Reusable vs Single Use: what Are the Device Trade-Offs in Improving Sustainability.

As autoinjector requirements become increasingly diverse and pharma companies look for quicker routes to market, with lower costs and improved sustainability, there is an increasing trend towards devices with a reusable element. The flexibility in reusable elements can be beneficial for pharma companies with access to these platforms, allowing a relatively rapid transition between different drug combinations. However, it can also lead to devices designed to cover a wide range of requirements which are over designed for their actual more limited end use. The challenge of creating both a cost and sustainability optimised platform device is significantly harder than if developing a single use device with a specific purpose in mind. This paper looks at the range of reusable products on the market, examining some of the assertions around the cost and sustainability benefits of these devices as well as where there are trade-offs relative to current single use format devices.

Reuse of N95/PFF2 masks in clinical practice: morphological and structural analysis.

OBJECTIVE: to analyze the integrity of N95/PFF2 masks in relation to fiber morphology, porosity, cracks and micro holes, as well as identify visible damage to their structure and components, after seven- and fifteen-day reuse protocols. METHOD: cross-sectional study. Structural and morphological characteristics of a new N95/PFF2 mask were analyzed in comparison with N95/PFF2 masks (n=10) used in seven- and fifteen-day protocols, through visual inspection and scanning electron microscopy. RESULTS: upon visual inspection, following the seven-day protocol, 40% and 60% of the N95/PFF2 masks showed, respectively, personal identification marks and external and internal dirt. Additionally, 20% exhibited loosening and/or tearing of the straps, while 100% showed some type of damage to the nose clips. In the fifteen-day protocol, all N95/PFF2 masks had dirt, loose straps and damaged nose clips, and 80% had folds. Electronic microscopy revealed an increase in pores and loosening in the weaves from seven days onwards, extending up to fifteen days, with the presence of micro holes and residues. CONCLUSION: the reuse of N95/PFF2 masks affects their structural and morphological integrity. It is crucial to carry out tests to measure the impact of this practice on the safety of health professionals.

A Life Cycle Assessment of Reusable and Disposable Surgical Caps.

INTRODUCTION: Surgical cap attire plays an important role in creating a safe and sterile environment in procedural suites, thus the choice of reusable versus disposable caps has become an issue of much debate. Given the lack of evidence for differences in surgical site infection (SSI) risk between the two, selecting the cap option with a lower carbon footprint may reduce the environmental impact of surgical procedures. However, many institutions continue to recommend the use of disposable bouffant caps. METHODS: ISO-14044 guidelines were used to complete a process-based life cycle assessment to compare the environmental impact of disposable bouffant caps and reusable cotton caps, specifically focusing on CO2 equivalent (CO2e) emissions, water use and health impacts. RESULTS: Reusable cotton caps reduced CO2e emissions by 79% when compared to disposable bouffant caps (10 kg versus 49 kg CO2e) under the base model scenario with a similar reduction seen in disability-adjusted life years. However, cotton caps were found to be more water intensive than bouffant caps (67.56 L versus 12.66 L) with the majority of water use secondary to production or manufacturing. CONCLUSIONS: Reusable cotton caps have lower total lifetime CO2e emissions compared to disposable bouffant caps across multiple use scenarios. Given the lack of evidence suggesting a superior choice for surgical site infection prevention, guidelines should recommend reusable cotton caps to reduce the environmental impact of surgical procedures.

Health Care Workers' Comfort Ratings for Elastomeric Half-Mask Respirators Versus N95® Filtering Facepiece Respirators During the COVID-19 Pandemic.

BACKGROUND: Reusable elastomeric half-mask respirators (EHMR) are an alternative to address shortages of disposable respirators. While respirator discomfort has been noted as a barrier to adherence to wearing an N95 filtering facepiece respirator (FFR) among health care personnel (HCP), few have examined EHMR comfort while providing patient care, which was the purpose of this study. METHOD: Among a cohort of 183 HCP, we prospectively examined how HCP rated EHMR tolerability using the Respirator Comfort, Wearing Experience, and Function Instrument (R-COMFI) questionnaire at Study Week 2 and Week 10. At the completion of the study (Week-12), HCP compared EHMR comfort with their prior N95 FFR use. Overall R-COMFI scores and three subscales (comfort, wear experience, and function) were examined as well as individual item scores. FINDINGS: The HCP reported an improved overall R-COMFI score (lower score more favorable, 30.0 vs. 28.7/47, respectively) from Week 2 to Week 10. Many individual item scores improved or remained low over this period, except difficulty communicating with patients and coworkers. The overall R-COMFI scores for the EHMR were more favorable than for the N95 FFR (33.7 vs. 37.4, respectively), with a large proportion of workers indicating their perception that EHMR fit better, provided better protection, and they preferred to wear it in pandemic conditions compared with the N95 FFR. CONCLUSION/APPLICATION TO PRACTICE: Findings suggest that the EHMR is a feasible respiratory protection device with respect to tolerance. EHMRs can be considered as a possible alternative to the N95 FFR in the health care setting. Future work is needed in the EHMR design to improve communication.

Endoscope channel drying, storage, and conditions after reprocessing: How safe are they in clinical practice?

INTRODUCTION AND AIMS: Adequate drying and proper storage of flexible endoscopes are essential for maintaining quality in their reprocessing. The aim of the present study was to evaluate the drying stages, storage, and channel conditions of endoscopes through borescope inspection. MATERIAL AND METHODS: The personnel responsible for endoscope reprocessing were interviewed. Storage conditions at 10 endoscopy facilities were inspected and an internal examination of the channels and ports of the stored equipment was carried out, utilizing a borescope. A total of 74 stored endoscope channels were evaluated. RESULTS: Only 10% of the facilities inspected utilized transport cases for storage and only 10% had rooms exclusively used for storage. Sixty percent of the facilities did not perform any shelf-life control. All the channels evaluated were scratched and fluids were present on 69% of them. CONCLUSIONS: Endoscope reprocessing can be improved through the implementation of drying and storage control and validation tools, as well as the use of borescopes and periodic clinical audits.

Investigation of Three Different UV-C Irradiation Schemes for Bacterial Decontamination of FFP2 Masks to Make Them Reusable.

The effect of filtering face piece grade 2 (FFP2) masks for infection prevention is essential in health care systems; however, it depends on supply chains. Efficient methods to reprocess FFP2 masks may be needed in disasters. Therefore, different UV-C irradiation schemes for bacterial decontamination of used FFP2 masks were investigated.Seventy-eight masks were irradiated with UV light for durations between 3 and 120 seconds and subsequently analyzed for the presence of viable bacteria on the inside. Ten masks served as the control group. Irradiation on the inside of the masks reduced bacteria in proportion to the dose, with an almost complete decontamination after 30 seconds. Outside irradiation reduced the quantity of colonies without time-dependent effects. Both sides of irradiation for a cumulated 30 seconds or more showed almost complete decontamination.Overall, this study suggests that standardized UV irradiation schemes with treatment to both sides might be an efficient and effective method for FFP2 mask decontamination in times of insufficient supplies.

Provider experiences with daily use of elastomeric half-mask respirators in health care.

BACKGROUND: During public health emergencies, demand for N95 filtering facepiece respirators (N95 FFRs) can outpace supply. Elastomeric half-mask respirators (EHMRs) are a potential alternative that are reusable and provide the same or higher levels of protection. This study sought to examine the practical aspects of EHMR use among health care personnel (HCP). METHODS: Between September and December 2021, 183 HCPs at 2 tertiary referral centers participated in this 3-month EHMR deployment, wearing the EHMR whenever respiratory protection was required according to hospital protocols (ie, when an N95 FFR would typically be worn) and responding to surveys about their experience. RESULTS: Participants wore EHMRs typically 1 to 3 hours per shift, reported disinfecting the respirator after 85% of the removals, and reported high confidence in using the EHMR following the study. EHMRs caused minimal interference with patient care tasks, though they did inhibit communication. DISCUSSION: HCP who had not previously worn an EHMR were able to wear it as an alternative to an N95 FFR without much-reported interference with their job tasks and with high disinfection compliance. CONCLUSIONS: This study highlights the feasibility of the deployment of EHMRs during a public health emergency when an alternative respirator option is necessary.

How to improve regulatory practices for refurbished medical devices.

Modern health-care facilities rely on medical devices and equipment. However, keeping up with the development of new technology is unfeasible for many health facilities, especially in low-resource settings. Thus, the demand for refurbished medical devices is increasing worldwide, especially in low- and middle-income countries. Refurbished medical devices are restored devices that are rebuilt to meet safety and performance requirements comparable to their condition when new, without changing the intended use of the original device. While new medical devices are controlled by well-established and stringent safety and quality regulations, a great variation in the regulations of refurbished medical devices exists across countries. Here we discuss the different regulations and practices specific to refurbished medical devices in countries of major markets. We also explore the opportunities and challenges for expanding the refurbished medical device market. Finally, we suggest that regulatory guidelines pertaining to the import, sale, labelling and use of a refurbished medical product are needed, and authorities should implement these guidelines to ensure a high quality and safety standard of refurbished devices.

Les établissements de soins de santé modernes dépendent d'équipements et dispositifs médicaux. Pour nombre de ces établissements, il est toutefois impossible de suivre l'évolution des nouvelles technologies, surtout dans les lieux manquant de ressources. La demande en dispositifs médicaux remis à neuf est donc en hausse partout dans le monde, en particulier dans les pays à revenu faible et intermédiaire. Il s'agit de dispositifs restaurés, remaniés pour répondre aux mêmes exigences de sécurité et de performances que lorsqu'ils sont neufs, sans que l'usage prévu du dispositif d'origine ne soit modifié. Alors que les dispositifs médicaux neufs sont soumis à des normes de qualité et de sécurité strictes et bien établies, leurs équivalents restaurés font l'objet de règles nettement plus variables d'un pays à l'autre. Dans le présent document, nous évoquons les différentes réglementations et pratiques spécifiques aux dispositifs médicaux remis à neuf dans les pays qui abritent les principaux marchés. Nous nous intéressons en outre aux opportunités et aux défis liés à un développement du marché des dispositifs médicaux remis à neuf. Enfin, nous suggérons l'adoption de lignes directrices réglementaires concernant l'importation, la vente, l'étiquetage et l'utilisation de tels dispositifs; ces lignes directrices sont à faire appliquer par les autorités afin de garantir les normes les plus élevées en matière de qualité et de sécurité.

Los centros sanitarios modernos dependen de dispositivos y equipos médicos. Sin embargo, mantenerse al día en el desarrollo de las nuevas tecnologías no es viable para muchos centros sanitarios, sobre todo en los de escasos recursos. Por este motivo, la demanda de dispositivos médicos renovados está aumentando en todo el mundo, especialmente en los países de ingresos bajos y medios. Los dispositivos médicos renovados son dispositivos restaurados que se reconstruyen para que cumplan unos requisitos de seguridad y rendimiento comparables a los que tenían cuando eran nuevos, sin cambiar el uso previsto del dispositivo original. Mientras que los dispositivos médicos nuevos están sujetos a reglamentos estrictos y bien establecidos en materia de seguridad y calidad, los reglamentos de los dispositivos médicos renovados varían mucho de un país a otro. En este artículo, se analizan los diferentes reglamentos y prácticas específicos de los dispositivos médicos renovados en los países de los principales mercados. También se exploran las oportunidades y los desafíos que plantea la expansión del mercado de dispositivos médicos renovados. Por último, se propone que se establezcan directrices reglamentarias relativas a la importación, venta, etiquetado y uso de los dispositivos médicos renovados y que las autoridades las apliquen para asegurar su calidad y seguridad.

Infection control in the bronchoscopy suite: effective reprocessing and disinfection of reusable bronchoscopes.

PURPOSE OF REVIEW: With advancements in technology, flexible bronchoscopes have become thinner in diameter and in need of more thorough reprocessing to prevent infection transmission than ever before. Many experienced bronchoscopists are not aware of the critical steps involved in effective bronchoscope reprocessing and we hope to bridge this gap by describing this process in detail. RECENT FINDINGS: Bronchoscope reprocessing includes several distinct steps (precleaning, leak testing, manual cleaning, visual inspection, terminal reprocessing, rinsing and drying). Each step is comprehensive and needs to be carried out systematically by trained personnel. Failure of any step can lead to serious downstream events such as outbreaks and pseudo-outbreaks. Some experts now recommend sterilization when feasible, although high-level disinfection remains the minimum standard. We also will review some literature on the utility of borescopes, automated endoscope reprocessors and disposable bronchoscopes. SUMMARY: Our article will focus on the most recent recommendations for effective reprocessing and disinfection of reusable bronchoscopes.

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.

A narrative review on current duodenoscope reprocessing techniques and novel developments.

Duodenoscopy-associated infections occur worldwide despite strict adherence to reprocessing standards. The exact scope of the problem remains unknown because a standardized sampling protocol and uniform sampling techniques are lacking. The currently available multi-society protocol for microbial culturing by the Centers for Disease Control and Prevention, the United States Food and Drug Administration (FDA) and the American Society for Microbiology, published in 2018 is too laborious for broad clinical implementation. A more practical sampling protocol would result in increased accessibility and widespread implementation. This will aid to reduce the prevalence of duodenoscope contamination. To reduce the risk of duodenoscopy-associated pathogen transmission the FDA advised four supplemental reprocessing measures. These measures include double high-level disinfection, microbiological culturing and quarantine, ethylene oxide gas sterilization and liquid chemical sterilization. When the supplemental measures were advised in 2015 data evaluating their efficacy were sparse. Over the past five years data regarding the supplemental measures have become available that place the efficacy of the supplemental measures into context. As expected the advised supplemental measures have resulted in increased costs and reprocessing time. Unfortunately, it has also become clear that the efficacy of the supplemental measures falls short and that duodenoscope contamination remains a problem. There is a lot of research into new reprocessing methods and technical applications trying to solve the problem of duodenoscope contamination. Several promising developments such as single-use duodenoscopes, electrolyzed acidic water, and vaporized hydrogen peroxide plasma are already applied in a clinical setting.

Elastomeric Respirators for COVID-19 and the Next Respiratory Virus Pandemic: Essential Design Elements.

Respiratory viruses are transmitted via respiratory particles that are emitted when people breath, speak, cough, or sneeze. These particles span the size spectrum from visible droplets to airborne particles of hundreds of nanometers. Barrier face coverings ("cloth masks") and surgical masks are loose-fitting and provide limited protection from airborne particles since air passes around the edges of the mask as well as through the filtering material. Respirators, which fit tightly to the face, provide more effective respiratory protection. Although healthcare workers have relied primarily on disposable filtering facepiece respirators (such as N95) during the COVID-19 pandemic, reusable elastomeric respirators have significant potential advantages for the COVID-19 and future respiratory virus pandemics. However, currently available elastomeric respirators were not designed primarily for healthcare or pandemic use and require further development to improve their suitability for this application. The authors believe that the development, implementation, and stockpiling of improved elastomeric respirators should be an international public health priority.

The properties of hot household hygroscopic materials and their potential use for non-medical facemask decontamination.

The widespread use of facemasks throughout the population is recommended by the WHO to reduce transmission of the SARS-CoV-2 virus. As some regions of the world are facing mask shortages, reuse may be necessary. However, used masks are considered as a potential hazard that may spread and transmit disease if they are not decontaminated correctly and systematically before reuse. As a result, the inappropriate decontamination practices that are commonly witnessed in the general public are challenging management of the epidemic at a large scale. To achieve public acceptance and implementation, decontamination procedures need to be low-cost and simple. We propose the use of hot hygroscopic materials to decontaminate non-medical facemasks in household settings. We report on the inactivation of a viral load on a facial mask exposed to hot hygroscopic materials for 15 minutes. As opposed to recent academic studies whereby decontamination is achieved by maintaining heat and humidity above a given value, a more flexible procedure is proposed here using a slow decaying pattern, which is both effective and easier to implement, suggesting straightforward public deployment and hence reliable implementation by the population.

Effectiveness of oolong tea and simethicone solution for lens cleansing during colonoscopy: A double-blinded randomized study.

BACKGROUND AND AIMS: water is an imperfect agent for lens cleansing during endoscopy due to its incompetence to clean hydrophobic dirt, whereas amphiphilic surfactants have the potential to overcome the limitation of water. The trial was aimed to evaluate the cleansing effectiveness of 2 typical surfactants (simethicone solution and oolong tea) for colonoscopic lens. METHODS: Oolong tea (O-), low concentration simethicone solution (S1-), high concentration simethicone solution (S2-) and distilled water (D-) were used as washing solutions for colonoscopic lens. Study I: The tip of the colonoscope was immersed in lard oil in order to simulate the blur, and photographs were taken toward a standard colonoscopy image in-vitro pre- and post- each cleansing procedure. The blurred areas of each image were quantified and compared. Study II: 395 consecutive patients who were due to colonoscopy examination were enrolled and randomized into O-, S2-, D-group. The volume of washing solution used and cleansing level during the examination procedure, adenoma and polyp detected per colonoscopy, insertion time and withdraw time were analyzed. RESULTS: Study I: There were no differences in 4 groups for the blurred areas on images before lens cleansing. The blurred areas after lens cleansing were significantly smaller in 3 groups (O- 8.47 ±â€Š20.91 vs S1- 13.06 ±â€Š10.71 vs S2- 6.76 ±â€Š8.49 vs D- 38.24 ±â€Š29.69, P < .05) than water. The decline range of blurred areas after lens cleansing in oolong tea, low concentration simethicone solution, high concentration simethicone solution groups were significantly higher than that in distilled water group (O- 87.35 ±â€Š20.81 vs S1- 78.12 ±â€Š19.24 vs S2- 89.57 ±â€Š8.50 vs D- 53.39 ±â€Š28.45, P < .05). Study II: The volume of washing solution used in S2-group was significantly smaller than that in O-group and D-group. The cleansing level of the colonoscopic lens of O-group was significantly superior than that of S2-group and D-group. CONCLUSIONS: The in-vitro test showed oolong tea and simethicone solution can effectively cleans the colonoscopic lens. The clinical trial demonstrated that oolong tea instead of water is effective to provide better visualization during colonoscopy.Registration: Chictr.org.cn No: ChiCTR1900025606.

Comparación de los desenlaces clínicos con cuatro técnicas de apendicetomía laparoscópica tras la implementación de políticas de reúso de dispositivos médicos / Comparison of clinical outcomes with four laparoscopic appendectomy techniques after implementation of medical devices reuse policy

Resumen Objetivo: En este estudio se comparan los desenlaces clínicos de cuatro técnicas de apendicectomía laparoscópica utilizadas en una institución colombiana para el manejo de la apendicitis aguda tras la adopción de políticas de reúso y reprocesamiento de dispositivos médicos para la Región de las Américas (2014). Materiales y Método: Mediante el análisis de varianza de una vía (ANOVA) y la prueba de Kruskal Wallis, se compararon las tasas de infección de sitio operatorio (ISO), reoperación no planeada, readmisión y mortalidad (en los primeros 30 días del postoperatorio) de las siguientes técnicas: Técnica 1: Ligadura del muñón apendicular con endonudo y disección del mesenterio apendicular con electrocoagulación bipolar convencional; Técnica 2: Clipaje del muñón con endoclip de polímero y disección del mesenterio con electrocoagulación bipolar convencional; Técnica 3: Clipaje del muñón con endoclip de polímero y disección del mesenterio con electrocoagulación monopolar; Técnica 4: Clipaje del muñón y disección roma y ligadura del mesenterio con endoclip de polímero. Resultados: Se incluyeron 551 pacientes. No se encontraron diferencias en los ANOVAs en cuanto a las características demográficas de los pacientes por cada técnica. Los desenlaces globales fueron: ISO (5,44%), reoperación no planeada (3,08%), readmisión (15,97%) y mortalidad (0,18%). Se encontraron diferencias significativas (p < 0,05) en estos desenlaces explicados por mayores tasas de ISO y reoperación con la Técnica-1. Conclusiones: Los desenlaces globales de la apendicectomía laparoscópica tras la adopción de políticas de reúso de dispositivos médicos se encuentran dentro de los aceptados globalmente cuando se utilizan las Técnicas 2-3-4 en poblaciones equivalentes de pacientes con apendicitis aguda. En este contexto, nuestros resultados invitan a utilizar con precaución la Técnica-1.

Aim: The present study sought to compare the clinical outcomes between four operative techniques for laparoscopic appendectomy in a Colombian institution, following the adoption of reuse and reprocessing policies for medical devices in the Region of Americas (2014). Materials and Methods: One-way analysis of variance (ANOVA) and Kruskal Wallis tests were used to compare the rates of Surgical Site Infection (SSI), unplanned reoperation, readmission and mortality (confined to 30 days after surgery) of these operative techniques: Technique 1: Ligature of appendiceal stump with endo stitch plus mesenteric dissection with conventional bipolar electrocoagulation; Technique 2: Clipping of stump with polymer endoclip plus mesenteric dissection with conventional bipolar electrocoagulation; Technique 3: Clipping of stump with polymer endoclip plus mesenteric dissection with monopolar electrocoagulation; Technique 4: Clipping of stump plus mesenteric dissection with polymer endoclip. Results: A total of 551 patients were included. No differences were found in the demographic characteristics of the patients between techniques during ANOVAs. The global outcomes were SSI (5.44%), unplanned reoperation (3.08%), readmission (15.97%) and mortality (0.18%). Significant differences were found (p < 0.05) in these outcomes explained by higher rates of SSI and unplanned reoperation with Technique 1. Conclusions: The overall outcomes of laparoscopic appendectomy, after the adoption of policies for the reuse and reprocessing of medical devices, are similar to those accepted globally when using operative techniques 2-3-4 in equivalent populations of patients with acute appendicitis. In this context, our results invite to use with caution technique-1.