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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TYLENOL Recall Confirms Congress, FDA Must Regulate Wood Pallets to Prevent Threats to U.S. Food, Drug Supply

/PRNewswire/ -- The expanded recall of TYLENOL Arthritis pain reliever is fresh evidence of the need for Congress and the FDA to regulate wood pallets used to transport food and pharmaceuticals in the United States because of the dangers they pose to human health.

The move earlier this week by McNeil Consumer Healthcare and FDA to expand the voluntary recall to include all lots of TYLENOL Arthritis Pain Caplet 100 count bottles comes on the heels of independent scientific studies showing wood pallets harbor deadly food poisoning bacteria and pathogens.

"How much more evidence does Congress and the FDA need? The TYLENOL recall proves wooden pallet shipping platforms are a dangerous threat to the pharmaceuticals we depend on, while recent independent studies we've commissioned in four cities demonstrate the dangers they pose to our food supply," said Bob Moore, Chairman & CEO, Intelligent Global Pooling Systems (iGPS Company LLC).

"The one to two billion wood pallets in circulation in the United States are the common denominator in the supply chain - practically every product we ingest is shipped on a wood pallet. Congress and FDA cannot afford to overlook them any longer as they consider ways to strengthen our national food safety law."

Chemicals used to treat wood pallets were cited as causing a moldy, musty or mildew-like odor in the TYLENOL product that caused nausea, vomiting, diarrhea and stomach pain in consumers. Wood pallets made with "engineered wood" components also contain urea formaldehyde - a known carcinogen - which may come into contact with food under a variety of scenarios when it is stored and shipped on wooden pallets. Formaldehyde is also released into the air when it off-gases from pallets in storage and transportation compartments, posing a risk to the health of workers and consumers.

Wood pallets pose other dangerous risks to food safety. Wood pallets are susceptible to insect infestation and require heat treatment or fumigation before they can be moved cross-border. Fumigation is often performed with methyl bromide, a highly toxic, ozone-depleting chemical. Rusty nails and wood shards that can penetrate food packaging are also a risk.

Recent tests commissioned by iGPS have found Salmonella, E. coli, Listeria and extremely high bacteria counts on scores of wood pallets pulled at random from pallet depots in Washington, DC, Baltimore, Philadelphia and Portland, ME. Listeriosis is responsible for approximately 2,500 illnesses and 500 deaths in the United States annually and is the leading cause of death among food borne bacterial pathogens, with fatality rates exceeding even Salmonella and Clostridium Botulinum.

The iGPS test results are consistent with similar findings by USDA and FDA. A new USDA study found salmonella-causing bacteria can be harbored on wooden shelving carts used for transporting eggs into processing plants. The FDA has also drawn attention to the health risks that wood pallets present. According to the FDA's Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods (February, 2008), "In areas where RF-RTE [refrigerated-ready to eat] foods are processed or exposed, we recommend that you use pallets that can be easily cleaned and keep them in good condition, and that you not use wood pallets in areas where RF-RTE foods are processed or exposed or in other areas for wet processing and storage."

A trip to virtually any wood pallet depot reveals thousands of wood pallets stacked outdoors, sitting in mud and water-logged (some even serving as nests for rodents) -- a clear violation of industry "best practices" calling for wood pallets to be stored in dry indoor locations.

"This is an industry that openly ignores its own safety rules and transports our food supply on deplorably unsanitary platforms," said Moore. "We call on Congress and the FDA to take a comprehensive look at the role wood pallets play in contaminating our food and drug supplies - and to take action."

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