Healthcare's Commitment to CT Scan Technology Safety
GE responds to an article in The New York Times, Sunday, August 1, 2010.
Each year, physicians turn to advanced computed tomography (CT) scan technology to aid in the diagnosis and early detection of cancer, cardiac, neurological and other conditions with the goal of significantly improving treatment plans and patient health outcomes.
Patient safety continues to be the primary concern of GE Healthcare and the Company will continue to support customer programs that provide user training on dose-reducing technologies and methods.
Diagnostic imaging is a state-of-the-art technology designed to be administered by qualified clinical teams with advanced training in all aspects associated with the safe use of equipment for generating high-quality diagnostic images. The technology is governed by best practice procedures to ensure "as low as reasonably achievable radiation" use, also known as the ALARA principle.
Medical imaging is heavily regulated and requires compliance with standards and guidelines established by the U.S. Food & Drug Administration (FDA), state regulatory health agencies, the International Electrotechnical Commission (IEC) and others to control exposure and minimize dose.
An August 1 New York Times article revisits information initially included in two 2009 FDA public notices regarding adverse events at a number of medical facilities. The article alleges safety control procedures were not followed during administration of these exams at these hospitals.
It is important to note the article states: "none of the overdoses can be attributed to malfunctions of the CT scanners, government officials say," referring to patients who had undergone a CT scan.
However, the article did not include provided information about how CT technology is used in the clinical setting by facilities or actions taken by the Company prior to and since the FDA notices to ensure CT scans are safely and effectively administered by medical professionals.
GE Healthcare CT diagnostic equipment has multiple built-in safeguards to ensure the medical professional is fully informed of the quantity of radiation to be administered during an examination. These safeguards are explained extensively in training materials and educational programs with radiology teams and include among the following:
GE and other stakeholders previously announced a radiation technology initiative designed to improve safety. This commitment includes:
The medical imaging community is also working with Congress and regulators to further improve radiation safety. Manufacturers endorse mandatory accreditation of facilities to ensure adherence to the highest degree of safety and quality assurance, certification of health care professionals and use of clinical guidelines at the point of order to allow for insightful diagnostics and appropriate use of the technology.
Radiation safety demands that GE Healthcare work together with our partners in hospitals and clinics and with regulators around the world to ensure that CT imaging which has been called one of the most significant advances in the history of healthcare continues to serve physicians and patients with important and life-saving diagnostic information.
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