Página 1 dos resultados de 3075 itens digitais encontrados em 0.011 segundos

Avaliação de eficácia da sanitização de um sistema de purificação de água. Esterilização de artigos médicos, dissipação residual do óxido de etileno e uso da proteína verde fluorescente (GFP) como inidicador de controle do processo; Evaluation of effectiveness of the sanitization of a water purification system. Sterilization of medical devices, residual dissipation of ethylene oxide and the use of green fluorescent protein (GFP) as an indicator of process control

Dias, Fabio Nunes
Fonte: Biblioteca Digitais de Teses e Dissertações da USP Publicador: Biblioteca Digitais de Teses e Dissertações da USP
Tipo: Dissertação de Mestrado Formato: application/pdf
Publicado em 22/08/2007 Português
Relevância na Pesquisa
67.175156%
A água exerce papel fundamental nas diferentes fases do processo de fabricação de artigos para saúde (médico-hospitalares, farmacêuticos, e clínicos), exigindo elevado grau de pureza, que certifique a sua inocuidade. Portanto, se faz necessário maior controle dos sistemas de purificação de água e suas etapas de tratamento, onde a formação de biofilmes pode contaminar os artigos para saúde e, consequentemente, causar injúria a pacientes submetidos à aplicação dos mesmos. Embora os artigos médicos sejam esterilizados por óxido de etileno (ETO), seu processo de manufatura deve prever o mínimo acréscimo possível de contaminantes. Considerando que a água purificada e a esterilização dos artigos para saúde são fatores determinantes para o sucesso de sua aplicação, este trabalho foi dividido em duas partes distintas. A primeira parte aborda o controle das etapas de purificação da água, que é destinada à lavagem de componentes termoplásticos, que são utilizados na fabricação de artigos para saúde. Os níveis máximos de carga microbiana (expressos em ciclos de log10 UFC/100mL) encontrados ao longo do sistema de purificação de água foram: 3,48 log10 na água de entrada; 3,57 log10 nos filtros multimeios; 3...

Engenharia clínica aplicada à definição e implementação de uma proposta desenvolvimentista para o sistema nacional de inovação de produtos médicos; Clinical engineering applyed to the definition and implementation of a developmental proposition for the national medical devices innovation system

Eduardo Jorge Valadares Oliveira
Fonte: Biblioteca Digital da Unicamp Publicador: Biblioteca Digital da Unicamp
Tipo: Tese de Doutorado Formato: application/pdf
Publicado em 13/08/2010 Português
Relevância na Pesquisa
67.328853%
A saúde configura um complexo de atividades produtivas de bens e serviços que alavanca segmentos-chave da sociedade contemporânea. Além de sua dimensão social vinculada à própria cidadania, a saúde possui uma dimensão econômica própria, articulando entidades públicas e privadas em uma ampla rede de assistência à saúde – pelo Sistema Único de Saúde (SUS) e Sistema Nacional de Saúde Suplementar – além de um parque industrial responsável pelo fornecimento de uma vasta cadeia de produtos destinados aos cuidados da saúde humana. É uma oportunidade única para o desenvolvimento nacional no contexto das políticas de saúde e de desenvolvimento. Os conhecimentos e as ferramentas em Engenharia Clínica aqui utilizados, permitiram realizar uma análise diferenciada do contexto sócio-econômico do setor, a sistematização e a percepção dos fatores e atores que induzem ou retardam o crescimento tecnológico do setor. Acredita-se que a atuação da Engenharia Clínica permite propor uma abordagem desenvolvimentista para o setor diferente daquelas de cunho estritamente economicista, tecnológica ou sanitarista. O trabalho busca mostrar a inter-relação entre os diversos atores do Sistema Nacional de Inovação de Produtos Médicos (SNIPM) e como intervenções em pontos específicos deste sistema podem gerar inflexões promotoras do setor de produtos médicos. A motivação para a elaboração e execução deste trabalho recaiu sobre a necessidade de se definir uma estratégia para promover o desenvolvimento do SNIPM considerando as atuais políticas desenvolvimentistas e a constante expansão do mercado brasileiro de produtos médicos que...

Inhibition of bacterial adhesion on medical devices

Rodrigues, L. R.
Fonte: Springer Publicador: Springer
Tipo: Parte de Livro
Publicado em //2011 Português
Relevância na Pesquisa
67.36269%
Microbial infections resulting from bacterial adhesion to biomaterial surfaces have been observed on almost all medical devices. Biofilm infections pose a number of clinical challenges due to their resistance to immune defence mechanisms and antimicrobials, and, regardless of the sophistication of the implant, all medical devices are susceptible to microbial colonisation and infection. Research efforts are currently directed towards eliminating or reducing infection of medical devices. Strategies to prevent biofilm formation include physiochemical modification of the biomaterial surface to create anti-adhesive surfaces, incorporation of antimicrobial agents into medical device polymers, mechanical design alternatives, and release of antibiotics. Nevertheless, the success of these alternatives has been modest, mainly due to the various environments into which devices are placed and the diversity of ways in which organisms can colonise surfaces. Biosurfactants have been reported as a promising strategy as they effectively inhibit bacterial adhesion and retard biofilm formation, and are thus potentially useful as a new generation of anti-adhesive and antimicrobial coatings for medical devices

Comparative study of friction coefficient in nonwovens applied for non active medical devices

Lima, Mário; Vasconcelos, Rosa; Abreu, Maria José Araújo Marques; Silva, Maria Elisabete
Fonte: Ege University Textile and Apparel Research & Application Center Publicador: Ege University Textile and Apparel Research & Application Center
Tipo: Artigo de Revista Científica
Publicado em /12/2008 Português
Relevância na Pesquisa
66.97695%
Surgical gowns are considered non active medical devices. They can be single-use or reusable and during an operation they are in constant contact with the human skin. Interaction with human senses is therefore an important performance property. When touched by the human hand, friction is one of the first feelings and therefore friction coefficient is an important parameter. A parameter laboratory instrument was designed at the University of Minho based on an innovative method of acessing friction coefficient of 2D surfaces (fabrics, nonwovens, soft papers). Unlike other methods, the instrument FRICTORQ is based on a rotary movement and therefore on the measurement of a friction reaction torque. A short description of the FRICTORQ instrument will be given as well as its fundamentals and working principle followed by a study, where a comparison of the coefficient of friction between three different materials for manufacturing surgical gowns was performed. The tested materials were two Spunlace nonwovens and one SMS (spunlaid-meltblowing-spunlaid). The results of the experimental work are analysed using various tools, including SPSS14.0 statistical package and discussed on the light of the importance of friction to the performance of surgical gowns. Differences in friction coefficient were detected...

Ethylene oxide sterilisation of medical devices : development of mathematical models for prediction of ethylene oxide diffusion and microbial lethality

Mendes, Gisela Cristina da Cunha
Fonte: Universidade Católica Portuguesa Publicador: Universidade Católica Portuguesa
Tipo: Tese de Doutorado
Publicado em 05/11/2011 Português
Relevância na Pesquisa
67.22212%
O óxido de etileno (EO) é um agente de esterilização dominante na indústria dos dispositivos médicos, devido à sua efectividade e compatibilidade com a maioria dos materiais. Considerando o crescimento exponencial do mercado de dispositivos médicos sensíveis, complexos e sofisticados, assim como de conjuntos de procedimento customizados (que combinam uma grande diversidade de produtos e gama de polímeros) utilizados em actos médicos e cirúrgicos específicos, o EO emerge como o método de esterilização de eleição. A optimização deste processo constitui um desafio devido ao facto da competitividade do mercado global exigir custo-efectividade, flexibilidade e redução do tempo de ciclo necessário à colocação dos produtos no mercado, sem prejuízo da segurança e assegurando o cumprimento dos requisitos reguladores. A esterilização por EO é um processo multi-paramétrico complexo, que exige uma fase final de arejamento dos materiais. A eficácia destes processos é influenciada por diversas variáveis (e.g. temperatura, humidade, concentração do agente, material alvo), pelo que a sua optimização exige o conhecimento da influência das condições impostas e das suas relações com os produtos. A modelização matemática do processo de esterilização e arejamento permite a definição das condições óptimas para morte microbiana e desgaseificação...

Evaluation of Brazilian medical devices using agar diffusion cytotoxicity assay

Vidal,Mirian N. P.; Aiub,Claudia; Abrantes,Shirley; Zamith,Helena P. S.
Fonte: Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular Publicador: Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular
Tipo: Artigo de Revista Científica Formato: text/html
Publicado em 01/04/2009 Português
Relevância na Pesquisa
67.12902%
Over the last decades, governmental actions and mechanisms created to protect consumer rights have been linked to a growing effort to guarantee the quality and reliability of products. Samples of condoms (latex), medical devices and blood bags (PVC - polyvinyl chloride) have been tested using the agar diffusion assay. This assay evaluates the cytotoxicity induced by biomaterials by measuring the biological reactivity of mammalian cell cultures in contact with these materials. PVC is used in the production of medical devices because of its specific properties, such as flexibility, obtained after the addition of plasticizers (phthalates), which can cause toxicity even at low doses. Latex is a natural elastomer used for surgical gloves and condoms with a formulation that includes dispersion of liquid latex and chemicals, such as antioxidants and a vulcanizing accelerator, both of which are able to induce cytotoxicity. Samples were analyzed by the National Institute of Quality Control in Health - INCQS of the Oswaldo Cruz Foundation (Fiocruz) in accordance with the governmental sanitary surveillance actions on respect to the quality control. We observed an increase in the quality of the products in relation to the results of the agar diffusion assay during the period between 2000 and 2007. This situation...

Reassessing Pre-market Regulation of Class III Medical Devices

Zollinger, Geri
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
Português
Relevância na Pesquisa
67.390522%
Regulation of medical devices has evolved over the past twenty-five years. Initially, Congress created a regime where the safety and efficacy of all medical devices would be reviewed to varying degrees, depending on the risk posed by the device. Class III devices, the most dangerous class of devices, were to each have a safety and efficacy review. To permit new market entrants on similar grounds as those marketing devices prior to the 1976 Amendments, Congress also created a premarket notification program, under which new devices were regulated in the same way as the pre-Amendment counterparts. However, the premarket notification program has evolved and taken over market authorization for all devices, including Class III devices. This paper argues that the premarket notification program has changed so much that it should be entirely eliminated for Class III medical devices.

Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance

Ransford, Benjamin; Molina-Markham, Andres; Stewart, Quinn; Fu, Kevin; Kramer, Daniel Bruce; Baker, Matthew Charles; Reynolds, Matthew R.
Fonte: Public Library of Science Publicador: Public Library of Science
Tipo: Artigo de Revista Científica
Português
Relevância na Pesquisa
67.306436%
Background: Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients’ stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. Methods: We used three comprehensive, publicly available databases maintained by the Food and Drug Administration (FDA) to evaluate recalls and adverse events related to security and privacy risks of medical devices. Results: Review of weekly enforcement reports identified 1,845 recalls; 605 (32.8%) of these included computers, 35 (1.9%) stored patient data, and 31 (1.7%) were capable of wireless communication. Searches of databases specific to recalls and adverse events identified only one event with a specific connection to security or privacy. Software-related recalls were relatively common, and most (81.8%) mentioned the possibility of upgrades, though only half of these provided specific instructions for the update mechanism. Conclusions: Our review of recalls and adverse events from federal government databases reveals sharp inconsistencies with databases at individual providers with respect to security and privacy risks. Recalls related to software may increase security risks because of unprotected update and correction mechanisms. To detect signals of security and privacy problems that adversely affect public health...

2.782J / 3.961J / 20.451J / HST.524J Design of Medical Devices and Implants, Spring 2003; Design of Medical Devices and Implants

Yannas, Ioannis V.; Spector, Myron
Fonte: MIT - Massachusetts Institute of Technology Publicador: MIT - Massachusetts Institute of Technology
Português
Relevância na Pesquisa
67.27679%
Solution of clinical problems by use of implants and other medical devices. Systematic use of cell-matrix control volumes. The role of stress analysis in the design process. Anatomic fit: shape and size of implants. Selection of biomaterials. Instrumentation for surgical implantation procedures. Preclinical testing for safety and efficacy: risk/benefit ratio assessment. Evaluation of clinical performance: design of clinical trials. Project materials drawn from orthopedic devices, soft tissue implants, artificial organs, and dental implants.

A software process development,assessment and improvement framework,for the medical device industry

Mc Caffery, Fergal; Donnelly, Peter; Dorling, Alec; Wilkie, F.G.
Fonte: University of Limerick Publicador: University of Limerick
Tipo: info:eu-repo/semantics/conferenceObject; all_ul_research; ul_published_reviewed
Português
Relevância na Pesquisa
57.360493%
peer-reviewed; This paper describes a software process development, assessment and improvement framework, structured to ensure regulatory compliance for the software developed in medical devices. Software is becoming an increasingly important aspect of medical devices and medical device regulation. Medical devices can only be marketed if compliance and approval from the appropriate regulatory bodies of the Food and Drug Administration (US requirement), and the European Commission under its Medical Device Directives (CE marking requirement) is achieved. Integrated into the design process of medical devices, is the requirement of the production and maintenance of a device technical file, incorporating a design history file. Design history illustrates the well documented, defined and controlled processes and outputs, undertaken in the development of medical devices and for our particular consideration with this framework - the software components.

A security assurance framework for networked medical devices

Finngegan, Anita; Mc Caffery, Fergal; Coleman, Gerry
Fonte: Springer Publicador: Springer
Tipo: info:eu-repo/semantics/conferenceObject; all_ul_research; ul_published_reviewed
Português
Relevância na Pesquisa
67.170063%
peer-reviewed; This paper presents work for the development of a framework to assure the security of networked medical devices being incorporated. The paper focuses on one component of the framework, which addresses system development processes, and the assurance of these through the use of a Process Assessment Model with a major focus on the security risk management process. With the inclusion of a set of specific security controls and assurance processes, the purpose is to increase awareness of security vulnerabilities, risks and controls among Medical Device Manufacturers with the aim of increasing the overall security capability of medical devices.

A process assessment model for security assurance of networked medical devices

Finnegan, Anita; Mc Caffery, Fergal; Coleman, Gerry
Fonte: Springer Publicador: Springer
Tipo: info:eu-repo/semantics/conferenceObject; all_ul_research; ul_published_reviewed
Português
Relevância na Pesquisa
67.380234%
peer-reviewed; The recent introduction of networked medical devices has posed many benefits for both the healthcare industry and improved patient care. However, because of the complexity of these devices, in particular the advanced communication ability of these devices, security is becoming an increasing concern. This paper presents work to develop a framework to assure the security of medical devices being incorporated into an IT network. It begins by looking at the development processes and the assurance of these through the use of a Process Assessment Model with a major focus on the security risk management processes. With the inclusion of a set of specific security controls, both the Healthcare Delivery Organisations and the Medical Device Manufacturers work together to establish fundamental security requirements. The Medical Device Manufacturer reports the achieved security assurance level of their device through the development of a security assurance case. The purpose of this approach is to increase awareness of security vulnerabilities, risks and controls among Medical Device Manufacturers and Healthcare Delivery Organisations with the aim of increasing the overall security capability of medical devices.

Pre-market approval and post-market direct-to-consumer advertising of medical devices in Australia: a case study of breast cancer screening and diagnostic devices

Vreugdenburg, T.; Willis, C.; Mundy, L.; Hiller, J.
Fonte: Blackwell Publishing Asia Publicador: Blackwell Publishing Asia
Tipo: Artigo de Revista Científica
Publicado em //2013 Português
Relevância na Pesquisa
67.310635%
While research investigating direct-to-consumer advertising of therapeutic goods in Australia has historically focused on prescription medicines, recent action taken by regulators against companies promoting medical devices has placed the industry into the spotlight. Despite the need to effectively regulate direct-to-consumer advertising of medical devices due to its potential harms, inadequacies in the current regulatory system have been noted. Under the present system, devices with a questionable evidence base may enter the Australian marketplace without an evaluation of their effectiveness, and regulators are reliant on industry self-regulation and consumer complaints to draw attention to cases of advertising misconduct. Although some successes in the present system have been observed, we argue that the outlined inadequacies continue to enable the promotion of medical devices to consumers without thorough or sufficient examination of evidence.; T. D. Vreugdenburg, C. D. Willis, L. Mundy and J. E. Hiller

The regulation of non-invasive medical devices in Australia: a case study of breast cancer imaging devices marketed direct-to-consumer.

Vreugdenburg, Thomas Dion
Fonte: Universidade de Adelaide Publicador: Universidade de Adelaide
Tipo: Tese de Doutorado
Publicado em //2014 Português
Relevância na Pesquisa
57.549478%
Background: The premarket assessment of medical devices by an independent regulator is necessary to ensure that devices are safe and effective before they are made available to consumers in Australia. This responsibility is further necessitated by the practice of direct-to-consumer advertising (DtCA), whereby devices can be promoted to, and accessed by consumers without the involvement of a registered healthcare practitioner. An increase in the number of complaints against medical device advertising in Australia has raised questions around the effectiveness of the current regulations at ensuring that devices and their advertising material are adequately supported by evidence. Aims: The aim of this thesis is to explore the relationship between scientific evidence and DtCA in the policy context of medical device regulation in Australia. This aim is investigated using a case study of three emerging breast cancer imaging devices: digital infrared thermal imaging (DITI), electronic impedance scanning (EIS) and electronic palpation imaging (EPI). In this thesis, the evidence supporting the safety and effectiveness of these devices is evaluated, the nature and frequency of claims presented in online advertisements for these devices are assessed and compared against the available evidence...

Reprocessing of single-use medical devices - a legislative issue of the EU countries

Abreu, Isabel; Abreu, Maria José; Coelho, Alexandra
Fonte: SPOSHO Publicador: SPOSHO
Tipo: Conferência ou Objeto de Conferência
Publicado em 01/02/2014 Português
Relevância na Pesquisa
67.12902%
Due to economical aspects, reprocessing single-use medical devices have been practiced by hospitals and companies raising important issues, mainly concerning to health safety of patients and legislative situation. This paper seeks to assay the situation of reprocessing single-use medical devices in Portugal and the Europe Union, the legislations and the main problems of this practice.; The financial funding from QREN, POFC, Vale Inovação Project Nº 2012/24228 is also gratefully acknowledged.

Superação das barreiras técnicas ao comércio internacional pelas pequenas e médias empresas de base tecnológica - o caso da exportação de produtos eletromédicos para a União Européia; Overcoming technical barriers to international trade by the small and medium technological based companies the case of medical devices exportation to European Community

D'Elia, Marco Antonio Grecco
Fonte: Biblioteca Digitais de Teses e Dissertações da USP Publicador: Biblioteca Digitais de Teses e Dissertações da USP
Tipo: Dissertação de Mestrado Formato: application/pdf
Publicado em 04/12/2007 Português
Relevância na Pesquisa
67.306436%
Com a redução das barreiras tarifárias ao comércio internacional, as normas técnicas, regulamentos técnicos e procedimentos de avaliação da conformidade vêm se tornando importantes mecanismos protecionistas e de restrição ao comércio. Esse trabalho tem por objetivo estudar essas questões, tendo como foco principal a exportação para a União Européia dos equipamentos eletromédicos produzidos por pequenas e médias empresas brasileiras. Realiza-se uma revisão bibliográfica buscando-se identificar e comparar as normas técnicas, os regulamentos técnicos e os mecanismos de avaliação da conformidade para os dispositivos eletromédicos, praticados pela União Européia e os vigentes no Brasil. É desenvolvida uma pesquisa junto a PMEs Pequenas e Médias Empresas fabricantes de dispositivos eletromédicos e exportadores para a União Européia, buscando-se identificar as dificuldades encontradas, as formas de superação dessas e os apoios recebidos. É elaborado um método, baseado nas experiências estudadas e adquiridas a partir da pesquisa junto às PMEs, para a identificação e superação das dificuldades técnicas para a exportação dos equipamentos eletromédicos para a União Européia. Conclui-se que não existem propriamente barreiras técnicas e que as dificuldades enfrentadas pelas empresas podem ser superadas com a participação nos fóruns de normalização...

The Scope of Medicare Reimbursement for New Medical Devices: Impact on Device Availability and the Standard of Care

Yeon, Susan B.
Fonte: Harvard University Publicador: Harvard University
Tipo: Paper (for course/seminar/workshop)
Português
Relevância na Pesquisa
67.26168%
Evolving standards of care motivated by advances in medical technology alter the characteristics and costs of delivered health care. Faced with shifting reimbursement demands, the Health Care Financing Administration (HCFA) has promulgated regulations setting forth criteria and procedures for making coverage decisions about health care technology and setting prospective payment limits for health care services including those related to new technology. The effects of such regulations extend beyond the Medicare program due to the tendency of other health insurers to mirror HCFA coverage, the impact of Medicare payments on cross-subsidization and other effects of Medicare reimbursement decisions on the demand for and supply of health care. The principle statutory authority for rules limiting coverage of health care technology is Section 1862(a)( 1) of the Social Security Amendments of 1965 (codified in 42 U.S.C. § 1395y(a)( 1)) which provides that no Medicare payment shall be made for items or services, including medical devices, "which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member." In 1989 HCFA proposed a rule describing criteria and procedures for health care technology Medicare coverage decisions. The rule defines a reasonable and necessary service as one which is safe and effective...

Putting medical devices in context: a systematic review of evidence on design targeting low-resource settings

Aranda-Jan, Clara B.; Cruickshank, Heather; Moultrie, James
Fonte: InderScience Publishers Publicador: InderScience Publishers
Tipo: Article; accepted version
Português
Relevância na Pesquisa
67.328853%
This is the author accepted manuscript. It is currently embargoed pending publication.; Most medical devices are inaccessible to healthcare facilities in low-resource settings (LRSs), severely limiting medical care for a vast proportion of the world?s population. This article characterises the process used for designing medical devices for LRSs and investigate how the context-of-use is integrated into the process. A systematic review of 64 papers was conducted to identify peer-reviewed studies of devices intended for LRSs. Using the Biodesign process as an analytic framework, a qualitative meta-analysis was conducted. Findings show the studies predominantly describe the later stages of medical device design, whilst largely neglecting how knowledge of the context is considered. To support engineers and improve outcomes, it is imperative that an understanding of the context is integrated throughout the design and product development process. This article highlights this gap and hopes to stimulate research into how context can be better incorporated into the design process for medical devices targeting those populations most in need.

Reutilização simulada de produtos médico-hospitalares de uso único, submetidos à esterilização com óxido de etileno; Simulated reuse of single use medical devices submitted to ethylene oxide sterilization

Silva, Mônica Valero da; Pinto, Terezinha de Jesus A.
Fonte: Universidade de São Paulo. Faculdade de Ciências Farmacêuticas Publicador: Universidade de São Paulo. Faculdade de Ciências Farmacêuticas
Tipo: info:eu-repo/semantics/article; info:eu-repo/semantics/publishedVersion; Artigo Avaliado pelos Pares Formato: application/pdf
Publicado em 01/06/2005 Português
Relevância na Pesquisa
67.235747%
Objetivando avaliar o risco/benefício da reutilização de produtos médico-hospitalares de uso único, aplicaram-se dois desafios simulados: um com esporos de Bacillus subtilis e outro com endotoxina bacteriana da Escherichia coli, em corpos de prova representados por cateteres intravenosos, torneira três vias e tubos de traqueostomia. Estes foram submetidos a ciclos de reprocessamentos simulados, sendo 300 unidades intencionalmente contaminadas com B. subtilis (10(7) ufc/unidade) e outro grupo de 90 unidades contaminadas com endotoxina bacteriana (200 UE/unidade). Os corpos de prova contaminados com B. subtilis foram lavados, enxaguados, secados e esterilizados em ETO/CFC 12:88. Os contaminados com endotoxina bacteriana foram submetidos à secagem, embalados e esterilizados. Após cada ciclo, dez unidades de cada corpo de prova contaminadas com B. subtilis foram avaliadas por contagem microbiana, testes de esterilidade, citotoxidade in vitro e microscopia eletrônica de varredura. Dos contaminados com endotoxina bacteriana, três de cada foram submetidos ao teste turbidimétrico após cada ciclo. No desafio com B. subtilis, verificou-se a presença de carga viável até 10³ ufc e ocorreram danos na integridade física dos corpos de prova após o décimo reprocessamento...

The shelf life of sterile medical devices

du Plessis,TA
Fonte: SA Orthopaedic Journal Publicador: SA Orthopaedic Journal
Tipo: Artigo de Revista Científica Formato: text/html
Publicado em 01/12/2014 Português
Relevância na Pesquisa
67.235747%
The issues of the shelf life of sterile medical devices and the concept of end-product sterility testing of a sample of devices to prove the sterility of a batch of sterile devices are discussed against the background of the probabilistic approach to sterility and sterilisation. The particular role that the sterilisation technique and the packaging materials used play in maintaining sterility are discussed against the background that sterility and the maintenance thereof is event- and not time-related, and the implications thereof on the shelf life of sterile medical devices.