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:
• At the time of the exam, the medical professional and his or her supervisor are responsible for setting and confirming scan parameters and dose levels to ensure images will meet the diagnostic purpose while following the ALARA principle. During this process, GE CT systems provide several safety precautions to the medical personnel.
• Both prior to and after the scan dose levels established by the operator for each test are displayed and recorded on the GE CT system. In addition, all technique factors and associated dosage are displayed on the same screen that must be confirmed by the operator before initiating each scan. (Please see the video below to view how the exam is administered.)
• The GE Healthcare CT systems also include a prominently displayed pop-up warning message on the screen during a brain perfusion scan – a procedure discussed in the New York Times article. This message warns the user about repeated scanning of the same anatomical location and requires the medical professional to acknowledge the warning before being able to proceed with the scan.
• GE Healthcare CT systems include the ability for healthcare facilities to restrict and control access to the CT system, for example, by establishing password protection for changes to the facility’s scan protocols (preset scanning techniques.)
GE and other stakeholders previously announced a radiation technology initiative designed to improve safety. This commitment includes:
• Radiation Dose Check—A new standardized feature will provide notifications and alerts to CT device operators when pre-defined radiation dose levels, as determined by hospitals and imaging centers, will be exceeded. An additional safeguard will allow facilities to set maximum radiation dose limits that will prevent scanning at higher than their institution’s pre-established levels.
• Standardized Dose Reporting—The CT industry has already established standards and begun implementing uniform capture of relevant CT dose information. This information will be available for inclusion in electronic medical records. This feature will allow physicians and patients to better track radiation exposure over time and help determine future reference dose levels.
• Enhanced Access Controls–Hospitals and imaging facilities set and control access to protocols and scan parameters that ultimately determine the level of radiation dose a patient receives. To support facilities in these efforts, the industry is enhancing and standardizing these access controls.
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.