Author Topic: Subtitle C-11 Sec. 2521 - National Medical Device Registry  (Read 15767 times)

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Offline Pinhead

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Subtitle C-11 Sec. 2521 - National Medical Device Registry
« on: September 10, 2009, 03:22:31 PM »
Subtitle C-11 Sec. 2521— National Medical Device Registry

Quote
The Secretary shall establish a national medical device registry (in this subsection referred to as the ‘registry’) to facilitate analysis of postmarket safety and outcomes data on each device that—‘‘(A) is or has been used in or on a patient; and ‘‘(B) is a class III device; or ‘‘(ii) a class II device that is implantable.


In “real world speak”, this new law, when fully implemented, provides the framework for making the United States the first Nation in the World to require each and every one of its citizens to have implanted in them a radio-frequency identification (RFID) microchip for the purpose of controlling who is, or isn’t, allowed medical care in their country.

It goes without saying, of course, that this new “Med-Chip” these American’s will be forced to have put inside them will not only control their access to medical resources, but will also enable their government to know their whereabouts, spending habits, and so much more as to effectively make these people nothing more than “human cattle” to be herded, controlled, and if they object to their new status, led to the slaughterhouse.  

ObamanableCare PDF
Doug

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Offline mark

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Re: Subtitle C-11 Sec. 2521 - National Medical Device Registry
« Reply #1 on: September 10, 2009, 03:39:42 PM »
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It's great.

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« Last Edit: September 10, 2009, 04:01:45 PM by mark »
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Offline SD750F

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Re: Subtitle C-11 Sec. 2521 - National Medical Device Registry
« Reply #2 on: September 10, 2009, 03:45:51 PM »
Pinhead,

You can't be serious! Really???

You read that title and you jump right to that conclusion??? I design medical products, and I will tell you that is not what it says. It says nothing more than that the Secretary of Health will use the current FDA electronic device registry will be used for safety concerns, product approval and patient use.

This covers the EKG device that is attached to you when you visit the ER. It covers the IV pump administrating any fluids including mind altering pain medications. And it covers any implantable device such as a Pacemaker, Insulin Pump, or Implantable TEMS device. Where do you, with the little clip, come to the conclusion that it directs or even mandates the use of a RFID device for patient tracking???

I bet, Glenn Beck, Rush Limbaugh, or maybe Sarah Palin and her tweet told you that is what it meant...
« Last Edit: September 10, 2009, 03:56:16 PM by SD750F »



Offline sangyo soichiro

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Re: Subtitle C-11 Sec. 2521 - National Medical Device Registry
« Reply #3 on: September 10, 2009, 04:00:30 PM »
Just throwing this into the mix...   :)

Quote from: God
And he causeth all, both small and great, rich and poor, free and bond, to receive a mark in their right hand, or in their foreheads:
And that no man might buy or sell, save he that had the mark, or the name of the beast, or the number of his name.
Here is wisdom. Let him that hath understanding count the number of the beast: for it is the number of a man; and his number [is] Six hundred threescore [and] six.
Rev 13:16-18
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Offline Pinhead

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Re: Subtitle C-11 Sec. 2521 - National Medical Device Registry
« Reply #4 on: September 10, 2009, 04:05:44 PM »
Quote
‘‘National Medical Device Registry
‘‘(g)(1) The Secretary shall establish a national med-
ical device registry (in this subsection referred to as the
‘registry’) to facilitate analysis of postmarket safety and
outcomes data on each device that—
‘‘(A) is or has been used in or on a patient; and ‘‘(B) is—
‘‘(i) a class III device; or
‘‘(ii) a class II device that is implantable,
life-supporting, or life-sustaining.
‘‘(2) In developing the registry, the Secretary shall,
in consultation with the Commissioner of Food and Drugs,
the Administrator of the Centers for Medicare & Medicaid
Services, the head of the Office of the National Coordi-
nator for Health Information Technology, and the Sec-
retary of Veterans Affairs, determine the best methods
for— ‘‘(A) including in the registry, in a manner con-
sistent with subsection (f), appropriate information
to identify each device described in paragraph (1) by
type, model, and serial number or other unique iden-
tifier;
‘‘(B) validating methods for analyzing patient
safety and outcomes data from multiple sources and
for linking such data with the information included
in the registry as described in subparagraph (A), in-
cluding, to the extent feasible, use of—
‘‘(i) data provided to the Secretary under
other provisions of this chapter; and ‘‘(ii) information from public and private
sources identified under paragraph (3); ‘‘(C) integrating the activities described in this
subsection with—
‘‘(i) activities under paragraph (3) of sec-
tion 505(k) (relating to active postmarket risk
identification);
‘‘(ii) activities under paragraph (4) of sec-
tion 505(k) (relating to advanced analysis of
drug safety data); and
‘‘(iii) other postmarket device surveillance
activities of the Secretary authorized by this
chapter; and
‘‘(D) providing public access to the data and
analysis collected or developed through the registry in a manner and form that protects patient privacy
and proprietary information and is comprehensive,
useful, and not misleading to patients, physicians,
and scientists.
‘‘(3)(A) To facilitate analyses of postmarket safety
and patient outcomes for devices described in paragraph
(1), the Secretary shall, in collaboration with public, aca-
demic, and private entities, develop methods to—
‘‘(i) obtain access to disparate sources of
patient safety and outcomes data, including—
‘‘(I) Federal health-related electronic
data (such as data from the Medicare pro-gram under title XVIII of the Social Secu-
rity Act or from the health systems of the
Department of Veterans Affairs);
‘‘(II) private sector health-related
electronic data (such as pharmaceutical
purchase data and health insurance claims
data); and
‘‘(III) other data as the Secretary
deems necessary to permit postmarket as-
sessment of device safety and effectiveness;
and
‘‘(ii) link data obtained under clause (i) with information in the registry.
‘‘(B) In this paragraph, the term ‘data’ refers to in-
formation respecting a device described in paragraph (1),
including claims data, patient survey data, standardized
analytic files that allow for the pooling and analysis of
data from disparate data environments, electronic health
records, and any other data deemed appropriate by the
Secretary.
‘‘(4) Not later than 36 months after the date of the
enactment of this subsection, the Secretary shall promul-
gate regulations for establishment and operation of the
registry under paragraph (1). Such regulations— ‘‘(A)(i) in the case of devices that are described
in paragraph (1) and sold on or after the date of the
enactment of this subsection, shall require manufac-
turers of such devices to submit information to the
registry, including, for each such device, the type,
model, and serial number or, if required under sub-
section (f), other unique device identifier; and
‘‘(ii) in the case of devices that are described in
paragraph (1) and sold before such date, may re-
quire manufacturers of such devices to submit such
information to the registry, if deemed necessary by
the Secretary to protect the public health;
‘‘(B) shall establish procedures— ‘‘(i) to permit linkage of information sub-
mitted pursuant to subparagraph (A) with pa-
tient safety and outcomes data obtained under
paragraph (3); and
‘‘(ii) to permit analyses of linked data;
‘‘(C) may require device manufacturers to sub-
mit such other information as is necessary to facili-
tate postmarket assessments of device safety and ef-
fectiveness and notification of device risks;
‘‘(D) shall establish requirements for regular
and timely reports to the Secretary, which shall be
included in the registry, concerning adverse event trends, adverse event patterns, incidence and preva-
lence of adverse events, and other information the
Secretary determines appropriate, which may include
data on comparative safety and outcomes trends;
and
‘‘(E) shall establish procedures to permit public
access to the information in the registry in a manner
and form that protects patient privacy and propri-
etary information and is comprehensive, useful, and
not misleading to patients, physicians, and sci-
entists.
‘‘(5) To carry out this subsection, there are author-ized to be appropriated such sums as may be necessary
for fiscal years 2010 and 2011.’’.
(2) EFFECTIVE DATE.—The Secretary of
Health and Human Services shall establish and
begin implementation of the registry under section
519(g) of the Federal Food, Drug, and Cosmetic
Act, as added by paragraph (1), by not later than
the date that is 36 months after the date of the en-
actment of this Act, without regard to whether or
not final regulations to establish and operate the
registry have been promulgated by such date.
(3) CONFORMING AMENDMENT.—Section
303(f)(1)(B)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(1)(B)(ii)) is amend-
ed by striking ‘‘519(g)’’ and inserting ‘‘519(h)’’.
(b) ELECTRONIC EXCHANGE AND USE IN CERTIFIED ELECTRONIC HEALTH RECORDS OF UNIQUE DEVICE
IDENTIFIERS.—
(1) RECOMMENDATIONS.—The HIT Policy
Committee established under section 3002 of the
Public Health Service Act (42 U.S.C. 300jj–12)
shall recommend to the head of the Office of the Na-
tional Coordinator for Health Information Tech-
nology standards, implementation specifications, and certification criteria for the electronic exchange and
use in certified electronic health records of a unique
device identifier for each device described in section
519(g)(1) of the Federal Food, Drug, and Cosmetic
Act, as added by subsection (a).
(2) STANDARDS,  IMPLEMENTATION CRITERIA,
AND CERTIFICATION CRITERIA.—The Secretary of
the Health Human Services, acting through the
head of the Office of the National Coordinator for
Health Information Technology, shall adopt stand-
ards, implementation specifications, and certification
criteria for the electronic exchange and use in cer-
tified electronic health records of a unique device
identifier for each device described in paragraph (1),
if such an identifier is required by section 519(f) of
the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360i(f)) for the device.

Unfortunately everything is written like the freekin tax code. So call me crazy... YOU tell me what it all means.
Doug

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Offline Pinhead

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Re: Subtitle C-11 Sec. 2521 - National Medical Device Registry
« Reply #5 on: September 10, 2009, 04:12:58 PM »
Look at the curious interactions between the US government and the only company licensed in the United States (since 2004) to implant microchips in human beings called the VeriChip Corporation.

Now what is widely known about the VeriChip Corporation and their microchip we can read from one report that states:
Quote
VeriChip is the first Food and Drug Administration (FDA)-approved human-implantable radio-frequency identification (RFID) microchip. It is marketed by VeriChip Corporation, a subsidiary of Applied Digital Solutions, and it received United States FDA approval in 2004. About twice the length of a grain of rice, the device is typically implanted above the triceps area of an individual’s right arm.[1] Once scanned at the proper frequency, the VeriChip responds with a unique 16 digit number which could be then linked with information about the user held on a database for identity verification, medical records access and other uses. The insertion procedure is performed under local anesthetic in a physician's office. As an implanted device used for identification by a third party.

What is NOT widely known about this VeriChip Corporation is the “new direction” they have taken since Obama has taken office, and as we can read directly from the website of their new subsidiary, VeriGreen Energy Corporation, and which says:
Quote
In March 2009, the Company formed a new subsidiary, VeriGreen Energy Corporation, to invest in the clean and alternative energy sector. The Company is currently evaluating several opportunities and is looking to invest in companies with existing operations and infrastructure.

Following the recently signed stimulus package, which will invest nearly $79 billion in renewable energy, the Company’s investments in clean and alternative sources of energy will complement its existing healthcare initiatives.

Now, what this IDC report says about VeriChip Corporation’s “sudden conversion” from being a maker of implantable microchips, to one of becoming a “green energy” giant lies not with them, but rather with Obama’s “Green Jobs Czar”, Van Jones, who is the sole determiner in who does, or doesn’t, receive billions in US taxpayer dollars already approved into law for dispersal for American’s green energy future, including an estimated $3 Billion to VeriGreen Energy Corporation.
Doug

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:D



Offline mark

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Re: Subtitle C-11 Sec. 2521 - National Medical Device Registry
« Reply #6 on: September 10, 2009, 08:22:43 PM »
you might need more protection than a homemade AFDB can provide.



upgrade to AFDB Pro immediately!



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Offline Ecosse

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Re: Subtitle C-11 Sec. 2521 - National Medical Device Registry
« Reply #7 on: September 11, 2009, 01:08:28 PM »
Quote
‘‘National Medical Device Registry
‘‘(g)(1) The Secretary shall establish a national med-
ical device registry (in this subsection referred to as the
‘registry’) to facilitate analysis of postmarket safety and
outcomes data on each device that—
‘‘(A) is or has been used in or on a patient; and ‘‘(B) is—
‘‘(i) a class III device; or
‘‘(ii) a class II device that is implantable,
life-supporting, or life-sustaining.
‘‘(2) In developing the registry, the Secretary shall,
in consultation with the Commissioner of Food and Drugs,
the Administrator of the Centers for Medicare & Medicaid
Services, the head of the Office of the National Coordi-
nator for Health Information Technology, and the Sec-
retary of Veterans Affairs, determine the best methods
for— ‘‘(A) including in the registry, in a manner con-
sistent with subsection (f), appropriate information
to identify each device described in paragraph (1) by
type, model, and serial number or other unique iden-
tifier;
‘‘(B) validating methods for analyzing patient
safety and outcomes data from multiple sources and
for linking such data with the information included
in the registry
as described in subparagraph (A), in-
cluding, to the extent feasible, use of—
‘‘(i) data provided to the Secretary under
other provisions of this chapter; and ‘‘(ii) information from public and private
sources identified
under paragraph (3); ‘‘(C) integrating the activities described in this
subsection with—
‘‘(i) activities under paragraph (3) of sec-
tion 505(k) (relating to active postmarket risk
identification);
‘‘(ii) activities under paragraph (4) of sec-
tion 505(k) (relating to advanced analysis of
drug safety data); and
‘‘(iii) other postmarket device surveillance
activities of the Secretary authorized by this
chapter; and
‘‘(D) providing public access to the data and
analysis collected or developed through the registry in a manner and form that protects patient privacy
and proprietary information and is comprehensive,
useful, and not misleading to patients, physicians,
and scientists.
‘‘(3)(A) To facilitate analyses of postmarket safety
and patient outcomes for devices described in paragraph
(1), the Secretary shall, in collaboration with public, aca-
demic, and private entities, develop methods to—

‘‘(i) obtain access to disparate sources of
patient safety and outcomes data, including—
‘‘(I) Federal health-related electronic
data (such as data from the Medicare program under title XVIII of the Social Secu-
rity Act or from the health systems of the
Department of Veterans Affairs)
;
‘‘(II) private sector health-related
electronic data (such as pharmaceutical
purchase data and health insurance claims
data
); and
‘‘(III) other data as the Secretary
deems necessary to permit postmarket as-
sessment of device safety and effectiveness
;
and
‘‘(ii) link data obtained under clause (i) with information in the registry.
‘‘(B) In this paragraph, the term ‘data’ refers to in-
formation respecting a device described in paragraph (1),
including claims data, patient survey data, standardized
analytic files that allow for the pooling and analysis of
data from disparate data environments, electronic health
records, and any other data deemed appropriate by the
Secretary.

‘‘(4) Not later than 36 months after the date of the
enactment of this subsection, the Secretary shall promul-
gate regulations for establishment and operation of the
registry under paragraph (1). Such regulations— ‘‘(A)(i) in the case of devices that are described
in paragraph (1) and sold on or after the date of the
enactment of this subsection, shall require manufac-
turers of such devices to submit information to the
registry, including, for each such device, the type,
model, and serial number or, if required under sub-
section (f), other unique device identifier; and
‘‘(ii) in the case of devices that are described in
paragraph (1) and sold before such date, may re-
quire manufacturers of such devices to submit such
information to the registry, if deemed necessary by
the Secretary to protect the public health;
‘‘(B) shall establish procedures— ‘‘(i) to permit linkage of information sub-
mitted pursuant to subparagraph (A) with pa-
tient safety and outcomes data obtained under
paragraph (3); and
‘‘(ii) to permit analyses of linked data;
‘‘(C) may require device manufacturers to sub-
mit such other information as is necessary
to facili-
tate postmarket assessments of device safety and ef-
fectiveness and notification of device risks;
‘‘(D) shall establish requirements for regular
and timely reports to the Secretary, which shall be
included in the registry, concerning adverse event trends, adverse event patterns, incidence and preva-
lence of adverse events, and other information the
Secretary determines appropriate, which may include
data on comparative safety and outcomes trends;
and
‘‘(E) shall establish procedures to permit public
access to the information in the registry in a manner
and form that protects patient privacy and propri-
etary information and is comprehensive, useful, and
not misleading to patients, physicians, and sci-
entists.
‘‘(5) To carry out this subsection, there are authorized to be appropriated such sums as may be necessary
for fiscal years 2010 and 2011.’’.
(2) EFFECTIVE DATE.—The Secretary of
Health and Human Services shall establish and
begin implementation of the registry under section
519(g) of the Federal Food, Drug, and Cosmetic
Act, as added by paragraph (1), by not later than
the date that is 36 months after the date of the en-
actment of this Act, without regard to whether or
not final regulations to establish and operate the
registry have been promulgated by such date.
(3) CONFORMING AMENDMENT.—Section
303(f)(1)(B)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(1)(B)(ii)) is amend-
ed by striking ‘‘519(g)’’ and inserting ‘‘519(h)’’.
(b) ELECTRONIC EXCHANGE AND USE IN CERTIFIED ELECTRONIC HEALTH RECORDS OF UNIQUE DEVICE
IDENTIFIERS.—
(1) RECOMMENDATIONS.—The HIT Policy
Committee established under section 3002 of the
Public Health Service Act (42 U.S.C. 300jj–12)
shall recommend to the head of the Office of the Na-
tional Coordinator for Health Information Tech-
nology standards, implementation specifications, and certification criteria for the electronic exchange and
use in certified electronic health records of a unique
device identifier for each device
described in section
519(g)(1) of the Federal Food, Drug, and Cosmetic
Act, as added by subsection (a).
(2) STANDARDS,  IMPLEMENTATION CRITERIA,
AND CERTIFICATION CRITERIA.—The Secretary of
the Health Human Services, acting through the
head of the Office of the National Coordinator for
Health Information Technology, shall adopt stand-
ards, implementation specifications, and certification
criteria for the electronic exchange and use in cer-
tified electronic health records of a unique device
identifier for each device described in paragraph (1),
if such an identifier is required by section 519(f) of
the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360i(f)) for the device.

Unfortunately everything is written like the freekin tax code. So call me crazy... YOU tell me what it all means.

dunno sd750f, those items i put in bold seem curious to me. you design medical products. that's swell... do you have a law degree? even IF the original intent of this is not to track the proletariats, such a bill/law can be manipulated by moderately creative legislators to fit their needs, and goes against the grain of anyone valuing their liberty/freedom. our "representatives" have been talking national health record database for years; thanks but no thanks, you can leave me out.

you're quick to jump all over the whacko rightwinger bandwagon here but if bush was in office when this bill came down the pike, ask your self how you would react. once the technology is (literally) embedded within society good luck extracting it.

i marvel at some people's breathless enthusiasm to surrender, drip by drip, their anonymity, autonomy, and liberty. i guess the leftists weren't so crackers the last 8 years for siting orwell's 1984.

btw: i took note of those items i didn't put in bold which is why i acknowledge the intent of this proposal for a "registry" may not be a scheme of big brother's. but like i said before, once there and taken for granted, the floodgates are open. see you in line brother.
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Offline DukieDukenDuke

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Re: Subtitle C-11 Sec. 2521 - National Medical Device Registry
« Reply #8 on: September 11, 2009, 02:10:39 PM »
Get in line for your deep tissue chip implants, sheep. Baaaaaaaaaaaa
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Offline Cvillechopper

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Re: Subtitle C-11 Sec. 2521 - National Medical Device Registry
« Reply #9 on: September 11, 2009, 02:41:25 PM »
WOW!  Just plain WOW!  They are not talking about having the ability to implant you with an RFI.  This is talking about the ability to create a database that houses identifiers of medical implanted devices and (the part that does worry me a little) somehow (yet to be determined) associate that with outcomes.  If you are on medicare, all of this information is already in the government's hands .  The intent is to evaluate which implantable devices work best (better outcomes).  Nobel idea but I don't see this being possible to implement without sacrificing personal freedoms. 

If you don't understand something don't post it with your quasi-crazy interpretations.  It only serves to fuel the fire raging out of control right now that is keeping all sides of the debate from working toward a solution.  Posting stuff like this makes others start calling names, telling you to get out the tinfoil hat, etc.  you would have gotten a much different reaction if you had posted the section that worried you and asked for someone to try and explain it.  Instead you look like a nut job.  Sorry if I'm offending you.  Personally I think everyone should actually take the time to understand what they are reading or ask for help, not jump to misconceived conclusions.
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Offline lynchj

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Re: Subtitle C-11 Sec. 2521 - National Medical Device Registry
« Reply #10 on: September 11, 2009, 03:34:16 PM »
what the heck is a "class 2 device that is implantable" My guess is it something like a pace maker but with all that legal mumbo jumbo who the heck knows.

Tooooooo many words. Why can't lawyers just get to the point!

I need to wrench something, aaaaagggggghhhhh!
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Offline DukieDukenDuke

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Re: Subtitle C-11 Sec. 2521 - National Medical Device Registry
« Reply #11 on: September 11, 2009, 03:52:28 PM »

Tooooooo many words. Why can't lawyers just get to the point!


That's lawyer's bread and butter, too many words and too much money.
"Well, Mr. Carpetbagger. We got somethin' in this territory called the Missouri boat ride."   Josey Wales

"It's Baltimore, gentlemen. The gods will not save you." Ervin Burrell

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Offline Pinhead

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Re: Subtitle C-11 Sec. 2521 - National Medical Device Registry
« Reply #12 on: September 11, 2009, 04:02:04 PM »
what the heck is a "class 2 device that is implantable" My guess is it something like a pace maker but with all that legal mumbo jumbo who the heck knows.

Tooooooo many words. Why can't lawyers just get to the point!

I need to wrench something, aaaaagggggghhhhh!


That's a good question. As categorized by the FCC,
http://www.nwemc.com/wireless/regulatory-trends-in-wireless-us-and-eu-approvals/
Quote
Licensed transmitters, or transmitters used in non­harmonized spectrum, are categorized as Class 2 equipment.


A Google search shows that bluetooth devices are an example of Class 2 transmitters.
« Last Edit: September 11, 2009, 04:03:35 PM by Pinhead »
Doug

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Offline Markcb750

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Re: Subtitle C-11 Sec. 2521 - National Medical Device Registry
« Reply #13 on: September 11, 2009, 06:33:13 PM »
 ???



 ::)


 :D
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Offline tramp

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Re: Subtitle C-11 Sec. 2521 - National Medical Device Registry
« Reply #14 on: September 11, 2009, 06:35:38 PM »
no implants for me, thank you
it is coming though
they do horses don't they
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Re: Subtitle C-11 Sec. 2521 - National Medical Device Registry
« Reply #15 on: September 11, 2009, 09:11:30 PM »
Class I: General Controls

Class I devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. These devices are subject only to general controls. General controls cover such issues as manufacturer registration with the FDA, good manufacturing techniques, proper branding and labelling, notification of the FDA before marketing the device, and general reporting procedures.[2] (Most Class I devices are exempt from the good manufacturing practices and/or the FDA notification regulations.)[2] These controls are deemed sufficient to provide reasonable assurance of the safety and effectiveness of the device; or the device is not life-supporting or life-sustaining and does not present a reasonable source of injury through normal usage. Devices in this category include tongue depressors, bedpans, elastic bandages, most hand-held dental instruments, examination gloves, and hand-held surgical instruments and other similar types of common equipment. Depending on the "stated/purported use" of a device, it may be necessary to obtain a Premarket Approval or 510K for the device, which is otherwise classifiable as a Class 1 device. Such devices are referred to as "reserved devices". The electrically powered arthroscope (which is really an endoscope powered electrically) is a case in point. While endoscopes are Class 1 devices, the electrically powered arthroscopes need a pre-market notification (510K) although the manual arthroscopes do not. Pre-market notified devices are marketed as "at least as safe and effective, that is, substantially equivalent, to a legally marketed device."

[edit]
Class II: General Controls with Special Controls

Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and additional existing methods are available to provide such assurances. Therefore, Class II devices are also subject to special controls in addition to the general controls of Class I devices. Special controls may include special labeling requirements, mandatory performance standards, and postmarket surveillance.[2] Devices in Class II are held to a higher level of assurance than Class I devices that they will perform as indicated and will not cause injury or harm to patient or user. Devices in this class are typically non-invasive and include x-ray machines, PACS, powered wheelchairs, infusion pumps, surgical drapes, surgical needles and suture material,acupuncture needles.

[edit]
Class III: General Controls and Premarket Approval

A Class III device is one for which insufficient information exists to assure safety and effectiveness solely through the general or special controls sufficient for Class I or Class II devices. Such a device needs premarket approval, a scientific review to ensure the device's safety and effectiveness, in addition to the general controls of Class I. Class III devices are described as those for which "insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of its safety and effectiveness or that application of special controls ... would provide such assurance and if, in addition, the device is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury."[3]

Examples of Class III devices which require a premarket approval include replacement heart valves, silicone gel-filled breast implants, implanted cerebral stimulators, implantable pacemaker pulse generators and endosseous (intra-bone) implants (with the exception of root-form endosseous dental implants which were recently reclassified as Class II).
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Offline johnyvilla

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Re: Subtitle C-11 Sec. 2521 - National Medical Device Registry
« Reply #16 on: September 11, 2009, 11:17:00 PM »
Someone call Sean Hannity!



Offline edbikerii

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Re: Subtitle C-11 Sec. 2521 - National Medical Device Registry
« Reply #17 on: September 11, 2009, 11:54:34 PM »
And don't forget the "health care reform" initiative for creating standardized Electronic Medical Records for easy databasing and searching.

IBM is still facing lawsuits seeking reparations for holocaust survivors and their families because their technology helped a fascist regime make their medical records more efficient.  Can anyone guess which regime that might have been?

Seem far-fetched?  Well, when I was a kid growing up in the Bronx, the neighbor across the hall used to pay me a quarter to turn on his stove on Saturdays (for religious reasons).  He had a number tattooed on his arm.

Just sayin'
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Offline demon75

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Re: Subtitle C-11 Sec. 2521 - National Medical Device Registry
« Reply #18 on: September 12, 2009, 07:04:01 AM »
Obviously we have gone past the times for foil beanies it has to be the full  "Cupro-Nickel Faraday Cage Helmet" and if you send me just $29.58 in Canadian funds I will send you plans for a proper C-NFCH,
guaranteed to stop brain control emission's from the E space as well ordinary ether, US funds will accepted at par for a limited time and if you order today I will personally include drawings for special attachment points to prevent unauthorized use by agents of change. But wait there's more, for a limited time I'll include a photo suitable for framing of Dick Cheney, George W Bush, shaking hands with Steven Harper.  Remember this is not available in stores and there maybe a 6 month delay crossing the border while it's checked for mind altering properties.
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Offline demon75

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Re: Subtitle C-11 Sec. 2521 - National Medical Device Registry
« Reply #19 on: September 12, 2009, 07:48:04 AM »
In respects to my last post, I forgot to include this disclamer I am not making huge profits from this offer, think of it as me giving back to my less fortunate brethren, i am not making huge profits and thank you ED for making my day.
Bill the demon



Offline DukieDukenDuke

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Re: Subtitle C-11 Sec. 2521 - National Medical Device Registry
« Reply #20 on: September 12, 2009, 12:15:43 PM »
So would the swine flu vaccine they are doling out to people with practically no testing by the FDA be considered a class III vaccine?

I mean, they don't have a hell of a lot of information on it, but there sure are trying to get everyone to take it.

Kool-aid anyone?
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Offline edbikerii

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Re: Subtitle C-11 Sec. 2521 - National Medical Device Registry
« Reply #21 on: September 12, 2009, 10:57:40 PM »
The whole swine flu thing is totally overblown.  Any simple research will show that the N1H1 swine flu is no more harmful than any normal, ordinary flu that we get every year in the US.  People who die from it, just like the surprising number of people who die from non-swine flu every year, typically have some other condition that has already weakened them so that they cannot fight off a flu.  Recent statistics show that 1 in 10 poeple in New York City have had swine flu this year.  That means that over 800,000 New Yorkers had the swine flu and didn't even know it.

The World Heath Organization labeled it a "pandemic" simply because they want to make Americans nervous about their health, and put the thought that "the government ought to do something about it" into people's heads.  These are the same clowns that rate health care in the United States behind health care in Columbia, Dominica, Costa Rica and Chile.  Those rankings are absolutely preposterous, but they are useful to help illustrate the political motives behind the WHO.

Just pure fear-mongering.

So would the swine flu vaccine they are doling out to people with practically no testing by the FDA be considered a class III vaccine?

I mean, they don't have a hell of a lot of information on it, but there sure are trying to get everyone to take it.

Kool-aid anyone?

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Offline MickeyX

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Re: Subtitle C-11 Sec. 2521 - National Medical Device Registry
« Reply #22 on: September 13, 2009, 12:47:30 AM »
Class II is typically noninvasive devices. So, that means they don't get implanted. Class III's are typically implanted things like pacers, defibrillators... It is more highly regulated and tested so they can make sure it won't hurt you. Like finding out pacers shouldn't go near arc welders or magnetic fields. So, right now, everything gets tracked by the docs, the hospitals, the manufacturer of the device... and within that circle, they try to use the info but it's hard to get a global idea of how this stuff is helping or if there is something better for certain individuals. I think this takes the proprietary secrets away and lets the info flow so it can be better utilized. Essentially, it is supposed to CUT the red tape a bit. I don't know if it will work, but at least they are trying to make it a better world by sharing info. Your personal info, like your name and such, is still protected. Think of it as those general demographic questionairres, just with all of the serial numbers and model numbers of equipment and short/long term outcomes instead.

Ed, as usual you are wrong and spreading lies about something you apparently don't know enough about. H1N1 is considered a pandemic flu simply because it isn't a seasonal variety. Also...

"According to the World Health Organization (WHO), a pandemic can start when three conditions have been met:

    * emergence of a disease new to a population;
    * agents infect humans, causing serious illness; and
    * agents spread easily and sustainably among humans.

A disease or condition is not a pandemic merely because it is widespread or kills many people; it must also be infectious. For instance, cancer is responsible for many deaths but is not considered a pandemic because the disease is not infectious or contagious."

Just because it isn't the top story on faux news, doesn't mean it isn't still very big. We have tons of patients with contact and droplet precautions at our hospital at this moment from H1N1. Since they are already compromised, we have to be extra vigilant. People are passing it just like other flus, it just isn't associated with a seasonal flux. Just because it hasn't affected you, doesn't mean it isn't harmful. So there you have it, it's not all about you this time, either. Sorry. You are really hilarious. Has Rush been sharing too much of his oxycodone with you?  ::) :D
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Offline kghost

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Re: Subtitle C-11 Sec. 2521 - National Medical Device Registry
« Reply #23 on: September 13, 2009, 01:33:41 AM »
Spanked by Mickey  ;D
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Offline edbikerii

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Re: Subtitle C-11 Sec. 2521 - National Medical Device Registry
« Reply #24 on: September 13, 2009, 01:52:32 AM »
Ha ha!  Not unless she buys me dinner first!

No doubt, MickeyX, your googling of the term pandemic is quite accurate.  I will not attempt to dispute that.

But face it, WHO's definition of the word "pandemic", is completely irrelevant compared with the fear-mongering effect of the word, or of the phrase "worldwide pandemic" that have been thrown around so freely in the media.  Do you think the population at large has any idea that a "pandemic" can be as impotent as swine flu really is?  What would they have liked the population at large to do about the scary "pandemic", other than shake in their boots and wait for the government to "save them"?  Nice social engineering by the WHO.  They are good at something, but it isn't honesty.

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1977 CB550K
1986 GL1200I

Jetting: http://forums.sohc4.net/index.php?topic=20869.msg258435#msg258435
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"Government is not reason, nor eloquence. It is force. And like fire, it is a dangerous servant and a fearsome master."
-- George Washington