomes associated with transfusions were obtained from AABB guidelines, meta-analyses, and other published clinical studies. Costs were obtained from reimbursement schedules and other published sources. RESULTS: Given 10,000 donated units, 9512, 9511, and 9651 units of PRT, LVDS5/2, and LVDS7 PCs were available for transfusion, respectively. With these units, 1502, 2172, and 2329 transfusions can be performed with similar levels of adverse events. Assuming 30 transfusions a day, a hospital would require 69,325, 47,940, and 45,383 units of PRT, LVDS5/2, and LVDS7 platelets to perform these transfusions. The mean costs to perform transfusions were significantly higher with PRT units. CONCLUSIONS: Compared with PRT, LVDS strategies were associated with lower costs and higher PC availability while patients experienced similar levels of adverse events. Increased utilization of LVDS has the potential to improve efficiency, expand patient access to platelets, and reduce health care costs.

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BACKGROUND: Total knee arthroplasty (TKA) is most frequently planned using conventional two-dimensional weight-bearing lower limb radiographs and is performed with conventional femoral and tibial cutting guides. Questions have been raised about the accuracy of conventional TKA instrumentation and planning for an anatomically standard or complex joint. Use of computed tomography (CT)-based three-dimensional (3D) templating and patient-specific cutting guides printed in 3D has shown improved postoperative lower limb alignment parameters. This case-control study compared costs and operative times of using CT-based, patient-specific, single-use instruments versus conventional metal instruments for TKA. METHODS: In this case-control, retrospective chart review, all TKAs were performed by one senior surgeon, using the F.I.R.S.T. posterior-stabilised knee prosthesis (Symbios, CH), with a similar protocol and identical operating room setup. Group A included 51 TKAs performed with patient-specific cutting guides and conventional metal instruments. Group B included 49 TKAs performed with patient-specific cutting guides and patient-specific, single-use instrumentation. Operation duration, number of instrumentation trays and sterilisation costs were evaluated. RESULTS: The groups were similar for age, body mass index, hip-knee-ankle angle and operation duration. The mean number of instrumentation trays was 8.0 ± 0.8 for group A (controls) and 5.1 ± 0.9 for group B (p<0.001). The mean sterilisation costs were 380 ± 47 Swiss Francs (CHF) for group A and 243 ± 55 CHF for group B (p<0.001), for a mean cost reduction of 130.50 CHF per intervention in group B. The time interval between two consecutive surgeries was 24 min for group A and 18 min for group B. There were no adverse events or complications, instrument-related or otherwise. CONCLUSION: Compared to conventional instrumentation, use of patient-specific, single-use instruments for TKA reduced the number of instrumentation trays by more than one-third and saved 36% in sterilisation costs. If fabrication costs of single-use instruments are included by the company, the total cost is significantly diminished. There was no operative time advantage for single-use instrumentation.

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IMPORTANCE: The COVID-19 pandemic has resulted in a persistent shortage of personal protective equipment; therefore, a need exists for hospitals to reprocess filtering facepiece respirators (FFRs), such as N95 respirators. OBJECTIVE: To perform a systematic review to evaluate the evidence on effectiveness and feasibility of different processes used for decontaminating N95 respirators. EVIDENCE REVIEW: A search of PubMed and EMBASE (through January 31, 2021) was completed for 5 types of respirator-decontaminating processes including UV irradiation, vaporized hydrogen peroxide, moist-heat incubation, microwave-generated steam, and ethylene oxide. Data were abstracted on process method, pathogen removal, mask filtration efficiency, facial fit, user safety, and processing capability. FINDINGS: Forty-two studies were included that examined 65 total types of masks. All were laboratory studies (no clinical trials), and 2 evaluated respirator performance and fit with actual clinical use of N95 respirators. Twenty-seven evaluated UV germicidal irradiation, 19 vaporized hydrogen peroxide, 9 moist-heat incubation, 10 microwave-generated steam, and 7 ethylene oxide. Forty-three types of N95 respirators were treated with UV irradiation. Doses of 1 to 2 J/cm2 effectively sterilized most pathogens on N95 respirators (>103 reduction in influenza virus [4 studies], MS2 bacteriophage [3 studies], Bacillus spores [2 studies], Escherichia virus MS2 [1 study], vesicular stomatitis virus [1 study], and Middle East respiratory syndrome virus/SARS-CoV-1 [1 study]) without degrading respirator components. Doses higher than 1.5 to 2 J/cm2 may be needed based on 2 studies demonstrating greater than 103 reduction in SARS-CoV-2. Vaporized hydrogen peroxide eradicated the pathogen in all 7 efficacy studies (>104 reduction in SARS-CoV-2 [3 studies] and >106 reduction of Bacillus and Geobacillus stearothermophilus spores [4 studies]). Pressurized chamber systems with higher concentrations of hydrogen peroxide caused FFR damage (6 studies), while open-room systems did not degrade respirator components. Moist heat effectively reduced SARS-CoV-2 (2 studies), influenza virus by greater than 104 (2 studies), vesicular stomatitis virus (1 study), and Escherichia coli (1 study) and preserved filtration efficiency and facial fit for 11 N95 respirators using preheated containers/chambers at 60 °C to 85 °C (5 studies); however, diminished filtration performance was seen for the Caron incubator. Microwave-generated steam (1100-W to 1800-W devices; 40 seconds to 3 minutes) effectively reduced pathogens by greater than 103 (influenza virus [2 studies], MS2 bacteriophage [3 studies], and Staphylococcus aureus [1 study]) and maintained filtration performance in 10 N95 respirators; however, damage was noted in least 1 respirator type in 4 studies. In 6 studies, ethylene oxide preserved respirator components in 16 N95 respirator types but left residual carcinogenic by-product (1 study). CONCLUSIONS AND RELEVANCE: Ultraviolet germicidal irradiation, vaporized hydrogen peroxide, moist heat, and microwave-generated steam processing effectively sterilized N95 respirators and retained filtration performance. Ultraviolet irradiation and vaporized hydrogen peroxide damaged respirators the least. More research is needed on decontamination effectiveness for SARS-CoV-2 because few studies specifically examined this pathogen.

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OBJECTIVES: Recognize the avoidable costs incurred due to overpacking of rhinoplasty instrument trays. Reduce rhinoplasty instrument trays by including only instruments used frequently. Establish methods to reduce trays prepared for other otolaryngologic procedures. METHODS: This is a prospective study. The study evaluates the specific use of instruments opened for rhinoplasty procedures at the New York Eye & Ear Infirmary of Mount Sinai. Instruments were counted in 10 rhinoplasty cases. Usage rate was calculated for each instrument. Additionally, all instruments used in at least 20% of cases were noted. This "20%" threshold was used to create new rhinoplasty tray inventories more reflective of actual instrument usage. Some instruments above the 20% threshold were included in multiples (i.e. two Adson Brown forceps vs. one curved iris scissor). RESULTS: 189 instruments were opened, and 32 instruments were used on average in each rhinoplasty. 55 instruments were used in at least 20% of cases. The 55 "high usage" instruments were used to create new, reduced rhinoplasty tray inventory lists. Based on our analysis, a new rhinoplasty tray inventory was created comprised of 68 instruments, a 64% reduction from 189. CONCLUSION: Instruments are sterilized and packed in gross excess for rhinoplasty procedures. Previously published figures estimate re-sterilization costs of $0.51 to $0.77 per instrument. Reduction in instruments opened from 189 to 68 is expected to lead to cost savings ranging from $62 to $93 per case, yielding a savings between $6200 and $9300 per 100 cases performed. LEVEL OF EVIDENCE: II-3.

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BACKGROUND: Surgical procedures account for 50% of hospital revenue and ∼60% of operating costs. On average, <20% of surgical instruments will be used during a case, and the expense for resterilization and assembly of instrument trays ranges from $0.51 to $3.01 per instrument. Given the complexity of the surgical service supply chain, physician preferences, and variation of procedures, a reduction of surgical cost has been extremely difficult and often ill-defined. A data-driven approach to instrument tray optimization has implications for efficiency and cost savings in sterile processing, including reductions in tray assembly time and instrument repurchase, repair, and avoidable depreciation. METHODS: During a 3-month period, vascular surgery cases were monitored using a cloud-based technology product (OpFlow, Operative Flow Technologies, Raleigh, NC) as a part of a hospital-wide project. Given the diversity of the cases evaluated, we focused on two main vascular surgery trays: vascular and aortic. An assessment was performed to evaluate the exact instruments used by the operating surgeons across a variety of cases. The vascular tray contained 131 instruments and was used for the vast majority of vascular cases, and the aortic tray contained 152 instruments. Actual instrument usage data were collected, a review and analysis performed, and the trays optimized. RESULTS: During the 3-month period, 168 vascular surgery cases were evaluated across six surgeons. On average, the instrument usage per tray was 30 of 131 instruments (22.9%) for the vascular tray and 19 of 152 (12.5%) for the aortic tray. After review, 45.8% of the instruments were removed from the vascular tray and 62.5% from the aortic tray, for 1255 instruments removed from the versions of both trays. An audit was performed after the removal of instruments, which showed that none of the removed instruments had required reinstatement. The instrument reduction from these two trays alone yielded an estimated costs savings of $97,781 for repurchase and $97,444 in annual resterilization savings. Annually, the removal of the instruments is projected to save 316.2 hours of personnel time. The time required for operating room table setup decreased from a mean of 7:44 to 5:02 minutes for the vascular tray (P < .0001) and from 8:53 to 4:56 minutes for the aortic tray (P < .0001). CONCLUSIONS: Given increasing cost constraints in healthcare, sterile processing remains an untapped resource for surgical expense reduction. A comprehensive data analytics solution provided the ability to make informed decisions in tray management that otherwise could not be reliably performed.

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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.

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Surgical site infections (SSIs) in developing countries have been linked to inadequate availability of sterilising equipment. Existing autoclaves are mostly unaffordable by rural healthcare practitioners, and when they managed to procure them, the electricity supply to power the autoclaves is epileptic. The solar-powered autoclave alternatives are too bulky with a very high initial cost. Hence, low-cost biofuel-powered autoclave becomes an attractive option, and this study sought to present the design, development and clinical evaluation of the device performance. With the global drive for the adoption of green energy, biofuel will not only reduce greenhouse gas emission but also provide revenue for local producers and reduce biomass associated health complications. The theoretical energy requirement for the sterilisation process was calculated. The standard pressure and temperature needed for sterilisation were tested to be 121 °C and 15 psi. The device was also clinically tested with Staphylococcus aureus bacteria obtained from the Department of Medical Microbiology and Parasitology, University of Ilorin Teaching Hospital using Brain heart Infusion Broth, MacConkey and Blood agar as cultured media. No bacteria growth was observed when the samples containing the bacteria colony were autoclaved by the designed autoclave and incubated at 37 °C for 2 d. Hence, the device met the mechanical and biological validation standards for effective sterilisation.

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BACKGROUND: Healthcare systems in the United States have increasingly turned toward the use of disposable medical equipment in an attempt to save time, lower costs, and reduce the transmission of infections. However, the use of disposable instruments is associated with increased solid waste production and may have negative impacts on the environment, such as increased greenhouse gas emissions. OBJECTIVE: The purpose of this study was to inform this discussion; we applied life cycle assessment methods to evaluate the carbon footprints of 3 vaginal specula: a single-use acrylic model and 2 reusable stainless steel models. STUDY DESIGN: The functional unit of the study was defined as the completion of 20 gynecologic examinations by either type of speculum. The greenhouse gas emissions (eg, carbon dioxide, methane, nitrous oxide) across all life cycle stages, which includes material production and manufacturing, transportation, use and reprocessing, and end-of-life, were analyzed with the use of SimaPro life cycle assessment software and converted into carbon dioxide equivalents. RESULTS: The reusable stainless steel grade 304 speculum was found to have a lesser carbon footprint over multiple model scenarios (different reprocessing techniques, autoclave loading/efficiency, and number of uses) than either the reusable stainless steel grade 316 or the disposable acrylic specula. The material production and manufacturing phase contributed most heavily to the total life cycle carbon footprint of the acrylic speculum, whereas the use and reprocessing phase contributed most to the carbon footprints of both stainless steel specula. CONCLUSION: The use of disposable vaginal specula is associated with increased greenhouse gas equivalents compared with reusable alternatives with no significant difference in clinical utility. These findings can be used to inform decision-making by healthcare systems, because they weigh a wide range of considerations in making final purchase decisions; similar analytic methods can and should be applied to other components of health systems' waste streams.

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Over the last decade, studies have compared the use of sterile gloves (SGs) versus nonsterile gloves (NSGs) on surgical site infection (SSI) rates in Mohs micrographic surgery (MMS). In this study, we sought to determine SSI rates before and after employment of NSGs for dermatologic procedures. Infection data were collected from January 2009 to December 2015 on 7365 tumors treated with MMS and 1620 tumors treated by surgical excision. For MMS procedures using chlorhexidine as the antiseptic, the SSI rate with SGs was 3.39% compared to 3.06% with NSGs. For surgical excisions, the SSI rate was 3.02% with SGs and 4.17% with NSG. Using NSGs for MMS tumor resection and reconstruction can provide cost savings without adversely affecting SSI rates, and could also be considered in dermatologic procedures, including electrodessication and curettage and surgical excisions.

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PURPOSE: Healthcare facilities could minimize the cost of surgical instrument and implant processing by using single-use devices. The main objective was to prospectively compare the total cost of a single-use and reusable device used in short lumbar spine fusion. METHODS: A 1-year, single-centre, prospective study was performed on patients requiring a one- or two-level lumbar arthrodesis. Patients were randomized in two groups treated with either reusable or single-use device. A cost minimization analysis was performed using a micro-costing approach from a hospital perspective. Every step of the preparation process was timed and costed based on hourly wages of hospital employees, cleaning supplies and hospital waste costs. RESULTS: Forty cases were evaluated. No significant difference in operation time was noted (reusable 176.1 ± 68.4 min; single use 190.4 ± 71.7 min; p = 0.569). Mean processing time for single-use devices was lower than for reusable devices (33 min vs. 176 min) representing a cost of 14€ versus 58€ (p < 0.05). Pre-/post-sterilization and spinal set recomposing steps were the most time-consuming in reusable device group. A total cost saving of 181€ per intervention resulted from the use and processing of the single-use device considering an additional sterilization cost of 137€ with the reusable device. The weight of the reusable device was 42 kg for three containers and 1.2 kg for the single-use device. CONCLUSIONS: Owing to the absence of re-sterilization, single-use devices in one- and two-level lumbar fusion allow significant money and time savings. They may also avoid delaying surgery in case of reusable device unavailability.

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Background: The efficacy of widely used povidone-iodine applicators for skin sterilization in abdominal surgery is unclear. The aim of this trial was to evaluate whether sterilization with a povidone-iodine applicator was not inferior to a conventional sterilization method. Methods: Patients undergoing elective abdominal surgery were assigned randomly to receive single sterilization with the applicator or conventional sterilization. The primary endpoint was wound infection rate. Secondary endpoints were rate of organ/space surgical-site infection (SSI), adverse effects of povidone-iodine, amount of povidone-iodine used and total cost of sterilization. Results: Of 498 patients eligible for the study between April 2015 and September 2017, 240 were assigned and analysed in the applicator group and 246 in the conventional group. Wound infection was detected in 16 patients (6·7 per cent) in the applicator group and 16 (6·5 per cent) in the conventional group (absolute difference 0·0016 (90 per cent c.i. -0·037 to 0·040) per cent; P = 0·014 for non-inferiority). There was no difference between the groups in the organ/space SSI rate (11 patients (4·6 per cent) in the applicator group and 16 (6·5 per cent) in the conventional group. Both the amount of povidone-iodine used and the total cost of sterilization were higher in the conventional group than in the applicator group (median 76·7 versus 25 ml respectively, P < 0·001; median €7·0 versus €6·4, P < 0·001). Skin irritation was detected in three patients in the conventional group. Conclusion: In abdominal surgery, this povidone-iodine applicator was not inferior to conventional sterilization in terms of the wound infection rate, and it is cheaper. Registration number: UMIN000018231 (http://www.umin.ac.jp/ctr/).

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Subcontracting our institution's sterilization activity induced the implementation of an automated cleaning facility. Following this development, some of the resterilizable stainless steel needle holders started to show abnormal corrosion. Our study goal was to investigate the causes of this corrosion in order to optimize the sterilization circuit. A full sterilization process mapping and Ishikawa diagram enabled us to identify potential causes of corrosion. The needle holders' intrinsic characteristics, like steel quality and manufacturing, were analyzed as well as extrinsic factors such as the influence of preprocessing soaking conditions, steel passivation, water quality and the impact of corrosion inhibitors. Each potential factor of corrosion was tested in real conditions on needle holders' kits. The needle holders steel grade complies with medical standards and the tests showed that passivation and pre-processing conditions were not involved in the occurrence of corrosion, contrary to soaking length and use of softened rinsing water, containing more chloride than reverse osmosis water, and, thus conducive to rust formation. Moreover, corrosion inhibitors were deemed ineffective or incompatible. Due to this analysis, the incidence of corrosion was reduced by switching softened water to osmosis water and by introducing dynamic drying in the automated cleaning process. In addition, this work stresses the importance of minimizing waiting times and auditing the sterilization circuit before any subcontracting. Management Guidelines related to sterilization's outsourcing would probably have helped to limit this episode.

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Given the complexity of the sterilization process, and the risk involved in absence of strict adherence to the protocol described by the medical device manufacturers, terminally sterilized devices are emerging and being promoted in the field of medical practices. The characteristics associated with conventional reprocessing are demanding logistics, costs of delay, operations and adverse events, and unacceptable liability. Demanding logistics were a result of decoupled staff between the operating room and sterilize processing department, understaffed and high-volume processing with an additional burden due to inventory management and inefficient training. Other costs arose from upkeep, delay in operating room, and surgical-site infections. Liability arose from the repeatedly use of an unquantifiable process thus adding uncertainties, limited shelf life of the reprocessed implants, contingency of flash sterilization and introduction of newer technology with higher demand on cleaning performances. In contrast, terminally sterilized single-use devices do not carry any of the aforementioned-characteristics, deeming it to be the simplest solution to the current conundrum. This review serves to provide an evaluation of logistics, costs, and potential adverse effects, both directly and indirectly, associated with current practices in the sterile processing department, and also describes as to how the use of terminally sterilized devices can help circumvent those.

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A implantação da CME centralizada na Atenção Primária mostrou-se uma alternativa para adequação do serviço de esterilização a legislação vigente. Com base nos resultados do presente estudo, assumimos a proposição de indicação da centralização do serviço de esterilização para todas as unidades de saúde que necessitem de reprocessamento de artigos enquanto uma medida de qualidade e segurança bem como investimento nas questões que precisam de avanço e implementação nas unidades básicas de saúde

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BACKGROUND: We analyzed the results of routine sterility testing performed in our center over the last 10 years, in the context both hematopoietic stem cell transplantation (HSCT) and Advanced Therapeutic Medicinal Products (ATMPs). METHODS: For sterility tests 14-day cultures were performed in culture media detecting aerobic and anaerobic microorganisms. RESULTS: In this study, 22/1643 (1.3%) of apheretic products for autologous or allogeneic HSCT were contaminated, whereas 14/73 bone marrow (BM) harvests (17.8%) were positive. In 22 cases, the contaminated HSCs were infused to patients, but there was no evidence of any adverse impact of contamination on the hematologic engraftment or on infections. Indeed none of the five positive hemocultures detected in patients following infusion could be linked to the contaminated stem cell product. Our Cell Factory also generated 286 ATMPs in good manufacturing practice (GMP) conditions since 2007 and all final products were sterile. In three cases of mesenchymal stromal cell expansions, the starting BM harvests were contaminated, but the cell products at the end of expansion were sterile, presumably thanks to the presence of an antibiotic in the culture medium. DISCUSSION: The decreased rate of contamination of cell harvests observed with time suggests that routine sterility testing and communication of the results to the collecting centers may improve clinical practices. Furthermore, we recommend the use of antibiotics in the medium for ATMP expansion, to decrease the likelihood of expanding microorganisms within clean rooms. Finally we discuss the costs of sterility testing of ATMPs by GMP-approved external laboratories.

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In 2016, NL's largest RHA was faced with serious challenges stemming from the discovery of stained surgical instruments at its two largest hospitals. This discovery prompted a series of postponed surgeries, an extensive internal mobilization of labour and the purchase of millions of dollars of new equipment. In tackling these challenges, the organization not only acquired a better understanding of its surgical tools, but it also gained renewed appreciation for the resilience of its human resources. By describing this incident and the lessons learned, we hope to offer insight to providers in similar circumstances.

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