Search

Objective: To construct and validate an instrument to assess events related to maintaining the sterility of processed healthcare products., Methods: This methodological study developed the instrument through analysis by a panel of experts, focusing on the integrity of commonly used packaging: spunbond-meltblown-spunbond and medical-grade paper. The instrument was analyzed using the Content Validity Index and Content Validity Ratio (≥ 0.80) and modified Kappa (≥ 0.74). The instrument underwent pre-testing., Results: Six experienced professionals participated in the expert panel. After two rounds, the final version of the instrument contained five dimensions. In the pre-test, 30 nursing professionals participated, of whom 86.67% considered the instrument good, and 90% found it understandable., Conclusion: The construction and validation followed literature recommendations. The instrument is available, aiding in the safe use of processed healthcare products.

Introduction: Point of use (POU) treatment is a critical first step of medical device reprocessing. Reusable instruments and flexible endoscopes require a minimum of terminal sterilization or high-level disinfection, neither of which can be guaranteed if POU is performed incorrectly. Compliance considerations for POU include hospital accreditation readiness, unique austere surgical mission requirements, and the transition of future conflict towards Large Scale Combat Operations. This integrative review aims to describe POU for reusable instruments and endoscopes, and extrapolate implications for Military Health System policies and future considerations., Materials and Methods: The authors performed an integrative review and comprehensive literature search in PubMed and CINAHL with the keywords "point of use," "point of use cleaning," "POU," "instrument," "high-level disinfection," "endoscope," and "clean." Articles were limited to "English" and "human" from 2017 to 2023. The authors also performed a thorough review of the Defense Health Agency and service-specific doctrine, as well as national guidelines regarding POU adherence., Results: The literature review yielded 18 articles that discussed the transport and reprocessing of reusable medical devices. Regulatory standards and national guidelines were used to supplement the literature. Seventeen evidence-based criteria were extrapolated from the literature to generate two step-by-step guides for the POU treatment of endoscopes and reusable instruments (Tables I and II). Despite increased morbidity and mortality rates linked to inadequate device reprocessing, compliance with POU procedures remains low. Barriers to practice included complex POU processes, intricately designed surgical instruments and endoscopes, lack of healthcare worker (HCW) knowledge and competency, and inadequate or ambiguously written policies. Training, competency assessments, and clearly written policies and procedures can be cost-effective, evidence-based, and feasible solutions., Conclusion: Completing POU treatment is critical to a successful surgical mission in both the hospital and austere environment. Implications to practice include implementing evidence-based POU programs that improve patient outcomes and readiness while decreasing costs., (© The Association of Military Surgeons of the United States 2024. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site–for further information please contact journals.permissions@oup.com.)

Background: In daily inspection, the nonstandard management of sterile articles in clinical departments of hospitals often leads to the destruction of the sterilization effectiveness of sterile articles. Therefore, it is necessary to strengthen governance and improve this phenomenon. This study intends to investigate the mode in which the disinfection supply center participates in the supervision and management of the management of sterile items in clinical departments. It played a role in improving the standardization of the management of sterile articles in clinical departments and ensured the closed-loop management of the sterilization effectiveness of sterile articles., Methods: Every quarter, the disinfection supply center of our hospital will inspect the standardized management of sterile articles in all clinical departments of the hospital, mainly including the storage environment and facilities of sterile articles, the cleanliness of storage cabinets, placement principles, whether they are stored by category, and the quality and validity management of sterile articles. The quarterly inspection results were summarized and analyzed to find the existing problems and the causes. The disinfection supply center shall supervise the improvement. After the disinfection supply center inspected the standardized management of sterile articles in all clinical departments of the hospital for the first time according to the inspection contents, under the guidance and assistance of the nursing department and the hospital infection department, it improved the sterile article management system, conducted knowledge training for the whole hospital, and incorporated the standardized management of clinical sterile articles into the quality control inspection of the nursing department. In the later stage, the disinfection supply center is responsible for conducting routine inspection and supervision on the standardized management of sterile articles in all clinical departments of the hospital every quarter according to the inspection contents, including summarizing, analyzing, and urging the clinical departments to achieve the improvement of the management of sterile articles in clinical departments., Results: The standardization of aseptic articles after improvement was significantly higher than before and during improvement, and the qualified rate was significantly different (99.4% vs 97.9% vs 89.5%, P < 0.05). The average number of lost packages caused by nonstandard management in the department was significantly reduced. The average rate of lost sterile packages during and after the improvement was significantly lower than that before the improvement (10.5% vs 97.9% vs 89.5%, P < 0.05). It also effectively reduced the cost caused by the loss of sterile packages., Conclusion: The disinfection supply center participates in the quality control and management of sterile articles in the nursing department and regularly inspects and supervises the management of sterile articles in clinical departments. It can effectively improve the standardized management of sterile articles in clinical departments, ensure the safety of sterile articles, and form a closed loop of sterilization effectiveness., Competing Interests: The authors declare that there are no conflicts of interest regarding the publication of this paper., (Copyright © 2022 Jia Ying et al.)

Background: Face masks, also referred to as half masks, are essential to protect healthcare professionals working in close contact with patients with COVID-19-related symptoms. Because of the Corona material shortages, healthcare institutions sought an approach to reuse face masks or to purchase new, imported masks. The filter quality of these masks remained unclear. Therefore, the aim of this study was to assess the quality of sterilized and imported FFP2/KN95 face masks., Methods: A 48-minute steam sterilization process of single-use FFP2/KN95 face masks with a 15 minute holding time at 121°C was developed, validated and implemented in the Central Sterilization Departments (CSSD) of 19 different hospitals. Masks sterilized by steam and H2O2 plasma as well as new, imported masks were tested for particle filtration efficiency (PFE) and pressure drop in a custom-made test setup., Results: The results of 84 masks tested on the PFE dry particle test setup showed differences of 2.3±2% (mean±SD). Test data showed that the mean PFE values of 444 sterilized FFP2 face masks from the 19 CSSDs were 90±11% (mean±SD), and those of 474 new, imported KN95/FFP2 face masks were 83±16% (mean±SD). Differences in PFE of masks received from different sterilization departments were found., Conclusion: Face masks can be reprocessed with 121 °C steam or H2O2 plasma sterilization with a minimal reduction in PFE. PFE comparison between filter material of sterilized masks and new, imported masks indicates that the filter material of most reprocessed masks of high quality brands can outperform new, imported face masks of unknown brands. Although the PFE of tested face masks from different sterilization departments remained efficient, using different types of sterilization equipment, can result in different PFE outcomes., Competing Interests: The authors have declared that no competing interests exist.

In Tunisia, Hospital sterilization guidelines recommend the establishment of a quality assurance system. The purpose of this study is to give an overview of the situation in a sterilization unit in order to assess the adherence to good practice criteria and to identify opportunities for improvement. We conducted a prospective study in the sterilization unit of the Hospital Tahar Sfar, Mahdia in 2019. Two internal audits were conducted under the same conditions and were carried out one year apart. The first audit identified failures and malfunctions and the outlining of an action plan. The impact of the measures undertaken was tested using a second audit. Data collection was carried out by direct observation of the existing resources and practices. Compliance rate was calculated taking into account compliant criteria and applicable criteria. The results of the first audit revealed a compliance rate of around 28.1%. The analysis used to observe deviations made it possible to identify 5 axes of improvement, in particular the implementation of a system of documentation and a quality management system. In total, we prepared 14 documents related to the managerial processes, 26 to the operational processes and 41 to the support processes. The actions put in place enabled to achieve a compliance rate of 60.4%. The approach taken to upgrade sterilization processes made it possible to standardize them while ensuring traceability., Competing Interests: Les auteurs ne déclarent aucun conflit d´intérêts., (Copyright: Mohamed Hedi Ben Cheikh et al.)

The sterility assurance community is facing significant challenges. A relatively recent challenge is the pressure on manufacturing supply chains resulting from the limited availability of capacity for terminal sterilization of healthcare products. The current challenge is finding solutions for innovative new products, especially biologics and combination products, that offer great promise for patients around the world. This challenge will become more prevalent in the future as products advance. This article frames new paradigms and tools being developed to address these challenges. Foundational principles and current realities from each sector are reviewed so that sterility assurance professionals have a solid base from which to build strategies., Competing Interests: TB was employed by company BryKor, LLC. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Lambert, Hansen, Bryans and Lam.)

Over the past few years, a large number of clinical studies for advanced therapy medicinal products have been registered and/or conducted for treating various diseases around the world and many have generated very exciting outcomes. Media fill, the validation of the aseptic manufacturing process, is the simulation of medicinal product manufacturing using nutrient media. The purpose of this study is to explain the media fill procedure stepwise in the context of cellular therapy medicinal products. The aseptic preparation of patient individual cellular product is simulated by using tryptic soy broth as the growth medium, and sterile vials as primary packaging materials.

Objectives: Non-traditional materials are used for mask construction to address personal protective equipment shortages during the coronavirus disease 2019 (COVID-19) pandemic. Reusable masks made from surgical sterilization wrap represent such an innovative approach with social media frequently referring to them as "N95 alternatives." This material was tested for particle filtration efficiency and breathability to clarify what role they might have in infection prevention and control., Methods: A heavyweight, double layer sterilization wrap was tested when new and after 2, 4, 6, and 10 autoclave sterilizing cycles and compared with an approved N95 respirator and a surgical mask via testing procedures using a sodium chloride aerosol for N95 efficiency testing similar to 42 CFR 84.181. Pressure testing to indicate breathability was also conducted., Results: The particle filtration efficiency for the sterilization wrap ranged between 58% to 66%, with similar performance when new and after sterilizing cycles. The N95 respirator and surgical mask performed at 95% and 68% respectively. Pressure drops for the sterilization wrap, N95 and surgical mask were 10.4 mmH2O, 5.9 mmH2O, and 5.1 mmH2O, respectively, well below the National Institute for Occupational Safety and Health limits of 35 mmH2O during initial inhalation and 25 mmH2O during initial exhalation., Conclusions: The sterilization wrap's particle filtration efficiency is much lower than a N95 respirator, but falls within the range of a surgical mask, with acceptable breathability. Performance testing of non-traditional mask materials is crucial to determine potential protection efficacy and for correcting misinterpretation propagated through popular media.

We aimed to understand the evaluation of different Bowie-Dick test (B-D test) on the performance of pressure steam sterilization equipment in the case of simulated gas leakage, and we selected a pulsating vacuum steam sterilizer to set 4 different gas leakage levels: 1.1, 1.3, 1.5, and 1.7 mbar/min during the B-D test phase. In terms of methods, 4 different brands of B-D test kits (devices) were tested at 4 different leakage rates, and a total of 48 experiments were conducted. The results from univariate analysis revealed that there are statistically significant differences in the judgment of test results among different personnel and brands. The results from multivariate logistic regression analysis displayed that the difference between different personnel was statistically significant (χ = 45.34, P < .001); the difference between different products was statistically significant (χ = 129.37, P < .001); and there was no statistically significant difference between different degree of leakage (χ = 6.99, P > .05). Result judgments of brand 1 and brand 2 are susceptible to subjective factors. The judgment of brand 3 is intuitive and consistent with the evaluation result of brand 4. In conclusion, the order of capacity to evaluate air leakage from best to worst is brand 4→brand 3→brand 1→brand 2.

Importance: Procuring respiratory protection for clinicians and other health care workers has become a major challenge of the coronavirus disease 2019 (COVID-19) pandemic and has resulted in nonstandard practices such as the use of expired respirators and various decontamination processes to prolong the useful life of respirators in health care settings. In addition, imported, non-National Institute for Occupational Safety and Health (NIOSH)-approved respirators have been donated or acquired by hospitals as a potential replacement for limited NIOSH-approved N95 respirators., Objective: To assess fitted filtration efficiencies (FFEs) for face mask alternatives used during the COVID-19 pandemic., Design, Setting, and Participants: For this quality-improvement study conducted between April and June 2020, we used the Occupational Safety and Health Administration's Quantitative Fit Testing Protocol for Filtering Facepiece Respirators in a laboratory atmosphere supplemented with sodium chloride particles to assess the FFEs of a variety of respirators worn by a male volunteer and female volunteer., Main Outcomes and Measures: The FFEs of respirators commonly worn by clinicians and other health care workers and available respirator alternatives during the COVID-19 pandemic., Results: Of the 29 different fitted face mask alternatives tested on 1 man and 1 woman, expired N95 respirators with intact elastic straps and respirators subjected to ethylene oxide and hydrogen peroxide sterilization had unchanged FFE (>95%). The performance of N95 respirators in the wrong size had slightly decreased performance (90%-95% FFE). All of the respirators not listed as approved in this evaluation (n = 6) failed to achieve 95% FFE. Neither of the 2 imported respirators authorized for use by the Centers for Disease Control and Prevention that were not NIOSH-approved tested in this study achieved 95% FFE, and the more effective of the 2 functioned at approximately 80% FFE. Surgical and procedural face masks had filtering performance that was lower relative to that of N95 respirators (98.5% overall FFE), with procedural face masks secured with elastic ear loops showing the lowest efficiency (38.1% overall FFE)., Conclusions and Relevance: This quality-improvement study evaluating 29 face mask alternatives for use by clinicians interacting with patients during the COVID-19 pandemic found that expired N95 respirators and sterilized, used N95 respirators can be used when new N95 respirators are not available. Other alternatives may provide less effective filtration.

Industrial sterilization of packaging and filling machineries by peracetic acid (PAA) is a widespread practice. In our study we assessed the resistance to PAA of three ascospore-forming molds (Chaetomium globosum ATCC 6205; Talaromyces bacillisporus SSICA 10915; Aspergillus hiratsukae SSICA 3913) compared to that of Aspergillus brasiliensis ATCC 16404 and Bacillus atrophaeus DSM 675, that are currently used as test microorganisms during industrial bio-validations of food packaging and machineries. Tests were carried out at 40 °C using 1,000 mg/l of PAA, with or without a supporting material (aluminium, tin-plate, PET). At all conditions tested, a greater resistance to PAA was registered for C. globosum, followed by T. bacillisporus, A. hiratsukae, A. brasiliensis and B. atrophaeus. D-values of C. globosum varied from 23 to 68 min, whereas T. bacillisporus showed D-values from 83 to 352 s and A. hiratsukae showed D-values from 32 to 65 s. Surprisingly, both test microorganisms (A. brasiliensis and B. atrophaeus) proved less resistant than ascospore-forming molds tested, their D-values being always lower than 30 s. Cells treated without a supporting material proved more resistant than those deposited on plastic or metallic strips, with the exception of tin-plate, where results approaching those obtained without a supporting materials were obtained. Based on the results obtained in this paper, test microorganisms currently used for bio-validations in industrial plants and also heat-resistant strains proved sensibly less resistant to PAA than C. globosum. Therefore, for practical purposes C. globosum should be furtherly studied to understand if its use during bio-validations of sanitizing processes could lead to more performing results., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Objective: To establish reuse process of positive pressure powered air-filter protective hoods during coronavirus disease 2019 (COVID-19) epidemic., Methods: The procedure of pretreatment, storage, recovery, cleaning, disinfection and sterilization process of positive pressure powered air-filter protective hoods, which were used in the treatment of COVID-19 infection patients was established in Central Sterile Supply Department of the hospital. The cleaning and disinfection effects of the protective hoods after treatment were examined by magnifying glass method, residual protein detection method, real-time PCR, and agar pour plate method., Results: Twenty five used protective hoods underwent totally 135 times of washing, disinfecting and sterilizing procedures. After washing, all the protein residue tests and COVID-19 nucleic acid tests showed negative results. After sterilizing, all the protective hoods met sterility requirement. All the tested protective hoods were undamaged after reprocessing., Conclusions: The established reuse procedures for used positive pressure powered air-filter protective hoods are safe.

Background: Reusable medical devices in healthcare facilities are decontaminated and reprocessed following standard practices before each clinical procedure. Reprocessing of critical medical devices (those used for invasive clinical procedures) comprises several processes including sterilization, which provides the highest level of decontamination. Steam sterilization is the most used sterilization procedure across the globe. Noncompliance with standards addressing reprocessing of medical devices may lead to inadequate sterilization and thus increase the risk of person-to-person or environmental transmission of pathogens in healthcare facilities. We conducted nationwide multicenter clustered audits to understand the compliance of primary- and secondary-care public hospitals in Nepal with the standard practices for medical device reprocessing, including steam sterilization., Methods: We developed an audit tool to assess compliance of hospitals with the standard practices for medical device reprocessing including steam sterilization. Altogether, 189 medical device reprocessing cycles which included steam sterilization were assessed in 13 primary and secondary care public hospitals in Nepal using the audit tool. Percentage compliance was calculated for each standard practice. Mean percentage compliances were obtained for overall primary and secondary care hospitals and for each hospital type, specific hospital and process involved., Results: For all primary and secondary care hospitals in Nepal, the mean percentage compliance with the standard practices for medical device reprocessing including steam sterilization was 25.9% (95% CI 21.0-30.8%). The lower the level of care provided by the hospitals, the lower was the mean percentage compliance, and the difference in the means across the hospital types was statistically significant (p < 0.01). The mean percentage compliance of individual hospitals ranged from 14.7 to 46.0%. The hospitals had better compliance with the practices for cleaning of used devices and transport and storage of sterilized devices compared with the practices for other processes of the medical device reprocessing cycle., Conclusion: The primary and secondary care hospitals in Nepal had poor compliance with the standard practices for steam sterilization and reprocessing of medical devices. Interventions to improve compliance of the hospitals are immediately required to minimize the risks of person-to-person or environmental transmission of pathogens through inadequately reprocessed medical devices.

SARS-CoV-2, and several other microorganisms, may be present in nasopharyngeal and salivary secretions in patients treated in dental practices, so an appropriate clinical behavior is required in order to avoid the dangerous spread of infections. COVID-19 could also be spread when patients touches a contaminated surface with infected droplets and then touch their nose, mouth, or eyes. It is time to consider a dental practice quite similar to a hospital surgery room, where particular attention should be addressed to problems related to the spreading of infections due to air and surface contamination. The effectiveness of conventional cleaning and disinfection procedures may be limited by several factors; first of all, human operator dependence seems to be the weak aspect of all procedures. The improvement of these conventional methods requires the modification of human behavior, which is difficult to achieve and sustain. As alternative sterilization methods, there are some that do not depend on the operator, because they are based on devices that perform the entire procedure on their own, with minimal human intervention. In conclusion, continued efforts to improve the traditional manual disinfection of surfaces are needed, so dentists should consider combining the use of proper disinfectants and no-touch decontamination technologies to improve sterilization procedures.

Background: An exceptionally high demand for surgical masks and N95 filtering facepiece respirators (FFRs) during the COVID-19 pandemic has considerably exceeded their supply. These disposable devices are generally not approved for routine decontamination and re-use as a standard of care, while this practice has widely occurred in hospitals. The US Centers for Disease Control and Prevention allowed it "as a crisis capacity strategy". However, limited testing was conducted on the impact of specific decontamination methods on the performance of N95 FFRs and no data was presented for surgical masks., Aim: We evaluated common surgical masks and N95 respirators with respect to the changes in their performance and integrity resulting from autoclave sterilization and a 70% ethanol treatment; these methods are frequently utilized for re-used filtering facepieces in hospitals., Methods: The filter collection efficiency and pressure drop were determined for unused masks and N95 FFRs, and for those subjected to the treatments in a variety of ways. The collection efficiency was measured for particles of approximately 0.037-3.2 μm to represent aerosolized single viruses, their agglomerates, bacteria and larger particle carriers., Findings: The initial collection efficiency and the filter breathability may be compromised by sterilization in an autoclave and ethanol treatment. The effect depends on a protective device, particle size, breathing flow rate, type of treatment and other factors. Additionally, physical damages were observed in N95 respirators after autoclaving., Conclusion: Strategies advocating decontamination and re-use of filtering facepieces in hospitals should be re-assessed considering the data obtained in this study., (Copyright © 2020 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.)

While the soil microbiome may influence pathogen survival, determining the major contributors that reduce pathogen survival is inconclusive. This research was performed to determine the survival of E. coli O157 in autoclaved and natural (unautoclaved) sandy soils. Soils were inoculated with three different E. coli O157 strains (stx1+/stx2+, stx1-/stx2-, and stx1-/stx2+), and enumerated until extinction at 30°C. There was a significant difference in the survival of E. coli O157 based on soil treatment (autoclaved versus natural) at 30°C on days 1 (P = 0.00022), 3, (P = 2.53e-14), 7 (P = 5.59e-16), 14 (P = 1.072e-12), 30 (P = 7.18e-9), and 56 (P = 0.00029), with greater survival in autoclaved soils. The time to extinction (two consecutive negative enrichments) for all three strains was 169 and 84 days for autoclaved and natural soils, respectively. A separate E. coli O157 trial supplemented with 16S rRNA gene sequencing of the soil microbiome was performed at 15°C and 30°C on days 0, 7, 14, and 28 for each soil treatment. Greater species richness (Chao1, P = 2.2e-16) and diversity (Shannon, P = 2.2e-16) was observed in natural soils in comparison with autoclaved soils. Weighted UniFrac (beta-diversity) showed a clear distinction between soil treatments (P = 0.001). The greatest reduction of E. coli O157 was observed in natural soils at 30°C, and several bacterial taxa positively correlated (relative abundance) with time (day 0 to 28) in these soils (P < 0.05), suggesting that the presence of those bacteria might cause the reduction of E. coli O157. Taken together, a clear distinction in E. coli O157 survival, was observed between autoclaved and natural soils along with corresponding differences in microbial diversity in soil treatments. This research provides further insights into the bacterial taxa that may influence E. coli O157 in soils., Competing Interests: The authors have declared that no competing interests exist.

In manufacture of heat labile sterile drug products, the final step involves filtration through sterilizing grade filters. It is the drug manufacturer's responsibility to check whether an integral filter has been used. One method used widely to check the integrity of a filter is the bubble point test. To confirm that the filter used is integral, the postuse integrity test is made obligatory by regulatory bodies. However, preuse/poststerilization integrity testing (PUPSIT) of filters remains debatable for the risks associated in its execution. Although PUPSIT is recommended by regulatory bodies, it poses a risk of compromising downstream sterility and involves high costs to mitigate such risks. This study highlights the impact of filter clogging on bubble point values with the consequent possibility of a nonintegral filter passing postuse integrity testing. The results clearly show an increase in postuse bubble point values, which can camouflage a possible flaw in sterilizing filters. The fluid streams 20% dextrose, 0.001% bentonite, paclitaxel, and 0.05% sodium hyaluronate were selected based not only on the commonality of their clogging propensity but also on the different nature of streams that influence the clogging of sterilizing filters. Paclitaxel is an injectable for oncotherapy, and 0.05% sodium hyaluronate is an ophthalmic. The study was conducted with 0.2 μm sterilizing filters from four different manufacturers. It was observed that some fluid streams show a significant increase in the postuse bubble point test values over the preuse bubble point values. This establishes the necessity of performing PUPSIT in certain cases based on the postfiltration shift in bubble point values. As part of the filter validation studies with specific drug products, additional testing should be carried out to establish the need for PUPSIT on a case-by-case basis., (© PDA, Inc. 2020.)

Eye drops are sterile preparations intended for instillation into the eye. All major pharmacopoeias require these products to pass the antimicrobial effectiveness test (AET). This test is similar to that used for an oral dosage form despite the fact that both product categories differ in their microbiological specifications. The eye drops might pass the official requirements of the AET, but in practice, contaminants introduced into the preparation might not be killed before its next use by the patient and this may compromise ocular health. The objective of this work was to investigate the possible application of a limited sterility testing in a multichallenge test that mimics more closely real life use of eye drops. The AET was performed on 12 brands of eye drops, and results were compared with the suggested pass criteria of various pharmacopoeias. The multichallenge test was designed and used to demonstrate the ability of each tested product to kill the entire challenge organism population within a few hours. The results demonstrated that all products investigated complied with the AET acceptance requirements of the USP <51> and the "B" criteria of the European Pharmacopoeia (Ph Eur) <5.1.3>. Only two of the tested products did not comply with the no recovery term of Ph Eur <5.1.3> "A" criteria. Products repeatedly challenged with Pseudomonas aeruginosa ATCC 9027 (103 CFU/mL) were found to be self-sterilizing within 2 h of each inoculation. In conclusion, all tested products passed the acceptance criteria of the USP <51>, class B of the Ph Eur <5.1.3>, and the multichallenge test. The size of the challenge organism population in the AET seems to be severe for eye drops, and the pass criteria of the British Pharmacopoeia Appendix XVI are the most stringent. The no recovery term given in the Ph Eur <5.1.3> should be defined to a specified range., (© PDA, Inc. 2020.)

Introduction: The sterilization of surgical drapes plays an important role in preventing infections associated with treatments. At the CNHU-HKM, sterilization procedure for drapes encounters problems. The purpose of this study was to examine the factors associated with the quality of sterilization of surgical drapes at the CNHU-HKM., Methods: We conducted a cross-sectional, descriptive and analytical study focusing on 20 sterile surgical drapes, 41 agents were involved in the management of drapes and 55 members of the surgical team. The probabilistic method was used for sterile surgical drapes, the non-probabilistic method for the others. Pearson's Chi-square Test and logistic regression were used to find the association, with a significant threshold and a p<0.05., Results: Eighty six point forty six percent of subjects were males with an average age of 42 years. The quality of the process of sterilization of the operative drapes was not good in the two departments responsible for processing the drapes. Bacteriological analysis showed that, out of 20 sterile surgical drapes, 9 had Acinetobacter spp. a multidrug-resistant germ causing nosocomial infections. Multivariate analysis showed that professional experience (p=0.015) and quality control of the procedure (p=0.034) were statistically associated with the quality of sterilization., Conclusion: The presence of Acinetobacter spp. on the sterilized drapes demonstrates that sterilization of drapes at the CNHU-HKM is of poor quality. Measures strengthening the skills of providers are necessary to improve the quality of sterilization procedures., Competing Interests: Les auteurs ne déclarent aucun conflit d’intérêts., (© Comlan Cyriaque Dégbey et al.)

Steam sterilization is widely used across the healthcare industry and is the most documented and standardized sterilization method. Despite its broad application, there is considerable confusion regarding the different process control considerations and sterilizer designs necessary for its successful use. The methods and equipment used for porous loads (equipment, components, and tools) are established to address air removal and steam penetration as these are critical to process efficacy. Sterilizing processes and equipment for non-porous loads (sealed aqueous containers) seek to minimize variations across the load and minimize the potential for under- or over-processing of portions of the load. These distinctions are not always evident in publications. The United States Pharmacopeia content brought attention to these differences in General Chapter <1229.1> Sterilization by Direct Contact and General Chapter <1229.2> Moist Heat Sterilization of Aqueous Liquids. This publication provides expanded content beyond that found in USP in a side-by-side comparison of the process considerations and equipment design details. It also reviews sterilization practices in laboratory, formulation, and biowaste sterilization applications, which often require the simultaneous sterilization of porous and non-porous items., (© PDA, Inc. 2020.)

Background: Inadequate training of health care workers responsible for the sterilization of surgical instruments in low- and middle-income countries compromises the safety of workers and patients alike., Methods: A mixed methods research study was initiated in the Lake Zone areas of Northwestern Tanzania in the summer of 2018. The goal was to identify the impact of education and training on sterile processing practices at ten hospitals. Quantitative data analyzed included hospital assessments of sterile processing practices prior to and 4 months after training, as well as participant test scores collected at the beginning of training, after 5 days of classes, and 4 months after mentorship was completed. Thematic analysis of interviews with participants 4 months post-training was completed to identify associated impact of training., Results: Improvement in test scores were found to be directly related to sterile processing training. The greatest sterile processing practice changes identified through hospital assessments involved how instruments were cleaned, both at point of use and during the cleaning process, resulting in rusted and discoloured instruments appearing as new again. Themes identified in participant interviews included: changes in practice, challenges in implementing practice changes, resource constraints, personal and professional growth, and increased motivation, confidence and responsibility., Conclusions: Providing education and follow up support for workers in sterile processing resulted in increased knowledge of best practices, application of knowledge in practice settings, and awareness of issues that need to be overcome to decrease risks for patients and health care workers alike. Further research is needed to identify the impact of mentorship on hospital sterile processing practices in order to provide clear direction for future spending on training courses., Competing Interests: Competing interestsOF is chair of SPECT; CF is SPECT’s founder and executive director. Safe Surgery 2020 (SS2020) is a collaboration of foundations, non-profits, educational institutions, and local governments that seek to make surgery safer across the globe. The research reported is part of the monitoring and evaluation aspect of a SS2020 initiative, funded by GE Foundation, between Sterile Processing Education Charitable Trust (SPECT), Assist International and the Tanzanian Ministry of Health., (© The Author(s). 2019.)

Sterilization is a critical process in the preparation of many drug products. Its execution and validation are addressed in numerous regulatory, pharmacopeial, and industry documents. EMA Annex 1: Manufacture of Sterile Medicinal Products stands alone in giving clear preference to physical measurements over those obtained from biological indicators. This paper reviews principles behind sterilization processes outlining the differences between physical and biological measurements as well as their relationship to each other. The assumptions associated with the use of physical measurement are explored and their derivation from microbiological results is traced with the intent of reaffirming the primacy of biological evidence. The arguments and objections to the use of biological indicators in sterilization are reviewed and deconstructed. LAY ABSTRACT: Sterilization validation is required by regulatory agencies around the globe. The accepted principles are derived from those originally established in the United States and the United Kingdom during the 1970s. Unfortunately, these have evolved into conflicting expectations. The U.K. placed greater emphasis on physical measurements initially in HTM-10, and this is reflected in the European Medicines Agency's Annex 1 statements for their preeminence over biological data. Practices, primarily in the U.S., give preference to microbiological challenges as confirmation of lethality. This paper reviews sterilization fundamentals and describes the relationship between physical and biological data. It critiques the various arguments for the superiority of physical measurements and supports why microbiological evidence should take precedence., (© PDA, Inc. 2019.)

Medical devices are sterilized before being used for invasive clinical procedures such as surgery, to prevent pathogen transfer. Failure to sterilize medical devices properly presents a risk of healthcare-associated infections. Studies and reports have indicated that inadequately sterilized medical devices are one of the causes of a higher rate of healthcare-associated infections in developing countries. Steam sterilization (autoclaving) is the most widely used method for sterilization and is considered the most robust and cost-effective method for sterilization of medical devices. The effectiveness of steam sterilization can be measured using biological indicators. A literature search was undertaken to understand the effectiveness of autoclaving in sterilizing reusable medical devices in healthcare facilities across the globe. Studies using biological indicators for measuring the effectiveness of autoclaving were obtained. Failures of steam sterilization practices were identified and discussed as a means of identifying factors that might be associated with the ineffectiveness of steam sterilization practices between different countries. The number of studies measuring the effectiveness of steam sterilization is small, and few evaluate the effectiveness of steam sterilization specifically in developing countries. There are fewer studies on higher level healthcare facilities than dental facilities. More evidence about the effectiveness of autoclaving in healthcare facilities is needed to draw firm conclusions, but the data suggest that there are inadequacies in autoclave procedures and operator education., Competing Interests: No Conflict of Interest is declared, (Copyright (c) 2019 Gopal Panta, Ann K Richardson, Ian C Shaw.)

Objectives: The sterilization unit of Pitié-Salpêtrière-Charles Foix hospital group is ISO 9001 certified on one of its sites. The purpose of this work is to describe how the unit prepared for the transition from the 2008 version to the 2015 version of the standard, as well as the conduct of the audit., Methods: The pharmaceutical team has received prior training from French national organization for standardization (Afnor) to understand the new requirements and how to apply them to the sterilization unit. SWOT and PESTEL methods were used. A 3-month retro planning has been established. Deadlines were the annual management review and the certification audit. Audits carried out by the Quality and Risk Management Department helped to identify the priorities., Results: The compliance of the quality management system (QMS) has led to the identification of internal and external challenges, relevant stakeholders and risks and opportunities. Management leadership and communication has been strengthened and control over external providers has improved. The auditor did not identify any non-compliance, but said that the system had to mature regarding the recent application of the new requirements., Conclusions: The QMS is more effective, new strengths and weaknesses have been identified and requirements of the unit and stakeholders have been better defined. The pharmaceutical investment necessary for this approach has been important. Involvement in the quality approach of all the staff of the unit lies to the success of the project., (Copyright © 2019 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.)

Purpose: Herein we aimed to investigate the degradation of surgical instruments in our hospital and how water quality affects the rate of metal corrosion., Materials and Methods: We observed 279 stainless steel instruments, and determined the presence of damage like metal corrosion or scale formation. We also measured the concentrations of chloride(Cl - )and silicate(SiO 4 4- )ions in the water used for cleaning in our operating rooms, including tap water from the city water supply and reverse-osmosis(RO)filtered water., Result: Pitting corrosion was observed on 71% of the instruments we investigated. The concentration of Cl - was 0.7mg/L in tap water and 0.1mg/L in RO water, while the concentration of SiO 4 4- was 0.3mg/L in both the tap and RO water., Discussion: Of the dissolved ions Cl - and SiO 4 4- , Cl - is more of a concern, as it causes pitting corrosion over time, while SiO 4 4- causes scale formation. Considering the typical water quality in the operating-room environment, degradation must be monitored for the general maintenance of metal surgical instruments.

The equilibration time of an autoclave is defined as the period of time that elapses between the attainment of the sterilization temperature at the reference measurement point of the autoclave chamber and the attainment of the sterilization temperature at all measurement probes within the dry goods load placed within the autoclave during a sterilization cycle.The equilibration time is an indicator of the ability of the autoclave to remove air from and to subsequently sterilize the dry goods load placed within the autoclave chamber. Therefore, the equilibration time is an indicator of the performance of an autoclave. Periodic measurements of the equilibration time and evaluation of the equilibration time data can assure continued performance of the autoclave.For autoclaves that support biopharmaceutical manufacturing plants, the equilibration time is generally measured by placing heat penetration probes within the dry goods load items placed within the autoclave during a sterilization cycle. However, measurement of the equilibration time in this fashion yields results that are highly variable and difficult to replicate.This paper presents a study that attempts to understand the impact of the following autoclave variables on the consistent measurement of the equilibration time and on the reduction of the equilibration time: type of dry goods load item placed inside the autoclave, location of the heat penetration probe placed within the dry goods load item, location of the dry goods load item inside the autoclave chamber, orientation of the dry goods load item inside the autoclave chamber, number of coils of the tubing elements of a dry goods load item, total thermal mass of the dry goods load items placed inside the autoclave, temperature of the dry goods load items at the start of the sterilization cycle, presence of residual moisture in the dry goods load items at the start of the sterilization cycle, number of steam and vacuum pulses used for preconditioning in the autoclave recipe, depth of the steam and vacuum pulses used for preconditioning in the autoclave recipe, and hold time of the steam and vacuum pulses used for preconditioning in the autoclave recipe.The focus of this paper is on tests performed to evaluate these variables followed by analysis and interpretation of the test data to identify key variables that have the highest impact on the measurement of the equilibration time. The conclusion of this paper presents a process to achieve shorter equilibration times in autoclaves through control of the key variables identified. LAY ABSTRACT: The equilibration time is an indicator of the performance of an autoclave. Periodic measurements of the equilibration time and evaluation of the equilibration time data of an autoclave can assure continued performance of said autoclave.This paper presents a study performed to develop a general guideline for consistent measurement of the equilibration time of an autoclave through identification and control of key sources of variability that impact the measurement. The focus of this paper is the testing and data analysis performed to identify these key sources of variability observed in a typical autoclave load sterilized through a typical autoclave cycle in a biopharmaceutical manufacturing plant. The conclusion of this paper presents a process to achieve shorter equilibration times in autoclaves through control of the key variables identified., (© PDA, Inc. 2019.)

Sterilization of implantable medical devices is of most importance to avoid surgery related complications such as infection and rejection. Advances in biotechnology fields, such as tissue engineering, have led to the development of more sophisticated and complex biomedical devices that are often composed of natural biomaterials. This complexity poses a challenge to current sterilization techniques which frequently damage materials upon sterilization. The need for an effective alternative has driven research on supercritical carbon dioxide (scCO 2 ) technology. This technology is characterized by using low temperatures and for being inert and non-toxic. The herein presented paper reviews the most relevant studies over the last 15 years which cover the use of scCO 2 for sterilization and in which effective terminal sterilization is reported. The major topics discussed here are: microorganisms effectively sterilized by scCO 2 , inactivation mechanisms, operating parameters, materials sterilized by scCO 2 and major requirements for validation of such technique according to medical devices' standards., (Copyright © 2019 Elsevier B.V. All rights reserved.)

The monitoring of quality indicators, combined with a detailed risk analysis, validates the process of automated blood culture. Here we report the methodology of 5 years monitoring for 5 indicators at the Biology Department of Foch Hospital: volume sampled, proportion of contaminants, proportion of positive blood cultures in each instrument and drawer, epidemiological indicator and proportion of false-positive instrument signals. The results obtained were outside the expected target for the volume sampled and were acceptable for the other indicators. The analysis of these results leads us to discuss the evolution of quality indicators and more particularly the implementation of corrective measures, their periodicity, their relevance as well as the need to refine their results to carry out targeted actions.

Liquid wastes from clinical biology automated systems are currently evacuated in the urban network after chemical treatment to eliminate a possible risk of infection. Since these wastes are ecotoxic because of the presence of numerous chemical reagents, we studied their intrinsic microbicidal power towards a selection of infectious agents widely found in clinical specimens. The objective was to determine if an additional anti-infectious treatment before elimination is necessary. Thus, we evaluated the bactericidal effect of liquid wastes of several automated systems towards four bacterial species (Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa and Enterococcus faecalis) and their virucidal activity against a non-enveloped virus, resistant in the environment (adenovirus). This effect was determined for different exposure times. Our results showed that the antibacterial activity was highly variable depending on the waste-bacteria pair considered (varying from no activity to complete sterilization of a strong bacterial inoculum). The liquid wastes were on the other hand globally inactive towards adenovirus.

Bone drilling causes focal temperature rise due to metal-to-bone contact, which may result in thermal osteonecrosis. Newly constructed internally cooled medical drill of an open type decreases temperature rise at a point of metal-to-bone contact although standard sterilization of such a drill could be inadequate due to bacteria retention within the drill lumen. The aim of this pilot study was to examine the effectiveness of sterilization and to propose sterilization recommendations for internally cooled open type bone drills. Unused internally cooled medical steel bone drills were tested. Drills were contaminated with Pseudomonas aeruginosa , Bacillus sp., beta-hemolytic Streptococcus sp., Enterobacter sp. and methicillin-resistant Staphylococcus pseudintermedius and then incubated for 24 hours at 37 °C. Afterwards, drills were autoclaved for 15, 20 and 30 minutes at 132 °C and 2.6 bar. When 15-minute sterilization was used, one out of 16 drills was contaminated with Pseudomonas aeruginosa , while the other 15 drills were sterile. Extended cycle sterilization in autoclave lasting for 20 and 30 minutes resulted in 100% sterility of all drills tested. In conclusion, lumened drills should be exposed to extended sterilization times in autoclave. Minimal recommended time for sterilization of lumened drills is 20 minutes.

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., (© AORN, Inc, 2019.)

In practice it is claimed that load characteristics influence a surface steam sterilization process. To the best of our knowledge, no information on this topic has been found in the literature. The purpose of this study was to find if a load influences the duration and related characteristics of a surface steam sterilization process. In a case study, every load monitoring using an objective, quantifying steam penetration test was performed during 30 days. This resulted in 98 production processes with load monitoring. The acquired data were analyzed. A relation between the weight of a load and the duration of a surface steam sterilization process has been found. In this case study, it is demonstrated that the process time increases with the weight of the sterilizer load. Additionally, it is concluded that when the duration of a process is longer, diffusion will have a greater effect and steam penetration increases. LAY ABSTRACT: Steam sterilization is applied in most health-care facilities that reprocess medical devices, in pharmaceutical industries, and in labs where specific instrumentation and equipment have to be sterile. Steam sterilization is still not fully understood, as demonstrated in the literature. Our manuscript contributes to understanding the surface steam sterilization process. The information shared in our manuscript demonstrates by a case study that relations exist between the weight of the load which is steam sterilized, the duration of a process, and the steam penetration in a process. A quantitative relation can be used to predict the duration of a process and the steam penetration. It is likely that for other steam sterilizers these relations can be found as well. This is of interest for institutes researching decontamination and sterilization, health-care facilities, developers and manufacturers of medical devices, and committees addressing standards for steam sterilization., (© PDA, Inc. 2019.)

Objectives: As a university teaching hospital, the call for tender for dental medical devices (dental implants and consumables) is done with the help of a team of hospital pharmacists and users. In order to optimize the definition of needs and evaluation criteria, an exhaustive review of the products was carried out., Methods: Dental medical devices suppliers were consulted in 2017 for reviewing their products. Their technical, clinical and economic data were compared. The products have been gathered into categories and its results had been submitted to a commission of dental experts of our university hospital for clinical opinion., Results: More than 30,000 references from 30 different suppliers were analyzed (orthodontics, dental implants, membranes and bone substitutes, various dental consumables). Relating to oral implantology, the opinions converged on clinical studies. On the contrary, diverging opinions have been proffered on the systematic use of single-use drills and customized guides for surgery and on the implant's choice. The definition of needs has been specified for orthodontics and consumables. Other criteria played a great role: single packaging (unit doses), product's sterility, paediatric needs, presence of allergens, traceability of devices and supplier diversity., Conclusions: This review led to the identification of new needs in more precise terms. The complexity and diversity of dental products and techniques requires this careful review and a better collaboration with practitioners., (Copyright © 2019 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.)

Objectives/hypothesis: Isolated case studies have shown improper sterilization or contamination of equipment from anesthesia carts can lead to transmission of disease and even death. Citing this literature, national accrediting agencies mandated all instruments in the otolaryngology airway carts at San Antonio Military Medical Center be packaged to prevent contamination. This study sought to determine the infection and safety implications of packaged airway cart instruments., Study Design: Retrospective chart review., Methods: A review of upper aerodigestive tract procedures, some of which penetrated mucosa, was performed by analyzing 100 patient records during the unpackaged period and 100 during the packaged period. A comparison of infections, deaths, and length of stay in the hospital was included in the analysis. Additionally, a timed simulation to setup a simple group of instruments for an emergency airway situation from both the unpackaged and packaged airway carts was performed using a total of 11 surgical technologists and nurses., Results: Each group had a total of four airway infections and neither had any deaths. The average length of hospital stay was 0.36 days for the unpackaged period and 0.44 days from the packaged period. None of these variables reached statistical significance. The average time to find and set out the correct instruments for the two groups was 46.6 and 95.5 seconds for the unpackaged and packaged airway carts, respectively (P = .004)., Conclusions: This study suggests individually packaging of instruments used for emergency airway cases may put lives at risk when time matters and fails to decrease the risk of infection., Level of Evidence: 3 Laryngoscope, 129:715-719, 2019., (© 2018 The American Laryngological, Rhinological and Otological Society, Inc.)

Process analytical technology was introduced by the U. S. Food and Drug Administration about 20 years ago to assist the pharmaceutical industry in making changes that should reduce batch failures, ensure performance, and enhance quality. Its premise is that "quality cannot be tested into preparations; it must be built-in or should be by design." One proposed advantage was to reduce end-product testing by ensuring each process was functioning properly. In compounding, there are a number of processes that could be advantageously incorporated into process analytical technology since end-product testing is not generally done due to the nature of compounding. The purpose of this article is simply to introduce the concept of process analytical technology into compounding with the understanding that it will take a number of years for it to be evaluated and implemented, even on a small scale. It is not feasible to do it all at once; just one step at a time. Since patient safety is uppermost in compounding, this concept should be considered., (Copyright© by International Journal of Pharmaceutical Compounding, Inc.)