s**********8
发帖数: 25265 | 1 Frequently Asked Questions About the IRB:
The following is a compilation of questions frequently asked regarding
Institutional Review Boards, human subject protection and compliance with
federal regulations. These questions are organized according to whether they
pertain to:
I. Institutional Review Board regulations;
II. Informed Consent regulations;
III. Clinical investigations involving drugs;
IV. Clinical investigations involving medical devices; and
V. Other
I. INSTITUTIONAL REV... 阅读全帖 |
|
s**********8
发帖数: 25265 | 2 来自主题: MedicalDevice版 - FDA The Food and Drug Administration (FDA or USFDA) is an agency of the United
States Department of Health and Human Services, one of the United States
federal executive departments. The FDA is responsible for protecting and
promoting public health through the regulation and supervision of food
safety, tobacco products, dietary supplements, prescription and over-the-
counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals,
blood transfusions, medical devices, electromagnetic radiati... 阅读全帖 |
|
k****i
发帖数: 1126 | 3 Investigations covered under the IDE regulation are subject to differing
levels of regulatory control depending on the level of risk. The IDE
regulation distinguishes between significant and nonsignificant risk device
studies and the procedures for obtaining approval to begin the study differ
accordingly. Also, some types of studies are exempt from the IDE regulations.
Significant Risk Device
A significant risk device presents a potential for serious risk to the
health, safety, or welfare of a s... 阅读全帖 |
|
k****i
发帖数: 1126 | 4 see the definition of medical device by FDA.
As long as one of the following is combined with a drug, it is called
combination.
Medical Device Definition
Medical devices range from simple tongue depressors and bedpans to complex
programmable pacemakers with micro-chip technology and laser surgical
devices. In addition, medical devices include in vitro diagnostic products,
such as general purpose lab equipment, reagents, and test kits, which may
include monoclonal antibody technology. Certain ele... 阅读全帖 |
|
s**********8
发帖数: 25265 | 5 zan! pacemaker? defibrillator? |
|
s**********8
发帖数: 25265 | 6 Six Sigma
From Wikipedia, the free encyclopediaJump to: navigation, search
Not to be confused with Sigma 6.
The often-used Six Sigma symbol.Part of a series of articles on
Industry
Manufacturing methods
Batch production • Job production
Continuous production
Improvement methods
LM • TPM • QRM • VDM
TOC • Six Sigma • RCM
Information & communication
ISA-88 • ISA-95 • ERP
SAP • IEC 62264 • B2MML
Process control
PLC • DCS
Six Sigma is... 阅读全帖 |
|
s**********8
发帖数: 25265 | 7 Biocompatibility
From Wikipedia, the free encyclopediaJump to: navigation, search
http://en.wikipedia.org/wiki/Biocompatibility
Biocompatibility is related to the behavior of biomaterials in various
contexts. The term may refer to specific properties of a material without
specifying where or how the material is used (for example, that it elicits
little or no immune response in a given organism, or is able to integrate
with a particular cell type or tissue), or to more empirical clinical
success ... 阅读全帖 |
|
s**********8
发帖数: 25265 | 8 Sterilization (microbiology)
http://en.wikipedia.org/wiki/Sterilization_(microbiology)
From Wikipedia, the free encyclopediaJump to: navigation, search This
article has multiple issues. Please help improve it or discuss these issues
on the talk page.
It may need reorganization to meet Wikipedia's quality standards. Tagged
since March 2008.
It is in need of attention from an expert on the subject. WikiProject
Microbiology may be able to help recruit one. Tagged since December 2010.
Contents [hide... 阅读全帖 |
|
a*i
发帖数: 1652 | 9 Medical Device Definition
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/O
Medical devices range from simple tongue depressors and bedpans to complex
programmable pacemakers with micro-chip technology and laser surgical
devices. In addition, medical devices include in vitro diagnostic products,
such as general purpose lab equipment, reagents, and test kits, which may
include monoclonal antibody technology. Certain electronic radiation
emitting products3 with medical application an... 阅读全帖 |
|
b*******s
发帖数: 5216 | 10 ☆─────────────────────────────────────☆
xiaoputi (小葡萄) 于 (Mon Jun 20 23:08:12 2011, 美东) 提到:
国内应该什么都有，但偶想总有些是美国的比较好，所以，问问，什么样的医疗器械是
国内缺少的。
恭喜开版～～
☆─────────────────────────────────────☆
skycaptain08 (太尉) 于 (Tue Jun 21 03:04:20 2011, 美东) 提到:
现在美国有的成熟器械， 大部分国内都有。 美国公司研发器械， 第一步是通过欧盟
认证 (CE mark). 对大公司来说， CE mark 很容易， 因为欧盟对器械管理主要看
safety, 对efficacy要求不高。 CE mark好比探路，公司一般用CE mark 的package来
申请美国的IDE (investiagtional device exemption), FDA 批准IDE后， 就可以在美
国进行clinical trial. clinical trial 完了以后申请P... 阅读全帖 |
|
b*******s
发帖数: 5216 | 11 ☆─────────────────────────────────────☆
xiaoputi (小葡萄) 于 (Mon Jun 20 23:08:12 2011, 美东) 提到:
国内应该什么都有，但偶想总有些是美国的比较好，所以，问问，什么样的医疗器械是
国内缺少的。
恭喜开版～～
☆─────────────────────────────────────☆
skycaptain08 (太尉) 于 (Tue Jun 21 03:04:20 2011, 美东) 提到:
现在美国有的成熟器械， 大部分国内都有。 美国公司研发器械， 第一步是通过欧盟
认证 (CE mark). 对大公司来说， CE mark 很容易， 因为欧盟对器械管理主要看
safety, 对efficacy要求不高。 CE mark好比探路，公司一般用CE mark 的package来
申请美国的IDE (investiagtional device exemption), FDA 批准IDE后， 就可以在美
国进行clinical trial. clinical trial 完了以后申请P... 阅读全帖 |
|
A*******s
发帖数: 9638 | 12 来自主题: Medicalpractice版 - 报道 lexian这省略了200个字，至少让200个ID心涯荡漾， 要是省略了2000个字， 干脆
springstep在本版开个心律失常门诊得了， 或者让garland做EP，放pacemaker。。。。 |
|
A*******s
发帖数: 9638 | 13 I think 昏迷原因 is 心跳只有20次每分钟.
I would do pacemaker. |
|
d********e
发帖数: 239 | 14 Dr. Hu Da Yi in Beijing who is expert for pacemaker replacement.
"著名心血管专家胡大一教授"
管。
CT |
|
d********e
发帖数: 239 | 15
管。
CT
Your father really needs permanent pacemaker replacement.
Needs to monitor his EKG 24 hours continuous
Check echo to his EF?
needs to check his lab for K+, Mg+ etc.
Sorry, I got to go to work. It is hard to discuss about these in few words
here.
Good luck for your father. |
|
A*******s
发帖数: 9638 | 16 颅内压增高放pacemaker？ 你得尊重一下国内的心内科医生吧？ ：） |
|
A*******s
发帖数: 9638 | 17 【 以下文字转载自 WaterWorld 讨论区 】
发信人: dashao (dashao), 信区: WaterWorld
标 题: 仲兴事件目前校方的回复
发信站: BBS 未名空间站 (Thu Jan 3 16:44:28 2013, 美东)
我是NJIT的学生，
白天给学校发了封邮件得到了如下回复
This is of course very upsetting to us as well. The body was found in a
very different area of the city---2nd Ave. and Mount Prospect. There was no
evidence of foul play—no bruises or wounds of any kind. The police are
conducting an autopsy. He was believed to have a pacemaker. We do not know
if this has anything to do with his heart. I exp... 阅读全帖 |
|
A*******s
发帖数: 9638 | 18 请教南山或其他专家，这个孩子如果真有pacemaker，为什么没有defibrillator？ |
|
n*******c
发帖数: 501 | 19 Maybe it is just a pure pacemaker with no ICD function. |
|
g*****d
发帖数: 991 | 20 What is "仲兴事件"?
By the way, pacemaker(PPM) is to regulate heart beat, treating slow heart
rate. Defibillator (ICD) is to treat Vtach/Vfib, preventing sudden cardiac
death. Those two are totally different devices. Implantation of either PPM
or ICD requires different indication. But now days, all ICD iinclude PPM
function.
no |
|
K*********1
发帖数: 95 | 21 帮邻居叔叔问一下，他心脏在6年前安装了pacemaker，可以坐飞机回国再飞回来吗？他
听说有一个教会的人坐飞机回来后就不行了。所以担心回国探亲对他有没有影响。谢谢
。 |
|
K*********1
发帖数: 95 | 22 帮邻居叔叔问一下，他心脏在6年前安装了pacemaker，可以坐飞机回国再飞回来吗？他
听说有一个教会的人坐飞机回来后就不行了。所以担心回国探亲对他有没有影响。谢谢
。 |
|
|
|
g*****d
发帖数: 991 | 25 should be PPM or DDD pacemaker. Pacing was the first. |
|
n*******c
发帖数: 501 | 26 嗯，我们之前看过一个病人，反复syncope,多次心脏科入院及Holter查不出毛病,心脏
科要求神经科会诊多次，考虑Abcent seizure,我们老板还是考虑cardiogenic，要求他
们放Loop recorder，结果有一次在急诊的时候一位心脏科医生示范carotid massage,
病人出现7秒的asystole...最后放了Pacemaker
in |
|
A*******s
发帖数: 9638 | 27 2016年，希拉里总统关闭所有保险公司，强制医生成为公务员。 美国医生说开subway
，麦当劳，CMG怎么办呢？
我说， 到中国开医院去。
中国的医院与美国相比很不同，他们收费很低，所以按照美国医院的运营模式是不可能
盈利的，医生工资相应的也低的可怜。 但是，事实上中国医院的效益并不差，医生实
际收入也不低，极少数甚至更高，原因就是以药养医。
中国的医院拥有药房，门诊的所有处方都由药房出药，这就相当于拥有了美国的CVS，
walgreen，riteaid等等所有药店，可想而知利润有多少。卖药只是一个方面， 有了医
院还可以买卖医疗设备，比方说CPAP，pacemaker，mobile wheelchair等等， 同样利
润丰厚，健康保健类的产品包括中药补品等等也是价格不菲。 如果可以买卖医疗保险
，那更是锦上添花，至于看病挣钱与否已经不重要了，低价高质量赢得的是名声，有了
好信誉就有病人， 而拥有了病人就拥有了一切。
读懂了中国医院的经营方式就可以理解目前的医患紧张关系。 病人付了高价以后得不
到相应的高价服务，又没有相应的法律措施理赔，所以只能该出手时就出手了。
中国目前的公费医疗... 阅读全帖 |
|
w*******y
发帖数: 60932 | 28 LINK:
http://www.woot.com
Warranty: 90 Day Woot Limited Warranty
Condition: New
Recommended Ages: 14 Years +
Product Warning: KEEP AWAY FROM ALL CHILDREN! Do not put in nose or mouth.
Swallowed magnets can stick together across intestines causing serious
infections and death. Seek medical attention if magnets are swallowed or
inhaled. Buckyballs should be kept away from electrical or magnetic devices,
including but not limited to credit cards, hard drives, or pacemakers. If a
Buckyball should be |
|
k*****e
发帖数: 22013 | 29 【 以下文字转载自 ChinaNews 讨论区 】
发信人: pipigou123 (鼠姐虎弟), 信区: ChinaNews
标 题: Re: 在美国，学中医的比这里大部分人赚得多
发信站: BBS 未名空间站 (Sun Aug 14 19:55:23 2011, 美东)
INTRODUCTION — The word "acupuncture" is derived from the Latin words "acus
" (needle) and "punctura" (penetration). Acupuncture originated in China
approximately 2000 years ago and is one of the oldest medical procedures in
the world.
Over its long history and dissemination, acupuncture has diversified and
encompasses a large array of styles and techniques. ... 阅读全帖 |
|
