医疗器械设备与CT控制系统特色化设计与开发

1、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 o

2、f 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 give

3、n 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 committe

4、e 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 dev

5、ices 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 subsequ

6、ent data about these issues.The electronic medical record as a tool for infection surveillance: Successful automation of device-daysManual collection of central venous catheter, ventilator, and indwelling urinary catheter device-days is time-consuming, often restricted to intensive care units (ICU)

7、and prone to error. MethodsWe 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. ResultsThe automated system had high s

8、ensitivity, 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

9、central venous catheter-days occurred outside the ICU. ConclusionDevice-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 environmen

10、ts in medical rehabilitationGlobally, 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, a

11、nd 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 t

12、hese 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 a

13、nd 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 andhospice nurses in North CarolinaNurses who provide care in the home are at risk of blood exp

14、osure 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 ex

15、amine 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 devicesTo propose a method for standardised data representation and demonstrate a technology that makes it possible to translate data from

16、 device dependent formats to this standard representation format. Methods and resultsOutcome 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 analys

17、is 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 o

18、n 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

19、new information. An example ontology is designed to demonstrate the feasibility and value of such a standardised structure. ConclusionsThe proposed technology makes possible capturing and storing of data from different devices in a structured and standardised format. Data can easily be transformed t

20、o 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 devicesA pilot study of key nursing aspects with different cooling methods and devices in the ICUTherapeutic hypothermia (TH) has become an integra

21、ted 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

22、and methodsThe 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

23、 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). ResultThere were significant differences in how the ICNs rated the nursing aspects of the different coo

24、ling 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 (P0.05). Only the Coolgard 3000 system scored significantly better than ice-w

25、ater soaked towels for visual patient monitoring (P0.001). For hygienic aspects, Artic Sun and Coolgard scored significantly higher than the others (P99% reduction in levels post cleaning. Our data support the need to monitor the water quality used in instrument washers. In addition, there is an urg

26、ent 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 med

27、ical centerPoly(glycerol-dodecanoate), a biodegradable polyester for medical devices and tissue engineering scaffoldsIn this paper we describe the mechanical and biological features of a thermosetting polyester synthesized from glycerol and dodecanedioic acid named Poly-Glycerol-Dodecanoate (PGD). T

28、his polymer shows a glass transition temperature (Tg) around 32C, and this accounts for its mechanical properties. At room temperature (21) PGD behaves like a stiff elastic-plastic material, while at body temperature (37C), it shows a compliant non-linear elastic behavior. Together with biodegradabi

29、lity 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 32C and higher. The mechanical properties together with biocompatibility/biodegradability and s

30、hape memory features make PGD an attractive polymer for biomedical applications.Ventricular Assist Devices: The Challenges of Outpatient ManagementThe need for mechanical assistance of the failing heart, whether acute after a myocardial infarction or permanent in patients with end-stage heart failur

31、e, 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. Ini

32、tially 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 individual

33、s 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 ph

34、ysiology 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 qua

35、lity 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 HFDevelopment of a Hybrid Decision Support Model for Optimal Ventricular Assist Device WeaningDespite the small but promising body of evidence for

36、 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. MethodsA clinical decision support system was developed based on a Bayesian Belief Network that co

37、mbined 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 wean

38、ing between 1996 and 2004. Artificial Neural Networks and Natural Language Processing were used to mine these data and extract sensitive variables. ResultsThree decision support models were compared. The model exclusively based on expert-derived knowledge was the least accurate and most conservative

39、. 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 u

40、ltimately. 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. ConclusionsA 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 insertionNew