US doctors push for unapproved medical devices
- added July 24, 2008
- 0 responses
-
-
-
- DeliaTheArtist
- added this
-
-
- related topics
-
- News and Politics (39507)
- Earth and Science (12544)
- Science (4141)
- Health (4111)
- US (3286)
- Children (1212)
- Research (603)
- Medical (394)
"Every year, Chicago-based cardiologist Ziyad Hijazi accompanies two or three children and their families to his native Jordan for heart operations using medical devices that are not approved in the United States.
In one such case, Hijazi implanted a device to close a hole between the lower chambers of the heart in a child from Massachusetts.
The device, called an amplatzer muscular VSD, manufactured by Minneapolis-based AGA Medical, was available for 9 years in Jordan before it was approved in the United States in 2007.
According to Hijazi, who is chief of paediatric cardiology at Rush University Medical Centre, and other doctors, children are getting worse treatment in the United States, and have even died, because paediatric medical devices are not approved.
Hijazi said that more than 90 percent of the medical devices he uses on children are "off-label," meaning that they are approved by the US Food and Drug Administration for other uses, for example for use in adults.
"We take responsibility as physicians for using unapproved devices on kids," he said.
"Development (of paediatric devices) is time-consuming, there are regulatory hurdles and how do you recoup your investment? The math generally does not work," he said.
Bram Zuckerman, Director of the Division of Cardiovascular Devices at the U.S. Food and Drug Administration, which regulates and approves medical devices, said part of the challenge is to get physicians to communicate better with both industry and regulators.
"The agency is very sensitive right now to the need to foster and develop paediatric devices and we're looking to develop many different pathways," Zuckerman said.
He said FDA will be more flexible in the way it evaluates data on devices."
So, is there no money in saving children, or is it just too risky to use adult devices on children?
In one such case, Hijazi implanted a device to close a hole between the lower chambers of the heart in a child from Massachusetts.
The device, called an amplatzer muscular VSD, manufactured by Minneapolis-based AGA Medical, was available for 9 years in Jordan before it was approved in the United States in 2007.
According to Hijazi, who is chief of paediatric cardiology at Rush University Medical Centre, and other doctors, children are getting worse treatment in the United States, and have even died, because paediatric medical devices are not approved.
Hijazi said that more than 90 percent of the medical devices he uses on children are "off-label," meaning that they are approved by the US Food and Drug Administration for other uses, for example for use in adults.
"We take responsibility as physicians for using unapproved devices on kids," he said.
"Development (of paediatric devices) is time-consuming, there are regulatory hurdles and how do you recoup your investment? The math generally does not work," he said.
Bram Zuckerman, Director of the Division of Cardiovascular Devices at the U.S. Food and Drug Administration, which regulates and approves medical devices, said part of the challenge is to get physicians to communicate better with both industry and regulators.
"The agency is very sensitive right now to the need to foster and develop paediatric devices and we're looking to develop many different pathways," Zuckerman said.
He said FDA will be more flexible in the way it evaluates data on devices."
So, is there no money in saving children, or is it just too risky to use adult devices on children?
-
-
-
-
- DeliaTheArtist
- 2 months ago
Login/Registration is required to add a response.
