Reconciling human health with the environment while struggling against the COVID-19 pandemic through improved face mask eco-design.

Surgical masks have become critical for protecting human health against the COVID-19 pandemic, even though their environmental burden is a matter of ongoing debate. This study aimed at shedding light on the environmental impacts of single-use (i.e., MD-Type I) versus reusable (i.e., MD-Type IIR) face masks via a comparative life cycle assessment with a cradle-to-grave system boundary. We adopted a two-level analysis using the ReCiPe (H) method, considering both midpoint and endpoint categories. The results showed that reusable face masks created fewer impacts for most midpoint categories. At the endpoint level, reusable face masks were superior to single-use masks, producing scores of 16.16 and 84.20 MPt, respectively. The main environmental impacts of single-use masks were linked to raw material consumption, energy requirements and waste disposal, while the use phase and raw material consumption made the most significant contribution for reusable type. However, our results showed that lower environmental impacts of reusable face masks strongly depend on the use phase since reusable face masks lost their superior performance when the hand wash scenario was tested. Improvement of mask eco-design emerged as another key factor such as using more sustainable raw materials and designing better waste disposal scenarios could significantly lower the environmental impacts.

Disposable Ureteroscopes in Urology: Current State and Future Prospects.

Ureteroscopy is the most common surgical modality for stone treatment. Reusable flexible ureteroscopes are delicate instruments that require expensive maintenance and repairs. Multiple single use ureteroscopes have been developed recently to combat the expensive and time-intensive sterilization and repair of ureteroscopes. Although multiple studies have looked at different aspects of reusable and single use ureteroscopes, there is significant heterogeneity in performance measures and cost between the 2 categories, and neither has a clear advantage. Both can be used successfully, and individual and institution level factors should be considered when deciding which ureteroscope to use.

Performance and impact of disposable and reusable respirators for healthcare workers during pandemic respiratory disease: a rapid evidence review.

OBJECTIVES: To synthesise evidence concerning the range of filtering respirators suitable for patient care and guide the selection and use of different respirator types. DESIGN: Comparative analysis of international standards for respirators and rapid review of their performance and impact in healthcare. DATA SOURCES: Websites of international standards organisations, Medline and Embase, hand-searching of references and citations. STUDY SELECTION: Studies of healthcare workers (including students) using disposable or reusable respirators with a range of designs. We examined respirator performance, clinician adherence and performance, comfort and impact, and perceptions of use. RESULTS: We included standards from eight authorities across Europe, North and South America, Asia and Australasia and 39 research studies. There were four main findings. First, international standards for respirators apply across workplace settings and are broadly comparable across jurisdictions. Second, effective and safe respirator use depends on proper fitting and fit testing. Third, all respirator types carry a burden to the user of discomfort and interference with communication which may limit their safe use over long periods; studies suggest that they have little impact on specific clinical skills in the short term but there is limited evidence on the impact of prolonged wearing. Finally, some clinical activities, particularly chest compressions, reduce the performance of filtering facepiece respirators. CONCLUSION: A wide range of respirator types and models is available for use in patient care during respiratory pandemics. Careful consideration of performance and impact of respirators is needed to maximise protection of healthcare workers and minimise disruption to care.

[Study on Testing Methods of Pen-injector's Dosing Accuracy].

OBJECTIVE: An accuracy test method is proposed to reduce the amount of reagents used in the test and reduce the cost of spot checks and self-tests. METHODS: According to the requirements of dose accuracy test in standard atmospheric conditions in ISO 11608-1:2014, dose accuracy test is carried out for the same batch of reusable pen injector samples by using the test method proposed in this paper and the test method in relevant foreign research, and the data measured by the two methods are processed. RESULTS: After experimental testing and analysis, the data measured by the two methods did not exceed the dose accuracy limit specified in the ISO standard. There was no significant difference between the two methods when the dose of 60 U and 30 U were tested, but there was significant difference when the dose of 1 U was tested. CONCLUSIONS: Both methods can be used to evaluate dose accuracy, however, the method proposed in this paper can reduce the usage of drugs by 2/3, so it can reduce cost of supervised test.

Reúso de dispositivos médicos de uso único e implicações para a segurança do paciente / Reuse of single use medical devices and implications for patienty safety / Reutilización de dispositivos médicos de uso individual e implicaciones para la seguridad del paciente

Objetivo: Descrever aspectos do reúso dos dispositivos médicos de uso único e as implicações dessa prática para a segurança do paciente. Método: Ensaio acadêmico, utilizando dados de revisão integrativa e expertise da autora. Resultados: O reúso de produtos de uso único é realidade mundial e ocasiona debates regulatórios, técnicos, econômicos, éticos e de segurança do paciente, denotando diversos interesses dos distintos atores envolvidos: Estado, fabricantes, serviços de saúde, academia, profissionais e usuários. Embora haja risco teórico, dados não identificam relação causal entre evento adverso e reúso desses produtos. Existem argumentos a favor e contra que compreendem riscos e benefícios e justiça distributiva e social. O rótulo desses produtos representa nó crítico e elemento fomentador dos dilemas que permeiam essa prática. Conclusão: Há consenso de que o reúso de um produto médico deve ter o mesmo padrão de segurança, independentemente se rotulado como de uso único ou de multiuso. Alguns produtos ditos de uso único podem ser seguramente reusados, mas essa prática requer condições organoestruturais dos serviços de saúde, além de expertise, adoção de protocolos e supervisão dessas atividades.

Objective: to describe aspects of the reuse of single-use medical devices and implications for patient safety. Method: academic essay, using integrative review data and author's expertise. Results: the reuse of single-use products is a worldwide reality and causes regulatory, technical, economic, ethical and patient safety debates, denoting several interests of the different actors involved: State, manufacturers, health services, academia, professionals and users. Although there is a theoretical risk, data do not identify a causal relationship between adverse events and reuse of these products. There are arguments for and against and are involved: risks and benefits, distributive and social justice. The label of these products represents a critical node and fomenting element of the dilemmas that permeate this practice. Conclusion: There is consensus that the reuse of a medical product should have the same safety standard, regardless of whether labeled as single-use or multipurpose. Some so-called single-use products can be safely reused, but this practice requires organo-structural conditions of health services, as well as expertise, adoption of protocols and supervision of these activities.

Objetivo: Describir aspectos de la reutilización de dispositivos médicos de un solo uso e implicaciones para la seguridad del paciente. Método: ensayo académico, utilizando datos de revisión integradores y la experiencia del autor. Resultados: La reutilización de productos de un solo uso es una realidad mundial y provoca debates regulatorios, técnicos, económicos, éticos y de seguridad del paciente, que denotan diversos intereses de los diferentes actores involucrados: Estado, fabricantes, servicios de salud, academia, profesionales y usuarios. Aunque existe un riesgo teórico, los datos no identifican una relación causal entre el evento adverso y la reutilización de estos productos. Hay argumentos a favor y en contra y están involucrados: riesgos y beneficios, justicia distributiva y social. La etiqueta de estos productos representa un nodo crítico y un elemento que fomenta los dilemas que impregnan esta práctica. Conclusión: Existe un consenso de que la reutilización de un producto médico debe tener el mismo estándar de seguridad, independientemente de si está etiquetado como de uso único o multipropósito. Algunos de los llamados productos de un solo uso pueden reutilizarse de manera segura, pero esta práctica requiere condiciones organoestructurales para los servicios de salud, además de experiencia, adopción de protocolos y supervisión de estas actividades.

Accuracy and Reliability of a Disposable Vascular Pressure Device for Arterial Pressure Monitoring in Critical Care Transport.

OBJECTIVE: Arterial catheterization is a commonly performed procedure in intensive care units to guide the management of critically ill patients who require precise hemodynamic monitoring; however, this technology is not always available in the transport setting because of cumbersome and expensive equipment requirements. We compared the accuracy and reliability of a disposable vascular pressure device (DVPD) with the gold standard (ie, the transducer pressure bag invasive arterial monitoring system) used in intensive care units to determine if the DVPD can be reliably used in place of the traditional pressure transducer setup. METHODS: This study was a single-center, prospective, observational study performed in the adult intensive care unit of a large academic university hospital. A convenience cohort of hemodynamically stable, adult critically ill patients with femoral, brachial, or radial arterial catheters was recruited for this study. The Compass pressure device (Centurion Medical Products, Williamston, MI) is a disposable vascular pressure-sensing device used to assure venous access versus inadvertent arterial access during central line placement. The DVPD was attached to an in situ arterial catheter and measures the mean intravascular pressure via an embedded sensor and displays the pressure via the integrated LCD screen. Using a 3-way stopcock, the DVPD was compared with the standard arterial setup. We compared the mean arterial pressure (MAP) in the standard setup with the DVPD using Bland-Altman plots and methods that accounted for repeated measures in the same subject. RESULTS: Data were collected on 14 of the 15 subjects enrolled. Five measurements were obtained on each patient comparing the DVPD with the standard arterial setup at 1-minute intervals over the course of 5 minutes. A total of 70 observations were made. Among the 15 subjects, most (10 [67%]) were radial or brachial sites. The average MAP scores and standard deviation values obtained by the standard setup were 83.5 mm Hg (14.8) and 81.1 mm Hg (19.3) using the DVPD. Just over half (51.4%) of the measurements were within a ± 5-mm Hg difference. Using Bland-Altman plotting methods, standard arterial measurements were 2.4 mm Hg higher (95% confidence interval, 0.60-4.1) than with the DVPD. Differences between the 2 devices varied significantly across MAP values. The standard arterial line measurements were significantly higher than the DVPD at low MAP values, whereas the DVPD measurements were significantly higher than the standard arterial line at high MAP values. CONCLUSION: The DVPD provides a reasonable estimate of MAP and may be suitable for arterial pressure monitoring in settings where standard monitoring setups are not available. The DVPD appears to provide "worst-case" values because it underestimates low arterial blood pressure and overestimates high arterial blood pressure. Future trials should investigate the DVPD under different physiological conditions (eg, hypotensive patients, patients with ventricular assist devices, and patients on extracorporeal membrane oxygenation), different patient populations (such as pediatric patients), and in different environments (prehospital, air medical transport, and austere locations).

Disposable Isolation Device to Reduce COVID-19 Contamination During CT Scanning.

RATIONALE AND OBJECTIVES: The use of chest computed tomography (CT) in the era of the COVID-19 pandemic raises concern regarding the transmission risks to patients and staff caused by CT room contamination. Meanwhile the Center for Disease Control guidance for air exchange in between patients may heavily impact workflows. To design a portable custom isolation device to reduce imaging equipment contamination during a pandemic. MATERIALS AND METHODS: Center for Disease Control air exchange guidelines and requirements were reviewed. Device functional requirements were outlined and designed. Engineering requirements were reviewed. Methods of practice and risk mitigation plans were outlined including donning and doffing procedures and failure modes. Cost impact was assessed in terms of CT patient throughput. RESULTS: CT air exchange solutions and alternatives were reviewed. Multiple isolation bag device designs were considered. Several designs were custom fabricated, prototyped and reduced to practice. A final design was tested on volunteers for comfort, test-fit, air seal, and breathability. Less than 14 times enhanced patient throughput was estimated, in an ideal setting, which could more than counterbalance the cost of the device itself. CONCLUSION: A novel isolation bag device is feasible for use in CT and might facilitate containment and reduce contamination in radiology departments during the COVID Pandemic.

3D-Printing to Address COVID-19 Testing Supply Shortages.

The recent SARS-CoV-2 outbreak has placed immense pressure on supply chains, including shortages in nasopharyngeal (NP) swabs. Here, we report our experience of using 3D-printing to rapidly develop and deploy custom-made NP swabs to address supply shortages at our healthcare institution.

Novel single-use duodenoscope compared with 3 models of reusable duodenoscopes for ERCP: a randomized bench-model comparison.

BACKGROUND AND AIMS: Multidrug-resistant infectious outbreaks associated with duodenoscope reuse have been documented internationally. A single-use endoscope could eliminate exogenous patient-to-patient infection associated with ERCP. METHODS: We conducted a comparative bench simulation study of a new single-use and 3 models of reusable duodenoscopes on a synthetic anatomic bench model. Four ERCP tasks were performed: guidewire locking (single-use and 1 reusable duodenoscope only), plastic stent placement and removal, metal stent placement and removal, and basket sweeping. The study schedule included block randomization by 4 duodenoscopes, 4 tasks, and 2 anatomic model ERCP stations. Ability to complete tasks, task completion times, and subjective ratings of overall performance, navigation/pushability, tip control, and image quality on a scale of 1 (worst) to 10 (best) were compared among duodenoscopes. RESULTS: All 4 ERCP tasks (total 14 subtasks) were completed by 6 expert endoscopists using all 4 duodenoscopes, with similar task completion times (median, 1.5-8.0 minutes per task) and overall performance ratings by task (median, 8.0-10.0). Navigation/pushability ratings were lower for the single-use duodenoscope than for the 3 reusable duodenoscopes (median, 8.0, 10.0, 9.0, and 9.0, respectively; P < .01). Tip control ratings were similar among all the duodenoscopes (median, 9.0-10.0; P = .77). Image quality ratings were lower for 1 reusable duodenoscope compared with the single-use and other 2 reusable duodenoscopes (median, 8.0, 9.0, 9.0, and 9.0, respectively; P < .01). CONCLUSIONS: A new single-use duodenoscope was used to simulate 4 ERCP tasks in an anatomic model, with performance ratings and completion times comparable with 3 models of reusable duodenoscopes.

Flexible ureteroscopy: reuse? Or is single use the new direction?

PURPOSE OF REVIEW: Single-use flexible ureteroscopes (su-fURS) aim at overcoming the main limitations of conventional reusable ureteroscopes in terms of acquisition and maintenance costs, breakages, and reprocessing. However, little data exist to date regarding the superiority of su-fURS at this regard. We aimed to perform a systematic literature review on available su-fURS performance with a focus on clinical data for all articles in the last 10 years. RECENT FINDINGS: To date, more than 10 different su-fURS are available on the market, with different characteristics and performance. Some of these devices have top-level features, almost catching up with those observed in reusable flexible ureteroscopes. Clinical evidence is mainly available only for two models, LithoVue and Uscope PU3022, and to date it is not strong enough to support routine adoption and use of su-fURS, with a consequent lack of consensus of specific clinical indications. Cost-effectiveness analyses seem to indicate an economic disadvantage in the routine adoption of su-fURS. Environmental issues related to the use of su-fURS also remain to be inquired and addressed. SUMMARY: Since their introduction, su-fURS have gained widespread popularity. Despite their ability at addressing reusable ureteroscope limitations, high-cost and a substantial lack of evidence are still limiting their routine adoption.

Study on Testing Methods of Pen-injector's Dosing Accuracy / 中国医疗器械杂志

OBJECTIVE@#An accuracy test method is proposed to reduce the amount of reagents used in the test and reduce the cost of spot checks and self-tests.@*METHODS@#According to the requirements of dose accuracy test in standard atmospheric conditions in ISO 11608-1:2014, dose accuracy test is carried out for the same batch of reusable pen injector samples by using the test method proposed in this paper and the test method in relevant foreign research, and the data measured by the two methods are processed.@*RESULTS@#After experimental testing and analysis, the data measured by the two methods did not exceed the dose accuracy limit specified in the ISO standard. There was no significant difference between the two methods when the dose of 60 U and 30 U were tested, but there was significant difference when the dose of 1 U was tested.@*CONCLUSIONS@#Both methods can be used to evaluate dose accuracy, however, the method proposed in this paper can reduce the usage of drugs by 2/3, so it can reduce cost of supervised test.

A Systematic Review of Disposable Sheath Use During Flexible Endoscopy.

Flexible endoscopes are exposed to blood, mucus, and other secretions during procedures. Single-use sheaths are designed to prevent contact between contaminants and reusable endoscope components. This systematic review examined findings from 22 studies that assessed endoscopic sheath use during urologic, gastrointestinal, or respiratory procedures. The evidence showed that sheaths were durable and yielded faster endoscope turnover times because their reusable components did not require high-level disinfection or sterilization. After a brief learning period, health care providers successfully assembled and maneuvered sheathed endoscopes. Patients generally did not experience greater discomfort during procedures in which sheaths were used. Microbial cultures of sheathed endoscopes were negative or similar to unsheathed endoscopes. More research is needed to evaluate the potential effect of disposable sheaths on infection risks. The evidence suggests that sheaths are a viable option for reliably providing a barrier between endoscopes and patients without affecting the quality of endoscopic procedures.

Preclinical evaluation of a new cryopreservation container for a limited number of human spermatozoa.

The aim of this study was to develop a new container for cryopreservation of a limited number of spermatozoa. To evaluate the efficacy and safety of this new container, we performed preclinical evaluations using human sperm or mouse oocytes and sperm. First, using human sperm that was frozen and then thawed, we demonstrated that the sperm recovery rate using the new container was 96.7% (58/60), which was significantly higher (P < 0.05) than the recovery rate of 21.2% (11/52) when using the Cryotop®. Sperm motility rates were 19.2% (10/52) using the Cryotop® and 35.0% (21/60) using the new container. Second, murine epididymal spermatozoa were divided into three groups: fresh spermatozoa, spermatozoa frozen using a straw, and spermatozoa frozen using the new container. Sperm motility, sperm membrane and DNA integrity, in vitro development of fertilized eggs, and offspring development after embryo transfer were assessed. The motility of freeze-thawed sperm was lower in spermatozoa that were frozen using the new container than in fresh spermatozoa or those that were frozen using a straw. After intracytoplasmic sperm injection, the survival rate was 96.7% (145/150), the 2-cell development rate was 90.3% (131/145), and the blastocyst development rate was 77.2% (112/145), when using the new container. There were no differences in the sperm membrane, DNA integrity, or in the embryo development rates to the blastocyst stage among the different frozen groups. Six offspring were derived from spermatozoa freeze-thawed in the new container, and they developed normally. Thus, the new container allows easy handling of a small number of sperms and minimizes sperm loss during cryopreservation.

Reprocessing Single-Use Devices in the Ambulatory Surgery Environment.

Reprocessing single-use surgical supplies and devices is an option for hospitals and ambulatory surgery centers (ASCs). The US Federal Government has recognized the practice since 2000, and regulatory oversight has increased dramatically since that time. Reprocessing single-use devices is safe when personnel use approved methods, and health care facilities can experience significant cost savings by participating in this type of initiative. This article explores reprocessing and its benefits in ASCs, including a review of the oversight that the US Food and Drug Administration currently has for reprocessing and a discussion of the results of studies pertaining to this practice. The article also describes some issues that ASC leaders need to be aware of when considering the implementation of a reprocessing program. Single-use device reprocessing can be an effective tool for ASC leaders to conserve and manage resources.

Reprocessing and reuse of single-use medical devices: perceptions and concerns of relevant stakeholders toward current practices.

BACKGROUND: Research and history have largely shown the covert billion-dollar global market of single-use medical device (SUD) reprocessing and reuse to be a safe endeavor, but awareness and perceptions of the practice both within and outside of healthcare have received limited attention. METHODS: Responses for patients, physicians, and medical practitioners were attained on both online and article-based surveys, in which attitudes and perceptions of SUD reprocessing and reuse were expressed in an assortment of closed-ended questions and partially closed-ended questions. RESULTS: Of the 214 participants, a collective 77% were unaware that the Food and Drug Administration allows SUD reprocessing and reuse. This included 65% of physicians and 84% of patients, which were significantly different proportions (P = 0.005). A significantly greater proportion of patients than physicians (92 vs. 68%) also felt that hospitals bear the responsibility of informing patients of the practice as part of their care (P < 0.001). CONCLUSION: There is a profound lack of awareness of SUD reprocessing and reuse among all relevant stakeholders. In addition, the overwhelming desire for transparency among patients further forces the debate of whether current, covert methods should be altered, in addition to the question of who bears this responsibility. Despite research and history having shown the practice to be safe, apprehension and misconceptions remain. Survey results suggest that education may be able to subdue such patient concerns.

Operating Room Waste Reduction.

One-fourth of all operating room (OR) waste is attributed to anesthesia-related material. The goal of this project was to reduce the waste and increase cost savings of opened and unused endotracheal (ET) tubes and disposable laryngoscope handles and blades in 2 separate OR environments. The production of these unused anesthesia supplies was assessed weekly in each of 2 OR environments for 8 weeks before an educational intervention, and for 8 weeks following the intervention. The average weekly waste production was summarized for each study period, compared between periods (preintervention vs postintervention), and analyzed per 100 surgeries using the 2-sample t test. The overall average weekly waste for ET tubes was significantly reduced from 26.7 ± 10.7 to 10.0 ± 6.1 from pre to post intervention (P = < .001), representing a 62.6% reduction. A similar significant reduction in waste was observed for laryngoscope handles (15.9 ± 8.1 vs 7.2 ± 3.1; P = .004; a 54.7% reduction) and laryngoscope blades (21.5 ± 11.0 vs 9.9 ± 4.4; P = .004; a 54.0% reduction). These results highlight the significance and feasibility of an educational intervention in reducing the environmental and economic waste produced by anesthetic practices in the OR.

Bouffant vs Skull Cap and Impact on Surgical Site Infection: Does Operating Room Headwear Really Matter?

BACKGROUND: The American College of Surgeons guidelines indicate that skull caps are acceptable, and the Association of Perioperative Registered Nurses recommends bouffant caps. However, no scientific evidence has shown a significant advantage in surgical site infection (SSI) reduction with either cap. The objective of this study was to determine the influence of surgical cap choice on SSIs. STUDY DESIGN: Data from a previously published prospective randomized trial on the impact of hair clipping on SSIs were analyzed. Patients were grouped by the attending surgeons' preferred cap choice into either bouffant or skull cap groups. RESULTS: Overall, 1,543 patients were included in the trial. Attending surgeons wore bouffant caps in 39% and skull caps in 61% of cases. Prevalence of diabetes and tobacco use were similar between the groups. Bouffant caps were used in 71% of colon/intestinal cases, 42% of hernia/other cases, 40% of biliary cases, and only 1% of foregut cases. Overall, SSIs occurred in 8% and 5% of cases with a bouffant and skull cap, respectively (p = 0.016); with 6% vs 4% classified as superficial (p = 0.041), 0.8% vs 0.2% classified as deep (p = 0.12), and 1% vs 0.9% classified as organ space (p = 0.79); however, when adjusting for the type of operation, no significant differences in SSI rates were observed for skull caps vs bouffant caps. CONCLUSIONS: Attending surgeon preference for bouffant vs skull cap does not significantly impact SSI rates after accounting for surgical procedure type. Future guidelines should consider these clinical outcomes data and surgeon preference should dictate operating room headwear.