Nachhaltigkeit im OP ­ korrelieren Sterilität, Sicherheit und Service auch mit einer ressourcenschonenden Verwendung von Medizinprodukten?

In times of an unprecedented energy crisis, sustainability is becoming increasingly important. This development does not stop at medicine and especially at the operating room, where a considerable amount of greenhouse gases is produced. Due to this development, the question arises whether sterility, safety and service can be reconciled with a resource-saving use of medical devices. One goal here must be to replace disposables, which offer a high degree of sterility, with safely reprocessable reusables. Due to rising energy costs as well as supply bottlenecks, reprocessing of products offers increasing independence for the hospital. Furthermore, the move towards renewable energy for reusable products is visibly improving the carbon footprint. The independence gained by clinics also offers greater safety for patients, as the risk of unavailable materials is reduced. In addition to the goal of increasing the use of reusable items, the recycling of disposable products will also play an increasing role. Life cycle assessments will increasingly guide the optimal choice of products in this regard. In summary, these options offer the possibility of implementing the increasing need for sustainability in the OR.

Single Use or Disposable Flexible Bronchoscopes: Bench Top and Preclinical Comparison of Currently Available Devices.

BACKGROUND: Data regarding the risk of infection related to reusable bronchoscopes, the global drive toward disposable technology and the COVID-19 pandemic have led to an increase in the use and production of single use or disposable bronchoscopes. An in-depth comparison of all available devices has not been published. METHODS: A benchtop comparison of the Ambu®aScopeTM, Boston Scientific® EXALTTM Model B, the Surgical Company Broncoflex© Vortex, Pentax® Medical ONE Pulmo™, and Vathin® H-SteriscopeTM (all 2.8 mm inner dimension other than the Pentax single-use flexible bronchoscope (3 mm)) was undertaken including measurement of maximal flexion and extension angles, thumb force required and suction with and without biopsy forceps. Thereafter, preclinical assessment was performed with data collected including experience, gender, hand size, and scope preference. RESULTS: The Vathin single-use flexible bronchoscope had the biggest range of tip movement from flexion to extension with and without forceps. The Boston single-use flexible bronchoscope required the maximal thumb force but had the least reduction of tip movement with forceps. The Boston single-use flexible bronchoscope significantly outperformed all other scopes including the standard Pentax scope and was the only scope capable of suctioning pseudo-mucus around the forceps. Although there was no significant difference in preference in the overall group, females and those with smaller hand size preferred the Pentax and males the Broncoflex single-use flexible bronchoscope. CONCLUSIONS: Currently available single-use flexible bronchoscopes differ in several factors other than scope sizes and monitor including suction, turning envelope, and handle size. Performance in the clinical setting will be key to their success.

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.

Intubation using VieScope vs. Video laryngoscopy in full personal protective equipment - a randomized, controlled simulation trial.

BACKGROUND: VieScope is a new type of laryngoscope, with a straight, transparent and illuminated blade, allowing for direct line of sight towards the larynx. In addition, VieScope is disposed of after single patient use, which can avoid cross-contaminations of contagious material. This has gained importance especially when treating patients with highly contagious infectious diseases, such as during the SARS-CoV2 pandemic. In this context, VieScope has not been evaluated yet in a clinical study. MATERIAL AND METHODS: This study compared intubation with VieScope to video-laryngoscopy (GlideScope) in normal and difficult airway in a standardized airway manikin in a randomized controlled simulation trial. Thirty-five medical specialists were asked to perform endotracheal intubation in full personal protective equipment (PPE). Primary endpoint was correct tube position. First-pass rate (i.e., success rate at the first attempt), time until intubation and time until first correct ventilation were registered as secondary endpoints. RESULTS: For correct tracheal tube placement, there was no significant difference between VieScope and GlideScope in normal and difficult airway conditions. VieScope had over 91% fist-pass success rate in normal airway setting. VieScope had a comparable success rate to GlideScope in difficult airway, but had a significantly longer time until intubation and time until ventilation. CONCLUSION: VieScope and GlideScope had high success rates in normal as well as in difficult airway. There was no unrecognized esophageal intubation in either group. Overall time for intubation was longer in the VieScope group, though in an acceptable range given in literature. Results from this simulation study suggest that VieScope may be an acceptable alternative for tracheal intubation in full PPE. TRIAL REGISTRATION: The study was registered at the German Clinical Trials Register www.drks.de (Registration date: 09/11/2020; TrialID: DRKS00023406 ).

Collateral impact of COVID-19 on environmental health derived from improper disposition of masks / Impacto colateral del COVID-19 en la salud ambiental derivado de la disposición inadecuada de mascarillas

El uso de mascarillas por parte de la población general como elemento de protección personal frente al COVID-19 se mantuvo en ascenso durante la primera mitad del 2020, en medio de constantes actualizaciones de la OMS acerca del público objetivo, su correcto uso y posibles beneficios, pero donde no se definieron protocolos para el manejo del desecho resultante. Durante el segundo semestre del 2020 la población mundial usaba diariamente 4.300 millones de mascarillas, de las cuales el 78,5% se descartaban de forma incorrecta, llegando a generar un volumen de 2,61 (2,26-2,94; IC=95%) millones de toneladas de desecho diseminadas en el medio ambiente. Los componentes plásticos incorporados en la fabricación de mascarillas como PP, PE y PET pueden tardar 400 años en degradarse en condiciones ambientales, fragmentándose paulatinamente en microplásticos, que afectan a la flora, fauna, agua y suelos de su entorno. Adicionalmente, algunos aditivos sintéticos antioxidantes (AO) usados en la fabricación de plásticos pueden retardar aún más las reacciones de degradación de las mascarillas descartadas hacia el ambiente, aumentando su daño potencial. Se calculó que 216,9 (188,5-245,3; IC=95%) toneladas de AO168, 190 (165,2-214,9; IC=96%) toneladas de AO168O y 442,7 (384,8-500,6; IC=95%) toneladas de AO1010 fueron expuestas al medio ambiente debido a la disposición incorrecta de mascarillas en la segunda mitad de 2020. Aunque la masa conjunta de estos componentes sintéticos sólo representa el 0,017% de las mascarillas desechadas en el mismo lapso, su concentración resulta suficiente para acrecentar el riesgo de daño al ambiente(AU)

The use of masks by the general population as an element of personal protection against COVID-19 continued to rise during the first half of 2020, amid constant updates from the WHO about the target audience, their correct use and possible benefits, but where no protocols were defined for the management of the resulting waste. During the second half of 2020, the world population used 4.3 billion masks daily, of which 78.5% were discarded incorrectly, generating a volume of 2.61 (2.26-2.94; IC = 95%) million tons of waste disseminated in the environment. The plastic components incorporated in the manufacture of masks such as PP, PE and PET can take 400 years to degrade under environmental conditions, gradually fragmenting into microplastics, which affect the flora, fauna, water and soils of their environment. Additionally, some synthetic antioxidant additives (OA) used in the manufacture of plastics can further delay the degradation reactions of discarded masks into the environment, increasing their potential damage. It was calculated that 216.9 (188.5-245.3; IC = 95%) tons of AO168, 190 (165.2-214.9; IC = 96%) tons of AO168O and 442.7 (384.8 -500.6; IC = 95%) tons of AO1010 were exposed to the environment due to the incorrect disposal of masks in the second half of 2020. Although the combined mass of these synthetic components only represents 0.017% of the masks discarded in the same period, its concentration is sufficient to increase the risk of damage to the environment(AU)

An initial evaluation of the safety of a disposable oscillating positive expiratory pressure device in patients with chronic obstructive pulmonary disease: a sort-term pilot study.

BACKGROUND: Handheld oscillating positive expiratory pressure (OPEP) devices have been a mainstay of treatment for patients with hypersecretory conditions such as cystic fibrosis (CF) and chronic obstructive pulmonary disease (COPD) since the 1970s. Current devices are reusable and require regular cleaning and disinfection to prevent harbouring potentially pathogenic organisms. Adherence to cleaning regimens for respiratory devices is often poor and in response to this, a prototype disposable OPEP device-the 'UL-OPEP' (University of Limerick-Oscillating Positive Expiratory Pressure device)-was developed to mitigate the risk of contamination by pathogens. The device was previously evaluated successfully in a group of paediatric CF patients. The aim of the current study was to initially evaluate the safety of the prototype in patients with COPD over a period of 1 month to ensure no adverse events, negative impacts on lung function, exercise tolerance, or quality of life. Data on user experience of the device were also collected during post-study follow-up. METHODS: A sample of 50 volunteer participants were recruited from pulmonary rehabilitation clinics within the local hospital network. The patients were clinically stable, productive, and not current or previous users of OPEP devices. Participants were invited to use a prototype disposable OPEP device daily for a period of 1 month. Pre- and post-study lung function was assessed with standard spirometry, and exercise tolerance with the 6-min-walk-test (6MWT). Quality of life was assessed using the St. George's Respiratory Questionnaire (SGRQ), and user experience of the prototype device evaluated using a post-study questionnaire. RESULTS: 24 Participants completed the study: 9 were female. Overall median age was 67.5 years, range 53-85 years. Lung function, 6-min walk test, and SGRQ scores showed no significant change post-study. User feedback was positive overall. CONCLUSIONS: The results indicate that the UL-OPEP is safe to use in patients with COPD. No adverse events were recorded during the study or in the follow-up period of 2 weeks. The device did not negatively impact patients' lung function, exercise tolerance, or quality of life during short term use (1 month), and usability feedback received was generally positive. Larger, longer duration studies will be required to evaluate efficacy. Registration The study was approved as a Clinical Investigation by the Irish Health Products Regulatory Authority (CRN-2209025-CI0085).

The efficacy of continuous use disposable N95 masks in clinical practice in the emergency department.

During the SARS-CoV-2 pandemic, many emergency departments (EDs) initiated continuous use of N95 disposable respirators (N95s) rather than discarding them after each use to conserve respirators. This study investigates the efficacy of wearing disposable N95s continuously during clinical work. METHODS: This is a prospective cohort study of ED staff required to wear N95s continuously throughout their shifts. Subjects were doctors, nurses, and technicians who were previously fitted for their assigned N95 by employee health. Subjects were fit tested periodically throughout their shifts. Investigators filled out a questionnaire for each subject noting the hours of continuous N95 wear. Data were analyzed using descriptive statistics. RESULTS: One hundred thirteen N95s were evaluated, with 23 failures at first testing. These were not retested. Twenty-seven N95s passed at the start of a shift and did not have repeat testing during the course of the shift. These were excluded from further analysis. Seventeen N95s passed testing after several hours of continuous wear, but only had a single fit test done partway or at the end of a shift. These were assumed to have passed if tested at shift start, and were assigned as "passes" for continuous use. Forty-six N95s had an initial pass and were evaluated for continuous use, of which 6 subsequently failed later in the shift, giving a fail rate with continuous use of 9.5%. CONCLUSION: Continuous use of disposable N95s throughout an ED shift is reasonable during a PPE shortage if wearers are assured of fit at the start of their shift.

Bronchoscopist's perception of the quality of the single-use bronchoscope (Ambu aScope4™) in selected bronchoscopies: a multicenter study in 21 Spanish pulmonology services.

BACKGROUND: The disposable bronchoscope is an excellent alternative to face the problem of SARS-CoV-2 and other cross infections, but the bronchoscopist's perception of its quality has not been evaluated. METHODS: To evaluate the quality of the Ambu-aScope4 disposable bronchoscope, we carried out a cross-sectional study in 21 Spanish pulmonology services. We use a standardized questionnaire completed by the bronchoscopists at the end of each bronchoscopy. The variables were described with absolute and relative frequencies, measures of central tendency and dispersion depending on their nature. The existence of learning curves was evaluated by CUSUM analysis. RESULTS: The most frequent indications in 300 included bronchoscopies was bronchial aspiration in 69.3% and the median duration of these was 9.1 min. The route of entry was nasal in 47.2% and oral in 34.1%. The average score for ease of use, image, and aspiration quality was 80/100. All the planned techniques were performed in 94.9% and the bronchoscopist was satisfied in 96.6% of the bronchoscopies. They highlighted the portability and immediacy of the aScope4TM to start the procedure in 99.3%, the possibility of taking and storing images in 99.3%. The CUSUM analysis showed average scores > 70/100 from the first procedure and from the 9th procedure more than 80% of the scores exceeded the 80/100 score. CONCLUSIONS: The aScope4™ scored well for ease of use, imaging, and aspiration. We found a learning curve with excellent scores from the 9th procedure. Bronchoscopists highlighted its portability, immediacy of use and the possibility of taking and storing images.

Implementation of an Elastomeric Mask Program as a Strategy to Eliminate Disposable N95 Mask Use and Resterilization: Results from a Large Academic Medical Center.

BACKGROUND: The COVD-19 global pandemic has placed a large demand on personal protective equipment for healthcare workers. N-95 respirators, required to perform aerosolizing procedures, are in short supply and have increased significantly in cost. The lack of a clear end to the pandemic requires hospitals to create a long-term, cost effective solution to the N95 shortage. We initially used previously described methods to reuse and resterilize N95 masks; however, we found they did not solve the issues related to just-in-time fit-testing and cost. STUDY DESIGN: We initiated a program with the aim to reduce our dependence on N95 masks by initiating a phased program to acquire industrial style elastomeric P100 masks as a substitute for reuse and resterilization of disposable N95s. We created an allocation strategy based on availability of the masks, as well as an operational plan to fit test, educate, and disinfect the masks. RESULTS: Within 1 month, we were able to reduce the number of N95s needed by our network by 95%. We also found that the cost was, conservatively, 10 times less per month than purchasing disposable N95s, and the cost benefit increases the longer they are needed. CONCLUSIONS: Establishment of an elastomeric mask program is feasible and less expensive than programs focused on reusing and disinfecting disposable N95 masks. A well thought out elastomeric distribution and disinfection program does not pose greater operational challenges than an N95 reuse and resterilization program. In addition, elastomeric masks can be stored for future surges and should be considered an essential part of all healthcare facilities' supply of personal protective equipment. Implementation of the program has eliminated our dependence on disposable N95s to maintain normal operations during the global pandemic.

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.

Reuse of Disposable Isolation Gowns in Rodent Facilities during a Pandemic.

Reuse of disposable personal protective equipment is traditionally discouraged, yet in times of heightened medical applications such as the SARS CoV-2 pandemic, it can be difficult to obtain. In this article we examine the reuse of disposable gowns with respect to still providing personnel protection. XR7, a fluorescent powder, was used to track contamination of gowns after manipulation of rodent cages. Mouse cages were treated with XR7 prior to manipulations. Disposable gowns were labeled for single person use and hung in common procedure spaces within the vivarium between usages. A simulated rack change of 140 cages was completed using XR7-treated cages. One individual changed all cages with a break occurring after the first 70 cages, requiring the gown to be removed and reused once. To simulate research activities, 5 individuals accessed 3 XR7-treated cages daily for 5 d. Each mouse in the XR7-treated cages was manipulated at least once before returning cages to the housing room. Disposable gowns were reused 5 times per individual. Gowns, gloves, clothing, bare arms, and hands were scanned for fluorescence before and after removing PPE. Fluorescence was localized to gloves and gown sleeves in closest contact with animals and caging. No fluorescence was detected on underlying clothing, or bare arms and hands after removing PPE. Fluorescence was not detected in procedure spaces where gowns were hung. The lack of fluorescence on personnel or surfaces indicate that gowns can be reused 1 time for routine husbandry tasks and up to 5 times for research personnel. A method for decontamination of used gowns using Vaporized Hydrogen Peroxide (VHP) was also validated for use in areas where animals are considered high risk such as quarantine, or for fragile immunocompromised rodent colonies.

National Economic and Environmental Benefit of Reusable Textiles in Cleanroom Industry.

In cleanroom facilities, both disposable and reusable textile garments (coveralls, boots, hoods, and frocks) meet the particulate standards from the most rigorous to the most basic levels. However, the reusables clearly offer two other important benefits, lower annual cost and lower environmental impact. The objectives of this article are to now provide quantitative reusable product benefits on a U.S. national environmental and economic basis. This is the first quantitative, novel multi-user economic evaluation of selecting cleanroom reusables over disposables. For personal protection equipment (PPE), these cost and environmental benefits indicate there is also an improved environmental and economic aspect to the increased national demand for reusables related to coronavirus disease 2019 (COVID-19), while necessary cleaning with approved detergents is easily achieved. The current reusable cleanroom market (14.1 million packages) was estimated to be 60% nonsterile and 40% sterilized. The total market is about 50% reusable and 50% disposable. This research documents that there is an annual cost reduction of about 58% when selecting reusables over disposables, giving an economic savings to the U.S. cleanroom sector from reusables of about $1.2 billion in the next decade. This is also saving the total U.S. about 136 million MJ natural resource energy/year (38 million kWh) and about 8.4 million kg CO2eq annually (removal of about 1,650 cars/year). A maximum hypothetical case for reusables at 87.5% of the market (12.5% are mandatory Hazmat disposable) would yield a U.S. national savings of nearly $2.1 billion/decade to the cleanroom sector bottom line, as well as 2.4 billion MJ nre savings in energy or removal of about 29,000 cars/decade. These results indicate there are effective, verifiable, and easily obtained environmental and economic benefits by the basic transition by diverse cleanrooms in deciding to select reusable garments.

Failure Rates During Reuse of Disposable N95 Masks in Clinical Practice in the Emergency Department.

INTRODUCTION: The coronavirus 2019 pandemic caused a shortage of disposable N95 respirators, prompting healthcare entities to extend the use of these masks beyond their intended single-use manufacturer recommendation with a paucity of supporting research. METHODS: We performed a prospective cohort study of ED healthcare workers (HCW) ("subjects") required to use respirators at an academic, Level I trauma center. Subjects had been previously fit tested and assigned an appropriately sized N95 mask per hospital protocol. Per study protocol, subjects were fit tested periodically throughout their shifts and on multiple shifts over the eight-week study period. Data points collected included the age of the mask, subjective assessment of mask seal quality, and fit test results. We analyzed the data using Fisher's exact test, and calculated odds ratios (OR) to determine the failure rate of disposable N95 masks following reuse. RESULTS: A total of 130 HCWs underwent fit testing and 127 were included for analysis. Mask failure rate climbed after day 2 of use, with 33.3% of masks failing at day 3, 42.9% at day 4, and 50% at ≥ day 5. Categorizing the masks into those being used for two or fewer days vs those in use for three or more, failure was more common on day 3 of use or older compared to those in the first two days of use (41.8% vs 8.3%, P < 0.0001) with an OR of failure with an older mask of 7.9 (confidence interval [CI], 2.8-22.3). The healthcare workers' assessment of poor seal was 33.3% sensitive (CI, 18.6-51.9) and 95.7% specific (CI, 88.8-98.6) for fit test failure. CONCLUSION: Disposable N95 masks have significant failure rates following reuse in clinical practice. Healthcare personnel also performed poorly in assessing the integrity of the seal of their disposable respirators.

Endoscopy mitigation strategy with telemedicine and low-cost device use for COVID-19 prevention: A fourth-level Colombian center experience.

BACKGROUND AND STUDY AIMS: The COVID-19 outbreak has reorganized surgical team conditions regarding endoscopy. The number of interventions has been reduced, the number of healthcare professionals must be limited, and both the patients and physicians are more protected than ever. PATIENTS AND METHODS: In the highest peak of contagion in Colombia, endoscopy, colonoscopy, and esophagogastroduodenoscopy were performed using a low-cost disposable device. A total of 1388 procedures were performed. Every patient was assessed for symptoms via a telephone call, at the health center, and after the procedure, following specific attention routes. RESULTS: After procedure follow-up, no positive cases of COVID-19 were noted. CONCLUSION: The methodology reduced the risk of infection during the COVID-19 pandemic.

Stethoscope hygiene: A call to action. Recommendations to update the CDC guidelines.

Healthcare-acquired infections are a tremendous challenge to the US medical system. Stethoscopes touch many patients, but current guidance from the Centers for Disease Control and Prevention does not support disinfection between each patient. Stethoscopes are rarely disinfected between patients by healthcare providers. When cultured, even after disinfection, stethoscopes have high rates of pathogen contamination, identical to that of unwashed hands. The consequence of these practices may bode poorly in the coronavirus 2019 disease (COVID-19) pandemic. Alternatively, the CDC recommends the use of disposable stethoscopes. However, these instruments have poor acoustic properties, and misdiagnoses have been documented. They may also serve as pathogen vectors among staff sharing them. Disposable aseptic stethoscope diaphragm barriers can provide increased safety without sacrificing stethoscope function. We recommend that the CDC consider the research regarding stethoscope hygiene and effective solutions to contemporize this guidance and elevate stethoscope hygiene to that of the hands, by requiring stethoscope disinfection or change of disposable barrier between every patient encounter.