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How Does the FDA Monitor Your Medical Implants? It Doesn’t, Really

From eroding surgical mesh to rusting artificial hips, the past decade has seen many medical devices malfunction. But the FDA doesn’t have a standardized national system to track and catch problems.

An x-ray picture of a pacemaker, one of the medical implants that have malfunctioned in past years. (Shutterstock)

May 8: This post has been updated and corrected.

Each prescription drug you take has a unique code that the government can use to track problems. But artificial hips and pacemakers? They are implanted without such government identification, as are many other medical devices. In fact, the FDA doesn’t know how many devices are implanted into patients each year – it simply doesn't track that data.

Many manufacturers imprint a serial number on their devices. But those numbers are not standardized and aggregated in such a way that the government can easily track them. And the past decade has seen numerous high profile cases of malfunctioning medical devices, which have led to injury or even death. Critics say the FDA's minimal monitoring of devices contributes to these problems.

“If you’re lucky, you might find a sticker on the operating room note that was left over from the product,” said Richard Platt, who runs the Harvard Pilgrim Health Care Institute. Otherwise, there is little way of knowing what device was used.

Right now, the FDA depends mostly on voluntary reports from doctors, patients, manufacturers and hospitals to notify them of problems with devices already on the market. The agency does have some power to require manufacturers to conduct further studies or track a particular device once it is sold. But many devices don’t get that level of surveillance.

“It’s much like a patchwork of streams of information getting to the FDA,” said cardiologist Frederic Resnic of Brigham and Women’s Hospital, who has worked with the FDA on medical device safety monitoring. “The FDA is relying on anecdotal and very variable information about the safety of medical devices.”

If manufacturers get word from a doctor or hospital about a death or injury that occurred as a result of their product, they are legally obligated to investigate the event and report it to the FDA. But the process isn’t straightforward, as has become clear in the recent controversy over the malfunctioning St. Jude’s Riata defibrillator leads (wires that connect a defibrillator to the heart). The FDA said an individual doctor’s report helped alert them to the problem, but it was months before the device was recalled.

According to attorney William Vodra, a regulatory law expert and member of the Institute of Medicine panel that published a report on medical device safety last year, the number of doctors who actually contact manufacturers is small.

And after being notified of patient harm, manufacturers can minimize their own responsibility if they point the blame elsewhere, said health policy expert Diana Zuckerman, president of the National Research Center for Women & Families.

For example, if someone dies from complications in a surgery to remove an implant, the manufacturer may argue that it was the surgery – not the implant – that killed the patient.

“You have a system that is not rigorous, the standards are not always understood, and they are interpreted differently by different people,” Zuckerman said.

The FDA responds to the criticism by pointing out that while every medical device carries a potential risk, the vast majority of devices perform well and improve patient health. An FDA spokeswoman emphasized that the agency must evaluate thousands of medical devices each year, and is constantly looking for ways to better and more quickly identify problems.

While the FDA makes the adverse event reports publically available in a searchable database, it doesn't have a standardized system for reviewing reports once they are sent in, said Vodra, the attorney. A disclaimer on the site specifically states that the data is "not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices."

“What you would normally consider the simplest kind of data analysis is not done,” said Zuckerman. Often, doctors catch a malfunctioning device before the FDA ever notices.

In one case, a group of Pennsylvania doctors noticed that several patients were showing severe complications a few years after getting an IVC filter – a device designed to capture blood clots. Bits of the filter were breaking off, causing chest pain and a dangerous build-up of fluid and pressure around the heart. In 2010 the doctors conducted their own study and found that the filter broke in a quarter of all patients who used it.

On the day that study was published, the FDA issued a warning saying it had received over 900 reports of problems with IVC filters since 2006, and that the device was meant to be removed after a few months, not left in permanently.

There have been numerous attempts at reform. Five years ago Congress ordered the FDA to set up a post-market surveillance system to track the safety of all medical projects, but a system hasn’t yet been set up for medical devices.

A year later the FDA announced the Sentinel Initiative, which would combine existing data from electronic health records and medical claims to track drugs, vaccines, and devices. Some groups of hospitals or other organizations have voluntarily set up registries to collect information about the make and model of devices.

While the FDA has made significant progress on tracking drugs, it’s not yet in a position to do the same thing for devices, according to Harvard’s Platt, who is the principal investigator of Mini-Sentinel, the FDA's pilot program for the national system. The data isn't there.

The FDA has long acknowledged the need for a unique device identifier system, and got permission from Congress to set one up five years ago. No such system of ID-tags exists yet, but after several recent high profile medical device failures, the issue getting some attention from Congress. A proposed Senate bill, which cleared the Health, Education, Labor and Pensions Committee last week, sets a timeframe for implementing a unique identification system, among other reforms.

“If UDI’s were used in a consistent way, we could use the same kinds of techniques we've developed for drugs for devices,” said Platt. “It would be a huge breakthrough.”

Correction: This post mistakenly stated that medical devices are implanted without identification. In fact, many manufacturers imprint serial numbers on their devices, but the government has not instituted a unique-identifier system that would allow it to easily track medical devices and any problems that occur with them. This post has been changed to clarify this distinction.

The FDA frequently abandons responsibility, often by outsourcing its work to unmonitored private firms.  For an exciting story about how well this goes, ask your favorite search engine about Truper Dawg.  You won’t be disappointed.

As for this situation in particular, it’s not a prospect that thrills me, for privacy reasons, but RFID chips can be had a few for a dollar.  If Wal-Mart can tell you what store a specific TV has arrived at, medical manufacturers can make sure you know which hip or valve has been implanted in you.

As I said, there’s a privacy issue that a passer-by could read your implants’ serial numbers, but I’m also just outlining a system that could be implemented in an afternoon for essentially pocket change.  Better can be done with more work.

The use of cosmetic implants, in any circumstance and all types, are just put into people and when the procedure is done, that is the end of the physician relationship.  There are no follow up visits unless there are issues. The notification of recalls or potential harm from any implants is never done.  Still further, how much communication from the government or other sources who find out about implants with potential harm actually gets to the physicians ear?  Even the physician may hear about things and it does not stick to take any further action as they believe the person in their office or hospital would have that responsibility to know if issues are occurring with the items ordered or already on their shelves.  Guess again?  No communication from development to five or ten years out in a person’s body.  So, pass that ball of responsibility again?  Who is responsible for this process?  Who is responsible when it fails?  Who really takes the fall in all cases?

The reality of what our medical community does is just a game and by design, they want you to return.  “Hey Doc, I have pain”.  Doctor:  Here’s some highly addictive medication.  “Hey Doc, I have a Stomach Ache.”  Doctor:  Here’s something that will damage your liver, see you in three weeks.  “Hey Doc, can you fit me with some new jugs?”  Doctor: “Sure can, I’ll see you in a couple of years for cancer”...  It really is a useless profession…

Emmett Smith

May 3, 2012, 8:30 p.m.

You want to fix the FDA? The only purpose of the FDA is to enact regulations that favor big companies so the 1% can get more money. This bureaucracy prolongs cancer so the same people can make money. It does the same thing to our food. It approves medication that causes problems so that more medication will be sold. It hopes that implants don’t last so they will have to be replaced. The only way to fix the FDA is to get rid of it.

Gadolinium metal injected for MRIs is a medical device, too, see what that does to you? Ever been told you have fibromyalgia, TMJ, CFS, allergy , depressed or just anxious or neurotic, MRI gadolinium can make you feel that way, when you get the skin sx and a skin biopsy for a condition that IS NOT rare, but the FDA hopes MDs will do a skin biopsy on you within 2 yrs to “see” if NSF/fibrosing sx occur.

Know radiation is cumulative and they will lie to you.
See http://www.mayomedicallaboratories.com for G for Gadolinium.It’s NOT RARE, even if the yale MD says so. The mfgr reports are much higher and the US is the highest user of gadolinium metal, which deposits in bones and you pee it out after 8 years, even with one injection, which you don’t need. See http://www.nyas.org Fourth Annual NSF e briefing, 13 Sept 2010. You’ll see the truth there.

See this month’s Consumer Reports re Radation and CT scans, 1CT=600 Chest Xrays,  1 CXR= 1 year of natural radiation. Think about it.  Hospitals, atleast the ones I’ve worked in for over 28 years do have an implant book with the mfgr stickers and conscientious RN’s will give the copy to the patient.

Mesh is used and this is recorded on the paper/electronic chart the mfgr code and many hospitals require the lot number and exp date of medications, to include Gadolinium used, regardless of the mfgr. But, this may not reach the pt if the Radiology Dept is too lazy to give it to the patient as in my case at UCH. The FDA needs to be regulated, too.
There are many people who need jobs and would be willing to do an honest days work , get the losers off the payrolls.

FDA also has Humanitarian Exemption Rules that MD’s can use and you can’d do anything about it, when they want to use some experimental “crap”, that applies at the end of your life, esp if no family is around to speak up for you against any experimental procedure, so better include this in your advanced directives, or you are screwed.

Most of the 90% of manmade cancers could be avoided by the simple word NO to all radiation and contrasts. Period.

“While the FDA has made significant progress on tracking drugs, it’s not yet in a position to do the same thing for devices, according to Harvard’s Platt…”

Eh?  From http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm

Quote:  “Reporting of adverse events and medication errors by healthcare professionals and consumers is voluntary in the United States.”

lolll…how many think a doctor is going to be 100% conscientious about reporting adverse drug reactions to drugs they prescribed?

How many patients know to report adverse drug reactions to the FDA?  Did you???

Janet,

I’m a current researcher associate in Magnetic resonance imaging (MRI), Orthopaedic Surgery, and a certified Nuclear medicine technologist. I feel some of your statements make unsubstantive claims that lack firm scientific support.  For example, when you write “Most of the 90% of manmade cancers could be avoided by the simple word NO to all radiation and contrasts. Period.” Can you please provide a source or publication for this. This finding would be equivalent to the finding that Tobacco products increase a person’s chance of developing cancer.  However, to incite a false claim for the purpose of supporting a personal view is conniving.  To randomly bring up these topics in such a forum is somewhat anachronistic.  An important point of this article is that certain medical devices are escaping regulatory oversight from the FDA by claiming a new medical device (e.g. Depuy J&J ASR XL Acetabular metal-on-metal hip prosthesis) meets FDA classification of substantially equivalent.  Please see in text hyperlinks to learn more about FDA 510(k) decision making.  Most likely, a majority of the failed medical devices circumvented FDA clinical trials by taking advantage of pre-market approval through the FDA 510(k) process.  See the article by Lena Groeger published on April 30th titled “Four Medical Implants That Escaped FDA Scrutiny”. 

This response however does not take into account some of your comments, therefore for the sake of argument I will address them.

Ionizing radiation like X-Rays, gamma rays, and beta emitting isotopes interact with cellular DNA to cause deleterious effects that can lead to cancer.  There is a difference in opinion of the current research model of radiation effects on the human body.  Two competing theories exist that attempt to explain the relationship between radiation exposure and cancer.  The first theory assumes a linear association between cancer and total radiation exposure and the second assumes there is a threshold where a person’s chance of developing cancer from radiation exposure is non-linear.  These theories were mainly from medical reports following the use of plutonium and uranium atomic bombs exploded over Nagasaki and Hiroshima and the Chernobyl incident.  Even though radiation fallout from these events have been well documented, a disparity perpetually exists.  Association between radiation dosimetry and cancer rates is a non-trivial question where an answer depends on multiple factors.  To date, it is almost impossible to predict a patient’s risk of developing cancer from diagnostic imaging that uses ionizing radiation.  There have been published epidemiology studies that have investigated cancer rates in pediatric patients that had Computed Tomography (CT) scans.  These studies have shown that pediatric patients exposed to ionizing radiation from CT scans calibrated for adults have increased rates of cancer.  The medical algorithm that dictates the decision to use diagnostic tests like CT scans always takes into account the risk vs. benefit to the patient.  This concept is used widely in medicine when a medical procedure puts a patient at risk.  A strong example would be the use of chemotherapy agents in pediatrics.  I personally did multiple diagnostic nuclear medicine scans on a young girl who had a rare sarcoma.  The cancer went into remission after a combination of radio- and chemotherapy.  However, the patient developed liver damage and cardiomyopathy that eventually resulted in her death. Without those treatments, the patient would have died from the anaplastic type of soft-tissue sarcoma at an earlier age.  Another example would be the use of Herceptin in patients with breast cancer.  Ionizing radiation from diagnostic tests is not arbitrarily prescribed but use decision trees and rubrics.

continued in part 2…

Part 2

I will not deny intravenous administration of Gadolinium based Magentic resonance imaging (MRI) contrast agents can cause Nephrogenic systemic fibrosis (NSF).  The incidence of NSF is higher in patients with poor kidney function. Patients recieving these agents (Magnevist, Omniscan, Prohance, Multihance, etc…) intravenously are screened for chronic kidney diseases (e.g. glomerular filtration rates <15 mL/min/1.73 m^2 is a contraindication).  Additionally, IV injection of different Gd-agents like gadodiamide (Omniscan) can increase the incidence of NSF by a factor of 16. [Thomsen S, Radiologic Clinics of N America (2009), 47(5);827-831]  The association between teratogenicity and Gadolinium agents however is not established.  Thus, precautions like avoiding the use of gadolinium contrast agents in pregnant women is avoided and surrogate diagnostic tests are performed if available.  The main issue with gadolinium contrast agents is if chelated gadolinium ions separate from the moiety.  This can result in toxic accumulation of gadolinium in specific organs that actively or passively uptake this ion.  I would be more worried about this possible serious adverse event than cancer.  If you are scheduled to have an contrast enhanced MRI that uses a gadolinium based agent, I would recommend you check the FDA website for any recalls related to the gadolinium contrast agents and check with the MRI department about what gadolinium agent they use.  If you are having an intra-articular injection then I would be less worried about adverse events.

For brevity, I will not address all comments.  I feel forums for discussion, specifically in this context, need to adopt similar standards as the journalists who investigate and objectively present their stories.  This is not a peer-reviewed forum therefore subjective comments should be avoided, especially those based on personal equipoise.  This applies to all posts I read related to this article.  Reporting of adverse of events related to drugs or sentinel events are voluntarily reported to the FDA by healthcare workers because the FDA is not the correct regulatory entity to report those types of errors.  The main regulator of hospitals in the US is the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).  Adverse events that result in death or serious harm are required to be reported to JCAHO.  Additionally, congress passed the Patient Safety and Quality improvement Act in 2005 which requires mandatory reporting to a government database.  These reports can be confidentially submitted and cannot be used in tort cases. For the sake of preserving the fidelity of published stories on propublica please keep your posts relevant and insightful.  If you want to speak out of your ass, please click on the blue bird icon located at the top of the page.

Thank you for reading.  Let me know if you have any questions.

@Mike, re “This applies to all posts I read related to this article. [...] Additionally, congress passed the Patient Safety and Quality improvement Act in 2005 which requires mandatory reporting to a government database. [...] These reports can be confidentially submitted and cannot be used in tort cases.”

lollll…buried that rather deeply, you did. 

You should, perhaps, have mentioned that said data can’t even be accessed by the public.  I.e., if a medical provider - to include a nuclear medicine technologist - routinely has…“adverse patient outcomes”...the public cannot identify that provider and choose a different provider in self-defense.

http://www.healthreformwatch.com/2010/04/25/patient-safety-and-quality-improvement-act-of-2005/

Quote:  “The success of the Act depends on providers voluntarily reporting medical errors. To this end, the Act includes federal privilege and confidentiality protections for PSWP. This protection alleviates provider concerns that reported information will be used against them in civil and criminal actions, specifically, medical malpractice litigation. Further, the Act forbids disciplinary actions as a result of a provider’s report. In order to ensure confidentiality of patient information, the Office for Civil Rights (OCR) will investigate allegations of violations and the HHS Secretary has the power to impose civil money penalty (CMP) of up to $10,000 per violation.

Observe the focus on civil and criminal actions….which is rather telling, were you to ask me; that is a declaration that the medical community is aware that - were the public to have all of the data - there indeed would be civil and criminal actions.  From a more pragmatic perspective, although various official agencies may be aware that there are medical providers who are a danger to the public, the public - you - are to be kept in the dark with the full force and power of the law.

And did you catch the bit about “forbids disciplinary actions as a result of a provider’s report”?  That rather encourages the provision of one story to this database but, potentially, something entirely different to a hospital disciplinary board.  I.e., the database may be aware of problematic providers, but those who could do something about them?  In the dark, like the rest of the public.

So welcome to the lottery, America!  Will you be one of the lucky estimated “98,000 people die in America each year due to medical errors”?  Perhaps because you made the mistake of going to a medical provider whose abysmal record is carefully shielded from public view?

I know some used car dealers who must be thinking “We need a union like that!”.

The healthcare industry is very…alert…to any possibility that the public may learn a little too much about “the best healthcare system in the world”:

http://www.mcclatchydc.com/2011/11/04/129261/iowa-sen-grassley-joins-fight.html

Thank you ibsteve2u. You are correct in that the reporting requirements for adverse events is voluntary and most doctors will never report these for fear of retribution from Pharma or the patient.  I have a serious problem with them telling the truth about anything.

Mike D, as far as the 90% of cancers being manmade, that is from the American Cancer Society’s webpage vs comparisons of manmade radiation, 1 CT =600 CXR, 1 CXR=1 year of natural radiation,sunlight.  You say you rxd’ young girl w rare sarcoma, but she succumbed to liver/cardiac damage. How much better would her quality of life been if she had been not treated at all? 
Gadolinium agents- http://www.nyas.org 13 Sept e-briefing, Fourth Annual NSF conference, Cowper slides show 366 pts vs the mfgr.Listen to J. Gauldie: just the tip of the iceberg, expect 10s of 1000s
cases in next decade. Panel 1’s ~ first line,“radiologists are terrorists”. J.Gauldie slides:If it’s in them, we put it there- radiologists are the only ones responsible for GBCA’s. FDA slide by Ira Krefting: FDA knows effects of Gd3+ for yrs and earlier than 1997 Danish study. Cowper’s poster of NSF with normal renal function and Gad injected. 2010

Notify FDA and Rx mfgrs, DO IT. It gets in med record. MD has to reply! I did wCarrimune, Wellbutrin, which the MD denied knowing the effects though he completed the report. Symbicort’s info did not get into record unless it’s hidden w skin bx w inc dermal mucin when I figured out gadolinium, he hinted,“do you take Chinese herbs? No, they have metal in them as I’m looking at most recent MRI w GADOLINIUM in first line. He hinted 2 other times,no more radiation,  MRI’s do not emit, except low level, he called me at home once to tell me, No more mecury. Why not just tell me no more MRI or CT contrasts? Why the lies? They are fired now. Gd+3 my skin /blood via Mayomedicallabs. Still w skin sores, never told lower kidney function, they knew it. FDA slide:Blackbox warnings on Gadolinium does not say it’s metal/ Slide for post marketing recommends a skin biopsy w/in 2 yrs of GBCA.

Any hospital that receives Federal funds, you/visitor, patient can make a complaint to HHS, Medicare, IG, Joint Commission, which is iffy as they are in collusion with hospitals and do surprise visits. California is requiring radiation doses/cumulative be recorded in patients records.

Silence re: radiation effects is detrimental to democracy as all silence is, it erodes the very foundation of democracy. Recently lies in local news by oped journalist as if the criticality accident here never happened.

Chernobyl lied, told most exposed citizens they had vegetative neurosis. US made Plutonium victims see psychiatrists to make sure they remained indoctrinated about radiation safety or they were deemed schizophrenic, others with secret society experiments, told they had “housewifes’ syndrome”

Currently the garbage re: Chronic Fatigue,TMJ, depression, anxiety, fibromyalgia and allergies is all BS, but covered up with the stupid meds to cover the sx of gadolinium or accumulated radiation.
http://www.epa.gov for health effects of Technetium. It’s put in common meds, Ditropan, Sustiva,and Ovide,: NME,  the FDA blocked these labeling alerts after I called them out on it to the public.
Read Mind Wars by Jonathan Moreno, PhD, Bioethicist and prestigous member of NYAS.

Injecting metal into people and they were still using it on transplanted kidneys, and people with ESRD with eGFR<30 who had all the symptoms of the painful, incurable fibrosis. bone pain, You have no idea how painful bone pain is> this happened to me, along with the livedo reticularis since 2008, the jerk ID and Immunology MD, who watched every drug reaction I had to drop FEV to 50%, who knew I have lower kidney function, begged for skin biopsy in 2008, I said no, knew they were up to no good.  What is really bad, is that MRIs will be used in the OR with gadolinium and the patient won’t know it. MRA uses 3x the gadolinium dose if it’s accurately recorded, if at all. So, how can an IR nurse write the fluoro dose for a picc line, but the raddocs cannot keep a record, but they do, with lot numbers, the pt just has to find it via FOIA, ACLU, investigative journalists, etc.
Read The Ambushed Grand Jury for fun, see the 10 year coverup. Read Deadly Monopolies, pts here did not even know they were gettin fake blood, polyheme. Most people don’t even know the FDA’s HDE rule, I suggest they search the Humanitarian Exemption Device rule, lest they get some experimental piece of S*** inserted into them by some intern or mad scientist…  Read Medical Apartheid,  The Cinncinati Radiation Experiments,  Mike, atleast you seemed concerned unless you are deceptively being kind to obtain information.
Read the va.gov atomic veterans, search radiation, then find the article about depleted uranium, but mostly see the troop units at Khamisayih in Mar 91 when the wmd, sarin/vx were incinerated with 2 mushroom clouds on that beautful, clear blue, sunny sky day, none of us donned MOPP gear, but low levels of nerve agent were present. Yes, I have genetic mutations and was perfectly healthy pre Desert Storm. etc, etc.

Janet,

Please reread your original post related to 90% of man-made cancers being associated with radiation exposure and gadolinium agents.  Either I misinterpreted your statement or you are incorrect.  Do you mean lung cancer accounts for 90% of man-made cancer?  That would be easier to believe.  I doubt the American Cancer Society would say, “90% of man-made cancers are caused by radiation and gadolinium exposure”.  In my opinion, the ACS uses too much of its funds to support administrative costs and focus on obvious cancer risks. It is a very general source of informative statistics or as the ACS calls it “Facts and Figures”.  I definitely spent 15 minutes of my life searching the ACS website looking for information that supports your statement.  Due to recent reporting requirements published in 2005 I have decided to voluntarily report my findings. 

Your last post was difficult to read.  The argot and pervasive use of undefined acronyms prevented me from deriving any meaningful information. This is not proven science, but I think reading your last post has a risk of making the reader dummer.  Please place a black box warning disclaimer before writing any future posts.  Sorry but I had to do it.  It was a long day today and I can’t help but be cynical and feel stoic in response. 

That was kind of mean but im 24 and need to acquiesce into my generation’s perceptions’ of how people should act.

@ Steve, RE: “You should, perhaps, have mentioned that said data can’t even be accessed by the public.  I.e., if a medical provider - to include a nuclear medicine technologist - routinely has…“adverse patient outcomes”...the public cannot identify that provider and choose a different provider in self-defense.”
Thank you for reading and posting an addendum to my comment related to reporting sentinel events in healthcare.

Just an FYI, nuclear medicine technologists are required to report sentinel events to the Nuclear Regulatory Commision (NRC).  Not only that, but if a CNMT makes a mistake you need to contact the patient within 24 hours of the event and notify the NRC.  You are definitely barking up the wrong tree when it comes to reporting sentinel events. Be forewarned, defamatory and provincial assumptions are quickly addressed with firm regulatory, old testament justice. 

All NRC reports are publically available.  For example, I worked at Providence Alaska Medical Center in 2009.  See the May 11th, 2009 NRC report and follow up letter.  Please note, those sanctions were delivered to the radiation oncology unit, not the nuclear medicine department. I guess you can automatically say, “therefore I know this to be fact because this rule can be taken advantage of”.  I’m sorry but not every industry is like Wallstreet, we actually have a lot more autonomy, beneficence, and non-malfeasance in the healthcare industry. 

To arbitrarily assume all medical errors are passively reviewed by hospital administrators and co-workers is extremely stupid.  It shows how little someone can know about something yet feel they are automatically correct.  Just because you read a short 300 word summary or identified specific clauses within the Patient Safety and Quality Improvement Act, you feel entitled to frivolously make inferences about a profession you obviously know so little about.  I am basically calling out your bluff because you found a loop-hole to spin a malignant argument.

Transparency in medicine and medical research is needed to assure patients receive unbiased treatment.  Luckily, the new healthcare reform bill signed into law in March 2010 will require all manufactures to report all payments to medical professionals on or before March 2013.  All “Industry” payments made to doctors, medical institutions, medical schools, etc… will be made publicly available on a website by September 2013.  Some companies have started to voluntarily report cash values paid to physicians.

Janet -

My response to your post from May 8th was rude and immature.  Please accept my apology.  Unfortunately I can’t delete or retract my post.  Thank you for recommending all the helpful resources.  If you haven’t had a chance, you should read a book called “Overdosed America” by John Abrahms.  Also, I recommend publications by Arnold Relman.  Both John Abrahms and Arnold Relman are professors at Harvard Medical School. In 1980, Dr. Relman published a paper in the New England Journal of Medicine titled, “The new medical-industrial complex”. 

Have a nice week,
Mike

Mike: I accept your apology, but you are inexperienced with the really dark side of medicine for now. Only when something happens to you and your profession betrays you if , when you find out will you see how you are treated, paperwork disappears and you are lied to and it’s not even your fault. See http://www.auntminnie.com forum under general radiology/contrasts agents…. see what they wrote to me, and how one threatened me in which I responded I’ll contact the FBI. Brian Casey only considered removing my comments/forum, instead, it was buried in other articles listed and sent to Europe. Well, the good that has come out of it so far, is that radiologists are using /testing the benefits of NAC pre CT contrast which is technetium/radioactive and the use of lower dose which is supposed to be already in place right? ALARA, so, why are higher doses being used if ALARA is the general rule?


The other site re 90% of man made cancers may be on the http://www.DOE.gov site, radiation experiments. FYI, GE is the nonprofit donation arm of Propublica.org and they will not address many comments about GE who has combined with Microsoft in a company called Caradigm and now MayoClinic has paired with them also. The patients/public in this country are in trouble. Thank God the last plutonium pacemaker is no longer used after 2010? Everyone needs to verify medications/adverse reactions and limit duration of medications used these days. search Jeff Gerths articles on this site.

With Technetium TC99 /radioactive tracers added to common medications and not on the label, patient ,buyer BEWARE.

Thanks for your references and I will research them. BE SAFE.
Read Diary of a Healthcare Hitman, Pfizer exec whistleblower, see what they did to him. I’m not sure if that’s the exact title, pretty close. I have Overtreated, Why too much medicine is making us sicker and poorer, and I have a book about Gadolinium, Pollonium, etc that I take to the MDs office on occassion. read http://www.rsna.org articles and http://www.auntminnie.com forums…. see how rude they are, raddoc, sardonicus, agentmichaelscarns, they make the same comments to almost anyone on almost every forum site, so I’m not so offended, but they have “big pockets, lots of money and will come after me”, but the medscape article that says pts who write bad reviews about docs can’t be sued, due to person opinion and if true, it’s not libel as I told agent michaelscarns with big pockets and also, the docs end up paying their own legal fees! HA!  All occurrence reports are sent to the risk management office, as part of discovery. Everyone needs to report all medication/product defects/ and keep a copy for your records. Yes, even the occurrence reports, that say , “do not copy:”. I did in most cases as most nurses do… if you creeps from auntminnie contact me , you’ll be getting a phone call or two. Got it?

Janet-

Just an FYI, I wasted another damn 15 minutes of my life looking for information that supports your statement that 90% of all man-made cancer comes from gadolinium/technetium. That statement smells like it came out of your @$$. 

You are not qualified, nor capable of providing accurate or supported information.  I wish to reinstate my retracted comment.  Your statements are misleading “opinions” and are not “facts”.  Multiple statements are FALSE.  You do not know what you are talking about!  Polonium! really?  NAC (N-acetylecystein) equals technetium?  Have you ever taken a basic chemistry class?  You speak about medical doctors poisoning patients with technetium and gadolinium but in truth your words are more poisonous.

I still can’t believe you bring a book on Polonium to the doctors office.  Really?  Polonium?  The poor doctor.  Are you planning on building a satellite or assassinating someone with an umbrella?

What the hell does GE have to do with anything?  Are you saying GE controls what is published on ProPublica and NBC?  Provide corporate memos between editorial staff and GE executives.  I would not be surprised if you have been sued for libel.

In summary, you are nothing more than a petty liar.  Maybe you should think before you write something slanderous and false.

@Mike D:  Given the evidence presented by your comments - your indication that you are aware that you are unnecessarily rude while nevertheless periodically resorting to a foul vocabulary and unnecessary rudeness in combination with your emotion-laden translation of comments applying to other portions of the broad medical industry into attacks personalized for your little slice of it - you might consider scheduling a thorough medical exam for yourself.

Beyond the hazards of your chosen field of work, I’ve seen Alzheimer’s patients display both a progressive inability to maintain emotional stability and an increasing paranoia and inability to deal with change that they translate as “conservatism”.

Better safe than sorry, eh?

I’m 24 steve, I don’t think I display antecedent descriptors for Alzheimers. Thanks for chiming in though.

Of course there is always the possibility - one suggested by the seeming linkage between rudeness contained and time of posting - that what I’m seeing is a symptom of…ethanol poisoning.

Very common, in the medical community.

I’ll plan on taking my medical advice from someone that went to 4 years of college, 4 years of medical school, and 4-6 years of residency/fellowship.  Not someone with a certificate from COSTCO [Idiocracy the movie]

Stupidity is a very common pathology in the general population.  It’s better to be safe than sorry.  I don’t want to have an unneccessary CT or PET scan because someone read a wikipedia article on Alzheimers and thinks I have Alzheimers.

@Mike D, re:  “I don’t want to have an unneccessary CT or PET scan…”

Oh, is that a potential problem in your field?

On second thought, I do believe that you answered the question with your “Stupidity is a very common pathology in the general population.”

Were that attitude as pervasive within the medical community as the fact that a member of the medical community is willing to publicly state it suggests, I suppose that there would be quite a lot of unnecessary - but highly lucrative - CT and PET scans ordered.

Im not the one that is ordering the studies.  Most of the time these scans are ordere because doctors would rather be safe than sorry.

I would say you were officially intellectual b***c slapped by someone half your age. Pet scans are never arbitrailily prescribed.  CMS reimburses for these scans. They used to use the NOPR registry but i think that appellation has changed. Anyways you are and idiot so quit wasting my time.

From offense, to defense…have you in your professional career seen instances wherein you felt that such an order was unjustified?  Perhaps even…ill-considered?

I would note that your response - sans specifics/limited to generalities - “cannot be used in tort cases”.

lolll…I would say ProPublica’s way of indicating identity can make a multitude out of one.

Oh, I do hope you don’t stop posting, “Mike [___]”.

The arrogance, conceit, and hubris you manage to incorporate does much to provide the public with a basis for reconsidering the automatic nature of their trust for the medical community.

You’ve managed to paint a portrait of a medical community that sees itself as infallible, justified in whatever they do solely because they want to do it, and - should their actions drive adverse outcomes - fully capable of repeating that pattern of behavior after the fleeting thought “No great loss…they’re pathologically stupid, anyway.”.

@ibsteve2u, RE: where’s the tape measurer

Your capricious interpretations of my comments and pedantic citations are the reason I will not engage in this pissing contest with you.  I am a research associate.  At the moment I do not do clinical work.  I mainly focus on Orthopaedic surgery research and MRI physics.

Any “right-minded” medical professional would quickly dismiss the statements from Janet.  This may prevent her from recieving the best possible treatment because she is questionning the medical decision algorithms that doctors use to establish treatment options.  If you have someone that is consistently citing esoteric and false information, doctors will take on a much more conservative approach that may have deleterious effects.

Your questions and derived conclusions are patronizing to years of scientific progress in the medical field.  The medical field relies on peer-review and objective studies to influence their medical opinion.  Thus, evidence based findings and interpretations are needed to support any conclusions med professionals make.  Subjective inferences are automatically regarded as poor evidence.  Its unfair to be critized based on poor evidence when you are basing your decisions on well established research and peer-reviewed publications. Therefore, those types of comments are met with stringent critisicm from the medical community.  Unfortunately, I brought that pragmatic approach into an open forum that is plagued with misinformation from unqualified individuals.

Anyways, you are asking me the wrong questions.  I am a researcher on Phase 1, 2 and 3 clinicals trials financially supported by a large orthopaedic manufacturer.  I would be more interested in asking me about conflicts of interest between the investigator and the manufacturer.  This creates researcher equipose and bias, which I have personally seen first hand.  As a result I have decided to resign and go to medical school.  I mentioned earlier in one of my posts that the medical industrial complex is a formidable enemy to the fidelity of medicine.  I will say this is very true.  It is scary how money can “possibly” or most likely influences clinical researcher.  Luckily, fianancial ties between researchers and medical professionals will be made publically available in Sept 2013.

You’ve manage to paint a picture of a lone individual whose arguments were quickly sanctioned for their inaccuracies. Rather than engage in active discussion, you relied on innate defense mechanisms to define your responses.  Its only human nature. 

I’m currently speaking with an investigative reporter from a major newspaper in regards to what I observed in the research field.  I can’t go into anymore details but exposing the corruption I’ve witnessed will hopefully bring public attention to fianacial associations between physicians and industry.  The public deserves to know how.

Have a nice week,
Mike

Consider the contrast between:

“Your capricious interpretations of my comments and pedantic citations are the reason I will not engage in this [insert juvenile word here] contest with you.”

and

“Its unfair to be critized [sic] [...] when you are basing your decisions on well established research and peer-reviewed publications. [...] Unfortunately, I brought that pragmatic approach into an open forum that is plagued with misinformation from unqualified individuals.”

On the one hand, you criticize the citation of any data that threatens your world view.  On the other hand, you lament - rather sophomorically - your inability to achieve the ends you desire by using the exact same approach. 

All in one gigantic (dare I say pedantic?) exposé of ego.

I believe that your intellectual weight is best revealed in your use of “Rather than engage in active discussion, you relied on innate defense mechanisms to define your responses.” as an attack - an attack which might be judged to be “projection” within some segments of the medical community.

I would close by offering you a little advice:  If you wish to spice your comments with acronyms as window dressing in order to add gravitas and then hasten on to make comments about potential conflicts of interest, you should bother yourself to know the mission statements of the entities you use as intellectual crutches.

For instance, the mission statement of the NOPR is “The National Oncologic PET Registry (NOPR) is a collaboration of the American College of Radiology Imaging Network (ACRIN), the American College of Radiology (ACR), and the Academy of Molecular Imaging (AMI), to ensure access to Medicare reimbursement for certain types of positron emission tomography (PET) scans.”

Nary a word about the interests of the patient, eh?

Mike, What is the matter with you? I only said I brought the book to one appt, it wasn’t a threat, he got my point, enough said about that. I was also an ortho trauma RN, for 4 years in a county/city hospital.

I don’t know what to say to you, you seemed reasonable when you apologized and I accepted, but I see now you need some help. Maybe those MRI’s are getting to you?  Please don’t become an MD, you need help, really. As far as the libel crap, as long as it’s true, not libel and if docs try to sue, they lose, big time. Want a reference for that, too?
FYI special reading today, see the article about the RT at Mayo/Jacksonville, Fl hospital infected patients hepatitis. Since you can’t seem to make any sense about much else. I don’t need to “make up ” crap as you say.

I have gad in my skin/blood and a few other symptoms that the public should know about. The medical community does not want them to know. Want any more references. You resorted to your true self again, so rude and crude to write what you did. No pity here, just any future patients if you make it through med school. God help us. Pray you don’t.

There’s probably a reason you were only a nurse for 4 years.

Janet you are a pathological liar. Saying you only brought the book “one time” is a lot different from “on occasion i bring a book on technetium to the doctors office.” Yet again you prove my point. Your statements are false! The question isnt what is my problem but what is yours.

I think he got you there Janice.  Why are making stuff up?

I said I brought the book on (2) occassions, does that help? Come on, Mike, you’re really mean, and you did not read what I wrote. Suddenly, you’re an expert at pathological lying. Wonder why? You’re so good at it , that’s why!

I did not connect Pollonium with NAC,  YOU DID. Please re read the above. Why are you so hot about this anyway? You are attacking people for no reason. I was an RN (U of Miami) for 28 years, some military and civilian as well as 4 years of ortho trauma in a county hospital. I have other military related medical conditions that occurred while you were probably still in kindergarten, we were in the Desert, or on active duty with 9-11. So, you have alot of catching up to do. Please try to calm down or call the suicide hotline or poison center for help. Enough. Try humanity instead.  Don’t become a doctor, please don’t think that will make you human.  You are ONE device the FDA should keep track of, .... some kind of biosimilar human, lol….

Harmony, Just what we need, yep, I like to make stuff up just to PO ol’ Mikey, there, doing a good job, too!.  yeah, he got me…. Oh Mikey, the book is Elements, Gadolinium, Pollonium, Plutonium, $20. at B&N , just in case. Oh, the Doc agreed with me, too. So did the derm doc and the mayoclinic labs.  Recent as of yesterday, 2 studies show use of NAC and Vit C, E is effective enough for antioxidant activity for TC99. And the FDA also is telling parents to question the use of radiation scans, alternate testing and to keep track of radiation doses due to lifetime exposures/cumulative doses of radiation , you know, cancer, the comment above you dismissed….

mikey: try WebMD.com/cancer,
so, I’ve read various sites and they all come up with the 90% number in some way or another, but this was not the site I read from , it was a professional journal site, not a paid/advertising/pharma site, either.
This WebMD site lists chest xray as = to 2.7? days of background radiation, where as I’ve read 1 cxr= 1 yr of natural radiation, I’d prefer it was 2.7 days of natural. I don’t think there will be an agreement on this, but this site did mention CT and fluoroscopy equivalents and again mentioned keeping track of radiation dose exposures. it has it’s own % on lifetime exposures vs number of people exposed. Whatever..

Mikey, I did not say 90% of cancers come from gadolinium and technetium, those are your words, again. In my very first post on 3 May, I wrote that I have been an RN for 28 years, so, you’ve misread almost everything written, been argumentative, changed the original writer’s words to yours, they don’t make sense when changed and no wonder you can’t find information as you wrote, because that is not what was written. 90% of manmade cancers are environmental, to include ionizing radiation, etal.OK? You took something and made a mess of it. Mean, too.

@ Janet, RE:  “... radiologists are using /testing the benefits of NAC pre CT contrast which is technetium/radioactive and the use of lower dose which is supposed to be already in place right?”

This statement is saying, N-Acetylcysteine (NAC) is [“which is”] technetium/radioactive.  Please check for typos because that can be confusing for the reader.  You may have been trying to communicate something different.

@ Janet, RE: “Most of the 90% of manmade cancers could be avoided by the simple word NO to all radiation and contrasts. Period.”

@ Janet, RE: “Mike D, as far as the 90% of cancers being manmade, that is from the American Cancer Society’s webpage vs comparisons of manmade radiation”

@ Janet, RE: “The other site re 90% of man made cancers may be on the http://www.DOE.gov site, radiation experiments.

@ Janet RE: “I did not say 90% of cancers come from gadolinium and technetium, those are your words, again.”

Again, I checked all sources and could not find supporting information for your original post from May 3rd.  Could you have been mistaken?

@ Janet, RE: “With Technetium TC99 /radioactive tracers added to common medications and not on the label, patient ,buyer BEWARE.”

Metastable Technetium-99 is not added to common medications. Please provide supporting documentation/references demonstrating Technetium-99 metastable (radioactive Tc-99m) is being added to common medications. 

@ Janet, RE: “What is really bad, is that MRIs will be used in the OR with gadolinium and the patient won’t know it.”

This is not true. Again, I think you may have been sloppy in writing some of your comments.  Please clarrify.  X-rays (e.g. C-arms) are used in the operating room (OR).  MRI is infrequently used in the OR due to a lot of surgical instruments being ferrous metals (i.e. ferromagnetic).

@ Janet, RE: “Most people don’t even know the FDA’s HDE rule, I suggest they search the Humanitarian Exemption Device rule, lest they get some experimental piece of S*** inserted into them by some intern or mad scientist…”

@ Janet, RE: “FDA also has Humanitarian Exemption Rules that MD’s can use and you can’d do anything about it, when they want to use some experimental “crap”, that applies at the end of your life, esp if no family is around to speak up for you against any experimental procedure, so better include this in your advanced directives, or you are screwed.”

You can find a list of recently approved Humanitarian Device exceptions on the FDA website under approved HDE.

Just by looking at all HDE approved devices since 1997 to the present I do not see any medical devices that are being unethically used in vulnerable populations.  Please provide documentation/references/specific devices.

If you are capable of providing objective information to the above queries I will gladly apologize for being, as you put it, “Mean”.

Recomendation:  Major Revision.

Please respond to all comments in a point by point response.  If you disagree with some of the comments, please provide an explanation.

I look forward to hearing your response.

-Mike D.

8 May 9:26am Mike wrote,

“I’m a current researcher associate in Magnetic resonance imaging (MRI), Orthopedic surgery, and a Nuclear medicine technologist…

then line 8 from bottom up, Part 1

‘I personally did multiple diagnostic nuclear medicine scans on a young girl who had a rare sarcoma. The cancer went into remission after a combination of radio-and chemotherapy. However, the patient developed liver damage and cardiomyopathy that eventually resulted in her death without this those treatments, the patient would have died from the anaplastic type of soft-tissue sarcoma at an earlier age.’

Does this guy have an MD license? No. Why the hell is HE treating a young girl with sarcoma? Did he write this in her chart or on her death certificate?  Wonder who supervised him? There is something wrong with this and needs further investigation…. Propublica? He even admits the adult vs pediatric radiation doses / benefit vs risk? Give me a break. Everyone in the medical field knows kids doses are way different than adults! Also, algorithms are not the only treatment, human thinking/reasoning is the best treatment. Pts don’t fit into algorithms. They are dangerous. so is Mike.

Janice, thank you for your kind message. 

You are correct in saying, “Does this guy have an MD license?”. No, I am a certified nuclear medicine technologist through the Nuclear Medicine Technology Certification Board and American Registry of Radiologic Technologists.  My formal certifications are CNMT, RT(NM).  I have a Bachelors of science in Nuclear Medicine Technology.  Additionally, I have a minor in chemistry.  I am about to become post-primary certified in Magnetic Resonance Imaging (MRI).

Per physician orders, I performed a Nuclear medicine bone scan (Tc99m-Methylene Diphosphonate) on the young girl.  Additionally we performed an Iodine-123 meta-iodobenzylguanidine (MIBG) study.  To evaluate the young girl’s liver function, the patient’s oncologist ordered a TcHepatobiliary Iminodiacetic Acid (HIDA) and Tc99m-sulfur colloid scan with Single Photon Emission Computed Tomgraphy (SPECT).  All prescribed studies were done using a calibrated dose that took into account the patient’s weight.  Additionally, all physician orders were reviewed and confirmed prior to beginning the studies.  The exact dose of I-123 and Tc99m labelled compounds was calculated using Dose Calibrator.  Per NRC requirements, all doses were within 20% of the prescribed dose.

@ Janet RE: “Everyone in the medical field knows kids doses are way different than adults!”

This is correct in most cases, however, on May 10th, 2012 (a couple of days ago) the Food and Drug Administration released new Industry draft guidance specifically related to “Device Improvements for Pediatric X-Ray Imaging” citing the following:

“Currently, most x-ray imaging devices are marketed with a general indication for use (IFU) statement.4 Many general use x-ray imaging devices neither address the unique issues associated with pediatric use nor contain labeling specific for use on pediatric patients, even though many (if not all) of these devices are used or could be used to image pediatric patients”

The drafted guidance will require new X-Ray imaging devices (e.g. Computed Tomography (CT) scanners, Angiographic scanners, Stationary X-Ray scanners, Extraoral scanners, and Intraoral scanners) to take into account pediatric populations.

Just to clarify your previous statement.

Janet: “He even admits the adult vs pediatric radiation doses / benefit vs risk? Give me a break. Everyone in the medical field knows kids doses are way different than adults!”

In response to your comment, NOBODY in the medical field knows pediatric x-ray doses are “way different” than adults because manufacturers are not required to take into account pediatric populations. 

@ Janet, RE: “risk/benefit”

Here is a statement from the FDA Pediatric X-Ray Imaging guidance.

[Sub-Heading] Benefits/Risks

“The individual risk from a necessary imaging exam is generally quite small when compared to the benefit of helping with accurate diagnosis or intervention.”

“While the benefit of a clinically appropriate X-ray imaging exam generally far outweighs the risk, efforts should be made to minimize this risk by reducing unnecessary exposure to ionizing radiation.”

“The medical community has emphasized dose reduction in CT because of the relatively high doses of CT exams and their increased use, as reported in the National Council on Radiation Protection and Measurements (NCRP) Report No. 160. However, the increased radiosensitivity of pediatric patients compared to adults makes it important to adjust equipment settings to optimize radiation exposure to pediatric patients for all types of X-ray imaging exams.”

“If there is a medical need for a particular imaging procedure and other exams using no or less radiation are unsuitable, then the benefits exceed the risks, and radiation risk considerations should not influence the physician’s decision to perform the study or the patient’s decision to have the procedure.”

Janet: “Does this guy have an MD license? No. Why the hell is HE treating a young girl with sarcoma?”

Please note I am a Nuclear medicine technologist and I was not treating the young girl for her disease. I was involved in the patient’s care by performing diagnostic nuclear medicine studies.  I am not required, nor is it legal for me, to document image findings related to diagnosis in a patient’s chart.

Janet: “Pts don’t fit into algorithms. They are dangerous. so is Mike.”

Treatment algorithms are frequently used in medicine.  They are not dangerous otherwise they would not be used. 

Thank you for your well organized and thoroughly researched comments.  I look forward to reading your response.  Please let me know if you have any questions or comments.

-Mike

Janet-

Please read Propublica’s Privacy Policy and Other Terms: Your Comments on Our Content.

“You agree that your posted comments intended for display on our site (“Reader-Submitted Content”) will not include any content that is illegal, indecent, profane, threatening, defamatory, invasive of privacy or otherwise injurious to third parties…”

You have made multiple defamatory statements.

“You may not use a false e-mail address, impersonate any person or entity, or otherwise mislead as to the origin of your Reader-Submitted Content.”

You have repeatedly provided misleading references to the source of your statements.

These terms are in place to prevent people like you from commenting, so please stop commenting.

(1) Janet, RE:  “... radiologists are using /testing the benefits of NAC pre CT contrast which is technetium/radioactive and the use of lower dose which is supposed to be already in place right?”

This statement is saying, N-Acetylcysteine (NAC) is technetium/radioactive.  Please check for typos because that can be confusing for the reader.  You may have been trying to communicate something different but from how it is written, it is false.

(2) Janet, RE: “Most of the 90% of manmade cancers could be avoided by the simple word NO to all radiation and contrasts. Period.”

(3) Janet, RE: “Mike D, as far as the 90% of cancers being manmade, that is from the American Cancer Society’s webpage vs comparisons of manmade radiation”

(4) Janet, RE: “The other site re 90% of man made cancers may be on the [Dept. of Energy] site, radiation experiments.

(5) Janet RE: “I did not say 90% of cancers come from gadolinium and technetium, those are your words, again.”

Again, I checked all sources and could not find supporting information for your original post from May 3rd.  Could you have been mistaken?

(6) Janet, RE: “With Technetium TC99 /radioactive tracers added to common medications and not on the label, patient ,buyer BEWARE.”

Metastable Technetium-99 is not added to common medications. Please provide supporting documentation/references demonstrating Technetium-99 metastable (radioactive Tc-99m) is being added to common medications.

(7) Janet, RE: “What is really bad, is that MRIs will be used in the OR with gadolinium and the patient won’t know it.”

This is not true. Again, I think you may have been sloppy in writing some of your comments.  Please clarify.  X-rays (e.g. C-arms) are used in the operating room (OR).  MRI is infrequently used in the OR due to a lot of surgical instruments being ferrous metals (i.e. ferromagnetic).

(8) Janet, RE: “Most people don’t even know the FDA’s HDE rule, I suggest they search the Humanitarian Exemption Device rule, lest they get some experimental piece of S*** inserted into them by some intern or mad scientist…”

(9) Janet, RE: “FDA also has Humanitarian Exemption Rules that MD’s can use and you can’d do anything about it, when they want to use some experimental “crap”, that applies at the end of your life, esp if no family is around to speak up for you against any experimental procedure, so better include this in your advanced directives, or you are screwed.”

You can find a list of recently approved Humanitarian Device exceptions on the FDA website.

Just by looking at all HDE approved devices since 1997 to the present I do not see any medical devices that are being unethically used in vulnerable populations.  Please provide documentation/references/specific devices.

If you are capable of providing objective information to the above queries I will gladly apologize for being, as you put it, “Mean”.

Please respond to all comments in a point by point response.  If you disagree with some of the comments, please provide an explanation.

I look forward to hearing your response.

-Mike D.

You are absolutely psychotic and want someone to argue with you.
You need to work in the “industry” and see all the BS that really happens outside your world. You have no idea what really goes on, do you?  I’ve given you plenty of references. You need something else to do. You’re nice and reasonable when you want something, then when answered, you are disagreeable, argumentative and confrontational.
I agree with IbSteve2u.  You are not current and up to date in your profession. try http://www.rsna.org for one place to see about miniaturized MRI’s and other medical devices. I can’t believe you are not current and twist words around, then to quote propublica.org rules. You need to search about GE being their non profit arm, you have missed alot of information which is why my comments do not get through to you.
FDA.gov/MedicalDevices/DeviceRegulationsand Guidance/  overview.

You still are mean, too.

Janet-

In regards to your posts and specifically your most recent one,  I recommend you seek psychiatric counseling from a medical doctor or licensed counselor.  I want to emphasize that I am not saying this because I am trying to prove a point or make a statement.  I am sincere. Although this is just an article discussion forum, I think your behavior and statements may be related to an underlying mental condition.  If you are currently in medical treatment for a mental disorder then great!  I personally have struggled with depression and was lucky enough to receive help.  Do not stigmatize yourself, approximately one in four adults in the US have a mental illness. [Reeves et al. Mental Illness Surveillance Among Adults in the United States. Morbidity and Mortality Weekly Report 60(03);1-32]

I apologize for any rude comments I made.

Have a nice day,
-Mike D.

Although this article was focused upon medical implants, given the introduction of the alternative track of unnecessary radiation exposure I thought the reader might be interested in this public notification of an FDA initiative:

http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/default.htm

from which I excerpt this explanatory quote:

“In 2010, FDA’s Center for Devices and Radiological Health (CDRH) launched an Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging and held a public meeting on Device Improvements to Reduce Unnecessary Radiation Exposure from Medical Imaging (March 30-31, 2010). These efforts were in response to increasing exposure to ionizing radiation from medical imaging highlighted in the National Council on Radiation Protection and Measurements Report No. 160 and safety concerns highlighted in FDA’s Safety Investigation of CT Brain Perfusion Scans.”

End quote.  There are a number of interesting links contained in that notification.

Nice find steve.  This is definitely a problem in the medical field.  Although I used to work in Nuclear medicine imaging (NRC regulated and not FDA regulated), I always thought it would be a good idea if we tracked the amount of radiation a patient receives, in their chart.  I think there is an effort to implement a strategy that tracks a person’s radiation exposure.  This oversight would most likely fall under state regulation.  I need to do some searching so take those last two sentences with a grain of salt.  I’ll see what I find.

I always dislike seeing that phrase “fall under state regulation”; it suggests foreknowledge that state legislators/regulators are a bargain in comparison to federal legislators/regulators.

Me, I figure the best way to deal with that possibility is the federal government sets the minimum safety standard, while state governments should be free to raise that standard if they believe those federal legislators and/or regulators have been bought.

After all, both state and the federal legislators are responsible to their real, live citizens regardless of what corrupting the Supreme Court can buy you in the way of broadening the definition of a human being to include corporations (which may or may not sell medical imaging equipment).

They’re supposed to be working to keep those real, live citizens alive.  Really.

Steve-

I got side tacked.  I am doing some research on retrievable IVC filters. I’ll post in the next hour then start looking into methods to track radiation dose related to medical use.

Re: After all, both state and the federal legislators are responsible to their real, live citizens regardless of what corrupting the Supreme Court can buy you in the way of broadening the definition of a human being to include corporations (which may or may not sell medical imaging equipment).

I agree with you completely, corporations have the same afforded rights as human citizens?!  If you ever have a chance, watch the documentary “The Corporation” from 2003 and directed by Mark Achbar and Jennifer Abbott.  It includes commentary from Noam Chomsky and Howard Zinn. Off subject, an older documentary/book you should look into is called Manufacturing Consent by Noam Chomsky. Also, the documentary “Why We Fight” provides a glimpse into the military industrial complex.  Again, I’m off subject but thought you might enjoy those.

Pardon the pun but I’ll keep you “posted” on tracking radiation doses.

-Mike

PART 1

As mentioned in the above article, on 8/9/2010 the FDA issued an initial warning related to 921* failed retrievable Inferior Vena Cava (IVC) filters (328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture).

The fact that the FDA released this report when the same doctors from Pennsylvania published a study on IVC filter sparked this reader’s interest. Thus I have performed a review of IVC filters, current practice standards, and 510(k) approved IVC filters. 

NOTE: Please update the in-text hyperlink to the study from the Pennsylvanian doctors that reported a 25% failure rate of an IVC filter, I’m having trouble identifying the study.

The August 9th, 2010 report says, “[The FDA] reviewed the literature and is conducting quantitative decision analysis modeling to evaluate the change in the risk/benefit profile after retrievable IVC filter implantation over time. More information about FDA’s decision analysis model including risk/benefit implantation timeframe suggestions will be made available in an update to this communication as well as in a future publication in a peer-reviewed medical journal.”

The update has not been published by the FDA. No time frame was presented. Based on two previous timeframes between FDA Initial communications and Updates on other devices, I estimate the FDA update should be available sometime between December 2011 (1.28 years) and May 2013 (2.73 years). It should be published soon because there is some confusion in the literature and practice of interventional radiology related to IVC filter failure and adverse events as detailed in the following standards document:

The Society of Interventional Radiology (SIR) Standards of Practice Committee (multiple authors with affiliations to some of the most prestigious medical schools and hospitals in the world). “Quality Improvement Guidelines for the Performance of Inferior Vena Cava Filter Placement for the Prevention of Pulmonary Embolism”.  J Vasc Interv Radiol 2011; 22:1499–1506. DOI: 10.1016/j.jvir.2011.07.012.

Table 1: Reported Rates and Thresholds for Complications
Table 2: Reported Incidences of Trackable Adverse Events

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