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2.
Medicine (Baltimore) ; 98(48): e18137, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31770249

RESUMO

RATIONALE: Recently, commercial indoor trampoline parks have been opened around the globe, and both the number of venues and the park users are increasing. Academic literatures have largely focused on home trampoline related injuries, and less is known about the injuries associated with trampoline parks due to the limited number of studies or cases reported. In this report, we present a complete spinal cord injury sustained at a commercial indoor trampoline park. PATIENT CONCERNS: A 26-year old male developed tetraplegia after plainly jumping on the trampolines and diving into one of the foam pits head first. DIAGNOSIS: C-spine CT revealed bilateral interfacetal dislocation on C6-7, and his C-spine MRI showed anterior translational injury at C6-7 with severe cord encroachment and complete discoligamentous complex disruption. He was diagnosed with complete spinal cord injury. INTERVENTIONS: The patient underwent 30 minutes each of physical therapy and occupational therapy twice a day for a total of 25 days of in-patient rehabilitation. Interventions included tilt table, passive range of motion exercises, functional electrical stimulation, sitting balance training, upper extremity strengthening exercise, and hand manipulation exercises. OUTCOME: Despite intensive rehabilitation and the patient's good spirit, there was no functional change in all physical examinations between evaluations at initial and at discharge. LESSONS: In conclusion, we aim to alert the risks associated with improper use of trampolines, promote safer entertainment environment, and aid in developing mandatory safety measures. We hope to alert the risks associated with improper use of trampolines, promote safer entertainment environment, and aid in developing mandatory safety measures.


Assuntos
Traumatismos em Atletas/complicações , Segurança de Equipamentos/normas , Quadriplegia/etiologia , Traumatismos da Medula Espinal/etiologia , Adulto , Traumatismos em Atletas/prevenção & controle , Traumatismos em Atletas/reabilitação , Humanos , Masculino , Parques Recreativos , Quadriplegia/prevenção & controle , Quadriplegia/reabilitação , Traumatismos da Medula Espinal/prevenção & controle , Traumatismos da Medula Espinal/reabilitação
3.
Int J Med Inform ; 131: 103932, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31557700

RESUMO

BACKGROUND: Poorly designed infusion pumps can lead to user errors and adverse incidents. Therefore, assessments of their usability and performance that can inform managerial decisions about the selection of appropriate medical devices are essential. OBJECTIVE: This study aimed to identify design deficiencies and evaluate the usability and performance of four infusion pump models and thus inform decisions about infusion pump selection. METHODS: Four evaluators evaluated the interface designs of the pumps according to a series of design principles in a heuristic evaluation in order to identify pump design deficiencies. Additionally, 60 registered nurses participated in simulated use testing to perform a series of tasks using the pumps in order to examine the pump performances. Outcome measures included task completion time, frequency of deviations, frequency of requests for assistance, and nurses' perceptions. RESULTS: Design issues identified included system status visibility, information access, and error prevention. The results of simulated use testing favored some pumps over others, depending on which outcome measures were considered. CONCLUSIONS: Heuristic evaluations and simulated use testing can provide information about the basic usability of medical devices and related operational issues. However, practitioners should select appropriate evaluation principles, testing tasks, and outcome measures based on the tested medical devices and contexts.


Assuntos
Segurança de Equipamentos/métodos , Heurística , Bombas de Infusão/estatística & dados numéricos , Erros Médicos/prevenção & controle , Enfermeiras e Enfermeiros/estatística & dados numéricos , Garantia da Qualidade dos Cuidados de Saúde/normas , Gestão da Segurança/organização & administração , Simulação por Computador , Segurança de Equipamentos/normas , Humanos , Variações Dependentes do Observador
5.
BMC Public Health ; 19(1): 461, 2019 Apr 30.
Artigo em Inglês | MEDLINE | ID: mdl-31039773

RESUMO

BACKGROUND: In China, reprocessing and reuse of single-use medical devices (SUDs) are banned. However, the actual situation has not been reported so far. The study aims to clarify the perceptions and concerns of various sectors of the community on the reuse of SUDs, and whether such practice exists. In addition, we are also wondering how acceptable the respondents are on this matter. METHODS: A cross-sectional study based on a national survey which was conducted on the professional online questionnaire survey platform ( www.wjx.cn ) from July 26 to August 4, 2015. We analyzed the data according to the work fields, sex, age, education level, professional background and participants' answers to 49 other questions. RESULTS: Five hundred forty-four nationwide respondents belong to nine different work fields. In general, participants had positive attitudes towards the reprocessing and reuse of SUDs. However, many respondents doubted the hygienic and functional safety of the reprocessed SUDs. They also tended to think that the reuse of SUDs should have lower prices and more technical training as well as patient advocacy. Further analysis demonstrated the work fields, education level and professional background of respondents were statistically associated with their responses to certain questions. CONCLUSIONS: The research indicated that although the reuse of SUDs is prohibited legally in China, there were extensive reprocessing and reuse in hospitals. Most responses tended to accept reprocessed SUDs if safety and low prices were guaranteed. These existing contradictions and the lack of relevant research led to policy makers in China will confront numerous challenges in building and improving this use system of medical devices to meet escalating demands of social sectors.


Assuntos
Reutilização de Equipamento/estatística & dados numéricos , Segurança de Equipamentos , China , Estudos Transversais , Reutilização de Equipamento/legislação & jurisprudência , Segurança de Equipamentos/normas , Pesquisas sobre Serviços de Saúde , Humanos , Higiene , Projetos Piloto
6.
Rev Bras Enferm ; 72(2): 505-512, 2019.
Artigo em Inglês, Português | MEDLINE | ID: mdl-31017216

RESUMO

OBJETIVES: To identify and analyze the scientific evidence regarding the occurrence of Medical Device-Related Pressure Injuries, considering the development sites; and to describe the devices of risk and the measures of prevention and treatment. METHOD: Integrative, search-based review: CINAHL, PubMed, Wiley InterScience, Scopus, and Web Of Science. The terms "pressure ulcer" and "medical devices" were used, including original articles and case studies published between 2010 and 2015. Nine studies were selected. RESULTS: Posterior cervical region and nose had the highest injury frequencies, respectively, 66.0% and 40.0%. Eleven risk devices were identified, with emphasis on Non-Invasive Ventilation masks and orotracheal tube. For prevention and treatment emerged recommendations specific to the device employed and general measures. CONCLUSION: Medical Device-Related Pressure Injuries are frequent problems, however, they can be prevented and treated based on the recommendations of the articles raised in this review.


Assuntos
Segurança de Equipamentos/normas , Lesão por Pressão/etiologia , Humanos
8.
Inj Prev ; 25(Suppl 1): i31-i38, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-30878975

RESUMO

OBJECTIVES: To describe firearm storage practices among US adults and examine the relationship between having received formal firearms training and firearm storage. METHODS: In 2015 we asked a nationally representative online sample of 2072 gun owners how they stored household firearms, their reasons for owning guns, the number and types owned, had they carried a loaded handgun in the prior month and whether they had formal firearms training (and if so, whether training covered suicide prevention, accident prevention, firearm theft prevention, safe handling and safe storage). Unadjusted associations between gun owner characteristics and storage practices were estimated using Pearson's χ2 tests; adjusted associations used multivariate logistic regressions. Final survey weights that combined presample and study-specific poststratification weights account for oversampling of firearm owners and survey non-response. RESULTS: 29.7% (95% CI 27.4% to 32.1%) stored ≥1 firearm loaded and unlocked. Of the 61.4% (95% CI 58.9% to 63.9%) of gun owners with firearms training, 32.3% (95% CI 29.4% to 35.3%) stored ≥1 firearm loaded and unlocked, compared with 25.8% (95% CI 22.3% to 29.7%) of those without training. Storage did not differ by training component, age, sex or race. However, firearms were more likely stored loaded and unlocked when respondents owned for protection, owned >1 firearm, owned handguns or carried a loaded gun. After adjusting for firearm-related characteristics, firearms training was not associated with storing firearms loaded and unlocked (adjusted OR=1.11, 95% Cl 0.80 to 1.53). CONCLUSION: Firearms training, as currently provided, is unlikely to reduce unsafe firearm storage.


Assuntos
Segurança de Equipamentos/normas , Armas de Fogo/estatística & dados numéricos , Propriedade/estatística & dados numéricos , Gestão da Segurança/organização & administração , Ferimentos por Arma de Fogo/prevenção & controle , Prevenção de Acidentes , Adulto , Feminino , Homicídio/prevenção & controle , Humanos , Masculino , Pessoa de Meia-Idade , Suicídio/prevenção & controle , Estados Unidos/epidemiologia , Ferimentos por Arma de Fogo/epidemiologia , Adulto Jovem
9.
Toxicol Pathol ; 47(3): 221-234, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30844339

RESUMO

Pathologic evaluation is crucial to the study of medical devices and integral to the Food and Drug Administration and other regulatory entities' assessment of device safety and efficacy. While pathologic analysis is tailored to the type of device, it generally involves at a minimum gross and microscopic evaluation of the medical device and associated tissues. Due to the complex nature of some implanted devices and specific questions posed by sponsors, pathologic evaluation inherently presents many challenges in accurately assessing medical device safety and efficacy. This laboratory's experience in numerous collaborative projects involving veterinary pathologists, biomedical engineers, physicians, and other scientists has led to a set of interrelated assessments to determine pathologic end points as a means to address these challenges and achieve study outcomes. Thorough device evaluation is often accomplished by utilizing traditional paraffin histology, plastic embedding and microground sections, and advanced imaging modalities. Combining these advanced techniques provides an integrative, comprehensive approach to medical device pathology and enhances medical device safety and efficacy assessment.


Assuntos
Aprovação de Equipamentos/normas , Segurança de Equipamentos/normas , Equipamentos e Provisões/normas , Patologia/métodos , Animais , Aprovação de Equipamentos/legislação & jurisprudência , Equipamentos e Provisões/efeitos adversos , Técnicas Histológicas/métodos , Técnicas Histológicas/normas , Humanos , Modelos Animais , Estados Unidos , United States Food and Drug Administration
10.
Toxicol Pathol ; 47(3): 264-279, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30832552

RESUMO

The design, production, and preclinical testing of neurothrombectomy devices is in a burgeoning phase as the demand escalates for safe and reliable treatment options following neurovascular stroke. Currently, there is a paucity of published data describing the development of iatrogenic vascular lesions occurring secondary to neurothrombectomy procedures. In an effort to test new devices, demonstrate device safety, satisfy regulatory requirements, and develop an understanding of the potential for associated vascular pathology, investigators are establishing appropriate methodology in suitable animal models. Significant challenges exist in identifying a single animal species that can be consistently utilized in all phases of device development. These aforementioned challenges are underscored by the intricacies of neurovascular pathology, thrombovascular interactions, and vascular responses to injury.


Assuntos
Artérias Cerebrais , Segurança de Equipamentos/normas , Acidente Vascular Cerebral/cirurgia , Trombectomia/instrumentação , Dispositivos de Acesso Vascular/normas , Animais , Artérias Cerebrais/lesões , Desenho de Equipamento/métodos , Desenho de Equipamento/normas , Legislação de Dispositivos Médicos , Estados Unidos , United States Food and Drug Administration , Dispositivos de Acesso Vascular/efeitos adversos
11.
Toxicol Pathol ; 47(3): 205-212, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30722747

RESUMO

Medical device pathologists are involved in the preclinical evaluation of medical devices that will be temporarily inserted or permanently and often irreversibly implanted in the human body. The medical device industry is technology based, allowing for rapid device iterations; innovations occur at an accelerated rate compared to the innovations in the pharmaceutical industry. The device pathologist provides the pathology results and is, by training and experience, in an ideal position to help the medical engineer and innovator tackle biomedical problems and to comment on the possible and actual outcomes of preclinical studies. Device pathology expertise is typically a necessity in the prelude for regulatory submission. However, there is a lack of detailed guidelines for a comprehensive preclinical pathology evaluation of the final product after implantation in a test animal. What specifically unites device pathologists is the reliance on gross pathology as the basis for spatial context needed for appropriate histopathologic analyses, the knowledge of detailed protocol instructions, a good understanding of wound healing including the "implant trauma," and interaction with ambitious device innovators. In this article, it is my aim to amalgamate the following articles in this issue with pertinent background information intended to be informative, critical, and stimulating.


Assuntos
Segurança de Equipamentos/normas , Equipamentos e Provisões/normas , Patologia/métodos , Animais , Aprovação de Equipamentos/legislação & jurisprudência , Aprovação de Equipamentos/normas , Equipamentos e Provisões/efeitos adversos , Testes de Toxicidade
12.
Toxicol Pathol ; 47(3): 235-249, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30764726

RESUMO

Histology of medical devices poses a variety of unique challenges. Comprehensive histologic assessment of medical devices often requires spatial context and high-quality retention of the device-tissue interface. However, the composition of many medical devices is often not amenable to traditional paraffin embedding and thus alternative specialized methodologies such as hard resin embedding must be used. Hard resin embedding requires specialized laboratory technical expertise and equipment, and the fixation techniques and resin composition used markedly impact the feasibility of immunohistochemistry. For the continuity of spatial context during histologic evaluation, additional imaging methods such as macrophotography, radiography, micro-Computerized Tomography (microCT), or magnetic resonance imaging (MRI) can be used to guide sectioning and to complement histologic findings. Although standardized approaches are scarce for medical devices, important considerations specific to medical device histology are discussed, including general specimen preparation, special considerations for devices by organ system, and the challenges of immunohistochemistry. Histologic preparation of medical devices must be thoughtful, thorough, and tailored to achieve optimal histologic outcomes for complex, valuable, and often limited implant specimens.


Assuntos
Materiais Biocompatíveis/normas , Segurança de Equipamentos/normas , Técnicas Histológicas/métodos , Teste de Materiais/métodos , Próteses e Implantes/normas , Algoritmos , Animais , Humanos , Imuno-Histoquímica , Teste de Materiais/normas , Próteses e Implantes/efeitos adversos , Manejo de Espécimes
13.
Toxicol Pathol ; 47(3): 250-263, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30599801

RESUMO

Thorough morphologic evaluations of medical devices placed in or near the nervous system depend on many factors. Pathologists interpreting a neurologic device study must be familiar with the regulatory framework affecting device development, biocompatibility and safety determinants impacting nervous tissue responses, and appropriate study design, including the use of appropriate animal models, group design, device localization, euthanasia time points, tissue examination, sampling and processing, histochemistry and immunohistochemistry, and reporting. This overview contextualizes these features of neurologic medical devices for pathologists engaged in device evaluations.


Assuntos
Desenho de Equipamento/normas , Segurança de Equipamentos/normas , Equipamentos e Provisões/normas , Sistema Nervoso/patologia , Patologistas , Animais , Materiais Biocompatíveis/normas , Humanos , Teste de Materiais/métodos , Legislação de Dispositivos Médicos
15.
Otolaryngol Clin North Am ; 52(1): 103-114, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30245039

RESUMO

Medical devices are essential in the diagnosis and treatment of otolaryngologic disease. The US Food and Drug Administration (FDA) is tasked with assuring the safety and effectiveness of these devices. Otolaryngologists, in turn, are often responsible for helping patients understand risks, benefits, and alternatives when deciding whether to rely on devices in their care. To best counsel patients, otolaryngologists should be aware of the strengths and limitations of device regulation by the FDA. This article reviews the FDA regulatory framework for medical devices, premarket evidentiary standards for marketing devices, and postmarket methods of safety surveillance.


Assuntos
Segurança de Equipamentos/normas , Equipamentos e Provisões , Otolaringologia/instrumentação , Humanos , Estados Unidos , United States Food and Drug Administration
16.
Int J Occup Saf Ergon ; 25(2): 228-240, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28604273

RESUMO

Nowadays every piece of working equipment and tools has to comply with safety standards and laws. This study investigated multi-criteria methods for selecting working equipment in order to optimize performance and occupational safety. The multi-criteria decision-making (MDCM) method was applied to the problem of selecting optimal working equipment using four different criterion weighting approaches (direct weighting, revised Simos procedure, Fuller's triangle and analytic hierarchy process). Groups of economic, technical and safety criteria were defined and five weighting scenarios were developed. Although the four weighting methods produced similar results, in some situations they produced different criterion weighting factors. The final output of the MCDM method was the identification of the optimal forklift in the five weighting scenarios. Although we have applied the MCDM method to a forklift selection problem, it can be applied to all sorts of working equipment in contexts where economic, technical and safety selection criteria can be identified.


Assuntos
Tomada de Decisões , Técnicas de Apoio para a Decisão , Segurança de Equipamentos/normas , Desenho de Equipamento/economia , Desenho de Equipamento/normas , Humanos , Saúde do Trabalhador
19.
Appl Radiat Isot ; 142: 92-103, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30273764

RESUMO

A Proton Accelerator based Boron Neutron Capture Therapy (A-BNCT) facility is under development in Korea. Neutron beams for treatment are produced from a beryllium (Be) target and an 8 mA, 10 MeV proton beam. The purpose of the research is a radiation shielding analysis and an activation analysis for the facility design satisfying the radiation safety requirements as well as obtaining an operating license for the radiation facility according to a domestic nuclear commissioning procedure. The radiation shielding analysis was performed using the MCNPX computational particle transport code. The radiation source terms in the facility were evaluated and utilized in the shielding calculations. The minimum concrete thickness satisfying the designated dose rate of 5 µSv/h for the worker's area and 0.25 µSv/h for the public area were estimated and applied to the design. For an assessment of the radiation safety inside the facility, the dose rates were evaluated at several positions, such as behind the shielding door, around the primary barriers near the radiation sources, and in the penetrations of the ducts. The dose rate distribution was mapped for verification of the radiation safety for the entire facility. An activation analysis was carried out for the concrete walls, air, target assembly, beryllium target, and cooling water using FISPACT-2010 code. Concentrations of the activation products and dose rate induced by the radionuclides after shutdown were evaluated for the purpose of safe operation of the facility. The results were reviewed with the radiation safety regulations in Korea. As a result, it was proved that the final facility design satisfies the safety requirements.


Assuntos
Terapia por Captura de Nêutron de Boro/instrumentação , Arquitetura de Instituições de Saúde , Terapia por Captura de Nêutron de Boro/normas , Segurança de Equipamentos/normas , Arquitetura de Instituições de Saúde/legislação & jurisprudência , Arquitetura de Instituições de Saúde/normas , Humanos , Licenciamento/legislação & jurisprudência , Licenciamento/normas , Exposição Ocupacional/prevenção & controle , Aceleradores de Partículas/legislação & jurisprudência , Aceleradores de Partículas/normas , Prótons , Exposição à Radiação/prevenção & controle , Proteção Radiológica/instrumentação , Proteção Radiológica/legislação & jurisprudência , Proteção Radiológica/normas , República da Coreia
20.
Orthop Clin North Am ; 49(4): 455-463, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30224007

RESUMO

The literature within the last 10 years on MRI use in patients with orthopedic implants is reviewed. A literature search returned 15 relevant articles. Only 2 discussed pediatric patients. Overall, significant displacement of implants was infrequent. Radiofrequency-induced heating of implants differed among the studies, but most reported increases of less than 1°C. The authors conclude MRI is safe in patients with orthopedic implants because implant displacement and heating pose little risk to patients. A risk-to-benefit ratio is warranted, however, to assess the clinical utility and necessity of the study. Further research and individual assessment of implant properties and MRI-related interactions are warranted.


Assuntos
Segurança de Equipamentos/normas , Imagem por Ressonância Magnética/instrumentação , Ortopedia , Próteses e Implantes , Humanos
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