Medical Physics News
The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals to stop using CardioGen-82 for cardiac positron emission tomography (PET) scans. The manufacturer, Bracco Diagnostics Inc., has decided to voluntarily recall CardioGen-82 this week after two patients set off radiation detectors at a U.S. border crossings due to strontium contamination.
It is the only FDA-approved generator-based PET myocardial perfusion agent. It uses a strontium (Sr)-82 generator to produce a rubidium (Rb)-82 radiotracer injection.
The FDA has received reports of two patients who underwent PET myocardial perfusion imaging scans with CardioGen-82 who had detectable levels of radiation several months after their PET scans. Both patients were crossing the border to/from the United States when radiation detectors identified radiation originating from the patients.
The radiation was found to originate from strontium (Sr-82 and Sr-85). A PET scan had been performed in each patient approximately two and four months earlier, respectively. Since Rb-82 has a half-life of 75 seconds and both patients reported that they had no other exposure to radioactive substances, the residual radiation is likely due to undetected strontium breakthrough.
See also: FDA Alert
The Chilton Hospital Foundation's 27th annual Golf Classic raised $140,000 with 192 golfers participating. The successful fundraising event was held on June 13 at Preakness Hills Country Club in Wayne, NJ.
All proceeds from the Golf Classic will support Chilton's $24 million modernization project, which includes renovations of patient care units, a conversion to 65 percent private rooms, and a new surgical services holding area, recovery area and waiting room.
Pictured is the winning golf tournament team sponsored by Bio-Med Associates in Flemington, NJ (left to right): Bio-Med physicist Jack McLean, Doug Stokes, Chilton Hospital's Quality Assessment/Utilization Review Director Barbara Lake, and Richard Harris. Each team member was awarded with gift certificates for the Country Club's Proshop.
For a woman who receives annual screening mammography from ages 40 to 80 years, the estimated lifetime risk of a radiation-induced thyroid cancer at the estimated 5 mGy mammography dose is 0.58 per 10,000,000 women screened, or 1 in 17.1 million women.
The total dose to the thyroid from bilateral 2-view mammography is 4.5 microGray. Using the weighting factor for the thyroid of 0.04 (from ICRP Report #103, 2007), the effective dose to the thyroid is 0.18 microsievert (4.5 microgray x 0.04 microsievert/microgray). Compared to the average annual natural background radiation received by each person in the United States of 3.1 millisievert, the effective dose to the thyroid from a bilateral 2-view mammogram is equivalent in terms of detriment to 30 minutes of natural background radiation (1/17,222th of annual natural background radiation).
In short, mammography results in a negligible amount of radiation dose to the thyroid, even without thyroid shielding.
See also: Mammography Saves Lives web site
The New Jersey DEP Bureau of X-Ray Compliance now requires all CT facilities to begin submitting copies of their annual survey results, for surveys conducted on or after January 1, 2011.
Failure to respond to this request may result in the issuance of an enforcement action and/or penalty assessment.
See also: NJ DEP Bureau of X-Ray Compliance web site
Beginning Feb. 7, 2011, the Centers for Medicare & Medicaid Services will reimburse sites participating in the National Oncologic Positron Emission Tomography (PET) Registry (NOPR) for F-18 sodium fluoride (NaF) PET scans. This is yet another example of how the NOPR is facilitating greater access to PET scans with the potential to help physicians provide the most appropriate care for their patients.
Approximately 1.5 million patients are diagnosed with cancer each year in the United States. Many of these patients will develop metastases to bone during the course of their disease. Now, physicians treating Medicare patients with known or suspected cancer metastatic to bone can much more widely order PET scans using the NaF radiotracer to help formulate treatment plans.
Gov Arnold Schwarzenegger of California has signed into law a medical radiation protection bill aimed at protecting patients from excessive radiation exposure received during CT scans and radiation therapy procedures. Greasing the wheels for the first state law of its kind in the U.S., SB 1237, as the bill is known, mandates strict new procedures and reporting requirements when it becomes effective July 1, 2012. It also provides an accreditation mandate for CT scanners slated to take effect six months later.
As a result of the Medicare Improvements for Patients and Providers Act (MIPPA) passed July 2008, effective January 1, 2012, all non-hospital providers that bill for MRI, CT, PET and nuclear medicine under the Medicare Part B Physician Fee Schedule must be accredited in order to receive technical component reimbursement from Medicare.
See also: Bio-Med Associates' MIPPA Accreditation Assistance Services
FMI12142 applies to Senographe DS and Senographe Essential systems and will bring significant enhancements, such as:
It brings critical asset information, provides overview reports to download and detailed exam information to enhance system performance. This offer is only included in some performance service contract (please contact you local service sales representative).
This FMI consists of software and/or hardware upgrades of the several of the major sub-systems of the mammography machine (AWS, IDC, Generator, and Gantry).
According to the MQSA policy, "Software changes or upgrades are considered by FDA to be major repairs, thus the facility must have a mammography equipment evaluation performed after installation of such a change or upgrade". The FDA also states that if any of the necessary tests after the software upgrade are required to be performed by the medical physicist, the mammography equipment evaluation must be performed in its entirety by the medical physicist on site.
Because of this requirement, we recommend that a medical physicist conducts a complete equipment evaluation after the application of the FMI12142, by performing the QC tests described in "Chapter 2 QC Tests for the Medical Physicist" from the Quality Control Manual 5305863-6-S-1EN (Senographe Essential)/5305756-4-S-1EN (Senographe DS).
If cost-cutting U.S. Preventive Services Task Force (USPSTF) mammography recommendations are adopted as policy, two decades of decline in breast cancer mortality could be reversed and countless American women may die needlessly from breast cancer each year. The recommendations - created by a federal government-funded committee with no medical imaging representation - would advise against regular mammography screening for women 40-49 years of age, provide mammograms only every other year for women between 50 and 74, and stop all breast cancer screening in women over 74.
The Federally Supported U.S. Preventative Services now recommends:
AGAINST routine screening mammography in women age 40-49
AGAINST teaching breast self examinations
AGAINST clinical breast examinations
AGAINST previously recommended routine screening for women 75 years or older
AGAINST annual screening mammograms for women age 50-74 (Recommending screening every OTHER year versus the currently recommended annual screening)
In other words, USPSTF is recommending against ALL commonly accepted routine breast cancer screening methods for women in their forties despite their statement that the ten year risk for breast cancer in a 40 year old woman is 1 in 69. They also rescind their previous recommendation providing for screening beyond 74 because "the shortened life among woman 75 and older" makes it more likely that she could die from another cause before the cancer kills her. Finally, even for those for whom they do recommend screening, delays in treatment resulting from less frequent screening will cost lives and result in more aggressive and debilitating treatment.
American Association of Physicists in Medicine states: There have been a number of CT related issues in the news over the past months pertaining to radiation dose, however there have been several misleading statements made with respect to radiation hazards from CT scanning. AAPM also addresses the recent articles published in the Archives of Internal Medicine and reported on National Public Radio this week stating that "much smaller radiation exposures (such as with CT) to many individuals can cause substantial increases in cancer incidence is certainly controversial and not universally accepted."
The Society of Breast Imaging publishes a 12 point discussion regarding the US Preventive Services Task Force (USPSTF) recent mammography screening guidelines.
Confusion continues to grow over the recent U.S. Preventive Services Task Force\'s (USPSTF) recommendations that women under the age of 50 no longer be screened for breast cancer. Women are wondering if their mammograms will now be covered by their insurance company and radiology practices are beginning to receive calls from women who want to cancel their scheduled yearly mammogram.
The ACR has revised its requirements for Medical Physicists and MR Scientists, as a result of receiving many thoughtful comments from individuals currently providing medical physics services, and after consultation with ACR legal counsel as well as the chairs of the Quality and Safety Commission and ACR Accreditation Subcommittees on Physics. These new requirements will go into effect on January 1, 2010. The new requirements (and this most recent revision) are critical for several reasons.
FDA has identified at least 50 additional patients who were exposed to excess radiation during CT perfusion scans and involved more than one CT scanner manufacturer. Furthermore they have received reports of possible excess exposures from healthcare providers in other states.
On the basis of its investigation to date, the FDA is providing interim recommendations for imaging facilities, radiologists, and radiologic technologists to help prevent additional cases of excess exposure. These recommendations apply to all CT perfusion images, including brain and heart, because they use similar procedures and protocols.
The majority of breast cancer patients who received MammoSite balloon brachytherapy treatment developed symptoms of moderate breast distortion within two years of treatment, according to an RSNA presentation on Tuesday.
Over an 18-month period, 206 patients at a particular facility received radiation doses that were approximately eight times the expected level. Instead of receiving the expected dose of 0.5 Gy (maximum) to the head, these patients received 3-4 Gy.
The American Association of Physicists in Medicine published a statement stating that it is premature to comment in depth regarding the FDA alert as all the facts surrounding the incidences have not been released.
Mammography Tech pleads guilty to 3rd degree forgery and is ordered to pay a $2000.00 fined and was sentenced to 1 year incarceration (suspended).
The Committee on Professional Licensure introduced a Bill to the PA House of Representative for licensure of individuals practicing medical physics in the State of PA citing in the Bill that "The practice of medical physics by unqualified individuals is a threat to public health and safety. It is, therefore, the responsibility of the Commonwealth to protect public health and safety from the harmful effects of excessive and unnecessary radiation by ensuring that the practice of medical physics is entrusted only to individuals licensed under this act."
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