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FDA Pediatric Guidance Document Aligns Manufacturers and Patient-safety Groups
By Matthew Skoufalos
 In May, the FDA¹ released for public comment a guidance document intended to ensure that manufacturers’ imaging devices are either suited for pediatric use or labeled with a warning that cautions against use in pediatric populations.
Citing the increased radiosensitivity of children (as compared with that of adults), the greater timeline along which overexposure could manifest itself as cancer, and the potential for children to be exposed to excessive radiation when machines calibrated principally for adults are used, the document would require manufacturers to explicitly incorporate pediatric settings, labeling, displays, and software on all new equipment or label it to caution against pediatric use.
Although everyone takes notice when the FDA issues such guidance, Marilyn J. Goske, MD, who chairs both the Alliance for Radiation Safety in Pediatric Imaging and the pediatric interest group of the ACR® Dose Index Registry, says that the increased focus on pediatric dose mitigation and patient safety is a slow crescendo that began about a decade ago.
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Vote yeah or nay on the FDA’s draft guidance on pediatric imaging:
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Protecting the Most Vulnerable Patients: Children’s Hospital Los Angeles
By Cheryl Proval
When it comes to radiation exposure, there is not much on which the medical community agrees. One exception (and point of consensus) is that children are more vulnerable to the effects of radiation than are adults, and therefore, they deserve the highest level of protection available.
As chair of radiology at Children’s Hospital Los Angeles (CHLA) in California, pediatric neuroradiologist Marvin D. Nelson, MD, MBA, bears the ultimate responsibility for protecting the young people treated in more than 400,000 encounters per year at the 314-bed hospital and level I pediatric trauma center from unnecessary exposure to radiation.
It is a charge that he takes very seriously and that involves developing his institution’s radiation-protection strategy, addressing parental concerns, and eventually creating a pediatric dose record that will stand alongside a child’s immunization record.
“Children are still developing, they have much more radiosensitive organs than adults do, and they are going to spend an entire lifetime with the burden of radiation that we give to them. In children, there is a longer period of time when the effects of radiation can manifest themselves, as opposed to the case of an adult (who is already many years down the road).”
—Marvin D. Nelson, MD, MBA
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A Dose of Prevention: The Role of the RIS in Preventing Overexposure
By Greg Thompson
In many ways, the problem of radiation overexposure still resembles a crime scene. Investigators come in after the fact and attempt to determine what really happened. There is another way, however, according to Charles W. Socia, RT, CIIP, product manager for the information-systems division of FUJIFILM Medical Systems USA—one that focuses on prevention. The 23-year radiology veteran is working to overcome the retroactive-response mentality that still dominates the industry.
The idea is to improve care on the spot, while the patient is still on the table. “The majority of the solutions today are focused after the event to analyze overexposures,” Socia explains. “The focus of the Fujifilm solution is to notify users prior to the exposure and provide immediate notification in the event of an overexposure. We provide tools to notify referring physicians, radiologists, and technologists as to patients’ risk levels.”
On the heels of several high-profile cases of excessive radiation exposure, the state of California has attempted to improve the situation through a new dose-reporting law, the Medical Radiation Safety Act of 2010 (which went into effect on July 1, 2012). While acknowledging that the state’s efforts probably will not hurt, Socia is not convinced that the law will actually help.
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The Best US Health IT Jobs
Fifteen health-care organizations were named among Computerworld’s 100 Best Places to Work in IT. Average salaries, diversity in management, training, and turnover rates were among the factors considered.
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Health IT’s Salaries Trail Those in Other Industries
While demand for IT professionals in health care is strong, their compensation lags behind pay in all other industries, according to the InformationWeek 2012 Salary Survey. Median annual base pay was $83,000 in 2012, $2,000 less than the median pay across all industries and up from $78,000 last year. Median compensation for health IT managers, however, was slightly higher than the median across all industries.
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Decision Support Is a Likely Focus of Stage 3 MU
In a recent meeting, a subcommittee on quality improvement signaled that decision support is likely to figure among the stage 3 requirements for meaningful use of health IT. Clinician alerts for drug interactions and clinician identification of a patient’s preferred method of communication were two use cases mentioned.
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New York Medical Informatics Symposium
Sponsored by by Staten Island University Hospital
September 10
New York, New York
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Planning for Pathology Informatics 2012
Sponsored by the University of Pittsburgh and the Association for Pathology Informatics
October 9–12
Chicago, Illinois
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RSNA 2012: Patients First
Sponsored by by the RSNA
November 25–30
Chicago, Illinois
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