Abstract
Certain incidents, such as the radiation overdose during perfusion brain CT imaging that caused adverse health effects on patients, have prompted the federal government to channelize its attention and efforts towards stringently regulating medical technology industry, particularly the imaging facilities that could release hazardous radiations from their overutilization . Following is the critical analysis of the responsibilities of the federal government and regulatory agencies like FDA in this arena and their ramifications on prevention of health risks associated with their overutilization. FDA has undertaken several research analyses and released legal documents pertaining the regulatory guidelines for radiation overutilization in medical technology. It describes the special focus of federal government in the last few years and the regulatory laws imposed to ensure a mandatory regulation of medical technology. These regulatory actions from the government are critical to prevent serious health hazards that have been demonstrated to be caused, owing to radiation overdose.
The federal government has recently revealed its amplified readiness to intercede in healthcare practices especially when the safety of the patient is on the line. The federal government plays quite a number of different roles in the use and development of medical technology like the Computed Tomography (CT) and the artificial heart. Putting the lives of the patients at stake is one of the key motivators of the government to intervene in the medical industry. For example, there were reports released establishing that in 2009 and 2010, about 400 patients received an overdose radiation during perfusion CT brain imaging . This made many patients lose their hair, and some change their skin color. Consequent to this incident, FDA earnestly investigated into the reasons for exposure of patients with such an intricate yet leniently regulated technology that released exorbitant radiation. After several months of pursuit, the FDA has detected comparatively more grave symptoms than loss of hair, such as long-term adverse effects of cancer and brain impairment. Patients reported to have experienced symptoms such as memory loss, headaches and confusion. Direct interaction of eyes to these radiations n high concentrations may elevate the risk of contracting cataracts . FDA was initially ignorant of the extent of radiation overdoses, but later started taking the issue seriously. It started warning hospitals to reevaluate their radiation output on these tests. Several hospitals in Los Angeles County, University of Southern California Medical Center, Bakersfield Memorial Hospital, reported cases of patients that received several fold higher than normal doses of radiation and none of these cases were owing to glitches in CT scanners .
Medical procedures such as fluoroscopy, CT and nuclear medicine imaging devices exhibit advantages and risks . While these imaging procedures have facilitated the process of medical diagnosis and consequent treatment, these kind of imaging systems expose patients to ionizing radiations, which may prove to be detrimental to one’s health and even cause dreadful diseases like cancer. Hence, it is crucial for federal government to step in and take stringent moves to regulate the medical technology industry. Management and regulation of these procedures involve two major principles :
Justification: The imaging technique needs to be reap more advantages than harm to a particular patient. Relevant rationalization for ordering and conducting every procedure is mandatory. Hence, all investigations involving ionizing radiation should be utilized only when absolutely required to solve a medical problem and aid in the treatment of a disease. The clinical symptoms and medical history of the user patient should be cautiously kept in mind prior to recommending any imaging investigation to a patient.
Dose optimization: Inconsistency in the application of reduction methods cause irrelevant exposures at both the level of patient and public. Medical imaging techniques should use techniques that have been calibrated to use the least dose that produces image quality sufficient for detection or intervention. In other words, a meticulous optimization of the dose of radiation administered is necessary . The technique and other parameters selected should be based on patient size, clinical symptoms and the anatomical region to be scanned and efficient maintenance of the device and its validation is very important .
One of the regulations that the government has put in place to see that technology is beneficial and safe for the patients is regulation of the personnel and the facilities that operate these medical technologies for example the CT. These regulations involve setting standards for personnel, inspections of the technological facilities and other safety measures that aim at improving the safety of the technology . Despite clear definition and understanding of the nature and extent of the CT safety issues, the federal government’s authority to mediate a solution, is restricted by the Constitutional power. In accordance to the 10th Amendment, powers not defined by the federal government under the U.S constitution are placed aside to the states. These limitations on power include the state’s authority for promotion of safety, ethics, and overall health and well-being of the society . Considering the constitution does not clearly ascribe federal power to control health care, this power has been traditionally reserved to the states. Also, the licensing of medical professionals and execution of health care regulations such as safety guidelines for CT imaging have been under the jurisdiction of the individual states . Over the last few decades, the federal government has play a significant role in specification and regulation of health care in the United States. However, the federal control of CT has been limited to FDA clearance of CT scanners at the manufacturing level. The federal government has not been involved in the supervision of hospital-related or nonhospital diagnostic imaging facilities. There has been a lack of certification requirements necessary for technologists handling the CT scanners. On the contrary, other areas of health care such as ambulatory surgical centers, health care organizations, clinical laboratories that are strictly regulated by federal accreditation requirements for years .
In terms of oversight, federal agencies that have been assigned the responsibility to regulate various segments of the medical industry, perform relevant research in specific areas and publish reports. For example, the federal agency that is responsible for the regulation of medical and drugs, FDA, performed research on radiation overdose in CT in November 2010 . FDA announced its recommendations and findings from the examinations of CT-associated radiation doses. In the legal documents released by the agency, FDA clarifies that it will influence its regulatory power under the Federal Food, Drug, and Cosmetic Act with three primary strategies to improve CT safety. As the first step, the FDA will initiate the implementation of novel hardware and software safety measures intended meant to avoid inadvertent overexposures. It is ambiguous, though, whether this will be achieved through new obligatory characteristics of production CT units or through non-attaching guidance documents. As a supervisor of device labeling, the FDA will need a more organized and all-inclusive user data with specific attention to quality assurance. Lastly, in its product scrutiny function, the FDA has to ensure that the imaging facilities comply to their legislative duty to report adverse incidents related to CT scanning, in order that the FDA can handle avoidable risks . With the goal of investigating into its own shortcomings in the regulatory arena, the federal government has also encouraged several technologists, radiologists, and experts from the industry to discuss and solve problems associated with the CT safety (Harvey, 2012).
There has also been placed various laws in the constitution to regulate the medical technology in the state. One of them is the Mammography Quality Standards Act of 1992 (MQSA), which established the vital quality and safety standards for all the facilities performing mammography . This Act ascertains that all women avail access to good quality mammography for early diagnostic detection of breast cancer in its preliminary stages. The Congress assigned the task of enforcing this law to FDA, following which, the latter started to implement certification and accreditation regulations and perform inspections of facilities conducting mammography . The Commerce Clause 3 of the U.S constitution, allocates the authority of controlling commerce among the various states, to federal government. This clause empowers the Federal government to broadly control the products of the interstate commerce that incudes nationally promoted medicines, diagnostic tests and medical devices, mediated by FDA. The Clause has also been utilized to execute stringent quality standards for all clinical laboratories examining human samples in the United States.
As a regulatory body, FDA has been making serious attempts to monitor imaging equipment and manufacturers . Of considerable importance, would be to establish critical collaborations with professional organizations, other government agencies and industry to assimilate radiation prevention principles in the quality control and credential assessment procedures of healthcare facilities. Considering the various hurdles and problems involved in CT imaging, a robust relationship between the regulatory organizations and the radiology community is necessary. Many huge organizations have undertaken many efforts to ascertain that each patient has access to the appropriate imaging technique, at the right time, with the appropriate radiation dosage. Several collaborative associations between CT manufacturers and FDA and the group of experts summoned by Congress, are some of the measures taken by federal government along these lines. FDA has set goals to offer a comprehensive strategy for collaborative measures in areas like education and awareness, appropriate usage, personnel qualifications and credentials, safety procedures associated with the equipment and research and development .
CONCLUSION
In the recent years, federal government has become increasingly active and responsible in addressing regulatory issues concerning CT safety. Several measures like increased FDA supervision and mandatory healthcare facility accreditations have been undertaken by federal government, in order to prevent accidental radiation exposures. However, these actions are incomplete by themselves, in tackling the CT safety problems. Therefore, it is essential for the government to work in collaboration with radiology community and states, to further take charge of providing more inclusive solutions for curbing overuse and optimization of radiation doses. However, considering the federal interference poses challenges to the federal-state equilibrium of power and has several shortcomings, sufficient justification is required for further federal action .
Keeping this in mind, it is of utmost significance that the federal government encourages developments and progress in medical technology. In response, the radiology community needs to be well prepared to participate and debate, if required, into the regulatory measures taken by the federal government. It is the responsibility of the government to ensure that the medical technology is safe, such that any patient receiving any imaging facility is confident that the tests availed by the patient will produce maximum advantages, with low risk of hazard. Therefore, regulatory measures and agencies have been put in place to ensure that these responsibilities are achieved .
References
About the Mammography Program. (2014, June 11). Retrieved from U.S. Food and Drug Administration. : http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/AbouttheMammographyProgram/default.htm
Bogdanich, W. (2010, July 30). After stroke scans, patients face serious health risks. Retrieved from NewYork Times: http://www.nytimes.com/2010/06/01/health/01radiation.html
Harvey, B. (2012). The Federal Government’s Oversight of CT Safety: Regulatory Possibilities. Radiology, 391-398.
radiation Emitting Products. (2010, February). Retrieved from www.fda.gov: http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/ucm2007191.htm
