Ostensibly in the wake of recent reporting on catastrophic injuries resulting from use and misuse of radiation emitting diagnostic tests such as CT scans and other nuclear medicine studies (e.g. MRI’s) and fluroscopy, the FDA announced yesterday a new three-prong initiative for patient safety in the design and use of these devices. See the announcement posted on their website for complete details.
While recognizing the value of such testing for diagnostic purposes, the FDA formally acknowledged that these imagining procedures “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…” The agency urges patients and their physicians to discuss “the medical need and associated risk for each procedure.” In legal parlance – health care providers should obtain the patient’s informed consent when using these studies.
“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.”
The announcement emphasizes two express principles of radiation protection for patients: “appropriate justification of the radiation procedure and optimization of the radiation dose used during each procedure.”
Were you aware that a CT scan of the abdomen involves the use of approximately 400 times the radiation dose of a chest x-ray? By comparison, perhaps, the FDA references the fact that a dental x-ray is approximately one-half the dose of the chest x-ray.
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 hearings 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.
For those of you who stay current with “Eye Opener,” you will recall that we recently posted on steps being taken through an independent initiative by the National Institute of Health for reporting in the electronic medical records just how much radiation its patients receive from CT scans and other procedures.
Other aspects of the FDA’s initiative would include matters such as a dose registry for establishing nationwide benchmark doses for such therapeutic tests; the development and dissemination of a patient medical imaging history card (think NIH) and a collaborative effort with the Center for Medicare and Medicaid Services ”to incorporate key quality assurance practices into the mandatory accreditation and conditions of participation survey processes for imaging facilities and hospitals.”
From my very limited vantage point of following stories on horrific events associated with these devices and the use of them by apparently under-qualified personnel, it would seem that the power of the press has once again brought about an awakening on the federal level of the need to control the use and users of these wonderful yet potentially injurious diagnostic machines. Kudos to those who have reported on the need to gain such control.