The U.S. Food and Drug Administration is warning consumers about the risk of ultraviolet radiation overdose with the Tootsie Tanner portable foot tanning device.
Use of the tanning device can lead to an overdose of ultraviolet radiation because its labeling recommends an improper duration of exposure to radiation and the device has an inadequate timer. The labeled exposure schedule indicates that the device may be used for 30 minutes, and the timer control permits 30 minutes exposure. Based on FDA testing, the maximum exposure time for this device is 20 minutes.
The device fails to provide prominent warnings about the need for protective eyewear. Use of this product according to the labeling could result in an overdose of ultraviolet radiation, which may cause immediate and delayed serious eye and skin injuries.
The FDA has issued a warning letter to the device manufacturer and distributor, IPCH, located in Sugarland, Texas. Since issuing the warning letter, the FDA learned that IPCH is no longer in business. Thus, the device will not be replaced or updated with the correct labeling. Refunds will not be available for the estimated 3,000 devices sold.
The FDA recommends that users of this device, which include tanning salon owners and operators, stop using this device, remove the lamps and safely discard all components of the device according to local environmental protection standards.
Although the FDA has received no adverse event reports to date, the agency is concerned about the risk of eye and skin injuries from an overdose of ultraviolet radiation.
Consumers may report serious adverse events (side effects) with the device to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax, or phone.
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Showing posts with label radiation. Show all posts
Showing posts with label radiation. Show all posts
Tuesday, August 24, 2010
Wednesday, February 10, 2010
FDA Unveils Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging
The U.S. Food and Drug Administration today announced an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: computed tomography (CT), nuclear medicine studies, and fluoroscopy. These procedures are the greatest contributors to total radiation exposure within the U.S. population and use much higher radiation doses than other radiographic procedures, such as standard X-rays, dental X-rays, and mammography.
CT, nuclear medicine, and fluoroscopic imaging have led to early diagnosis of disease, improved treatment planning, and image-guided therapies that help save lives every day. The FDA continues to support a strong dialogue between patients and physicians over the medical necessity and risk associated with these types of imaging studies.
However, like all medical procedures, CT, nuclear medicine, and fluoroscopy pose risks. These types of imaging exams expose patients to ionizing radiation, a type of radiation that can increase a person’s lifetime cancer risk. Accidental exposure to very high amounts of radiation also can cause injuries, such as skin burns, hair loss and cataracts. Health care decisions made by patients and their physicians should include discussions of the medical need and associated risks for each procedure.
“The amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The goal of FDA’s initiative is to support the benefits associated with medical imaging while minimizing the risks.”
While there is some disagreement over the extent of the cancer risk associated with exposure to radiation from medical imaging, there is broad agreement that steps can and should be taken to reduce unnecessary radiation exposure.
For example, the radiation dose associated with a CT abdomen scan is the same as the dose from approximately 400 chest X-rays. In comparison, a dental X-ray calls for approximately one-half the radiation dose of a chest X-ray. Both diagnostics serve important, sometimes critical, public health needs.
Through the FDA’s regulatory oversight of medical imaging devices, such as CT scanners, and through collaboration with other federal agencies and health care professional groups, the FDA is advocating the adoption of two principles of radiation protection: appropriate justification of the radiation procedure and optimization of the radiation dose used during each procedure.
“Working together,” said Shuren, “the FDA and other organizations hope to help patients get the right imaging exam, at the right time, with the right radiation dose.”
The three-pronged initiative the FDA is announcing will promote the safe use of medical imaging devices, support informed clinical decision-making, and increase patient awareness of their own exposure.
The FDA intends to issue targeted requirements for manufacturers of CT and fluoroscopic devices to incorporate important safeguards into the design of their machines to develop safer technologies and to provide appropriate training to support safe use by practitioners. The agency intends to hold a public meeting on March 30-31, 2010, to solicit input on what requirements to establish.
Examples could include a requirement that these devices display, record, and report equipment settings and radiation dose, an alert for users when the dose exceeds a diagnostic reference level (the optimal dose for most patients), training for users, and a requirement that devices be able to capture and transmit radiation dose information to a patient’s electronic medical record and to national dose registries.
In addition, the FDA and the Centers for Medicare and Medicaid Services are collaborating to incorporate key quality assurance practices into the mandatory accreditation and conditions of participation survey processes for imaging facilities and hospitals. These quality assurance practices will improve the quality of oversight and promote the safe use of advanced imaging technologies in those facilities.
The FDA recommends that health care professional organizations continue to develop, in collaboration with the agency, diagnostic radiation reference levels for medical imaging procedures, and increase efforts to develop one or more national registries for radiation doses.
A dose registry would pool data from many imaging facilities nationwide, capturing dose information from a variety of imaging studies. This registry will help define diagnostic reference levels where they do not yet exist, validate levels that do exist, and provide benchmarks for health care facilities to use in individual imaging studies.
In a bid to empower patients and increase awareness, the FDA is collaborating with other organizations to develop and disseminate a patient medical imaging history card. This tool, which will be available on the FDA’s Web site, will allow patients to track their own medical imaging history and share it with their physicians, especially when it may not be included in their medical records.
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CT, nuclear medicine, and fluoroscopic imaging have led to early diagnosis of disease, improved treatment planning, and image-guided therapies that help save lives every day. The FDA continues to support a strong dialogue between patients and physicians over the medical necessity and risk associated with these types of imaging studies.
However, like all medical procedures, CT, nuclear medicine, and fluoroscopy pose risks. These types of imaging exams expose patients to ionizing radiation, a type of radiation that can increase a person’s lifetime cancer risk. Accidental exposure to very high amounts of radiation also can cause injuries, such as skin burns, hair loss and cataracts. Health care decisions made by patients and their physicians should include discussions of the medical need and associated risks for each procedure.
“The amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The goal of FDA’s initiative is to support the benefits associated with medical imaging while minimizing the risks.”
While there is some disagreement over the extent of the cancer risk associated with exposure to radiation from medical imaging, there is broad agreement that steps can and should be taken to reduce unnecessary radiation exposure.
For example, the radiation dose associated with a CT abdomen scan is the same as the dose from approximately 400 chest X-rays. In comparison, a dental X-ray calls for approximately one-half the radiation dose of a chest X-ray. Both diagnostics serve important, sometimes critical, public health needs.
Through the FDA’s regulatory oversight of medical imaging devices, such as CT scanners, and through collaboration with other federal agencies and health care professional groups, the FDA is advocating the adoption of two principles of radiation protection: appropriate justification of the radiation procedure and optimization of the radiation dose used during each procedure.
“Working together,” said Shuren, “the FDA and other organizations hope to help patients get the right imaging exam, at the right time, with the right radiation dose.”
The three-pronged initiative the FDA is announcing will promote the safe use of medical imaging devices, support informed clinical decision-making, and increase patient awareness of their own exposure.
The FDA intends to issue targeted requirements for manufacturers of CT and fluoroscopic devices to incorporate important safeguards into the design of their machines to develop safer technologies and to provide appropriate training to support safe use by practitioners. The agency intends to hold a public meeting on March 30-31, 2010, to solicit input on what requirements to establish.
Examples could include a requirement that these devices display, record, and report equipment settings and radiation dose, an alert for users when the dose exceeds a diagnostic reference level (the optimal dose for most patients), training for users, and a requirement that devices be able to capture and transmit radiation dose information to a patient’s electronic medical record and to national dose registries.
In addition, the FDA and the Centers for Medicare and Medicaid Services are collaborating to incorporate key quality assurance practices into the mandatory accreditation and conditions of participation survey processes for imaging facilities and hospitals. These quality assurance practices will improve the quality of oversight and promote the safe use of advanced imaging technologies in those facilities.
The FDA recommends that health care professional organizations continue to develop, in collaboration with the agency, diagnostic radiation reference levels for medical imaging procedures, and increase efforts to develop one or more national registries for radiation doses.
A dose registry would pool data from many imaging facilities nationwide, capturing dose information from a variety of imaging studies. This registry will help define diagnostic reference levels where they do not yet exist, validate levels that do exist, and provide benchmarks for health care facilities to use in individual imaging studies.
In a bid to empower patients and increase awareness, the FDA is collaborating with other organizations to develop and disseminate a patient medical imaging history card. This tool, which will be available on the FDA’s Web site, will allow patients to track their own medical imaging history and share it with their physicians, especially when it may not be included in their medical records.
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Tuesday, January 27, 2009
Motorcycle Seats NOT The Cause of Impotence or Erectile Dysfunction for Bikers
TT Note: Just in case you had a burning desire to know.
/PRNewswire/ -- "A 2005 Japan impotence study uses soft words about hard seats suggesting motorbike 'vibration may cause ED' and 'more studies are needed to determine the cause,' " says patent-granted author Randall Dale Chipkar. "Based upon limited information one cannot conclude motorcycle seats as causation for impotence."
"Bicycling or hard scooter seats on rough roads are much more rigorous on the groin rather than modern day cruising seats. Not to mention motorcycle rubber-mounted engines, sophisticated suspensions, smooth asphalt and contoured padded seats," Chipkar says.
"Subtle groin vibrations increase blood flow and are actually stimulating not debilitating on our tissues. Regular motorcycle seat vibration is not going to damage penile nerves," Chipkar adds.
The pelvis and perineum are designed for prolonged sitting properly displacing pressure and any eventual discomfort can be walked off without sustaining biological harm or compromised blood flow.
"Causation of impotence or erectile dysfunction involves many issues including lifestyle habits. Unfortunately, I feel there is a much greater issue than pressure or vibration linking impotence to motorcycle riders," says Chipkar.
"Most motorcycles have electrical components beneath the seat. Extremely low frequency electromagnetic field (ELF EMF) radiation passes through the seat penetrating into the rider's groin. ELF EMFs can disrupt zinc ions which are linked to impotence and erectile dysfunction. Furthermore, excessive ELF EMF invasion compromises electromagnetic homeostasis involving neuron function, hormone imbalance and adrenal fatigue all linked to impotence and libido loss," Chipkar says.
"I discovered up to 500 milliGauss of ELF EMF radiation above motorcycle seats zapping the prostate. In contrast, many doctors raise cancer concerns involving 3 to 5 milliGauss of ELF EMF exposure from hydro tower power lines and other sources," adds Chipkar.
"On my website doctors prove ELF EMF danger. Impotence, erectile dysfunction, infertility, sterility, prostatitis, and benign prostatic hyperplasia (BPH) are linked not to motorcycle seats but what's 'rising up' through them," Chipkar says.
Chipkar authored Motorcycle Cancer? to expose the truth. Chipkar is now campaigning worldwide to enhance the motorcycle industry to keep riders safer.
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/PRNewswire/ -- "A 2005 Japan impotence study uses soft words about hard seats suggesting motorbike 'vibration may cause ED' and 'more studies are needed to determine the cause,' " says patent-granted author Randall Dale Chipkar. "Based upon limited information one cannot conclude motorcycle seats as causation for impotence."
"Bicycling or hard scooter seats on rough roads are much more rigorous on the groin rather than modern day cruising seats. Not to mention motorcycle rubber-mounted engines, sophisticated suspensions, smooth asphalt and contoured padded seats," Chipkar says.
"Subtle groin vibrations increase blood flow and are actually stimulating not debilitating on our tissues. Regular motorcycle seat vibration is not going to damage penile nerves," Chipkar adds.
The pelvis and perineum are designed for prolonged sitting properly displacing pressure and any eventual discomfort can be walked off without sustaining biological harm or compromised blood flow.
"Causation of impotence or erectile dysfunction involves many issues including lifestyle habits. Unfortunately, I feel there is a much greater issue than pressure or vibration linking impotence to motorcycle riders," says Chipkar.
"Most motorcycles have electrical components beneath the seat. Extremely low frequency electromagnetic field (ELF EMF) radiation passes through the seat penetrating into the rider's groin. ELF EMFs can disrupt zinc ions which are linked to impotence and erectile dysfunction. Furthermore, excessive ELF EMF invasion compromises electromagnetic homeostasis involving neuron function, hormone imbalance and adrenal fatigue all linked to impotence and libido loss," Chipkar says.
"I discovered up to 500 milliGauss of ELF EMF radiation above motorcycle seats zapping the prostate. In contrast, many doctors raise cancer concerns involving 3 to 5 milliGauss of ELF EMF exposure from hydro tower power lines and other sources," adds Chipkar.
"On my website doctors prove ELF EMF danger. Impotence, erectile dysfunction, infertility, sterility, prostatitis, and benign prostatic hyperplasia (BPH) are linked not to motorcycle seats but what's 'rising up' through them," Chipkar says.
Chipkar authored Motorcycle Cancer? to expose the truth. Chipkar is now campaigning worldwide to enhance the motorcycle industry to keep riders safer.
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