医疗器械设备与CT控制系统特色化设计与开发

The role of the U S Food and Drug Administration in device evaluation and monitoring 政府机构 食品医药研究所对与医疗设备的评估与监控的作用 The American Society for Gastrointestinal Endoscopy ASGE Technology Committee provides reviews of existing new or emerging endoscopic technologies that have an impact on the practice of GI endoscopy Evidence based methodology is used by performing a MEDLINE literature search to identify pertinent clinical studies on the topic and a MAUDE U S Food and Drug Administration Center for Devices and Radiological Health database search to identify the reported complications of a given technology Both are supplemented by accessing the related articles feature of PubMed and by scrutinizing pertinent references cited by the identified studies Technology Status Evaluation Reports are drafted by 1 or 2 members of the ASGE Technology Committee reviewed and edited by the committee as a whole and approved by the Governing Board of the ASGE When financial guidance is indicated the most recent coding data and list prices at the time of publication are provided For this review the MEDLINE database was searched through October 2009 for articles and references related to devices and the U S Food and Drug Administration by using the keywords FDA and devices In addition the Web was searched using the same keywords The U S Food and Drug Administration website was also thoroughly reviewed Practitioners should continue to monitor the medical literature for subsequent data about these issues The electronic medical record as a tool for infection surveillance Successful automation of device days Manual collection of central venous catheter ventilator and indwelling urinary catheter device days is time consuming often restricted to intensive care units ICU and prone to error Methods We describe the use of an electronic medical record to extract existing clinical documentation of invasive devices This allowed automated device days calculations for device associated infection surveillance in an acute care setting Results The automated system had high sensitivity specificity and positive and negative predictive values 0 90 compared with chart review The system is not restricted to ICUs and reduces surveillance efforts by a conservative estimate of over 3 5 work weeks per year in our setting Eighty percent of urinary catheter days and 50 of central venous catheter days occurred outside the ICU Conclusion Device days may be automatically extracted from an existing electronic medical record with a higher degree of accuracy than manual collection while saving valuable personnel resources A perspective on intelligent devices and environments in medical rehabilitation Globally the number of people older than 65 years is anticipated to double between 1997 and 2025 while at the same time the number of people with disabilities is growing at a similar rate which makes technical advances and social policies critical to attain prolong and preserve quality of life Recent advancements in technology including computation robotics machine learning communication and miniaturization of sensors have been used primarily in manufacturing military space exploration and entertainment However few efforts have been made to utilize these technologies to enhance the quality of life of people with disabilities This article offers a perspective of future development in seven emerging areas translation of research into clinical practice pervasive assistive technology cognitive assistive technologies rehabilitation monitoring and coaching technologies robotic assisted therapy and personal mobility and manipulation technology 智能化医疗设备与医院就诊 住院的适宜性环境 一个普通使用者的视角 Provision and use of safety engineered medical devices among home care and hospice nurses in North Carolina Nurses who provide care in the home are at risk of blood exposure from needlesticks Using safety engineered medical devices reduces the risk of needlestick The objectives of this study were to assess provision of safety devices by home care and hospice agencies as well as the use of these devices by home care and hospice nurses in North Carolina and to examine the association between provision and use 家用与护士用医疗设备的安全工程应用与分类 北加利福尼亚州的经验和例子 Using ontologies to integrate and share resuscitation data from diverse medical devices To propose a method for standardised data representation and demonstrate a technology that makes it possible to translate data from device dependent formats to this standard representation format Methods and results Outcome statistics vary between emergency medical systems organising resuscitation services Such differences indicate a potential for improvement by identifying factors affecting outcome but data subject to analysis have to be comparable Modern technology for communicating information makes it possible to structure store and transfer data flexibly Ontologies describe entities in the world and how they relate Letting different computer systems refer to the same ontology results in a common understanding on data content Information on therapy such as shock delivery chest compressions and ventilation should be defined and described in a standardised ontology to enable comparison and combining data from diverse sources By adding rules and logic data can be merged and combined in new ways to produce new information An example ontology is designed to demonstrate the feasibility and value of such a standardised structure Conclusions The proposed technology makes possible capturing and storing of data from different devices in a structured and standardised format Data can easily be transformed to this standardised format compared and combined independent of the original structure 医疗设备的数据共享与信息孤岛 医疗设备用管道材料与零部件设计 Finite element modelling of medical devices A pilot study of key nursing aspects with different cooling methods and devices in the ICU Therapeutic hypothermia TH has become an integrated part of neurointensive care Still little data exists on the actual experience with cooling patients in the ICU from the intensive care nurse ICN perspective The purpose of this survey was to evaluate important nursing aspects with different cooling methods and devices in ICU use Materials and methods The ICNs used a four point rating scale 1 worst 4 best possible to evaluate a ease of application b visual patient monitoring c work load d hygiene and e noise level with four cooling methods used in our ICU Our simple initial method of towels soaked in iced water spread over the torso was compared to three commercial cooling methods used 1 Coolgard 3000 Alsius Irvine USA 2 Thermowrap MTRE Yavne Israel and 3 Artic Sun Medivance Louisville USA Result There were significant differences in how the ICNs rated the nursing aspects of the different cooling methods Ice water soaked towels over the torso scored high with respect to ease of application and noise level For work load all the three commercial devices scored significantly better than ice water soaked towels P 0 05 Only the Coolgard 3000 system scored significantly better than ice water soaked towels for visual patient monitoring P 0 001 For hygienic aspects Artic Sun and Coolgard scored significantly higher than the others P 99 reduction in levels post cleaning Our data support the need to monitor the water quality used in instrument washers In addition there is an urgent need for establishment of standardised criteria for rapid cleaning indicators for instrument washers to ensure that they provide a clinically relevant method for monitoring washers used in healthcare facilities Trends in tubal sterilization and intrauterine device uptake at an urban academic medical center Poly glycerol dodecanoate a biodegradable polyester for medical devices and tissue engineering scaffolds In this paper we describe the mechanical and biological features of a thermosetting polyester synthesized from glycerol and dodecanedioic acid named Poly Glycerol Dodecanoate PGD This polymer shows a glass transition temperature Tg around 32 C and this accounts for its mechanical properties At room temperature 21 PGD behaves like a stiff elastic plastic material while at body temperature 37 C it shows a compliant non linear elastic behavior Together with biodegradability and biocompatibility PGD has distinct shape memory features After the polymer is cured no matter what the final configuration is we can recover the original shape by heating PGD to temperatures of 32 C and higher The mechanical properties together with biocompatibility biodegradability and shape memory features make PGD an attractive polymer for biomedical applications Ventricular Assist Devices The Challenges of Outpatient Management The need for mechanical assistance of the failing heart whether acute after a myocardial infarction or permanent in patients with end stage heart failure has increased with improvements in medical therapy and a growing aged population Over the past few decades much progress has been made in the development and refinement of ventricular assist devices VADs medical devices capable of maintaining circulatory output of the diseased ventricle Initially designed as a temporary support to allow ventricular recovery or as a bridge for patients to cardiac transplantation these devices are now being used as a permanent form of destination therapy Improvements in technological design durability and medical management have allowed individuals with VADs to be managed in their communities Although these devices provide excellent hemodynamic support and enhance patient functional status discharged individuals face many unique challenges In this article we discuss 1 the spectrum of VADs for outpatient therapy including their basic physiology and hemodynamics 2 the multidisciplinary approach required to care for a patient with such a device in the community 3 routine general cardiac issues that are encountered 4 associated long term device and nondevice related complications and 5 the reported overall improvements in quality of life 医用辅助装置与设备 管理与外出使用时的维护 Comparison of Medical Treatment in Outpatients Receiving Device Therapy for Systolic Dysfunction A Report from IMPROVE HF Development of a Hybrid Decision Support Model for Optimal Ventricular Assist Device Weaning Despite the small but promising body of evidence for cardiac recovery in patients that have received ventricular assist device VAD support the criteria for identifying and selecting candidates who might be weaned from a VAD have not been established Methods A clinical decision support system was developed based on a Bayesian Belief Network that combined expert knowledge with multivariate statistical analysis Expert knowledge was derived from interviews of 11 members of the Artificial Heart Program at the University of Pittsburgh Medical Center This was supplemented by retrospective clinical data from the 19 VAD patients considered for weaning between 1996 and 2004 Artificial Neural Networks and Natural Language Processing were used to mine these data and extract sensitive variables Results Three decision support models were compared The model exclusively based on expert derived knowledge was the least accurate and most conservative It underestimated the incidence of heart recovery incorrectly identifying 4 of the successfully weaned patients as transplant candidates The model derived exclusively from clinical data performed better but misidentified 2 patients 1 weaned successfully and 1 that needed a cardiac transplant ultimately An expert data hybrid model performed best with 94 74 accuracy and 75 37 to 99 07 confidence interval misidentifying only 1 patient weaned from support Conclusions A clinical decision support system may facilitate and improve the identification of VAD patients who are candidates for cardiac recovery and may benefit from VAD removal It could be potentially used to translate success of active centers to those less established and thereby expand use of VAD therapy A medical simulator for subcutaneous contraceptive implant insertion New con