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Expert Rev Med Devices ; 17(6): 483-489, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32434400


To predict the spread of coronavirus disease globally and consequently prepare the hospital facilities with the required technology is a challenge. The availability of essential medical equipment to support patients affected by Covid-19 is globally limited. Areas covered This perspective gives a technical view of the pandemic focusing on the main actions taken by regulatory agencies to cope with the shortage of devices. The risk/benefit assessment and the main infection control policies in the clinical practices are also looked at. Expert opinion Regulatory agencies have amended their medical devices directives to address the pandemic, but each in a different way. In this exceptional situation scientist and technology experts in collaboration with medical specialists should work together to re-assess the risk analysis on medical equipment management and their use and re-use in this context with the aim to improve global health care Every effort must be made to provide the necessary devices at least with the minimum acceptable performances for Covid-19 patients while maintaining a high standard of safety for users. The aim of the present manuscript is to highlight the technical challenges in order to prevent, through targeted actions, operating standards from falling below the standards of care due to a lack of medical devices. Abbreviations AKI: acute Kidney Injury; ARGMD: Australian Regulatory Guidelines for Medical Devices; Covid-19: Coronavirus disease; FDA: Food and Drug Administration; ECMO: Extracorporeal Membrane Oxygenation; EU: European Union; ICU: Intensive Care Unit; WHO: World Health Organization; MHRA: Medicines and Healthcare products Regulatory Agency; MDR: Medical Device Regulation; SARI: Severe Acute Respiratory Infection.

Betacoronavirus/fisiologia , Infecções por Coronavirus/epidemiologia , Equipamentos e Provisões/virologia , Pneumonia Viral/epidemiologia , Humanos , Unidades de Terapia Intensiva , Pandemias , Assistência ao Paciente , Medição de Risco , Controle Social Formal
J Med Virol ; 87(4): 583-8, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25611818


In September 2010, an outbreak of acute hepatitis B virus (HBV) infections in a nursing home was notified to public health authorities in Northern Germany. To identify the route of transmission and prevent further cases a retrospective cohort study was conducted. Blood samples of residents were tested for serologic markers of HBV infection and HBV subgenotypes and sequences were analyzed. Outbreak-related cases were defined as residents of the nursing home with detection of hepatitis B surface antigen (HBsAg) and the HBV DNA sequence of the outbreak strain in 2010. Information on possible risk factors as patient care, invasive diagnostic, and therapeutical procedures was collected using a standardized questionnaire. Risk ratios (RR) and 95% confidence intervals (CI) were estimated with exact Poisson regression and binomial regression. Sixty-four residents were included in the study, 5 of them were outbreak-related cases, 12 had a past HBV infection. The outbreak strain belonged to HBV genotype D2 (HBsAg subtype ayw3, Ala118) which is not prevalent in Germany but in Eastern Europe. All cases (median age 81) were female, had diabetes, blood glucose monitoring, and chiropody. In multivariable analysis only blood glucose monitoring was associated with HBV infection (RR = 22, 95%CI 3.0-∞). Blood glucose monitoring was reported to be done by nursing home staff with patient-based reusable lancet devices. In nursing home settings the use of single use lancets for blood glucose monitoring is recommended strongly to prevent transmission. National guidelines on the handling of point-of-care devices and reusable equipment in long-term care facilities should be developed.

Surtos de Doenças , Equipamentos e Provisões/virologia , Hepatite B/epidemiologia , Hepatite B/transmissão , Casas de Saúde , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Feminino , Genótipo , Alemanha/epidemiologia , Antígenos de Superfície da Hepatite B/sangue , Vírus da Hepatite B/classificação , Vírus da Hepatite B/genética , Vírus da Hepatite B/isolamento & purificação , Humanos , Estudos Retrospectivos , Fatores de Risco , Inquéritos e Questionários
J Infect Public Health ; 7(2): 153-60, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24314741


BACKGROUND: Ultrasound transducer reprocessing is required to prevent the transmission of infections between patients. In some regions, reprocessing practices are not sufficient to achieve high-level disinfection (HLD), which can result in contaminated probes. Furthermore, current manual HLD methods use toxic chemicals and are prone to operator error/variability. The development of automated, non-toxic HLD disinfection devices may reduce the risk of transmission and reduce safety risks for operators and patients. This study investigated the disinfection efficacy of a hydrogen peroxide-based, automated HLD device, the Trophon(®) EPR, against a range of international standards. METHODS: Disinfection efficacy was assessed in carrier and simulated use tests against 21 different species of bacteria, fungi and viruses. Carrier tests were performed by placing carriers throughout the disinfection chamber and measuring the log reduction in viable organisms following disinfection. These tests were performed according to Association of Analytical Communities International Official Methods and European and ASTM International Standards for bactericidal, fungicidal, mycobactericidal, sporicidal and virucidal disinfection. Simulated use tests involving the disinfection of six widely used ultrasound probe models were conducted according to ASTM-E1837-96 using Mycobacterium terrae as a test organism. RESULTS: The device satisfied criteria for HLD and sporicidal disinfection efficacy under all standards tested. CONCLUSIONS: Automated, hydrogen peroxide-based disinfection devices offer an alternative to manual ultrasound probe disinfection technologies. Such devices reduce the risks of operator error and can improve patient and operator safety by preventing exposure to toxic chemicals. The adoption of next-generation disinfection devices may help to decrease infection risk and improve patient safety.

Desinfetantes/farmacologia , Desinfecção/métodos , Equipamentos e Provisões/microbiologia , Equipamentos e Provisões/virologia , Peróxido de Hidrogênio/farmacologia , Bactérias/efeitos dos fármacos , Fungos/efeitos dos fármacos , Viabilidade Microbiana/efeitos dos fármacos , Ultrassonografia/instrumentação , Vírus/efeitos dos fármacos
Biotechnol Bioeng ; 110(7): 2058-62, 2013 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-23436242


The infectivity of high-titer, cell-free HIV in culture media and human milk is rapidly reduced upon exposure to polyethylene slides painted with the linear hydrophobic polycation N,N-dodecyl,methyl-polyethylenimine (DMPEI). Accompanying viral p24 protein and free viral RNA analysis of solutions exposed to DMPEI-coated surfaces suggests that virion attachment to the polycationic surface and its subsequent inactivation are the likely mechanism of this phenomenon.

Desinfetantes/farmacologia , Microbiologia Ambiental , Equipamentos e Provisões/virologia , HIV/efeitos dos fármacos , Polietilenoimina/análogos & derivados , Humanos , Viabilidade Microbiana/efeitos dos fármacos , Polietilenoimina/farmacologia , Carga Viral
BMC Infect Dis ; 12: 174, 2012 Aug 03.
Artigo em Inglês | MEDLINE | ID: mdl-22856652


BACKGROUND: The near-patient environment is often heavily contaminated, yet the decontamination of near-patient surfaces and equipment is often poor. The Nanoclave Cabinet produces large amounts of ultraviolet-C (UV-C) radiation (53 W/m2) and is designed to rapidly disinfect individual items of clinical equipment. Controlled laboratory studies were conducted to assess its ability to eradicate a range of potential pathogens including Clostridium difficile spores and Adenovirus from different types of surface. METHODS: Each test surface was inoculated with known levels of vegetative bacteria (10(6) cfu/cm(2)), C. difficile spores (10(2)-10(6) cfu/cm(2)) or Adenovirus (10(9) viral genomes), placed in the Nanoclave Cabinet and exposed for up to 6 minutes to the UV-C light source. Survival of bacterial contaminants was determined via conventional cultivation techniques. Degradation of viral DNA was determined via PCR. Results were compared to the number of colonies or level of DNA recovered from non-exposed control surfaces. Experiments were repeated to incorporate organic soils and to compare the efficacy of the Nanoclave Cabinet to that of antimicrobial wipes. RESULTS: After exposing 8 common non-critical patient care items to two 30-second UV-C irradiation cycles, bacterial numbers on 40 of 51 target sites were consistently reduced to below detectable levels (≥ 4.7 log10 reduction). Bacterial load was reduced but still persisted on other sites. Objects that proved difficult to disinfect using the Nanoclave Cabinet (e.g. blood pressure cuff) were also difficult to disinfect using antimicrobial wipes. The efficacy of the Nanoclave Cabinet was not affected by the presence of organic soils. Clostridium difficile spores were more resistant to UV-C irradiation than vegetative bacteria. However, two 60-second irradiation cycles were sufficient to reduce the number of surface-associated spores from 10(3) cfu/cm(2) to below detectable levels. A 3 log10 reduction in detectable Adenovirus DNA was achieved within 3 minutes; after 6 minutes, viral DNA was undetectable. CONCLUSION: The results of this study suggest that the Nanoclave Cabinet can provide rapid and effective disinfection of some patient-related equipment. However, laboratory studies do not necessarily replicate 'in-use' conditions and further tests are required to assess the usability, acceptability and relative performance of the Nanoclave Cabinet when used in situ.

Adenoviridae/efeitos da radiação , Clostridium difficile/efeitos da radiação , Desinfecção/métodos , Microbiologia Ambiental , Equipamentos e Provisões/microbiologia , Equipamentos e Provisões/virologia , Raios Ultravioleta , Contagem de Colônia Microbiana , DNA Viral/efeitos da radiação , Humanos , Viabilidade Microbiana/efeitos da radiação , Reação em Cadeia da Polimerase , Esporos Bacterianos/efeitos da radiação
J Hosp Infect ; 78(3): 163-70, 2011 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-21664533


The Spaulding classification, originally proposed in 1957, is a widely used system for matching the disinfection and sterilization of surfaces, particularly those of re-usable medical/surgical devices, with available processes. It presents a ranking, from simple disinfection through to sterilization, that should be considered in the reprocessing of devices, based on the risks associated with their use, ranging from 'critical' (presenting a high risk), through 'semi-critical' to 'non-critical' (presenting a low risk). The different levels of disinfection are based on demonstrating antimicrobial activity against established marker micro-organisms representing a range of pathogens. Although this classification system is probably as valid today as it was in 1957, the understanding of microbiology and micro-organisms has changed. This article discusses some examples of disinfection studies with viruses, bacteria, protozoa and prions that challenge the current definitions and expectations of high-, intermediate- and low-level disinfection. In many of these examples, the test micro-organisms demonstrate atypical tolerance or resistance profiles to disinfection processes. In addition to laboratory-based studies, there is now clinical evidence for at least some of these micro-organisms that biocide resistance can lead to infection outbreaks due to unexpected disinfection failure. These reports should encourage the reader to challenge current dogma, and reconsider the expectations of disinfection and sterilization practices.

Infecção Hospitalar/prevenção & controle , Desinfecção/métodos , Microbiologia Ambiental , Equipamentos e Provisões/microbiologia , Esterilização/métodos , Resistência a Medicamentos , Equipamentos e Provisões/parasitologia , Equipamentos e Provisões/virologia , Humanos