Monica Hogan

Technological advances make it possible for patients to be involved with their own health care on a daily basis, according to Dr. Leslie Saxon, chief of the division of cardiovascular medicine at the University of Southern California, Los Angeles.

Speaking last month at the TEDMED 2012 conference in Washington, touted as a gathering of visionaries discussing the future of health and medicine, Dr. Saxon told fellow physicians it was their job to help patients edit the unique health stories they are living.

"We want to use the 5 billion cell phones in the world to collect the heartbeat of every person around the world."

"As physicians, it’s really our signature challenge to do that editing more accurately and efficiently as digital health scales globally."

Dr. Saxon, also founder of USC’s Center for Body Computing and a Cardiology News Editorial Advisory Board member, said her goal is to help create a global digital health platform.

"We want to use the 5 billion cell phones in the world to collect the heartbeat of every person around the world" through the use of manufacturer-agnostic sensors. She envisions the "digital dialogue" that would follow as creating a revolution in medical care.

"Imagine getting a call from your doctor who may be somewhere else in the world [telling you] that you’re about to get sick ... vs. you having to proactively reach out. It’s truly a different paradigm."

In the mid-1990s, Saxon was helping to design sophisticated cardiac devices at the University of California, San Francisco, she said, while at the same time down the road in Silicon Valley, a digital revolution was taking place outside medicine. "My world was changing because of the information age, but the way I practiced medicine wasn’t changing at all."

It would be several years before the medical device makers were invited to join investors and technologists in Silicon Valley to discuss the "unbelievable potential in bringing the information age to health care to scale across hundreds of millions of patients," she said.

According to Saxon, research shows that patients with implantable devices who view and transmit their medical data to doctors on a daily basis live longer than do those who have the same devices but do not see or transmit the data.

"You’re suddenly changing this centuries-old paradigm," Saxon said. "It’s no longer paternalistic in the same way. You’re learning from each other, and you don’t have to wait months to intervene." That is especially important with patients at risk for stroke, for example.

Saxon said there has been push back from some in the medical community who don’t believe patients can handle such data unless a doctor filters them first, even though many physicians are inaccessible much of the time.

"I’ve come to view this – patients being able to continuously interact with their data and with their providers – as one of the more important civil rights issues of our era," Saxon said.

She encouraged physicians to "truly enfranchise patients, daily, in their care." But she also admitted that "the pull is going to have to come from the public, the consumer of health care, which is the patient."

This coverage is provided courtesy of "The Gray Sheet." This news organization and "The Gray Sheet" are both owned by Elsevier.

Technological advances make it possible for patients to be involved with their own health care on a daily basis, according to Dr. Leslie Saxon, chief of the division of cardiovascular medicine at the University of Southern California, Los Angeles.

Speaking last month at the TEDMED 2012 conference in Washington, touted as a gathering of visionaries discussing the future of health and medicine, Dr. Saxon told fellow physicians it was their job to help patients edit the unique health stories they are living.

"We want to use the 5 billion cell phones in the world to collect the heartbeat of every person around the world."

"As physicians, it’s really our signature challenge to do that editing more accurately and efficiently as digital health scales globally."

Dr. Saxon, also founder of USC’s Center for Body Computing and a Cardiology News Editorial Advisory Board member, said her goal is to help create a global digital health platform.

"We want to use the 5 billion cell phones in the world to collect the heartbeat of every person around the world" through the use of manufacturer-agnostic sensors. She envisions the "digital dialogue" that would follow as creating a revolution in medical care.

"Imagine getting a call from your doctor who may be somewhere else in the world [telling you] that you’re about to get sick ... vs. you having to proactively reach out. It’s truly a different paradigm."

In the mid-1990s, Saxon was helping to design sophisticated cardiac devices at the University of California, San Francisco, she said, while at the same time down the road in Silicon Valley, a digital revolution was taking place outside medicine. "My world was changing because of the information age, but the way I practiced medicine wasn’t changing at all."

It would be several years before the medical device makers were invited to join investors and technologists in Silicon Valley to discuss the "unbelievable potential in bringing the information age to health care to scale across hundreds of millions of patients," she said.

According to Saxon, research shows that patients with implantable devices who view and transmit their medical data to doctors on a daily basis live longer than do those who have the same devices but do not see or transmit the data.

"You’re suddenly changing this centuries-old paradigm," Saxon said. "It’s no longer paternalistic in the same way. You’re learning from each other, and you don’t have to wait months to intervene." That is especially important with patients at risk for stroke, for example.

Saxon said there has been push back from some in the medical community who don’t believe patients can handle such data unless a doctor filters them first, even though many physicians are inaccessible much of the time.

"I’ve come to view this – patients being able to continuously interact with their data and with their providers – as one of the more important civil rights issues of our era," Saxon said.

She encouraged physicians to "truly enfranchise patients, daily, in their care." But she also admitted that "the pull is going to have to come from the public, the consumer of health care, which is the patient."

This coverage is provided courtesy of "The Gray Sheet." This news organization and "The Gray Sheet" are both owned by Elsevier.

Technological advances make it possible for patients to be involved with their own health care on a daily basis, according to Dr. Leslie Saxon, chief of the division of cardiovascular medicine at the University of Southern California, Los Angeles.

Speaking last month at the TEDMED 2012 conference in Washington, touted as a gathering of visionaries discussing the future of health and medicine, Dr. Saxon told fellow physicians it was their job to help patients edit the unique health stories they are living.

"We want to use the 5 billion cell phones in the world to collect the heartbeat of every person around the world."

"As physicians, it’s really our signature challenge to do that editing more accurately and efficiently as digital health scales globally."

Dr. Saxon, also founder of USC’s Center for Body Computing and a Cardiology News Editorial Advisory Board member, said her goal is to help create a global digital health platform.

"We want to use the 5 billion cell phones in the world to collect the heartbeat of every person around the world" through the use of manufacturer-agnostic sensors. She envisions the "digital dialogue" that would follow as creating a revolution in medical care.

"Imagine getting a call from your doctor who may be somewhere else in the world [telling you] that you’re about to get sick ... vs. you having to proactively reach out. It’s truly a different paradigm."

In the mid-1990s, Saxon was helping to design sophisticated cardiac devices at the University of California, San Francisco, she said, while at the same time down the road in Silicon Valley, a digital revolution was taking place outside medicine. "My world was changing because of the information age, but the way I practiced medicine wasn’t changing at all."

It would be several years before the medical device makers were invited to join investors and technologists in Silicon Valley to discuss the "unbelievable potential in bringing the information age to health care to scale across hundreds of millions of patients," she said.

According to Saxon, research shows that patients with implantable devices who view and transmit their medical data to doctors on a daily basis live longer than do those who have the same devices but do not see or transmit the data.

"You’re suddenly changing this centuries-old paradigm," Saxon said. "It’s no longer paternalistic in the same way. You’re learning from each other, and you don’t have to wait months to intervene." That is especially important with patients at risk for stroke, for example.

Saxon said there has been push back from some in the medical community who don’t believe patients can handle such data unless a doctor filters them first, even though many physicians are inaccessible much of the time.

"I’ve come to view this – patients being able to continuously interact with their data and with their providers – as one of the more important civil rights issues of our era," Saxon said.

She encouraged physicians to "truly enfranchise patients, daily, in their care." But she also admitted that "the pull is going to have to come from the public, the consumer of health care, which is the patient."

This coverage is provided courtesy of "The Gray Sheet." This news organization and "The Gray Sheet" are both owned by Elsevier.

A push to better publicize prices paid by hospitals for implantable devices could gain more steam in response to a recent report from the Government Accountability Office, but device makers contend they should retain the right to keep secret the prices they negotiate with hospitals.

"Lack of price transparency may hamper hospitals’ ability to be prudent purchasers of implantable medical devices," GAO concluded in the report issued earlier this month. It identified substantial variation in prices that hospitals paid for the same type of device based on a survey of dozens of U.S. hospitals, group purchasing organizations (GPOs) and government health care systems. This might indicate Medicare is paying more than it should for certain device-heavy procedures such as cardiac stenting and joint replacements, some policymakers suggest.

In response to the report, Sen. Max Baucus, D-Mont., Senate Finance Committee Chairman who requested the report in 2010, floated the prospect of requiring hospitals that treat Medicare beneficiaries to report to CMS the prices they pay for implantable devices.

Device makers vehemently oppose such an approach, according to David Nexon, senior executive vice president of AdvaMed. Such laws would "disrupt a very well-functioning competitive market and would be bad for the public," he said in an interview.

But hospitals and group purchasing organizations say that the current secrecy puts them at a disadvantage in negotiations with manufacturers, leading to prices that are higher than they would be in a more transparent market. The GAO report offers more support for a statutory change to right the situation, they say.

Jeffrey Lerner, CEO of ECRI Institute, a nonprofit research and services firm for hospitals, is calling for legislation that would simply remove pricing confidentiality clauses from manufacturers’ purchase contracts with hospitals and GPOs.

"In my view, the legislation should be quite simple," Mr. Lerner said in an interview. "It should say, ‘If you want to do business with Medicare, you cannot restrict the sharing and comparing of prices paid.’"

Group purchasing organizations also want to work with Sen. Baucus and other lawmakers to help shape legislation that would prohibit the use of confidentiality clauses in device manufacturers’ purchase contracts. "The medical device companies have essentially made price a proprietary piece of information, which we completely disagree with," said Curtis Rooney, president of the Healthcare Supply Chain Association, the trade group for GPOs.

The American Hospital Association would likely support outlawing gag clauses, said Don May, VP of policy for AHA. But AHA would also be happy to see new rules at least making it easier for hospitals to share more pricing information with the clinical teams that practice at their facilities, Mr. May said.

According to GAO, a manufacturer’s purchase contract often limits a hospital from discussing prices even with its own physicians, which makes it more difficult for surgeons to consider cost when selecting among devices.

Particularly with the evolution toward value-based reimbursement programs and accountable care organizations, hospitals are stepping up efforts to coordinate with physicians to reduce costs. But the lack of price transparency makes those efforts more difficult, hospitals suggest.

Parties on both sides of the price transparency debate admit that any legislation striking down confidentiality clauses would not altogether eliminate variation in device prices charged to hospitals.

"There’s a whole set of reasons prices between hospitals will vary," Mr. Nexon said. This is one reason he argued that it is difficult to come to any policy conclusions based on the data in the GAO report.

Mr. Nexon, citing the work of some economists, also floats the possibility that device prices could actually go up rather than down if full pricing transparency were imposed on manufacturers. Companies may be less willing to give discounts, he explained, "because if you’re going to give a discount to somebody, then how do you justify not giving it to somebody else."

Whether the GAO report actually ends up driving momentum toward legislation in this area remains to be seen. GAO issued a number of caveats in the report, noting, for example, that "the data we obtained on cardiac and orthopedic [device] prices are not generalizable" and "differences in how hospitals purchase the parts or components needed for certain procedures may limit the comparability" of pricing information. Further, the investigators acknowledged that they cannot specify how much implantable device pricing impacts government spending because Medicare reimburses for procedures that incorporate the devices, not the implantables themselves.n

This article was edited from "The Gray Sheet," which is also an Elsevier publication.

A push to better publicize prices paid by hospitals for implantable devices could gain more steam in response to a recent report from the Government Accountability Office, but device makers contend they should retain the right to keep secret the prices they negotiate with hospitals.

"Lack of price transparency may hamper hospitals’ ability to be prudent purchasers of implantable medical devices," GAO concluded in the report issued earlier this month. It identified substantial variation in prices that hospitals paid for the same type of device based on a survey of dozens of U.S. hospitals, group purchasing organizations (GPOs) and government health care systems. This might indicate Medicare is paying more than it should for certain device-heavy procedures such as cardiac stenting and joint replacements, some policymakers suggest.

In response to the report, Sen. Max Baucus, D-Mont., Senate Finance Committee Chairman who requested the report in 2010, floated the prospect of requiring hospitals that treat Medicare beneficiaries to report to CMS the prices they pay for implantable devices.

Device makers vehemently oppose such an approach, according to David Nexon, senior executive vice president of AdvaMed. Such laws would "disrupt a very well-functioning competitive market and would be bad for the public," he said in an interview.

But hospitals and group purchasing organizations say that the current secrecy puts them at a disadvantage in negotiations with manufacturers, leading to prices that are higher than they would be in a more transparent market. The GAO report offers more support for a statutory change to right the situation, they say.

Jeffrey Lerner, CEO of ECRI Institute, a nonprofit research and services firm for hospitals, is calling for legislation that would simply remove pricing confidentiality clauses from manufacturers’ purchase contracts with hospitals and GPOs.

"In my view, the legislation should be quite simple," Mr. Lerner said in an interview. "It should say, ‘If you want to do business with Medicare, you cannot restrict the sharing and comparing of prices paid.’"

Group purchasing organizations also want to work with Sen. Baucus and other lawmakers to help shape legislation that would prohibit the use of confidentiality clauses in device manufacturers’ purchase contracts. "The medical device companies have essentially made price a proprietary piece of information, which we completely disagree with," said Curtis Rooney, president of the Healthcare Supply Chain Association, the trade group for GPOs.

The American Hospital Association would likely support outlawing gag clauses, said Don May, VP of policy for AHA. But AHA would also be happy to see new rules at least making it easier for hospitals to share more pricing information with the clinical teams that practice at their facilities, Mr. May said.

According to GAO, a manufacturer’s purchase contract often limits a hospital from discussing prices even with its own physicians, which makes it more difficult for surgeons to consider cost when selecting among devices.

Particularly with the evolution toward value-based reimbursement programs and accountable care organizations, hospitals are stepping up efforts to coordinate with physicians to reduce costs. But the lack of price transparency makes those efforts more difficult, hospitals suggest.

Parties on both sides of the price transparency debate admit that any legislation striking down confidentiality clauses would not altogether eliminate variation in device prices charged to hospitals.

"There’s a whole set of reasons prices between hospitals will vary," Mr. Nexon said. This is one reason he argued that it is difficult to come to any policy conclusions based on the data in the GAO report.

Mr. Nexon, citing the work of some economists, also floats the possibility that device prices could actually go up rather than down if full pricing transparency were imposed on manufacturers. Companies may be less willing to give discounts, he explained, "because if you’re going to give a discount to somebody, then how do you justify not giving it to somebody else."

Whether the GAO report actually ends up driving momentum toward legislation in this area remains to be seen. GAO issued a number of caveats in the report, noting, for example, that "the data we obtained on cardiac and orthopedic [device] prices are not generalizable" and "differences in how hospitals purchase the parts or components needed for certain procedures may limit the comparability" of pricing information. Further, the investigators acknowledged that they cannot specify how much implantable device pricing impacts government spending because Medicare reimburses for procedures that incorporate the devices, not the implantables themselves.n

This article was edited from "The Gray Sheet," which is also an Elsevier publication.

A push to better publicize prices paid by hospitals for implantable devices could gain more steam in response to a recent report from the Government Accountability Office, but device makers contend they should retain the right to keep secret the prices they negotiate with hospitals.

"Lack of price transparency may hamper hospitals’ ability to be prudent purchasers of implantable medical devices," GAO concluded in the report issued earlier this month. It identified substantial variation in prices that hospitals paid for the same type of device based on a survey of dozens of U.S. hospitals, group purchasing organizations (GPOs) and government health care systems. This might indicate Medicare is paying more than it should for certain device-heavy procedures such as cardiac stenting and joint replacements, some policymakers suggest.

In response to the report, Sen. Max Baucus, D-Mont., Senate Finance Committee Chairman who requested the report in 2010, floated the prospect of requiring hospitals that treat Medicare beneficiaries to report to CMS the prices they pay for implantable devices.

Device makers vehemently oppose such an approach, according to David Nexon, senior executive vice president of AdvaMed. Such laws would "disrupt a very well-functioning competitive market and would be bad for the public," he said in an interview.

But hospitals and group purchasing organizations say that the current secrecy puts them at a disadvantage in negotiations with manufacturers, leading to prices that are higher than they would be in a more transparent market. The GAO report offers more support for a statutory change to right the situation, they say.

Jeffrey Lerner, CEO of ECRI Institute, a nonprofit research and services firm for hospitals, is calling for legislation that would simply remove pricing confidentiality clauses from manufacturers’ purchase contracts with hospitals and GPOs.

"In my view, the legislation should be quite simple," Mr. Lerner said in an interview. "It should say, ‘If you want to do business with Medicare, you cannot restrict the sharing and comparing of prices paid.’"

Group purchasing organizations also want to work with Sen. Baucus and other lawmakers to help shape legislation that would prohibit the use of confidentiality clauses in device manufacturers’ purchase contracts. "The medical device companies have essentially made price a proprietary piece of information, which we completely disagree with," said Curtis Rooney, president of the Healthcare Supply Chain Association, the trade group for GPOs.

The American Hospital Association would likely support outlawing gag clauses, said Don May, VP of policy for AHA. But AHA would also be happy to see new rules at least making it easier for hospitals to share more pricing information with the clinical teams that practice at their facilities, Mr. May said.

According to GAO, a manufacturer’s purchase contract often limits a hospital from discussing prices even with its own physicians, which makes it more difficult for surgeons to consider cost when selecting among devices.

Particularly with the evolution toward value-based reimbursement programs and accountable care organizations, hospitals are stepping up efforts to coordinate with physicians to reduce costs. But the lack of price transparency makes those efforts more difficult, hospitals suggest.

Parties on both sides of the price transparency debate admit that any legislation striking down confidentiality clauses would not altogether eliminate variation in device prices charged to hospitals.

"There’s a whole set of reasons prices between hospitals will vary," Mr. Nexon said. This is one reason he argued that it is difficult to come to any policy conclusions based on the data in the GAO report.

Mr. Nexon, citing the work of some economists, also floats the possibility that device prices could actually go up rather than down if full pricing transparency were imposed on manufacturers. Companies may be less willing to give discounts, he explained, "because if you’re going to give a discount to somebody, then how do you justify not giving it to somebody else."

Whether the GAO report actually ends up driving momentum toward legislation in this area remains to be seen. GAO issued a number of caveats in the report, noting, for example, that "the data we obtained on cardiac and orthopedic [device] prices are not generalizable" and "differences in how hospitals purchase the parts or components needed for certain procedures may limit the comparability" of pricing information. Further, the investigators acknowledged that they cannot specify how much implantable device pricing impacts government spending because Medicare reimburses for procedures that incorporate the devices, not the implantables themselves.n

This article was edited from "The Gray Sheet," which is also an Elsevier publication.

Monica Hogan is with “The Gray Sheet.” This publication and “The Gray Sheet” are published by Elsevier.

WASHINGTON — One congressional hearing on medical radiation safety may not be enough for the Health Subcommittee of the House Energy and Commerce Committee. “We probably will need an additional hearing because I just have so many questions that came out of this today,” chairman Frank Pallone Jr. (D-N.J.) observed during a recent hearing.

Several witnesses called for the immediate passage of the CARE Act (Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act of 2009), which was introduced in the Energy and Commerce committee last September by Rep. John Barrow (D-Ga.). The CARE Act would mandate minimum education and training requirements, as well as state licensure, for personnel who plan or perform radiation oncology treatments or medical-imaging scans.

Subcommittee members and witnesses suggested that additional oversight may be needed as well, in the form of new regulatory agencies, quality standards, specialty practice guidelines, facility accreditation programs, and increased manufacturer participation in the process.

Industry Asked To Play Its Part

Manufacturers could move patient safety forward by immediately adopting agreed-upon standards for reporting radiation dose information from CT scans, said Dr. Rebecca Smith-Bindman, a radiology professor at the University of California, San Francisco.

Industry has said that it supports an FDA plan to collect and track data on patient dose from CT scans. “If these standards were adopted by the manufacturers, we could quickly know what's going on and then determine how closely different facilities abide by those guidelines that we have put out,” Dr. Smith-Bindman said.

Manufacturers can also help ensure that patients receive the lowest possible dose from CT scans, she added, urging industry to draft and adopt guidelines on how device representatives set default settings as they install equipment and help establish treatment protocols with hospital physicians and physicists.

Doses for the most typical scans that patients undergo could be reduced by 50% without reducing image quality, Dr. Smith-Bindman said. CT scan vendors have recently developed software algorithms that work with existing equipment to help lower doses dramatically, she added.

News Report Led to Hearing

The Feb. 26 hearing was called largely in response to a Jan. 24 New York Times article that described in graphic detail the adverse effects of too much medical radiation, including a fatal overexposure from image-modulated radiation therapy received by a patient named Scott Parks.

At the hearing, the patient's father, James Parks, described how an error in equipment setup went unnoticed for 3 days of his son's treatment, in part because the supervising physicist was off site. He asked manufacturers of such “deadly machines” to develop “fail-safe, interactive, expert systems that can interact with human technicians to reduce or eliminate human errors.”

“It is further recommended that such dangerous equipment never be operated by anyone not fully trained and qualified,” he stated. “Oncologists and supervising physicists must learn to micromanage every aspect of the radiology department. It is outrageous that any untrained and unskilled personnel can get anywhere near such dangerous equipment.”

Need for User Training Highlighted

Other witnesses supported the need for radiation therapists and physicists to be trained on new equipment as it is installed, and on an ongoing basis.

Kenneth Mizrach, director of the Veterans Affairs New Jersey Health Care System, said his group decided to shut down its radiation oncology program in East Orange, N.J., after an internal investigation confirmed concerns over quality standards.

As the program was rebuilt, the facility established continuous education for all staff, with a major component dedicated to initial and ongoing training on new technology and equipment, Mr. Mizrach said. Manufacturers were brought in to work with the staff and observe simulations in preparation for the facility's reopening.

“We are conducting routine tests of our machines, simulating patient encounters, checking dose calculations, tracking patient outcomes, and instituting routine quality reviews of care, including peer review,” he said.

Eric Klein, Ph.D., professor of radiation oncology at Washington University in St. Louis, suggested that equipment vendors could send independent physicists to hospitals to help them become accustomed to new machines.

Referring to a case in Florida in which 77 brain cancer patients were overradiated when a new machine was not properly set up, Dr. Klein noted that manufacturers do not typically have any direct control over the hospital personnel who determine the patients' dose rate.

“If the manufacturer had said, 'Okay, you're buying this very expensive piece of equipment. It's complex and is potentially dangerous. We are going to supply an expert physicist to come in from the outside to validate what you're doing,' [that is] a very simple solution that would have caught what had happened,” he said.

Although radiation oncology equipment goes through much manufacturer testing, users could be trained better on exactly what “fault” messages mean, Dr. Klein continued.

Inconsistent Error Reporting

Dr. Klein added that there is wide variation among manufacturers in reporting machine malfunctions to all their customers.

Sometimes, malfunctions are reported anecdotally or via Listserv, rather than by direct communication to all users of this equipment, Dr. Klein explained. “It might be better to do overkill communication. Right now, it's just scant and irregular.” In most states, hospitals are not required to report errors with linear accelerators as they occur, he noted.

Dr. Tim R. Williams, chair of the American Society for Radiation Oncology, said that ASTRO's 6-point plan to improve patient safety and quality includes a recommendation to work closely with regulatory authorities to create a national database for the reporting of linear accelerator medical errors. The ASTRO plan also attempts to ensure that radiation therapy technologies from different manufacturers can transfer treatment information seamlessly to help reduce medical errors.

CMS Could Foster Safety

Michael Herman, Ph.D., representing the American Association of Physicists in Medicine, called for rigorous minimum standards for accrediting clinical practices, specifically including the oversight of dose and quality assurance for medical-imaging and radiation therapy technology. He asked that reimbursement from the Centers for Medicare and Medicaid Services be directly tied to such accreditation.

The CMS could also help foster radiation safety by funding residencies for physicists in the field, as it does for physicians, said Dr. Klein. He noted that starting in 2014, the American Board of Radiology will allow only physicists who have completed a residency program to sit for board certification.

John Donahue, vice chairman of the radiology benefits management company Medicalis Inc., suggested that the CMS specify radiation safety among the appropriateness criteria it will test in its pilot program on advanced imaging. MIPPA (Medicare Improvement for Patients and Providers Act of 2008) calls for a 2-year demonstration project to test appropriateness criteria for CT scans and other advanced imaging technology.

The American College of Radiology wants accreditation requirements for advanced imaging centers to be extended to hospitals and all clinical settings that perform advanced imaging and radiation therapy procedures, according to Dr. E. Stephen Amis Jr., former ACR chair.

Under the CARE Act, radiology personnel would be subject to new education, training, and licensing requirements.

Source Joel Johndro/iStockphoto.com

Monica Hogan is with “The Gray Sheet.” This publication and “The Gray Sheet” are published by Elsevier.

WASHINGTON — One congressional hearing on medical radiation safety may not be enough for the Health Subcommittee of the House Energy and Commerce Committee. “We probably will need an additional hearing because I just have so many questions that came out of this today,” chairman Frank Pallone Jr. (D-N.J.) observed during a recent hearing.

Several witnesses called for the immediate passage of the CARE Act (Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act of 2009), which was introduced in the Energy and Commerce committee last September by Rep. John Barrow (D-Ga.). The CARE Act would mandate minimum education and training requirements, as well as state licensure, for personnel who plan or perform radiation oncology treatments or medical-imaging scans.

Subcommittee members and witnesses suggested that additional oversight may be needed as well, in the form of new regulatory agencies, quality standards, specialty practice guidelines, facility accreditation programs, and increased manufacturer participation in the process.

Industry Asked To Play Its Part

Manufacturers could move patient safety forward by immediately adopting agreed-upon standards for reporting radiation dose information from CT scans, said Dr. Rebecca Smith-Bindman, a radiology professor at the University of California, San Francisco.

Industry has said that it supports an FDA plan to collect and track data on patient dose from CT scans. “If these standards were adopted by the manufacturers, we could quickly know what's going on and then determine how closely different facilities abide by those guidelines that we have put out,” Dr. Smith-Bindman said.

Manufacturers can also help ensure that patients receive the lowest possible dose from CT scans, she added, urging industry to draft and adopt guidelines on how device representatives set default settings as they install equipment and help establish treatment protocols with hospital physicians and physicists.

Doses for the most typical scans that patients undergo could be reduced by 50% without reducing image quality, Dr. Smith-Bindman said. CT scan vendors have recently developed software algorithms that work with existing equipment to help lower doses dramatically, she added.

News Report Led to Hearing

The Feb. 26 hearing was called largely in response to a Jan. 24 New York Times article that described in graphic detail the adverse effects of too much medical radiation, including a fatal overexposure from image-modulated radiation therapy received by a patient named Scott Parks.

At the hearing, the patient's father, James Parks, described how an error in equipment setup went unnoticed for 3 days of his son's treatment, in part because the supervising physicist was off site. He asked manufacturers of such “deadly machines” to develop “fail-safe, interactive, expert systems that can interact with human technicians to reduce or eliminate human errors.”

“It is further recommended that such dangerous equipment never be operated by anyone not fully trained and qualified,” he stated. “Oncologists and supervising physicists must learn to micromanage every aspect of the radiology department. It is outrageous that any untrained and unskilled personnel can get anywhere near such dangerous equipment.”

Need for User Training Highlighted

Other witnesses supported the need for radiation therapists and physicists to be trained on new equipment as it is installed, and on an ongoing basis.

Kenneth Mizrach, director of the Veterans Affairs New Jersey Health Care System, said his group decided to shut down its radiation oncology program in East Orange, N.J., after an internal investigation confirmed concerns over quality standards.

As the program was rebuilt, the facility established continuous education for all staff, with a major component dedicated to initial and ongoing training on new technology and equipment, Mr. Mizrach said. Manufacturers were brought in to work with the staff and observe simulations in preparation for the facility's reopening.

“We are conducting routine tests of our machines, simulating patient encounters, checking dose calculations, tracking patient outcomes, and instituting routine quality reviews of care, including peer review,” he said.

Eric Klein, Ph.D., professor of radiation oncology at Washington University in St. Louis, suggested that equipment vendors could send independent physicists to hospitals to help them become accustomed to new machines.

Referring to a case in Florida in which 77 brain cancer patients were overradiated when a new machine was not properly set up, Dr. Klein noted that manufacturers do not typically have any direct control over the hospital personnel who determine the patients' dose rate.

“If the manufacturer had said, 'Okay, you're buying this very expensive piece of equipment. It's complex and is potentially dangerous. We are going to supply an expert physicist to come in from the outside to validate what you're doing,' [that is] a very simple solution that would have caught what had happened,” he said.

Although radiation oncology equipment goes through much manufacturer testing, users could be trained better on exactly what “fault” messages mean, Dr. Klein continued.

Inconsistent Error Reporting

Dr. Klein added that there is wide variation among manufacturers in reporting machine malfunctions to all their customers.

Sometimes, malfunctions are reported anecdotally or via Listserv, rather than by direct communication to all users of this equipment, Dr. Klein explained. “It might be better to do overkill communication. Right now, it's just scant and irregular.” In most states, hospitals are not required to report errors with linear accelerators as they occur, he noted.

Dr. Tim R. Williams, chair of the American Society for Radiation Oncology, said that ASTRO's 6-point plan to improve patient safety and quality includes a recommendation to work closely with regulatory authorities to create a national database for the reporting of linear accelerator medical errors. The ASTRO plan also attempts to ensure that radiation therapy technologies from different manufacturers can transfer treatment information seamlessly to help reduce medical errors.

CMS Could Foster Safety

Michael Herman, Ph.D., representing the American Association of Physicists in Medicine, called for rigorous minimum standards for accrediting clinical practices, specifically including the oversight of dose and quality assurance for medical-imaging and radiation therapy technology. He asked that reimbursement from the Centers for Medicare and Medicaid Services be directly tied to such accreditation.

The CMS could also help foster radiation safety by funding residencies for physicists in the field, as it does for physicians, said Dr. Klein. He noted that starting in 2014, the American Board of Radiology will allow only physicists who have completed a residency program to sit for board certification.

John Donahue, vice chairman of the radiology benefits management company Medicalis Inc., suggested that the CMS specify radiation safety among the appropriateness criteria it will test in its pilot program on advanced imaging. MIPPA (Medicare Improvement for Patients and Providers Act of 2008) calls for a 2-year demonstration project to test appropriateness criteria for CT scans and other advanced imaging technology.

The American College of Radiology wants accreditation requirements for advanced imaging centers to be extended to hospitals and all clinical settings that perform advanced imaging and radiation therapy procedures, according to Dr. E. Stephen Amis Jr., former ACR chair.

Under the CARE Act, radiology personnel would be subject to new education, training, and licensing requirements.

Source Joel Johndro/iStockphoto.com

Monica Hogan is with “The Gray Sheet.” This publication and “The Gray Sheet” are published by Elsevier.

WASHINGTON — One congressional hearing on medical radiation safety may not be enough for the Health Subcommittee of the House Energy and Commerce Committee. “We probably will need an additional hearing because I just have so many questions that came out of this today,” chairman Frank Pallone Jr. (D-N.J.) observed during a recent hearing.

Several witnesses called for the immediate passage of the CARE Act (Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act of 2009), which was introduced in the Energy and Commerce committee last September by Rep. John Barrow (D-Ga.). The CARE Act would mandate minimum education and training requirements, as well as state licensure, for personnel who plan or perform radiation oncology treatments or medical-imaging scans.

Subcommittee members and witnesses suggested that additional oversight may be needed as well, in the form of new regulatory agencies, quality standards, specialty practice guidelines, facility accreditation programs, and increased manufacturer participation in the process.

Industry Asked To Play Its Part

Manufacturers could move patient safety forward by immediately adopting agreed-upon standards for reporting radiation dose information from CT scans, said Dr. Rebecca Smith-Bindman, a radiology professor at the University of California, San Francisco.

Industry has said that it supports an FDA plan to collect and track data on patient dose from CT scans. “If these standards were adopted by the manufacturers, we could quickly know what's going on and then determine how closely different facilities abide by those guidelines that we have put out,” Dr. Smith-Bindman said.

Manufacturers can also help ensure that patients receive the lowest possible dose from CT scans, she added, urging industry to draft and adopt guidelines on how device representatives set default settings as they install equipment and help establish treatment protocols with hospital physicians and physicists.

Doses for the most typical scans that patients undergo could be reduced by 50% without reducing image quality, Dr. Smith-Bindman said. CT scan vendors have recently developed software algorithms that work with existing equipment to help lower doses dramatically, she added.

News Report Led to Hearing

The Feb. 26 hearing was called largely in response to a Jan. 24 New York Times article that described in graphic detail the adverse effects of too much medical radiation, including a fatal overexposure from image-modulated radiation therapy received by a patient named Scott Parks.

At the hearing, the patient's father, James Parks, described how an error in equipment setup went unnoticed for 3 days of his son's treatment, in part because the supervising physicist was off site. He asked manufacturers of such “deadly machines” to develop “fail-safe, interactive, expert systems that can interact with human technicians to reduce or eliminate human errors.”

“It is further recommended that such dangerous equipment never be operated by anyone not fully trained and qualified,” he stated. “Oncologists and supervising physicists must learn to micromanage every aspect of the radiology department. It is outrageous that any untrained and unskilled personnel can get anywhere near such dangerous equipment.”

Need for User Training Highlighted

Other witnesses supported the need for radiation therapists and physicists to be trained on new equipment as it is installed, and on an ongoing basis.

Kenneth Mizrach, director of the Veterans Affairs New Jersey Health Care System, said his group decided to shut down its radiation oncology program in East Orange, N.J., after an internal investigation confirmed concerns over quality standards.

As the program was rebuilt, the facility established continuous education for all staff, with a major component dedicated to initial and ongoing training on new technology and equipment, Mr. Mizrach said. Manufacturers were brought in to work with the staff and observe simulations in preparation for the facility's reopening.

“We are conducting routine tests of our machines, simulating patient encounters, checking dose calculations, tracking patient outcomes, and instituting routine quality reviews of care, including peer review,” he said.

Eric Klein, Ph.D., professor of radiation oncology at Washington University in St. Louis, suggested that equipment vendors could send independent physicists to hospitals to help them become accustomed to new machines.

Referring to a case in Florida in which 77 brain cancer patients were overradiated when a new machine was not properly set up, Dr. Klein noted that manufacturers do not typically have any direct control over the hospital personnel who determine the patients' dose rate.

“If the manufacturer had said, 'Okay, you're buying this very expensive piece of equipment. It's complex and is potentially dangerous. We are going to supply an expert physicist to come in from the outside to validate what you're doing,' [that is] a very simple solution that would have caught what had happened,” he said.

Although radiation oncology equipment goes through much manufacturer testing, users could be trained better on exactly what “fault” messages mean, Dr. Klein continued.

Inconsistent Error Reporting

Dr. Klein added that there is wide variation among manufacturers in reporting machine malfunctions to all their customers.

Sometimes, malfunctions are reported anecdotally or via Listserv, rather than by direct communication to all users of this equipment, Dr. Klein explained. “It might be better to do overkill communication. Right now, it's just scant and irregular.” In most states, hospitals are not required to report errors with linear accelerators as they occur, he noted.

Dr. Tim R. Williams, chair of the American Society for Radiation Oncology, said that ASTRO's 6-point plan to improve patient safety and quality includes a recommendation to work closely with regulatory authorities to create a national database for the reporting of linear accelerator medical errors. The ASTRO plan also attempts to ensure that radiation therapy technologies from different manufacturers can transfer treatment information seamlessly to help reduce medical errors.

CMS Could Foster Safety

Michael Herman, Ph.D., representing the American Association of Physicists in Medicine, called for rigorous minimum standards for accrediting clinical practices, specifically including the oversight of dose and quality assurance for medical-imaging and radiation therapy technology. He asked that reimbursement from the Centers for Medicare and Medicaid Services be directly tied to such accreditation.

The CMS could also help foster radiation safety by funding residencies for physicists in the field, as it does for physicians, said Dr. Klein. He noted that starting in 2014, the American Board of Radiology will allow only physicists who have completed a residency program to sit for board certification.

John Donahue, vice chairman of the radiology benefits management company Medicalis Inc., suggested that the CMS specify radiation safety among the appropriateness criteria it will test in its pilot program on advanced imaging. MIPPA (Medicare Improvement for Patients and Providers Act of 2008) calls for a 2-year demonstration project to test appropriateness criteria for CT scans and other advanced imaging technology.

The American College of Radiology wants accreditation requirements for advanced imaging centers to be extended to hospitals and all clinical settings that perform advanced imaging and radiation therapy procedures, according to Dr. E. Stephen Amis Jr., former ACR chair.

Under the CARE Act, radiology personnel would be subject to new education, training, and licensing requirements.

Source Joel Johndro/iStockphoto.com

WASHINGTON — One congressional hearing on medical radiation safety may not be enough for the Health Subcommittee of the House Energy and Commerce Committee. “We probably will need an additional hearing because I just have so many questions that came out of this today,” chairman Frank Pallone Jr. (D-N.J.) observed during the Feb. 26 hearing.

Several witnesses called for the immediate passage of the CARE Act (Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act of 2009), which was introduced in the Energy and Commerce committee last September by Rep. John Barrow (D-Ga). The CARE Act would mandate minimum education and training requirements, as well as state licensure, for personnel who plan or perform radiation oncology treatments or medical-imaging scans.

Subcommittee members and witnesses suggested that additional oversight may be needed as well, in the form of new regulatory agencies, quality standards, specialty practice guidelines, facility accreditation programs, and increased manufacturer participation in the process.

Manufacturers could move patient safety forward by immediately adopting agreed-upon standards for reporting radiation dose information from CT scans, said Dr. Rebecca Smith-Bindman, a radiology professor at the University of California, San Francisco.

Industry has said that it supports an FDA plan to collect and track data on patient dose from CT scans. “If these standards were adopted by the manufacturers, we could quickly know what's going on and then determine how closely different facilities abide by those guidelines that we have put out,” Dr. Smith-Bindman said.

Manufacturers can also help ensure that patients receive the lowest possible dose from CT scans, she added, urging industry to draft and adopt guidelines on how device representatives set default settings as they install equipment and help establish treatment protocols with hospital physicians and physicists.

“It turns out [that] you get prettier pictures if you turn the dose up higher,” she explained. “And those default settings are crucial in terms of what [dose levels] most patients receive. … And if those default settings are set in such a way that you get the most beautiful pictures, then it turns out the patients are getting higher radiation doses than they need to [in order] to support those pictures.”

Manufacturers have many ways they can help lower patient dose, Dr. Smith-Bindman said, noting that doses for the most typical scans that patients undergo could be reduced by 50% without reducing image quality.

CT scan vendors have recently developed software algorithms that work with existing equipment to help lower dose dramatically, Dr. Smith-Bindman added.

On Feb. 25, a day ahead of the hearing, the Medical Imaging & Technology Alliance announced a pledge by several CT makers to incorporate radiation dose alerts in software updates for existing CT scanners (see sidebar).

The Feb. 26 hearing was called largely in response to a Jan. 24 New York Times article that described the adverse effects of too much medical radiation, including a fatal overexposure from image-modulated radiation therapy received by a patient named Scott Parks.

At the hearing, the patient's father, James Parks, described how an error in equipment setup went unnoticed for 3 days of his son's treatment, in part because the supervising physicist was off site. He asked manufacturers of such “deadly machines” to develop “fail-safe, interactive, expert systems that can interact with human technicians to reduce or eliminate human errors.”

“It is further recommended that such dangerous equipment never be operated by anyone not fully trained and qualified,” Mr. Parks stated. “Oncologists and supervising physicists must learn to micromanage every aspect of the radiology department. It is outrageous that any untrained and unskilled personnel can get anywhere near such dangerous equipment.”

Michael Herman, Ph.D., representing the American Association of Physicists in Medicine, called for rigorous minimum standards for accrediting clinical practices, specifically including the oversight of dose and quality assurance for medical-imaging and radiation therapy technology. He asked that reimbursement from the Centers for Medicare and Medicaid Services be directly tied to such accreditation.

The CMS could also help foster radiation safety by funding residencies for physicists in the field, as it does for physicians, said Dr. Klein. He noted that starting in 2014, the American Board of Radiology will allow only physicists who have completed a residency program to sit for board certification.

John Donahue, vice chairman of the radiology benefits management company Medicalis Inc., suggested that the CMS specify radiation safety among the appropriateness criteria it will test in its pilot program on advanced imaging. MIPPA (Medicare Improvement for Patients and Providers Act of 2008) calls for a 2-year demonstration project to test appropriateness criteria for CT scans and other advanced imaging technology.

The American College of Radiology wants accreditation requirements for advanced imaging centers to be extended to hospitals and all clinical settings that perform advanced imaging and radiation therapy procedures, according to Dr. E. Stephen Amis Jr., former ACR chair.

Monica Hogan is with “The Gray Sheet.” This publication and “The Gray Sheet” are published by Elsevier.

CT Makers Unveil Safety Features

Manufacturers of computed tomography machines have agreed to standardized features to ensure that patients receive appropriate radiation doses.

In a conference call with reporters, Dave Fisher, executive director of the Medical Imaging & Technology Alliance (MITA), said the industry had been working for years to make CT machines safer and that the timing of the announcement (Feb. 25) was not related to the Food and Drug Administration's recent heightened interest in radiation or the impending House Energy & Commerce Health Subcommittee hearing.

The FDA planned to hold an advisory committee meeting on radiation safety March 30-31.

The five CT manufacturers—General Electric, Siemens, Philips, Toshiba, and Hitachi—agreed to participate in the MITA “dose check” initiative, said Mr. Fisher.

First, machine operators will receive an on-screen alert—possibly a pop-up window—when they exceed recommended dose levels. The alert is akin to a yellow caution flag, said Mr. Fisher. The recommended (reference) dose will be determined by clinicians at hospitals and imaging centers, not manufacturers, he said.

The second safeguard will be a warning if the dose reaches hazardous levels that could result in burns, hair loss, or other injuries. This “red flag” can be configured to prevent the scan, Mr. Fisher said.

Finally, manufacturers will standardized the storage of images so they can be incorporated into a registry proposed by the Obama administration.

The new features should be available by early 2011 as software upgrades to older machines or add-ons to new scanners. The process may be delayed for possible regulatory clearance by the FDA, said Mr. Fisher.

—Alicia Ault

WASHINGTON — One congressional hearing on medical radiation safety may not be enough for the Health Subcommittee of the House Energy and Commerce Committee. “We probably will need an additional hearing because I just have so many questions that came out of this today,” chairman Frank Pallone Jr. (D-N.J.) observed during the Feb. 26 hearing.

Several witnesses called for the immediate passage of the CARE Act (Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act of 2009), which was introduced in the Energy and Commerce committee last September by Rep. John Barrow (D-Ga). The CARE Act would mandate minimum education and training requirements, as well as state licensure, for personnel who plan or perform radiation oncology treatments or medical-imaging scans.

Subcommittee members and witnesses suggested that additional oversight may be needed as well, in the form of new regulatory agencies, quality standards, specialty practice guidelines, facility accreditation programs, and increased manufacturer participation in the process.

Manufacturers could move patient safety forward by immediately adopting agreed-upon standards for reporting radiation dose information from CT scans, said Dr. Rebecca Smith-Bindman, a radiology professor at the University of California, San Francisco.

Industry has said that it supports an FDA plan to collect and track data on patient dose from CT scans. “If these standards were adopted by the manufacturers, we could quickly know what's going on and then determine how closely different facilities abide by those guidelines that we have put out,” Dr. Smith-Bindman said.

Manufacturers can also help ensure that patients receive the lowest possible dose from CT scans, she added, urging industry to draft and adopt guidelines on how device representatives set default settings as they install equipment and help establish treatment protocols with hospital physicians and physicists.

“It turns out [that] you get prettier pictures if you turn the dose up higher,” she explained. “And those default settings are crucial in terms of what [dose levels] most patients receive. … And if those default settings are set in such a way that you get the most beautiful pictures, then it turns out the patients are getting higher radiation doses than they need to [in order] to support those pictures.”

Manufacturers have many ways they can help lower patient dose, Dr. Smith-Bindman said, noting that doses for the most typical scans that patients undergo could be reduced by 50% without reducing image quality.

CT scan vendors have recently developed software algorithms that work with existing equipment to help lower dose dramatically, Dr. Smith-Bindman added.

On Feb. 25, a day ahead of the hearing, the Medical Imaging & Technology Alliance announced a pledge by several CT makers to incorporate radiation dose alerts in software updates for existing CT scanners (see sidebar).

The Feb. 26 hearing was called largely in response to a Jan. 24 New York Times article that described the adverse effects of too much medical radiation, including a fatal overexposure from image-modulated radiation therapy received by a patient named Scott Parks.

At the hearing, the patient's father, James Parks, described how an error in equipment setup went unnoticed for 3 days of his son's treatment, in part because the supervising physicist was off site. He asked manufacturers of such “deadly machines” to develop “fail-safe, interactive, expert systems that can interact with human technicians to reduce or eliminate human errors.”

“It is further recommended that such dangerous equipment never be operated by anyone not fully trained and qualified,” Mr. Parks stated. “Oncologists and supervising physicists must learn to micromanage every aspect of the radiology department. It is outrageous that any untrained and unskilled personnel can get anywhere near such dangerous equipment.”

Michael Herman, Ph.D., representing the American Association of Physicists in Medicine, called for rigorous minimum standards for accrediting clinical practices, specifically including the oversight of dose and quality assurance for medical-imaging and radiation therapy technology. He asked that reimbursement from the Centers for Medicare and Medicaid Services be directly tied to such accreditation.

The CMS could also help foster radiation safety by funding residencies for physicists in the field, as it does for physicians, said Dr. Klein. He noted that starting in 2014, the American Board of Radiology will allow only physicists who have completed a residency program to sit for board certification.

John Donahue, vice chairman of the radiology benefits management company Medicalis Inc., suggested that the CMS specify radiation safety among the appropriateness criteria it will test in its pilot program on advanced imaging. MIPPA (Medicare Improvement for Patients and Providers Act of 2008) calls for a 2-year demonstration project to test appropriateness criteria for CT scans and other advanced imaging technology.

The American College of Radiology wants accreditation requirements for advanced imaging centers to be extended to hospitals and all clinical settings that perform advanced imaging and radiation therapy procedures, according to Dr. E. Stephen Amis Jr., former ACR chair.

Monica Hogan is with “The Gray Sheet.” This publication and “The Gray Sheet” are published by Elsevier.

CT Makers Unveil Safety Features

Manufacturers of computed tomography machines have agreed to standardized features to ensure that patients receive appropriate radiation doses.

In a conference call with reporters, Dave Fisher, executive director of the Medical Imaging & Technology Alliance (MITA), said the industry had been working for years to make CT machines safer and that the timing of the announcement (Feb. 25) was not related to the Food and Drug Administration's recent heightened interest in radiation or the impending House Energy & Commerce Health Subcommittee hearing.

The FDA planned to hold an advisory committee meeting on radiation safety March 30-31.

The five CT manufacturers—General Electric, Siemens, Philips, Toshiba, and Hitachi—agreed to participate in the MITA “dose check” initiative, said Mr. Fisher.

First, machine operators will receive an on-screen alert—possibly a pop-up window—when they exceed recommended dose levels. The alert is akin to a yellow caution flag, said Mr. Fisher. The recommended (reference) dose will be determined by clinicians at hospitals and imaging centers, not manufacturers, he said.

The second safeguard will be a warning if the dose reaches hazardous levels that could result in burns, hair loss, or other injuries. This “red flag” can be configured to prevent the scan, Mr. Fisher said.

Finally, manufacturers will standardized the storage of images so they can be incorporated into a registry proposed by the Obama administration.

The new features should be available by early 2011 as software upgrades to older machines or add-ons to new scanners. The process may be delayed for possible regulatory clearance by the FDA, said Mr. Fisher.

—Alicia Ault

WASHINGTON — One congressional hearing on medical radiation safety may not be enough for the Health Subcommittee of the House Energy and Commerce Committee. “We probably will need an additional hearing because I just have so many questions that came out of this today,” chairman Frank Pallone Jr. (D-N.J.) observed during the Feb. 26 hearing.

Several witnesses called for the immediate passage of the CARE Act (Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act of 2009), which was introduced in the Energy and Commerce committee last September by Rep. John Barrow (D-Ga). The CARE Act would mandate minimum education and training requirements, as well as state licensure, for personnel who plan or perform radiation oncology treatments or medical-imaging scans.

Subcommittee members and witnesses suggested that additional oversight may be needed as well, in the form of new regulatory agencies, quality standards, specialty practice guidelines, facility accreditation programs, and increased manufacturer participation in the process.

Manufacturers could move patient safety forward by immediately adopting agreed-upon standards for reporting radiation dose information from CT scans, said Dr. Rebecca Smith-Bindman, a radiology professor at the University of California, San Francisco.

Industry has said that it supports an FDA plan to collect and track data on patient dose from CT scans. “If these standards were adopted by the manufacturers, we could quickly know what's going on and then determine how closely different facilities abide by those guidelines that we have put out,” Dr. Smith-Bindman said.

Manufacturers can also help ensure that patients receive the lowest possible dose from CT scans, she added, urging industry to draft and adopt guidelines on how device representatives set default settings as they install equipment and help establish treatment protocols with hospital physicians and physicists.

“It turns out [that] you get prettier pictures if you turn the dose up higher,” she explained. “And those default settings are crucial in terms of what [dose levels] most patients receive. … And if those default settings are set in such a way that you get the most beautiful pictures, then it turns out the patients are getting higher radiation doses than they need to [in order] to support those pictures.”

Manufacturers have many ways they can help lower patient dose, Dr. Smith-Bindman said, noting that doses for the most typical scans that patients undergo could be reduced by 50% without reducing image quality.

CT scan vendors have recently developed software algorithms that work with existing equipment to help lower dose dramatically, Dr. Smith-Bindman added.

On Feb. 25, a day ahead of the hearing, the Medical Imaging & Technology Alliance announced a pledge by several CT makers to incorporate radiation dose alerts in software updates for existing CT scanners (see sidebar).

The Feb. 26 hearing was called largely in response to a Jan. 24 New York Times article that described the adverse effects of too much medical radiation, including a fatal overexposure from image-modulated radiation therapy received by a patient named Scott Parks.

At the hearing, the patient's father, James Parks, described how an error in equipment setup went unnoticed for 3 days of his son's treatment, in part because the supervising physicist was off site. He asked manufacturers of such “deadly machines” to develop “fail-safe, interactive, expert systems that can interact with human technicians to reduce or eliminate human errors.”

“It is further recommended that such dangerous equipment never be operated by anyone not fully trained and qualified,” Mr. Parks stated. “Oncologists and supervising physicists must learn to micromanage every aspect of the radiology department. It is outrageous that any untrained and unskilled personnel can get anywhere near such dangerous equipment.”

Michael Herman, Ph.D., representing the American Association of Physicists in Medicine, called for rigorous minimum standards for accrediting clinical practices, specifically including the oversight of dose and quality assurance for medical-imaging and radiation therapy technology. He asked that reimbursement from the Centers for Medicare and Medicaid Services be directly tied to such accreditation.

The CMS could also help foster radiation safety by funding residencies for physicists in the field, as it does for physicians, said Dr. Klein. He noted that starting in 2014, the American Board of Radiology will allow only physicists who have completed a residency program to sit for board certification.

John Donahue, vice chairman of the radiology benefits management company Medicalis Inc., suggested that the CMS specify radiation safety among the appropriateness criteria it will test in its pilot program on advanced imaging. MIPPA (Medicare Improvement for Patients and Providers Act of 2008) calls for a 2-year demonstration project to test appropriateness criteria for CT scans and other advanced imaging technology.

The American College of Radiology wants accreditation requirements for advanced imaging centers to be extended to hospitals and all clinical settings that perform advanced imaging and radiation therapy procedures, according to Dr. E. Stephen Amis Jr., former ACR chair.

Monica Hogan is with “The Gray Sheet.” This publication and “The Gray Sheet” are published by Elsevier.

CT Makers Unveil Safety Features

Manufacturers of computed tomography machines have agreed to standardized features to ensure that patients receive appropriate radiation doses.

In a conference call with reporters, Dave Fisher, executive director of the Medical Imaging & Technology Alliance (MITA), said the industry had been working for years to make CT machines safer and that the timing of the announcement (Feb. 25) was not related to the Food and Drug Administration's recent heightened interest in radiation or the impending House Energy & Commerce Health Subcommittee hearing.

The FDA planned to hold an advisory committee meeting on radiation safety March 30-31.

The five CT manufacturers—General Electric, Siemens, Philips, Toshiba, and Hitachi—agreed to participate in the MITA “dose check” initiative, said Mr. Fisher.

First, machine operators will receive an on-screen alert—possibly a pop-up window—when they exceed recommended dose levels. The alert is akin to a yellow caution flag, said Mr. Fisher. The recommended (reference) dose will be determined by clinicians at hospitals and imaging centers, not manufacturers, he said.

The second safeguard will be a warning if the dose reaches hazardous levels that could result in burns, hair loss, or other injuries. This “red flag” can be configured to prevent the scan, Mr. Fisher said.

Finally, manufacturers will standardized the storage of images so they can be incorporated into a registry proposed by the Obama administration.

The new features should be available by early 2011 as software upgrades to older machines or add-ons to new scanners. The process may be delayed for possible regulatory clearance by the FDA, said Mr. Fisher.

—Alicia Ault