Posts Tagged ‘radiation exposure’

Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

Monday, April 12th, 2010

The FDA has recently launched a comprehensive new study regarding ways to reduce radiation exposure as a result of medical imaging.  The on-line article sets the background for the study, then provides comprehensive scientific and medical information for support:

Like all medical procedures, computed tomography (CT), fluoroscopy, and nuclear medicine imaging exams present both benefits and risks.  These types of imaging procedures have led to improvements in the diagnosis and treatment of numerous medical conditions.  At the same time, these types of exams expose patients to ionizing radiation, which may elevate a person’s lifetime risk of developing cancer.  As part of a balanced public health approach, the U.S. Food and Drug Administration (FDA) seeks to support the benefits of these medical imaging exams while minimizing the risks.

Through the Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging, FDA is advocating the universal adoption of two principles of radiation protection: appropriate justification for ordering each procedure, and careful optimization of the radiation dose used during each procedure.  Each patient should get the right imaging exam, at the right time, with the right radiation dose.

The related White Paper discusses types of medical imaging procedures,  factors causing the unnecessary exposure, and proposes possible solutions.  The factors include: Issues relating to Device Use, as well as Issues Relating to Clinical Decision Making.  Solutions include: Promoting Safe Use of Medical Imaging Devices, supporting informed clinical decision making, as well as increasing patient awareness.

At Hearing on Radiation, Calls for Better Oversight

Monday, March 1st, 2010

In an article posted by the New York Times, the dangers of radiation, specifically being over/errantly exposed in medical procedures, is graphically detailed.  The article also references an in-depth investigative report that the New York Times featured in January of this year. The tragic story of Scott Jerome-Parks, is described in both articles, with many of the sad details provided in the New York Times January investigation:

As Scott Jerome-Parks lay dying, he clung to this wish: that his fatal radiation overdose — which left him deaf, struggling to see, unable to swallow, burned, with his teeth falling out, with ulcers in his mouth and throat, nauseated, in severe pain and finally unable to breathe — be studied and talked about publicly so that others might not have to live his nightmare.
Sensing death was near, Mr. Jerome-Parks summoned his family for a final Christmas. His friends sent two buckets of sand from the beach where they had played as children so he could touch it, feel it and remember better days.

Mr. Jerome-Parks died several weeks later in 2007. He was 43.

A New York City hospital treating him for tongue cancer had failed to detect a computer error that directed a linear accelerator to blast his brain stem and neck with errant beams of radiation. Not once, but on three consecutive days.

The frequency and occurrence of radiation being utilized in medical procedures continues to be on the rise.  Many leaders from the healthcare industry agree that more needs to be done, in so far as making sure radiation continues to help, and not harm, patients.  The New York Times examined thousands of pages of records, and conducted numerous interviews with healthcare professionals.  Some of the results revealed the following:

The Times found that while this new technology allows doctors to more accurately attack tumors and reduce certain mistakes, its complexity has created new avenues for error — through software flaws, faulty programming, poor safety procedures or inadequate staffing and training. When those errors occur, they can be crippling.

“Linear accelerators and treatment planning are enormously more complex than 20 years ago,” said Dr. Howard I. Amols, chief of clinical physics at Memorial Sloan-Kettering Cancer Center in New York. But hospitals, he said, are often too trusting of the new computer systems and software, relying on them as if they had been tested over time, when in fact they have not.

Identifying radiation injuries can be difficult. Organ damage and radiation-induced cancer might not surface for years or decades, while underdosing is difficult to detect because there is no injury. For these reasons, radiation mishaps seldom result in lawsuits, a barometer of potential problems within an industry.

In 2009, the nation’s largest wound care company treated 3,000 radiation injuries, most of them serious enough to require treatment in hyperbaric oxygen chambers, which use pure, pressurized oxygen to promote healing, said Jeff Nelson, president and chief executive of the company, Diversified Clinical Services.

While the worst accidents can be devastating, most radiation therapy “is very good,” Dr. Mettler said. “And while there are accidents, you wouldn’t want to scare people to death where they don’t get needed radiation therapy.”

A good portion of the hearing last week dealt with CT Scans and the proper amount of radiation to which one should be exposed.  One of the concerning issues with CT Scans is the vast difference between exposure levels at different facilities.  Even within the same facility, doses can vary widely between patients.

CT Scans are only one example of the multitude of issues presented at the Congressional hearings last week.  The mandatory accreditation of radiologic units as well as the standardized reporting of medical errors were called for by some at the hearings.

FDA Unveils Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

Wednesday, February 10th, 2010

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.