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Evilution of Man
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Business: Cdi (center For Diagnostic Imaging)

Radiologist
Winter Park, Florida


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Cdi (center For Diagnostic Imaging)
1295 Orange Ave.
Winter Park, FL 32789

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www.cdiradiology.com

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Overall Score
as rated by caveatemptor
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Overall score given by caveatemptor on 07/01/10

2


caveatemptor edited this scorecard on 07/02/10

2
2009

My mother underwent an MRA at CDI in  Dec. of last year.   There was a conflict in the results of this test and in the ensuing arteriogram that was performed at FL Hospital. 

  In reading Mother's report, I noticed that the contrast agent used at CDI was Omniscan, a gadolinium based contrast agent that is implicated in most of the reported cases of NSF. (nephrogenic systemic fibrosis)  

There is inherent risk with all of these gadolinium based contrast agents, particularly in the elderly, since kidney function declines at a rate of about 2 to 3 percent per year after the age of 50.  It only stands to reason that if someone is operating with 30 to 40 percent of the kidney function that they had when they were 'young', this would not be a good choice and the risk for this test might outweigh the benefits.  In other words, no matter what the GFR, or the creatinine level, an older person's kidneys will not clear this contrast agent as quickly as a younger person's kidneys will, making it much riskier for the elderly.  And since Omniscan is the LEAST stable of the contrast agents, that means that there is greater propensity for it to have an adverse effect.

If this test must be done in an elderly person, the least that the radiologist could do would be to immediately send the person for dialysis within a two hour window of being injected with this contrast agent.  In addition, there is 2 to 3 times more contrast agent injected during an MRA than an MRI, and this was never discussed or made known to us, which flies in the face of informed consent.  

There have been plenty of FDA warnings regarding Omniscan, (as far back as 2007, and also articles in 2008 in 'Radiology Today'.  Of all of the GBCA (gad based contrast agents), Omniscan is the LEAST stable, so to find out that this is still in use today is appalling.  http://www.fda.gov/Drugs/DrugSafety/DrugSafetyNewsletter/ucm142889.htm

http://www.ismrm.org/special/10_08_1038_1.pdf


To CDI's  credit, I did get to speak to a very receptive tech at CDI.   She even offered to have a radiologist call me, but to what end....he/she would have told me the same thing that the tech told me.  I brought to her attention that there are FDA warnings on Omniscan and plenty of information out there that it is dangerous and should no longer be in use, or at the very least, used with extreme caution.  I called other radiology imaging facilities in this area (FRI and VinCon) and found that they do NOT use this GBCA any longer. I also brought  to her attention the points that I made regarding the elderly and decline in kidney function, and the fact that one does not have to have renal insufficiency in order to have a reaction to this substance.  She was very kind, thanked me for calling back and alerting her to the fact that other facilities no longer use Omniscan.   She promised to relay my concerns to the director of the facility.

Although it may be deemed as 'safe' for those who screening labs are within 'normal' range and those who are not found to have renal insufficiency, no two people react the same when ingesting any substance, whether that is an OTC drug, a prescription drug, or a contrast agent.  In addition, it is suspected that there is a cumulative effect for exposure/injection of this substance, just as there is with radiation. 

It is sad that we, the patients and patient advocates, who have no medical training, have to do the research on these issues when it should be those administering /ordering the test, or the facility director/radiologists, upon whose shoulders the safety of the patients should rest.

Please refer to the above referenced links (particularly the second one), which contain photographs of those suffering from NSF.   And be sure to ask your doctor which GBCA will be used for your MRA/MRI, and if it is Omniscan,   personally, I would be very cautious in proceeding.  While it is too late to 'undo' what was done to Mother, perhaps this can help another patient.   

Apparently, customers have been given financial incentives  by GE to purchase Omniscan, in spite of the fact that the American College of Radiology issued guidance that Omniscan posed a greater risk for NSF than its competitor GBCA's .  This excerpt is taken from the same article that I cited below:


 

After the FDA issued its blanket warning, GE reinstated requirements that customers purchase certain minimum amounts of Omniscan in order to receive financial incentives, according to Kathryn E. Goldstein, a spokeswoman for Novation, a purchasing organization for 25,000 health-care providers. Kanal, the Pittsburgh medical professor, says he confronted GE managers over what he considered their 'inappropriate' decision to induce customers to buy Omniscan. Fitzgerald, the GE spokesman, confirmed the switch in financial incentives but declined to address Kanal’s criticism.

Kanal, who heads a blue-ribbon panel on magnetic resonance safety for the American College of Radiology, says he is pressing the FDA to analyze a public database created by plaintiffs and manufacturers in the NSF litigation, among other new information. The FDA’s Rieves has agreed to meet with Kanal on Oct. 20 and says he is receptive to new data: 'We want to see it.'


Additional comments posted on 07/02/10:
http://www.propublica.org/article/ges-omniscan-the-spectre-haunting-ge-1026


The suspected culprit Some prominent physicians applaud the company’s efforts to cooperate. Dr. Jeffrey C. Weinreb is a Yale School of Medicine professor of diagnostic radiology who has consulted with GE. 'As far as I can tell,' he says, the company 'made a good-faith effort to provide relevant information' to medical professionals about Omniscan and the incidence of NSF. But Yale-New Haven Hospital, where Weinreb practices, has had several NSF patients die in recent years, he adds, and decided 'to play it safe' and stop buying Omniscan in late 2006. Omniscan and comparable products contain the potentially toxic metal gadolinium. During MRIs, the metal helps physicians see the brain and other parts of the body. Healthy kidneys filter out gadolinium. But patients with severely impaired kidneys can become victims of NSF, according to the FDA. NSF starts with painful swelling in the legs and arms. It progresses to lesions in the skin and connective tissues, and it can attack organs, causing death. So far, there is no cure. GE got into the contrast-agent business in 2004, when it acquired Amersham, a British maker of scanning drugs. About a week after the Danish Medicines Agency issued its international alert, GE Healthcare sent a letter to physicians acknowledging the Danish findings [8] but stressing that the company was committed to keeping patients safe and informed. GE noted that Omniscan had been used 30 million times since its introduction in 1993. A 'causal relationship' between NSF and gadolinium-based contrast agents 'has not been established,' the company said. By early 2007, however, regulators across Europe and in Japan were scrutinizing contrast agents. Omniscan appeared to be linked with more reported cases of NSF than its market share would have predicted, some regulators found. That March, the American College of Radiology, the professional group for doctors who administer imaging scans, issued guidance that Omniscan posed a greater risk than rival products [9]. The radiologists’ warning contributed to decisions by several large hospitals in New York, Pennsylvania, and elsewhere to stop buying Omniscan. GE responded to the marketing challenge by making it easier for hospitals to receive financial incentives if they continued to purchase some Omniscan, according to court records and hospital executives.

Additional comments posted on 09/12/10:
Pursuant to my prior post regarding Onimscan (and now other GBCA (gad based contrast agents), the following was taken directly from the FDA website alerts: Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm225375.htm Gadolinium-based Contrast Agents: Class Labeling Change - Risk of Nephrogenic Systemic Fibrosis Ablavar (gadofosveset trisodium), Eovist (gadoxetate disodium), Magnevist (gadopentetate dimeglumine), Multihance (gadobenate dimeglumine), Omniscan (gadodiamide), Optimark (gadoversetamide injection), Prohance (gadoteridol) AUDIENCE: Radiology, Nephrology, Dermatology ISSUE: FDA is requiring changes in the professional labeling for gadolinium-based contrast agents (GBCAs) to minimize the risk of nephrogenic systemic fibrosis (NSF), a rare, but serious, condition associated with the use of GBCAs in certain patients with kidney dysfunction. NSF has not been reported in patients with normal kidney function. Patients at greatest risk for developing NSF after receiving GBCAs are those with impaired elimination of the drug, including patients with acute kidney injury or chronic, severe kidney disease. BACKGROUND: GBCAs are intravenous drugs used in diagnostic imaging procedures to enhance the quality of magnetic resonance imaging or magnetic resonance angiography. RECOMMENDATION: Healthcare professionals should screen patients prior to administration of a GBCA to identify those with acute kidney injury or chronic, severe, kidney disease. See the Drug Safety Communication for the complete list of recommendations to healthcare professionals and patients. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report.htm Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm225375.htm

Additional comments posted on 09/13/10:
http://www.aolhealth.com/2010/09/10/drug-used-during-mris-can-be-deadly/?icid=main%7Cmain%7Cdl3%7Csec3_lnk1%7C170077 Federal health officials say certain drugs injected during MRIs can cause a rare, potentially deadly condition in patients with kidney disease. The Food and Drug Administration said it will add its strongest warning label to the drugs used in medical imaging scans and cautioned doctors to administer the injections with care, according to the Associated Press. The risks have been found in people with kidney problems who are given medicines containing the chemical gadolinium. "These label changes are intended to help ensure these drugs are used appropriately," the FDA said on its website. The warnings will be in boldface at the very top of the drug labels. The medicines can cause a sometimes fatal disorder called nephrogenic fibrosing dermopathy, which leads the skin to harden and tissue to grow in the internal organs, eyes and joints, the FDA said. There is no known cure or treatment for the syndrome, but kidney transplants sometime slow or reverse the disease. The gadolinium injections, called contrast agents, are given to improve the clarity of imaging scans of the heart and other organs. The use of seven of the drugs was approved by the FDA in 1988. The risk of the syndrome exists with all seven, but three have a greater likelihood of triggering it: General Electric Healthcare's Omniscan, Covidien's Optimark and Bayer Healthcare's Magnevist. An FDA spokeswoman said those three drugs are "chemically more unstable" than the others and more likely to release the gadolinium into the bloodstream. Gadolinium, a metal with magnetic properties that improves visibility in MRIs, is toxic to the liver. The four other drugs are Prohance and Multihance made by Brocco Diagnostics, Eovist by Bayer, and Ablavar from Lantheus Medical Imaging. The FDA said doctors should test for kidney disease before giving the drug to patients having MRIs. There have been no reports of problems in those who have normal kidney function. GE Healthcare said in a statement that MRI contrast agents "continue to be a valuable diagnostic tool with a proven safety record for the overwhelming majority of patients to whom they are prescribed." Bayer said it "will make periodic safety reports to the FDA and other regulators," according to the AP.

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