RESUMO
PURPOSE: To investigate the stability of osmolality in non-humidified and humidified incubators for assisted reproductive technologies (ART). METHODS: Drops of three single-step culture media (media A, B, and C) were incubated for 5 or 6 days covered with four different mineral oils (oils A, B, C, and D) in non-humidified incubator A, non-humidified incubator B, or humidified incubator C to investigate the effects of incubator environment (humidification), drop volume, culture media, and mineral oil on the stability of osmolality in microdrops. RESULTS: A significant and linear increase was shown in the osmolality of 50-µL and 200-µL microdrops covered with mineral oil during 5 days incubation in non-humidified benchtop incubators. The maximum increase was 20 mOsm/kg, and the extent of the increase was affected by microdrop volume and possibly by the type of mineral oil used to cover the drops. In contrast, the osmolality of 50-µL and 200-µL microdrops did not change during 5 days incubation in a humidified benchtop incubator. CONCLUSIONS: Mineral oil alone may not adequately prevent gradual changes in the osmolality of low-volume microdrops during extended in vitro culture of human embryos in non-humidified incubators. As a result, the osmolality may increase to high enough levels to stress some human embryos and adversely affect clinical outcomes. We therefore recommend that the stability of osmolality should be given more consideration to ensure optimal culture conditions for ART.
Assuntos
Técnicas de Cultura Embrionária/instrumentação , Embrião de Mamíferos/citologia , Fertilização in vitro/normas , Umidade/normas , Incubadoras/normas , Meios de Cultura , Técnicas de Cultura Embrionária/métodos , Técnicas de Cultura Embrionária/normas , Desenvolvimento Embrionário , Feminino , Humanos , Óleo Mineral , Concentração OsmolarRESUMO
BACKGROUND: Approximately half of the 55,000 very low birth-weight infants (<1500 g) born in the United States each year develop bronchopulmonary dysplasia (BPD). Many etiologies have been associated with the development of BPD, including aberrant temperature/humidity levels of artificial ventilation. PURPOSE: The purpose of this literature review is to explore what is known regarding inspired air temperature/humidity levels from artificial ventilation in very premature infants, focusing on what levels these infants actually receive, and what factors impact these levels. METHODS/SEARCH STRATEGY: PubMed, CINAHL, Scopus, and Web of Science were searched. Of the 830 articles retrieved, 23 were synthesized for study purpose, sample/study design, and temperature/humidity findings. FINDINGS/RESULTS: Heating and humidification practices studied in neonatal ventilation did not maintain recommended levels. In addition, human neonatal studies and noninvasive neonatal ventilation research were limited. Furthermore, ventilation settings, environmental temperatures, and mouth position (in noninvasive ventilation) were found to impact temperature/humidity levels. IMPLICATIONS FOR PRACTICE: Environmental temperatures and ventilatory settings merit consideration during artificial ventilation. In addition, aberrant temperature/humidity levels may impact infant body temperature stability; thus, employing measures to ensure adequate thermoregulation while receiving artificial ventilation must be a priority. IMPLICATIONS FOR RESEARCH: This review underscores the need for further research into current warming and humidification techniques for invasive and noninvasive neonatal ventilation. A focus on human studies and the impact of aberrant levels on infant body temperature are needed. Future research may provide management options for achieving and maintaining target temperature/humidity parameters, thus preventing the aberrant levels associated with BPD.
Assuntos
Displasia Broncopulmonar/terapia , Temperatura Alta/uso terapêutico , Umidade , Respiração Artificial/métodos , Respiração Artificial/normas , Ventiladores Mecânicos/normas , Humanos , Umidade/normas , Recém-Nascido , Recém-Nascido Prematuro , Recém-Nascido de muito Baixo Peso , Ventilação não Invasiva/métodos , TemperaturaRESUMO
There is a direct relationship between the quality of the environment of a workplace and the productivity and efficiency of the work accomplished. Components such as temperature, humidity, ventilation, drafts, lighting, and noise each contribute to the quality of the overall environment and the sense of well-being of those who work there.The modern operating room is a unique workplace with specific, and frequently conflicting, environmental requirements for each of the inhabitants. Even minor disturbances in the internal environment of the operating room can have serious ramifications on the comfort, effectiveness, and safety of each of the inhabitants. A cool, well-ventilated, and dry climate is optimal for many members of the surgical team. Any significant deviation from these objectives raises the risk of decreased efficiency and productivity and adverse surgical outcomes. A warmer, more humid, and quieter environment is necessary for the patient. If these requirements are not met, the risk of surgical morbidity and mortality is increased. An important task for the surgical team is to find the correct balance between these 2 opposed requirements. Several of the components of the operating room environment, especially room temperature and airflow patterns, are easily manipulated by the members of the surgical team. In the following discussion, we will examine these elements to better understand the clinical ramifications of adjustments and accommodations that are frequently made to meet the requirements of both the surgical staff and the patient.
Assuntos
Meio Ambiente , Salas Cirúrgicas/normas , Local de Trabalho/normas , Humanos , Umidade/normas , Iluminação/normas , Saúde Ocupacional/normas , Temperatura , Ventilação/métodos , Ventilação/normasRESUMO
BACKGROUND: The minimum inhaled gas absolute humidity level is 20âmgH2O l for short-duration use in general anaesthesia and 30âmgH2O l for long-duration use in intensive care to avoid respiratory tract dehydration. OBJECTIVE: The aim is to compare the effects of different fresh gas flows (FGFs) through a circle rebreathing system with or without a heat and moisture exchanger (HME) on inhaled gas absolute humidity in adults undergoing general anaesthesia. DESIGN: Systematic review and meta-analyses of randomised controlled trials. We defined FGF (lâmin) as minimal (0.25 to 0.5), low (0.6 to 1.0) or high (≥2). We extracted the inhaled gas absolute humidity data at 60 and 120âmin after connection of the patient to the breathing circuit. The effect size is expressed as the mean differences and corresponding 95% confidence intervals (CI). DATA SOURCES: PubMed, EMBASE, SciELO, LILACS and CENTRAL until January 2017. RESULTS: We included 10 studies. The inhaled gas absolute humidity was higher with minimal flow compared with low flow at 120âmin [mean differences 2.51 (95%CI: 0.32 to 4.70); Pâ=â0.02] but not at 60âmin [mean differences 2.95 (95%CI: -0.95 to 6.84); Pâ=â0.14], and higher with low flow compared with high flow at 120âmin [mean differences 7.19 (95%CI: 4.53 to 9.86); Pâ<â0.001]. An inhaled gas absolute humidity minimum of 20âmgH2O l was attained with minimal flow at all times but not with low or high flows. An HME increased the inhaled gas absolute humidity: with minimal flow at 120âmin [mean differences 8.49 (95%CI: 1.15 to 15.84); Pâ=â0.02]; with low flow at 60âmin [mean differences 9.87 (95%CI: 3.18 to 16.57); Pâ=â0.04] and 120âmin [mean differences 7.19 (95%CI: 3.29 to 11.10); Pâ=â0.003]; and with high flow of 2âl min at 60âmin [mean differences 6.46 (95%CI: 4.05 to 8.86); Pâ<â0.001] and of 3âl min at 120âmin [mean differences 12.18 (95%CI: 6.89 to 17.47); Pâ<â0.001]. The inhaled gas absolute humidity data attained or were near 30âmgH2O l when an HME was used at all FGFs and times. CONCLUSION: All intubated patients should receive a HME with low or high flows. With minimal flow, a HME adds cost and is not needed to achieve an appropriate inhaled gas absolute humidity.
Assuntos
Anestesia com Circuito Fechado/métodos , Anestesia Geral/métodos , Anestésicos Inalatórios/administração & dosagem , Temperatura Alta , Umidade , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Administração por Inalação , Anestesia com Circuito Fechado/instrumentação , Anestesia Geral/instrumentação , Temperatura Alta/uso terapêutico , Humanos , Umidade/normas , Resultado do TratamentoRESUMO
In 2010, the Addendum D to ASHRAE Standard 170, "Ventilation of healthcare facilities," lowered the minimum relative humidity (RH) requirement of anesthetizing locations (including operating rooms, operating/surgical cystoscopic rooms, delivery rooms (Caesarean), recovery rooms, critical and intensive care, newborn intensive care, treatment rooms, trauma rooms (crisis or shock), laser eye rooms, newborn nursery suites, and endoscopy rooms) from 30 % to 20 %. The new minimum limit was adopted based on the results of a review paper that suggested that lowering humidity levels will have little or no impact on providing a safe environment for patients, staff, or medical equipment. That review paper reached this conclusion by assuming that there were no medical device failures due to electrostatic discharge (ESD). However, in an examination of the FDA's MAUDE database of reported defects and recalls, we identified numerous medical device failures explicitly due to ESD. This paper presents technical reliability and safety concerns regarding the new guidelines and recommends that such changes should not be implemented and that the guidelines should be revoked.
Assuntos
Falha de Equipamento , Umidade/normas , Salas Cirúrgicas/normas , Eletricidade Estática/efeitos adversos , Ventilação/normas , Humanos , Reprodutibilidade dos TestesRESUMO
Inadequate gas conditioning during non-invasive ventilation (NIV) can impair the anatomy and function of nasal mucosa. The resulting symptoms may have a negative effect on patients' adherence to ventilatory treatment, especially for chronic use. Several parameters, mostly technical aspects of NIV, contribute to inefficient gas conditioning. Factors affecting airway humidity during NIV include inspiratory flow, inspiratory oxygen fraction, leaks, type of ventilator, interface used to deliver NIV, temperature and pressure of inhaled gas, and type of humidifier. The correct application of a humidification system may avoid the effects of NIV-induced drying of the airway. This brief review analyses the consequences of airway dryness in patients receiving NIV and the technical tools necessary to guarantee adequate gas conditioning during ventilatory treatment. Open questions remain about the timing of gas conditioning for acute or chronic settings, the choice and type of humidification device, the interaction between the humidifier and the underlying disease, and the effects of individual humidification systems on delivered humidity.
Assuntos
Umidade , Nebulizadores e Vaporizadores , Respiração com Pressão Positiva/métodos , Humanos , Umidade/normas , Mucosa Nasal/patologia , Mucosa Nasal/fisiologia , Nebulizadores e Vaporizadores/normas , Respiração com Pressão Positiva/normas , Apneia Obstrutiva do Sono/fisiopatologia , Apneia Obstrutiva do Sono/terapiaRESUMO
The study describes the housing conditions of 106 dwellings in the town of Chieti (Abruzzo region, central Italy), inspected by Local Health Authority, in the period between the 1st of January 2009 and the 28th of February 2011. In 59.4% of them lived Italians, while in the remaining 40.6% lived foreigners. 35.8% of the houses met minimum law requirements, 24.5% were anti-hygienic, 24.5% anti-hygienic and overcrowded, 13.2% overcrowded, 1.9% uninhabitable. The main issues were moisture and molds (52.8%). The second one was the inadequacy of floor area in relation with inhabitants (37.7%). Other problems were bedrooms (9.4%), baths (8.5%) and kitchens not complying minimum law requirements, but also not sufficient both ceiling hights (3.7%) and windows (2.8%) of rooms. Considering that human population in richest countries spend up to 90% of their lives in indoor environment, especially at home, the links between housing and health are really strong, and more must be done to improve general consideration of these themes both in general population and involved professionists (i.e. physicians, other health professionists, social workers, architects and engineers).
Assuntos
Poluição do Ar em Ambientes Fechados/análise , Fungos , Habitação/estatística & dados numéricos , Habitação/normas , Microbiologia do Ar/normas , Emigrantes e Imigrantes/estatística & dados numéricos , Nível de Saúde , Calefação/normas , Humanos , Umidade/normas , Itália/epidemiologia , Densidade Demográfica , Pobreza/estatística & dados numéricos , Saúde Pública , Estudos Retrospectivos , Estudos de AmostragemRESUMO
PURPOSE: The study was carried out to evaluate the effect of exposing solid tetanus toxoid to moisture in two different ways on the structure and function of the toxoid. METHODS: Tetanus toxoid was exposed to moisture by (i) the addition of an optimized amount of buffer and (ii) incubation under an environment provided by a saturated solution of K(2)CrO(4.) The changes in the conformational, structural and antigenic properties of tetanus toxoid were measured and compared. RESULTS: Results show that even at a similar level of moisture-induced aggregation, the amounts of water absorbed by the two preparations of tetanus toxoid are different. Differences in antigenicity and changes in structure of the toxoid at primary, secondary and tertiary structure levels were seen. CONCLUSION: Although both conditions are used to mimic accelerated stability conditions in the laboratory, the final products are different in the two cases. Thus, conditions for 'accelerated stability studies' for therapeutic proteins need to be selected with care so that they resemble the fate of the actual product.
Assuntos
Umidade , Toxoide Tetânico/química , Estabilidade de Medicamentos , Umidade/normas , Toxoide Tetânico/normas , Fatores de TempoRESUMO
BACKGROUND: Humidification by artificial means must be provided when the upper airway is bypassed during mechanical ventilation. Heated humidification (HH) and heat and moisture exchangers (HMEs) are the most commonly used types of artificial humidification in this situation. OBJECTIVES: To determine whether HHs or HMES are more effective in preventing mortality and other complications in people who are mechanically ventilated. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library 2010, Issue 4) and MEDLINE, EMBASE and CINAHL (January, 2010) to identify relevant randomized controlled trials. SELECTION CRITERIA: We included randomized controlled trials comparing HMEs to HHs in mechanically ventilated adults and children. We included randomized crossover studies. DATA COLLECTION AND ANALYSIS: We assessed the quality of each study and extracted the relevant data. Where appropriate, results from relevant studies were meta-analyzed for individual outcomes. MAIN RESULTS: We included 33 trials with 2833 participants; 25 studies were parallel group design (n = 2710) and 8 crossover design (n = 123). Only 3 included studies reported data for infants or children. There was no overall effect on artificial airway occlusion, mortality, pneumonia, or respiratory complications; however, the PaCO(2) and minute ventilation were increased when HMEs were compared to HHs and body temperature was lower. The cost of HMEs was lower in all studies that reported this outcome. There was some evidence that hydrophobic HMEs may reduce the risk of pneumonia and that blockages of artificial airways may be increased with the use of HMEs in certain subgroups of patients. AUTHORS' CONCLUSIONS: There is little evidence of an overall difference between HMEs and HHs. However, hydrophobic HMEs may reduce the risk of pneumonia and the use of an HMEs may increase artificial airway occlusion in certain subgroups of patients. Therefore, HMEs may not be suitable for patients with limited respiratory reserve or prone to airway blockage. Further research is needed relating to hydrophobic versus hygroscopic HMEs and the use of HMEs in the pediatric and neonatal populations. As the design of HMEs evolves, evaluation of new generation HMEs will also need to be undertaken.
Assuntos
Temperatura Alta/uso terapêutico , Umidade , Respiração Artificial/métodos , Adulto , Criança , Humanos , Umidade/normas , Ensaios Clínicos Controlados Aleatórios como Assunto , Respiração Artificial/efeitos adversos , Respiração Artificial/mortalidadeRESUMO
During the detection of industrial toxic gases, such as triethylamine (TEA), poor selectivity and negative humidity impact are still challenging issues. A frequently reported strategy is to employ molecular sieves or metal-organic framework (MOF) membranes so that interference derived from surrounding gases or water vapor can be blocked. Nevertheless, the decline in the response signal was also observed after coating these membranes. Herein, an alternative strategy that is based on a hydrophobic, TEA adsorption-selective p-n conjunction core-shell heterostructure is proposed and is speculated to simultaneously enhance selectivity, sensitivity, and humidity resistance. To verify the practicability of the proposed strategy, a thickness-tunable nitrogen-doped carbon (N-C) shell-coated α-Fe2O3 nano-olive (N-C@α-Fe2O3 NO)-based core-shell heterostructure that is obtained via a unique all-vapor-phase processing method is selected as the research example. After forming the core-shell heterostructure, a relatively hydrophobic and TEA adsorption-selective N-C@α-Fe2O3 NO surface was experimentally confirmed. Particularly, a chemiresistive sensor that comprises N-C@α-Fe2O3 NOs exhibits satisfactory selectivity and response magnitude to TEA when compared with the sensor using α-Fe2O3 NOs. The detection limit can even reduce to be 400 ppb at 250 °C. Furthermore, the sensor based on N-C@α-Fe2O3 NOs shows desirable humidity resistance within the relative humidity (RH) range of 30-90%. For practical usage, a sensing prototype based on the N-C@α-Fe2O3 NO probe is fabricated, and its satisfactory sensing performance further confirms the potential for future applications in industrial organic amine detection. These promising results show a bright future in enhancing the humidity resistance and selectivity as well as sensitivity of chemiresistive sensors by simply designing a hydrophobic and target gas adsorption (e.g., TEA) preferred p-n junction core-shell heterostructure.
Assuntos
Etilaminas/química , Umidade/normas , Interações Hidrofóbicas e Hidrofílicas , AdsorçãoRESUMO
The main objective of this study was to evaluate the correlation between the Environmental Relative Moldiness Index (ERMI) values in the Department of Housing and Urban Development American Healthy Homes Survey (AHHS) homes and an alternative analysis frequently used in mold investigations, i.e., the inspector's "walk-through" assessment of visual or olfactory evidence of mold combined with occupant's answers to a questionnaire about mold odors and moisture. Homes in the highest ERMI quartile were in agreement with visual inspection and/or occupant assessment 48% of the time but failed to detect the mold in 52% of the fourth quartile homes. In about 7% of lowest ERMI quartile homes, the inspection and occupant assessments overestimated the mold problem. The ERMI analysis of dust from homes may be useful in finding hidden mold problems. An additional objective was to compare the ERMI values in inner city east-Baltimore homes, where childhood asthma is common, to the AHHS randomly selected homes.
Assuntos
Fungos , Habitação/normas , Umidade/normas , Poluição do Ar em Ambientes Fechados , Baltimore , Poeira , Fungos/isolamento & purificação , Inquéritos Epidemiológicos , Estados Unidos , United States Government Agencies/normasRESUMO
This paper emphasizes the importance of environmental protection regarding the reduction of energy consumption while maintaining living standards. The aim of the research is to observe the effects of mechanical and natural ventilation on energy consumption and building operation as well as indoor environmental quality (IEQ). The results of indoor environmental quality testing show that the mean relative humidity (31%) is in the permissible range (30%-70%); the mean CO2 concentration (1050.5 ppm) is above the recommended value of 1000 ppm according to Pettenkofer; and the mean PM10 concentration (43.5 µg/m3) is under the limit value of 50 µg/m3. A very large positive correlation is found between relative humidity and concentration of CO2 as well as between the concentration of PM5 and the concentration of CO2. The most commonly occurring sick building syndrome (SBS) symptoms are found to be fatigue and the feeling of a heavy head.
Assuntos
Poluição do Ar em Ambientes Fechados/prevenção & controle , Umidade/normas , Ventilação , Ar Condicionado , Dióxido de Carbono , Humanos , Material Particulado , Fenômenos FísicosRESUMO
BACKGROUND: High-flow nasal cannula (HFNC) therapy is used for patients with respiratory failure. Recently, HFNC therapy with very high gas flows (ie, gas flows of 60-100 L/min) was reported to generate higher positive airway pressure and an associated decrease in breathing frequency. However, the humidification of HFNC therapy with very high gas flow remains to be clarified. METHODS: We evaluated 3 heated humidifier systems: a single MR850, the Hummax2, and parallel MR850s. The MR850 is a pass-over humidifier system, and the Hummax2 works with a porous hollow polyethylene fiber membrane. The parallel MR850 system included 2 MR850s connected in parallel to the lung with a 22 mm Y-piece. Gas flow was set at 40-90 L/min in increments of 10 L/min, and FIO2 was set at 0.21. Heated humidifiers in the MR850 systems were set in invasive mode (40°C/-3), and with the Hummax2 the vapor temperature was set at 39°C. The simulated external nares were connected to a test lung via a standard ventilator circuit. One-way valves prevented mixing of inspired and expired gases. Compliance of the test lung was 0.05 L/cm H2O and resistance 5 cm H2O/L/s. Simulated tidal volumes (VT) were 300, 500, and 700 mL, with a breathing frequency of 10 or 20 breaths/min and an inspiratory time of 1.0 s. Temperature, relative humidity, and absolute humidity (AH) of inspired gas downstream of the external nares were measured using a hygrometer for 1 min, and results for the last 3 breaths were extracted. RESULTS: With the single MR850, when gas flow was > 80 L/min, AH decreased as gas flow increased (P < .001). With the Hummax2, as gas flow increased, AH decreased (P < .001). With the parallel MR850s, regardless of gas flow, AH was constant. As breathing frequency increased, AH increased in all systems. CONCLUSIONS: During HFNC therapy with very high gas flows in this bench study, conventional heated humidifiers did not provide adequate humidification. Caution is advised when using HFNC therapy with very high gas flows with conventional heated humidifiers.
Assuntos
Calefação , Umidificadores/normas , Oxigenoterapia/instrumentação , Insuficiência Respiratória/terapia , Cateterismo/métodos , Simulação por Computador , Desenho de Equipamento , Calefação/métodos , Calefação/normas , Humanos , Umidade/normas , Teste de Materiais/métodos , Oxigenoterapia/efeitos adversos , Oxigenoterapia/métodosAssuntos
Centers for Medicare and Medicaid Services, U.S./normas , Ambiente de Instituições de Saúde/normas , Umidade/normas , Salas Cirúrgicas/normas , Códigos de Obras/normas , Códigos de Obras/tendências , Centers for Medicare and Medicaid Services, U.S./tendências , Ambiente de Instituições de Saúde/tendências , Humanos , Estados UnidosRESUMO
Existing thermal comfort field studies are mainly focused on the relationship between the indoor physical environment and the thermal comfort. In numerous chamber experiments, physiological parameters were adopted to assess thermal comfort, but the experiments' conclusions may not represent a realistic thermal environment due to the highly controlled thermal environment and few occupants. This paper focuses on determining the relationships between upper extremity skin temperatures (i.e., finger, wrist, hand and forearm) and the indoor thermal comfort. Also, the applicability of predicting thermal comfort by using upper extremity skin temperatures was explored. Field studies were performed in office buildings equipped with split air-conditioning (SAC) located in the hot summer and cold winter (HSCW) climate zone of China during the summer of 2016. Psychological responses of occupants were recorded and physical and physiological factors were measured simultaneously. Standard effective temperature (SET*) was used to incorporate the effect of humidity and air velocity on thermal comfort. The results indicate that upper extremity skin temperatures are good indicators for predicting thermal sensation, and could be used to assess the thermal comfort in terms of physiological mechanism. In addition, the neutral temperature was 24.7 °C and the upper limit for 80% acceptability was 28.2 °C in SET*.
Assuntos
Ar Condicionado/normas , Umidade/normas , Temperatura Cutânea/fisiologia , Temperatura , Extremidade Superior/fisiologia , Adulto , China , Feminino , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
The atomic force microscope (AFM) colloid probe technique was utilized to measure cohesion forces (separation energy) between three drug systems as a function of relative humidity (RH). The subsequent data was correlated with in vitro aerosolization data collected over the same RH range. Three drug-only systems were chosen for study; salbutamol sulphate (SS), triamcinolone acetonide (TAA), and di-sodium cromoglycate (DSCG). Analysis of the AFM and in vitro data suggested good correlations, with the separation energy being related inversely to the aerosolization performance (measured as fine particle fraction, FPF(LD)). In addition, the relationship between, cohesion, RH, and aerosolization performance was drug specific. For example, an increase in RH between 15% and 75% resulted in increased cohesion and decreased FPF(LD) for SS and DSCG. In comparison, for TAA, a decrease in cohesion and increased FPF(LD) was observed when RH was increased (15-75%). Linear regression analysis comparing AFM with in vitro data indicated R(2) values > 0.80, for all data sets, suggesting the AFM could be used to indicate in vitro aerosolization performance.
Assuntos
Aerossóis/análise , Coloides/análise , Microscopia de Força Atômica/métodos , Nebulizadores e Vaporizadores/normas , Administração por Inalação , Aerossóis/química , Aerossóis/normas , Coloides/química , Coloides/normas , Umidade/normas , Pós/análise , Pós/classificação , Pós/normas , Valor Preditivo dos TestesRESUMO
This synopsis of the background to the standardization of medical devices allows a comparison of the functional operation of two regulatory authorities, the FDA and the European Commission. It can be seen that with time they have developed many common features. However, there remains a significant difference with the older style of regulation imposed by the FDA, in particular the obligation to comply with USA Federal Law and Federal Codes of Regulation. Further, the FDA expects manufacturers, when submitting medical devices for approval, to provide their own supportive evidence by showing compliance with ISO and IEC good manufacturing practice and safety standards. Finally, it is only pragmatic to accept that marketing permission for all devices is ultimately overseen, inspected and enforced solely by the FDA. By comparison, within Europe it is the more modern Medical Device Directives of the European Commission that are the statutory legislation. In order to market a medical device, the only fundamental responsibility of the manufacturer is that it must have a CE marking, which is achieved by showing compliance with the Essential Requirements. One means of accomplishing this is to conform with the provisions of relevant harmonized standards. Such concurrence may be verified if needed, by one of the international pool of independent Notified Bodies, who are ultimately overseen by the Competent Authorities of the individual States of the Community. The preparation of standards for medical devices is a slow process, involving the cooperation of the multiple stakeholders with an interest in the device. They are expected to produce a final document that is fair, consistent and practical for all the parties involved, from the initial designer to the final patient to whom the device is attached. Analysis of the three standards applicable to humidifiers, HME and BSF demonstrates some of the difficulties encountered in meeting these obligations. It is to be hoped that the solutions which were found achieve the ultimate goal of all medical device standards-specifically that the equipment should not cause a hazard to either the patient or user. But it is interesting to wonder whether it can be shown that any BSF meets one of the prime requirements of the FDA, to wit that all medical devices must be able to demonstrate efficacy. There is a dearth of clinical trials supporting the allegation of BSF manufacturers that the routine use of these devices improves patient care, which can only be taken to mean that to date such claims are difficult to vindicate. This paralogism must be countered by the indisputable fact that BSF can significantly increase the work of breath-ing, enlarge the deadspace and even, as has been shown recently, result ina complete blockage of the breathing system. Whatever standards are in place with reference to any particular medical device, it must never be forgotten that it is only the clinician who will finally be accountable for the safe and effective operation of the equipment. While caveat emptor must always be the shibboleth of the purchaser, statutory or advisory regulations are no defense for an incompetent user.
Assuntos
Filtração/normas , Umidade/normas , Respiração Artificial/instrumentação , Dispositivos de Proteção Respiratória , Gestão da Segurança/normas , Canadá , União Europeia , Regulamentação Governamental , Humanos , Cooperação Internacional , Padrões de Referência , Estados UnidosRESUMO
In a previous study, hydroxypropyl cellulose (HPC)-based capsular shells prepared by injection molding and intended for pulsatile release were successfully coated with 10mg/cm(2) Eudragit® L film. The suitability of HPC capsules for the development of a colon delivery platform based on a time dependent approach was demonstrated. In the present work, data logging devices (PyroButton®) were used to monitor the microenvironmental conditions, i.e. temperature (T) and relative humidity (RH), during coating processes performed under different spray rates (1.2, 2.5 and 5.5g/min). As HPC-based capsules present special features, a preliminary study was conducted on commercially available gelatin capsules for comparison purposes. By means of PyroButton data-loggers it was possible to acquire information about the impact of the effective T and RH conditions experienced by HPC substrates during the process on the technological properties and release performance of the coated systems. The use of increasing spray rates seemed to promote a tendency of the HPC shells to slightly swell at the beginning of the spraying process; moreover, capsules coated under spray rates of 1.2 and 2.5g/min showed the desired release performance, i.e. ability to withstand the acidic media followed by the pulsatile release expected for uncoated capsules. Preliminary stability studies seemed to show that coating conditions might also influence the release performance of the system upon storage.